Addressing Quality in MeTA - Ghana

1. Addressing Quality in MeTA - Ghana Daniel Kojo Arhinful PhD Senior Technical Advisor MeTA Ghana

2. Situation Analysis in Ghana Counterfeit & substandard drugs have been a serious problem across the globe but capacity to deal with it is limited Some successes made in International anti-counterfeiting interventions Counterfeiters becoming more sophisticated to vulnerable markets Distribution of sub-standard drugs also exploit weak regulatory capacity Ghana’s medicine regulatory mechanisms incorporate quality assurance during registration and post market surveillance. Counterfeiters and grey importers of sub-standard drugs do not use official channels and are able to outwit the current system. The Food and Drugs Board (FDB) Ghana is improving monitoring using GPHF- Minilab MeTA funding has been a welcome support of monitoring initiative

3. How MeTA has addressed quality 1 FDB/MeTA/World Bank/DfID Antibiotics Study; sentinnel testing using GPHF minilabs Study Dec 2009 Full monograph analysis BP, USP and Validated In House methods Assessed the quality of the various formulations of 3 antibiotics: Amoxicillin, Co-Amoxiclav (Amoxicillin + Clavulanic Acid ) & Ciprofloxacin 350 products were sampled from health facilities and outlets in July/August 09 84% products sampled conformed to specifications ; 14% failed the analysis, 40% not registered

4. How MeTA has addressed quality 2 FDB/MeTA/World Bank/DfID Study 2 Minilab and confirmatory full monograph analysis for 20 samples Assessed the quality of Mebandazole & Glibenclamide tablets in health facilities & medicines outlets 90 products were sampled in All Glibenclamide sampled conformed to current BP specifications for assay However except the innovator product all other failed dissolution. This can be explained by the fact that dissolution only became a BP requirement in 2009; all the products sampled were manufactured before 2009. 17.8% not registered; 7.8% pending registration

5. Successes • All two studies successfully carried out • Regulatory Interventions were immediately taken by the FDB to address the problems identified by both studies • Withdrawal of products • Re-analysis of retained samples • Communication to providers and public • Withdrawal of all unregistered products • Intensified Post market surveillance. • Opportunity to continue with collaboration subject to funding availability

6. Challenges Sustainability of funding for further monitoring studies in doubt Study far exceeded expected reporting time Sensitivities surrounding funding Need for resources to purchase more minilabs and train more staff to cope with increasing demand for minilab testing and validation tests What do you do to enhance best practice of manufacturers and importers?

7. Lessons Learned Increased enforcement of regulatory requirements by the FDB is essential to ensure medicines are of right quality The minilab technique has tremendous impact on quality testing of medicines MeTA should seek ways of facilitating support in capacity building for local manufacturers Need to strengthen the Post-market surveillance activities of the FDB to ensure that post registration quality of products are maintained. Every little support helps and MeTA should explore ways of sustaining such collaboration with FDB.

8. Thank you Name of presenter: Daniel Kojo Arhinful Email: darhinful@noguchi.mimcom.org Mobile number: + 233 244 932139 Skype: Website: http://www.noguchimedres.org/