Operational Guide to Improve Drug Quality in LowIncome Countries

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Operational Guide to Improve Drug Quality in
Low-Income Countries
Phanouvong S, Ssali P, Rahman E, Trin VQ,
Mahlangu G, Smine A, Wondemagegnehu E, Dicken T,
Vrakking H, Bwire R, Tran D, and Blum N
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Presentation outline

• Background and rationale
• Can drug quality be guaranteed?
• How whom the DQ Guide can help?
• What does this document contain?
• What are the implications to drug use?

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Background and Rationale
Poor drug quality is due to many factors

• Lack of compliance with national and/or
  international standards of GMP
• Lack of functional QA/QC
• Lack of resources and/or regulatory capabilities
  for registration, inspection, testing, and
  post-marketing surveillance.

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Background and Rationale
Use of poor quality drugs is a global concern

• Adversely affects health outcomes
• Wastes of the already scarce resources
• for health care
• May contribute to antimicrobial
• resistance, already a problem in
• infectious diseases

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Can drug quality be guaranteed?
Important criteria and roles for good drug
quality

• Manufacturers follow GMP standards
• Importers, distributors and wholesalers follow
  quality standards for procurement, storage, and
  distribution of drugs
• DRAs perform, verify, and enforce core
• functions
• - Registration
• - Inspection
• - Laboratory testing
• - Drug advertisement and promotion
• - Post-marketing surveillance

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Design and Methodology

• It is based on extensive literature review of
  drug quality systems.
• Authors have extensive active experience in
  regulatory affairs and drug quality issues.
• Topics were identified and selected based on
• wide-ranging consultations with experts.
• Consultations continue throughout all processes
  developing, drafting, reviewing, and finalizing.

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Objectives

• A tool to evaluate strengths and weaknesses of
• existing QA/QC
• Help to prioritize efforts to fill QA/QC gaps
• Guidance to local and international NGOs to
• develop specific plans for procurement,
• handling and storage of pharmaceutical products
• Guidance to government DRAs to regulate local
• pharmaceutical industry and its services
• Step-wise implementation of QA/QC in a country

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What Does the Guide Contain?

• Role of policy makers
• Key functions and responsibilities of DRA
• Different level-testing program
• QA and drug procurement
• QA and storage and distribution
• QA and dispensing
• QA and GMP
• Practical example in ensuring quality of
  antimalarial medicines
• Planning and implementation of the Guide
• Rapid assessment of technical and managerial
  capabilities of a DRAs QA/QC and check lists to
  guide decision making and implementation

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Content Example 1
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Content Example 2 QA and Procurement
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Content Example 3 QA and Distribution
Dispatch/ Delivery
Receipt of medicines
Storage

• Receiving of incoming goods
• Follow SOP for receiving goods, incl. checking
  for
• completeness, accuracy and validity of
  documents
• Quarantine
• Carry out visual/physical inspection
• Take suspected samples for lab testing
• Record any damages and discrepancies
• All incoming goods/shipments must be on
  quarantine until receiving report is
  finalized/cleared by the responsible person
  before they are released into stock.

Transportation
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Key Lessons Learned

• The process of developing this guide by
  volunteers individuals, government authorities,
  and various organizations located all over the
  world requires
• dedication of personal time, energy, resources,
• and commitments
• the approval and support of each writers
• organization

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Potential Implications

• The potential implications of the Guide to the
  use
• of medicines include
• Improved in-country drug QA program and QC
  systems and
• Gradual increased availability of quality
  medicines for use and reduced prevalence of poor
  quality medicines over time.

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Conclusion

• This drug quality handbook is intended to provide
• practical drug quality guide for countries with
• limited resources.
• It is applicable to all key players in medicines
• Government regulatory authorities
• Government health programs
• Drug manufacturers
• Drug importers, wholesalers, and retailers
• Local and international NGOs
• It is expected to be available by the end of 2004.

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Corresponding authors contact Global
Assistance Initiatives United States Pharmacopeia
Drug Quality and Information Program United
States Pharmacopeia 12601 Twinbrook Parkway,
Rockville, MD 20852, USA. Phone (1)
301-816-8582. Fax [phone]. Email
sxp_at_usp.org