East, Central & Southern Africa Health Community (ECSA-HC)

REPORT

PROGRAMMATIC MANAGEMENT OF DRUG RESISTANT TB (PMDT) MISSION TO KENYA

15-19 July, 2013

Report by

Dr. Stephen K. Muleshe, Program Manager, HIV/AIDS/TB & Other Infectious Diseases Ms. Ann Masese, Program Officer, HIV/AIDS/TB & Other Infectious Diseases

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Table of Contents

Contents Table of Contents .......................................................................................................................................... 2

Acknowledgement ........................................................................................................................................ 5

1.0 INTRODUCTION ................................................................................................................................. 6

2.0 BACKGROUND ......................................................................................................................................... 6

2.1 Global & Regional TB/DR-TB Situation ................................................................................................ 6

2.2 TB/DR TB Situation in Kenya ................................................................................................................... 8

2.2.1 Drug Sensitive TB ............................................................................................................................. 8

2.2.2 Drug Resistant TB (DR-TB) ......................................................................................................... 8

3.0 RATIONALE ............................................................................................................................................ 10

4.0 OBJECTIVES ........................................................................................................................................... 11

5.0 APPROACH ............................................................................................................................................ 11

6.0 FINDINGS ............................................................................................................................................... 11

7.0 MAJOR GAPS & CHALLENGES ............................................................................................................... 21

8.0 KEY LESSONS LEARNT ............................................................................................................................ 22

9.0 ANNEXES ............................................................................................................................................... 23

Annex 1: ECSA HMC TB Resolutions 1999-2010 ..................................................................................... 23

Annex 2: PMDT Mission Authorization Letter ........................................................................................ 25

Annex 3: Program for the ECSA PMDT Mission to Kenya, 15-19 July, 2013 ........................................... 26

Annex 4: List of Key people met and interviewed .................................................................................. 27

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List of Acronyms and Abbreviations

ACSM Advocacy, Communication & Social Mobilization AIDS Acquired Immunodeficiency Syndrome ART Anti-Retroviral Treatment ARVs Anti-retrovirals BSL CDC Centers for Disease Prevention and Control CNR Case Notification Rate CPT Cotrimoxazole Preventive Therapy DLTLD DOTS Directly Observed Treatment Short Course DR Drug Resistance DR-TB Drug Resistance TB DRS Drug Resistant Survey DLTLD Division of Leprosy, Tuberculosis and Lung Diseases DST Drug Susceptibility Testing ECSA East, Central & Southern Africa Health Community EQA External Quality Assurance FDC Fixed Dose Combination GFATM Global Fund Facility to fight AIDS, TB and Malaria GLC Green Light Committee HIV Human Immunodeficiency Virus HMC Health Ministers Conference IEC Information, Education & Communication IOM International Organization for Migration IPC Infection Prevention & Control IPT Isoniazid Preventive Therapy ISTC International Standards for Tuberculosis Care KAPTLD KEMSA KNCV Royal Netherlands TB Foundation KNH Kenyatta National Hospital LPA Line Probe Assay LED Light-emitting diode LMIS Laboratory Management Information System MDR-TB Multi-Drug Resistance TB MTRH MTB/RIF MSH NRL National Reference Laboratory NTP National Tuberculosis Program NQCL OR Operational Research

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PAL Practical Approach to Lung Health PLHIV People Living with HIV PMDT Programmatic Management of Drug Resistance TB PPM Public Private Mix QA Quality Assurance SLDs Second Line Drugs SOP TB Tuberculosis TAT Turn around time TBCARE TB Collaboration/Coordination/Access/Responsiveness and

Evaluation Program TIBU TSR Treatment Success Rate UNHCR United Nations High Commissioner for Refugees UNION International Union against TB & Lung Disease USAID United States Agency for International Development UVGI Ultra Violet Germicidal Irradiation WHO World Health Organization XDR-TB Extensively Drug Resistant TB

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Acknowledgement

The Principal Secretary Ministry of Health, Kenya for granting us approval to visit the Division of Leprosy, Tuberculosis and Lung Disease to conduct the monitoring mission. Special gratitude goes to the Head, Division of Leprosy, Tuberculosis, and Lung Disease Dr. Joseph Sitienei for the tremendous support he offered us through his staff in facilitating visits to different departments, organizations and facilities where we were able to gather most of the information to help us attain our objectives. We also sincerely thank Dr. Maureen Kamene, James Gachengo and Dr. Richard Muthoka who played a key role in coordinating our activities during the mission. We acknowledge staff at the Central Reference Laboratory, Kenya Medical Supplies Authority (KEMSA), Kenyatta National Hospital MDR-TB unit, Pharmacy and Poisons Board, partners supporting the Division of Leprosy, Tuberculosis and Lung Disease, Umoja health centre and patients visited in the community for sharing their valuable time and insights with the team during the field visits Finally ECSA-HC acknowledges its collaborating Partner KNCV for providing both technical and financial support for this mission. Dr. Stephen K. Muleshe Program Manager, HIV/AIDS, TB & ORID East, Central and Southern Africa, Health Community (ECSA-HC)

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1.0 INTRODUCTION

The East, Central and Southern African Health Community (ECSA-HC) with support from KNCV undertook a mission in Kenya from 15-19 July, 2013 in line with the resolutions passed by the ECSA Health Ministers during their 52nd conference held in Harare, Zimbabwe in 2010. The main goal of the mission was to determine the extent to which Kenya has implemented PMDT especially in view of the resolutions passed by HMC in the last 10 years. The mission was undertaken by Dr. Stephen K. Muleshe, the Program Manager HIV/AIDS/TB & other Infectious Diseases, and Ms. Ann Masese the Program Officer. This report gives a brief background of the TB/MDR TB situation both globally and regionally and also the TB/MDR TB situation in Kenya. It highlights the objectives of the mission, key findings and recommendations.

