Zelalem Mamo Sahile
Technical Advisor (regulatory System Strengthening | Promoting the Quality of Medicines Plus (PQM+) Program | US Pharmacopeia (USP)
Introduction: Market Surveillance and Control (MSC) is an essential function for national medicine regulatory authorities (NMRAs) seeking Maturity Level 3 or 4, as measured by WHO’s Global Benchmarking Tool. The COVID-19 pandemic has forced NMRAs to shift resources to prioritize access to COVID-19 related products while still carrying out regular MSC activities. Risk-based post-marketing surveillance (RB-PMS) has emerged as a critical way for NMRAs in low- and middle-income countries (LMICs) to sustainably institutionalize the function while maximizing available resources. This approach has proved particularly useful during health emergencies, such as COVID-19.
Methods: The USAID-funded and USP-implemented Promoting the Quality of Medicines Plus (PQM+) program supports NRMAs in LMICs in institutionalizing RB-PMS programs. This includes development of customized national guidelines and practical RB-PMS sampling protocols using the Medicines Risk Surveillance (MedRS) tool. MedRS enables countries to determine which medical products pose the greatest risk to the population and calculate a representative sample size for collection. A risk-based and tiered approach is also used for sample testing to reduce laboratory testing costs while maintaining the ability to detect poor-quality products.
Results: Since 2018, USP has supported RB-PMS in 20+ LMIC countries with 150+ staff trained. Results from several countries indicate RB-PMS programs yield significant cost-savings. For example, prior to adoption of RB-PMS, laboratory testing in Ethiopia averaged approximately $875 (USD). With RB-PMS, the cost of sampling and testing has been reduced by 70%, to approximately $200. Other countries, such as Bangladesh, are expanding surveillance activities to new COVID-19 vaccines.
Discussion: Effective RB-PMS programs optimize the use of limited resources and can help enable NMRAs to leverage resources for maximum public health benefit. During health emergencies, such as COVID-19, RB-PMS programs can help expand surveillance activities to critical new products such as vaccines, even as testing capacity for new products is being established.
Acknowledgements:
I would thank Souly Phanouvong and Timothy Ngowo
Conflict of Interest:
None declared.
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