Managing Pharmaceuticals and Implications for Global Initiatives

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Managing Pharmaceuticals and Implications for
Global Initiatives

• Douglas Keene, Management Sciences for Health
• RPMPlus Project

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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

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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. 

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Pharmaceutical Management Cycle
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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

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Impact of Legislation on Policy
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Selection (The Essential Medicines Target)
Source WHO/EDM
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Pharmaceutical Regulation

• According 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

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Procurement (1)

• Quantification (morbidity/consumption)
• Tendering and contracting
• Pooled procurement/group purchasing
• Price monitoring
• Donor coordination
• Donations

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Procurement Efficiency
Percentage of Average International Price Paid
for One Regular Procurement
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Procurement (2)

• Assuring quality of products and services
• Prequalification of suppliers
• Monitor product quality
• Supplier performance monitoring and evaluation

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

• Alternative models
• Central Medical Stores
• Direct delivery
• Primary distributor (prime vendor)
• Private pharmacy services
• Vertical vs. integrated programs
• Kit system
• Inventory management

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Availability of Tracer Products in El Salvador
Ministry of Health Distribution System, 1993
Source MSH. 1993. Ministry of Health of El
Salvador Rational Pharmaceutical Management
Project.
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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
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The Drug Use Process
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Retail Outlet Transactions for Upper
Respiratory Illness with Inappropriately
Recommended Antibiotics
Percentage of Transactions
Source SEAM assessments, 2001
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An Overview of the Process of Changing Drug Use
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Management Support

• Organization and management
• Analyzing and controlling expenditures
• Financial planning and management
• Information management (PMIS)
• Human resources

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Financing Pharmaceutical Needs
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LEVELS
PRIVATE SECTOR
PARTNERS
PUBLIC SECTOR
International Procurement Agencies
International
Multinational Suppliers
Donors
National
Third-Party Payers
Local Manufacturers
Government Supply Services
Regulatory Agencies
Local Wholesalers
Academic Institutions
Distributors
Regional
Regional Facilities
District
District Facilities
Shops, Pharmacies
Community
Private Prescribers
Primary Care Facilities
Community Organizations
CMS system flow Alternative flow Information flow
Users
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Dimensions of Access
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Geographic Accessibility Cambodia
Average Number of Facility Operating Hours
per Day
Hours
35 of the population is more than 10 km or 2
hours walk away from any basic health-care
facility
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Availability Selected Countries
Percentage of a Set of Unexpired Key Items in
Stock
Percentage
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Affordability Cambodia, El Salvador, Ghana, India
Number of Days Needed to Pay for Pneumonia
Treatment
Number of Days
Child 1-5 years old, co-trimoxazole Adult,
amoxicillin
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Acceptability / Satisfaction
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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

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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

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Pharmaceutical Management, Access, and Use of
Medicines
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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

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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)

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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
• USAIDs Millennium Challenge Account (MCA)

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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

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An Often-Forgotten Reality

• It 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

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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

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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)

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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

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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