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Report on Post Marketing Quality Surveillance of Selected Health Products and Technologies used in Public Health Programs in Kenya

The Pharmacy and Poisons Board (PPB) in collaboration with the National technical working group on pharmacovigilance and post-marketing surveillance (PV/PMS TWG) implemented post-marketing quality surveillance of selected health products and technologies (HPTs) circulating on the Kenyan market. The product categories that were sampled and tested were; Antimicrobials (Amoxicillin and ciprofloxacin), Anti-cancer agents (Doxorubicin), Antihypertensives (Enalapril and Losartan), Analgesics (Paracetamol), contraceptives. (Levonorgestrel), Anti-histamines (Cetirizine) and anti-ulcer medicines (Omeprazole). The medical devices include the male latex condoms.

The counties and healthcare facilities where samples were collected from were determined based on risk-ranking using an excel based medicines-risk based surveillance (MedRS) tool.

The samples were collected from the following fifteen (15) counties; Bungoma, Busia, Garissa, Kajiado, Kiambu, Kisumu, Kwale, Lamu, Mandera, Migori, Mombasa, Nairobi, Nyeri, Siaya and Vihiga

A total of two hundred and seventy nine (279) were collected from 142 pharmaceutical outlets and healthcare facilities. All samples were subjected to visual and physical inspection while 171 samples were subjected to MiniLab analysis. All samples complied with the parameters for visual and physical inspections. Similarly; all samples that were analyzed using MiniLabs complied with specifications for all the test parameters analyzed. A total of 72 samples were subjected to compendial testing at the National quality control laboratory (NQCL) and all except one sample complied with specifications for all the test parameters analyzed. The sample that failed to comply is Enril-5 (Enalapril 5 mg) , batch No. KN532 which is manufactured by Prism Lifesciences Limited, India. The product failed assay test ( 81.5%, while the specification limits are 90.0 – 110). The PPB initiated immediate recall of the product from the Kenyan market.

The continuous monitoring of the quality of HPTs in the Kenyan market is critical in ensuring and assuring their safety and efficacy and hence achieving desirable patient outcomes as well as enhancing confidence in the healthcare delivery system.

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