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Report on Risk-Based Post-Marketing Surveillance of the Quality of Selected Medicines in Kenya

The constitution of Kenya 2010 provides that every person has the right to the highest attainable standard of health. The highest standards of health are only attainable if the quality of medical products and health technologies in the market are of the right quality.
The Pharmacy and Poisons Act CAP 244 laws of Kenya mandate the Board to regulate the trade in medical products and health technologies. Sections 3 (A)(f), 3B (2) (k, l, and m) mandate the Board to implement market surveillance ac activities to monitor the quality, safety, and efficacy of medical products and health technologies circulating in Kenya.
Medical products and health technologies are essential components of healthcare service delivery (Bigdeli, M., Jacobs, B., Tomson, G., Laing, R., Ghaffar, A., Dujardin, B., & Van Damme, W.). Sustainable Development Goal 3.8 specifically mentions the importance of “access to safe, effective, quality and affordable essential medicines and vaccines for all” as a central component of Universal Health Coverage (UHC) and Sustainable Development Goal 3 .b emphasizes the need to develop medicines to address persistent treatment gaps (Sachs). Access to good quality health products and technologies increases public confidence in healthcare systems (Kruk, M. E., Gage, A. D., Arsenault, C., Jordan, K., Leslie, H. H., Roder-DeWan, S., ... & Pate, M.).
The quality of medical products and health technologies is an important factor in disease prevention and treatment. Quality is fundamental to their effectiveness and safety, hence a healthy outcome for the patient. Ensuring quality requires the concerted effort of all stakeholders in the entire lifecycle of health products and technologies (Porter, M. E., & Teisberg, E. O.).
A very important component of ensuring that the public gets quality medicines is by establishing and implementing a Post-market surveillance (PMS) system that involves monitoring the safety and quality of a pharmaceutical drug or medical device after it has been released on the market. PMS enables the detection of Substandard and Falsified (SF) products, registration status, and the effects of storage conditions on the quality and stability of the products (Newton, P. N., Lee, S. J., Goodman, C., Fernández, F. M., Yeung, S., Phanouvong, S., ... & White, N. J.; Kramer, D. B., Baker, M., Ransford, B., Molina-Markham, A., Stewart, Q., Fu, K., & Reynolds, M. R. ). Previously the PMS activities were conducted using conventional approaches and there was a need to develop a tool that would have a risk-based approach resulting in a scientific, convenient, efficient, and cost-effective PMS exercise. Given this the Med-RS tool was developed in conjunction with USP - QPM supported by USAID.
Collaboration of institutions making up the post-marketing surveillance/ pharmacovigilance Technical Working Group (PMS/PV TWG) represents a promising strategy toward the Sustainable Development Goal of ensuring access to quality, safe, and efficacious health products, and technologies. The PMS/PV TWG is comprised of the Pharmacy and Poisons Board (PPB) which is the National Medicine Regulatory Authority, Procurement agents including Kenya Medical Supplies Authority (KEMSA) and Mission for Essential Medical Supplies, Public Health Programs including the Division of Malaria Control, National AIDS and STI Control Program, National Tuberculosis Leprosy and Lung Disease Program, Maternal and Child Health Program, teaching and research institutions including Kenya Medical Research Institute and University of Nairobi and the official medicines control laboratory, National Quality Control Laboratory (NQCL).
Post-marketing surveillance is an important regulatory function in monitoring the quality of health products and technologies post- authorization.
Post-marketing surveillance (PMS) is an important regulatory function in monitoring the quality of health products and technologies that are available to the Kenyan public. The PPB in collaboration with DNMP, and NQCL set out to survey to assess the quality of anti-malarial and RMNCH medicines circulating in the Kenyan market. The Pharmacovigilance and Post Marketing Surveillance Technical Working Group (PV/PMS TWG) of the Pharmacy and Poisons Board (PPB) was established in 2020 with the support of Promoting Quality of Medicines Plus (PQM+); a United States Agency for International Development (USAID) program being implemented by United States Pharmacopoeia (USP). One of the mandates of the TWG is the development and implementation of a PMS strategy. Members of the TWG include the Pharmacy and Poisons Board, Kenya Medical Supplies Authority (KEMSA), Mission for Essential Medical Supplies (MEDS), the Public Health Programs and teaching and research institutions, and the National Quality Control Laboratory.
The selection of the drugs for sampling was done using the Medicines Risk- based Surveillance (MedRS) tool. The tool has both online and excel based versions. The PV/PMS TWG team used the excel-based version. The MRS tool uses a risk-based approach to identify the samples and the facilities from which they were sampled.

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