NATIONAL TB CONTROL STRATEGIC PLAN

“VISION 2020” January 2014

National TB Control Program Pakistan Ministry of National Health Services, Regulations & Coordination

Islamabad

Foreword

It is a matter of great pleasure and satisfaction that National TB Control Program has taken

initiative towards development of 7 years National Strategic Plan for NTP Pakistan (2014-2020)

titled as “Vision 2020”.

Tuberculosis (TB) is a leading cause of death and a major public health problem not only globally but also in Pakistan as currently the country ranks 5thamongst the 22 HBCs and 4th among 27 MDR high burden countries in the world, constituting 65% of TB burden in EMRO.

Since the revival of NTP Pakistan, subsequent to declaration of TB as national emergency in 2001, the government of Pakistan has committed itself to control of tuberculosis in the country through DOTS strategy. National TB Control Program, working under the Ministry of National Health Services, Regulation & Coordination, integrated with Primary Health Care (PHC) system implemented by the district health authorities with the support of Provincial TB Control Programs (PTPs), is fighting against Tuberculosis in the country to reduce mortality, morbidity and spread of TB infection. NTP entails free of cost diagnosis and treatment of every TB patients through uninterrupted provision of quality assured anti TB drugs. 100% DOTS coverage in public sector was achieved in 2005 and MDG targets of 70% case detection and 85% treatment success rate were achieved by NTP in 2015.

This strategic plan has been developed in response to recent global and national innovative

interventions and approaches towards TB care and control with a vision to ensure universal

access of TB care and achieving Zero TB Death in the country.

Global innovations include “Systematic screening for active TB cases” to effectively address

missed and delayed TB cases, “WHO-approved rapid diagnostics (WRD)” such as Xpert MTB/RIF,

WHO recommended “Revised case definitions & reporting framework 2013” and most

importantly “Global Strategy beyond 2015”involving multi-sectoral strategic approaches and

new international targets for the post-2015to accelerate the global expansion of tuberculosis

care and control.

Of the most significant national developments to revise national strategic plan were,results of

“National TB prevalence survey (2011-12) and “National drug resistance survey” (2012-13)

defining revised targets for incidence and prevalence for both susceptible and drug resistant TB,

health sector devolution, limited public sector financing for TB control, stagnant TB case

notification, high number of undetected/undiagnosed TB cases in the community, Increasing

drug-resistant TB, managerial and governance issues and effects of social determinants

increasing poverty & social inequalities complicating the TB scenario in Pakistan.

National TB Strategic Plan “Vision 2020” entails developing innovative strategies that will:

1. Improve the performance and impact of TB control with maximizing public sector

investment and accountability in TB control activities.

2. Address sensitive and drug resistance TB by: (a) reducing diagnostic delay, (b) reducing

the duration and improving the efficacy of treatment, (c) preventing disease, and (d)

increasing access to DOTS and DR-TB treatment, etc.

3. Invest in new diagnostic and TB management tools and approaches that are less labor

intensive, more cost-effective, and can be delivered close to patients to minimize the

health workforce burden and help improve patient access, thereby increasing case

detection and enhance treatment success rates.

4. Prioritize research that has the potential to change policy and practice in TB care in the

country.

On behalf of Ministry of National Health Services, Regulations & Coordination, we appreciate

the joint efforts made by NTP / PTP / RTP teams and all national / international partners in the

development of this document. We are sure that National Strategic Plan “Vision 2020”will

enable NTP Pakistan to accelerate its pace towards achievement of its vision and targets for TB

care and control in Pakistan.

____________________ Mrs. Saira Afzal Tarar

State Minister, Ministry of National Health Services, Regulations & Coordination

Government of Pakistan Islamabad

________________ Dr. Ejaz Qadeer National Manager

National TB Control Program Pakistan Islamabad

March, 2014

2

NATIONAL STRATEGIC PLAN

“VISION 2020” January 2014

National TB Control Program Pakistan

Ministry of National Health Services, Regulations & Coordination,

Islamabad

3

Contents

1 INTRODUCTION ................................................................................................................... 14 1.1 POLITICAL AND ECONOMIC SITUATION ...................................................................... 14 1.2 SOCIO-DEMOGRAPHY OF PAKISTAN ........................................................................... 15 1.3 HEALTH SITUATION: ..................................................................................................... 15

1.3.1 Health infrastructure: Public sector 15

1.3.2 Health infrastructure: Other Public sector outlets (Other public sector) 17

1.3.3 Health infrastructure: Private sector 17

2 TUBERCULOSIS CONTROL: BURDEN AND EPIDEMIOLOGY ................................................. 21

3 STRATEGIC PLAN “VISION 2020” ......................................................................................... 22 3.1 NATIONAL TB STRATEGIC PLAN: 2012-16 .................................................................... 22 3.2 PROGRESS TOWARDS MDGs ....................................................................................... 23 3.3 IMPLEMENTATION OF STRATEGIC PLANS AND IMPACT ............................................. 23 3.4 INTERNATIONAL TB REVIEW MISSION: NOVEMBER, 2013 ......................................... 26 3.5 DEVELOPMENT PROCESS OF NATIONAL STRATEGIC PLAN “VISION 2020”................. 27

4 NATIONAL TB CONTROL PROGRAM PAKISTAN ................................................................... 35 4.1 EVOLUTIONARY PERSPECTIVE ..................................................................................... 35 4.2 STRUCTURE & FUNCTION ............................................................................................ 35

4.2.1 NTP arrangements for coordination of TB control activities in the country 36

4.3 LEVELS & RESPONSIBILITY............................................................................................ 37 4.4 TB CONTROL IN POST DEVOLUTION CONTEXT ............................................................ 39

5 SITUATION ANALYSIS ........................................................................................................... 42 5.1 POLITICAL COMMITMENT ........................................................................................... 42 5.2 TB CASE NOTIFICATION ............................................................................................... 44

5.2.1 TB burden analysis 44

5.2.2 Re-treatment cases 47

5.2.3 TB care facilities in Pakistan 48

5.2.4 TB Control service delivery in districts 52

5.2.5 Diagnostic algorithms 54

5.3 TB TREATMENT AND CASE HOLDING .......................................................................... 55 5.4 HOSPITAL DOTS LINKAGES ........................................................................................... 57 5.5 EXTRA-PULMONARY TB DIAGNOSIS ............................................................................ 59 5.6 CHILDHOOD TUBERCULOSIS ........................................................................................ 60 5.7 TB/HIV .......................................................................................................................... 61

4

5.8 TB IN ELDERLY .............................................................................................................. 63 5.9 TB, OTHER CHRONIC AILMENTS AND TOBACCO USE .................................................. 63 5.10 TB and diabetes ........................................................................................................... 64 5.11 MANAGEMENT OF CONTACTS .................................................................................... 64 5.12 QUALITY ASSURED BACTERIOLOGY ............................................................................. 65 5.13 DRUG-RESISTANT (DR) TB ............................................................................................ 79 5.14 PUBLIC-PRIVATE MIX ................................................................................................... 95 5.15 DRUG MANAGMENT .................................................................................................. 106 5.16 ACSM .......................................................................................................................... 111 5.17 MONITORING, EVALUATION, RESEARCH AND LEARNING (MERL) ............................ 113 5.18 OPERATIONAL RESEARCH .......................................................................................... 114 5.19 HUMAN RESOURCE DEVELOPMENT .......................................................................... 118

6 SWOT ANALYSIS ................................................................................................................ 120 6.1 POLITICAL COMMITMENT ......................................................................................... 120 6.2 TB CASE NOTIFICATION ............................................................................................. 120 6.3 CONTACT INVESTIGATION ......................................................................................... 121 6.4 CHILDHOOD TB .......................................................................................................... 121 6.5 HOSPITAL DOTS LINKAGE (HDL) i.e. TEACHING HOSPITAL ........................................ 122 6.6 ACSM .......................................................................................................................... 122 6.7 DRUG MANAGEMENT ................................................................................................ 122 6.8 TRAINING ................................................................................................................... 123 6.9 TB CARE IN ELDERLY AND HIGH RISK GROUPS .......................................................... 124 6.10 TB-HIV CO-INFECTION ................................................................................................ 124 6.11 TB AND CHRONIC AILMENTS AND TOBACCO SMOKING ........................................... 124 6.12 LABORATORY NETWORK ........................................................................................... 124 6.13 DRUG RESISTANT-TB .................................................................................................. 129 6.14 PUBLIC PRIVATE MIX (PPM) ....................................................................................... 131 6.15 MONITORING AND SUPERVISION .............................................................................. 133 6.16 OPERATIONAL RESEARCH .......................................................................................... 134 6.17 STOP TB PARTNERSHIP .............................................................................................. 135 6.18 TRANS-BORDER TB ..................................................................................................... 135 6.19 TB AND POVERTY ....................................................................................................... 135

7 GAP ANALYSIS .................................................................................................................... 137 7.1 FUNDING MAINLY DEPENDS ON EXTERNAL SUPPORT .............................................. 137 7.2 LOW TB CASE NOTIFICATION ..................................................................................... 137 7.3 LOW PROPORTION OF TB CONTACT ARE INVESTIGATED FOR TB ............................. 138 7.4 CHILDHOOD TB CASES NOT FULLY REPORTED TO NTP ............................................. 138 7.5 HOSPITAL DOTS LINKAGE (HDL) NOT FULLY OPERATIONAL ...................................... 138 7.6 ACSM STRATEGY NOT ABLE TO CREATE AN IMPACT ON INCREASING CASE FINDING138 7.7 SIGNIFICANT ISSUES IN DRUG MANAGEMENT.......................................................... 139 7.8 SIGNIFICANT ISSUES IN TRAINING IN TB CONTROL ................................................... 139 7.9 NO SPECIFIC ACTIONS HAVE BEEN ESTABLISHED TO TARGET ELDERLY .................... 139 7.10 LIMITED IMPLEMENTATION OF TB/HIV COLLABORATIVE ACTIVITIES ...................... 140

5

7.11 NOSPECIFIC INTERVENTION HAS BEEN ESTABLISHED TO ADDRESS TB & CHRONIC AILMENTS AND TB &TOBACCO USE .......................................................................... 140

7.12 TB LABORATORY NETWORK NOT FULLY OPTIMIZED ................................................ 140 7.13 MANY CARE PROVIDERS OUTSIDE THE NTP NETWORK ARE NOT INVOLVED IN TB

CARE AND CONTROL EFFORTS ................................................................................... 143 7.14 A HIGH PROPORTION OFDR-TB PATIENTS ARE NOT DETECTED ................................ 145 7.15 ISSUES IN OPERATIONALIZING MONITORING, SUPERVISION AND EVALUATION AT

PROVINCIAL AND DISTRICT LEVELS ............................................................................ 146 7.16 TB CONTROL PROBLEMS NOT ADDRESSED THROUGH OPERATIONAL RESEARCH .... 147 7.17 NON FUNCTIONING NATIONAL STOP TB PARTNERSHIP ........................................... 147 7.18 TB IN TRANS-BORDER POPULATIONS NOT OPERATIONAL........................................ 147 7.19 NOSPECIFIC INTERVENTION HAS BEEN ESTABLISHED TO ADDRESS TB &POVERTY,

Legislation on drug sale, declaring TB as notifiable disease ...................................... 147

8 STRATEGIES AND ACTIVITIES: TB CONTROL “VISION 2020” ............................................. 150 8.1 OVERVIEW: NATIONAL TB STRATEGIC PLAN “VISION 2020” .................................... 150 8.2 GOAL AND OBJECTIVES: ............................................................................................. 151 8.3 PRIORITY PROGRAM AREAS:...................................................................................... 151

9 LIST OF LITERATURE REVIEWED (REFERENCES AND ANNEXURES) ................................... 174

List of Tables

Table 1: Status of health facilities, GoP: 2009 .............................................................................. 16

Table 2: Private health care providers by country/province4 2009-10 ........................................ 18

Table 3: Private health care providers 2009-10 by type, size and province4 ............................... 19

Table 4: Out-patient service providers 2009-10 by type and province3 ...................................... 20

Table 5: Process of Strategic Plan Development .......................................................................... 28

Table 6: NTP Human Resource and funding support .................................................................... 36

Table 7: PSDP allocation- Post devolution (2011-2014) ............................................................... 43

Table 8: PC-1 status in TB Control Pakistan .................................................................................. 43

Table 9:Year-wise notified TB cases and NSS+ Pakistan ............................................................... 45

Table 10: Estimates of TB burden 2012 ........................................................................................ 46

Table 11: Proportion of re-treatment cases reported .................................................................. 48

Table 12: BMUs 2013 (Public i.e. Health Sector) and (Other Government Run Facilities i.e. Other

public sector) ................................................................................................................................ 49

Table 13: BMUs 2013 by source of funding (Private) and (GP clinics) ......................................... 50

Table 14: Districts with urban/sub-urban population ≥ one million ............................................ 51

Table 15: Characteristics of essential Anti-TB drugs..................................................................... 55

Table 16: Type of FDCs recommended by NTP ............................................................................. 56

Table 17: FLDs prescription schedule ........................................................................................... 56

Table 18: Contribution of HDL in core TB DOTS, 2012 ................................................................. 59

6

Table 19: TB/HIV Intervention Sites .............................................................................................. 63

Table 20: Milestones achieved by the laboratory network .......................................................... 66

Table 21: Functional level /location and current defined responsibilities are as follows ............ 66

Table 22: LED numbers by donor support and location ............................................................... 68

Table 23: Microscopy services coverage by population ............................................................... 68

Table 24: Gene-Xpert Expansion Plan ........................................................................................... 70

Table 25: TB Culture expansion plan ............................................................................................ 71

Table 26: Drug resistance pattern at NRL 2012 ............................................................................ 72

Table 27: Training categories for Microscopy network staff ........................................................ 73

Table 28: Laboratory training support in 2012 ............................................................................. 74

Table 29: Diagnostic network in Pakistan ..................................................................................... 75

Table 30: Trend of key laboratory indictors 2006 to 2012 ........................................................... 77

Table 31: Participating Laboratories in National EQA Scheme for DST 2012 ............................... 78

Table 32: Estimates of DR-TB in Pakistan 2012 based on WHO estimates .................................. 80

Table 33: SLDs for DR-TB patients recommended by NTP ........................................................... 85

Table 34: SLDs need assessment .................................................................................................. 86

Table 35: Province wise PMDT sites and cases (2012) ................................................................. 89

Table 36: Province wise TB culture sites and diagnosis and follow-up performance .................. 90

Table 37: TB DST expansion plan 2013 ......................................................................................... 91

Table 38: Status Gene Xpert tests (2012) and expansion plan (2013) ......................................... 92

Table 39:Category and training days for DR-TB ............................................................................ 95

Table 40: GPs involved in TB care by province, 2013 ................................................................. 101

Table 41:Type and number of PHC facilities being management by PPHI/PRSP in Pakistan ..... 103

Table 42: Type and number of facilities: Armed Forces ............................................................. 104

Table 43: Type and number of facilities: Fauji Foundation ........................................................ 105

Table 44: Type and number of facilities: Social Security ............................................................ 106

Table 45: Anti-TB drugs situation................................................................................................ 110

Table 46: ACSM activities status ................................................................................................. 112

Table 47: Recommended staff training in NTP/PTPs .................................................................. 118

Table 48: TB suspects to be identified 2014-2020 ...................................................................... 154

Table 49: TB cases projection 2014-2020 ................................................................................... 155

Table 50: TB treatment success projection 2014-2020 .............................................................. 156

Table 51: Contact management projection 2014-2020 .............................................................. 156

Table 52: Childhood TB case projection 2014-2020 ................................................................... 157

Table 53: Projected TB cases to be screened for HIV at sentinel sites 2014-2020 .................... 160

Table 54: Number of suspects to be identified 2014-2020 ........................................................ 161

Table 55: Number of GeneXpert machines required 2014-2020 ............................................... 162

Table 56: Number of culture laboratories required 2014-2020 ................................................. 163

7

Table 57: Number of DST laboratories required 2014-2020 ...................................................... 163

Table 58: Contribution projected for PPM in country 2014-2020 .............................................. 164

Table 59: DR-TB cases to be enrolled 2014-2020 ....................................................................... 167

List of Figures

Figure 1: Impact of interventions on decrease TB incidence over years ...................................... 24

Figure 2 Impact of interventions on decrease TB prevalence over years .................................... 24

Figure 3 Impact of interventions on decrease TB mortality over years ....................................... 24

Figure 4: Organization of TB control program Pakistan ............................................................... 36

Figure 5: Financial Allocation for National TB Control Program 2004 – 2012 (Million PKR) ........ 42

Figure 6: Contribution to TB control activities by funding source5: 2012-13 ............................... 44

Figure 7: Provincial TB Case notification and population proportion .......................................... 46

Figure 8: Case notification by age (%) – National – 2012 ............................................................. 47

Figure 9: Diagnostic procedure for suspected pulmonary TB ...................................................... 54

Figure 10: Microscopy EQA coverage and performance .............................................................. 75

Figure 11: PPM contribution in total case notification NSS+ (2001-2012) ................................... 98

Figure 12: Case notification: Public - Private 2012 ....................................................................... 99

Figure 13:PPM CONTRIBUTION NSS+ –ALL PROVINCES (Q1 2013) .............................................. 99

Figure 14: Province wise PPM contribution: TB new sputum smear positive cases/ all types .. 100

Figure 15: System of M&E operations in the country ................................................................ 114

Figure 16: Percentage of anti-TB drugs sold in private market .................................................. 117

8

Foreword

•

It is a matter of great pleasure and satisfaction that National TB Control Program has taken

initiative towards development of 7 years National Strategic Plan for NTP Pakistan (2014-

2020)titled as “Vision 2020”.

Tuberculosis (TB) is a leading cause of death and a major public health problem not only

globally but also in Pakistan as currently the country ranks 5thamongst the 22 HBCs and 4th

among 27 MDR high burden countries in the world, constituting 65% of TB burden in EMRO.

Since the revival of NTP Pakistan, subsequent to declaration of TB as national emergency in

2001, the government of Pakistan has committed itself to control of tuberculosis in the country

through DOTS strategy. National TB Control Program, working under the Ministry of National

Health Services, Regulation & Coordination, integrated with Primary Health Care (PHC) system

implemented by the district health authorities with the support of Provincial TB Control

Programs (PTPs), is fighting against Tuberculosis in the country to reduce mortality, morbidity

and spread of TB infection. NTP entails free of cost diagnosis and treatment of every TB

patients through uninterrupted provision of quality assured anti TB drugs.100% DOTS coverage

in public sector was achieved in 2005 and MDG targets of 70% case detection and 85%

treatment success rate were achieved by NTP in 2015.

This strategic plan has been developed in response to recent global and national innovative

interventions and approaches towards TB care and control with a vision to ensure universal

access of TB care and achieving Zero TB Death in the country.

Global innovations include “Systematic screening for active TB cases” to effectively address

missed and delayed TB cases, “WHO-approved rapid diagnostics (WRD)” such as Xpert

MTB/RIF,WHO recommended “Revised case definitions & reporting framework 2013” and most

importantly “Global Strategy beyond 2015”involving multi-sectoral strategic approaches and

new international targets for the post-2015to accelerate the global expansion of tuberculosis

care and control.

Of the most significant national developments to revise national strategic plan were, results of

“National TB prevalence survey (2011-12) and “National drug resistance survey” (2012-13)

defining revised targets for incidence and prevalence for both susceptible and drug resistant TB,

health sector devolution, limited public sector financing for TB control, stagnant TB case

notification, high number of undetected/undiagnosed TB cases in the community, Increasing

9

drug-resistant TB, managerial and governance issues and effects of social determinants

increasing poverty & social inequalities complicating the TB scenario in Pakistan.

National TB Strategic Plan “Vision 2020” entails developing innovative strategies that will:

1. Improve the performance and impact of TB control with maximizing public sector

investment and accountability in TB control activities.

2. Address sensitive and drug resistance TB by: (a) reducing diagnostic delay, (b) reducing

the duration and improving the efficacy of treatment, (c) preventing disease, and (d)

increasing access to DOTS and DR-TB treatment, etc.

3. Invest in new diagnostic and TB management tools and approaches that are less labor

intensive, more cost-effective, and can be delivered close to patients to minimize the

health workforce burden and help improve patient access, thereby increasing case

detection and enhance treatment success rates.

4. Prioritize research that has the potential to change policy and practice in TB care in the

country.

On behalf of Ministry of National Health Services, Regulations & Coordination, we appreciate

the joint efforts made by NTP / PTP / RTP teams and all national / international partners in the

development of this document. We are sure that National Strategic Plan “Vision 2020”will

enable NTP Pakistan to accelerate its pace towards achievement of its vision and targets for TB

care and control in Pakistan.

____________________

Mrs. SairaAfzalTarar

State Minister,

Ministry of National Health Services, Regulations &

Coordination

Government of Pakistan

Islamabad

________________

Dr. Ejaz Qadeer

National Manager

National TB Control Program

Pakistan

Islamabad

March, 2014

10

LIST OF ABBREVIATION ADR Adverse Drug Reaction AFB Acid Fast Bacilli AJK Azad Jammu Kashmir AKHSP Aga Khan Health Services

Pakistan AKU Aga Khan University BHU Basic Health Unit BMU Basic Management Unit CCM Country Coordinating

Mechanism CDC Communicable Disease Control CHW Community Health Worker CPT Co-trimoxazole Preventive

Therapy DDHO Deputy District Health Officer DGHS Director General Health

Services DHO District Health Officer DHQ District Headquarter Hospital DLS District Laboratory Supervisor DMU Drug Management Unit DTC District TB Coordinator DO Direct Observation DOTS Directly Observed Treatment

(short course) DR TB Drug Resistant TB DRS Drug Resistance Survey DST Drug Sensitivity Testing EDO Executive District Officer EQA External Quality Assurance EPTB Extra Pulmonary TB FATA Federally Administered Tribal

Area FLD First Line Drug GB GilgitBaltistan GDF Global Drug Facility GF Global Fund GFATM Global Fund to Fight Against

AIDS, Tuberculosis and Malaria GP General Practitioner GNP Gross National Product HCP Health Care Practitioner HMIS Health Management

Information System

HIV Human Immunodeficiency Syndrome

HPF High-Power Field IEC Information, Education and

Communication ICT Islamabad Capital Territory INH Isoniazid IPC Interpersonal Communication KP KhyberPakhtunkhwa LED Light Emitting Diode LHW Lady Health Worker LPA Line Probe Assay MALC Marie-Adelaide Leprosy Center MDR-TB Multi-drug Resistant

Tuberculosis MDG Millennium Development Goals M&E Monitoring and Evaluation MO Medical Officer MS Medical Superintendent NGOs Non-government Organizations NSP National Strategic Plan NTP National Tuberculosis Control

Program PATA Pakistan Anti-TB Association PCS Pakistan Chest Society PC-1 Planning Commission Proforma-

1 PSCM Procurement and Supply Chain

Management PHC Primary Health Care PTB Pulmonary TB PMA Pakistan Medical Association PMDT Programmatic Management of

Drug Resistant TB PPHI People’s Primary Health Care

Initiative PPM Public Private Mix PR Principal Recipient PRL Provincial Reference Laboratory PTP Provincial Tuberculosis Control

Program RHC Rural Health Center RR-TB Rifampicin-resistant TB SLD Second Line Drug STAG-TB Strategic and Technical

Advisory Group on TB TB Tuberculosis

11

TBC Tuberculosis Clinic THQ Tehsil Headquarter Hospital XDR-TB Extensively Drug-resistant TB WHO World Health Organization

WRD WHO-approved Rapid Diagnostics

12

LIST OF CONTRIBUTERS

National TB Control Program, Pakistan

Provincial / Regional TB Control Programs

Global/National Experts/Partners

Consultants

Dr. EjazQadeer, National Manager

AJ&K Dr. Shabbir Ahmed Dar - Manager Dr. SaeedAwan, Dr. NajeebAhsan BALOCHISTAN Dr. GhulamMurtaza Shah - Manager Dr. LubnaSiddiqui Dr. Ahmad Wali Dr. Muhammad Ashraf Dr. IrfanRaisani FATA Dr. SartajYousafzai - Manager Dr. Qasim Dr. Nekdad GILGIT BALTISTAN Dr. Mubeen Ahmed - Manager Dr. Ghulam Mustafa KHYBER PAKHTUNKHWA Dr. UbaidHussain – Project Director Dr. Maqsood Ali Khan Dr. Amir Rafiq Dr. Dost Muhammad Dr. SaeedAbid ICT Dr. Azhar DHO ICT Dr. NajeebDurrani Dr. Imtiaz Ali Memon PUNJAB Dr. Muhammad Naeem – Manager Dr. ZarfishanTahir Dr. Ahmed Nadeem Dr. ZakiaParveen Dr. Muhammad Zubair SINDH Dr. Ismat Ara, Director Dr. Amanullah Ansari Dr. Syed Saleem Hassan Dr. Muzaffar Ali Khoharo Dr. MansoorButtoo

Global TB Program WHO-Geneva - Dr. Christpher Gilpin, Scientist/Lab, Diagnostics -Dr.Douglas Fraser Wares,Lab, Diagnostics & Drug Resistance Ines Garcia Baena, Economist - Ms. Soleil Global Fund Werner Buehler Indus Hospital Karachi Dr. Amir Khan W.H.O Dr. GhulamNabiKazi, Stop TB Partnership Dr. Iqtidar Ahmad, ASD Dr. Amir Khan, Mercy Corps Dr. Farah Naureen Dr. Arif Noor Ms. Jennifer Norman ACD Dr. AkmalNaveed Dr. Abdul Latif Ojha Institute Dr. ShahinaQayyum BRIDGE Foundation Dr. Sharaf Ali Shah Greenstar Dr. Khalid Farough Dr. Haroon Ibrahim MSH Edmund Rutta Ms. Maheen Malik Shifa International Prof. Dr. Ejaz Khan MALC Mr. Muhammad Shabbir Pakistan Chest Society Dr. Wajid Ali PIMS Dr. Maqbool Ahmed GIZ Ms. Kathy Fiekert Ms. DarinkaPerisic KFW-Epos Dr. MazharHussain USAID Dr. Muhammad Isa

Dr. Salah Ottmani (International) Dr. Nauman Safdar (National)

Dr. Basharat Javed-NTO, Focal Person for National/Provincial Strategic Plans

PIU Dr. Raja Ayub Dr. FakhraNaheed Dr. Amir Safdar

PR Unit Dr. AbulKhaliqGhauri Dr. Furqan Ahmed

NRL Dr. SabiraTahseen Dr. Laeeq Ahmed

TB-Drug Mgt Unit Dr. Zia Dawar Dr. WaqasRabbani

M&E Unit Dr. FarooqKhattak Mr. Tanveer Ahmed Mr. Mhammad Zia Samad

DR-TB Dr. ZafarIqbalToor Dr. AsifAwan Dr. Salem Barghout

Research Unit Dr. Razia Fatima

Infection Control Col. Dr.Amjad Dr. YasirWaheed

Finance Unit Syed Mubashar Ahmed

IT Unit

Medhi Abas Hemani

PPM Unit Dr. HussainHadi

13

COREPLAN

SECTION A1- BACKGROUND

14

1 INTRODUCTION

1.1 POLITICAL AND ECONOMIC SITUATION The Islamic Republic of Pakistan has a parliamentary system of government. The President of

Pakistan is the head of state, the Prime Minister is head of government, and there is a multi-

party system. Executive power is exercised by the government and legislative power is largely

vested in the parliament. The bicameral federal legislature consists of the Senate (upper house)

and National Assembly (lower house). However, in the past few decades the country went

through several political transitions including parliamentary, presidential or semi-presidential

and marshal law. Pakistan is currently facing challenges within and across the border including

conflicts in a few districts resulting in internally displaced populations.

The Government of Pakistan vide 18th constitutional amendment devolved multiple functions,

including federal units of health programs, to the provinces with effect from 1st July 2011.

However, recognizing the importance of several health functions, including the management of

a few key public health programs, a Federal Ministry of National Health Services, Regulations &

Coordination (NHS, R&C) has been established in Islamabad; the National TB Control Program

(NTP) is being managed by this Ministry.

The country belongs to a group of low-income high TB burden countries, has primarily an

agrarian economy (66% population lives in the rural area), and has diverse cultural and

geographical patterns. Health cannot be segregated from the country’s overall economic and

social development. Pakistan’s Human Development Index (0.515) ranks low 146 out of 187

countries and its GDP per capita is estimated as 2,566 US$. Life expectancy and education are

also low; 0.487, 0.217.1. The annual per capita health expenditures for Pakistan as per National

Health Accounts (NHA) 2009-10 are (Rs.2,611) 31.2 US$2. For comparison, the respective figures

reported to WHO by India and Bangladesh are 51.0 US$ and 25.0 US$, respectively. According

to the NHA, the ratios of health expenditures over GDP (2009-10) are 3.0% while this ratio for

public and private sector health expenditures is 9.2% and 2.5% respectively. In the health

sector, Pakistan is receiving major international grants from the Global Initiative for Vaccination

and Immunization (GAVI), the Global Fund to Fight against AIDS, TB and Malaria (GFATM) and

USAID.

According to the HDI, 60.3% of Pakistan's population lives on under $2 a day and some 21% live

on under $1 a day. Wealth distribution in Pakistan is highly uneven. This situation creates a

severe impact on diseases of poor among which TB is the lead communicable disease.

1United Nations Development Program, HDI report 2013

2 National Health Accounts 2009-10, Pakistan Bureau of Statistics, Government of Pakistan

15

Globally, a huge loss in income was observed3 before and after TB diagnosis (26% and 33%

respectively).

1.2 SOCIO-DEMOGRAPHY OF PAKISTAN Pakistan belongs to the South Asian region and covers an area of about 796,096 sq. kilometers.

It is bordered by Afghanistan to the north-west and Iran to the west while the People's Republic

of China borders the country in the north and India to the east. The last population census was

done in 1998. Currently the country population4 is estimated at 182.5million with 35% urban

and 65% rural. Pakistan has five provinces; Balochistan, Gilgit-Baltistan (GB), Khyber

Pakhtunkhwa (KP), Punjab, Sindh, and three regions; Azad Jammu Kashmir (AJK), Federally

Administered Tribal Areas (FATA) and Islamabad Capital Territory (ICT). The highest population

density is in Punjab province and lowest in Balochistan province. The population5 between 0-14

is 39%, 15-64 is 57% and above 65 years is 4% whereas, and there are 1.07 male / female in the

country.

The national language of the country is Urdu whereas the official language is English. 98% of

languages spoken in Pakistan are Indo-Iranian (sub-branches: 75% Indo-Aryan and 20% pure

Iranian), a branch of Indo-European family of languages. The major ethnic groups of Pakistan in

numerical size include: Punjabis, Pashtuns, Sindhis, Saraikis, Muhajirs, Balochis, Hindkowans,

Chitralis and other smaller groups.

In past few years, Pakistan has faced several natural disasters including earthquakes and

flooding in several districts across the country and is prone to such natural disasters in future.

1.3 HEALTH SITUATION: In Pakistan the distribution of years lost by causes is mainly due to communicable diseases

(64%)6 followed by non-communicable disease (26%) and injuries (9%). The under-5 mortality

rate (per 1000 live births) is 72, whereas the maternal mortality ratio (per 100,000 live births) is

260 in 2011. Pakistan ranks as the 5th highest TB burden country in the world, 7th globally

among the highest number of people living with diabetes and 9th globally in terms of tobacco

use among men, which is continuously increasing.

1.3.1 Health infrastructure: Public sector

The health system is generally weak and services are highly unregulated. Communicable

diseases are still the leading causes of morbidity and mortality and non-communicable diseases

3Eliminating the financial hardship of TB via universal health coverage and other social protection measures: WHO,

2013. 4 National Institute of Population Studies, Government of Pakistan, 2012

5 Pakistan Demographic and Health Survey, 2012-13

6 Pakistan health profile, WHO, 2013

16

are on the rise. The public sector is the main source for the provision of preventive care and

hospital care to the urban and rural populations. In the provision of curative care for minor

ailments, the public sector caters services to around 25% of the population. Health services in

the public sector are provided by various types of general and specialized hospitals. There is

also a network of primary health care outlets including Rural Health Centers (RHCs), Basic

Health Units (BHUs), dispensaries and Maternity and Child Health (MCH) centers, which are

mainly under the control of the provincial departments of health. Other organized semi-public

sectors include health care institutions established and run by armed forces, police, railways,

fauji foundation, municipal authorities, and employees’ social security institution. Under the

constitutional devolution process in 2001, districts were the implementing units and Executive

District Officer Health was in charge of all preventive, promotional and curative health

programs and services. In each district usually there is one District Headquarter (DHQ) Hospital,

three to four Tehsil Headquarter (THQ) Hospitals, 10 to 15 Rural Health Center (RHC) and 50 to

100 Basic Health Units (BHU). RHC and BHU are first level Primary Health Care facilities and

generally deal with uncomplicated routine cases, in addition to preventive and promotional

activities. DHQ and THQ level hospitals are secondary level facilities and are involved in the

treatment of less complicated cases. There are Tertiary Level Hospitals in Provincial capitals and

in some large districts, which deal with referred and complicated cases. According to MoH data,

the status of the various health facilities are as under:

Table 1: Status of health facilities7, GoP: 2009

Year Number of Facilities Total

Hospital Dispensaries MCH

Centers

RHCs BHUs TBCs Facilities Beds

1971 495 2136 668 87 249 79 3714 34077

1980 602 3466 812 217 736 98 5931 47412

1990 756 3795 1050 459 4213 220 10493 72997

2000 876 4635 856 531 5171 274 12343 93907

2005 919 4632 907 556 5334 289 12637 101490

7Ministry of Health, Government of Pakistan, Year book 2009

17

2007 945 4725 903 560 5349 290 12772 103285

2009 968 4813 906 572 5450 293 13002 103709

The capacity of the district health authorities is generally considered suboptimal and this is one

of the main reasons for unsatisfactory progress in health care delivery and indicators. Another

issue at the district level is lack of coordination among the various stakeholders. This includes

the district health management teams, coordinators of vertical programs and NGOs. The

Government has contracted NGOs such as the Punjab Rural Support Program (PRSP) in Punjab

and People’s Primary Health Care Initiative (PPHI) in Balochistan, Sindh, KP and AJK and the

financial and administrative control of BHUs have been handed over to them. Although the

utilization of health services and availability of drugs improved after this initiative, the focus has

been diverted towards curative services. Preventive programs and routine promotional

activities are not being performed as well as they previously were in these centers8.