2.0 BACKGROUND

2.1 Global & Regional TB/DR-TB Situation

Drug-resistant tuberculosis, and particularly Multi-Drug Resistant Tuberculosis (MDR-TB) and Extensively Resistant Tuberculosis (XDR-TB), is a momentous threat to TB control due to the limited treatment options available. The situation is worsened by the HIV epidemic and cross border transmission of drug resistant strains of Mycobacterium from neighboring countries. In 2011, the WHO estimated that there were 310,000 MDR-TB cases among notified TB patients with pulmonary TB globally and about 9% of these are XDR-TB. Most of the ECSA countries are among the 22 high TB burden countries and most of these countries have reported Extensively drug resistant cases (XDR-TB). Despite the progress made in the last few years in detection and treatment of MDR-TB, the number of MDR-TB cases notified in 2011 according to WHO, represents only 19% of the estimated global burden. According to the WHO global TB report for 20121, the trend over time shows that there is low and declining incidence, prevalence and mortality of TB both regionally and globally (See Figure 1 & 2)

1 WHO Global TB Report, 2012

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Figure 1: Regional Declining TB Burden (Africa) Figure 2: Global Declining TB Burden

Source: WHO Global TB Report 2012

A worrying trend is the increasing cases of MDR TB among new TB cases as depicted in Figure 3 below; Figure 3: Percentage of New TB Cases with MDR TB

Source: WHO Global TB Report 2012

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2.2 TB/DR TB Situation in Kenya

2.2.1 Drug Sensitive TB

Kenya is among the 22 high TB burden countries and has been ranked 13 according to the WHO global TB report of 2010. In 2012, Kenya notified 99159 cases of all forms of TB with an estimated incidence rate of 288/100,000 population. According to the 2009 Population Census report, the country has a population of 38.9 Million people. The graph below shows the trends in TB case finding in Kenya over the years. Figure 4: TB Case Finding in Kenya from 1987 – 2012

Source: DLTLD data, Kenya

Figure 5: The graph below shows the case detection rate over the years

2.2.2 Drug Resistant TB (DR-TB)

According to WHO 2012 global report, it is estimated that Kenya has 3.1 % of TB cases with MDR-TB 10% of who are retreatment cases. In 2011 there were an estimated 2, 400 MDR-TB

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cases among notified pulmonary TB cases. A national drug resistant survey was done in 2002; however, the results of the survey were not published. The country is now in its final preparations of a nationwide Drug Resistant Survey (DRS) to commence this year. Surveillance for Drug Resistant TB started in 2003 with the main focus on retreatment cases and those in high risk groups. Decentralization of DR-TB surveillance is ongoing. New diagnostic methods have been adopted in the country and these include: the Gene Xpert MTB/RIF, Line Probe Assay and liquid cultures; drug susceptibility testing (DST) for both first and second line drugs is being done. These new diagnostic methods have greatly increased the number of cases diagnosed and significantly reduced the turnaround time of laboratory results. Treatment for MDR-TB in Kenya started in 2006 in the private sector and 2008 in the public sector. By the end of 2012; 917 MDR-TB patients had been diagnosed and 558 put on treatment. Figure 6: Percentage of patients diagnosed, treated and % treated from 2006-2012

Source: DLTLD data, Kenya

When treatment started in 2008, there were only two sites providing treatment; the Kenyatta National Hospital (KNH) and the Moi Teaching and Referral Hospital (MTRH), soon after as the numbers increased a third site was started in Homa Bay. Currently, there are 156 sites providing MDR treatment in Kenya. The treatment outcomes have improved as shown below:

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Figure 7: Treatment outcomes for the 2009 and 2010 cohorts

Source: DLTLD data, Kenya

Kenya is using the standardized WHO regimen for treatment. Second line drugs are procured directly through the GDF with support from Global Fund. The country has not experienced stock out of medication in the past one year

3.0 RATIONALE

M/XDR-TB poses a real threat to global and regional public health security and efforts to reduce the global and regional burden of tuberculosis. The Beijing Call for Action on Tuberculosis Control and Patient Care, and the World Health Assembly resolution on prevention and control of M/XDR-TB recognize the challenges posed by M/XDR-TB and call for urgent action to address the situation. Adequate and timely treatment of TB is the most effective way to reduce the further emergence of acquired drug resistance. In addition, the transmission of M/XDR-TB can be reduced by early diagnosis, treatment and adequate infection control measures. For this reason, the national TB control programs (NTPs) need to integrate Programmatic Management of Drug-Resistant TB (PMDT) into routine activities and to link up with private providers, hospitals, and congregate settings such as prisons to ensure a comprehensive response to the M/XDR-TB threat. The rationale for the ECSA-HC monitoring mission is to work closely with Member States’

