Managing Pharmaceuticals and Implications for Global Initiatives

Douglas Keene, Management Sciences for Health

RPMPlus Project

Objectives • Introduce frameworks for understanding,

analyzing, and making decisions about pharmaceutical management

• Describe the complexity of the pharmaceutical management system and interrelationships with other components of the larger health-care system

• Discuss challenges of implementing programs funded through global initiatives

Pharmaceutical Management

Pharmaceutical management is the set of practices aimed at ensuring the timely availability and appropriate use of safe, effective, quality medicines and related products and services in any health-care setting. 

Pharmaceutical Management Cycle

Selection

ManagementSupport

Distribution

ProcurementUse

Policy and Legal Framework

Policy and Legal Framework

• Registration of pharmaceuticals– Proof of safety and efficacy– Pharmacopeial standards

• Accreditation/licensing– Hospitals, clinics, pharmacies, providers

• Pharmaceutical sector regulations/laws– Procurement, retail sales, importation

• Pharmacy benefits

Impact of Legislation on Policy

Selection (The Essential Medicines Target)

DispensaryS S

All medicinesworldwide

Registered medicines

National list ofessential medicines

Levels of use

Supplementaryspecialistmedicines

CHW

Health center

Hospital

Referral hospital

Private sectorSource: WHO/EDM

Pharmaceutical RegulationAccording to WHO, of 192 Member States:

• One in six have well-developed capacity to regulate medicines

• About two in six have varying capacity

• About one in six have limited or no capacity

Source: WHO Essential Drugs and Medicines Policy Department

Procurement (1)

• Quantification (morbidity/consumption)

• Tendering and contracting

• Pooled procurement/group purchasing

• Price monitoring

• Donor coordination

• Donations

Procurement Efficiency

0

50

100

150

200

250

300

350

400

MozambiqueGhana

El Salvador

Guatemala

JamaicaOECS

Nepal

Per

cen

t o

f A

vg.

Int.

P

rice

Percentage of Average International Price Paid for One Regular Procurement

Procurement (2)

• Assuring quality of products and services– Prequalification of suppliers

– Monitor product quality

– Supplier performance monitoring and evaluation

Percentage of Countries with National Mechanisms for Drug Quality Control, 2000

56%63%

58% 62%

100%

75%

Per

cent

age

AFR AMR EMR EUR SEAR WPR

Region

Distribution

• Alternative models– Central Medical Stores– Direct delivery– Primary distributor (prime vendor)– Private pharmacy services

• Vertical vs. integrated programs• Kit system• Inventory management

Availability of Tracer Products in El Salvador Ministry of Health Distribution

System, 199394%

81%78%

100%

90%

80%

91%

65%

77%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Central Medical Store Regional Medical Stores Health Facilities

PharmaceuticalsContraceptive ProductsMedical Supplies

Source: MSH. 1993. Ministry of Health of El Salvador Rational Pharmaceutical Management Project.

What Is Rational Use of Medicines?

» [WHO, 1988]

The rational use of drugs requires that patients receive medicines appropriate to their clinical needs, in doses

that meet their own individual requirements, for an adequate period of time, and at the lowest cost to them

and the community. World Health Organization, 1988

The Drug Use Process

% Retail Outlet Transactions for Upper Respiratory Illness with Inappropriately

Recommended Antibiotics

0102030405060708090

100

Per

cen

tag

e o

f T

ran

sac

tio

ns

Source: SEAM assessments, 2001

An Overview of the Process of Changing Drug Use

1. EXAMINE1. EXAMINEMeasure PracticesMeasure Practices

(Descriptive (Descriptive Quantitative Studies)Quantitative Studies)

2. DIAGNOSE 2. DIAGNOSE Identify Problems and Identify Problems and

CausesCauses(In-depth Quantitative (In-depth Quantitative

and Qualitative Studiesand Qualitative Studies))

3. TREAT3. TREATDesign and Design and Implement Implement

InterventionsInterventions(Collect Data to (Collect Data to

Measure Outcomes)Measure Outcomes)

4. FOLLOW UP4. FOLLOW UPAssess Changes in Assess Changes in

OutcomesOutcomes(Quantitative and (Quantitative and

Qualitative)Qualitative) Improve Improve InterventionIntervention

Improve DiagnosisImprove Diagnosis

Management Support

• Organization and management

• Analyzing and controlling expenditures

• Financial planning and management

• Information management (PMIS)

• Human resources

Financing Pharmaceutical Needs

-

2,000,000

4,000,000

6,000,000

8,000,000

10,000,000

12,000,000

14,000,000

16,000,000

18,000,000

20,000,000

1999 2000 2001 2002 2003 2004 2005

US

$

Estimated Needs Total MoH Budget MOH Funds Non-MOH Funds MoH Budget + efficiency gains