1.3.2 Health infrastructure: Other Public sector outlets (Other public sector)

This mainly includes; Hospitals and health care centers being managed by organizations such as

the Pakistan Armed Forces, which has more than 50 hospitals with mostly specialized facilities,

Social Security having a chain of 50 hospitals and health centers in the country, and Fauji

Foundation with almost 70 hospitals and health centers. In addition, there are many health

facilities in the country, which are being managed by the department of Police and Jails,

Railway, etc. These health facilities have an enormous potential to contribute to TB care

delivery in the country.

1.3.3 Health infrastructure: Private sector

The private sector is large and unregulated comprising both qualified and unqualified service

providers in the disciplines of Allopathy, Homeopathy and tibb(Traditional Herbal Medicine).

The private sector caters to about 75% of the population’s curative primary healthcare needs in

addition to low cost hospital care. Qualified providers include the not-for-profit NGOs as well as

for-profit private sector institutions and individual practitioners. The not-for profit NGOs range

from small-scale local setups to a countrywide network of health outlets such as PRSP/PPHI

(managing about 4,000 primary health care facilities in the country). The technical and

managerial capacity of the NGOs varies widely. In context of TB control services there is a vast

network of health centers country-wide, being managed by the Pakistan Anti-TB Association

(PATA), which are exclusively providing TB care services.

8Nishtar, S 2006, p s61

18

Table 2: Private health care providers by country/province4 2009-10

Country/province Urban Rural Total

Number % Number % Number %

Pakistan 83,689 40 123,023 60 206,712 100

Punjab 47,005 36 83,406 64 130,411 63

Sindh 23,642 71 9,637 29 33,279 18

KP 11,047 29 27,052 71 38,099 18

Balochistan 1,995 41 2,928 59 4,923 2

Table 2 shows the total estimated health care providers at the national level was 206, 712 in

2009-10. The distribution of health care providers varies among the provinces. Punjab, being

the most populous province, leads with 63% of the total private sector health care providers. As

the least populated province, Balochistan has only 2% of the total private sector health care

providers. Sindh and Khyber Pakhtunkhwa (KP) contain 16% and 18% of the total private sector

health care providers respectively.

The urban/rural comparison for the provinces shows that Sindh has the highest percentage of

urban health care providers (71%) followed by Balochistan (41%), Punjab (36%) and KP (29%).

With respect to rural health care providers, KP has the highest percentage (71%) followed by

Punjab (64%), Balochistan (59%) and Sindh (29%).

19

Table 3: Private health care providers 2009-10 by type, size and province2

Country/province

Hospitals Out-

patient

service

providers

Laboratory

and

Diagnostic

services

providers

Total Big (>50

beds)

Small

(<50

beds)

Total

Number

Pakistan 125 4,255 4,380 196,843 5,489 206,712

Punjab 66 2,610 2,676 125,171 2,564 130,411

Sindh 46 1,018 1,064 30,742 1,473 33,279

KP 11 568 579 36,205 1,315 38,099

Balochistan 2 59 61 4,725 137 4,923

%

Pakistan 0.1 2.0 2.1 95.2 2.7 100

Punjab 0.1 2.0 2.1 96.0 2.0 100

Sindh 0.1 3.1 3.2 92.4 4.4 100

KP 0.0 1.5 1.5 95.0 3.5 100

Balochistan 0.0 1.2 1.2 96.0 2.8 100

Table 3 above shows the estimated number and percentage of health care providers by three

major service provision categories including the breakdown per size of hospital. As expected,

the number of out-patient service providers are much greater in number than ‘Hospitals’ and

‘Laboratories and diagnostic service providers’. It is estimated that there are 125 big hospitals

and 4,255 small hospitals in Pakistan; for both sizes Punjab has the highest number, followed by

Sindh, KP and Balochistan.

20

Table 4: Out-patient service providers 2009-10 by type and province3

For all of Pakistan, the estimated total number of out-patient health service providers is

196,843; of these, individually run solo clinics (Allopathic clinics) have the highest proportion

(49%) followed by Traditional Birth Attendant/ Dai (15%), Hakeem/Herbalist clinics (14.7%),

Homeopathic clinics (14%), Dental clinics (3.3%) and others (3.3%). Punjab has the highest

proportion (64%) of the total out-patient service providers followed by KP (18%), Sindh (16%)

and Balochistan (2%).

In addition, anecdotal information suggests that there are three times more unqualified than

qualified providers in Pakistan.

Co

un

try pro

vince

Ind

ividu

ally run

solo

clin

ics

Ou

t-patien

t cen

ters

Den

tal clinics

Ho

meo

path

ic clinic

Hakee

m/H

erbalist

clinic

Traditio

nalb

irth

attend

ant/D

ai

Oth

ers

Total

Number

Pakistan 96,645 916 6,443 27,819 28,985 29,445 6,590 196,843

Punjab 47,749 541 3,865 22,584 23,402 21,264 5,766 125,171

Sindh 19,548 99 1,214 2,241 3,062 4,169 409 30,742

KP 26,222 258 1,230 2,830 2,2225 3,049 391 36,205

Balochistan 3,126 18 134 164 296 963 24 4,725

%

Pakistan 49.1 0.5 3.3 14.1 14.7 15.0 3.3 100

Punjab 38.1 0.4 3.1 18.0 18.7 17.0 4.6 100

Sindh 63.6 0.3 3.9 7.3 10.0 13.6 1.3 100

KP 72.4 0.7 3.4 7.8 6.1 8.4 1.1 100

Balochistan 66.2 0.4 2.8 3.5 6.3 20.4 0.5 100

21

2 TUBERCULOSIS CONTROL: BURDEN AND EPIDEMIOLOGY

Tuberculosis (TB) is a serious, debilitating and highly contagious disease affecting millions of

people worldwide and if treated properly, is curable. Until the mid-20th century, it remained a

leading cause of death in the developed world, and still a public health problem in many

developing countries. Treating TB is challenging, even in developed countries where there is a

modern health care system and infrastructure. Despite efforts to control and treat tuberculosis,

there were an estimated 8.7 million incident cases of TB globally in 2011 (13% co-infected with

HIV). There were also 1.4 million deaths from TB (990,000 deaths among HIV-negative

individuals and 430,000 among people who were HIV-positive). These deaths included 0.5

million among women, making TB one of the top killers of women worldwide9.

Drug resistance, including multi- and extensively drug resistant TB (MDR-TB and XDR-TB),

coupled with the growing number of people co-infected with TB and HIV, make the pandemic

more threatening and more deadly.

Globally, about two billion people are infected with TB, about one out of every three people on

the planet. Mycobacterium tuberculosis (MTB), causing tuberculosis, is present in one-third of

the world's population, though not everyone shows signs of the disease.

Pakistan ranks 5thamongst the 22 HBCs and 4th among 27 MDR high burden countries in the

world10. Pakistan contributes about 65% of the tuberculosis burden in the Eastern

Mediterranean Region. According to national prevalence survey results (2010-11), the incidence

of ‘all type’ TB cases in Pakistan is 276/100,000 population or around 420,000 TB cases. The

prevalence of the disease is estimated at 348/100,000 population or approximately 620,000

cases11. In 2013, 298,476 TB cases (all ages, all forms) were notified in Pakistan.

Globally, the impact targets are “to halt and begin to reverse the incidence of TB by 2015, and

to reduce by 50%, prevalence and mortality rates by 2015, relative to the 1990 levels.” The

incidence target is part of target 6.c of the MDGs, while targets for reducing prevalence and

death rates are based on a resolution passed in the 2000 meeting of the Group of Eight (G-8)

industrialized countries in Kinawa, Japan. The outcome targets i.e. “to achieve a case detection

rate of at least 70% for new SS+ cases and to reach a treatment success rate of at least 85% for

such cases,” were first established by the World Health Assembly (WHA) in 1991. Within the

MDG framework, these indicators are defined as the proportion of cases detected and cured

under DOTS. The ultimate goal of eliminating TB, defined as the occurrence of less than 1 case

per million population per year by 2050, was stipulated by the Stop TB Partnership.

9 WHO Global Tuberculosis Report 2013

10WHO. Global Tuberculosis Control; WHO Report 2013

11National TB Prevalence Survey Report, NTP Pakistan, 2012-13

22

According to WHO Global Report 2013, the estimated incidence of DR TB was 3.5% among new

TB cases and 32% among retreatment TB cases.

The NTP has addressed the reduction of death rate i.e. the number of cases that died during the

course of treatment out of the total number of cases under treatment was 2% in 2012.

However, the case fatality rate i.e. the number of cases that died due to TB out of the total

number of incident TB cases in the country is not possible to measure in Pakistan due to the

unavailability of vital registration data in the country. The mortality rate i.e. the number of total

deaths due to TB was 34/100,000 in 2012.

Further details are given in the situation analysis section.

3 STRATEGIC PLAN “VISION 2020”

National TB Strategic Plan is a “full expression of demand” and is an advocacy tool to primarily

provide insight for the TB program, sensitize policy makers and partners and provide a basis to

generate resources. The following sections provide the background which led to the

development of the National TB Strategic Plan “Vision 2020”.

3.1 NATIONAL TB STRATEGIC PLAN: 2012-16 The last National Strategic Plan12 (2012-16) set the stage for implementation of the six key

elements of the strategy in Pakistan, which are in line with the components of the Stop TB

Strategy, i.e. a) pursuing high quality DOTS, b) addressing TB-HIV, MDR-TB and other challenges,

c) contributing to health systems strengthening, d) enabling all care providers, e) empowering

people with TB, and communities, f) enabling and promoting operational research. The

program objectives were developed in light of the ‘Global Plan to Stop TB 2011-2015’ which

included a) sustain and consolidate the achievement of 70/85 targets, and b) achieve the

targets to effectively engage all care providers, enhance program capacity to detect and

manage 80% of incident smear-positive MDR-TB cases, and reduce TB prevalence and mortality

by 50%. The total requirements for these five years were estimated at US$ 476 million. This

plan emphasized the importance of sustaining and consolidating the program achievements.

However, at the time of development of NSP 2012-16, the devolution process was in the early

phase of implementation and roles and responsibilities of provinces were not very clear. As a

result, the strategic plan was unable to capture the provincial TB control context in devolution.

Many intervention models at that time were not able to contribute substantially to increasing

12

STOP TB Strategic Plan 2012-16, National TB Control Program, MoH ,GoP

23

the TB case notification in the country. Moreover, the TB prevalence survey findings were not

available and the projection of TB cases was based on WHO estimates.

3.2 PROGRESS TOWARDS MDGs The country is progressing towards achieving the 2015 MDG-6, Target 8: i) Indicator 23 i.e. to

have halted by 2015 and begun to reverse the incidence, prevalence and deaths associated

with TB and; ii) indicator 24 i.e. proportion of TB cases detected and cured under DOTS.

Similarly the TB control program is working to achieve the 2050 - Stop TB Partnership targets

i.e. by 2015: reduce TB prevalence and death rates by 50% relative to 1990 and; by 2050:

eliminate TB as a public health problem (1 case per million population).

However, more support and efforts at the national and provincial levels for TB control activities

would help in fully meeting these targets within the given time period.

3.3 IMPLEMENTATION OF STRATEGIC PLANS AND IMPACT Two NSPs were developed before the current one. The first covered the years 2005-2010 and

the second 2011-2015. The 2011-2015 NSP was not continued beyond 2013. A great deal of

strategic interventions specified in these two formers NSPs were funded by Global Fund

through the Rounds 2, 6, 8 and 9; the Rounds 6, 8 and 9 grants were merged in a single stream

of funding in 2012 which will end up in June 2015. The first NSP focused on expanding DOTS in

order to reach the WHO global targets (detecting 70% of estimated TB cases and treating

successfully 85% of detected TB cases). The second NSP targeted the MDGs (halving TB

prevalence and mortality by 2015 compared to 1990) and focused on the implementation of

the 6 components of the Stop TB Strategy of WHO.

100% population DOTS coverage was achieved at the end of 2005 in the public health sector.

The number of notified TB cases was 20,707 in 2001, when DOTS was initiated, and 97,245 in

2004, just prior to 2005-2010 NSP implementation, and reached 298,981 in 2013. The

treatment success rate increased from 77% in 2001 to 91% in 2007 and remained, since then, at

this level. It is worthwhile to highlight that 1.9 million TB patients were successfully treated in

Pakistan between 2001and 2012.

The decline in estimated incidence and prevalence due to implementation of various

interventions has been presented in the figure 1-3 below. The incidence is falling at a rate of 1-9

per year, prevalence has declined 38% since 1990 and 51% reduction in TB related mortality

since 1990.

24

Figure 1: Impact of interventions on decrease TB incidence over years

Figure 2 Impact of interventions on decrease TB prevalence over years

Figure 3 Impact of interventions on decrease TB mortality over years

25

The significant increase in TB case notification and treatment success rate is likely to be

associated with the tremendous increase in the population coverage by TB care and control

services as defined in the national strategies.

In the year 2000, there were less than 50 TB microscopy laboratories in the public sector and

there was no national reference laboratory (NRL); with the financial support of Global Fund, a

national TB laboratory network has been established within the last 10 years. This network

includes currently about 1,396 microscopy laboratories (including 204 laboratories in the

private health sector), 115 intermediate laboratories in charge of supervision and external

quality assurance (EQA), 7 provincial/regional laboratories performing smear microscopy et

culture, ensuring supervision of TB laboratory activities and performing EQA. This laboratory

network is under the responsibility a NRL that was created in 2009. The EQA system was

initiated in 2005/2006 and is presently covering the entire TB laboratory network. The

acceptable performance showed by EQA increased from 29% in 2006 to at least 70% from 2011

onwards. Three laboratories are performing drug susceptibility testing (DST); two of them are in

private sector.

Significant managerial capacities have been built since 2005 at province level in order to ensure

appropriate management and supervision of NTP activities within the provincial network.

Moreover, more than 16,000 health workers have been trained on TB care and control as

defined in the national policy. The contribution to the other care providers practicing outside

NTP network was quasi nil in 2004 and before. Their contribution increased from 5.5% in 2005

to 20% in 2009 and remained, since then, at this level. The programmatic management of drug-

resistant TB (PMDT) cases was initiated with the enrolment of 236 MDR-TB patients in 2010 in 3

centers. This number has been progressively increasing for the last years. In 2013, 1,570 MDR-

TB cases were managed in currently established 18 PMDT centers. The treatment outcome

reported was 69% in 2013.

The last WHO estimates highlights that the prevalence and mortality of TB have declined by

38% and 51% respectively in 2012 compared to 1990. It is not clear to which extent the

tremendous efforts that have been made since 2001, in collaboration with many partners,

especially the Global Fund, in implementing sound TB care and control service, have

contributed in the decrease of TB prevalence and mortality.

However, based on the first population-based national prevalence survey which was carried out

in Pakistan in 2010/2011, the prevalence is still very high i.e. 348 per 100,000 population. The

current NSP Vision 2020 has just been initiated and is expected to strengthen and improve the

gain made and address the challenges to which TB control efforts are confronted in Pakistan.

26

3.4 INTERNATIONAL TB REVIEW MISSION: NOVEMBER, 2013 In a recent international review of TB care activities in the country, several sets of

recommendations were given to the program to more comprehensively address the TB control

challenges in the country. The major set of recommendations were focused on: the importance

of developing a long-term plan for sustainable financing of the different components of the TB

program as well as; the need for a robust program, with strong NTP leadership, to support the

various TB interventions in the country, such as active case finding and contact tracing as per

WHO recommendations, re-examining the role of Xpert MTB/RIF in TB case finding, especially

for SS- and extra-pulmonary cases and; introducing the revised WHO TB definitions and

reporting framework. In addition, there were several recommendations to address major

program components such as:

laboratory, by adopting SOPs for culture & DST and infection control and strengthening

supervision

childhood TB by improving case detection in children (eg, symptomatic screening at

school entry; use of gastric aspirate) and systematic contact screening

interventions in monitoring and evaluation

PMDT interventions such as procurement of Gene Xpert machines to match the

continued roll-out of PMDT centres

consideration for introducing a short-term regimen and interventions in infection

control

TB/HIV

ACSM

PPM recognized as a major need to address for reaching additional cases

The annexure-1 gives the detailed recommendations from the international review mission in

November, 2013.

The NSP Vision 2020 has ensured that the strategic interventions proposed in the plan are in-

line with the major recommendation of this international review mission.

27

3.5 DEVELOPMENT PROCESS OF NATIONAL STRATEGIC PLAN “VISION 2020” The last national strategic plan (NSP)13which covered the years 2010-2015to control TB in

Pakistan focused on the implementation of the six components of the Stop TB Strategy as

recommended by WHO and other international agencies. In line with the Global Plan to Stop TB

2006-2015,the goals of this NSP was to contribute to reducing by 50% TB prevalence and

mortality by 2015 compared to 1990 and its objectives were to achieve 70% TB case detection

by 2015 and to maintain TB treatment success rate at 85% at least. The total budget to

implement the strategic interventions identified in this NSP was estimated at US$ 476 million.

When the implementation of the NSP 2010-2015 was initiated, the devolution process was also

at its early stage of implementation in provinces; however, the roles and responsibilities of

provinces were not very clearly defined. As a result, the new context of devolution could not

be reflected in the existing NSP for TB care and control. Moreover, the findings of the national

population-based TB prevalence (2010-11) and drug resistance surveys (2012-13) resulted in

the revision of the estimates of TB burden and, therefore, pointed out the need for revision of

targets of TB control. Meanwhile, innovations in TB diagnosis and management have occurred

after the year 2010. The process of devolution, the establishment of new estimates of TB

burden and the introduction, at global level, of new approaches for TB care and control, all, led

the NTP to take the decision to re-formulate a new national strategic plan for TB control which

covers the years 2014-2020. The development process of the new NSP was initiated in mid-

2013. It started with a consultative meeting involving the core team members of the NTP

Central Unit to approve and initiate development process and identify the focal person and

potential consultants. Then, it passed through broad-based and multi-stage consultations which

involved national, provincial, regional, community and international stakeholders, including

partners. Indeed, preliminary meetings were organized in each province and region on the need

of development of provincial/regional strategic plans for TB control. Then, a notional workshop

on the methodology to develop a strategic plan for TB control was organized, by the NTP

Central Unit, in Islamabad with in August 2013. The workshop was attended by the teams’

members of the NTP Coordination Units of the five provinces and the three regions, partners

and NGOs, involved in TB control efforts in Pakistan, and facilitated by a WHO consultant.

Following this workshop, the teams of the nine coordination unit of NTP developed their

strategic plan for TB control for their respective province and region, in collaboration with the

local partners and the relevant NGOs, with the support of the relevant staff of NTP Central Unit.

Meanwhile, a review of the NTP, involving national and international experts, was undertaken

in early November 2013. Based on the provincial and regional strategic plans that were

prepared, a draft of the 2014-2020 NSP for TB control, with its relevant components, was

developed. This draft was then revised and discussed in an international workshop on NSP

13

STOP TB Strategic Plan 2010-2015, National TB Control Program, Ministry of Health,Government of Pakistan; 2009.

28

development that was held in November 2013, in Cepina, Italy. The two professionals, who are

in charge of the development of Pakistan NSP within the NTP Central Unit, attended this

workshop. The NSP was then refined according to the revision and comments made in the

international workshop of Cepina and the findings and recommendations of the review of NTP.

It was labelled: National Strategic Plan For TB Control – Vision 2020. The budget to implement

the strategic interventions and activities specified in the NSP is estimated at US $ 876 million.

Table 5: Process of Strategic Plan Development

DATE ACTIVITY PARTICIPANTS OUTCOME

April 15,

2013

NTP initiative by

National Manager NTP

NTP Core team • Consultation with NTP core

team.

• Approval of draft inception

“VISION 2020”

April22,

2013

• Nomination of

focal person

• Engaging

consultants

National Manager NTP • Focal person nominated

• Consultants engaged

14 June 1st National

Consultative Meeting

• Consultants

• Focal person

• NTP/PTPs

• Partners

• Outline of NSP defined

• Way forward agreed

24 June 2nd National

Consultative Meeting

Technical and

Implementing Partners

• Strategic outlines formulated

• Technical Working Groups/focal

points formed

1 July -12

August

-Template formulated

for TWG

-Information gathered

-Members TWG

-National Consultant

Recommendations received from TWG

August 12,

2013

3rd National

Consultative Meeting

• Consultant

• Focal Person NSP

• Members TWG

Finalization of inputs from TECHNICAL

WORKING GROUPS

For initiation of “Zero Draft”

29

August 19-

22, 2013

4th National

Consultative Meeting

Consultants/Focal

person NSP

NTP/PTPs Technical

Partners

• Orientation of PTPs on NSP

formulation process

• “Zero draft” developed &

circulated to PTPs/Focal persons

for review and adaptation

August 23-

26, 2013

Intra NTP meetings of

focal persons with

consultants

• Consultants

• NTP focal

persons

- Goals and objectives defined

- Gap Analysis done

September-

October,

2013

1st Round - Provincial

/Regional Consultative

Meetings

Balochistan (5-7 Sep)

Punjab (10-11 Sep)

KPK (23-24 Sep)

Sindh (25-26 Sep)

ICT (27 Sep)

AJK (28 Sep)

GB (30 Sep)

FATA (2 Oct)

Focal Person NTP/

Consultant

PTP Manager, Deputy

Manager, PRL team,

NPOs

-Provincial /Regional “Zero Draft” of Core

Plan(Objectives, Background, Situation,

SWOT, Gap analysis, Strategic

interventions, Activities)

October 3-

5, 2013

Refinement of

Provincial Core

Strategic Plans

-PTPs

-Focal person NSP

-Consultants

-Completed “First Draft” of Provincial

Core Strategic Plans (05) and Regions

(03)

October 7-

9, 2013

5th National

Consultative Meeting

(Costing , M& E and

Operational plan and

TA Plan)

• Provincial

Technical and

Financial expert

• National Focal

Persons and

financial expert

• Consultants

• Provincial Core Strategic Plan

• Costing

• M&E Plan

• Operational Plan

• Technical Assistance Plan

30

October 10-

20, 2013

Refinement of

National Strategic Plan

• National

Technical group

• Focal person NSP

• Consultants

Completion of “First Draft” of National

Strategic Plan

November

17-27, 2013

Global workshop on

“Development of

National Strategic

Plan)” at Cepina (Italy)

Consultants:

NTP Focal Person:

Refinement of draft core plan

Development of Budget Plan

based on WHO Budgeting &

Planning Template

December

2013

2nd Round

Provincial /Regional

Consultative Meetings

Balochistan, Punjab,

KPK, Sindh, FATA, GB,

AJK, ICT

PTP Manager, Deputy

Manager, PRL team,

NPOs

-Provincial /Regional “Preliminary Draft”

of Strategic Plan including;

1 – Core Plan

2 – Epidemiological Projections

3 – Operational Plan

4 – Budget Plan

January 31,

2014

Refinement of NSP NTP/Consultant NSP Preliminary draft and circulated to

NTP focal persons for review and

refinement

March 12,

2014

6th National

Consultative Meeting

for finalization of

Provincial/National

Strategic Plans

NTP/PTPs Technical

Partners

Preparation of Final Draft

Submission to NTP for approval from

Ministry of NHSR&C

31

1st National Consultative Meeting

June, 2013 - Islamabad

32

2nd National Consultative Meeting

July, 2013 - Islamabad

33

3rd National Consultative Meeting

September, 2013 - Islamabad

34

Global Consultative Workshop

November, 2013 – Italy

35

4 NATIONAL TB CONTROL PROGRAM PAKISTAN

4.1 EVOLUTIONARY PERSPECTIVE WHO declared TB a global emergency in year 1993 which was endorsed by the Government of

Pakistan. The TB Control Program (TCP) was revived in 2001 and TB was declared as National

emergency. The NTP Pakistan embarked upon the implementation of DOTS in year 2000/2001

and achieved 100% public sector DOTS coverage in country by year 2005. High government

commitment coupled with strong technical leadership in the program resulted in a clear vision,

which was translated into a multi-year strategic plan (2001 – 2005) to achieve 100% DOTS

coverage by the year 2005. The strategic plan was revised in 2005 for the period from 2005 to

2010. TB Control Program recently revised a strategic plan for 2012 – 2016.

A well-functioning DOTS Program is the key to success to TB control in a country. The

Government has accorded high priority for the control of communicable diseases (including

tuberculosis) as embodied in its National Health Policy (existing as well as new i.e. 2009 - draft).

4.2 STRUCTURE & FUNCTION National TB Control program (NTP) is fighting against Tuberculosis in the country with the

support of Provincial TB Control Programs (PTPs). TB control program is a horizontal program

integrated into Primary Health Care (PHC). The NTP is responsible for overall coordination of

the TB Control Program in the country. The NTP is not directly involved in TB care delivery,

which is the responsibility of the provincial/regional/district health authorities. The main

responsibilities of the NTP includes; policy formulation and strategic planning, technical support

to the provinces, supervision, monitoring and evaluation, coordination and communication

with partners, and research and development.

The Provincial Tuberculosis Control Programs (PTPs), under their respective departments of

health, are responsible for coordinating the planning, implementing, managing and financing of

the tuberculosis control activities in their respective provinces/regions. The PTPs are involved in

supporting the district health services, teaching hospitals, and other partners for effective

implementation of DOTS in their respective constituencies. The main responsibilities of the PTP

includes; participation in strategic, program and operational planning, technical and material

support to the districts and partners, supervision, monitoring and evaluation support to the

districts and coordination and communication with partners.

In the devolution context, the district authorities are primarily responsible for advocating,

planning, financing, implementing, and monitoring TB care services in their respective districts.

The delivery and management of TB care has been integrated within district healthcare services

so that continuing care can be provided close to the patient's home.

36

4.2.1 NTP arrangements for coordination of TB control activities in the country

NTP has the stewardship role in TB control efforts in the country. The figure below reflects the

organization of TB control activities in the country.

Figure 4: Organization of TB control program Pakistan

The NTP has various categories of management, technical and administrative staff working at

the national and provincial levels.

Table 6: NTP Human Resource and funding support

Human Resource (from public sector) Human Resource (from GF and USAID)

• Sociologist (2)

• Filed officer (0)

• Deputy Head Lab (1)

• C. Operator (1)

• Lab Technicians (7)

• Microscopist (2)

• PTO (4)

• NPO (31)

• Microbiologist (5)

• Microscopist (1)

• Lab Technicians (06)

• Logistic officer (3)

PTP Manager PTP Medical Officers GF Staff

Federal Level NTP (MoNHSR&C)

GF Grant Management Resource

mobilization Technical support to

PTP

Public Sector BMU/TC

Care Provider DOTS facilitator Microscopist

GF grant implementation Coordination with SRs Logistics support to Dist

Recording and reporting

Private Sector GP Clinics/Labs

District Level

Provincial Level PTP (MoH)

EDO/DHO DTC DLS

National Manager PIU

Program Implementation

Recording and reporting

Monitoring

TB Case Management

C O M M U N I T Y

ORGANIZTION - TB CONTROL PROGRAM

37

• Lab Attendants (2)

• Office Assistant (1)

• Drivers (80)

• Field Officer 1 (vacant)

• UDC (1)

• NaibQasid (1)

• Sweepers (1)

• Stock officer (3)

• ACSM coordinator (03)

• Data Management Officers (1)

• IT Assistant (1)

• Office Assistants (2)

• Resource Center Person (1)

• HR Officer (1)

• SLS (11)

• MDR Staff (11)

• Drivers (4)

Total: 100 Total: 88

The table above shows that more than 95% of the human resources provided through public

sector resources is support staff, whereas the situation is entirely opposite as more than 95% of

the human resources provided through donor support is technical staff which has also high cost

implications as far as sustainability is concerned. Almost 50% of the donor-supported human

resources provided to the NTP are based in provinces and regions to supports provincial and

regional TB control programs. The annexure-3 provides, in detail, the functions of these staff.

About 95% of the technical staff is supported through donor funding, mainly from Global Fund

grants.

4.3 LEVELS & RESPONSIBILITY The different level of responsibilities are summarized below:

At the NTP Level:

– Secure public and donor sector funding to support TB control activities

– Develop TB control national policies and TB standards for TB management

including diagnostic algorithms and treatment protocols, patient education

material, recording and reporting forms, etc

– Adapt and pilot innovative approaches to TB diagnosis and ensuring patient

compliance

– Procure/ Arrange new diagnostic equipment (such as GeneXpert, LED

microscope) and supplies and FLDs and SLDs to address gaps in the provinces

– Manage the national data base and report to the Government of Pakistan, UN

agencies and Donor agencies

38

– Contribution to the Global TB Report by WHO

– Advocacy and awareness at the national level

– Donor coordination and develop linkages with international institutions of TB

excellence

– Support TB implementation activities in ICT

– Develop Global Fund proposals and manage as a Principal Recipient (PR)

– Conduct monitoring and evaluation and manage national (including quarterly

inter-provincial meetings) and international reviews

– Surveillance

– Global, EMRO Region and National Coordination

– Manage National TB Reference Laboratory activities

– Conduct National Surveys and Operational Research

– Capacity building

At the Provincial/Regional Level:

– Coordinate with NTP in TB control activities

– Maintain Provincial Management Unit (PMU)

– Secure public sector funding and manage donor support

– Implement TB control interventions as per strategic plan

– Adopt and implement new TB initiatives

– Capacity building

– Coordinate and supervise districts including public and private sector TB care

providers

– Monitoring and Evaluation & Surveillance (including quarterly inter-

district/agency review meetings)

– Manage the Drug Management System

39

– Manage Provincial/Regional Reference Laboratory (PRL/RRL) activities

At the District/Agency Level:

– Coordinate with PTP/RTP in TB control activities

– Service Delivery (Diagnose, Manage, Treat and Report TB Patients) in TB care

facilities in public and private sector

– Train Critical Mass of Human Resources

– Monitor and supervise public (including other public health sector) and private

sectors ( including quarterly intra-district/agency meetings)

– Receive, Store , and Consume Logistics (ATT ,Lab Reagents, Equipment)

– Maintain Quality Lab Services and implement EQA

– Prepare and submit Quarterly TB Reports

– Coordinate with Sub Recipients

4.4 TB CONTROL IN POST DEVOLUTION CONTEXT Since the inception of the TB control program, its activities have been integrated in Primary

Health Care (PHC) in the country. The NTP, in consultation with the project management team,

has developed the following strategy to contribute to the devolution process and to devolve

future Global Fund and other grants, to the extent which is acceptable to both donors and

provinces. This implies:

- Capacity building of the provinces to implement new interventions, including donor

grants, and to become eligible as Sub-Recipients in subsequent grants

- Active support to provinces in implementation including addressing uniform policies

and standards, supplies and logistics gaps, capacity gaps, M&E, research, etc.

- Establishment of provincial grant management units and devolution of certain

activities and funds related to these activities for institutional strengthening at the

provincial level

- Capacity building/ trainings

According to the operational details laid out under the devolution process, international/

donor funded projects are affiliated with the Economic Affair Division. It disburses the funds to

40

the concerned departments who are in turn responsible for the management of the funds and

implementation of the funded activities.

In contrary to other donor funding, Global Fund Grants are performance-based and are

disbursed in the countries only through Principal Recipients. Later, keeping in view the

requirements of Global Fund grants and in order to comply with the procedures laid out by the

CCM, the three public sector PRs (National TB Control Program, National AIDs Control program

and Directorate of Malaria) were affiliated and placed under administrative control of the

newly established Ministry of National Health Services, Regulations & Coordination (NHS,R&C).

At this time, the NTP is implementing three grants with the support of Global Fund i.e. Round 6,

8 and 9 grants, consolidated as per policy of the Global Fund in Single Stream Funding (SSF) to

facilitate the process of grant implementation and reporting. The NTP has signed a contract to

receive these grants as Principal Recipient. The Project Management Unit, established with

grant support and under the supervision of the National Manager, TB Control has successfully

been implementing these grants.

The NTP presence is necessary at the central levels for maintaining national stewardship and

fulfilling global commitment towards the MDGs. The recent review of NTP roles and

achievements has also highlighted the need to address the challenges due to on-going

decentralization of health programs in the country14. The NTP will act as a collaborating body at

the central level for development of uniform policies and strategies, which is also a

requirement of financial partners; for example the GFATM. The NTP at the central level will

facilitate donor liaison at the national and international levels. Disease surveillance is another

important area at the national level for impact evaluation, tracking toward policy development.

Currently the NTP is maintaining electronic surveillance for reporting to the MoH, WHO and

other donors and partners.

14

Third-party evaluation of NTP, TRF 2011

41

SECTION A2–

A2/1: SITUATION ANALYSIS

42

5 SITUATION ANALYSIS

5.1 POLITICAL COMMITMENT A well functioning DOTS program is the key to TB control in a country. The rapid expansion of

DOTS in Pakistan has only been possible due to high levels of government and partners’

commitment. The exponential increase in the financial commitment for DOTS, during the last

few years, reflects the high level of government (federal as well as provincial) and partners’

commitment.