National TB Programs in identifying the processes that have been undertaken in response to

the challenges of MDR-TB while documenting best practices and lessons learnt with the sole

aim of determining innovative strategies and interventions for improving laboratory capacity

for diagnosis of MDR TB; accessibility to treatment for MDR, strengthening the implementation

of the DOTS strategy, PMDT and advocacy for involvement of communities in prevention &

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control of TB with the view of supporting Member States to effectively implement these

strategies and interventions.

4.0 OBJECTIVES

The mission had four specific objectives to: - 1. Share with the NTP and the Ministry of Health Officials about ECSA-HC & the

HIV/AIDS/TB & ID program; 2. Assess the implementation of the ECSA Health Ministers conference (HMC) Resolutions

on TB /MDR TB; 3. Document best practices/lessons learnt in implementation of the HMC Resolutions on

TB & PMDT; and 4. Identify/Understand challenges/gaps in service provision related to implementation of

the resolutions, PMDT and corresponding strategies.

5.0 APPROACH

During the mission, the team held briefing meeting with the NTP manager and the PMDT focal

person and later visited various institutions to conduct Key Informant interviews with Senior

Officers at the HIV Program, Pharmaceutical Department, Central Reference Laboratory, the

Kenyatta National Hospital, The Kenya Medical Supplies Authority (KEMSA), The Poisons and

Pharmacy Board (PPB), Partners supporting TB activities in the county, Umoja Health Centre

and visited one patient currently on MDR-TB treatment.

The mission was conducted from 15-19 August 2013 by the Manager and Programme Officer HIV/AIDS, TB and Infectious Diseases Programme of ECSA-HC. The mission employed the following approach to gather the required information: -

1. Completion of a questionnaire/tool on ECSA HMC Resolutions on TB/MDR TB; 2. Key Informant interviews with relevant senior managers at the Ministry of health,

National TB & HIV/AIDS Programme, selected facility supervisors at national level and implementing partners;

3. Review of key program documents including registers, reports, summaries, guidelines, IEC materials; and

4. Observation during the departmental and field visits.

6.0 FINDINGS

The ECSA HMC resolutions on TB & HIV and the six stop TB strategies were used as the basis for the assessment. The ECSA Health Ministers conference2 for the last ten years has passed ten resolutions related to TB & HIV (See Annex 1). On the other hand, the stop TB Strategy 2006-2015 clearly stipulates the key interventions TB programs should adopt for successful

2 East, Central & Southern Africa Health Community, www.ecsahc.org

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prevention and control of TB with the aim of achieving the 2015 targets. 3 The resolutions were mainly based on the global TB strategy. 6.1 PURSUING HIGH-QUALITY DOTS EXPANSION

6.1.1Secure political commitment, with adequate and sustained financing

Findings According to WHO, Kenya has a total budget of US$ 51 Million for TB control activities; only 31% of this is funded with slightly more than half on this budget coming from domestic sources. The Government of Kenya is committed to the prevention and control of TB through its direct support to the NTP. The government has a budget line for TB activities in the national budget; this has steadily increased from Ksh. 170 Million in 2010 to Ksh. 220 Million in 2013. The NTP has adequate funding with most of the staff working in the NTP employed by the government. Major positions in the program are also filled. The program has a National Strategic Plan for the period 2011 – 2015 and also has National MDR-TB guidelines and Standard Operating Procedures for PMDT are in place. Kenya enjoys the support of many partners funding TB activities. The Ministry of Finance is the

principle recipient of Global fund which is supporting 23% of the total funding available in 2013.

Management Sciences for Health (MSH) has focused on quality of diagnostics, sample

transportation, they provide technical assistance in the management of anti-TB drugs. TBCARE

1 provides patient socio-economic support, training in major aspects of TB control; they

support supportive supervision and also provide technical support in the development of

manuals, guidelines and reporting tools. The Kenya AIDS NGOs Consortium (KANCO) plays a key

role in advocacy for TB patients’ welfare, increased local funding for TB and general advocacy

for TB matter through the media and leaders in government. The UNHCR supports mapping

treatment of refugees in their camps, however, managing the refugees has not become

challenging due to the sudden influx of MDR-TB patients from Somalia who are diagnosed but

not treated there and thus seek medical attention from Kenya. The Kenya-Somali border is also

very porous; many Somalis are still getting their way into Kenya despite closure of this border

four years ago. Despite the challenges above the UNHCR reported very good treatment

outcomes and minimal mortalities; they also reported very good collaboration and coordination

with IRC and IOM.