GAP 1

GAP 2

LEVELS PRIVATE SECTOR PUBLIC SECTOR PARTNERS

International International Procurement Agencies Donors

National Government Supply Services

Third-Party Payers

Regulatory AgenciesLocal Wholesalers

Academic Institutions

Regional Regional Facilities

District

Private Prescribers

Community

District Facilities

Primary CareFacilities

Users

Local Manufacturers

Multinational Suppliers

Distributors

Shops, Pharmacies

CMS system flowAlternative flowInformation flow

Community Organizations

Dimensions of Access

GEOGRAPHICACCESSIBILITY

AVAILABILITYACCEPTABILITY

AFFORDABILITY

SAFEEFFICACIOUS

QUALITYCOST-EFFECTIVE

12.4 12.4

6.6

0

9.9

7.7

11.3 11.7

0

4

8

12

16

20

24

Private Pharmacy Public

NGO Clinic Private Clinic

Weekdays Weekends

Geographic Accessibility: Cambodia

35% of the population is more than 10 km or 2 hours’ walk away from

any basic health-care facility

Hou

rs

Average Number of Facility Operating Hours per Day

Availability: Selected Countries

0.00

10.00

20.00

30.00

40.00

50.00

60.00

70.00

80.00

90.00

Public Facilities 46.90 57.29 82.49 68.00 42.60 72.00

Private Facilities 38.10 56.42 40.00 34.30 67.00

NGO/Mission Facilities 41.00 50.35 56.75 66.00 18.00 84.00

Private Pharmacies 78.00 66.82 73.70 67.00 51.00 79.00

Brazil Cambodia El Salvador Ghana India Tanzania

Percentage of a Set of Unexpired Key Items in Stock

Per

cen

tag

e

Affordability: Cambodia, El Salvador, Ghana, India

0.00

0.50

1.00

1.50

2.00

2.50

3.00

Public Facilities 0.13 1.52

Private Facilities 2.89 0.45 1.72 0.17

NGO/Mission Facilities 0.91 0.28 1.33

Private Pharmacies 0.75 2.48 1.99 0.09

Cambodia* El Salvador* Ghana** India*

*Child 1-5 years old, co-trimoxazole**Adult, amoxicillin

Number of Days Needed to Pay for Pneumonia Treatment*N

um

be

r o

f D

ay

s

Acceptability / Satisfaction

010

2030

405060

7080

90100

Brazil Ghana Tanzania

OverallPublicMissionPrivate

Designing and Implementing Interventions

• Intervention should address identified access gaps

• Multifaceted targeting of different barriers is more likely to succeed than single interventions

• Evaluation of impact is essential

Strategies to Improve Access in Tanzania

Gaps

• Availability, especially in public sector

• Quality and affordability of products and services, especially in the private sector serving rural areas

Interventions

• Approving additional sources of supply to Medical Stores Department for public sector

• A regulated network of accredited drug dispensing outlets (ADDOs)

• A quality assurance strategy to permit improved screening of drugs entering and circulating in the market

Pharmaceutical Management, Access, and Use of Medicines

Global Fund to Fight AIDS, Tuberculosis and Malaria

(GFATM)

“For activities involving the use of essential drugs, there should be a description of the products and treatment protocols as well as resources (human and systems, etc.) in place to ensure rational use and maximizing adherence and monitoring of resistance.” GFATM Web site

Some Examples of Multilateral Initiatives/Partnerships

• Global (TB) Drug Facility (GDF)/Stop TB partnership

• Green Light Committee (GLC)/Stop TB partnership

• Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM)

• Roll Back Malaria (RBM)

• Malaria Action Coalition (MAC)

Some Examples of Multilateral Initiatives/Partnerships (2)• Accelerating Access Initiative (AAI)

• Global Alliance for Vaccines and Immunization (GAVI)

• Prevention of Mother-to-Child Transmission (PMTCT) Initiative

• UN Millennium Resolution and Development Goals

• USAID’s Millennium Challenge Account (MCA)

What Is Different About Recent Global Initiatives?

• Greater use of public relations and advocacy

• A growing use of “non-government/non-health” outside partners

• Emphasis on the speed of disbursement, for the purpose of getting rapid results

• Promotion of vertical programs rather than systems strengthening

An Often-Forgotten RealityIt is often assumed that increased resources

(funds, medicines, etc.) = more people cured of disease.

This assumption is only partially true; the following are also essential to achieve better cure rates: • Strengthened systems

• Management tools

• Human resources

• Capacity building

How to Know What to Strengthen

• The best way is to conduct an assessment (or update a recent assessment) of the pharmaceutical management system in conjunction with stakeholders to identify bottlenecks and determine:– Where strengthening is needed

– How to strengthen (identify options)

– At what levels capacity building is required

– Which interventions are highest priority

GFATM• To date, two rounds of proposals have been

reviewed; the submission deadline for the third round is May 30, 2003

• As a result of Rounds 1 and 2, it is hoped:– 500,000 additional people will receive ARVs – 4 million courses of arteminisin-based medicines will

be provided to treat drug-resistant strains of malaria– 2 million people will receive TB treatment (one-third

of TB grants contain a component for treating people with drug-resistant strains of TB)

Summary• Pharmaceutical systems are complex

– Decision-making process is complex– Many stakeholders are involved– Systems operate in a dynamic environment– Multiple interrelated components– Part of larger health system

• The pharmaceutical management cycle and access framework guide the systematic analysis of pharmaceutical systems

Messages to Take Home• Although it is great to have more financial

resources, this is not enough; strengthened systems, management tools, and human resources are also needed

• Assessments are useful to assist in determining what, where, and how to best strengthen systems and identify capacity building requirements

• It is essential to have appropriate technical assistance to bring programs successfully to scale