Figure 5: Financial Allocation for National TB Control Program 2004 – 2012 (Million PKR)

(Source: National TB Control Program Pakistan)

43

Table 7: PSDP allocation- Post devolution (2011-2014)

(Rs. In Million)

Sr. No. Province/Region PSDP Allocation

2011-2012

PSDP Allocation

2012-2013

PSDP Allocation

2013-2014

1 KhaberPakhtunkhwa 16.051 16.051 16.051

2 Balochistan 7.708 7.708 7.708

3 Punjab 64.202 64.202 64.202

4 Sindh 25.928 25.928 25.928

5 AJK 3.704 3.704 3.704

6 GilgitBaltistan 3.087 3.087 3.087

7 Fata 3.087 3.087 3.087

8 ICT - - -

Total 123.767 123.767 123.767

(Source: National TB Control Program Pakistan)

Table 8: PC-1 status in TB Control Pakistan

Status

National Approved (but fund not released)

Balochistan In development stage

GB Not developed

KP Operational

Punjab In process of approval

Sindh Approved (but fund not released)

AJK In process of approval

ICT Not developed

FATA Not developed

Currently most of the provincial and regional PC-1s are not operational.

44

Figure 6: Contribution to TB control activities by funding source5: 2012-13

In recent years the confidence and commitment of the partners/donors has been increasing.

This is mainly because of transparent decision-making at the National level with involvement of

all stakeholders, demonstrated success endorsed by national and international missions, and

continued encouragement/ facilitation of all program partners. This high dependence on donor

inputs (85%) is a caution to NTP/PTPs to work in parallel and access an equitable contribution

from the public sector funding.

5.2 TB CASE NOTIFICATION

5.2.1 TB burden analysis

Steady progress can be witnessed during the last decade to improve the case detection and

treatment success rate by emphasizing quality assurance of smear microscopy, drug

management, community mobilization, involving tertiary care hospitals, NGOs, and inter-

sectoral organizations and, above all, involving private sector for service delivery. Between

2001 and 2012, 2.14 Million TB patients have been diagnosed and treated free of cost under

the National TB Control Program. With reference to expansion, 141 districts were detecting TB

cases from five provinces [Balochistan, GilgitBaltistan (GB), Khyber Pakhtunkhwa, Punjab and

Sindh] and three regions (ICT, FATA and AJ&K) in the country with a network of 1,230 public

sector Basic Management Units (BMUs).

45

Table 9:Year-wise notified TB cases and NSS+ Pakistan

Year Estimated TB Case

Burden in Pakistan

Case detection NSS+ Re-treatment

2001 259,886 20,707 6,703 702 (3%)

2002 263,505 49,186 15,446 2,952 (4%)

2003 269,033 75,528 21,033 4,449 (6%)

2004 274,184 97,245 31,557 4,890 (5%)

2005 279,667 144,771 48,220 5,425 (4%)

2006 285,260 179,780 65,711 5,565 (3%)

2007 290,792 234,100 88,747 7,738(3%)

2008 296,779 248,678 100,103 7,982(3%)

2009 302,767 267,451 101,887 9,200(3%)

2010 317,607 269,290 104,263 10,805 (4%)

2011 413,450 270,422 105,733 11,417 (4%)

2012 416,000 285,410 110,545 11,717 (4%)

The table above shows that the case detection has increased in initial years, as has the number

of NSS+ and re-treatment cases. Since 2008, case reporting has remained stagnant (2-3%

annual increase seen in the country).

46

Table 10: Estimates of TB burden 201215

Impact Rate (per 100000 population)

Mortality 34 (15-61)

Prevalence 348 (287-409)

Incidence 276 (158-424)

Figure 7: Provincial TB Case notification and population proportion

Case notification (%) – All Provinces and regions – 2012

Population (%) – All Provinces and regions – 2012

The figure above shows that the most populous province i.e. Punjab is providing the greatest

proportion of notified cases (62.2%) in the country, where as Sindh and KPK contribute 19.4%

and 11.9% of the total notified cases respectively. Smaller provinces and regions have a joint

contribution of 6.5%.

15

National TB Prevalence Survey Report, NTP Pakistan , 2012-13

AJK 1.8%

B'TAN 2.4%

FATA 1.3%

GB 0.5%

KPK 11.9%

PJB 62.2%

SINDH 19.4%

ICT 0.5%

AJK B'TAN FATA GB KPK PJB SINDH ICT

PJB 54%

Sindh 22%

B'TAN5%

KPK 13%

GB 0.70%

AJK 2%

FATA 2%

ICT 0.60%

PJB Sindh B'TAN KPK GB AJK FATA ICT

47

Figure 8: Case notification by age (%) – National – 2012

(Source: National TB Control Program)

The majority of the cases reported are in the age group 15-24 years. However, also around 10%

of the total notified cases are being reported in adults above 65 years.

5.2.2 Re-treatment cases

The table below shows that, at the national level in 2012, the overall number of re-treatment

cases reported was 15,688 (4%) i.e. the number of re-treatment cases, including other re-

treatment SS+ cases, was 11,717 and the number of other re-treatment SS- and EP cases was

3,971. The low proportion of re-treatment cases shows that program implementation is not at

the desired level. The highest proportion (7%) of re-treatment cases has been reported from

the province of Sindh, followed by Punjab, KP and AJK (each 3%).

According to WHO (2013 report) it is estimated that 3.5% and 32% of the new and re-treatment

cases, respectively, will be potential DR-TB cases in Pakistan. According the preliminary results

of the DRS, completed in 2013, the prevalence of drug resistance in new and retreatment cases

is 4.3% and 19.4% respectively.

4% 5% 4% 4% 4% 4% 4% 4% 4% 5%

4% 4% 4%

28% 28% 26% 26%

24% 24% 24% 23% 24% 25% 25% 25% 26%

5% 6% 6%

8% 8% 8% 9% 9% 9% 10% 9% 10% 10%

0%

5%

10%

15%

20%

25%

30%

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 Q1-13

0-14 15-24 65 OR >

48

Table 11: Proportion of re-treatment cases reported

(Province/Region/National 2001- 2012)

20

01

20

02

20

03

20

04

20

05

20

06

20

07

20

08

20

09

20

10

20

11

20

12

AJK 3% 3% 5% 4% 3% 4% 4% 3% 3% 4% 2% 3%

B'tan 1% 2% 2% 2% 1% 2% 2% 2% 2% 3% 3% 2%

FATA 1% 4% 4% 4% 2% 2% 2% 3% 5% 6% 2% 2%

GB 1% 0% 0% 0% 0% 0% 0% 1% 0% 1% 1% 1%

KPK 4% 4% 5% 5% 4% 3% 3% 4% 3% 3% 3% 3%

PJB 3% 3% 6% 3% 3% 2% 3% 3% 3% 3% 3% 3%

SINDH 4% 8% 10% 9% 6% 6% 5% 5% 6% 8% 7% 7%

ICT 1% 3% 3%

PAKISTA

N

3% 4% 6% 5% 4% 3% 3% 3% 3% 4% 3% 4%

5.2.3 TB care facilities in Pakistan

The table below reflects the current status of TB care facilities in the public and private sectors.

This reflects that public sector facilities (TCH/DHQ/THQ and RHC) are almost 100% covered for

TB case management as per NTP protocols and guidelines. A large number of BHUs in the

country (up to 50%) are managed by NGOs (PRSP/PPHI) and, among them, a significant number

of BHUs have the potential to be strengthened for TB diagnostic services.

Similarly, many health facilities under the public sector (Army, Social Security, Railway, Mining

department, etc.) are currently not fully involved in TB case management as per the NTP

protocols and guidelines but have the potential to be involved as BMUs.

As far as the private sector is concerned a large number of GPs and laboratories in the country

are not in partnership with the NTP. Similarly many NGO run clinics and private hospitals (PATA,

AKF, MALC, etc) are not in full partnership with the NTP, while others are not partnering at all.

49

Table 12: BMUs 2013 (Public i.e. Health Sector) and (Other Government Run Facilities i.e.

Other public sector)

# BMU (PUBLIC SECTOR) Reporting # BMU (OTHER PUBLIC SECTOR) Reporting

Pro

vince

BH

U/

Disp

ensary

RH

C/U

HC

THQ

/ Go

vtHs

DH

Q

TCH

Oth

er (TB

H

s,

Service H

s, C

DF,

Lepro

sy H

s,

Mate

rnal

Ch

ild

etc)

Pu

blic

secto

r

/Dep

artmen

t

invo

lved

GF-Su

pp

orte

d

No

n-G

F

Sup

po

rted

Punjab 11 281 98 37 19 91 0 0 0

Sindh 21 100 61 14 7 15 0 5 1

KPK 54 76 13 28 7 1 11 3 8

ICT 1 3 0 0 3 0 6 0 0

AJK 15 28 8 8 0 0 0 0 0

Balochista

n

25 33 1 27 5 0 1 0

FATA 3 5 2 7 9

Total 130 526 183 121 50 107 17 9 9

50

Table 13: BMUs 2013 by source of funding (Private) and (GP clinics)

PRIVATE

GF SUPPORTED GP CLINICS/OTHER

PUBLIC SECTOR HOSPITALS

Non-GF SUPPORTED

GP CLINICS

Pro

vince

# o

f N

GO

s

invo

lved

# R

epo

rting

BM

U in

review

qu

arter

Imp

lemen

ting

partn

er (SR)

# R

epo

rting

in

review

qu

arter

PP

M lab

s

Oth

er P

ub

lic

Sector

Ho

spitals

Imp

lemen

ting

Partn

ers (SR)

# R

epo

rting in

review

qu

arter

Punjab 0 0 3 1,130 125 10 0 0

Sindh 0 41 4 669 57 5 0 2

KPK 28 28 3 213 37 7 4 48

ICT 0 1 1 22 3 0 0 0

AJK 0 0 1 52 9 0 0 0

Balochistan 0 2 3 124 13 2

GB 1 34 1

FATA

Total 28 72 6* 2,24 245 24 4 50

*The total number of SR is 6 (including MC-PIU). Some SRs are working in more than one

province/region.

51

Table 14: Districts with urban/sub-urban population ≥ one million

Province/Regions

Districts with populous

cities with overcrowded

suburban areas

Population

TB cases (all

age, all forms),

2013

Balochistan Quetta 963,104 2,134

GB -

KP Peshawar 2,555,389 5,869

Punjab

Lahore 8,383,436 7,397

Faisalabad 6,448,816 3,124

Multan 3,798,438 6,336

Gujranwala 4,203,123 11,932

Rawalpindi 4,109,112 13,490

Sindh Karachi 13,230,747 18,029

Hyderabad 1,971,189 2,623

AJK -

ICT Islamabad 1,054,430 1,597

FATA - 46.7 million 72,531

TOTAL

It is estimated based on the incidence figure that there are about 130,000 TB cases which needs

to be detected and treated. In 2013, 72531 (56%) case were reported from these district/cities.

There is a huge potential in these mega cities to capture additional TB cases through active case

finding approaches.

52

5.2.4 TB Control service delivery in districts

The delivery and management of TB care has been integrated within district healthcare services

so that continuing care can be provided close to the patient's home. TB care has become an

integral part of healthcare at all levels starting from district hospitals to primary healthcare

facilities to community health workers. This integration has made it possible to plan and carry

out TB control in a district without the addition of a TB-specific care delivery staff. In the

context of devolution, the district health authorities i.e. Executive District Officer Health (EDO),

District Health Officer (DHO), Medical Superintendent of District Head Quarter Hospital, District

TB Coordinator (nominated person), In-charge doctors, DOTS facilitators and Laboratory

technician of Rural Health Centers, Basic Health Units, and the District Laboratory Supervisor

are the key district personnel that are involved in TB control activities at the district level. The

district EDO-H/DHO and the DTC are primarily responsible for advocating, planning, financing,

implementing, and monitoring TB care services in their respective districts.

The district and sub-district hospitals, the rural health centers and selected BHUs (where

needed) in public health /other health sector works as BMUs. A BMU has a laboratory with

laboratory staff and a doctor/qualified medical staff who is trained to diagnose and initiate

treatment. The BMU is also a facility where patients return for re-examination and confirmation

of cure. The BMU maintains record on standard formats and provides periodic reports to the

district coordinator including report on treatment outcome.

Role of BMU

Screen people with respiratory symptoms (suspected as TB patient) by sputum smear

examination

Diagnose and prescribe drugs to confirmed TB patients

Register TB patients, and identify suitable treatment center, and refer the patient

Do follow up smear examinations

Prepare quarterly reports on case finding, smear conversion and treatment outcome

Maintain patients record, and stock books for drugs and materials

Provide patient and family education, both pre-treatment and during treatment

Act as a treatment center for those living nearby

a) The primary healthcare facilities such as basic health units and dispensaries work as

treatment centers. The treatment center is the nearest or most convenient health

53

facility for the patient to continue the treatment. The health facility supplies anti-TB

drugs and ensures that the "direct observation" is carried out through appropriately

selected supporter. Some patients who live close to a diagnostic center may prefer to

avail all the TB care including periodic collection of drugs, supervised drug

administration etc. at the BMU. If this is the case, then the BMU also becomes a

treatment center.

Treatment Centers: Role

Refer people with respiratory symptoms (suspected as TB patient) to the BMU

Provide or arrange community-based observation of treatment

Supply anti-TB drugs to the patients

Maintain patients record

Refer patients with drug reaction to district hospital

Refer patients to BMU for follow up examination

Identify and arrange retrieval of patients showing delay/interruption in drug

intake/collection.

Maintain the stock register for drugs and materials

Provide patient and family education, both pre-treatment and during treatment

The tertiary/specialized hospitals, district and sub-district hospitals and TB clinics offer TB

services as diagnostic centers. The district, teaching and specialized hospitals also provide care

to difficult to diagnose and manage adult TB cases as well as childhood TB cases. Selected

teaching, specialized and district hospitals also offer diagnosis and case management of MDR-

TB cases (with capacity enhancement and support from the program). The medical schools and

post-graduate training institutions would continue contributing in the under-graduate and post-

graduate training of doctors and chest specialists as well as TB related research.

TB care diagnostic and treatment facilities in private sector settings includes a variety of

implementing models (see relevant section on PPM).

54

5.2.5 Diagnostic algorithms

The diagnostic algorithm is as follows:

Figure 9: Diagnostic procedure for suspected pulmonary TB

(Source: Guidelines for Diagnosis and Management of Tuberculosis in Pakistan, NTP 2012)

*New TB cases, started on FLD, who report smear positive at the end of month 2 should be

referred for Xpert testing.

**Retreatment/Other Positive cases on FLDs, reported smear positive at the end of month 3

should be referred for Xpert testing.

TB suspect

( cough >2wks)

2-Sputum smear for AFB

1 or >1 AFB smear +ve

NEW TB Case

Register start FLD*

Retreatment + Other Case

Xpert-MTB/RIF assay

MTB+ RR+

Refer TO MDR MU

MTB+RR-ve

Regsiter start FLD(re-treatment

regimen)**

Two AFB Sm -ve

Broad spectrum antibiotics (clinician

decision)

Chest X-ray

Consistent with TB

Retreatment case +OTHER neg**

Xpert MTB/RIF

MTB+ RR+

Refere to MDR MU

MTB+RR-ve

Register start FLS(re-tr regimen)

MTB-ve

Culture /clinical evaluation

NEW SM -ve TB Case

Register Start FLD

55

Currently the NTP policy is to diagnose and treat TB through the passive case finding approach.

Passive case finding focuses on:

- TB suspects with relevant symptoms who present themselves at health facilities

- A patient who for any reason has had a radiological examination of the chest showing an

abnormality consistent with TB.

There are several challenges which have led to stagnant case notification over the past several

years. The national TB prevalence survey showed that patient diagnostic rate of 41.5% and case

detection rate of 45.4% suggest that high proportion of cases present in the community is being

missed. The limitation of screening algorithm (cough for more than 2 weeks is the TB suspect

identification) whereas research has shown that only 30% patients present with a cough for

more than 2 weeks or hemoptysis; TB is concentrated more and more among high risk groups;

active-case finding carried out on limited scale, and passive v/s active creates provider pushed

to create demand are the factors which requires special focus.

Experience suggests that passive case finding is likely to delay diagnosis and treatment of TB

and increase M. tuberculosis transmission. Therefore, strategies like active and systematic

screening need to be considered.

5.3 TB TREATMENT AND CASE HOLDING Treatment

TB patients must be treated with the anti-tuberculosis drug regimens recommended by NTP

Pakistan. It is the responsibility of the medical officer at the BMU to prescribe the standardized

drug regimen according to the category of a diagnosed patient. The NTP recommended drug

regimens are very effective and can successfully treat almost all cases of tuberculosis if used in

the right dosage and for the right duration. Currently the treatment period for new TB cases

lasts 6 months. The five essential anti-TB drugs used in the NTP Pakistan, with their mode of

action and dosage (in mg per kg body weight), are given in the table below.

Table 15: Characteristics of essential Anti-TB drugs

Essential anti-TB drugs (Abbreviation)

Mode of action Dosage

(mg/ kg) Common drug preparations

Isoniazid (H) Bactericidal 5 (4-6) Tab: 100mg

Rifampicin (R)* Bactericidal 10 (8-12) Tab: 150, 300, 450mg

Pyrazinamide (Z) Bactericidal 25 (20-30) Tab: 500mg

56

Streptomycin (S) Bactericidal 15 (12-18) Amp: 1000mg

Ethambutol (E) Bacteriostatic 15 (15-20) Tab: 400mg

The TB Control Program strongly recommends the use of FDC drugs for the treatment of all

types of TB cases. The recommended formulations currently used are shown in the table below:

Table 16: Type of FDCs recommended by NTP

Drug Combination Strength for daily use

Isoniazid+ Rifampicin (HR) 100+150mg

Isoniazid+ Rifampicin+ Pyrazinamide+ Ethambutol (HRZE) 75+150+400+275mg

The table below summarizes the drugs and the duration of intensive and continuation phase in

two categories of TB patients.

Table 17: FLDs prescription schedule

Category Intensive Phase Continuation Phase

Duration in month Drugs Duration in month Drugs

CAT-I 2 HRZE 4 RH

CAT-II 3 HRZE +S* 5 RHE

*Streptomycin is used only for two months during intensive phase of Cat-II

Case holding

Directly Observed Treatment (DOT) ensures that TB drugs are taken and prevents the

development of resistance to Rifampicin. The risk of drug resistance is higher during the early

stages of anti-TB drug treatment when there are more TB bacilli. According to the WHO, there

can be flexibility and innovation in observing treatment, if the treatment supporter is

accountable to the health services and accessible to the patient.

Based on National and International experiences, the NTP Pakistan has recommended the

following types of treatment supporters for TB patients.

o Health facility based worker i.e. health staff member at the selected treatment

center

57

o Lady health worker i.e. woman formally working with National Program for PHC &

FP.

o Community health worker i.e. any person formally associated with / accountable to

health services and living close to patient’s place

o Family member i.e. father, mother, husband etc person which has influence on the

patient.

o Community volunteer i.e. suitable person selected from community e.g. teacher,

maulvi (religious scholars) etc.

The NTP/PTPs has trained about 12,000 LHWs in the districts to support patients in taking

treatment. However, a large number i.e. more than 80,000 LHWs are still not being involved in

patient support.

5.4 HOSPITAL DOTS LINKAGES The Hospital DOTS Linkage (HDL) intervention was begun in 2008 under the Global Fund Round

6, in order to expand DOTS coverage to tertiary care hospitals; the largest health facilities in the

country. Present in most metropolitan centres, tertiary care hospitals traditionally see heavy

patient loads and thus constituted a natural venue for DOTS expansion. In these settings, the

lack of implementation of standardized TB DOTS protocols, deficiency of resources and linkages

and TB suspect and patients being scattered across various departments was allowing cases to

be missed, treatment failure to occur and was amplifying the risk of drug resistant TB.

HDL implementation has enabled expansion of DOTS coverage in these settings. Furthermore,

domains impacted by the HDL intervention; linkage building, diagnostic support to the

laboratory, and implementation of standardized treatment protocols have built key capacities

of both personnel and systems in implementing hospitals

The HDL intervention included management of adult and childhood TB cases according to the

national guidelines. Through this initiative, over 4,000 doctors, paramedics and lab technicians

in 32 tertiary care hospitals were trained on TB DOTS as well as adult difficult-to-diagnose and

childhood TB management. This initiative is now being scaled up across the country in all

district headquarters hospitals and 16 additional tertiary care hospitals.

Historically, it has always been difficult to include tertiary care hospitals in TB DOTS

implementation, but NTP along with its implementing partners, was able to introduce core TB

DOTS interventions for pulmonary, extra-pulmonary and childhood TB in these tertiary care

hospitals. The program continued to face challenges such as weak linkages between different

departments within the hospital as well as with peripheral facilities. Due to high turn over of

58

staff and resistance from consultants and hospital administration, uniform implementation of

national TB guidelines is still a challenge.

The teaching hospitals, at the tertiary care level, are mainly located in major and all

metropolitan cities of the country. They have a catchment population of their own district and,

in some cases, patients are also referred from adjacent districts. There are about thirty-five

teaching and specialized hospitals in Pakistan. Most of the teaching and specialized TB hospitals

are in the public sector whereas as few are in the private sector.

Below are the public sector hospitals which have own management authority.

Existing partners

Various types of stakeholders exist under this partnership. It mainly includes 27 Public Sector

and more than 10 Private Sector teaching hospitals under the Hospital DOTS Linkage (HDL)

initiative:

Punjab: LGH, Services, Jinnah, Mayo, Ganga Ram, BBH, Holy Family, DHQ Rawalpindi, Nishtar,

SheikZaid, Allied Hospital,

Sindh:Ojha Institute of Chest Diseases, Indus Hospital, Aga Khan

Balochistan: Bolan Medical Complex

KPK: LRH Pesh, HMC Pesh, AMC Abbott, King Abdullah Hospital

ICT: PIMS, FGSH

Arrangements

Through Global Fund support, the Hospital DOTS Linkage (HDL) model was implemented in

2008 teaching/specialized hospitals in the country. This includes: an advocacy and

implementation planning events, provision of anti-TB medicine and laboratory strengthening,

intra-hospital linkages and monitoring, and external linkages with district health services. In

addition, an HDL mobilizer was also made available through GF support in each hospital to

support the working of DOTS facilitator. Several other components of the TB program have

been added to the ongoing DOTS implementation in teaching and specialized hospitals include

the management of; difficult to diagnose and treat TB patients, TB-HIV co-infection, and

childhood TB (the details are described in relevant sections). Recently the support for this

implementation through GF has completed and there is a need to sustain the activities in these

hospitals.

59

Contribution

The table below provides an overview of the contribution of the HDL component in routine TB

care in year 2012.

Table 18: Contribution of HDL in core TB DOTS, 2012

Province Annual NSS+ % of Annual Provincial

Registration

% of Annual National

Registration

NSS+ All types

Punjab 3400 -

Balochistan 200 -

Sindh 3600 -

KPK 400 -

GB - -

AJK - -

ICT - -

FATA - -

Total 7600 - 7.5% 11%

5.5 EXTRA-PULMONARY TB DIAGNOSIS The current NTP arrangements have limited emphasis on the diagnostic arrangement for extra-

pulmonary TB, which accounts for a substantial proportion (30%) of all types of TB cases

diagnosed in a year. Aspirates or tissues requiring histopathology/ cytology can only be

examined in laboratories where a pathologist is available, which are mainly at the DHQ or

tertiary hospitals. There is almost no facility available at the primary health care level to

support the diagnosis of extra-pulmonary TB cases, which results in under diagnosis of smear-

negative TB.

60

5.6 CHILDHOOD TUBERCULOSIS Overview

Data about prevalence and incidence of TB in children is lacking. WHO estimates are that

children may comprise 3-23 % of the disease burden in high TB burden countries. However

globally, of the estimated 8.8 million new cases of TB that occurred in 2010, about 11%

occurred in children (<15 years of age). It is estimated, that with accurate diagnosis and good

reporting systems, children are likely to contribute 10-20% of the disease burden in areas

where TB is poorly controlled.

In Pakistan, the National Institute of Population Studies projects that, by 2020, there will be

about 67 million children (35% of the population) between ages 0-14 year in the country. The

exact proportion of children with TB in Pakistan is unknown. NTP surveillance data did not

differentiate age category of all registered child TB cases until 2010. Childhood TB case

reporting comprised of about 4% of all cases from 2002 to 2009. The reporting was of only

sputum smear positive cases. The incidence of pediatric TB provides an accurate measure of

ongoing transmission within communities, which is a key indicator of epidemic control.

After the revision of NTP reporting tools in 2010, the number of child cases notified was 25,737

(12%) in 2011. However, based on field experience, high smear positivity rate among adult TB

cases and limited contact screening it is expected that childhood TB cases may be much higher

than currently notified.

Through Global Fund support childhood TB interventions were implemented in a phased

manner:

• First phase

• 2004- 2008

• GF R2 support

• Guideline developed

• 42 districts

• Second phase

• 2009-2010

• GF R6 support

• Guidelines revised

61

• 27 TCHs

• Third phase

• 2011

• CG support

• 32 TCHs

• 30 Districts

• 25,737childhood TB cases notified in country from Jan-Dec 2011

• Fourth phase

• 2013- onward

• Scaling up of Childhood TB intervention in 141 DHQ Hospitals across the country

Childhood TB guidelines and materials

In the last few years the NTP has developed a comprehensive set of guidelines and training

materials for standardizing the management of childhood TB cases. Moreover, the new

recording and reporting tools have also incorporated key variables required to monitor

childhood TB care services. The materials developed include:

- Childhood Technical Guidelines

- Childhood TB case management desk guide

- Childhood TB training materials

The paediatricians involved in childhood TB case management receive a three-day training on

NTP childhood TB materials.

5.7 TB/HIV Pakistan is a low prevalence country for HIV (ANC prevalence 0.045%), however, recent

surveillance data (HASP Round 4, 2011) shows that Pakistan has a concentrated epidemic of HIV

with HIV prevalence rates higher than 5% in most-at-risk populations including injecting drug

users and transgendered sex workers. The prevalence among the Injecting Drug Users (IDUs) is

37.5%, and in transgendered sex workers, it is 7.2%. The prevalence of HIV among female sex

workers (FSWs) in Pakistan is 0.8%, and among male sex workers, it is 3.2%. Behavioral data

shows significant overlaps between different key populations, which provide a possible conduit

62

of spread of infection between these populations, and eventually into the general population

through a large bridging group (clients of sex workers). The National AIDS Control Program

(NACP) Pakistan has established 18 HIV Treatment and Care centers nationwide. These Centers

provide comprehensive HIV care services including free antiretroviral therapy, HIV counseling

and testing, care and treatment for opportunistic infections, acute and chronic HIV care, in-

patient admissions, linkages with social support NGOs, and advanced HIV diagnostic testing to

people infected or affected by HIV/AIDS and their families. Currently 7,568 known HIV cases are

registered with these 18 centers, about half of which (4,391) are on anti-retroviral therapy

(NACP 2014). From November 2007 to December 2012, NTP and its implementing partners

under the Global Fund-funded TB/HIV co-infection interventions screened 1,054 PLHIV for TB,

out of which 61 were diagnosed with TB (less than 6%).

The NTP is coordinating with the NACP for providing quality care to those suffering from TB/HIV

co-infection. A national level TB/HIV Board has been constituted to steer the two programs’

coordinated work for TB/HIV co-infection and MDR-TB. The existing HIV Treatment and Care

centers have been strengthened through the Global Fund Round 6 support to manage TB

screening and care for TB-HIV co-infected cases. The strengthening of these centers includes:

staff training, infection control measures, provision of materials, referral linkages, and

monitoring support to provide quality counseling and testing, and referral services.

Operational arrangements

A joint collaborating board for MDR-TB and TB/HIV, and a national technical working group for

TB/HIV have been constituted. The NTP/PTPs are following a policy of Intensified Case Finding

(ICF) – active TB case detection among PLHIV. It is recommended that Isoniazid (INH) Preventive

Therapy (IPT) should be administered to HIV patients after excluding active TB. The screening of

TB infection among HIV patients is also carried out.

Those found co-infected with TB and HIV is managed for TB/HIV co-infection at the nearest HIV

Treatment and Care Center. Active TB case finding among people living with HIV/AIDS at ARV

treatment centers is also carried out. To standardize care delivery, National guidelines were

developed and introduced for screening of TB patients for HIV. To date, 49,039 TB patients have

been counseled and screened for HIV. 160 HIV cases were detected among these TB patients.

Moreover, 1,054 People Living with HIV/AIDS (PLHIVs) were screened for TB among, out of

which 61 TB cases were detected and registered for treatment. 45 People Living with HIV/AIDS

(PLHIVs) diagnosed with latent TB were also put on INH prophylaxis.

There are 16 NTP Sentinel sites operating in Pakistan. The majority of the ART/ DOTS/ Sentinel

facilities are in same facility. The current situation, including proposed sites, is shown in the

table below.

63

Table 19: TB/HIV Intervention Sites

Balochistan KPK Punjab Sindh

Federal (ICT)/

G.B

Exisiting NTP

– (Sentinel

Site)

01 02

06 07 -

NACP (ART

Centers) 01 02

09 (8 Public,

01 Private)

03 01

Difference in

site location - 01

05 (4 Public,

01 Pvt)

01 (Private

Hospital Agha

Khan)

-

New

proposed

- 02

(Abbottabad,

Malakand)

05 sites 01 Agha Khan

Hospital

From NTP.

01 each Site

proposed in

GB & AJK by

2018

5.8 TB IN ELDERLY Only 10% of annually reported cases (NTP data 2012) are among the elderly patients, who are

diagnosed with TB and reported to the NTP.

Currently no specific interventions addressing TB in elderly as vulnerable population are in

place.

5.9 TB, OTHER CHRONIC AILMENTS AND TOBACCO USE Pakistan ranks 7th globally among the highest number of people living with diabetes and 9th

globally in terms of tobacco use among men, which is continuously increasing. Several recent

studies and interventions have demonstrated that TB is linked with tobacco smoke16 and

diabetics are also at high risk of developing TB. Therefore, programmatic interventions are

required to address these issues.

16

Sanjay Basu, etalProjected effects of tobacco smoking on worldwide tuberculosis control: mathematical modelling analysis. BMJ, 2011

64

5.10 TB and diabetes Diabetes, a chronic metabolic disease is increasing globally, including in settings with high

burden of tuberculosis (TB) such as Pakistan. It is associated with higher risks of TB17 and

adverse TB treatment outcomes18. The increase in the number of people with diabetes may

further complicate control of TB, especially in population with high burden of both diseases19’20.

Diabetes can pose a challenge for the management of TB, and TB can worsen glycaemic control

in people with diabetes. Individuals with both conditions thus require careful clinical

management. Currently limited experience is available in Pakistan regarding TB-Diabetes joint

management. Strategies are needed to ensure that optimal care is provided to patients with

both diseases.

5.11 MANAGEMENT OF CONTACTS In year 2012, the total number of contacts screened were 143,667 and 4,504 TB cases were

diagnosed among them i.e. 32 contacts per TB case, which is a reasonable performance. This

shows that only 3% of contacts have been diagnosed.

For tuberculosis, a contact is defined as a person who shares the air with a known infectious TB

case. Close contacts, particularly household and workplace contacts, are considered to be at

high risk of contracting TB infection and disease. In low-incidence settings an average of 5–10

contacts are identified for each incident tuberculosis case. In high-prevalence countries, about

50% of household contacts have latent infection, and about 10–20% have active tuberculosis at

the time of initial investigation. Evidence suggests that contact investigation in high incidence

settings is a high-yield strategy for case finding. Contact management is therefore a tool for

early and active case finding and for reducing the duration of infectiousness of the case i.e. to

reduce TB transmission and burden.

High-risk contacts are contacts that are at a particularly high risk of developing TB disease if

they are exposed to an index case with smear positive tuberculosis. These are:

- Children under 5 years of age with no symptoms or above 5 years of age with symptoms

- HIV/AIDS patients

- People exposed to Silica

17

Jeon CY, et al. Diabetes mellitus increases the risk of active tuberculosis: a systematic review of 13 observational studies. PLoS Medicine, 2008, 5:e152. 18

Baker MA, et al. Systematic review: the impact of diabetes on tuberculosis treatment outcomes BMC Medicine accepted 2011, 9: 81. 19

Goldhaber-Fiebert JD, et al. Diabetes mellitus and tuberculosis in countries with high tuberculosis burdens: individual risks and social determinants. International Journal of Epidemiology, 2011, 40:417–428. 20

Dye C et al. Nutrition, Diabetes and Tuberculosis in the Epidemiological Transition. PLoS ONE, 2011, 6(6):e21161 (doi:10.1371/journal.pone.0021161).

65

In additional there are also certain groups which can be at a higher risk than the general

population for developing TB; thisincludes people with diabetes mellitus, COPD and smokers.

Contact management is one of the main strategies for TB elimination. The National TB control

program has declared contact tracing as integral part of the program and recommends

screening of close contacts of all infectious TB cases. The objective is to identify the people

suffering from TB disease at an early stage and stop TB transmission by treating identified TB

cases amongst contacts.

5.12 QUALITY ASSURED BACTERIOLOGY

Overview

The laboratory network established by the TB control Program in Pakistan to support the

diagnosis and quality of services has evolved over the years. The basic microscopy network in

the public sector, which is performing AFB microscopy, is established at RHCs, THQ/DHQ

hospital and tertiary care hospitals. It has also been extended into the private sector, under the

PPM model, and is also involved in DR-TB care based on standardized criteria.

There are about 1,230 microscopy centres in 141 districts of Pakistan which have been

strengthened with the provision of a light microscope, slides and reagents, sputum cups and

print materials and training for a microscopist who performs sputum smear microscopy. Only a

few BHUs also have these arrangements and, to a certain extent, are performing AFB

microscopy. On average, at the end of 2012, one microscopy laboratory was serving a

population of 131,421 population country wide; this varies from province to province /region

depending on population density and geographical terrain which ranges from 54,254 in GB to

164,791 in Punjab.

