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Quality Problems with Antimalarials

Quality Problems with Antimalarials. Dr Mary R. Couper Quality Assurance and Safety: Medicines World Health Organization. Quality of Medicines. Good quality medicines are essential to promote public health - in some African countries 30-50% of samples tested are of poor quality

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Quality Problems with Antimalarials

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  1. Quality Problems with Antimalarials Dr Mary R. Couper Quality Assurance and Safety: Medicines World Health Organization

  2. Quality of Medicines • Good quality medicines are essential to promote public health - in some African countries 30-50% of samples tested are of poor quality • 429 samples from Cameroon, Madagascar, Chad tested - 18% failed, 16 were counterfeit • 175 samples from Tanzania tested - 17% failed • 581 samples from Nigeria tested - 48% failed • 788 samples tested in Zimbabwe - 17% failed

  3. Identifying quality problem Seven-country study: antimalarial quality differs among countries - content and dissolution problems Samples were judged to have “failed” if content was <93% or >107%, and dissolution <80% in 45 minutes. Samples were judged to have “failed” if content was <90% or >110%, and dissolution <65% in 30 minutes.

  4. Quality problems • Many African countries medicines are sold in open market places and by street vendors • Many medicines are smuggled or imported illegally • Most domestic manufacturers do not meet Good Manufacturing Practices • Storage and distribution conditions are inappropriate • Corruption is a serious problem

  5. About 50% of the countries in sub-Saharan Africa have very limited/no capacity to control the market-where regulatory authorities exist enforcement is weak

  6. Antimalarial Drugs on WHO’s Essential Drug List • artemether + lumefantrine (core) • chloroquine (core) • primaquine (core) • quinine (core) • doxycycline (comp.) • sulfamethoxazole+pyrimethamine (comp.) • artemether (restrict) • artesunate (restrict)

  7. Artemisinin derivatives available • artesunate (oral) • arteminol (dihydroartemisinin) (oral and rectal) • artemether (oral and i.m.) • artemether+lumefantrine (oral) • artesunate (i.v. and i.m.) • artemotil (i.v and i.m.) • artesunate + mefloquine (oral) • artesunate + amodiaquine (oral) • artesunate + sulfadoxine/pyrimethamine (oral)

  8. Quality concerns • Partners in Roll Back Malaria, such as WHO, UNICEF, and UNDP, and many other UN organizations are involved in the procurement of antimalarial drugs. • The supply of antimalarial products that are effective and of acceptable quality has become a major concern at both international and country level.

  9. Prequalification scheme • Why was the launch considered? • Countries and other interested parties asking WHO to initiate pre-qualification of essential drugs referring to positive experience of vaccines pre-qualification • Increasing pressures to increase access to artemisinin derivatives owing to resistance • … but artemisinin combinations are not typical “generic” drugs

  10. Not Typical “generic” drugs • Usually generic drugs “well established” … • Artemisinin combinations are relatively new, or very new drugs • Limited information available in public domain • For most artemisinin products reference standards not readily available and for combinations no “originator” product exists • Difficulties of proving “interchangeability” • Regulators have limited experience with this group of drugs ...

  11. Activities of Prequalification Scheme • Assessment of dossiers: teams of professionals from national drug regulatory authorities::Including Canada, Denmark, Estonia, Finland, France, Hungary, Indonesia, Malaysia, Philippines, Spain, South-Africa, Sweden and Zimbabwe • Manufacturing site inspections:teamwork of inspectors:WHO representative (qualified GMP inspector), inspector from well-established inspectorate (Pharmaceutical Inspection Cooperation Scheme countries) and inspector(s) from national drug Regulatory authorities

  12. Current Status • 20 Product dossiers assessed • 2 Manufacturers have been inspected • No dossier meets WHO standards yet • Incomplete data include lack of safety and efficacy data, lack of specifications for starting materials, information on method of manufacture of the product, lack of process validation, incomplete stability data. • Assessment is ongoing

  13. How WHO can help • Issue guidelines and information • Provide training seminars - 3 planned for 2003 • New monographs for all artemisinin based products recently published in International Pharmacopoeia • http://www.who.int/medicines/library/pharmacopoeia/pharmacop-content.shtml • Provide Basic Tests for confirmation of identity of active ingredient

  14. Counterfeit • 40% of artemisinin-based antimalarials on the market are counterfeit • Nigeria reported 50% of the medicines on the market are counterfeit • Some other African countries show that about 19% of products are counterfeit

  15. Counterfeit database 2002 • Reports from 46 countries of which 3 are African countries: • Zambia - chloroquine phosphate • Gabon - chloroquine and quinine • Tanzania - quinine

  16. Examples of Counterfeit

  17. Challenge • Quality of products can only be achieved by building reliable and effective national regulatory authority

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