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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
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
% 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
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
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