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By Isaac O. Kibwage

COUNTERFEITING OF DRUGS AND THE NECESSITY OF QC SYSTEMS IN DEVELOPING COUNTRIES: THE KENYAN EXPERIENCE. By Isaac O. Kibwage. Authors: G.N. Thoithi 1 , K.O. Abuga 1 , H.K. Chepkwony 2 and I. O. Kibwage* 1 Department of Pharmaceutical Chemistry, University of Nairobi, Kenya.

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By Isaac O. Kibwage

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  1. COUNTERFEITING OF DRUGS AND THE NECESSITY OF QC SYSTEMS IN DEVELOPING COUNTRIES: THE KENYAN EXPERIENCE By Isaac O. Kibwage

  2. Authors: G.N. Thoithi1, K.O. Abuga1, H.K. Chepkwony2 andI. O. Kibwage* 1Department of Pharmaceutical Chemistry, University of Nairobi, Kenya. 2National Quality Control Laboratory (NQCL), Nairobi, Kenya

  3. Quality of Medicines • Quality of medicines • Impact of quality on consumers • Kenyan mass media reports – drug quality concerns • Poor quality • Expired products • Counterfeits • Lack of adequate policy • Limited market surveillance

  4. Daily Nation, Monday May 2, 1988 PSK Symposium1988: Debate on quality of locally produced medicines stopped by PSK chairman

  5. Kenya Times, Tuesday May 3, 1988

  6. Africa Health Market Letter, Vol. 6 No. 4, April 1992 VLIR, KUL – UON Project for QC of drugs

  7. Sunday Standard, Nov. 9, 1997 Sale of non-registered loperamide & sulfadoxine/pyrimethamine in the Kenyan market. Chief pharmacist admitted dispensing malpractices and the presence briefcase imports in the country

  8. Sunday Standard, Nov. 9, 1997 Sale of non-registered loperamide & sulfadoxine/pyrimethamine in the Kenyan market. Chief pharmacist admitted dispensing malpractices and the presence briefcase imports in the country

  9. Specialties authorized for the Kenyan market:1982-2007

  10. Historical Background DARU: Established in 1977 Work started in1980 VLIR funded KUL-UoN project was a major boost NQCL: Established in 1993 Takeoff slow - inadequate facilities 2004 – Enhanced budgetary allocation + donor funding WHO certification in the process

  11. Sources of Drugs • Central Medical Stores • Government and Private Hospitals • Pharmaceutical industry • Pharmacy and Poisons Board • Community Pharmacies • Doctors, Dentists and patients

  12. Sources of Drugs • Local Manufacturers • Imported • India • China • Israel • Far East • Western/ Eastern Europe

  13. Results for DARUPeriod: 1980 - 2007

  14. Results for DARUPeriod: 1980 - 2007

  15. Results for DARUPeriod: 1980 - 2007 Therapeutic categories (% Failure)

  16. Results for DARUPeriod: 1980 - 2007

  17. Failure Rate for Analgesics (%)

  18. Failure Rate for Antibiotics (%)

  19. Failure Rate for Antimalarial Drugs (%)

  20. Failure Rate for Antitubercular Drugs (%)

  21. Failure Rate for Skin Preparations (%)

  22. Observations • 2001-2007: Quality of drugs has improved • Failure rate slightly higher in locally manufactured drugs • Drugs of greatest concern • 1980 – 1990: skin preps (50% failure) • nutritional preps (25-38%) • antibiotics (about 30%). • 1996-2007: antimalarials, especially S/P (30%)

  23. Possible Reasons for Improved Quality • Improved technology globally • Professional advice given to local industry following failure of their products. • Investment in QC Labs • More pharmacists in the industry • Greater vigilance by the regulatory authority.

  24. Results for NQCLPeriod: 1996 - 2007

  25. Results for NQCLPeriod: 1996 - 2007

  26. Failure Rate for Analgesics (%)

  27. Failure Rate for Antibiotics (%)

  28. Failure Rate for Antimalarials (%)

  29. Failure Rate for Antitubercular Drugs

  30. Observations • 2001-2007: Quality of drugs has improved • Failure rate slightly higher in imported drugs • Drugs of greatest concern by end 2007 • antibiotics (17.3%) • anthelmintics (10%) • antituberculars. (17.4%) • antimalarials, (13.8%)

  31. Counterfeit Medicines

  32. Counterfeit Medicines

  33. Counterfeit Medicines

  34. PREDINSOLONE TABLETS COUNTERFEIT (NQCL) TWO PACKS WITH THE SAME BATCH TABLETS LOOK DIFFERENT

  35. METAKELFIN TABLETS COUNTERFEIT (NQCL) Counter feit Genuine product

  36. METAKELFIN TABLETS COUNTERFEIT (NQCL) Genuine product Counter feit

  37. DUO-COTECXIN TABLETS COUNTERFEIT (DARU) Counterfeit product Genuine product

  38. DUO-COTECXIN TABLETS COUNTERFEIT (DARU) New product bears the hologram ‘FACT’

  39. DUO-COTECXIN TABLETS COUNTERFEIT (DARU) Counterfeit Genuine product New genuine pack

  40. DOU-COTECXIN TABLETS COUNTERFEIT (DARU) Counterfeit Genuine product New pack

  41. DUO-COTECXIN TABLETS COUNTERFEIT (DARU) Counterfeit Genuine product New pack

  42. The Financial Standard, Tuesday April 20,1999

  43. The People Daily, Friday August 6, 2004

  44. The Financial Standard May 18,1999

  45. Market Surveillance

  46. Market Surveillance Reports

  47. Market Surveillance • Market surveillance is weak in Kenya • Concern for quality • Availability of substandard products in the market • Regulatory authority needs to be more stringent

  48. Conclusions • Counterfeits harm health, results in economic loss • Meaningful surveillance • Strong DRA • Well equipped QC facilities • Comprehensive policies on handling and distribution of drugs

  49. ACKNOWLEDGEMENTS VLIR: Equipment Human resource development Technology transfer DARU: Staff NQCL: Staff GoK, PPB Donors: GTZ, DANIDA, WHO

  50. ACKNOWLEDGEMENTS NATIONAL QUALITY CONTROL LABORATORY (NQCL) STAFF

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