Finally, the government receives support from KAPTLD which was founded by chest physicians

in the country with the aim of improving case finding and treatment outcomes especially in the

private sector. This organization provides technical support to the National TB Program

including providing training of health care workers and laboratory strengthening. They carry out

3 WHO Stop TB Strategy 2006-2015, www.who.int/tb

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activities in fourteen (14) urban cities in Kenya and have 252 private health institutions (clinics,

hospitals and laboratories) in their network all these report to the NTP.

The program also receives support from other bilateral and multilateral donors and technical

agencies such as the Presidential Emergency Plan for AIDS Relief (PEPFAR) through the Centre

for Disease Control & Prevention (CDC) and USAID, the WHO, and the Royal Netherlands

Tuberculosis Foundation (KNCV).

Recommendations In view of the challenges and gaps noted, the mission makes the following recommendations;

i. Increase advocacy for mobilization of domestic resources to support TB Services ii. Coordinate and capitalize on the immense partner support for the National TB Program

6.1.2 Ensure early case detection and diagnosis through quality-assured bacteriology

Findings Kenya has a TB Reference Laboratory located in Nairobi. It is the only public health laboratory doing TB Cultures in the country. The laboratory is linked to a number of SRL’s for EQA. The laboratory is mandated to conduct routine TB Drug resistance surveillance, provide policy on TB diagnosis, train laboratory personnel on best laboratory practices, coordinate external quality assurance and support supervision. The laboratory does smear microscopy, culture, LPA, Gene Xpert MTB/rif as well as both first and second line DST. There are 1700 microscopic sites in the country that are run by laboratory technicians and about 40 Gene Xpert machines both in the public and private sector with 11 more expected this year and plans to increase the number to 440 machines by 2015. The laboratory reported that the total number of specimen referrals has been increasing over the last years; this increased fourfold from 2511 in 2006 to 8870 in 2011 and this has been attributed to a very efficient courier system by G4S that supports the entire country except the hard to reach areas in the Northeastern part. The laboratory staff receives continuous capacity building support. The laboratory was recently renovated to enable it attain BSL II capacity. The introduction of liquid culture as well as LPA and Xpert MTB/Rif has seen drug resistant cases managed better due to the fast generation of preliminary results. The laboratory also supports Quality Assurance/Panel testing of all the above mentioned technologies to other laboratories in the country to maintain quality. There is 88% EQA coverage in the country. The laboratory management is committed to the implementation of quality management systems which meet the requirement of the ISO 15189 standard. This standard contains management and technical requirements that support the quality management systems in line with the ISO 15189. The laboratory is currently a star three (3). The laboratory carries out continues MDR-TB Surveillance which started in 2003 in the country.

This is done on retreatment cases, DR TB contacts, new smear positive who do not convert at

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month 2/3, health care workers diagnosed with TB and all smear positive refugees. The figure

below shows surveillance trends in retreatment cases in the past six years.

Figure 8: Proportion of retreatment cases screened for MDR-TB

Source: Division of Leprosy, Tuberculosis and Lung Disease

Surveillance had been paper based till 2010/2012 when the implementation of the LMIS system was put in place and this has managed to directly link the communication to the Provincial TB coordinators for quick relay of results and notification of samples received. Generally the NRL has a dedicated team of trained staff. There is constant supply of quality reagents with no reported stock outs in the past one year. The laboratory environment is clean and well organized. Infection control measures are in place with the staff adhering to them. SOPs are available and are well displayed in the laboratory Recommendations

1. Sustain the good laboratory network in the country 2. Strengthen the MDR-TB Surveillance for all the retreatment and high risk cases

6.1.3 Provide standardized treatment with supervision, and patient support

Findings The DLTLD adopted the Directly Observed Therapy Short Course (DOTS) strategy for the control of TB in 1993 and achieved countrywide geographic DOTS coverage in 1997 it also adopted the 1993 World Health Assembly global TB control targets of 70% detection of infectious cases and cure 85% of the detected cases by 2005. The country also has adopted the TB control Millennium Development Goals of halving and beginning to reverse the mortality and prevalence of TB by 2015. The DLTLD, in line with international trends, has launched several new approaches to increase access to DOTS and expand population DOTS coverage. These approaches include community based DOTS (CB-DOTS), Public-Private Mix for DOTS (PPMDOTS), collaboration between TB and HIV control programs and the development of an elaborate advocacy, communication and social mobilization strategy aimed at influencing communities to seek care early when TB symptoms occur and to remain on treatment until this is completed when treatment is initiated.

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In Kenya the treatment for MDR-TB is based on the WHO recommended standard regimen using the following drugs: 6 Km-Pto-Lfx-Cs-(E/Z) / 18 Pto-Lfx-Cs-(E/Z). The country uses hospital based DOTS with all patients on treatment receiving their DOTS in a nearby health facility. The health care workers actively screen for side effects which are managed as soon as possible; drugs to manage side effects are available to the patients when required. MDR-TB patients on treatment are provided with social support. They are given an equivalent of US$6 to cater for transport and lunch at every visit. Recommendation The following are the recommendations;

i. Scale up CB-DOTS in order to cover the hard to reach populations ii. Adopt a sustainable system for social support to patients as this has shown to improve