66

Table 20: Milestones achieved by the laboratory network

Year Situation/ Milestones

2000 >50 microscopy lab / No network/ No NRL/ No IDL

2001 NRL/PRL designated

2005 Microscopy network coverage in entire public sector

2005-06 EQA piloted in one district

2006-09 EQA implemented to cover >90% of centers. IDL established

2009 NRL started culture +DST services

2009-13 Expansion of TB culture and DST services

2010-11 TB disease prevalence survey

2011-13 Early implementation and expansion of XPERT

2012-13 Drug Resistance Survey

5.12.1 Organization of laboratory network

Pakistan’s TBC TB laboratory network has evolved over years. It is now arranged at four tiers

and is comprised of one National Reference Laboratory, 4 Provincial Reference Laboratories,

115 district laboratories and > 1400 peripheral laboratories (inclusive of the private sector)

Table 21: Functional level /location and current defined responsibilities are as follows

Level Location Main Responsibilities

National reference

laboratory

Federal

Capital

All technical functions +Policy guideline, SOP, TOT

and Monitoring, Surveys

Provincial reference

laboratory

Provincial HQ All technical functions +Planning ,Training

,supervision, monitoring of District lab network

67

District TB laboratory DHQ, DTO,

EDO-office

AFB microscopy + EQA implementation,

supervision, stain preparation lab supply

management

AFB Microscopy

Laboratories

DHQ, THQ,

RHC, TCH

AFB microscopy

The key set of indicators which the NTP is currently monitoring under core laboratory network

includes:

- Suspect positivity rate

- Follow-up smear positivity rate

- Proportion false positive

- Proportion false negative

- Efficiency of microscopy (agreement rate)

5.12.2 Diagnostic services and coverage

5.12.2.1 AFB microscopy services

The NTP guidelines recommend AFB microscopy as the initial diagnostic tool for screening of TB

suspects. Direct smear, ZN staining technique and Bright field microscopes are used. Two

specimens are examined for diagnosis of pulmonary TB and, for treatment monitoring, one

specimen is examined for AFB smear at the end of 2, 4 and 6 months of treatment.

The initially recommended policy for three sputum specimens was replaced with two sputum

specimens for diagnosis of TB in 2012 as the EQA coverage expanded.

Introduction of LED FM: The Program plans to phase in LED fluorescent microscopy in high

workload laboratories. Support available include 200 LED microscopes through USAID funding,

36 microscopes through Global fund round 9, and 250 microscopes through KFW for KP

province. Training of trainers (TOT) was organized at the NTRL and training is currently in

process at the provincial level.

68

Table 22: LED numbers by donor support and location

Support Number Implementation Sites

Global fund 36 In culture and DST laboratories

USAID 200 High Volume laboratories

KFW 250 All microscopy laboratories KP

Microscopy coverage: The basic microscopy network in the public sector has been established

at RHCs, THQ/DHQ hospital and tertiary care hospitals. To improve access to diagnosis, basic

health units in some districts have also been upgraded as microscopy centres.

By the end of 2011 there were 1197 microscopy centres in 141 districts of Pakistan, including

104 in the private sector, in addition to those supported by GF. In 2012, access to microscopy

services was further improved by expansion in the private sector(GFR-9 support) and 204

laboratories in the private sector were engaged in TB control in the last 2 quarters of 2012 and

24 underutilized centres in the public were closed in 2012 ( 15 in AJK and 9 in FATA).

Table 23: Microscopy services coverage by population

Pro

vince

/

Regio

n

DH

Q

THQ

RH

C

BH

U

TCH

Oth

ers

NG

O/P

VT

ho

sp

Private

labs

Total

Avg.p

op

cov/

DC

Punjab 32 73 293 6 14 50 26 103 597 164597

Sindh 20 46 97 15 8 38 50 56 330 123833

KPK 24 15 73 8 4 59 21 29 233 102293

B. Tan 24 3 38 26 1 13 2 11 118 74833

FATA 7 2 5 2 0 3 0 0 17 246264

GB 3 0 2 1 0 12 4 0 22 54254

AJK 10 4 20 11 0 7 0 2 54 77830

69

ICT - - 2 3 1 1 3 10 100,000

Total 120 143 530 69 30 183 104 204 1381 131421

5.12.2.2 Xpert MTB /RIF assay services

After endorsement of Xpert MTB/RIF assay in December 2010 by the World Health

Organization (WHO) for both HIV-negative and HIV-positive individuals, Pakistan, with financial

support of US (DOS), successfully implemented Gene-Xpert at eleven sites across the country in

2011-2012.

Piloti testing for the diagnostic algorithm for early diagnosis of rifampicin resistance was

completed in December 2012. The National criteria adopted for the use of Xpert MTB/RIF

includes:

All retreatment categories (failure, default, relapse); Persons who have been treated

with anti-TB drugs and in whom pulmonary TB has again been diagnosed

Persons suspected of having pulmonary TB and considered at risk of harboring MDR-TB

bacilli (MDR contact, health care workers)

Immune-compromised individual suspected of having pulmonary TB (HIV positive,

seriously ill or hospitalized )

Children under 15 years of age

In year 2012, a total of 14,862 patient were tested using Gene-Xpert, 9,737 were detected with

MTB and 1,691 were reported as Rifampicin resistant (17.3%). Many challenges were faced in

the implementation of Xpert; these were mainly related to short shelf-life of cartridges,

infrastructure requirement regarding temperature, and uninterrupted power supply (2hour

minimum). Successful implementation requires UPS, room air-conditioner and a refrigerator for

KITs storage

Xpert MTB/RIF assay coverage: Due to the limited number of Xpert machines, priority is given

to PMDT sites providing services for early screening of patients at risk of DR tuberculosis. In

2012, 15 machines were procured by the National TB Control Program (GFR-9) and 10 Xpert

machines were procured by the PTP - KPK (KFW), which are being installed in phased manner.

However, as KP province has more Xpert equipment than PMDT-identified sites, districts with

higher population are also selected for installation.

70

Table 24: Gene-Xpert Expansion Plan

5.12.2.3 TB Culture & DST services

Through GFR-6 and 9 grant resources were secured to establish 6 TB Culture + DST and 16 TB

culture laboratories to provide equal access population in different geographical areas of

Pakistan.

Laboratories are being established by upgrading existing structure to improve bio-safety

conditions and workflow. TB culture and DST laboratories expansion were delayed due to

procedural complexities, and limited technical capacity. Civil work has now been recently

completed in one DST lab (PRL Karachi) and 3 Culture lab including one in Sindh (ICD) one in

Punjab (AHF) one in KP (ATH). TB laboratories performing culture and DST have been

established in the in Private sector. Two main Private laboratories, providing TB culture and

DST services for PMDT program, are located in Karachi i.e TB laboratory in Agha Khan Hospital

Indus Hospital.

5.12.3 TB culture services

TB culture policy: Services are required for bacteriological diagnosis of tuberculosis in smear

negative and extra-pulmonary tuberculosis and monitoring of treatment of patient on second

line treatment.

Diagnosis of smear negative and EPTB cases: There is no clear guideline /diagnostic algorithm

on use of culture for bacteriological diagnosis of smear negative and extra-pulmonary

tuberculosis. Introduction of Xpert MTB /Rif assay has largely reduced the need of culture

laboratories for diagnosis of Tuberculosis.

Nat

ion

al

Pu

nja

b

Sin

dh

KP

K

Bal

uch

ista

n

FATA

AJK

GB

Tota

l

2011 1 5 3 1 1 0 0 0 11

2012 1 6 3 4 1 0 0 0 15

2013/

2014 2 12 8 10 3 6 1 1 43

71

Treatment monitoring of patient on SLD: For DRTB patient enrolled in PMDT, TB culture is

performed every month during the intensive phase and every alternate month during

continuation phase. For every enrolled patient a minimum of 16 cultures are required during

treatment.

Techniques/media: TB culture using solid egg based culture media is used in TB laboratories in

public sector and the same methodologies will be adopted in new culture laboratories. Keeping

in view the cost of liquid culture kits, short shelf life and storage restriction, automate for liquid

culture (MGIT960) will be used in six DST laboratories only.

Culture services coverage: By the end 2013, in addition to the National TB reference laboratory

(NTRL), Indus Hospital, and AKUH, six other TB culture laboratories started performing or

extended culture services for patient enrolled in PMDT. Infrastructure up-gradation work is in

progress in another eight laboratories. It is expected that by the end of 2014 a total of 16 TB

laboratories will be functioning in the public sector and each culture will have capacity to

perform 6000-10000 cultures annually.

Table 25: TB Culture expansion plan

Nat

ion

al

Pu

nja

b

Sin

dh

KP

K

Bal

uch

ista

n

FATA

AJK

GB

Tota

l

2012 1 2 2 1 1 0 0 0 7

2013 1 5 4 2 2

1 1 16

In 2012, 15,000 TB cultures were performed including 9000 for treatment monitoring.

5.12.4 TB DST services

Other than the NTRL, the other planned DST laboratories in the public sector have not yet

started DST services for clinical management. Whereas the NTRL remains heavily engaged in

surveys, DST services for the PMDT program are currently being done mainly through AKUH

and Indus Hospital TB laboratory.

Refurbishment of the planned DST laboratories is underway to improve bio-safety conditions

and it is expected that these 6 laboratories will start functioning as DST laboratories in 2014. All

72

these DST laboratories will be equipped with Liquid Culture (MGIT) and molecular diagnosis of

MDR using line probe assay technique.

5.12.5 National Reference Laboratory

The TB laboratory in the federal TB center of Rawalpindi was designated as the National

Reference laboratory in 2002. While in the struggling phase to develop its technical capacity,

its structure was demolished on administrative grounds in 2005. While the national reference

laboratory played a key role in strengthening the microscopy network and implementation of

EQA, technical functions related to culture and DST remained suspended for four years due to a

lack of space. In 2009 the building was allocated in the premises of the federal general hospital

near NIH. After up-gradation the NTRL started functioning and soon achieved 100% proficiency

for First line DST (16th round of panel testing coordinated by SNRL Antwerp Belgium) and in the

subsequent year achieved proficiency for second line DST as well in the 17th Round. The NRL

maintained its proficiency in subsequent years.

A major accomplishment in 2012 was completion of the Prevalence survey, and the start of the

FIRST NATIONAL DRUG RESISTANCE SURVEY. Currently the DRS survey is in progress, field

work was completed in September 2013 and the interim report will be available by the second

quarter of 2014.

Table 26: Drug resistance pattern at NRL 2012

NEW Cases Retreatment Cases

2009

(Q-4) 2010 2011 2012

2009

(Q-4) 2010 2011

2012

Available DST for

H & R

112 252 186 461 23 118 109 154

Resistant to H

but not R

8 14 13 37 4 10 11 9

Resistant to R

but not H

1 1 0 2 1 3 1 2

Resistant to R+H

(%)

5

(4 %)

8

(3 %)

11

(5.9%)

19

(4.1%)

7

(30 %)

39

(33 %)

28

(25.6%)

55

(35.7%)

73

Besides providing diagnostic services for surveys, the NTRL is also providing TB culture and DST

services to PMDT sites in the capital as well as for adjacent districts of Punjab and KP provinces

(Lady reading hospital and Abbottabad teaching hospital. This is done as interim arrangement

till specific provincial laboratories acquire required capacity.

MDR reported in routine is 3.0- 4.1% in new cases and 30% -35.7% in previously treated cases.

5.12.6 Human resource for laboratory network

HR for Microscopy services: At the district level services are provided by regular laboratory

staff at the health facility and no additional HR is inducted at this level. Similarly, at

intermediate district level (IDL) district TB laboratory supervisors (DTLS) and controllers have

been designated from existing staff who perform TB work along with other tasks. Designated

district staff (DLS and X-checker) are paid small incentives for additional roles assigned for

supervision, logistic supply management and rechecking slides(GF).

However, keeping in view the critical role of Provincial laboratories in supervision and

monitoring , additional human resource was inducted for this level and have been sustained

since 2006 (GFR-6-9).

As per policy minimum one trained lab staff must be available at each Microscopy laboratory.

All training for human resources development for microscopy network (Peripheral and

intermediate laboratories lab staff and district TB coordinated) are conducted in respective

Provincial reference laboratories.

Table 27: Training categories for Microscopy network staff

Training Category Duration Participants Venue

1 Initial training on AFB microscopy 10days Lab staff BMU, IDL,

PRL PRL/NRL

2 Refresher training on AFB microscopy . 3-days Lab staff BMU PRL/NRL

3 Initial Training for QA microscopy 10days Lab staff BMU PRL/NRL

4 Refresher training for QA microscopy 3-days Lab staff BMU PRL/NRL

5 Initial Training for NON lab supervisors 3-Days DTC/DTO, NPO, M and

E officers PRL/NRL

74

During initial DOTS implementation, training was mostly supported through public sector

funding but with passage of time and availability of global fund grants most of training are now

conducted through global fund grants.

Table 28: Laboratory training support in 2012 Cate

gory

Area/

staff

Fed

Pu

njab

Sind

h

KP

K

B-Tan

AJK

NA

FATA

Total

Initial

training

AFB microscopy

(Peripheral lab staff ) 0 53 37 23 28 10 14 0 165

Gene Xpert/AFB

smear 5 7 9 2 3 1 2 0 29

QA AFB microscopy

(DLS) 0 6 0 0 0 0 0 0 6

Non Lab supervisors 0 5 0 0 0 0 0 0 5

Training of Trainer

(LED) 4 4 2 2 2 0 0 0 14

Culture 9 10 5 3 3 0 0 0 30

DST 2 3 2 2 2 0 0 0 11

Refresher AFB microscopy

(Peripheral lab staff ) 0 61 28 32 17 8 0 0 146

DLS 0 6 0 9 0 10 0 0 25

Culture 2 3 0 0 1 0 0 0 6

Xpert services: Currently human resource inducted through GF grant for TB culture/ DST

laboratories were trained in NRL on Xpert and posted to work at Xpert sites.

Culture and DST services: There is a shortage of qualified / trained laboratory staff. Due to

these shortages additional qualified human resource has been inducted for all culture and DST

75

laboratories. Newly inducted staff is then trained in NRL. All training for culture and DST

laboratories is centralized and is organised at NTRL.

5.12.7 Quality management systems within the laboratory network

Quality assurance of microscopy services: The external quality assurance (EQA) by blinded

rechecking remains the corner stone for quality assured microscopy services. The intermediate

laboratory at the district level plays a critical role in EQA activities, preparation and distribution

of lab supplies. Every quarter sample of slides are collected for rechecking during intra-district

meeting

In 2012, 1,179 DCs (including 84 DCs of PPM-GF) in 127 districts were covered by EQA.

Continued support was provided for quality assured microscopy services including human

resource development, participation of laboratory staff in quarterly surveillance meeting and

provision of laboratory supplies.

Figure 10: Microscopy EQA coverage and performance

Table 29: Diagnostic network in Pakistan

1026

1131 1148 1159 1181 1187

1381

324 360

940 1005

1106 1097 1179

95 188

570 640

749 827 840

0

200

400

600

800

1000

1200

1400

1600

2006 2007 2008 2009 2010 2011 2012

# DC # DC under EQA # acceptable performance

76

Mic

rosc

op

y N

etw

ork

Year

Pu

njab

Sind

h

KP

B.T

AN

AJK

GB

FATA

ICT

Total

2005 445 237 163 63 35 11 28 - 982

2006 445 237 181 80 35 18 28 - 1026

2007 472 259 199 102 57 18 24 - 1131

2008 473 262 203 102 62 22 24 - 1148

2009 473 264 199 108 67 22 26 - 1159

2010 486 270 202 108 67 22 26 - 1181

2011 487 274 203 108 67 22 26 - 1187

2012 494 274 204 107 52 22 17 7 1177

2012(PPM-GF)

103 56 29 11 2 0 0 3 204

EQA

co

vera

ge

2006 111 84 71 29 18 11 0 - 324

2007 118 91 81 40 18 12 0 - 360

2008 420 234 200 57 13 2 14 - 940

2009 441 262 191 91 0 0 20 - 1005

2010 482 268 200 93 48 0 15 - 1106

2011 480 268 199 98 53 0 14 - 1112

2012 491 270 201 89 53 0 17 3 1124

2012(PPM-GF)

33 45 5 0 1 0 0 0 84

# o

f C

en

ters

w

ith

ac

cep

tab

le

resu

lt

2006 20 15 31 22 2 5 0 - 95

2007 42 61 49 21 4 11 0 - 188

2008 257 125 124 43 7 2 12 - 570

2009 282 138 127 75 0 0 18 - 640

2010 319 149 149 85 34 0 13 - 749

2011 361 167 133 89 25 NA 13 - 788

2012 368 165 132 74 38 NA 17 3 797

2012(PPM-GF)

28 36 4 NA 1 NA NA NA 69

77

Due to the security situation, EQA activities and reporting of laboratory, performance has been

affected badly in Baluchistan, where 40% failed to report Microscopy laboratory performance

report or participate in EQA activities. Furthermore, EQA in GigitBaltistan has not yet been

implemented.

Impact of EQA: With the implementation of EQA services, the efficiency of microscopy services

has shown gradual improvement with a decline in the proportion of false positive and false

negative reporting. However, still 30% of centers have yet to achieve a level of acceptable

performance.

The slide positivity rate among TB suspects has declined to some extent, which probably is an

indicative of improved suspect referral to laboratories. However, great variation in suspect

positivity rate is seen from district to district and center to center indicating lack of uniform

adherence to National guideline on suspect identification.

Positivity rate among follow-up examination, which is considered a more sensitive indicator of

quality of smear microscopy, is still lower than expected (5-10%) and uniform impact of EQA is

not seen in all districts and provinces.

Table 30: Trend of key laboratory indictors 2006 to 2012

Indicators 2006 2012

Suspect positivity rate 16.6 15.03

Follow up Smear positivity rate 2.4 3.28

Proportion false positive 8.7 2.4

Proportion false Negative 3.6 0.7

Efficiency of microscopy (agreement rate) 94.5 98.5

(Source: NTP annual report 2012)

About 75% of the microscopy centers in the public sector are doing less than 2 smears per day..

National EQA Scheme for DST: The NRL is linked with the SNRL –Antwerp-Belgium and

participates in the annual scheme of EQA of DST as a regular activity organized by the

Supranational Reference Laboratory Network.

The NRL started organizing a national EQA scheme for DST in 2009, Subsets of Panel strains

received from SNRL are sent to willing public and private sector laboratories.

78

Table 31: Participating Laboratories in National EQA Scheme for DST 2012

#

Participating

Laboratories

First National EQA

Scheme-2010

Second National EQA

Scheme-2011

Third National EQA

Scheme-2012

#

participation

#

qualified

#

participation

#

qualified

#

participation

#

qualified

Public 2 - 3 - 4 -

FLD 1 1 2 2 3 1

FL+ SL 1 0 1 0 1 0

Private 2 - 4 - 4 -

FLD 2 1 3 2 3 2

FL+SLD - - 1 0 1 0

5.12.8 Management of laboratory commodities and supplies within the TB laboratory

network

Microscopy services: laboratory commodities and supplies for microscopy services are partially

funded through the public sector and partly through donor funded grants.

More than 60% of microscopes to peripheral microscopy network were provided with support

of federal level public sector and donor funded programme (CIDA + GF)

LED microscopes are provided by USAID for initial roll out to 200 microscopy laboratories and

36 through GF grant for culture and DST laboratories, whereas KFW has supported

procurement of 250 LED microscopes to replace ZN microscopy in all centres.

Xpert MTB/RIF services: 42, 4-module Gene-Xpert machines (including 12 by US(DOS), 15 by GF

(9) and 15 by KFW) and kits are acquired through donor funding. There is no public sector

contribution besides GF (9) for planned procurement of Xpert Kits for next two years.

TB culture and DST services: For scale up of TB culture and DST services beside infrastructure

and human resource, support is also provided for equipment and laboratory commodity and

supplies.

79

In KP, laboratory commodities and supplies are supported through KFW (PRL in Peshawar),

however besides this only a very small fraction of equipment has been provided by provincial

programme in Sindh province. All other laboratories are supported through Global Fund grants.

5.12.9 Laboratory information and data management for the TB laboratory network

Microscopy services: recording and reporting tools are developed for microscopy as well as for

the QA programme; reporting is done on paper form at the district and sub districts level

whereas paper reports are consolidated at the provincial level and entered in a data base

developed in access

A web-based system for collecting TB Laboratory data has been introduced and is managed on-

line www.ntp.gov.pk. The new system allows the NRL as well as the PRL staff to complete the

quarterly routine performance and EQA data collection forms online.

Laboratory staff regularly participate in quarterly meetings held at the district level while the

DLS attend quarterly meetings organized by provincial labs.Xpert Services: specimen request

forms and recording and reporting tools have been developed and are used by staff working at

Xpert sites. Data is maintained in an excel file and shared regularly with the PTP and the NTRL.

Revised reporting and recording (2013) are not yet implemented.

Xpert data is regularly submitted to WHO.

TB culture and DST services: recording and reporting forms are developed and paper forms are

used in established culture and DST laboratories. An electronic recording and reporting system

is not yet developed.

5.12.10 Sample referral system for the TB laboratory network

Although specimen transport has been successfully used in the TB disease prevalence survey

and ongoing drug resistance survey and, to some extent, is now also used for transportation of

specimens from PMDT sites to culture laboratories. However, the transport system is not yet

established for transportation of specimens from BMUs to either Xpert sites or culture and DST

laboratories.

5.13 DRUG-RESISTANT (DR) TB 5.13.1 Overview

Drug resistance tuberculosis (DR-TB) is caused by organisms that are resistant to a first-line or

second-line anti-TB drug. The term DR-TB is used as it covers, in addition to MDR-TB, other

different types of drug resistant TB. Multi-Drug Resistant tuberculosis (MDR-TB) which is the

most common form of DR-TB, is caused by organisms that are resistant to Isoniazid and

80

Rifampicin (two first-line anti-TB drugs). According to Global TB Report 2013, there were

estimated 450,000 New MDR cases in the world in 2012 (range 300,000-600,000). The DR-TB is

a continued threat to the progress that Pakistan has made in controlling TB21.

Pakistan ranks 4th among 27 MDR-TB high burden countries in the world22. According to WHO

Global Report 2013, the 2012 estimated incidence for DR-TB was 3.5% among new TB cases and

32% among retreatment cases. At the same time, the NTP thorough GF support has conducted

and Drug Resistance Survey in 2012-2013; the preliminary results are 4.3% among new cases

and 19.4% among retreatment cases.

Since the Beijing’s call for action in April 2009, the NTP Pakistan has shown its commitment to

address MDR-TB through a structured and comprehensive approach, which includes developing

policies, strategies, guidelines and phased expansion of implementation activities. The NTP has

acted in accordance with the Beijing call to establish a comprehensive MDR-TB programme,

based on the recommendations of the call.

5.13.1 DR-TB estimates in Pakistan

Based on the 2012 National TB Data, using the WHO percentage of TB cases with MDR –TB, the

following table presents the estimates of DR-TB cases in the country:

Based on the National TB Data, using the preliminary results of DRS percentage of Pulmonary

TB cases with MDR-TB, the following table presents the estimates of DR-TB cases in the

country:

Table 32: Estimates of DR-TB in Pakistan 2012 based on WHO estimates

Year New Pul (B+,B-)

Retreatment cases

MDR-TB among notified TB case (using DRS preliminary estimates)

Total MDR estimates

Among New (4.3%)

Among Retreatment (19.4%)

2012 219970 11717 9459 2273 11732

2013 230496 10997 9911 2133 12044

5.13.2 Diagnostic approach to DR-TB

The use of Gene Xpert has been recommended as a first step testing to the following high risk

groups (DR-TB suspects) followed by routine culture and DST for all rifampicin resistant cases.

21

National Guidelines for PMDT, 2011, NTP-Pakistan 22

http://www.who.int/tb/publications/global_report

81

The NTP has recommended that the screening of DR-TB (presumptive TB cases) suspects

should be based on the following criteria (in order of priority):

GROUP I: TB PATIENT / Symptomatic at risk of DR-TB

A. ALL RETREATMENT TB CASES: All TB cases (AFB SS+ve or negative) with history of

previous ATT should be tested for Xpert at month zero of enrolment. This includes:

• Treatment Failure Cat-I (F-1)

• Treatment Failure Cat-II (F-2)

• Relapse after Cat-I (R-1)

• Relapse after Cat-II (R-2)

• Treatment after loss to follow up Cat-1(D-1)

• Treatment after loss to follow up Cat-II (D-2)

• Other Retreatment

B. SYMPTOMATIC CONTACTS OF DR-TB PATIENT:

All household and workplace symptomatic contacts of DR-TB patients should be screed for

RRTB. Specimen from these individuals should be processed for AFB smear and then the

specimen is referred for Xpert MTB/RIF assay irrespective of smear results.

C. TB PATIENTS UNDER TREATMENT WHO FAIL TO CONVERT AT THE END OF INTENSIVE

PHASE

• AFB smear +ve patient on Cat-1 who fail to convert at the end of month #2 of

treatment.

• AFB smear +ve patient on Cat- II who fail to convert at the end of 3 months.

• AFB smear negative Patient who is reported AFB smear positive at the end of intensive

phase

GROUP II: TB Symptomatic among vulnerable population

Screening of RRTB, for early diagnosis and management, is important to all individuals who are

potentially at risk of DR-TB and belong to vulnerable population. The specimen from these

individuals should be processed for AFB smear and then is referred for Xpert MTB/RIF assay

irrespective of Smear results. This group includes:

82

• Children under 15 years of age

• HIV positive

• Other immune-compromised (Diabetic, on immunosuppressive or chemotherapy)

• Injecting drug users

• Contact of TB

• Health Care workers including laboratory workers

• Hospitalized

• Prisoners

Group III: Individual suffering from a Life threatening disease or having difficulty in clinical

diagnosis

• Specimen from individuals suffering from life threatening illness, and at risk of TB,

should be tested with Xpert/MTB Rif assay (eg.CSF).

GROUP IV: AFB Smear Negative Clinically Diagnosed TB cases Not at risk of DR-TB:-

If not listed in any of the groups group mentioned above you may follow the program guidance

on Xpert testing on this group. Program may formulate new or revised policies for this group

based on resources.

The following groups are eligible to be enrolled on DR-TB treatment:

a) Patients detected as Rifampicin resistant on Gene Xpert.

b) Patients who have been confirmed to have DR-TB by DST

c) Patients with strong suspicion (high likelihood) of DR-TB (in absence of Gene-Xpert, the

patient might be enrolled on treatment while waiting for DST results).

83

5.13.3 Procedures for DR-TB enrolment, and follow-up management

The following procedures are used for enrolment of DR-TB on treatment:

a- An Initial meeting at the PMDT site with the DR-TB treatment coordinator

and management team to review all referring documents, laboratory and

radiological testing, perform all the clinical and laboratory examinations, fill

out all the necessary forms for enrolment and registry, evaluate the medical

conditions of the patient and decide on the best mode of care (Ambulatory

vs Hospitalized based), educate the patient about DR-TB treatment and care

and write a prescription order to the pharmacy to prepare for drugs. This

initial meeting will be followed by another visit after 2 weeks to ensure that

all elements of DR-TB management are taken care of and to make sure that

patient is doing well. The PMDT treatment site, along with PTP, DTC and DTO

will work together to identify the nearest DOT center (BMU), the treatment

supporter for DOT and monitoring & evaluation.

b- Patient’s Follow Up schedule at Month 1 – 8 of treatment after Enrolment

(Intensive Phase management):

The DR-TB patient, accompanied by treatment supporter, is expected to visit the nearest DOTS

center or PHC on a weekly basis during the Intensive Phase of treatment for early detection and

management of any adverse reaction and drugs replenishment, if applicable. The treatment

supporter administers each dosage under strict DOT.

On the other hand, the patient and treatment supporter are instructed to visit the PMDT site on

a monthly basis during the Intensive Phase of treatment for comprehensive review, laboratory

testing including monthly sputum for smear microscopy and culture, detection and

management of any adverse reaction and replenishment of drugs on a monthly basis.

c- Evaluation of DR-TB Patient’s Progress at the end of Month-8 of treatment:

At the end of Month-8 of treatment, the patient meets with the DR-TB clinician to review

eligibility for switching from the Intensive Phase to Continuation Phase management if the

patient has completed at least 8 months of injectable with at least 6 months of treatment after

culture conversion. If the patient did not meet the above criteria then the intensive phase will

be expanded until such a time when the patient meets the recommended criteria.

d- Patient’s Follow Up Visits to the PMDT site after the discontinuation of

Injectable (Continuation Phase management):

84

After the discontinuation of the injectable, the DR-TB patient, accompanied by treatment

supporter, is expected to visit the PMDT site every other month (unless otherwise indicated) for

the same above. Follow Up work up is listed in point #b.

5.13.4 Treatment selection of DR-TB cases23

In principle the following criteria (table below)can be used as guiding principles in treatment

selection which is in line with the National Guidelines of DR-TB management, WHO and other

well know International Guidelines for DR-TB (For more information on treatment selection,

please refer to the National Guidelines for DR-TB management):

Patient previous SLD history and DST Treatment Selection

Patient did not use SLD before (or not

found to be resistant to)

8Am-Lfx-Eto-Cs-Z+ B6 /16 Lfx-Eto-Cs-Z+ B6

Patient received FQ previously (or found

to be resistant to FQ)

8Am-Lfx-Eto-Cs-PAS-Z+ B6 /16 Lfx-Eto-Cs-PAS-Z+B6

patient received Am or Km previously

(or found to be resistant to Am or Km)

8Cm-Lfx-Eto-Cs-Z+B6 /16 Lfx-Eto-Cs-Z+B6

5.13.5 Second-line drug management

Since the beginning of the National MDR program in 2010, Second Line Drugs (SLDs) have been

procured through GDF mechanism. Drugs are shipped and stored at the central warehouse in

Islamabad and from there the drugs are dispersed on a quarterly basis to the various PMDT

sites based on the National MDR Program Enrolment Plan for new cases as well as the needs for

the patients who are already on treatment. The Drug Management (DM) Cycle is properly

managed through the Central DMU in close collaboration with the International MDR

Consultant, Central MDR unit, Provincial Officers and PMDT sites managers.

Reporting and recording tools have been developed for regular monitoring and evaluation of

SLD throughout the entire program which include, but not limited to, the following reports:

23

National MDR Expansion Plan for 2013 – 2017, NTP Pakistan

85

A monthly Computerized Central Warehouse inventory, bin card and stock balance

report.

A monthly PMDT Stock balance and matrix reports reflecting the monthly

consumption rate and stock balance at each treatment site.

A monthly update of the DR-TB Register (ENRS) for monitoring and evaluation new

and current enrolled patients’ treatment and follow up progress.

the NTP receives these reports on a monthly basis for proper analysis, verification, early

detection and immediate management of any possible stock out or drugs with short expiry

dates.

The NTP uses the following combined SLD procurement methods:

1- An Excel based calculated sheet reflecting the various treatment regimens and the

percentage of the new cohort using these regimens.

Table 33: SLDs for DR-TB patients recommended by NTP

Treatment regimen percentage of the

cohort using this

regimen

8 Am-Lfx-Cs-Eto-(PAS)+Z / 16 Lfx-Cs-Eto-(PAS)+Z. 85%

8 Cm-Lfx-Cs-Eto-(PAS)+Z /16Lfx-Cs-Eto-(PAS)+Z. 10%

Number of patients will need PAS 75%

8 Cm-Mfx-Cs-Eto-PAS + Z + Clr +Clo+Amo-Clav / 16Mfx-

Cs-Eto-PAS+ Z+ Clr+ Clo +Amo-Clav. 5%

2- An estimated SLD needs for the patients who are already on treatment at the time of

placing a SLD order request.

86

Table 34: SLDs need assessment

Dru

g

Form

Do

se**

Un

its***

No

. o

f D

ays

(Mo

nth

s)

Total U

nits/ P

atient

Total

No

. o

f

Patien

ts R

eceivin

g

the D

rug

Total

Ad

justed

R

equ

est/

for

the

first 12

mo

nth

s o

f

treatmen

t

Pro

du

ct

Per D

ay

Patien

t

will

take

dru

g

Req

uest/U

nits

A B C =A*B D E=C*D F*

Amikacin Amp 500 mg 2 240 (8) 480 0 0 0

Capreomycin Amp 1 gm 1 240 (8) 240 0 0 0

Levofloxacin Tab 250 mg 2 720 (24) 1440 0 0 0

Levofloxacin Tab 500 mg 1 720 (24) 720 0 0 0

Ethionamide Tab 250 mg 3 720 (24) 2160 0 0 0

Cycloserin Tab 250 mg 3 720 (24) 2160 0 0 0

P-aminosalicylate

sodium 60% (PAS)

Jar /

100

gms

each

9.2 gms

twice

/day 18.4 720 (24) 13248 0 0 0

Others products

Z Tab 400mg 4 720 (24) 2880 0 0 0

B6 Tab 50 mg 3 720 (24) 2160 0 0 0

87

5.13.6 Criteria to establish a programmatic management of DR-TB (PMDT) treatment site

The NTP Pakistan has established standard criteria for a DR-TB site:

a) Functional Gene-Xpert machine or access to the machine for testing suspected DR-TB

cases.

b) Establish TB culture and DST services or access to the services.

c) Infection control for outpatients, inpatients and community care of DR-TB cases in

place.

d) Access and ability to manage second line drugs.

e) Senior and mid-level doctors, paramedics and laboratory staff with role-specific training

and tools for delivering care as per national guidelines.

f) Arrangements to deliver Ambulatory based Model of Care of DR-TB care and established

linkage with a strong network of functioning DOTS clinics in public as well as private

sector.

g) Social support arrangements for patients and treatment supporters.

5.13.7 DR-TB guidelines and materials

The NTP has developed a set of materials and guidelines to structure the delivery of DR-TB care

through public and private sector hospitals. The materials include;

- National Guidelines on PMDT

- National TB Infection Control Guidelines

- Guidelines for management of second-line drugs

- DR-TB Recording and Reporting Tools (17 tools)

5.13.8 NTP/PTP arrangement for management of DR-TB initiative

The NTP has a fully established unit to manage the MDR-TB initiative at the national level.

