Regulation of Medical Products & Patient Safety: A Narrative Review

1. Regulation of Medical Products & Patient Safety- A Narrative Review Charles Ouma Management Sciences for Health Kenya

2. Background • Substandard, spurious, falsely labelled, falsified & counterfeit medicals product (SSFFCs)- significant risk to public health • Harm patients &undermine confidence in medical products, healthcare professions & health systems • Adverse drug event (ADEs) from poor product quality a growing problem- increased morbidity & mortality • Authenticated products pose additional risks- ADRs with considerable economic & clinical costs

3. Why Regulation? • Effective regulation intended to mitigate this harm, promote & protect public health and contribute to better health outcomes • Should target to ensure the quality, safety & efficacy of medicines or performance of devices to safeguard health of citizens • Improve overall access to medical products and technologies • Effective regulatory systems an essential component of health systems strengthening

4. Regulation & Dimensions of Access to Medicines

5. Scope of Regulatory Functions • Licensing of products, manufacturers & distributors • Inspection of manufacturing sites and distribution facilities • Laboratory testing/Quality validation • Control of clinical trials • Control of advertising and promotions • Post Marketing surveillance of quality and safety • Consumer education

6. Drug regulation is a multi- faceted activity at the centre of complex interactions Government Experts Manufacturers Regulatory authority Prescribers Products Medicines Patients/Consumers Importers/Wholesalers/Retailers

7. Methodology • Narrative review of published literature on regulation & patient safety in SSA • Qualitatively describe the status of medicines regulation in the region • Determine impact on public health • Synthesize recommendations to address identified gaps • Literature reviewed included online databases, libraries, journals , authoritative publications and texts

8. Results • NMRAs exist in almost all SSA countries • Legal framework for operation is fragmented and sometimes not well articulated • Capacity is highly variable, some with no capacity at all • Funding/resource constraints limit the capacity of these NMRAs to fulfil their mandate

9. Differences in regulatory capacity in WHO African Region Medicines Regulatory capacity in 46 WHO AFRO Member States Due to chronic shortages of human, technical, financial and other resources many National Medicines Regulatory Authorities (NMRAs) in Africa don't have the full capacity to perform most core regulatory functions Source:WHO/AFRO/EDP/04.5: Availability of Drug Regulatory and Quality Assurance Elements in Member States of the WHO African Region, 2004, Brazzaville.

10. Impact/Outcomes • Inadequate capacity & resources for PV and post-market surveillance for quality & safety – significant impact on patient safety • Access to required essential medicines limited by insufficient regulatory capacity • Poor uptake of new and existing health solutions costs millions of lives in many of these countries

11. What is the situation in Kenya? • NMRA- legal framework, capacity, funding? • Most important question- So what? • Are our patients protected from SSFFCs & the resultant problems? • Have all the dimensions of access been adequately addressed in country? What gaps exist & how can they be addressed? • What is the contribution of NMRA activities to public health & patient safety? • What is the status of pharmacy practice in the country?

12. Conclusion/Recommendations • Regulatory activities have a direct and significant impact on patient safety & public health • Globalization has resulted in the need for strengthened & more stringent regulation • Regulation can no longer be implemented as a fragmented single country activity • Need for fast-tracking efforts to harmonize and integrate regulatory activities across countries for standardization & improved efficiency

13. Thank you