adherence to medication 6.1.4 Ensure effective drug supply and management

Findings Second line anti-TB drugs are procured through the GDF by the Kenya Medical Supplies Agency (KEMSA), who also does the storage and distribution of the medicines. The program has not reported any stock outs of SLD in the past 12 months. There is an 8 months buffer stock available in the central store and 3 months in the twelve regional stores which receive drugs quarterly for distribution to the health facilities on a monthly basis. The drug store at KEMSA has optimum storage conditions. The cold chain management is well maintained with evidence of temperature recording. There is an electronic system in place that maintains up to date stock counts in the warehouse. The program carries out an annual focused quantification that involves all stakeholders and partners who implement TB activities. Two years quantification is done and this is reviewed every 6 months. The Pharmacy and Poisons Board (PPB) in Kenya is responsible for ensuring quality of medicines. Analysis of medicines is done at the National Quality Control Laboratory (NQCL) however; this has not been done for second line drugs (SLD). Post market surveillance has been done for first line anti TB drugs but not for the SLD. There is a pharmacovigilance system in place and this has recently been made electronic to ease the reporting of adverse events/ reactions. Reporting on TB has just begun. There is a tool in place to facilitate reporting and this can be found online on www.pv.parmacyboardkenya.org it was launched in April this year. The PPB also has pharmacovigilance guidelines in place. The PPB has started training health workers on pharmacovigilance.

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Figure 9: Some of the side effects reported are presented below.

Source: DLTLD Data

Recommendations The following are the key recommendations;

i. Strengthen pharmacovigilance in the country ii. Train more health workers on pharmacovigilance

6.1.5 Monitor and evaluate performance and impact

Findings The program has an electronic monitoring and evaluation (M&E) system in place with a focal point for M&E. This electronic M&E system called TIBU (Treatment Information Basic Unit) was launched in September 2012 and has an MDR-TB component for recording, reporting and following up of patients. Data is regularly collected, analyzed and updated. With help from KAPTLD, the national program notifies patients from the private sector who accounted for about 10% of the total cases notifies in 2012. The country is planning to conduct a DRS this year with plans currently at advanced stages. Recommendations The following are the recommendations;

i. Maintain regular recording and reporting on MDR-TB ii. Conduct the planned DRS and disseminate the results to all the stakeholders as opposed

to 2002 DRS

6.2 ADDRESSING TB/HIV, MDR-TB AND OTHER CHALLENGES

6.2.1 Scale–up collaborative TB/HIV activities

Findings

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There is good collaboration between the TB and HIV program with both programs having focal persons responsible for the other program’s activities. Guidelines for implementing TB-HIV Collaborative activities are in place. Surveillance of HIV among TB patients started in 2005. In 2012, 93% of TB patients were tested for HIV, 72% of HIV positive TB patients were put on ART and 93% were put on CPT. The TB/HIV co infection rate is 39% for susceptible TB and 25% for MDR-TB. There is active screening of TB in PLHIV. IPT is being offered in few selected facilities in three regions with plans to roll it out to reach 30,000 people by end of 2013. The IPT guidelines are included in the National TB and Leprosy treatment guidelines. The program has a screening tool for ICF/IPT that is used for routine screening of patients at every visit. There are TB infection control guidelines in place. Recommendations The following are the recommendations;

i. All TB/HIV patients should be put on ART within the WHO recommended period ii. TB/HIV collaboration should be strengthened at all the levels

iii. Ensure comprehensive TB/HIV services for patients in all the health facilities

6.2.2 Scale-up prevention and management of multidrug-resistant TB (MDR-TB)

Findings Treatment for MDR-TB in Kenya started in 2006 in the private sector and 2008 in the public sector. By the end of 2012, a total of 917 MDR-TB patients had been diagnosed and 558 enrolled on treatment. The country started offering MDR-TB treatment in only two sites; the Kenyatta National Hospital (KNH) and the Moi Teaching and Referral Hospital (MTRH), soon after as the numbers increased a third site was started in Homabay. Currently, there are 156 sites providing MDR treatment in Kenya. There are plans to increase the number of Gene Xpert machine in the county to 440 by 2015, this will greatly increase the numbers being diagnosed. There is an expansion plan for the next three years as shown below:

Year 2012 2013 2014 2015 2016

Newly enrolled cases annually

216 290 275 300 325

Total number on treatment each year

351 547 630 662 708

Source: DLTLD Kenya

The national TB Program has a focal point in the program to coordinate MDR-TB activities. The country is planning to conduct a Drug Resistant Survey (DRS) this year to ascertain the true burden of M/XDR TB. The last Drug Resistant Survey was carried out in 2002 however; the results of this survey were not published.