Under the overall management of the National Manager, the MDR-TB unit is led by a National

MDR-TB coordinator supported by an international consultant. MDR-TB management is

implemented throughout the country with 5 sub recipient to the Global Fund grant. These

recipients are responsible for establishment and preparation of the MDR-TB management unit

(HR, training and logistics etc).

88

The provincial TB control programs, with the support of Global Fund grants, have been provided

with Provincial MDR-TB Coordinators and office assistants. The responsibility of the PTP is to

ensure the proper implementation of DR-TB programme.

5.13.9 Contribution of PMDT sites: National

By the end of 2013 18 PMDT treatment sites have been functional in the tertiary care hospitals

in the country whereas by September of 2014, 12 more PMDT sites are scheduled to be

prepared to begin enrollment of DR-TB case in different provinces of the country. Eighteen

additional PMDT sites, 12 in 2016 and 6 in 2017, are required for the MDR Expansion plan. The

current intervention is supported by the TGF Round 9 grant until mid 2015.

89

Table 35: Province wise PMDT sites and cases (2012)

S.# Province SR PMDT Sites / Hospitals Public/ Private

Status Date PMDT Started

1 ICT ASD PIMS Hospital, Islamabad Public Functional Nov-2013

2 Sindh IHK Indus Hospital, Karachi Private Functional June 2010

3 Sindh NTP/PTP Ojha Hospital, Karachi Public Functional June 2010

4 Sindh IHK Institute of Chest Diseases, Kotri

Public Functional Q1 2013

5 Sindh IHK Civil Hospital, Sukkur Public Functional Q1 2013

6 Sindh IHK JPMC Hospital, Karachi Public Functional June-2013

7 Sindh IHK DHQ Hospital, Nawabshah Public Q-3, 2013 Non-Functional

8 Sindh IHK CMC Hospital, Larkana Functional June-2013

9 Sindh IHK DHQ Hospital, MirpurKhas Public Q-3, 2014 Non-Functional

10 Punjab NTP/PTP Gulab Devi Hospital, Lahore Private Functional June 2010

11 Punjab ASD Leprosy Hospital, Rawalpindi Private Functional June 2011

12 Punjab ASD Nishtar Hospital, Multan Public Functional Q1 2013

13 Punjab ASD Mayo Hospital, Lahore Public Functional Q1 2013

14 Punjab ASD Samli Sanatorium, Murree Public Functional Q1 2013

15 Punjab ASD Jinnah Hospital, Lahore Functional June-2013

16 Punjab ASD Allied Hospital, Faisalabad Q-2, 2013 Non-Functional

17 Punjab ASD DHQ Hospital, Sargodha Public Functional Sept-2013

18 Punjab ASD DHQ Hospital, Bahawalpur Public Q-1, 2014 Non-Functional

19 Punjab ASD DHQ Hospital, Sialkot Public Q-2, 2014 Non-Functional

20 Punjab ASD Holy Family Hospital, Rawalpindi

Q-2, 2014 Non-Functional

21 Punjab ASD Sheikh Zaid Hospital, Rahim Yar Khan

Q-3, 2014 Non-Functional

22 Azad Kashmir ASD District Head Quarter, Muzaffarabad

Public Q-3, 2014 Non-Functional

23 KPK ACD Lady Reading Hospital, Peshawar

Public Functional March 2012

24 KPK ACD Ayub Teaching Hospital, Abbottabad

Public Functional Q1 2013

90

Note:As of end of July 2013, the total number of enrolled cases was 2,210.

5.13.10 DR-TB culture services

In 2012, 6 laboratories in the country were performing DR-TB culture services. So far 15,260

cultures were performed for patients in culture facilities linked with PMDT sites. It is expected

that 15 more will be operational in 2013, and 23 laboratories in 2015, with the support of GF.

Table 36: Province wise TB culture sites and diagnosis and follow-up performance

Sr.# Site/ Hospital Culture Performance

Total Diagnosis Follow-up

National

1. NRL 2233 2218 4451

Punjab

2. PRL-Punjab 1337 404 1741

3. GDH 1025 1313 2338

Sindh

4. PRL-Sindh 1005 4531 5536

25 KPK ACD DHQ Hospital, Swat Public Q-2, 2014 Non-Functional

26 KPK ACD DHQ Hospital, DI Khan Public Functional Sept-2013

27 GilgitBaltistan ACD District Head Quarter, Gilgit Public Q-3, 2014 Non-Functional

28 Baluchistan IHK Fatima Jinnah Hospital, Quetta Public Functional Q1 2013

29 Baluchistan IHK DHQ Hospital, Turbat Public Q-1, 2014 Non-Functional

30 Baluchistan IHK DHQ Hospital, Khuzdar Public Q-3, 2014 Non-Functional

91

KPK

5. PRL-KPK 540 279 819

Balochistan

6. PRL-Balochistan 86 289 375

Grand Total 6226 9034 15260

5.13.11 TB drug susceptibility testing laboratories

Currently, 7 laboratories are providing TB drug susceptibility testing services (BSL-3 level) in the

country. There are plans to upgrade 8 more laboratories to BSL-3 in 2013.

Table 37: TB DST expansion plan 2013

Provinces/ Regions 2012 2013 Total 2013

Federal/National 1 - 1

Punjab 2 2 4

Sindh 2 2 4

KPK 1 1 2

Balochistan 1 1 2

AJK - 1 1

GB - 1 1

TOTAL 7 8 15

(Source: NTP Draft Annual Report, 2012)

5.13.12 XPERT sites

Currently Xpert services are available at 11 (2011) and 15 (2012) sites/hospital in the country.

NTP is planning to extend these services in 42 labs in 2013.

92

Table 38: Status Gene Xpert tests (2012) and expansion plan (2013)

Sr.# Name of site/

hospital (2012) Public/private Gene Xpert performance 2012 Planned

sites 2013 # tests # RR %RR

Federal/National 2

1. NRL (NIH) Public 3161 321 10%

2. PMRC Public 6 4 67%

Punjab 12

3. RYK Public 148 16 11%

4. NMC-Multan Public 272 97 36%

5. Allied Hospital-

Faisalabad Public 120 19 16%

6. GDH- Lahore Private 810 289 36%

7. Jinnah Hospital

Lahore Public 112 13 12%

Sindh 8

8. PRL Karachi- Ojha

Institute Public 2496 278 11%

9. Kotri Public 578 200 35%

10. Larkana Public 344 85 25%

KPK 10

11. LRH Public 705 208 30%

12. PRL KP Public 306 53 17%

13. MMC Public 48 8 17%

93

14. KTH Public 282 21 7%

Balochistan 3

15. PRL Quetta Bolan

Medical Complex Public 236 76 32%

TOTAL 1688 18%

Proposed, 2013

FATA 5

AJK 1

GB 1

TOTAL (2013) 42

(Source: NTP Draft Annual Report, 2012)

5.13.13 Infection control services

Acquisition of TB among health care workers as well as hospital-based outbreaks of MDR-TB is

known. The risk is high in Pakistan, where the disease burden is considerable and the quality

infection control services are non-existent. It is known that with simple and inexpensive TB

control measures disease transmission can be reduced considerably. The NTP has given its

policy guidelines on implementing control of TB transmission in health care setting at three

levels.

a) Administrative control; which will reduce health care worker and patient exposure to

infection

b) Environmental control; which will reduce the concentration of infectious droplet nuclei

c) Personal respiratory protection; which will protect health care workers in areas where

the concentration of droplet nuclei cannot be adequately reduced by administrative and

environmental controls.

A comprehensive infection control plan has been launched in line with GF-9 grant. In the first

phase 10 facilities will be completed by mid 2013. The second batch of 8 facilities have been

assessed and work is currently in process. A total of 30 sites will be up-graded by the mid of

94

2014. At the meantime, DR management has already started in some of these sites while

infection control upgrading is going on.

The hospital facilities shall be upgraded keeping Infection Control Principals in view and this

process includes establishing waiting areas separately for MDR Patients, improvements in

Milieu Interior of hospitals including Out-patient departments, MDR wards, X-ray department,

Procedure & Bronchoscopy suites, XDR rooms with Installations of HVAC units where ever

required.

5.13.14 Social support services

TB patient compliance to treatment both in sensitive and drug-resistant TB is a known problem.

In the case of treatment for DR-TB the patient has to take the medicine and injectables for two

years which is a significant challenge, not only for the patient but also for the care

givers/families who are supporting him/her in this treatment. Keeping in view the above stated

factors, and to enhance the compliance of patient to treatment, the NTP is offering social

support to DR-TB patients as well as their treatment supporters.

Each DR-TB patient is provided with a “food basket coupon” and “travel reimbursement” on

his/her monthly follow-up visit to the hospital. The patient is initially hospitalized for 1-2 weeks

if indicated and after that the patient is managed on an ambulatory base with the help of a

treatment supporter and visits the hospital for follow up (clinical & lab evaluation and provision

of medicine) on monthly basis. The NTP is providing social support package (essential food

items) to patient and treatment supporter on their monthly visit to treating hospital. In addition

to the social support package, the DR-TB patient is also provided with travel expenses. The

social support packages are procured from utility stores and provided to patients and treatment

supporters through peripheral outlets.

The social support provision has definitely enhanced treatment adherence and reduced the

number of “lost to found” cases. In view of this, NTP plans to continue this support to DR TB

patients in future also.

Currently, the social support program in Pakistan contains:

a) Each patient receives a monthly food basket, which costs today $22.88, and travel

incentive of $6.53.

b) Each Treatment Supporter receives also a monthly food basket (same value as above)

with no travel incentive.

95

5.13.15 MDR- training

The NTP has currently conducting training for the following categories at various PMDT sites

and districts through the implementing SRs. The NTP has initially trained master trainers from

the national and provincial programs and partners who are responsible for scale-up trainings.

Table 39:Category and training days for DR-TB

Sr.No. Category of training Training Days Average Batch size

1. Professors, senior registrar and registrar 2 5 participants

2. Doctors 6 10

3. Paramedics 4 15

4. Treatment Supporter 2 15

5. Data Management 4 10

6. SLD Management and Warehousing 4 25

5.14 PUBLIC-PRIVATE MIX 5.14.1 Overview

In most resource-poor countries with a high TB-burden, patients with symptoms suggestive of

tuberculosis (TB) seek care from a wide array of health-care providers. These care providers,

often not linked to National Tuberculosis (NTP), serve a large proportion of TB suspects. The

size, types and roles of these care providers vary greatly within and across countries. In some

settings, there is a large private commercial sector and numerous non-governmental

organizations (NGOs) while in others there are public sector providers (such as general and

specialized hospitals) that operate outside the scope of NTPs. Evidence suggests that failure to

involve all care providers used by TB suspects and patients hampers case detection, delays

diagnosis, leads to inappropriate and incomplete treatment, contributes to increasing drug

resistance and places an unnecessary financial burden on patients. Engaging all relevant health

care providers in TB care and control through public-private mix approaches is an essential

component of the World Health Organization's (WHO's) Stop TB Strategy. Currently, nearly all

high TB burden countries are implementing PPM activities and it is one of the priority strategic

areas of Stop TB plan 2006-2015.

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Reports from countries and several project evaluations have shown that PPM has supported in

increasing case detection (between 10% and 60%), improving treatment outcomes (over 85%),

reaching the poor and saving costs. Effective PPM could help NTP in detecting and curing all TB

cases, not just 70/85 and progressing from "care" to "cutting transmission".

Tremendous progress has been made in Pakistan for tuberculosis control in recent years

through implementation of DOTS. It has been acknowledged that TB control efforts are

impressive but, not sufficient. The CDR remains 63% means missing at least 37% of the patients.

As in most countries with a significant burden of TB, DOTS implementation is limited largely to

public sector services under national tuberculosis programs (NTPs). In reality, however, many

patients with symptoms of TB, including the very poor, do seek and receive care from a wide

variety of health care providers outside the network of NTP services mostly not following

National Guidelines. Thus the TB patients they serve are deprived of the benefits of DOTS and

poses an obvious risk of drug resistant TB.

5.14.2 NTP/PTP model of PPM

Since 2010, the NTP/PTPs, in collaboration with its partners, are implementing a district led

model of PPM in almost 50% of Pakistan i.e. 62/133 districts in five provinces of Pakistan, AJK

and ICT. This initiative is supported by the Global Fund, with Mercy Corps as the Principal

Recipient. The NTP/PTPs are planning to expand the model of PPM to the entire country by

strengthening current partners and bringing more partners into PPM. The figure below

presents the key features of the NTP/PTP model of PPM.

There are basic six types of models24 which exist currently under the PPM and are contributing

in increasing case notification and treatment success.

1. District led model: The model has the main stewardship with the district health

authorities, District TB coordinator has a pivotal role . All the TB related activities and

implementation is done through the public sectors. The NGO supporting the project has

mainly a role of coordination between the GPs and the Public sector, providing logistics

for the project and organizing community awareness activities.

2. NGO led model: The model is experienced mainly in Punjab where Pakistan Anti TB

association has a large network which mainly provide TB care, self operated , supported

by local philanthropists. The AKHSP is working in GB and MALC is operational with few

centers in Sindh.

24

NTP Pakistan, National Guidelines for Public Private Mix in TB-DOTS

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3. Social franchising: Franchise network of Green Star Social Marketing and 1000 GPs are

engaged mainly in five metropolitan cities.

4. Large private hospitals: Includes large private hospitals and private Tertiary Care

Hospitals e.g (Gulab Devi and Indus). The large private hospitals are engaged with PTPs

which directly supervises the TB DOTS implementation, provides drugs & trainings, and

generates quarterly reports e.gGhurki trust hospital, Bethania hospital etc

5. Parastatal Model: Includes Social Security, Faujifoundation ,Wapda, Railways

Cantonment hospitals and other Parastatal in all the four provinces of Pakistan

6. Engagement of Pharmacies in TB control : This has been piloted in four large urban cities

of Pakistan to develop referral linkages between pharmacies and service delivery points.

For the purpose of this document, the six models are grouped as:

a) Public- private i.e. between NTP/PTP and the private sector (mainly non-government

organizations ‘NGOs’ hospitals, private hospitals, GPs and private hospitals and health

centers)

b) Public-public i.e. between NTP/PTP and other public sector hospitals (Teaching/Tertiary

and general hospitals, prison and social security organizations)

There are other key organizations and settings in the country which can play a potentially

significant role in fight against TB both in urban and rural settings. This includes;

- Armed forces hospitals

- PRSP/PPHI (managed primary health care facilities in the rural settings)

- Pharmacies

- Workplace TB care

PPM also implies engaging relevant care providers in prevention and management of MDR-TB

and in the implementation of TB/HIV collaborative activities, which the NTP is considering to

implement. The potential role of PPM in MDR and TB/HIV is discussed in the relevant sections.

5.14.3 PPM guideline and materials

The NTP has developed a set of materials and guidelines to structure the delivery of TB care

through PPM. The materials include;

- National Guidelines for Public Private Mix in TB-DOTS

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- Case management guidelines and training modules for private providers

5.14.4 Contribution of PPM: National

The figure below presents the PPM contribution of TB cases all types over years in comparison

to the public sector.

Figure 11: PPM contribution in total case notification NSS+ (2001-2012)

(Source: NTP Pakistan data base)

It has been observed that since 2009 the cases notification from PPM is almost stagnant, while

the resources (anti-TB drugs, funds for training, materials, M&E) provided by the NTP/PTPs to

the partners to implement the PPM remained uninterrupted. The possible reasons which may

explain this situation is that the existing partnerships established with GPs, NGOs, Hospitals, etc

are currently not contributing to their optimal capacity due to several issues such as lack of

incentives, minimal human resources available for implementation, inconsistent quality of

training and monitoring. The extent of partnership is also small, and it is mainly focused on the

urban areas and there are quality issues and high rates of attrition. It is plausible to consider

new partnerships in this context by addressing the unreached population in the rural/peri-

urban areas.

99

Figure 12: Case notification: Public - Private 2012

(Source: NTP data base)

Figure 13:PPM CONTRIBUTION NSS+ –ALL PROVINCES (Q1 2013)

5.14.5 Contribution of PPM: Province wise

The figure below presents the province wise contribution of PPM. It has been observed that

most of the case notification is coming from the province of Punjab where the most number of

partnerships currently exits whereas, the contribution from Balochistan is almost negligible

18%

67%

2%

13% 17%

74%

1%

8%

0%

20%

40%

60%

80%

KPK Punjab B,Tan Sindh

NSS+ All

Public 89605 (81%)

Private 20940 (19%)

NSS+

Public Private

Public 228122 (80%)

Private 57288 (20%)

All Type

Public Private

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where the partnerships are also few. One possible reason for limited partnerships in

Balochistan is due to its geography, which is mostly rural and difficult to access areas.

Innovations are required in Balochistan to increase the number of partnerships so that PPM

contributions to increase the case notification can get visible.

Figure 14: Province wise PPM contribution: TB new sputum smear positive cases/ all types

(Source: NTP Pakistan data base)

5.14.5.1 Public- Private

The partnership is between NTP/PTPs and the private sector. This constitutes those health

centres which are either private sector owned or public sector health centres being managed

by the NGOs. These are mainly outdoor facilities, but few centres also have admission facilities

available. Moreover, it constitutes private hospitals most of which are specialized TB hospitals

or have a TB unit with both indoor and outdoor facilities and General practitioners (GPs)

Existing partners:

Four main networks of non-government partners ‘NGOs’ which are currently offering TB

services under NTP/PTP partnership are:

- Pakistan Anti-TB Association (PATA)

- Aga Khan Health Services Pakistan (AKHSP)

- Marie Adelaide Leprosy Center (MALC)

- Private sector hospitals

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Punjab (6):GulabDavi, Marie Adelaide Leprosy Hospital, GTH, FMH, AllamaIqbal Memorial

Hospital, Bethania Hospital

Sindh (7):FatemaBaqai Hospital, Shoukat U Hospital, Sir Syed Medical University & Hospital,

Indus Hospital, Bantwa Hospital, Murshid Hospital, Kharadar Hospital

Balochistan (1):Al Shifa Hospital

KPK(4): Mission hospital (2), Kuwait Hospital, Kai Hospital,

(Source: NTP consolidated data, 2012)

- Clinics run by General Practitioners (GPs)

- Laboratories in major cities

Number of GPs

The table below shows the number of GPs involved in each province and regions of Pakistan.

Table 40: GPs involved in TB care by province, 2013

PROVINCE GPs

ENGAGED REPORTING

AJK 52 8

BALOCHISTAN 124 28

FATA (FR/AGENCY) - -

GB 34 -

KPK 213 160

PUNJAB 1130 527

SINDH 669 442

ICT 22 14

PAKISTAN 2244 1179

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Arrangements:

The PATA has a countrywide network of 83 diagnostic centers (basic TB management unit),

whereas AKHSP runs a network of 24 diagnostic and 48 treatment centers in various parts of

the country. The MALC has about 15 centers, mainly in Karachi and Sindh. In addition, MALC

also supports DOTS in about 140 public sector centers mainly in Azad Jammu Kashmir and

Northern areas of Pakistan. The NGO partners manage staff inputs as well as facility operations

for TB care through their own resources which includes anti-TB medicines and microscopy. The

NTP/PTP contributes by supplementing anti-TB medicines for routine cases and laboratory

supplies, print materials and monitoring support. The non-government partners do face

challenges in sustaining the inputs and operations in the absence of additional project

resources.

For GPs: The NTP/PTPs are providing anti-TB drugs, trainings and monitoring and surveillance

support. The private partners are managing their centres with their human resource,

infrastructure and laboratory equipment and supplies. They are in compliance with the NTP

policy of providing free drugs and sputum smear microscopy to TB patients.

Through support from the Global Fund under the SSF grant, the PPM model is currently being

implemented in 62 districts including 5 metropolitan cities. Mercy Corps is the principal

recipient for this grant with six NGOs implementing the PPM model in these districts which

include; Green Star Marketing (GSM), Bridge, PYLC, Association for Community Development

(ACD), Association for Social Development (ASD) and Mercy Corp (MC).

In the PPM model there are solo laboratories attached with the private hospitals, which are

strengthened to support the GPs in diagnosing TB. The Private labs are enabled through GF

support and are linked with GPs to provide diagnostic support at subsidized rates.

Contribution:

The PATA is currently reporting from its 51/83 health centers [Punjab (34), Sindh (5), KPK PATA

(12) and Anti-TB association Geneva (3)] whereas, AKHSP is reporting from 21 of its health

centers [(Punjab (4), Sindh (9), KPK (8)]. The annually register about 11,000 and 500 smear-

positive TB cases, with treatment success rate of 90% or more (i.e. about 11% and 0.5% of

national registration respectively). MALC centers [(Sindh (11), KPK (2)], Dioces of Hyderabad [(

Sindh (4)], Bahbood Association [(Sindh (2)], register and treat about 3,500 new smear-positive

cases each year (i.e. about 3.5% of national registration). Based on the ongoing experience, this

sector is currently managing about 15% of the registered new smear-positive TB patients (NSS+)

in the country.

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The situation is not very convincing. Only three types of partnerships are providing the major

20-30% contribution to the overall case notification, whereas all others are contributing less

than 5% in overall case notification. This poses a strong challenge to the NTP/PTPs to review the

strength and weaknesses of current low performing PPM management partners and to

incorporate learning from successful experiences and models into current implementation.

Table 41:Type and number of PHC facilities being management by PPHI/PRSP in Pakistan

Type/number of PHC facility Estimated

RHC BHU MCH Dispensary Population

coverage

Balochistan(30

districts) 1 563 - 4 1,128,000

GB - - - - -

KP(13/24 districts) - 425 - - 2,125,000

Punjab(14/36

districts) - 923 18 212 23,525,000

Sindh(21/23

districts) 9 647 34 435 14,781,520

AJK - - - - -

ICT - - - - -

FATA - - - - -

5.14.5.2 Public-Public

The partnership is between NTP/PTPs and other public sector hospital.

Existing partners (Other public sector Hospitals):

The other public sector organizations offer free health care to their entitled employees and

families through respective infrastructure. The entitlement of employees and their families

makes this more accessible and thus a preferred source of medical help. The NTP/ PTPs are in

partnership with various type of semi-government or autonomous organizations which are

implementing TB care in their respective hospitals. Other public health sector organizations

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offering health services include: railways, social security, Fauji Foundation, army, police, prisons

etc. About 10 million (i.e. 6%) of the country population is covered through other public sector

health services.

The National TB Control Program has already established partnership with four other public

sector institutions i.e. Social Security, Railways, Fauji Foundation and prisons. In first phase,

total 29 hospitals run by three institutions and a network of prison health facilities in all parts of

the country are enabled to provide quality care to the population of about 8.5 million people.

This has improved the access to quality DOTS care for about 5% of the country population,

benefiting about 10,000 TB patients each year. In subsequent years, further expansion will be

planned in light of these experiences.

Currently following other public sector hospitals are working under PPM model in various

provinces:

Punjab (8): Railway Hospital Lahore, SSH Shadara Lahore, SSH Rawalpindi, Railway Hospital

Rawalpindi, SSH Sialkot, SSH Gujranwala, SSH Multan, PESSI Lahore

Sindh (4): Railway H Kch, Railway H Sukkur, SESSI ValikaKch, SESSILandhiKch

Balochistan:

KPK: (10): Cant General, F.GovtHospt, Jail Haripur, Jail Peshawar, Police Hosp, Railway Hosp,

SS Hosp, WapdaHosp, PTCL, Fouji Foundation

Table 42: Type and number of facilities: Armed Forces

Type/number of Hospitals Estimated

CMH PAF PNS MH Population coverage

Balochistan 4 - - -

GB 2 - - -

KP 12 - - -

Punjab 14 2 - 1

Sindh 6 2 2 -

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AJK 2 - - -

ICT - 1 1 -

FATA - - - -

National (TOTAL) 40 5 3 1 620,000 (active

personnel)

Table 43: Type and number of facilities: Fauji Foundation

Type/number of Hospitals/H.F OPD cases

Urban Semi-

Urban Rural

Medical

centers/Disp

Outdoor patients

(2012)

Balochistan - - - 2 47,292

GB - - - 2 34,344

KP 1 - 1 10 236,033

Punjab 2 5 1 29 1,377,893

Sindh 1 - 1 11 415,969

AJK - - - 2 21,936

ICT - - - - -

FATA - - - - -

National (TOTAL) 2,133,467

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Table 44: Type and number of facilities: Social Security

Hospitals Medical centers/other

Balochistan - -

GB - -

KP 1 28

Punjab 11 -

Sindh 4 5

AJK - -

ICT 1 -

FATA - -

National (TOTAL) 17 33

5.15 DRUG MANAGMENT The National and Provincial TB Control Programs provide uninterrupted, quality-assured, and

free of cost anti-TB drugs to every enrolled patient in the county. The NTP with the support of

the Global Fund is implementing a multi-dimensional program to procure essential anti-TB

drugs, upgrade and refurbish national, provincial and district warehouses, train public and

private healthcare providers on TB Drug management and strengthen the drug management

information system for TB across the country.

5.15.1 Operational Arrangements

At NTP, a Drug Management Unit has been established looking after all anti-TB drugs (FLDs,

SLDs, Ancilliary drugs) management related issues including procurement and storage,

distribution, correspondence with partners and implementers, monitoring & implementation of

TB-DMIS and developing and implementing drug management guidelines across the country.

Drug Management Unit ensures the implementation of a TB pharmaceutical management

system which involves four basic functions: selection, procurement, distribution, and use.

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5.15.2 TB Pharmaceutical Management (Drug Management) Cycle:

Selection involves choosing high-quality TB medicines, appropriate dosage forms (e.g., fixed-

dose combination [FDC] medicines) and appropriate packaging, such as patient kits. The TB

drugs are included in the Pakistan national essential medicine list and registered in the country.

ATT medicines are selected in accordance with the latest National Model List of Essential

Medicines, particularly in the form of FDCs, and the latest TB treatment guidelines for National

TB Control Program.

Quantification and forecasting of ATT drugs is based on case notification. However, other

factors are also taken into consideration like available stock position, consumption pattern,

expiry of the drugs and supplies in pipeline.

Procurement of ATT medicine are ensured through selecting appropriate procurement

methods, managing tenders, establishing contract terms, ensuring adherence to those terms,

and assuring pharmaceutical quality. At federal level through donor supports NTP procures

selected medicines through WHO / GDF mechanism from manufacturers and suppliers whose

products meet the WHO prequalification program standards to ensure transparent and cost-

effective procurement of quality goods and services. Provinces procure ATT drugs from their

provincial allocations as per the rules set forth by Provincial Procurement Committee.

Storage & Distribution: The procured medicines are distributed to the service delivery points on

time and in the right quantity, to ensure proper inventory control, and stored under the

recommended storage conditions.

Storage: One of the considerable achievements of the NTP, under Round-8 GF Grant, was a

successful refurbishment of its warehouses and stores across the supply chain. To achieve

optimal storage conditions, the NTP has provided and installed the supplies mandatory for a

warehouse or a store’s conducive environment i.e. Air-Conditioner, Pallets, Racks, Exhaust Fans,

Hygrothermometer, fire-extinguisher etc. to all the 141 warehouses across the country (that

include central, provincial/ regional and district stores).

Currently all the drugs (FLDs, SLDs, Ancillary & Pediatric) and laboratory supplies are stored at

the central, provincial, district and MDR sites’ warehouses/ stores. At the Central level, the NTP

has leased a warehouse, with sufficient storage space up to ten thousand square feet and

where WHO recommended good storage practices are being followed, to house all TB Drugs.

Distribution and supply mechanism:

The FLDs are supplied with standard blister and defined pack size hence does not require any

re-packaging while distributing further to provinces/ districts.

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These TB drugs are then distributed to each Provincial and Regional TB Control Program

according to the need communicated by the respective PTPs/ RTPs to NTP.

The consignment from supplier arrives at the NTP central warehouse, where physical inspection

is done; quantities are verified and recorded for inventory management. All relevant

information like supplier name, quantity, batch wise information, shelf life etc are properly

entered in store stock register and samples are collected for quality testing. The stock is then

delivered to the Provincial and Regional warehouses, as per their requirements where the

drugs are stored and distributed to districts based on their consumption pattern along with

observance of case notification and stock positions. District stores followthe same practice of

supply to Basic Management Units (BMUs), both in public and private sectors. However, to

cater the special needs of those private sector providers which are linked with some network

like Greenstar’sGoodLife program, the drugs are provided to the organization for onward

distribution to its network providers.

Flow chart showing distribution of drugs from Central Warehouse up to the end user:

From Central warehouse to provinces/ districts the drugs are distributed /supplied by road;

however, quite a few items (SLDs) are distributed by air. The drugs are then transported

through official vehicles from districts to SDPs.

For the transportation of commodities, NTP on annual basis solicits bids from Goods

Forwarding Agencies, through open competitive bidding procedure and in the bid document it

is clearly outlined that, “complete and secure transportation of commodities is the

NTP

Central

warehous

e

Provincial/

regional

Warehouses’

Districts Drug stores

Public Health Facilities

Private Care Providers and institutions(e.g. GS)

TB Patients

109

responsibility of Goods Forwarding Agency, failing to which the agency is liable to reimburse

NTP for the total cost of commodity (s) in case of damage, theft or loss”.

Also NTP has procured 5 mini loader trucks installed with special containers for transportation

of program drugs and other commodities. The truck at Central Warehouse would be used for

transportation to Provincial / Regional Warehouses of KP, AJK and FATA, whereas,

transportation to Punjab, Sindh, GB and Balochistan would be done through hiring of services

of GFA. Keeping in view the large quantities of ATT drugs to be transported and large

geographical spread, NTP would need more such loader trucks for transportation both at

central as well as provincial level.

Usage includes diagnosing, prescribing, dispensing, administration, and proper consumption by

the patient. Each function builds on the next, forming the pharmaceutical management cycle.

Then, correct medicines are ensured to be given to TB patients in correct dosages to maximize

their efficacy. TB patients are encouraged to take their medicines for the prescribed periods

through direct observation to achieve cure by adhering to the treatment protocol and to

prevent the development of multidrug-resistant tuberculosis.

5.15.3 Securing Funding for ATT Drugs Up till 2015:

NTP is detecting and treating about 274,000 cases annually. NTP as a regulatory body is

mobilizing resources for the provision of quality assured drugs free of cost to the patients.

Global Fund has been supporting NTP Pakistan to bridge the financial gaps through R-2, 3, 6, 8

&9 grants. R-8 grant primarily has been awarded to bridge the funding gap of first line drugs

(FLDs). GF commitment for FLDs through R-8 grant had been for 50% of country needs. The

contribution reduced to a cumulative of 33% during phase-2 approval (year 2011-2014) with

the understanding that this gap will be addressed while consolidating the TB grants in the

country. Based on successful implementation of the R-8 grant NTP is able to secure more than

60 Million USD for the procurement of FLDs and SLDs in SSF budget.

FLDs additional support of 8 Million:

As per WHO guidelines to avail 100 buffer stocks of FLDs across the supply chain; Drug

Management Unit has done a comprehensive gap analysis of FLDs in country and on the basis

of this gap analysis successfully able to get additional grant of 8 million USD from Global Fund

and became the first country to get GF interim funding.

WHO Emergency Grant of 7 Million:

In collaboration with World Health Organization and Stop TB Partnership Geneva, NTP / DMU

has conducted a GDF review mission in year 2013 to assess the activities of Drug Management.

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On the valuable recommendations of GDF review mission a grant of about 7 Million USD is

approved for the provision of FLDs and Paediatric drugs to be used in year 2014.

PC-1 Procurements of Provinces:

After strong follow up and advocacy with the provinces; allocations for the procurement of

FLDs from Provincial resources are materialized and almost 92000 patient’s courses were

procured during year 2013.

Other Donor Contributions:

USAID, KFW, GIZ, MALC are also contributing in the procurement of FLDs and SLDs to bridge the

gap of ATT drugs and secure un interrupted supply of ATT drugs up till 2015.

5.15.4 NTP support of Anti-TB drugs and logistics to the provinces

During fiscal year 2012-2013 NTP is able to distribute 210,000 patient courses to provinces Out

of 250,000 courses as an annual need.

Table 45: Anti-TB drugs situation

Provinces

Punjab Sindh KPK Balochistan

Support First Line Drugs

Patient Courses (July

2011 to June 2012

supplied / in pipeline)

159300 49250 11250 3800

Pediatric Drugs to be

Supplied 15000 7000 4000 1000

Warehouse

Refurbishment 37 23 25 30

Loader trucks 01 01 01 01

Logistician

Pharmacists 01 01 01 01

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5.15.5 Guidelines and materials

NTP Drug Management Unit has developed the following guidelines providing details of

selection of medicines, their quantification, procurement, storage, distribution and usage

across the supply chain:

1st line and 2nd line anti-TB Drug management guidelines

Drug dispensing manual

Standard operating procedures (SOPs) for pharmaceutical management

Quality assurance plan

5.15.6 Drug Management Information System:

The Drug management information system (DMIS) serves as the engine for supply chain

management programs. A functioning DMIS is the key to programmatic success. Accessing web-

based technology to enhance DMIS timely reporting and accuracy creates the ability to make

prompt supply decisions using accurate data.

Fully functional and developed TB DMIS is being developed and handed over to NTP by Green

Star through GF funding; TB DMIS training across the country and accordingly implementation

national/provincial/district level are in progress to develop a pool of skilled personnel for

smooth functioning and execution of this task.

NTP management is confident that with the implementation of TB DMIS, robust analysis of

inventory management, consumptions patterns of drugs, monitoring stock outs, over stocking

and timely availability of precious drugs to patients will be done on regularly basis.

5.16 ACSM Government of Pakistan declared Tuberculosis as National emergency in year 2001. National TB

Control program piloted and started implementation of DOTS strategy across the country

through public sector health facilities. ACSM has been an integral component of the TB control

program right from the beginning of the program but gained momentum in year 2005 when

100% DOTS coverage in public sector was in place. NTP secured funding from Global Fund

through R-2 grant and a full fledge ACSM component was implemented in selected districts of

the country which included development of Behaviour change strategy (BCC). Latter in R-6

funding from GF was secured for ACSM strategywhich included mass media communication,

social mobilization and public relations.

The strategy primarily addressed following areas:

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Public awareness regarding sign and symptoms of TB through mass media and inter-

personal communication

Public awareness regarding availability of TB management services highlighting TB brand

Advocacy with policy makers including parliamentarians

Establishing consistent brand identity of NTP and engaging a celebrity as TB

ambassador.

Installation of billboards in cities promoting NTP brand

Patient empowerment by establishing patient groups in the districts

Establishment of NTP resource centre

NTP, Pakistan is being recognized as a leader on producing high quality advocacy,

communication and social mobilization products. NTP/ACSM Unit has further modeled Public-

Public and Public-Private partnerships with a number of institutions related to health sector in

the country. The activities conducted in last two years with the support of GF are as under:

Table 46: ACSM activities status Serial # Activity Total conducted/

trained

1 Number of community based ACSM events (theatre, music, drama, etc) conducted

7,694

2 Number of Journalists oriented/ trained 29,195

2.1 Articles published/ ACSM activities coverage 2,263

3 Orientation of Advocates (policy makers, opinion leaders, key influencers)

81,544

4 No. of Community coalitions meetings held 1,945

5 No. of service providers trained in inter-personnal communication (including district level health care providers i.e. LHWs, DOTS facilitators)

81,808

6 Number of healthcare providers trained on quality assurance for interpersonal communication

61,516

7 Number of National Steering Committee meetings conducted

11

8 Number of Provincial Steering Committee meetings conducted

10

9 Number of capacity building session with TB Patients at Provincial level

25

113

10 Number of quarterly meetings with EDOs & NPOs 4

11 Number of TV spots aired 1,759

12 Number of Radio spots aired 2,384

13 Capacity building workshops As per requirements

In addition, NTP ACSM Unit as well as Principal Recipient and implementing partners have

conducted several capacity building workshops, and advocacy meetings and seminars with

media and other stakeholders.

5.16.1 Stop TB Partnership Pakistan

Stop TB Partnership Pakistan, established with the assistance of Stop TB Partnership EMRO, is

chaired by the Vice Chancellor, Dow University of Medical Sciences, Karachi. The partnership is

holding meetings at regular intervals.

5.16.2 World TB Day

World TB Day has been commemorated every year on March 24th. Every year National TB

Control Program (NTP) designs and implements a number of activities to commemorate World

TB Day on March 24 in line with Stop TB Partner Ship theme.

5.16.3 Results of the mid-term evaluation of ACSM

Independent international and national consultants were commissioned to conduct a mid-term

evaluation of the Mercy Corps intervention districts. Empirical results from a multistage,

random sample of populations in the intervention districts identified a number of significant

findings. Participant recall of TB was considerable with 64.6% recalling any TB information

without prompts, while 31.4% specifically recalled the TB brand following prompting.

Comparisons of knowledge, attitudes and practices (KAP) of participants aware of TB

information (AwareTBinfo) vs. those that were unaware of TB information (UnawareTBinfo)

found AwareTBinfo participants to have significantly better knowledge than their

UnawareTBinfo counterparts (p< .01).

5.17 MONITORING, EVALUATION, RESEARCH AND LEARNING (MERL) 5.17.1 Overview of M&E

The NTP/PTPs has an efficient M & E and supervision system in place, which is the backbone to

maintain the quality of TB services in the country. The NTP has developed structured approach

to M & E by developing monitoring and supervision module/ tools. They are conducting regular

surveillance meetings at national, provincial and district levels. In additional there are annual

114

program reviews, internal and third party evaluations, online laboratory data management

system and electronic reporting system – piloting started, followed by countrywide expansion.

The human resource to perform the M & E function at National level it includes; Full-time M & E

officers/ filed officers/ program officers, National Program Officers (NPOs) at regional level and

Senior Laboratory Supervisor (SLS) at regional level. At the provincial level it includes; Full-time

Provincial Program Officers and Medical Officers and Laboratory Supervisors and at district level

it includes; Designated District TB Coordinator (DTC) and Full-time District Laboratory

Supervisor (DLS).

Except the DTC, all other M& E staff is supported from donor supports in which Global Fund has

the major contribution.

Figure 15: System of M&E operations in the country LEVEL ACTIVITY

NTP

PTPs

DISTRICTS

BMUs

The above system is all based on the donor support mainly from Global Fund.

Note: The other Components i.e. Effective Drug Supply and Management, Childhood TB,

Difficult to Diagnose TB, TB-HIV Co-infection and ACSM are covered as separate sections.

5.18 OPERATIONAL RESEARCH Research is a key strategic area identified in the National strategic and operational (PC1) plans

as well as the new stop TB strategy. The strategy describes operational research as a core

component of NTP work. Designing and conducting locally relevant operational research can

help in identifying problems and workable solutions, testing them in the field and planning for

the scaling up of activities.

Inter-Provincial Meeting held by 07th day of the SECOND

month following end of Qtr.

Inter-District Meeting of all DOTS Districts of the Province held

by 25th day of the month following end of Qtr.

Intra-District Meeting of BMUs held by the 15th day of the

month following end of a Qtr.

BMU record data in TB Register. At the end of the Qtr. compile

& complete Forms 07,08& 09

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There are several objectives which include:

- To provide research leadership to establish National research/development

agendas, attracts resources, new researchers and research groups, and develops

Institutional networks.

- Provide management capacity for carrying out specific research projects to ensure

relevance, quality, timeliness, efficiency and accountability.

- Develop critical mass of personnel with up-to-date R&D skills.

- Enable the means and opportunities for participating in international R&D.

- Develop road maps for new researches based on need and priority of NTP.

- Develop collaborations with international academic institutes to perform

international standard quality research.

Arrangements

The NTP has a well organized Research Unit in place. In last few years NTP has designed and

implemented several OR projects and national level surveys on priority program needs.

Contribution

Below is the list of few significant contributions of Research Unit in last few years.

5.18.1.1 National TB prevalence survey

The National TB prevalence survey was completed in Dec 2011/12. The final report has been

published and shared with stakeholders on the 24thMarch, 2014.

5.18.1.2 Capture re-capture project

Between 1st January 2012 and 31st March 2012 a capture re-capture project was carried out by

NTP. The study aim was to determine TB Disease Burden and to observe TB case management

practices of public and private non-NTP providers in the 12 selected districts as part of a

strategy of the National TB Control Program to create additional data sources for improving

case notification. The study was done in parallel to the Disease Prevalence survey and was of

tremendous importance which showed 28% under-reporting in the study only 32% of cases

were found registered with the NTP which opened up the need to engage private providers on

priority with the program to enhance TB case notifications. The results of the study are will be

published in international Journal.

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5.18.1.3 TB REACH Wave 1

The project was completed in 2011-12 and a total of 3117 tuberculosis positive cases were

detected; 1707 through chest camps and 1410 from GPs clinics. During the project, the total

number of smear positive TB notification rate increased 226% progressively from chest camp

intervention over the intervention period. The project was proven to be very successful

receiving an A Grade in international monitoring and it is has been recommended that these

same activities be replicated in other hard to reach areas of the country.

5.18.1.4 TB REACH Wave 2

Recently a study to test the “Effectiveness of widening the circle of contact screening from

within the household to 100 m around the house of index case on case finding through

outreach using GIS” has been launched. The project introduces active contact investigation in

four cities. Household contacts, i.e. those normally resident or sharing the same airspace, will

initially be verbally screened, followed by screening of a wider circle of close community

contacts. The project will use Gene-Xpert among smear negatives TB cases and chest X-ray

suggestive of TB.

5.18.1.5 Indus hospital project TB REACH

In Karachi Indus Hospital used community laypeople, mobile phones, and awareness campaigns

to screen ~500K people at 54 private clinics and a large hospital. The results demonstrated that

case detection doubled in one year and the Indus hospital became the second largest reporting

center in Pakistan. The control area saw no significant change in TB case notifications.

(Source: Aamir J Khan, et al; Engaging the private sector to increase tuberculosis case detection:

an impact evaluation study)

5.18.1.6 Enabling pharmacies in TB control

Private sector pharmacists are a crucial partner in increasing the number of people who are

properly diagnosed and treated for tuberculosis (TB). Pharmacists often have close ties to the

community and frequently serve as the first point of contact with the health system. It has been

reported that private markets in four countries i.e. Pakistan, the Philippine, Indonesia and India

had the largest relative sales volumes; annually, they sold enough first line TB drugs to provide

65-117% of the respective countries annual incident cases with a standard 6-8 months regimen

(Source: William.A.Wells, et al; Size and usage pattern of private TB drug market in the high

burden countries). This calls for appropriate policy and market response i.e. expansion of PPM,

greater reach, flexibility, regulatory and quality enforcement, etc. The figure below presents the

percentage of anti-TB drugs sold in the private market.

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Figure 16: Percentage of anti-TB drugs sold in private market

(Source: Global Alliance for TB Drug Development, Annual Report, 2009)

Recently the NTP, in collaboration with Pakistan Pharmacists Association and DEV-NET,

supported by USAID-funded initiative of “Engaging Pharmacists in TB Care and Control in

Pakistan”. Pharmacists have historically been underutilized in TB prevention and care. An

impact evaluation study in Pakistan found that training laypeople in the community to screen

for TB in private clinics and then linking patients to free diagnosis and treatment from a NTP

approved private facility was one of several interventions that increased case detection two-

fold over that observed in the control area. However, Pakistan cannot afford to ignore retail

pharmacies in TB control, given their ease of accessibility, presence of few qualified staff, and

lack of knowledge of both TB and the NTP. The NTP can benefit from engaging private

pharmacies for rationale use of drugs (good prescribing habits), screening & referrals (case

detection), supervised treatment, counseling, education and awareness.

0

20

40

60

80

100

120

140

Drugs sold in the private market

65

%

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5.19 HUMAN RESOURCE DEVELOPMENT Health services cannot be delivered effectively and efficiently without trained human

resources. Attaining, training and retaining of human resource are challenges in developing

countries.

The table below presents the NTP/PTPs recommended category of core staff in each district to

be involved in core TB service delivery and the guidelines and materials to be used. The training

of health care providers is an on-going process including refresher courses. Moreover, in order

to incorporate new interventions and recommendation in TB control, updating of the training

modules and guidelines is also an on-going process.

Table 47: Recommended staff training in NTP/PTPs

Staff Category

Training

Participants Duration (Days)

Material Location

Doctors 6 NTP Doctors Module District Hospital and PHC Doctors

Paramedics (all) 3 NTP Paramedic’s Module District Hospital and PHC paramedics

Paramedic (BMUs only)

1 NTP Quarterly Reporting Module

District 1 paramedic per BMU

Laboratory staff 10 NTP laboratory staff module

Province Prefer: Provincial Reference laboratory

District laboratory supervisor

10 NTP Province Prefer: Provincial Reference laboratory

Lady Health Worker 1 NTP LHW Module Facility Prefer: Associated health facility

District Managers 2 NTP Planning/ Review Guide

District

District manager include: EDO, DOH, DTC, In-charge DHDC, MS DHQ/THQ Product: District TB plan

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SECTION A2 –

A2/2: SWOT ANALYSIS

120

6 SWOT ANALYSIS

STRENGTHS WEAKNESSES OPPORTUNITIES THREATS

6.1 POLITICAL COMMITMENT

The NTP has support from the Ministry(NHS,R&C) PTPs have support from their respective department of health.

The NTP has almost negligible public sector funding since devolution. Slow pace at PTPs to get PC-1 approved.

Devolution has given an opportunity to strength the provincial TB control programs in the country. The new Ministry at the federal level will support the NTP.

In the absence of regular funding it will be difficult to sustain high quality DOTS expansion and enhancement beyond 2015 at national and provincial level.

Moving towards achieving MDGs targets: -TB Prevalence dropped 34% since 1990. -TB Mortality decreased 52%.

Current rates are based on estimates. The preliminary findings of the recent prevalence survey 2012 shows that there is a high prevalence of bacteriologically confirmed cases in the adult population i.e 295/100000.

The final TB prevalence survey report will reveal more up-dated figures. Components such as childhood TB, difficult to diagnose TB and TB-HIV co-infection will be strengthened. Therefore the TB related mortality will further decrease.

The assumptions and requirements will change based on the survey report and may require re-calculations for inputs, revising indicators, resources, etc.

6.2 TB CASE NOTIFICATION

TB Case notification reached 31%.

Case detection has been stagnant over the last few years in the public sector. The current PPM model has not contributed substantially to increasing case notification. The PPM model has been implemented in almost 45% of districts in the country. Many other key public sector

New National Strategic Plan is an opportunity to develop strategic interventions to address the weakness

Slow pace of expansion in un-tapped private sector Constraints in developing partnership with key other public sector. Funding limitations to carry out expansion.

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organizations are not currently in partnership with NTP.

Diagnosis is based on passive case finding.

New diagnostic algorithms are not in place in which active TB disease will be detected through passive, active and enhanced case finding approaches. Care providers will require training on new algorithms.

New plans at the National and provincial levels will include requirement to introduce new TB diagnostic algorithms in the country.

Enhanced case finding will increase the load on the laboratories and care provides, which may affect quality of care.

6.3 CONTACT INVESTIGATION

TB contact investigation is part of the National TB policy

Implementation is not as per the required pace

Guidelines need to be refined and properly implemented.The strategy will incorporate the activities which will require addressing the issues around TB contact investigation.

Expansion of services implies stringent quality assurance.

6.4 CHILDHOOD TB

- 32 TCHs - 30 Districts - 25,737childhood TB cases

notified in country from Jan-Dec 2012

-Accuracy in diagnosis- more dependency on laboratory tests -Non-Involvement of the private sector -Adequate knowledge, skills on diagnostic tools -Shortage of trained healthcare staff for Childhood TB Case Management -TB cases are not reported separately in National data. -Non-availability of Child friendly ATT (FLD/SLD) -PPD-procurement, transportation (high wastage, cold chain

The strategy will incorporate activities which will require addressing the issues around childhood TB case management.

Expansion of services implies stringent quality assurance.

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maintenance) and distribution issues. -Poor childhood TB case management at peripheral levels (THQs/RHCs/BHUs) -No ACSM strategy

6.5 HOSPITAL DOTS LINKAGE (HDL) i.e. TEACHING HOSPITAL

Experience of implementation of TB DOTS in tertiary care hospitals Collaboration with Pakistan Chest Society and Pakistan Paediatric Association in the development and endorsement of Adult and childhood TB management guidelines

Weak linkages within the tertiary care hospitals ACSM activities were not appropriately targeting the TCH settings Weak M&E of HDL component Weak external linkages with peripheral facilities

Rapid turnover of trained staff

Staff capacity and motivation

High clientele at TCH

Legislation to make TB a notifiable disease

Lack of ownership of hospital management

Continued lack of communication between departments within the hospital

Lack of integration of TB data in

the hospital’s medical records

system

6.6 ACSM

Key ACSM activities has been carried out including; -Community awareness -Community coalitions -Involvement of electronic and print media -Patient empowerment interventions, etc -ACSM resource materials were produced and distributed

-Highly dependent on GF and other donor support and since the completion of funding the ACSM activities almost stopped. -Public sector support is negligible.

New national and provincial plan will incorporate sustaining key ACSM interventions.

6.7 DRUG MANAGEMENT

Using FDCs proven bioavailability as first line anti-TB.

Procurement of quality FDCs at the local level is a challenge.

The local pharmaceutical industry is becoming sensitized

Process of approvals will take time.

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Foreign exchange required for international procurements.

to addressing the NTP requirements.

Treatment success rate 88%.

Only 15-20% of LHWs are involved in the direct observation of TB patients. Direct Observation of Treatment is not adequately monitored

The expansion plan should address involvement of LHWs and other type of treatment supporters in supervising patient’s drug intake.

Additional load on LHWs.

-Uninterrupted supply of anti-TB drugs -Refurbished ware houses for ATT available at the national, provincial levels and in all the districts in the country.

-Public sector i.e. PSDSP support is negligible.

The future plans will support: - Securing TB drugs supply beyond 2014-16 -Pediatric TB interventions across the country -Implementation of TB DMIS -Up gradation of BA/ BE study centers as per WHO standards -Legislation for ban on over the counter sale of TB drugs

-Highly dependent on GF and other donor support In the absence of urgent public sector support the supply of anti-TB drugs will highly get affected.

6.8 TRAINING

Paper-based training materials and guidelines prepared for all categories of staff involved in TB and DR-TB care. Curriculum development for undergraduates and nurses/paramedics by NTP

Limited number of Master Trainers at the national, provincial and district levels Supervisory modules have not been updated No electronic training database available. Approval and introduction of training material in relevant academic institution

All Master Trainers have access to computers Can develop blended learning materials (paper and e-based platforms). Role of academia

Power shortages and limited internet connectivity at the grass-roots levelmay restrict use blended learning platform. Rapid turnover and transfer of Master Trainers . Approval from PMDC and PNC

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6.9 TB CARE IN ELDERLY AND HIGH RISK GROUPS

TB care includes services for the elderly patients and other risk groups

Utilization of services is low among the elderly and high risk groups

Availability of global strategic guidelines to address TB in elderly and high risk groups

Stigmatization of high risk groups deters care seeking

6.10 TB-HIV CO-INFECTION

The program has six years of experience implementing TB/HIV co-infection interventions There at least 19 sites across Pakistan where counseling and testing for TB and HIV has been made available through TB/HIV collaboration National TB/HIV Collaborating Boards and provincial coordination committees have been formed

- Interventions implemented so far are not specifically targeting key populations where risk of infection (both TB and HIV) is higher

- Coordination between TB and HIV programs has been sub-optimal

- Low coverage of sentinel sites -Private sector healthcare providers not engaged in TB/HIV co-infection - Lack of innovations and Operations Research

- Addressing TB/HIV co-infection is an international priority - Engagement of private sector healthcare providers and facilities provides an opportunity to include TB/HIV interventions - Data on prevalence of HIV in key populations is available through HASP Round 4 conducted in 2011 - Opportunities exist to enhance collaboration between TB and HIV programs

- Socio-cultural stigma - HIV is a low priority

6.11 TB AND CHRONIC AILMENTS AND TOBACCO SMOKING

The NTP has demonstrated successful implementation of new initiatives

No policy and guidelines at the national level

New strategic plan will provide strategic interventions to address these areas

Strong lobbying by the tobacco manufacturers

6.12 LABORATORY NETWORK

-Microscopy Network functional

in all 141 districts.

-Access to microscopy services is

not uniform in all settings.

-To improve access by

establishing diagnostic facilities

-High cost implication on DOH for new induction of HR.

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- Microscopy coverage is

complete with almost one

laboratory /150K population

-90% of microscopy network is

EQA covered .

-486 LED microscope available for initial roll out

Province/ District plan to improve

access to diagnosis / establish new

BMUs is missing.

-In high volume microscopy centres

one full time lab staff is not

sufficient to handle all TB work with

quality.

-Interruption of services in case of

absentees /or leave of staff /Polio

duties

-Sensitivity of AFB microscopy has

not reached optimal level. 30% of

centres have unacceptable

performance and Positivity rate in

follow-up smear is below expected

range.

-Slow roll out of FM microscopy. -Lack of interest to work in TB lab due to free services being offered ( No incentives for staff) -Infrastructure and Infection control/ waste management practices are generally poor in laboratories -No arrangement at any level for maintenance and repair of microscopes -No practical training for Skill development in TB diagnosis in MLT schools

in rural and engaging more

private labs in urban settings.

-Devolution is an opportunity

to strength the provincial TB

control and district

arrangements.

-Sustainability of EQA after with drawl of donor support. -Lack of legislation/control on use of serological test for diagnosis of TB in private labs -Lack of legislation/ controls on sale of substandard staining reagents and supply

-Successful roll out of GeneXpert -Limited access of Xpert diagnostic - Strongly recommended by -Sustainability after donor’s

126

with installation at 18 sites.

-Piloting done for early diagnosis

of rifampicin resistance

services to all patient at risk of

MDR.

- Lack of specimen referral and

transport mechanism.

Weak logistic and supply systems

for effective storage and

transportation of kits at provincial

level.

New R and R tool (2013) not yet

implemented.

Delay in procurement and

calibration of equipment

- Minimal contribution of domestic

funding in Xpert implementation.

WHO as initial test in Patient at

risk of MDR

GF support available for Xpert

KITs to support initial scale up

of PMDT programme

withdrawal.

-Challenges of Int. Procurement

from public sector finances..

-Resources available for

establishing 16 culture

laboratories

-6 culture laboratories established

and offering services for PMDT.

-Limited access to culture services

due to low coverage and lack of

specimen referral and transport

mechanism.

-No policy on use of culture for

confirmation of AFB smear negative

and EPTB cases.

-Weak infrastructure, low

counterpart funding for overheads

and maintenance cost.

-Limited in country capacity

maintenance/ repair of equipment.

-Paper based recording and

-WHO guidance on need and

coverage of TB culture and DST

services.

-Initial capital investment for

establishing 16 culture facilities

available through GF.

-Failure to enhance domestic

funding for TB diagnostic.

-Sustainability on withdrawal of

donors (services ,

infrastructure , supplies,

maintenance)

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reporting of laboratory results

-Provision of Human resource required for managing new TB laboratory is lacking at institutional level.

-No mechanism of regular service contract, periodic preventive maintenance (PPM) of equipment and infrastructure (HVAC) -

-Lack of ownerships of local

institutes.

-DST laboratories resources

available for establishing 6 culture

laboratories.

National EQA scheme for DST

laboratories implemented

-QA DST laboratories available in

public/private sector.

-Low in-country expertise for

establishing and certification,

maintenance of Bio-safety

laboratories.

-Availability of uninterrupted power

supply 24/7 for use of liquid culture

(MGIT)

-Supply and logistics for DST

laboratories especially liquid

culture.

-bio-safety and biosecurity issues

are not addressed as per global

standards

-NO Health surveillance programme

for staff working in Tb laboratories

-WHO guideline/advocacy on

need and coverage of TB culture

and DST services.

-With introduction of gene-

Xpert, need of TB DST

laboratories for diagnosis of

MDR has minimized

Same as above

-NO legislation/control of TB DST

services provided in private sector

( outside NTP)

128

-NRL functional with Technical

staff.

-NRL linked with SNRL and Target

proficiency attained/maintained

for First and second line DST

since 2010.

-NRL providing technical support

for functionalizing newly

established TB lab

-Training plans for Capacity

building of all Culture and DST are

implemented by NRL.

-Suboptimal infrastructure of NRL

-Limited space is barrier to enhance

its scope of work and research

needs.

-Not ISO certified

Important Role of TB NRL at

country level is globally

recognised (WHO) and is

benchmark of effective TB

control effort.

Devolution process may

undermine need of technically

strong NRL at central level

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6.13 DRUG RESISTANT-TB

NTP has a DR-TB structure: Full-

time MDR-TB unit with logistics.

-Although budgets and posts have been initiated, yet PTP structure and management capacity have yet to be strengthened.

-NTP MDR-TB unit needs

strengthening to address the

expansion phase.

-Devolution has given an

opportunity to strength the

provincial TB control programs

in the country.

-New Ministry formulated in

Islamabad.

Without additional National and

International financial resources it

will be difficult to sustain MDR-TB

programmatic activities beyond

2015 in the country.

84% of the 2013 target of

enrollment has been achieved.

-High DR-TB incidence among new

(4.3%) and re-treatment TB cases

(19.4%).

-16% of the 2013 target of

enrollment has been missed.

-Following a passive approach to

case detection.

-Private sector not fully onboard in

DR-TB care.

- Other public sector health care

providers as well as parastatal are

not fully involved in DR-TB care.

-Revised case finding strategy

has been established to

increase case enrollment

-MDR-TB expansion plan has

been developed.

Without the full implementation

of the revised case finding

strategy and active involvement

of PPM, it will be very difficult to

achieve the target.

-18 PMDT sites functional in four

provinces till the end of

December 2013

-Infection control arrangement in

place.

-Human resource trained.

-Funding is available

-Expansion of PMDT sites not in full

accordance with the work plan.

- Delays in infection control

arrangements

-12 more PMDT sites will be

established in 2014.

-Expansion plan which will be

reflected in National and

Provincial Strategic Plans will

accommodate the

establishment of more PMDT

-Lack of adequate Funding for

expansion and sustainability of

the PMDT.

-Lengthy procurement processes

delay the establishment of PMDT

sites and consumables.

130

sites.

-There is GF commitment for SLDs

up to June 2015.

-Ware houses established to

manage the supplies.

-Delay in international

procurement/shipment process,

receiving, and clearance.

-Lack of adequate space and human

resource for warehousing at all

levels.

New strategic plan can address the gaps.

Assisting of the Local

Pharmaceutical companies to

become internationally quality

assured SLD manufacturer

Without additional National and

International sources of funding

it will be very difficult to sustain

adequate SLD procurement

beyond 2015 at national and

provincial level

-International procurement

through public sector funds is an

issue.

Commitment of Global Fund till

June 2015 for PMDT.

-In-adequate national and provincial

public sector funding are available

for TB control

- Commitments of Donor assistance

beyond 2015 is not fully available

-Provincial PC-1 development

and approvals in process in

most of the provinces

-New Ministry formulated at

national level which can be

approached for NTP

requirements including

accessing donor support. New

Funding Model from Global

Fund is available till end of 2016

-Delay in Provincial PC-1

formulation, approval and

releases may delay the activities

-Donor assistance may not be

secured

National Plans are available for training of doctors and paramedics at BMU Level

-Pool of Master trainers has been

established in all the provinces.

-Capacity at the provincial level is

limited

-No capacity at the district level.

-New provincial plan can

address involvement of

additional master trainers -

Enhancement of capacity of

BMU doctors and paramedics

through approved training plan.

-Decentralizing training to the

district level may affect the

quality.

- Turnover of the trained HCWs at

all levels

MDR-TB case management is

organized and cases are treated in

-Provincial capacity to monitor the

quality of ambulatory based model

-New plans and funding could

address the need of additional

-Rapid expansion of DR-TB

services in coming years would be

131

line with WHO and national

guidelines.

of care in DR-TB services is not

adequate.

-Inadequate HR at all levels to

monitor PMDT

trained human resource and

logistics.

a challenge for TB control

programs.

- Social Support that is provided

to Patient and Treatment

supporter enhance case holding

among DR-TB cases.

-Costly.

- No public sector funding for social support

New plans for funding including

PC-1 could address the social

support.

-Difficult to sustain

-Public sector has limited

precedence

Technical assistance currently

available at national level through

GF and donor agencies

Limited technical assistance

available at provincial level

-New plans and funding could

address the national and

provincial TA needs.

-Post devolution situation can

provide opportunity to

strengthen the provincial

programmes

Sustainability for long term

technical assistance

6.14 PUBLIC PRIVATE MIX (PPM)

TB case contribution from PPM is 20% of the overall national case notification.

Case detection has been stagnant over the last few years. The current PPM model has not contributed substantially in increasing the case notification.

New plans can incorporate interventions to strengthen the existing model.

High cost initiative and difficult to get support from public sector finances.

Diagnosis is based on passive case finding.

New diagnostic algorithms are not in place in which active TB disease will be detected through passive, active and enhanced case finding approaches. Care providers will require training on new algorithms.

New plans at National and provincial levels will include the requirement to introduce new TB diagnostic algorithms in the country.

Enhanced case finding will increase the load on the laboratories and care provides which may affect quality of care.

About 200 NGO managed clinics Key NGO set-up is not in current About 10% of PHC facilities

132

involved in PPM model (PATA, AKHSP, MALC, etc)

partnership such as PPHI/PRSP. managed by PPHI/PRSP can contribute to case detection and the remaining in suspect screening and referral. About 30 million population with expected 68,000 cases can be addressed.

About 18 large hospitals managed by private sector/NGOs in major cities are involved in PPM model.

Still many private sector hospitals in big cities need to be brought in to partnership.

New plans can incorporate involving additional private hospitals in TB care.

Without rigorous monitoring the quality of service will be compromised.

About 10 million population are provided TB services through other public sector facilities. About 30 other public sector hospitals in big cities under the PPM model.

Many key other public sector organizations are not currently in partnership with NTP. Expansion is very slow.

Expanding the PPM initiative by involving currently un-tapped private sector and involving key other public sector organizations.

Slow pace of expansion in un-tapped private sector Constraints in developing partnership with key other public sector. Funding limitations to carry out expansion.

2300 GPs involved in current PPM model implemented in 45% of districts in the country.

Slow implementation. High attrition rate among GPs. Coverage in the private sector is not 100%. Chest specialists and medical specialist are not involved in PPM model. Involvement of PMA and PSS not significant. No involvement of Society of family physicians.

Devolution has given an opportunity to strength the provincial TB control programs in the country to monitor PPM activities. Opportunity to expand the current model in 100% district involving 5,000 GPs.

Sustaining quality of services will be a challenge.

133

Private laboratories involved in PPM model.

Expansion is slow. Require continued review and quality assessment to be addressed in new national and provincial plans.

Pharmacy engagement piloted No strategy in place for expansion of pharmacy PPM

NSP includes full engagement of the pharmacies including pharmacy DOT

Scale up plan for pharmacy PPM expansion to be developed

Linking PPM pharmacies with other PPM models already in place in the country

In the long terms, enhanced regulatory action with passing of law that prohibits over the counter sale of TB medicines

Participation of significant number of pharmacies in rural and urban settings is key to success of PPM pharmacy and its contribution to TB control

6.15 MONITORING AND SUPERVISION

Regular monitoring meeting at district, province and national level.

-Mainly dependent on donor support. -Ineffective implementation of the feedback mechanism -Weak beneficiary verification system -Weak capacity of the provinces -Varied ownership at the district level

Evolving role of provinces after 2011 devolution

-Competing priorities for resource allocation at the district level

A well structure NTP technical -Suboptimal technical capacity of New plans at the National and In the absence of regular public

134

unit in place the provincial units. Dependent on donor funding which is available up to 2015.

provincial levels will include requirements to sustain the current technical unit at NTP/PTPs

and donor funding it will be difficult to sustain.

Arrangements in place to coordinate TB control activities in districts.

District TB Coordinator (DTC) is a designated officer from the district health office and has additional responsibilities.

New plans at the National and provincial levels may include a dedicated DTC in all 141 districts.

Shortage of staff in the districts. Additional recruitment implies high cost.

6.16 OPERATIONAL RESEARCH

-National Prevalence Survey conducted -OR projects of significant importance conducted

-Operational difficulties in implementing surveys in areas with natural disasters and effected with law and order situation.

Identified priority research areas i.e. MDR default tracing mechanism (e DOTS), Community management of MDR, Infection control of MDR patients once released in community, contact screening among sensitive and resistant TB.

- High MDR Defaults because of poor linkages with the district health system -Weak involvement of treatment center in treatment support of MDR Patients. -Poor infection control at household and community levels may lead to MDR among contacts and disease progression -Current program routine data shows poor yield from contact tracing interventions among sensitive and resistant TB

-Pilot of GIS based-DOTS and scale up -OR on the diagnostic center and treatment center link model to improve community management of MDR -Pilot of infection control strategies at the household and community level s and then scale up -Innovative strategies to enhance yields from contact tracing among sensitive and resistant TB

New Survey to estimate disease burden and under-reporting

Huge private sector in the country , the under-reporting involving Non NTP private and public sector need

Inventory study will be done in 2016 again to re-estimate the disease burden in the country

135

to be done

Established linkages with international academic institutions

The national academia is not engaged

The national academia can support many community activities. Sustain and expand linkages with other international institutions.

6.17 STOP TB PARTNERSHIP

Basic structure is available Not fully organized and not operational

Stop TB coalition at district level may provide a community level structure New innovation required strong STOP TB partnership in the country

6.18 TRANS-BORDER TB

Initial implementation started Not fully opertionalized New strategic plan will address this innovation

Geo political and security situation poses an obvious threat

6.19 TB AND POVERTY

Social support initiative for DR-TB patients

Limited experience New strategic plan will address this innovation

Multi-disciplinary involvement may result in difficulties mainly not in purview of the NTP

SECTION A2 –

A2/3: GAP ANALYSIS

137

7 GAP ANALYSIS

7.1 FUNDING MAINLY DEPENDS ON EXTERNAL SUPPORT 7.1.1. Even though TB control is organized in the framework of a well-structured national

program

7.1.2. Ongoing devolution process

7.1.3. Coordination between the NTP and International technical and donor agencies exists

7.1.4. TB control is a health priority for health department of the provinces

7.1.5. Not enough public sector funds are allocated in the provinces and, if allocated, there are

not enough released to cover all the needs of TB control

7.1.6. PC-1 are either newly developed and releases are not timely or are in the process of

being developed

7.1.7. Limited public sector funds are allocated from the federal level to implement TB control

activities in the provinces

7.1.8. Many components of TB control are dependant on international funding. For instance,

the implementation of MDR-TB case management activities are fully financed by GF.

7.2 LOW TB CASE NOTIFICATION 7.2.1. According to the last WHO estimate, 64% of smear-positive TB cases are being detected.

However, based on the preliminary results of the last TB prevalence survey, which shows

that prevalence of bacteriologically confirmed TB is about 295/100000 among adult

population, in fact the TB case notification is much lower i.e. 31%.

7.2.2. Passive case finding has been implemented and there is no national policy on active and

enhanced case finding.

7.2.3. A significant proportion of the rural population has limited access to screening services,

or are not screened for TB

7.2.4. In major cities (10) of the country, a significant proportion of the population is poor and

live in overcrowded downtown and suburban/slum areas and therefore have limited

access to TB diagnostic services.