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The program has IPC guidelines that are being adhered to in the Kenyatta National Hospital MDR-TB unit. This unit was opened in 2007 but did not start treatment of patients until 2008 when the government was able to procure SLD through the GLC mechanism. Cumulatively 84 patients have been treated in this facility with 16 patients currently on treatment. The facility opened an isolation ward in May 2013 with optimum infection control measures in place including negative pressures and UVGI. There are IC SOPs developed but these are yet to be disseminated. Health care workers are not routinely screened for TB; they are only screened once on employment into the facility. The Kenyatta National Hospital has an IC Plan in place and an active team that meets every three months. A risk assessment was done in May 2013 and the recommendations from this assessment will be implemented soon. Generally infection control needs to be observed especially in the casualty areas. Most health care workers in this unit have been trained both locally and internationally on the management of MDR-TB however; there is a high turnover rate of the health workers especially those who have been trained. Confirmed MDR-TB cases are treated on ambulatory basis and admission is only for the very ill or those with adverse drug effects/events. The program uses fixed-dose combinations (FDCs) drugs hence reduced pill burden to the patient. The program uses facility based DOTS, once patients are initiated on treatment they come to the facility on a daily basis, those who stay far from the initiation centre are managed in facilities close to their homes. The program and the major facilities offer mentorship, supervision and training to the other peripheral treatment centers. There has been an upsurge of patients in this facility in the past few years due to immigrants from Somalia. In 2012 more than 50% of patients managed in the MDR-TB unit were of Somali origin. These patients have also made defaulter tracing very challenging. Some of the other challenges sited by the medical officer in charge of this unit included; managing TB in children, managing TB Co-morbidities, inability to carry out preliminary tests due to their high cost e.g audiometry, patients are unable to afford some auxiliary medicines and finally stigma on MDR-TB patients even from health care workers. The unit actively screens for and manages side effects due to medication. Recommendations

i. Ensure infection control measures are in place in the whole hospital ii. Routinely screen health care workers for TB

iii. Continue training and mentoring health care workers in TB management 6.3 ADDRESS THE NEEDS OF TB CONTACTS, AND POOR AND VULNERABLE POPULATIONS

Findings Contact tracing and screening is done by the program. IPT is administered to children under five years, those who are HIV positive and prisoners after TB has been ruled out. The contacts are re-evaluated on subsequent visits. There is an ICF/IPT card used by the health facilities. Inmates are also screened for TB and have contributed to 0.8% of the total TB cases notified in the country.

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Recommendations

i. All children under five years and are contacts of TB patients with no active disease should be commenced on IPT

ii. Scale up IPT in the country iii. Scale up implementation of activities to address TB in prisons

6.4 Contributing to health system strengthening

6.4.1 Help improve health policies, human resource development, financing, supplies, service delivery

and information

Findings There is a National TB Policy and a national Strategic Plan 2011-2015 in place. National TB Guidelines, MDR-TB and IPC Guidelines are in place, there are also SOPs on PMDT. There is a shortage of health workers at all levels, with some supported by donors. The capacity to manage MDR-TB among health workers still needs to be improved at all levels. Recommendations

i. Increase domestic resource mobilization ii. Train a large pool of health care workers in the country to manage TB and MDR-TB

6.4.2 Strengthen infection control in health services, other congregate settings and households

Findings With the IPC guidelines in place, Infection Control (IC) measures are being implemented especially at the MDR-TB ward in Kenyatta National Hospital, each hospital has a TB IC plan in place. This needs to be implemented in other congregate settings e.g. prisons. Recommendations

i. Implement IC measures in other congregate settings e.g. Prisons and households especially in the slum areas

ii. Increased training of Health care Workers on TB IC 6.4.3 Upgrade laboratory networks, and implement the Practical Approach to Lung Health (PAL)

Findings The reference laboratory has modern diagnostics in place e.g. LED microscope, liquid (MGIT), and solid media (L-J) cultures, Xpert MTB/Rif machines and Line Probe Assay (LPA) with short TAT. Most laboratories in the country are networked through the LMIS. Implementation of PAL was noted to be low in the facilities visited. Recommendations

i. Develop guidelines and train Health workers on Implementation of the Practical Approach to Lung Health (PAL)

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6.4.4 Adapt successful approaches from other fields and sectors, and foster action on the social

determinants of health

Findings TB health services are available to all the citizens at no cost in the public sector, however there are other costs e.g. registration fee, payment for laboratory tests and auxiliary medicines that are incurred by patients in autonomous hospitals e.g. KNH and private hospitals. Recommendations

i. There is need to address the plight of poor TB patients through social support ii. The government should introduce Social Health Insurance for the needy

6.5 ENGAGING ALL HEALTH CARE PROVIDERS

6.5.1 Involve all public, voluntary, corporate and private providers through Public-Private Mix (PPM)

approaches

Findings The Private sector is greatly involved in the diagnosis and management of TB patients, they diagnose and treat a substantial number of TB patients (10.5% in 2012), and with the help of KAPTLD, the private sector notifies cases to the NTP. There is a PPM focal point in the program. Recommendations

i. Develop a PPM strategy 6.5.2 Promote use of the International Standards for Tuberculosis Care (ISTC)

Finding Elements of ISTC are implemented.