7.2.5. A significant proportion of patients who seek care for a 2-week cough in health facilities

are not screened for TB. Data suggest that respiratory patients that are evaluated for TB

are those who have symptoms that heavily suggest TB. For example, data from TB

laboratory registers point out that 15% of TB suspects are smear-positive in Pakistan.

7.2.6. It is believed that a non-negligible number of TB patients who have been identified

through sputum smear examination are neither registered nor notified. For instance, in

Sindh Province, 9% of smear-positive TB cases detected in2012 were not registered nor

notified and therefore not promptly treated.

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7.3 LOW PROPORTION OF TB CONTACT ARE INVESTIGATED FOR TB 7.3.1. TB contact investigation is included in the national strategy to control TB. There is no

specific national guide for contact investigation, but guidance is provided in the

national TB treatment guidelines’ document and in MDR-TB case management guide.

7.3.2. The definitions of TB index case and contact are not quite in line with the WHO

recommendations and the algorithm and SOPs need further specifications.

7.3.3. There is an information system that generates some data on TB contact investigation

activities. These data suggest that TB contact investigation is far from being fully

implemented. It seems that only 1% of the identified contacts are screened for TB.

7.4 CHILDHOOD TB CASES NOT FULLY REPORTED TO NTP 7.4.1. Out of 110,000 SS+ all age groups diagnosed in 2012, childhood SS+ TB cases were 4,400

(4%).

7.4.2. Out of 285,410 total cases in 2012, children were 25,737 (9%).

7.4.3. About 40% of the district hospitals in the country are currently not implementing

childhood TB as per NTP protocols.

7.4.4. It is expected that with the high prevalence of bacteriologically confirmed TB among

adults 295/100000, there will be more children who will be in contact of these cases, are

getting TB, and need to be diagnosed and managed.

7.5 HOSPITAL DOTS LINKAGE (HDL) NOT FULLY OPERATIONAL A significant proportion of TCH are not linked to NTP. This minimizes the opportunity to reach a

large volume of presumptive TB patients that seek services at TCHs.

Effective referrals systems between periphery and TCH have not been established, leading to

weak implementation of TB DOTS in these settings

Sub-optimal inter-departmental coordination in the hospitals

Lack of integration of TB data into the hospital’s medical records system

7.6 ACSM STRATEGY NOT ABLE TO CREATE AN IMPACT ON INCREASING CASE FINDING 7.6.1. The prevalence survey has indicated that about 60% of TB patients have not visited any

health facility for their symptoms.

7.6.2. Huge gaps exits in term of providing information and mobilizing the patients who are

symptomatic to health facilities.

7.6.3. Involvement of community health workers (Lady Health Workers, Community Mid Wives,

mobile vaccinators, etc) in suspect identification and referral are almost non-existent

7.6.4. Although extensive ACSM activities have been implemented at the national, provincial

and district level in recent years, they have shown almost no effect in increasing case

detection in the districts. For example in the province of Punjab the ACSM districts when

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compared with non-ACSM districts shows either static or decreases in case notification

over time.

7.6.5. ACSM policy, strategy and operations need significant revision.

7.7 SIGNIFICANT ISSUES IN DRUG MANAGEMENT 7.7.1. Currently the major proportion of FLDs and all SLDs procured at the National level are

being provided from the GDF through the NTP, which will continue up to 2015-16. Beyond

that, no plan exists to sustain procurement at the National level.

7.7.2. The current procurement procedure does not address the issues related to availability of

quality assured drugs at the national and provincial levels, especially SLDs.

7.7.3. Even though, there are clearly defined procedures to manage TB drugs at the district and

BMU levels, these procedures are usually not respected by the staff at these levels; this

results in overstocking, a stock of TB drugs that remain beyond their shelve life and

simply a waste of TB drugs. In contrast, stock out of TB drugs occasionally occurs in some

BMUs.

7.7.4. In addition, the level of buffer stock, as required in the national guidelines on TB drug

management is not always maintained.

7.7.5. Many districts do not receive their stocks of TB drugs on time as planned because of the

limited availability of appropriate transportation system between the province and

district levels.

7.8 SIGNIFICANT ISSUES IN TRAINING IN TB CONTROL 7.8.1. The management of training activities is still quite under the leadership of the NTP

Central Unit. The national training modules and programs are well established for the

different areas of TB control and for the various categories of health professionals.

7.8.2. The training agendas of the provinces are often established by the NTP focal point for

training in coordination with the provincial manager for TB program. Planning of training

activities is not pro-actively shared with the PTP and is not always based on provincial

training needs and is not a bottom-up approach.

7.8.3. No core of national and/or provincial trainers have been established. The trainers that

need to be involved in training activities are identified on ad hoc basis.

7.9 NO SPECIFIC ACTIONS HAVE BEEN ESTABLISHED TO TARGET ELDERLY 7.9.1. The recent TB prevalence survey has reported that the prevalence of TB among people

aged 65 years and over is approximately 1.2% and 6.7 times higher than TB prevalence in

those aged 15-24 years.

7.9.2. To date, no specific strategy has been defined to actively screen elderly for TB and

establish appropriate mechanisms to manage patients with TB belonging to this age

group in Pakistan.

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7.10 LIMITED IMPLEMENTATION OF TB/HIV COLLABORATIVE ACTIVITIES 7.10.1. The prevalence of HIV in the general population is less than 0.1%. The sentinel

surveillance system for TB/HIV, established by the NTP and involving 16 sites throughout

Pakistan, reported that the prevalence HIV infection among TB patients was 0.3% in

2012.Less robust data showed that the prevalence of TB in HIV-positive persons was 5.6%

for the same year. There is at present no robust system of data collection to establish

national and provincial prevalence of TB among HIV positive persons and vice versa.

7.10.2. There is Joint Coordination Board (JCB) for TB/HIV at the national level and in each

province. These JCBs include clearly identified members and have well defined terms of

reference. However, they do not meet on a regular basis.

7.10.3. The national guidelines for TB/HIV and training materials have not been updated in light

of the latest HASP data, and guidelines for targeting key populations have not been

developed.

7.10.4. No strategy has been designed and implemented to address needs of the key

populations.

7.10.5. As TB/HIV has been a low priority, domestic resources have been minimal for these

interventions.

7.11 NOSPECIFIC INTERVENTION HAS BEEN ESTABLISHED TO ADDRESS TB & CHRONIC AILMENTS AND TB &TOBACCO USE

7.11.1. No specific strategy has been defined or operationalized to address TB and Poverty

7.11.2. No specific strategy has been defined or operationalized to address TB in context of

Chronic ailments such as Diabetes and COPD

7.11.3. No specific strategy has been defined or operationalized to address TB control among

Tobacco Smokers

7.12 TB LABORATORY NETWORK NOT FULLY OPTIMIZED The National TB laboratory network includes 1381 microscopy laboratories, seven culture

laboratories among which three are performing DST and 22 laboratories were equipped with

Xpert machines by the end of 2013.

7.12.1: Microscopy Network for diagnosis of smear positive TB cases

Coverage: Distribution of Microscopy laboratories and catchment population varies from

province to province (due to variation in density population) between districts and also with in

districts. Mapping of functioning microscopy centres and accessibility of catchment population

to a diagnostic facility is not done. Plans to improve access by establishing more diagnostic

facilities engaging private sector laboratories or using specimen transport mechanism (sputum

or smeared slides) do not exist. Involvement of community health workers in suspect

identification and referral is minimal.

AFB smear microscopy is not done as a routine test in most private laboratories, rather all sorts

of serological test are being offered for TB diagnosis in private sector.

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Infrastructure:- Microscopy services are integrated within multipurpose routine laboratories in

most of health facilities. Infrastructure of laboratories is mostly suboptimal in terms of space,

ventilation and infectious waste disposal arrangement. Infection control issues are not

addressed (improper place for specimen reception, specimen collection and waste

management).

Workload: Tb suspect identification is low furthermore TB services are not yet fully

decentralized. As a consequence workload in microscopy network is unevenly distributed, most

of peripheral microscopy laboratories ( RHC) have very low workload (<2 sm/day) in contrast to

laboratories at secondary level (DHQ,THQ) with workload exceeding 30 or more smears per

day.

Human resource for TB laboratories:- There is high staff turnover as result of contractual

appointment or transfer and posting which sometime reaches up to 40% in a year leading to

long queue of staff in waiting for formal training. System for on-job training or training on

induction at the district level is not in place and, as a result, a considerable number of

microscopy laboratories are functioning with untrained staff.

As TB microscopy services are offered FREE to patient with no incentive to Lab staff whom

otherwise likely to receive some incentive from other lab tests done. Therefore, lab staff is

more interested in doing non TB work due to financial benefit. Staff turnover is more

pronounced in private laboratories as service structure do not exist and salary scale are very

low in most of small scale laboratories.

There is a lack of dedicated TB Laboratory supervisors. Although District TB laboratory

supervisors have been identified in all districts, staff have been designated to perform these

additional TB laboratory duties besides their own routine tasks; as a result the commitment and

quality of work varies a great deal from district to district.

Trainings are conducted at the provincial level but no follow up is done of the human resources

trained. The database of HR working in TB laboratories is not maintained on a regular basis and

HR cannot be located if transferred from one health facility to another.

Training curriculum and practical facilities for TB diagnosis are inadequate in laboratory

technician schools and there is limited capacity of tutors. Graduates from these schools often do

not have any practical exposure to TB diagnosis.

Equipment for Microscopy services: Good quality microscopes are available in most health

facilities but there is no established system for regular servicing and repair of equipment.

There is no documented policy for the procurement and frequency of replacing and servicing

microscopes.

400 LED microscopes, distributed to the provinces for the introduction of FM microscopy in high

volume laboratories, have not yet been implemented at most of sites. Availability of resources

for LED microscopes varies from province to province and is not proportional to the number of

high volume laboratories.

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Laboratory staining reagents and chemicals: There are significant barriers to the

implementation of policy guidelines for laboratory staining reagents and chemicals required for

TB diagnosis. The quality of reagents procured is not uniform.

The guidelines for the contribution to the logistics of the microscopy network do not exist at

various levels.

Quality assurance: External quality assessment by blinded re-checking is implemented in 90% of

the TB microscopy laboratories but its quality and outcome varies from district to district. Weak

monitoring (onsite and desk) and on-the-job training and feedback is not optimal at all levels.

7.12.2: Culture/Xpert laboratory for diagnosis of smear negative tuberculosis

Approximately half of all pulmonary TB cases are smear negative in Pakistan and these are not

bacteriologically confirmed due to a lack of resources, limited capacity, and absence of policy

guidelines.

The culture and GeneXpert laboratory network is expanding, but optimal utilization of these

services cannot be achieved without an effective specimen transport and referral mechanism.

7.12.3: Culture and DST laboratories for management of DR-TB:

Coverage:- Currently resources are available for establishing one DST laboratory for 25 Million

population. With the expected revision in guidelines, in light of Xpert rollout, this number will

need to be reviewed.

Infrastructure:- Upgrading the infrastructure of the planned laboratories is in process through

global fund but there are serious concerns regarding sustained maintenance and overhead costs

of the established laboratories after close out of the project.

There is a power crisis in the country and most institutes are facing power outages. Provision of

uninterrupted power supply to run the equipment (especially MGIT for liquid DST) requires high

capacity generators and regular funding for fuel charges.

Equipment:- Maintenance of the equipment, including the national TB laboratory, is a

continuous and major problem. Additionally, in-country capacity for certification of BSC and

repair of equipment in very limited.

Funding to sustain these services has not been secured after 2015.

New diagnostic tools Infrastructure requirements and short shelf life are the main challenges for

rolling out new technologies.

Harsh environmental conditions (temperature >400C in most part of country for most part of

year), compounded by the prevailing power crises, is one of major challenges to ensuring

uninterrupted functioning of Xpert and MGIT.

There is limited funding contribution from the public sector for introduction/maintenance or

supply of Kits for running new diagnostic tools.

Human resources: All technical staff are funded through GF for new TB culture and DST

laboratories including both the national and provincial reference laboratories, however there is

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still a shortage of trained staff because the public sector has not been able to provide the

required staff due to gaps in HR.

As a result continuity of services beyond 2015 will be a challenge.

There is lack of dedicated full time TB Laboratory managers at the provincial levels, as currently

TB in-charges at the provincial levels have many other assigned tasks which limits their

commitment for TB.

TB Laboratory supplies and management: Most laboratory supplies are provided to all TB

culture and DST laboratories through donor funding with little contribution from the provinces

or host health institutes.

7.12.4: National TB Reference laboratory

The NTRL is providing services for PMDT and handling large numbers of highly infectious

specimens (11 XDR reported in 2013) but weak infrastructure and bio-safety standards pose a

risk to laboratory staff. Issues pertaining to Biosafety and bio-security are not addressed.

The NTRL is a central place for HRD of TB culture and DST laboratory networks but due to small

space, it is difficult to implement training and routine services simultaneously; therefore training

quality or routine services are compromised.

The national EQA scheme for DST has been established but there is a need for capacity building

to implement a quality management system.

There is need to properly manage and analyze, on a regular basis, data generated both at the

NTRL and National laboratory network levels. Capacity of the NTRL to conduct operational

research, based on program needs, and publish in international peer reviewed journals is

limited.

The molecular section of the NTRL is not yet fully established.

Gaps in reaching ISO laboratory accreditation /certification include infrastructure, bio- safety,

equipment maintenance, training, recording and reporting.

There is need to establish one centre of excellence in the country with the capacity to train ,

conduct research and address the need for advanced tuberculosis diagnostics.

7.13 MANY CARE PROVIDERS OUTSIDE THE NTP NETWORK ARE NOT INVOLVED IN TB CARE AND CONTROL EFFORTS

7.13.1. Pakistan has a wide and unregulated health sector and includes many varieties of

care providers, including a significant number of traditional healers.

7.13.2. Moreover, not all health facilities and type of health care providers are

appropriately linked with the existing TB diagnostic and referral services.

7.13.3. There are approximately 5,000 basic health units (BHU) and each of them covers

2,000 to 25,000 population. The daily attendance in each BHU ranges from 2 to 50

patients. Nearly all the BHUs are not under the responsibility of the District health

Authorities but under that of NGOs (PPHI, PRSP), therefore, they have quasi or no

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linkages with the NTP. The available information suggests that very few patients

are referred from the BHU setting to the BMU network.

7.13.4. According to the National Health Accounts of 2009, there are about

100,00qualified general practitioners (GP) in Pakistan. Significant efforts have

been made to link them to NTP network. At present, roughly 2,500 GPs are

collaborating with the NTP/PTPs. A significant proportion of the GPs have never

notified any TB case or stopped notification. It is estimated that around 5% of TB

cases are notified by the GPs with some provincial variation. The NTP has not yet

initiated any action to involve the private chest specialists and professionals,

medical associations such as Pakistan Medical Association (PMA), Pakistan Chest

Society (PCS), Society of General Practitioners and Family Medicine, Pakistan

Pediatric Association (PPA) and others. The policy, strategy and operations of

involving and sustaining GPs in TB control activities need significant revision.

7.13.5. There are more informal and unqualified private care providers than qualified

care providers particularly in rural areas and poor urban settings where TB is

usually highly prevalent. To date, no strategy has been established by the NTP to

explore how these informal and unqualified health workers can be linked to TB

control network. In addition, care services are provided in comparable number of

medicine stores without any regulation.

7.13.6. There are many private retail pharmacies in rural areas and poor urban setting

where clients with TB like symptoms seek care first. To date, no strategy has been

put in place how to engage the retail pharmacies to contribute to early case

detection, referral and pharmacy DOTS where TB treatment can be appropirately

dispensed accroding to national treatment guidelines. In addition, lack of of

regulatory enforcement to ensure that TB medicines are not freely sold in the

retail pharmacies has contributed to inappropriatness of TB management and

potentially contributed to increased resistance to TB medicines.

7.13.7. In Pakistan, there are many health services provided by other public sector

(corporate) sector such as the social security, army forces, Pakistan Railways,

mining societies and others. To date, limited linkages have been established

between the NTP and this sector.

TB in penitentiary system

7.13.8. TB control in prison system is included in the national policy to control TB. This

intervention was implemented in all 32 prisons of Punjab Province through the

TBREACH Project. To make this experience successful specific SOPs have been

developed. The data generated through this project suggest that the prevalence

of TB in prison is 1.3%.

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7.13.9. The TBREACH Project was over at the end 2012 and TB control activities were

maintained in the 32 prisons.

7.13.10. The SOPs used for the TBREACH Project have not been yet adopted at

national level and no other TB control activities have been implemented outside

the prisons of Punjab Province.

TB in mining settings

7.13.11. There is no national policy for TB control in mining settings. There is no

collaboration established between the NTP and the health services of mining

corporations. The NTP has no information on TB burden and TB control in these

settings. There is no specific system generating such information.

7.14 A HIGH PROPORTION OFDR-TB PATIENTS ARE NOT DETECTED 7.14.1. A high proportion of DR-TB patients are not detected.

7.14.2. The annual estimate of DR-TB cases in Pakistan is 12044. At the same time our GF

based target for 2014 is 4518. Our current projected rate is at 42% of the GF

target

7.14.3. It is expected with new strategy in place, the DR-TB case finding will increase

proportionately which will require more material and logistic support to manage

these cases

7.14.4. Appropriate guidelines for PMDT are in place and operational plan has been

established for expansion with substantial funding mobilized from Global Fund.

However, diagnostic and follow-up laboratory facilities are limited.

7.14.5. Management of DR-TB cases is established through PMDT treatment sites which

are located throughout the country focusing primarily on Ambulatory Based

Model of care. However other health care system (i.e. BMUs, National

Programme, NRSP and PRSP, PPHI etc) are not fully involved yet in Ambulatory

based model of care.

7.14.6. Infection Control measures are generally in place in PMDT sites. However there

have been delays in the implementation of the plan among some PMDTs.

Infection control measures at the community level is inadequate

7.14.7. Lack of adequate administration and monitoring of social support component.

7.14.8. National guidelines on TB infection control are available. Infection control has

been implemented in 6 PMDTS with trained staff in line with the international

standards.

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7.14.9. There is an operational plan to expand TB infection control in 30 PMDTS; funding

from GF is available for the procurement of the required supplies and to print

training modules and guidelines. But, there is no funding to organize training

sessions of the staff of these PMDTS.

7.14.10. No TB infection control has been implemented in HIV care facilities and in

health centres ensuring TB/HIV collaborative activities.

7.14.11. No clear approach has been defined for TB infection control in the BMUs

dealing with the majority of routine TB patients among which many will be

potential M/XDR-TB.

7.14.12. No system has been implemented to monitor and evaluate TB infection

control measures. There is no information system monitoring the health workers

who are affected with TB.

7.15 ISSUES IN OPERATIONALIZING MONITORING, SUPERVISION AND EVALUATION AT PROVINCIAL AND DISTRICT LEVELS

7.15.1. The monitoring and evaluation system is not properly structured at all the administrative

levels therefore; the quality of supervision is sub-optimal.

7.15.2. The M&E activities are the responsibility of both district (DHO/DTC), regional (NPOs) and

provincial staff (PTP). The NTP has provided PTO, NPOs and M&E officers to look after a

cluster of districts in the province but there are usually delays in recruitment and attrition

of staff is often so most of the regions were not supervised on a regular basis due to

shortage of NPOs.

7.15.3. At the regional level (divisional) there is no arrangement to monitor and evaluate TB

activities.

7.15.4. At the district level there is no formal arrangement to monitor and evaluate routine TB

activities. Additional case finding activities would demand more strong human resource

arrangement at district level.

7.15.5. The surveillance activities, data validation and analysis is sub-optimal. The data

generated by the monitoring and evaluation system in not analysed for decision making

at the provincial and district levels.

7.15.6. The supervision of TB control activities is well structured and its proceeding is well

established. The Central Unit supervises the province which supervises the district which

supervises BMUs. The three levels establish supervision agendas for one or three

months. The district level usually informs the province level on the supervision that will

be undertaken at its level and does not submit any supervision report.

Weak managerial capacities at district level

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7.15.7. The NTP is well structured with a Central Unit and Managerial units at the province and

district levels. The mission of the Central Unit is well defined and includes sufficient

number of staff. All the interventions defined in the national strategy to control TB are

covered by appropriate staff.

7.15.8. The ongoing process of devolution constitutes an opportunity to improve the capacities

of the NTP through the decentralization of many managerial responsibilities at province

level.

7.15.9. This process of decentralization needs to be appropriately defined, established and

technically assisted, especially at province level.

7.15.10. The capacities of the managerial units of the provinces need to be developed; to

adapt the national policy for TB control, to establish strategic plans for the province, to

set mechanisms for the organization of the supervision and training activities in the

provinces, to ensure appropriate TB surveillance, the monitoring of the TB control

activities implementation as well as TB care and control services delivery, the evaluation

of TB control outcome and to organize and develop the managerial capacities at district

level.

7.15.11. Significant weaknesses are identified at the district level in terms of management

of the TB control program.

7.16 TB CONTROL PROBLEMS NOT ADDRESSED THROUGH OPERATIONAL RESEARCH 7.16.1. Data collected from the NTP system is not fully analyzed to hypothesize for issues to be

addressed through operational research

7.16.2. There is no up-dated agenda for operational research at the national and provincial levels

7.16.3. Academic institutions are not fully collaborating with the NTP in operational research

7.16.4. The Operational Research which is done is inadequately translated into practice

7.16.5. Provincial and district capacity is limited to design and conduct of operational research

7.16.6. There is no comprehensive policy on operational research

7.17 NON FUNCTIONING NATIONAL STOP TB PARTNERSHIP 7.17.1. The National Stop TB Strategy for Pakistan was created in 2004. An executive secretariat

was established with clear terms of reference. But since that time, no action has been

undertaken by this partnership, especially to raise funds within country.

7.18 TB IN TRANS-BORDER POPULATIONS NOT OPERATIONAL 7.18.1. The province of KP and Balochistan has a border with Afghanistan and Iran from where

trade and refugee movement is frequent. To date, no specific strategy has been

defined to operationalize TB in trans-border population.

7.19 NOSPECIFIC INTERVENTION HAS BEEN ESTABLISHED TO ADDRESS TB &POVERTY, Legislation on drug sale, declaring TB as notifiable disease

7.19.1. No specific strategy has been defined or operationalized to address TB and Poverty

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7.19.2. No current legislation on the sales of Anti-TB drugs in the market

7.19.3. No current legislation to declare TB a notifiable disease

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SECTION A3 –

STRATEGIC GOALS, OBJECTIVES, INTERVENTIONS

& ACTIVITIES

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8 STRATEGIES AND ACTIVITIES: TB CONTROL “VISION 2020”

8.1 OVERVIEW: NATIONAL TB STRATEGIC PLAN “VISION 2020” TB Control at the National, Provincial and Regional levels is currently going through a

rejuvenating phase of program development due to several reasons, including;

i) Health sector devolution;

ii) Limited public sector financing for TB control and shrinking donor assistance;

iii) Stagnant TB case notification over the last several years;

iv) High number of TB cases undetected in the community;

v) Effect of social determinants such as increasing poverty and societal inequalities;

vi) Global innovations in TB diagnosis and management;

vii) Increasing drug resistant TB;

viii) Managerial and governance issues;

ix) High risk behaviors such as increased use of tobacco;

x) Increase in the occurrence of COPD, diabetes and HIV/AIDS, etc.

This implies strategic thinking at all levels to address the challenges faced today by the TB

control program in Pakistan. The National TB Strategic Plan (NSP) “Vision 2020” is drawn from

provincial and regional strategic plans and consists of strategic interventions that will be

implemented under the purview of the NTP, in the context of the devolved health sector and in

the wake of the national TB prevalence survey.

The National TB Strategic Plan “Vision 2020” entails developing innovative strategies that will:

1- Improve the performance and impact of TB control by maximizing public sector investment

and accountability in TB control activities.

2- Address sensitive and drug resistant TB by: (a) reducing diagnostic delays, (b) reducing the

duration and improving the efficacy of treatment, (c) preventing disease, and (d) increasing

access to DOTS and DR-TB treatment, etc.

3- Invest in new diagnostic and TB management tools and approaches that are less labor

intensive, more cost-effective, and can be delivered close to patients to minimize the health

workforce burden and help improve patient access, thereby increasing case detection and

enhance treatment success rates.

4- Universal access to TB services, which implies expanding TB DOTS through all types of

healthcare providers including the large and currently unregulated private sector

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5- Prioritize research that has the potential to change policy and practice in TB care in the

country.

The NSP vision 2020 entails achieving the following:

Vision: TB Free Pakistan

Mission: To ensure universal access to quality diagnosis and treatment for people with TB.

8.2 GOAL AND OBJECTIVES: Goal: To reduce 50%, the prevalence of TB by 2025 in comparison to 2012.

Objectives:

i) To increase the number of notified TB cases from 298,981 in 2013 to at least 420,000 by

2020 while maintaining the treatment success rate above 90%;

ii) To reduce, by at least 5% per year by 2020, the prevalence of MDR-TB among TB patients

who have never received any TB treatment

iii) Strengthen programmatic and operational management capacity of the TB Control Program

while enhancing public sector support for TB control by 2020;

8.3 PRIORITY PROGRAM AREAS:

For objective 1, the priority program areas are:

Increase gradually the number of suspects evaluated for TB from 839,371 in 2013 to

3,320,000 in 2020; the ratio number of suspects evaluated to identify 1 bacteriologically

confirmed pulmonary TB case was 7.5 in 2013; this ratio will progressively increase to 8 in

2014, 10 to 2015, 12 in 2016, 15 in 2017, 2018 and 2019 and 16 in 2020

Increase the number of bacteriologically confirmed TB cases who are notified from

111,916 in 2013 to 208,000 in 2020; the proportion of bacteriologically confirmed

pulmonary TB cases among all notified new pulmonary TB cases is 48% in 2013; in order

to improve the quality of TB diagnosis this proportion will gradually increase to reach at

least 70% from 2017 onwards (72% in 2020)

Ensure uninterrupted TB drug supplies through the improvement of TB drug

management at national, provincial and district levels

Enhance case-holding when TB patients are on treatment

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Improve and expand TB contact investigation

Expand childhood TB case management

Improve the organization of TB care and control services within tertiary care level

hospitals as well as their linkages with their external health environment

Design and implement advocacy and awareness activities for policy makers, communities

and TB patients and their families

Improve training capacity and develop human resource development at national,

provincial and district level

Improve TB detection in elderlies

Improve TB detection and management in coal miners

Improve TB care and control services in vulnerable populations: slums’ dwellers,

internally displaced people/refugees and brick kiln workers

Strengthen and scale up TB/HIV collaborative activities

Improve co-management of TB and chronic conditions (diabetes and tobacco smoking)

Implement PAL

Optimizing and enhancing TB laboratory network: from 1,365 in 2013 to

1,953 AFB microscopy laboratories in 2020

Increase the number of Xpert machines from 43 in 2013 to 70 in 2020

Increase the number of laboratories performing culture from 10 in 2013 to 30in 2020 and

the number de DST sites from 2 in 2013 to 15 in 2020

Expand partnerships with private sector in an effort to engage all health care providers in

delivering quality diagnostic and treatment services for TB control in Pakistan; the

contribution of the private health sector in TB notification is expected to increase from

20% in 2013 to at least 35% in 2017onwards.

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For objective 2, the priority program areas are:

Optimizing drug-resistant (DR) TB management by increasing the number of MDR-TB

cases to be detected and managed from 1,560 MDR-TB cases in 2013 to 14,316in 2020

Sustaining 30 PMDT sites in the country

Strengthen and expand TB infection control

Ensure social support for MDR-TB patients

Establish a sentinel surveillance system in 2018 to monitor the trend over time of MDR-

TB prevalence among TB cases who has never received any TB treatment

For objective 3, the priority program areas are:

Revitalization of the National Stop TB Partnership Pakistan (created in 2006)

Mobilization of public funding for TB control included as a top priority in the agenda of

National Stop TB Partnership Pakistan including formulation of respective provincial and

regional PC-1s.

Advocacy by National Stop TB Partnership Pakistan for increasing public TB funding in the

sub-committees for Health of the Senate and the National Assembly of Pakistan; this will

enhance at federal level the allocation by the Council of Common Interest for TB control

funding

Advocacy by National Stop TB Partnership Pakistan for increasing public TB funding

through the 60 medical doctors who are members of the Senate and the National

Assembly; this will contribute to sensitizing the members of the sub-Committees for

Health of the Senate and the National Assembly of Pakistan as well as the members of

the Council of Common Interest

Advocacy by National Stop TB Partnership Pakistan for increasing public TB funding in the

sub-committees for Health of the Provincial and Regional Assemblies; this will help

improve the funding allocation for TB control in the provinces and regions.

Strengthen the managerial capacities at national, provincial and regional levels, including

of recruitment of technical and operational staff (coordination of various program

components, finance, administration, etc)

Development of operational research activities to address programmatic needs

Staff coordination meetings on quarterly basis at all levels

Organize the supervision of TB control activities

154

Develop and distribute guidelines, SOPs and tools (including retooling of new definitions

and algorithms)

Ensure surveillance activities and monitoring and evaluation of TB control interventions

Initiate procedures on the legislation regarding sale of first and second line TB drugs

Organize external reviews of NTP

Office supplies and equipment at all levels

Infrastructure renovations

NOTE: The quantification and phasing of “activities” will be part of Operational Plan

1. Objective 1: To increase the number of notified TB cases from 298,981 in 2013 to at least

420,000 by 2020 while maintaining the treatment success rate above 90%

1.1. Increase suspect screening from 956,105 from 2014 onward to 3,328,770 in 2020

(assumption: screen 15 suspects to detect 1 B+ case)

Table 48: TB suspects to be identified 2014-2020 2014 2015 2016 2017 2018 2019 2020

No. of suspects needed to be assessed bacteriologically for TB

956,105

1,413,243

1,943,369

2,931,596

3,061,621

3,064,682

3,328,770

List of activities

1.1.1. Review and adapt the “Definitions and reporting framework for tuberculosis WHO,

2013” in national context (Annexure-4)

1.1.2. Develop protocols, guidelines and training modules on new definitions and reporting

framework

1.1.3. Implement the revised definitions and reporting framework in all BMUs in the country

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1.2. Increase bacteriologically confirmed case notification of pulmonary TB cases from

119,513 in 2012 to at least 208,048 in 2020 (assumption: average annual increase of

7.5%)

Table 49: TB cases projection 2014-2020

2014 2015 2016 2017 2018 2019 2020

Population (Projected, million)

185 188 191 193 197 200 203

All Type Cases Notified

313,930 337,475 362,785 377,297 382,956 383,339 379,506

Pulmonary TB cases

Total number of new pulmonary TB cases bacteriologically confirmed

119,513 141,324 161,947 195,440 204,108 204,312 208,048

Total number of new pulmonary TB cases clinically diagnosed

119,513 115,629 107,965 83,760 87,475 87,562 80,908

EPTB cases

Total new extra-pulmonary cases notified

56,068 60,273 67,478 69,800 68,396 68,464 67,780

List of activities

1.2.1. Review and adapt the approaches and algorithms “Systematic screening for active

tuberculosis: Principles and recommendation WHO, 2013” in the national context

(Annexure-5)and “Improving the diagnosis of smear negative and extra-pulmonary TB

among adults and adolescents, WHO”.(Annexure -11)

1.2.2. Re-design roles of various care providers in implementing new approaches and

algorithms

1.2.3. Develop protocols, guidelines and training modules on new approaches and algorithms

1.2.4. Implement the adapted version of algorithms in all BMUs in the country

1.2.5.

1.3. Increase the treatment success rate from 92% in 2014 while maintaining it to 93%in

2020

156

Table 50: TB treatment success projection 2014-2020

2014 2015 2016 2017 2018 2019 2020

Treatment success rates among new smear positive cases and/or culture-positive (%)

92% 92% 93% 93% 93% 93% 93%

List of activities

1.3.1. Develop innovative approaches to improve treatment success rate

1.3.2. Develop protocols, guidelines and tool to implement innovative approaches to increase treatment success

1.3.3. Train 80,000 LHWs in offering treatment support arrangement in all over the country.

1.3.4. Develop mechanism and guidelines to monitor treatment support activities.

1.3.5. Implement treatment support protocols in 141 districts in the country in both the public as well as the private sector.

1.3.6. Consider other types of treatment support arrangement such as family DOT, etc.

1.3.7. Consider incentives for patients especially sputum smear positive cases in intensive phase of treatment.

1.3.8. Involve high school students in patient support

1.3.9. Involve community volunteers in patient support

1.4. Increase contact management from 246,989 in 2014 to 1,156,973 2020 (assumption:

with annual increases in proportion of index case to be investigated from 0.3 in 2014 to

0.8 in 2020)

Table 51: Contact management projection 2014-2020

2014 2015 2016 2017 2018 2019 2020

Proportion of Index cases to be investigated

30

50

60

70

80

80

80

No. of HH contacts eligible for screening

823,297

979,503

1,148,132

1,390,590

1,419,276

1,420,695

1,446,216

No. of HH contacts to be screened (6 contacts/HH)

246,989

489,751

688,879

973,413

1,135,421

1,136,556

1,156,973

No. of HH contacts less than 5 years eligible for IPT

30,874

61,219

86,110

121,677

141,928

142,070

144,622

No. of HH contacts <5 years that need to be treated by IPT

30,565

60,607

85,249

120,460

140,508

140,649

143,175

157

List of activities

1.4.1. Review and adapt the “Recommendations for the investigation of contacts of persons

with infectious tuberculosis in low and middle income countries, WHO” in to national

context (Annexure-6)

1.4.2. Re-design roles of various care providers in implementing new approaches for contact

investigation

1.4.3. Develop protocols, guidelines and training modules on new approaches for contact

investigation

1.4.4. Implement the adapted version of contact investigation in all BMUs in the country

1.4.5. Initial training /refresher of specialist and doctors: Contact investigation

1.4.6. Initial training /refresher of DOTS facilitator: Contact investigation

1.5. Country-wide expansion of childhood TB case management from current(30 DHQ

hospitals and 34 TCHs in 2012) to all THQ/DHQ/TCH hospitals in 141 districts by 2015

Table 52: Childhood TB case projection 2014-2020 2014 2015 2016 2017 2018 2019 2020

Childhood TB cases to be managed

40,000

50,000

60,000

70,000

75,000

80,000

82,000

List of activities

1.5.1. Up-date national guidelines and training module on childhood TB case management

1.5.2. Universal access to childhood TB management through trained pediatricians/staff in

selected public private sector facilities in the country.

1.5.3. Implement new guidelines in all tertiary care hospitals, district and tehsil hospitals in the

country public sector and other public sector health facilities

1.5.4. Implement new guidelines in selected private sector i.e. NGOs, Private hospitals, Private

Paediatricians and chest specialist clinics in the country

1.5.5. Ensure that all childhood TB cases are detected according to the National Childhood TB

Guidelines

1.5.6. Conduct advocacy workshops focusing clinical diagnosis of Childhood TB in collaboration

with Pakistan Pediatric Association.

1.5.7. Use of GeneXpert to diagnose selected cases in children

1.5.8. Initial training /refresher of specialist and doctors: Childhood TB case management

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1.5.9. Initial training /refresher of DOTS facilitator: Childhood TB case management

1.5.10. Ensure availability of simple drug dosages according to pediatric formulations.

1.5.11. Effective supply chain management for PPD(Despite poor diagnostic value, PPD is still

recommended by WHO as initial tool and should continue as such; Positive test HELPS

but negative does not exclude)

1.6. Strengthen Hospital DOTS internal and external linkage in all tertiary care hospitals by

2015

1.6.1. Scale up TB DOTS implementation including pulmonary and extra-pulmonary and

childhood TB management in TCHs and DHQs

1.6.2. Strengthen bacteriological diagnosis of extra-pulmonary and childhood TB at the TCH and

DHQs

1.6.3. Implement ACSM interventions in the TCH and DHQ settings

1.6.4. Streamline external linkage mechanisms with public and private peripheral TB care

services, including strengthening of pre-registration referral to the BMU nearest to the

patient residence

1.6.5. Advocacy with the provincial Department of Health, hospital management, senior

consultants and specialists

1.6.6. Build capacity of staff of relevant departments within the hospital

1.6.7. Implement strong M&E systems to measure performance, identify challenges and

implement solutions

1.7. ACSM strategy to be re-designed and require focused implementation

List of activities

1.7.1. Review and refine the current model of ACSM in country

1.7.2. Implement focused ACSM intervention for TB patients including DR-TB cases

1.7.3. Involve electronic and print media in advocacy

1.7.4. Community events in mobilizing TB patients

1.7.5. National level events: high-level discussions around TB

159

1.7.6. Field visits for high-level officials or journalists

1.7.7. Production of IEC materials to improve knowledge of TB in the general population

1.7.8. Mass media campaigns: Broadcast materials (Public Service Announcement)

1.7.9. Initial training /refresher of specialist and doctors: ACSM

1.7.10. Initial training /refresher of DOTS facilitator: Community involvement

1.7.11. Initial training /refresher of DOTS facilitator: Advocacy and Communication

1.7.12. Initial training /refresher of community health workers/volunteers: Community

involvement

1.7.13. Initial training /refresher of community health workers/volunteers: Advocacy and

Communication

1.8. Improve drug management at national, provincial and district levels

List of activities

1.8.1. First-line drug procurement and management

1.8.2. Second-line drug procurement and management. “The use of bedaquiline in the

treatment of MDR-TB, WHO 2012”. (Annexure-12)

1.8.3. Strengthen and sustain the national, provincial and district capacity to store drugs (FLDs

and SLDs)

1.8.4. Strengthen and sustain the logistics for transporting drugs to all BMUs and PMDT sites in

the country

1.8.5. Up gradation of BA/BE study center as per WHO standards “A practical handbook on the

pharmaco-vigilance of medicines used in the treatment of Tuberculosis enhancing the

safety of the TB patient-WHO, 2012”.Annexure 7

1.8.6. Support PTPs to develop their BA/BE stud centers.

1.8.7. Monitor and evaluate the implementation.

1.8.8. Initial training /refresher of managers and TB coordinators at all level: drug management

1.9. Improve training capacity and develop human resource development (HRD) at national,

provincial and district

List of activities

1.9.1. Training (at national and international level) of managers and coordinators at national,

provincial and district level: Program management and operational research on technical

160

areas related to diagnosis, DR-TB management, drug management, supervision and

monitoring, surveillance and operational research)

1.9.2. Develop a core of master trainers at national, provincial and district level on various

components of TB

1.10. Improve diagnosis in elderly patients with TB, living in urban slums, IDPs, refugees, etc

List of activities

1.10.1. Develop model of care for elderly patients with TB, living in urban slums, IDPs, refugees

1.10.2. Pilot the intervention model

1.10.3. Review the experience and scale-up

1.11. Strengthen and scale up TB/HIV care delivery specifically targeting key populations

Table 53: Projected TB cases to be screened for HIV at sentinel sites 2014-2020 2014 2015 2016 2017 2018 2019 2020

No. of sentinel sites for screening TB cases for HIV

16 32 32 32 32 32 32

No. of TB cases to be screened

38,479

44,417

50,074

58,655

61,146

61,207

62,306

No. of HIV screening kits required

38,479

44,417

50,074

58,655

61,146

61,207

62,306

List of activities

1.11.1. Scale up existing TB/HIV co-infection services from 16 sites especially considering areas

with concentrated epidemic of HIV

1.11.2. Update training materials to address TB/HIV co-infection especially in key populations.

1.11.3. Enhance collaboration with the relevant stakeholders working in TB and HIV including

disease control programs, national and international organizations, and UN and bilateral

agencies.

1.11.4. Engage private healthcare providers and facilities to expand the coverage and availability

of TB/HIV services.

1.11.5. Conduct periodic assessments and operations research to assess the burden of TB in key

populations.

1.11.6. Continue to conduct HIV screening of all enrolled MDR-TB patients.

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1.12. TB and chronic ailments, TB and Tobacco and PAL

List of activities

1.12.1. Develop guidelines to address TB among diabetic and tobacco smokers

1.12.2. Adapt and pilot interventions of PAL strategy

1.12.3. Pilot test the interventions in selected hospitals in the country

1.12.4. Review and refine the intervention model

1.12.5. Scale-up in teaching and district level hospitals Initial training /refresher of specialist and

doctors: PAL

1.12.6. Initial training /refresher of DOTS facilitators: PAL

1.12.7. Pilot test PAL intervention model in teaching and district level hospitals

1.12.8. Review and refine and scale-up PAL interventions

1.13. Optimizing laboratory network: from 1,365 in 2014 to 1,953 AFB microscopy

laboratories in 2020, from 43 in 2014 to 70 Xpert machines in 2020, from 10 in 2014 to

30 in 2020 culture laboratories, from 4 in 2014 to 15 in 2020 DST laboratories

Table 54: Number of suspects to be identified 2014-2020 2014 2015 2016 2017 2018 2019 2020

No of suspects needed to be assessed bacteriologically for TB

956,105

1,413,243

1,943,369

2,931,596

3,061,621

3,064,682

3,328,770

No of sputa to be examined, including follow up

2,103,432

3,109,135

4,275,412

6,449,512

6,735,565

6,742,301

7,323,295

No of sputa examined per microscopy center per day (provincial calculations)

6

8

10

15

15

15

15

No of additional microscopy center required

-

150

205

-

76

2

155

No. of total laboratories that need to be functional/year

1,365

1,515

1,720

1,720

1,796

1,798

1,953

List of activities

1.13.1. Establish/Strengthen microscopy laboratories (Public, Other public sector, Private

Hospitals, NGOs, Private labs): Equipment and supplies

162

1.13.2. Establish/ Strengthen LED microscopy laboratories (Public, Other public sector, Private

Hospitals, NGOs, Private labs): Equipment and supplies

1.13.3. Initial training/refresher of laboratory technicians (Public Sector): AFB microscopy

1.13.4. Initial training/refresher of laboratory technicians (Other public sector Sector): AFB

microscopy

1.13.5. Initial training/refresher of laboratory technicians (Private Hospitals): AFB microscopy

1.13.6. Initial training/refresher of laboratory technicians (NGOs): AFB microscopy

1.13.7. Initial training/refresher of laboratory technician (Private labs)s: AFB microscopy

1.13.8. Initial training/refresher of laboratory technicians (Public Sector): LED microscopy

1.13.9. Initial training/refresher of laboratory technicians (Other public sector): LED microscopy

1.13.10. Initial training/refresher of laboratory technicians (Private Hospitals): LED

microscopy

1.13.11. Initial training/refresher of laboratory technicians (NGOs ): LED microscopy

Table 55: Number of GeneXpert machines required 2014-2020 2014 2015 2016 2017 2018 2019 2020

No. of tests to be done on GeneXpert

59,612

92,849

148,801

206,448

208,771

208,979

213,004

No. of total GeneXpert machines required

20

31

50

69

70

70

71

No. of GeneXert machines available

43

43

43

50

69

70

70

No. of additional GeneXpert machines needed

0 0 7 19 1 0 1

1.13.12. Establish/strengthen Xpert sites (Public, Other public sector, Private Hospitals,

NGOs):

1.13.13. Structure enhancement, equipment and suppliesPurchase additional Gene-Xpert

machines to implement in the selected centers by 2020 .

1.13.14. Purchase cartridges for Xpert machines for continued DR-TB care. Purchase

additional equipment and materials to establish sites.

1.13.15. Train human resource to conduct Xpert tests.

163

Table 56: Number of culture laboratories required 2014-2020 2014 2015 2016 2017 2018 2019 2020

No. of cultures to be done

79,517

118,619

160,019

230,937

239,299

239,538

251,964

No. of laboratories required for culture (8,000 cultures/lab/year)

10

15

20

29

30

30

31

No. culture laboratories available

10

23

23

23

29

30

30

No. of additional culture laboratories needed

0 0 0 6 1 0 1

1.13.16. Establish/strengthen culture laboratories (Public, Other public sector, Private

Hospitals, NGOs): Structural enhancement, equipment and supplies

1.13.17. Purchase equipment and supplies to establish culture laboratories in the selected

centers by 2020

1.13.18. Infrastructure enhancement for new culture laboratories

1.13.19. Initial training/refresher of laboratory technicians (Public Sector): Culture

1.13.20. Initial training/refresher of laboratory technicians (Other public sector): Culture

1.13.21. Initial training/refresher of laboratory technicians (Private Hospitals): Culture

1.13.22. Initial training/refresher of laboratory technicians (NGOs): Culture

Table 57: Number of DST laboratories required 2014-2020 2014 2015 2016 2017 2018 2019 2020

No. of DST to be carried out

4,970 7,414 10,001 14,434 14,956 14,971 15,748

No. of DST laboratories required

5 7 10 14 15 15 16

No. DST laboratories available

4 5 7 10 14 15 15

No. of additional DST laboratories needed

1 2 3 4 1 0 1

1.13.23. Establish/strengthen laboratories performing molecular tests (Public, Other public

sector, Private Hospitals): Structural enhancement, equipment and supplies

1.13.24. Infrastructure enhancement for new culture laboratories

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1.13.25. Purchase equipment and supplies to establish DST laboratories in the selected

centers by 2020

1.13.26. Initial training/refresher of laboratory technicians (Public Sector): DST

1.13.27. Initial training/refresher of laboratory technicians (Other public sector): DST

1.13.28. Initial training/refresher of laboratory technicians (Private Hospitals): DST

1.13.29. Initial training/refresher of laboratory technicians (NGOs): DST

1.13.30. Initial training/refresher of laboratory technicians (Public Sector): molecular test

1.13.31. Establish/strengthen EQA for microscopy, LED, Xpert, culture, DST, molecular

testing (Public, Other public sector, Private Hospitals, NGOs, Private labs): Human

Resource, Logistics, Equipment and supplies

1.14. Expand partnerships with private sector in an effort to engage all healthcare providers

in delivering quality diagnostic and treatment services for TB control in Pakistan;

increasing contribution in total national TB case notification from 20% in 2012 to 32% in

2020

1.14.1. Policy advocacy at national and provincial level for appropriate policies, legislation and

regulatory framework for involving private sector providers

Table 58: Contribution projected for PPM in country 2014-2020 2014 2015 2016 2017 2018 2019 2020

TB Case notification (all ages, all forms)

313,930 337,475 362,785 377,297 382,956 383,339 379,506

Number of TB case notification from PPM intervention

69,065

84,369

108,836

120,735

122,546

122,669

121,442

Proportion of TB case notification from PPM intervention

22% 25% 30% 32% 32% 32% 32%

1.14.2. Establish and implement standardized training and quality assurance mechanisms

including ISTC through a central PPM Unit and provincial steering committees

Target audience: Private sector healthcare providers, NGO clinics and hospitals, pharmacies,

professional bodies, small and large private laboratories, corporate sector, philanthropy,

other public sector healthcare providers, Hakims and homeopaths, and informal healthcare

providers.

165

1.14.3. Implement ‘hard’ contracts with collaborating private sector providers/hospitals/NGO

clinics/other public sector organizations

1.14.4. Establish and implement accreditation and certification mechanisms

1.14.5. Incentivize collaboration of private providers and TB patients in TB control activities

1.14.6. Implement a robust system of monitoring and evaluation that employs modern

technology including m-Health for data recording and reporting in simplified formats, and

follow up and tracking of TB patients.

1.14.7. Address urban DOTS and TB in key populations (including urban slums, drug users, street

children, migrants and Madrassasetc.) through active case finding

1.14.8. Establish referral linkages with Xpert and PMDT sites

1.14.9. Engage pharmacies in identification and referral of presumptive TB cases and treatment

support

1.14.10. Support PPM interventions with a comprehensive and strategic advocacy and

communication campaign

1.14.11. Advocacy at the provincial level with the policy makers, policy implementers and

media

1.14.12. Awareness raising and advocacy with key stakeholders at the provincial and

national levels including professional bodies, specialists, hospitals, NGOs, corporate

sector companies, philanthropy, media etc.

1.14.13. Stop TB Coalitions at the district level

1.14.14. Communication at the local level about availability of services through

community-based media and local mass media

1.14.15. Use of mobile phones for raising awareness and ensuring adherence of the TB

patients to treatment

1.14.16. Conduct operations research to inform the design and implementation of the

PPM interventions, make course correction, and document and disseminate the results

166

2. Objective 2:To reduce, by at least 5% per year from 2018 onwards, the prevalence of MDR-

TB among New Pulmonary TB patients (who have never received any TB treatment)

2.1. Optimizing DR-TB management by detecting and managing 1,570 DR-TB cases from

2013 to 14,316 DR-TB cases in 2020

Based on the international recommendations of the Global Plan Every DR-TB case should have access to treatment by 2015 However, keeping the country situation and provincial caseload, the strategy For DR-TB case detection and management will be phased gradually to reach 100% by 2020. NTP will be using the following revised case finding strategies:

GROUP I: TB PATIENT / Symptomatic at risk of DR-TB

A. ALL RETREATMENT TB CASES: All TB cases (AFB SS+ve or negative) with history of previous ATT should be tested for Xpert at month zero of enrolment. This includes:

• Treatment Failure Cat-I (F-1)

• Treatment Failure Cat-II (F-2)

• Relapse after Cat-I (R-1)

• Relapse after Cat-II (R-2)

• Treatment after loss to follow up Cat-1(D-1)

• Treatment after loss to follow up Cat-II (D-2)

• Other Retreatment

B. SYMPTOMATIC CONTACTS OF DR-TB PATIENT:

All household and workplace symptomatic contacts of DR-TB patients should be screed for RRTB. Specimen from these individuals should be processed for AFB smear and then the specimen is referred for Xpert MTB/RIF assay irrespective of smear results.

C. TB PATIENTS UNDER TREATMENT WHO FAIL TO CONVERT AT THE END OF INTENSIVE PHASE

• AFB smear +ve patient on Cat-1 who fail to convert at the end of month #2 of treatment.

• AFB smear +ve patient on Cat- II who fail to convert at the end of 3 months.

• AFB smear negative Patient who is reported AFB smear positive at the end of intensive phase

167

GROUP II: TB Symptomatic among vulnerable population

Screening of RRTB, for early diagnosis and management, is important to all individuals who are potentially at risk of DR-TB and belong to vulnerable population. The specimen from these individuals should be processed for AFB smear and then is referred for Xpert MTB/RIF assay irrespective of Smear results. This group includes:

• Children under 15 years of age

• HIV positive

• Other immune-compromised (Diabetic, on immunosuppressive or chemotherapy)

• Injecting drug users

• Contact of TB

• Health Care workers including laboratory workers

• Hospitalized

• Prisoners

Group III: Individual suffering from a Life threatening disease or having difficulty in clinical diagnosis

• Specimen from individuals suffering from life threatening illness, and at risk of TB, should be tested with Xpert/MTB Rif assay (eg.CSF).

GROUP IV: AFB Smear Negative Clinically Diagnosed TB cases Not at risk of DR-TB:-

If not listed in any of the groups group mentioned above you may follow the program guidance on Xpert testing on this group. Program may formulate new or revised policies for this group based on resources

Table 59: DR-TB cases to be enrolled 2014-2020

2014 2015 2016 2017 2018 2019 2020

Total estimated

DR-TB cases 13,932 14,977 16,533 17,495 16,996 17,013 16,843

Est. DR-TB case

(@4.3% of New) 10,278 11,049 11,606 12,006 12,538 12,551 12,425

Est. DR-TB cases

(@19.4% of Re-

treatment)

3,654 3,928 4,927 5,490 4,458 4,462 4,417

No. of DR-TB

Suspects (Re-

treatment cases)

to be tested

10,360 13,162 20,316 25,468 20,680 20,700 20,493

No. of DR-TB 3,585 5,653 9,717 19,544 20,411 20,431 20,805

168

Suspects (New

cases) to be tested

Total DR-TB cases

to be put on

treatment

4,518 6,740 9,092 13,121 13,597 13,610 14,316

List of activities

2.1.1. Revision of National Guidelines, Training Modules, Desk Guide, Ambulatory Based Model

of Care and any other relevant materials.

2.1.2. In addition to 30 PMDT sites that are expected to be functional by 2014, additional 32

sites have to be established by 2020. This will include recruitment of HR, infrastructure

up gradation, trainings and logistic support.

2.1.3. Additional 60 gene Xpert machines along with laboratory reagents and xpert kits to have

a minimum of 1 machine for each district for the population of 1 million and more. (total

102 machines).

2.1.4. Establishment of sample transport mechanism to link the Basic Management Units (TB-

DOTS centers) will Gene Xpert testing sites.

2.1.5. Training of 5500 Doctors (BMUs and BHUs) on Ambulatory Based Model of Care by 2020

2.1.6. Enrolment of DR-TB, according to table 58, is based on following criteria: Patients who

are found to be Xpert MTB/RIF positive with rifampicin resistance; Patients who have

been confirmed to have DR-TB by DST; Patients with strong suspicion (high likelihood) of

DR-TB.

2.1.7. Orientation of Chest specialists and doctors on TB and DR-TB case management (Public,

Other public sector, Private Hospitals, NGOs, Private Sector) on the case finding strategy

for DR-TB, referral system for diagnostic and management of the cases.

2.1.8. Piloting short course DR-TB regimen under programmatic conditions.

2.1.9. Piloting a compassionate use of Bedaquilin among selected DR-TB cases under

programmatic management.

2.2. Expand/strengthen infection control arrangement in Culture, DST labs in the country

List of activities

2.2.1. Infrastructure enhancement

2.2.2. Introduction of minimum TB IC care package in hospitals & community settings

2.2.3. Implementation of outpatient triage for cough

169

2.2.4. Arrangement for collection of sputum outdoors or in separate, sufficiently ventilated

rooms

2.2.5. Arrangement for adequate ventilation in other consultation/examination areas, waiting

areas and TB wards

2.2.6. Isolation of TB patients in separate inpatient TB wards

2.2.7. All-staff training about TB, TB infection control, and the clinic’s TBIC implementation plan

2.2.8. Development of TB IC software to monitor monthly implementation of TB IC practices

including; For IC M&E of clinical sites, administrative/ environmental controls & PPE

usages (Hand Hygiene Survey , Staff Risk Assessment Log), and to Measure and Compare

Quality of Services / Time Spent in the Facility

2.2.9. Monitoring of health facilities implementing infection control intervention and

surveillance of HCWs

2.2.10. Data verification form HCFs on quarterly basis

2.2.11. Develop a confidential data collection system for TB disease among staff and a means to

share the aggregate data with the workers.

2.2.12. Develop a case notification & data collection system and tools i.e. TB registry, staff risk

assessment forms, analysis reports.

2.2.13. Identify and train persons responsible for confidential recording, collecting and reporting,

importance of prompt disease notification, stigma reduction and support for their ill

colleague(s).

2.2.14. Identify role-models to give talks to others.

2.2.15. Evaluate the impact of control measures and if needed re-adjust interventions.

2.2.16. Identify and plan technical assistance priorities in DR-TB control.

2.2.17. Identify and arranging financial resources for provision of technical assistance in priority

areas

2.2.18. Initial training /refresher of specialist and doctors: Infection control

2.2.19. Initial training /refresher of DOTS facilitator: Infection control

2.2.20. Initial training /refresher of Laboratory technician at microscopy centres: Infection

control

2.2.21. Initial training /refresher of Laboratory technician at culture laboratories: Infection

control

170

2.2.22. Initial training /refresher of Laboratory technician at DST laboratories: Infection control

2.3. Increase and improve social support/incentives for patients and care provides 1,570 DR-

TB cases from 2013 to 14,316 DR-TB cases in 2020

List of activities

2.3.1. Conduct situational analysis to assess the quality of services and delivery mechanism of

social support needs to be developed

2.3.2. Qualitative research, involving focus groups, is needed to identify gaps and needs of the

patients and care/service providers in order to assess their needs and jointly plan

support

2.3.3. Development of operational guidelines/SOPs, on the basis of identified gaps, is needed in

order to improve quality of services of social support.

2.3.4. Secure additional funds to bring required changes and improvement in the incentives and

food basket items (by revising the budget of social support in line with agreement of GF)

3. Objective 3: To optimize and sustain the programmatic deliverables (technical and

managerial) at operational level by 2018

3.1. Recruitment of technical and operational staff (coordination of various program

components, finance, administration etc)

3.2. NTP to secure public sector support through PC-1

List of activities

3.2.1. Develop PC-1 to support development, implementation and research activities

3.2.2. Advocacy with key stakeholders to sensitize them for approval and release of PC-1 funds

3.2.3. Effective implementation of the operational plan through PC-1 support

171

3.3. NTP to secure support from international donors

3.4. Coordinate with international technical and donor agencies (Global Fund, USAID, DFID,

KFW, etc)

3.5. Increase international technical and donor assistance to meet the financial gaps for TB

control activities at all levels

3.6. Provincial and Regional TB control programs to develop and operationalize PC-1s in

context of devolution context

3.7. Develop PC-1 to support development, implementation and research activities

3.8. Advocacy with key stakeholders to sensitize them for approval and release of PC-1

funds

3.9. Effective implementation of operational plan through PC-1 support

3.10. District health authorities to delegate funds for TB control activities in districts

3.11. Secure 5-10% of the total budgetary allocation for procurement of quality assured ATT

drugs

3.12. Adequate support to the district TB team (EDO/MS/DoH/DDoH/DTC/DLS/Cross-

checker) for monitoring and supervision

3.13. Design and implement operational research activities i.e. at least 2 operational

research projects at national and same number in each province every year

List of activities

3.13.1. Develop national TB policy on operation research. “Priorities for Tuberculosis Research,

WHO”. (Annexure-7)

3.13.2. Develop and implement operational research projects

3.13.3. Strengthen provincial TB control staff in implementing operational research projects

3.13.4. Establish partnerships with research academic institution nationally and internationally

3.14. Staff coordination meetings on quarterly basis at all levels including supervision,

monitoring and evaluation

List of activities

3.14.1. Sustain the functions of the National and Provincial Technical Unit to manage M&E

activities in the country

172

3.14.2. Sustain IACC meetings.

3.14.3. Plan and arrange for timely preparation and dissemination of annual provincial and

national progress reports.

3.14.4. Sustain the support for field monitoring activities of the program and the district staff.

This also includes mobility support, staff training, and technical assistance.

3.14.5. National level (Quarterly Inter-Provincial Meetings)

3.14.6. Provincial level (Quarterly Inter-District Meetings)

3.14.7. District level(Quarterly Intra-District Meetings)

3.15. Development, production and distribution of guidelines and tools(including retooling of

new definitions/algorithms)

List of activities

3.15.1. Guidelines development - consultations and/or workshops

3.16. Design and implement operational research on priority program needs.

List of activities

3.16.1. Pilot of GIS based e DOTS and scale up

3.16.2. Operational Research on the diagnostic centre and treatment centre link model to

improve community management of MDR

3.16.3. Pilot of infection control strategies in household and community level and then scale up.

3.16.4. Innovative strategies to enhance yield from contact tracing among sensitive and resistant

TB.

3.16.5. Inventory study will be done in 2016 again to re-estimate the disease burden in the

country

3.16.6. Operational research on involvement of Pharmacies in TB control

3.16.7. Sustain and expand linkages with other international institutions

3.17. Surveillance activities

List of activities

3.17.1. Integrate e-surveillance with current paper based system in all BMUs in the country.

“Electronic recording and reporting for TB care and control, WHO 2012”. Annex-8

3.17.2. Train human resource in BMUs in all 141 districts on e-surveillance

173

3.17.3. Train human resource in all 141 districts in the country.

3.17.4. Build provincial level capacity in DMIS.

3.17.5. Monitor the quality of implementation.

3.18. Legislation for ban over the counter sale of anti-TB drugs both FLD and SLD.

List of activities:

3.18.1. Develop plan of action to ban counter sale of anti-TB drugs with the pharmaceutical

society

3.18.2. Advocacy with key stakeholders

3.18.3. Develop counter sale ban policy in collaboration with stakeholders.

3.18.4. Implement ban policy.

3.19. Review by third party

3.20. Transportation (New vehicles, maintenance i.e. old and new, fuel i.e. old and new)

3.21. Office supplies and equipment at all levels

List of activities

3.21.1. Procurement/provision at National level

3.21.2. Procurement/provision at Provincial level

3.21.3. Procurement/provision at District level including BMUs

3.22. Infrastructure new and renovations

List of activities

3.22.1. National level (DST/Culture/Gene-Xpert/Drugs)

3.22.2. Provincial level (DST/Culture/Gene-Xpert/Drugs)

3.22.3. District level/BMUs (Gene-Xpert/Drugs)

174

9 LIST OF LITERATURE REVIEWED (REFERENCES AND ANNEXURES)

1. United Nations Development Program, HDI report 2007-08

2. National Health Accounts 2009-2010, Pakistan Bureau of Statistics, Government of Pakistan

3. Eliminating the financial hardship of TB via universal health coverage and other social

protection measures: WHO, 2013.

4. National Institute of Population Studies, Government of Pakistan, 2012

5. Pakistan Health Profile, WHO, 2013

6. Ministry of Health, Government of Pakistan, Year book 2009

7. Nishtar, S 2006, p s61

8. WHO Global Tuberculosis Report 2012

9. WHO. Global Tuberculosis Control; WHO Report 2013

10. WHO. Tuberculosis Profile, Pakistan 2011

11. Sanjay Basu, etal.Projected effects of tobacco smoking on worldwide tuberculosis control:

mathematical modeling analysis. BMJ, 2011

12. National TB Control Pakistan, Data base 2011

13. Third-party evaluation of NTP, TRF 2011

14. Pakistan TB ACSM mid-term evaluation report , Mercy Corps, 2011

15. ACSM National Strategy and Operational Guidelines, NTP-MoH, 2010

16. National Guidelines for PMDT, 2011, NTP-Pakistan

17. Gesine Meyer-Rath, etal. The Impact and Cost of Scaling up GeneXpert MTB/RIF in South

Africa, PloS 2012

18. MDR-TB fact sheet, WHO, 2013

19. Ejaz M et al, Prevalence of multi-drug resistant tuberculosis in Karachi, Pakistan:

identification of at risk groups. Trans R Soc Trop Med Hyg 2010

20. H.K.Khoharo, et al, Drug resistance patterns in pulmonary tuberculosis, JPMA, 2011

21. National MDR Expansion Plan for 2013 – 2017, NTP Pakistan

22. NTP Pakistan, National Guidelines for Public Private Mix in TB-DOTS

23. SamiaIqbal, etal, Challenges faced by general practitioners in Pakistan in management of

tuberculosis: a qualitative study. Rawal Medical Journal, 2013

24. Sven GudmundHinderaker, Razia Fatima, Lost in time and space: the outcome of patients

transferred out from large hospitals, Public Health Actions, 2013

25. DOTS Expansion Working Group Strategic Plan 2 0 0 6 – 2 0 1 5, WHO/STOP TB partnership

175

26. Joint Review of Global Fund Grants 6 & 9 in Pakistan, July 2012

27. German - Pakistan Technical Cooperation Support for Tuberculosis Control - GIZ/AGEG PPM

Situation Analysis, 2013

28. Strategic plan for the prevention and control of multidrug-resistant and extensively drug-

resistant tuberculosis in the Eastern Mediterranean Region (2010–2015) , WHO

29. Narrowing the gap: Expanding access to new diagnostics for patients at risk of multi-drug

resistant tuberculosis (MDR-TB), World Health Organization, Global Laboratory Initiative

Foundation for Innovative New Diagnostics, Global Drug Facility, 2012

30. Multi-Drug Resistant Tuberculosis (MDR-TB) Indicators.A minimum set of indicators for the

programmatic management of MDR-TB in national tuberculosis control programs, WHO 2010

31. Management of Multidrug-Resistant Tuberculosis in Children: A Field Guide. USAID, TB Care

II, 2012

32. Definitions and reporting framework for tuberculosis WHO, 2013

33. Systematic screening for active tuberculosis: Principles and recommendation WHO, 2013

34. Improving the diagnosis of smear negative and extra-pulmonary TB among adults and

adolescents, WHO

35. Recommendations for the investigation of contacts of persons with infectious tuberculosis in

low and middle income countries, WHO

36. The use of bedaquiline in the treatment of MDR-TB, WHO 2012

37. A practical handbook on the pharmaco-vigilance of medicines used in the treatment of

Tuberculosis enhancing the safety of the TB patient-WHO, 2012

38. National Guidelines for PPM-NTP Pakistan

39. Guidelines for the programmatic management of DR-TB, WHO 2011

40. Priorities for Tuberculosis Research, WHO

41. Electronic recording and reporting for TB care and control, WHO 2012

42. Guidelines for clinical and operational management of DR-TB, Union.2013

176

SECTION B –

BUDGET SUMMARY

2014 2015 2016 2017 2018 2019 2020 Total

1. Improving diagnosis $

7,952,543 $

9,603,232 $

12,860,708 $

20,579,485 $

18,653,639 $

18,148,021 $

20,002,247 $

107,799,875

2. Patient support $

6,375,802 $

9,511,121 $

12,830,630 $

18,516,977 $

19,187,439 $

19,206,626 $

20,202,970 $

105,831,565

3. First-line drugs procurement and management

$ 8,565,633

$ 9,278,683

$ 10,295,749

$ 10,928,927

$ 10,711,747

$ 10,722,459

$ 10,625,245

$ 71,128,443

4. M&E $

1,134,590 $

1,254,590 $

1,144,590 $

1,154,590 $

1,144,590 $

1,154,590 $

1,144,590 $

8,132,133

5. Programme management and supervision

$ 960,816

$ 1,042,764

$ 623,539

$ 684,545

$ 698,733

$ 625,467

$ 654,285

$ 5,290,148

6. HRD: Staff $

6,516,676 $

7,200,024 $

7,912,597 $

8,703,851 $

10,030,154 $

11,033,177 $

12,136,481 $

63,532,959

7. HRD: International technical assistance

$ -

$ 106,000

$ 160,000

$ 191,000

$ -

$ -

$ -

$ 457,000

8. HRD: Training $ -

$ 5,228,966

$ 192,683

$ 1,850,899

$ 1,002,333

$ 2,043,582

$ 7,399,032

$ 17,717,495

9. Collaborative TB/HIV activities $

523,567 $

604,372 $

681,335 $

798,095 $

831,989 $

832,820 $

847,776 $

5,119,954

10. MDR-TB $

27,756,920 $

41,084,344 $

55,399,740 $

79,911,265 $

82,751,354 $

82,834,063 $

87,128,895 $

456,866,581

11. High risk groups $ -

$ 1,387,500

$ 137,500

$ 137,500

$ 137,500

$ 137,500

$ 137,500

$ 2,075,000

12. Infection control $

822,463 $

981,080 $

1,132,718 $

1,380,362 $

1,440,708 $

1,442,145 $

1,471,462 $

8,670,938

13. Involving all care providers: PPM/ISTC

$ 11,741,050

$ 14,342,730

$ 18,502,120

$ 20,524,950

$ 20,832,820

$ 20,853,730

$ 20,645,140

$ 127,442,540

14. Partnering initiatives $

96,448 $

213,933 $

96,448 $

213,933 $

96,448 $

213,933 $

96,448 $

1,027,590

15. Community involvement $

910,519 $

978,808 $

1,052,218 $

1,094,307 $

1,110,722 $

1,111,832 $

1,100,714 $

7,359,121

16. Operational research $ -

$ 293,580

$ 171,080

$ -

$ -

$ 4,574,846

$ -

$ 5,039,506

Total costs for TB control

$ 73,357,026

$ 103,111,726

$ 123,193,656

$ 166,670,685

$ 168,630,177

$ 174,934,792

$ 183,592,785

$ 993,490,848

SECTION C –

TECHNICAL ASSISTANCE PLAN (attached)