Recommendation i. Elements of ISTC should be available to all clinicians at the TB Clinics

6.6 EMPOWER PEOPLE WITH TB, AND COMMUNITIES THROUGH PARTNERSHIP

6.6.1 Pursue advocacy, communication and social mobilization

Findings There are Health Education activities that are carried out to inform and educate the public about TB, there are IEC pamphlets in the TB Clinic and posters displayed. There are ACSM guidelines within the TB manual. Recommendation

i. Develop and implement a comprehensive ACSM Strategy ii. Disseminate TB/HIV IEC material

6.6.2 Foster community participation in TB care, prevention and health promotion

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Findings The program carries out TB advocacy in the community to sensitize the public on TB, its prevention and management. The program also carries out campaigns in the country and through the media on the management of TB and health promotion Recommendation

i. Stregnthen community participation on TB prevention and management through regular health education initiatives

6.6.3 Promote use of the Patients' Charter for Tuberculosis Care

Findings Some elements of the patient charter are being implemented. However the Charter on rights and responsibilities of patients is not available in the TB clinics. Recommendations

i. Sensitize the health care workers on the patient charter and avail it in all the clinics 6.7 ENABLING AND PROMOTING RESEARCH

6.7.1 Conduct programme-based operational research

Findings The program has a strong research unit that identifies areas where evaluation information is needed and this information is gathered through specific operational research studies. The program staff are trained on operational research and are engaged in numerous TB research studies in the country in collaboration with research institutions and other partners e.g the World Bank, CDC e.t.c The program is planning to conduct a Drug Resistant survey this year. Recommendations

i. Strengthen Operational Research activities in order to influence policy ii. Identify and document priority areas for operational research

6.7.8 Advocate for and participate in research to develop new diagnostics, drugs and vaccines

The program is not currently participating in any research on new diagnostics, drugs and vaccines.

7.0 MAJOR GAPS & CHALLENGES

Despite gains made in the National TB program, there are some gaps and challenges that were identified;

7.1 Cross-border Management of TB There is a big challenge with Cross-border TB management in Kenya with an upsurge of immigrants from Somalia seeking refugee status, and with the diagnosis of MDR-TB in

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Mogadishu with no treatment in the country, most of the patients diagnosed cross over to Kenya to receive treatment. This has caused a big crisis since the program had not factored the huge numbers in to their budgeting.

7.2 Regulation of the private sector in TB management The private sector is responsible for diagnosing and managing a substantial proportion of TB patients in the country, however, they do not always follow the laid out national protocols and guidelines.

7.3 Pharmacovigilance for SLD It was also noted that there is pharmacovigilance system in place however; this is not being done for SLD.

7.4 Stigma from Health care workers It was noted that patients with MDR-TB are stigmatized especially by health care workers who do not want to attend to them and some of them even refuse to work in the MDR-TB unit.

7.5 Routine screening of Health Care Workers Health care workers are not routinely screened for TB. Screening is only done during employment.

8.0 KEY LESSONS LEARNT

A number of lessons were learnt from the TB program in Kenya:- 8.1 Strong Political Commitment There is political commitment given that the government commits resources for TB management. The government has a line budget for TB activities and the funds have been rising each year. The government is also supporting key positions in the program. 8.2 Utilization of MDR-TB isolation ward at KNH & MRTH The Kenyatta National Hospital recently opened an MDR-TB isolation ward with optimum infection control measures in place and dedicated staff managing patients. 8.3 Operational Research The national TB program has a unit within the program dedicated to conduct operational research. This team is well trained on research and is overseeing a number of research activities in the country. 8.4 PPM The program in collaboration with KAPTLD has managed to engage a huge proportion of private health care facilities in the management of TB in line with the National guidelines. 252 private health institutions are in a network that records and reports cases to the National TB Program.

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9.0 ANNEXES

Annex 1: ECSA HMC TB Resolutions 1999-2010

1. ECSA/HMC34/R 2: Resource Mobilization for Strengthening Health Systems Prepare plans and budgets to enable member states to access the Global Health Fund and other sources of funds for HIV/AIDS, Malaria, TB, and other priority health problems

2. ECSA/ HMC38/R 1: Scaling up health interventions Develop/strengthen plans for scaling up health interventions including Anti Retroviral Therapy (ART), Malaria, TB prevention and control and reproductive health and child survival;

3. ECSA/HMC 40/R2: Promote the integration of reproductive health and child health programmes with HIV/AIDS, malaria and TB programmes as appropriate for synergy.

4. ECSA/HMC 40/R4 a) Review existing national HIV/AIDS/TB policies, programmes and strategies and accelerate provision of ARVs,

VCT, PMTCT services b) Promote and support TB and HIV/AIDS programme collaboration

5. RHMC/42/R2.6 1. Fully endorse the 2005 WHO Regional Committee for Africa resolution by declaring TB a national emergency. 2. Rapidly scale up DOTS expansion best practices, especially public-private partnerships and community

involvement in the delivery of TB control services 3. Scale up TB/HIV collaborative activities including HIV testing and ART to dually infected TB patients in the

context of universal access.

6. ECSA/HMC44/R3 1. Review current supply chain management for commodities used in the management of HIV/AIDS and TB

patients in order to improve quality of care within 12 months. 2. Explore and document research on MDR and XDR TB treatment and disseminate findings to all member states

by July 2008.

7. ECSA/HMC48/R7 1. Develop action plan on ACSM, integrate into national plans for TB, HIV and Malaria and mobilize adequate

resources to support implementation of ACSM activities. 2. Establish and strengthen laboratory services for monitoring MDR and XDR TB and conduct assessment studies

to evaluate the magnitude of MDR and XDR TB 3. Ensure that management of drug resistant TB is mainstreamed into national TB control plans.

8. ECSA/HMC50/R6

1. Maximize available opportunities from Global Fund and other partners to obtain additional resources for scaling up interventions to achieve MDGs.

2. Develop a proposal for mobilizing resources for an integrated regional HIV/AIDS, TB and Malaria Programme

9. ECSA/HMC50/R10 1. Establish X/MDR Task Force to ensure implementation and monitoring of the Global framework and report on

the number of X/MDR cases notified and treated 2. Develop and expand capacity for diagnosis of drug resistant TB, strengthen quality DOTS and allocate

adequate resources for management of X/MDR-TB.

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10. ECSA/HMC52/R8 1. Ensure adequate supply of quality assured second line anti-TB drugs to all DR-TB patients, backed by

strengthened Pharmacovigilance and surveillance systems; and 2. Number of TB adverse events reported through TB Pharmacovigilance/ surveillance system 3. Prioritize the implementation of infection control measures in health care settings

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Annex 2: PMDT Mission Authorization Letter

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Annex 3: Program for the ECSA PMDT Mission to Kenya, 15-19 July, 2013

Date Activity

Day 1 Meeting with the Programme manager & staff

Meeting with HIV/AIDS Coordinator

Meeting with Pharmaceutical focal person

Day 2 Visit to the National Reference Laboratory

Visit the MDR-TB unit at KNH

Visit to KEMSA

Day 3 Visit Umoja Health Centre

Visit patient in the community

Visit the National Pharmacy and Poisons Board

Day 4 Meeting with partners supporting TB activities: MSH, TBCARE1, UNHCR, KAPTLD, KANCO

Day 5 Debriefing the NTP and the MOH Officials

Coordinator of the Mission: Dr. Kamene and Mr. Gachengo, TB Focal Persons in the DLTLD

Annex 4: List of Key people met and interviewed

NO.

NAME DESIGNATION TELEPHONE EMAIL

1 Joseph Sitiene Head DCTLD 0722740130 jsitienei@nltp.co.ke

2 KameneKimenye PMOT Coordinator 0722472751 kimaureen@yahoo.com

3 Herman Weyenga TBHN Coordinator 0722645515 howeyenga@gmail.com

4 James Gachengo PMDT – DRCO +255 0726568527 gachengo@yahoo.com

5 Jeremiah MCT +255 0720328016 Jeergov@gmail.com

6 Richard Muthoka SCM – Pharmacist 0711128821 rmuthoka@mty.co.ke

7 Stanley K. Ayabez Senior RCO – MDR-TB 0722657707 Stanleykimutai21@yahoo.com

8 Geoffrey Kisianjaw SMOI 0722706451 kisianganigeoffrey@gmail.com

9 Rosemary Odongo SNO 0724431446

10 Dorothy Mibei DTLC 0723990827 doemibei@yahoo.com

11 GandensiaOganyo N. O

12 John Broke Otieno CHN 0729833762

13 MilkaAdhiambo MDR Patient

14 James Mugo SRCO - DLTLD 0726568529 gachengo@yahoo.com

15 Dr. BertonWagache 0733880881

16 Dr. Grace Gitonga Program Manager

KAPTLD 0721902191 ggitonga@kaptld.or.ke

17 Evelyn Kibuchi Kenya Aids NGOs

Consortium 0722319987 ekibuchi@kanco.org

18 Dr. Kinyanjui Samuel

Regional Senior TB Technical Advisor

0731688003 skinyanjui@msh.org

19 Sara Massaut Country Director TB

Care, Kenya 0732925458 massauts@kncutbc.nl

20 Dr. Fred Siyoi P Register PPB +254 717768661 Jmsiyoi@gmail.com

21 Edward Abwao Snr PHO UNHCR +254 722644824 edwardabwao@gmail.com

22 Charles Juma Director Procurement 0727999911 charlesjuma@kemsa.co.ke

23 Joshua Obell Operations Director 0714642515 Joshua.obell@kemsa.co.ke

24 Healther Njuguna Program Officer (TB) 0723985359 Heather.njuguna@kemsa.co.ke

25 Paul Macharia Warehouse Officer 0722421362 Paul.macharia@kemsa.co.ke

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26 Dominic dKabiru PR &Comms Manager 0722710676 Dominic.kabiru@kemsa.co.ke

27 John Kabuchi Procurement Manager 0721733395 John.kabuchi@kemsa.co.ke

28 Mr. Philip Omondi Director Finance &

Admin 0722611373 Philip.omondi@kemsa.co.ke

1 James Mugo SRCO DLTLD 0726568529 gachengo@yahoo.com

2 Dr. BertonWagacho Snr PHO UNHCR burtonj@unhcr.org

3 Dr. Grace Gitonga Program Manager KAPTLD

ggitonga@kaptld.or.ke

4 E. Kibuchi KANCO – TB Manager ekibuchi@kanco.org