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

The Pharmacy and Poisons Board in collaboration with Ministry of Health and the national PV/PMS TWG, with the support of the Global Fund implemented the 7th round of post-marketing surveillance of health products used management of Malaria, HIV and TB in the public health programs.

The counties and healthcare facilities where samples were collected from were determined based on risk-ranking using an excel based MedRS tool (Counties with highest risk of substandard health product were considered). The following 26 counties were selected; Bungoma, Busia, Embu, Garissa, Homabay, Kajiado, Kakamega, Kericho, Kiambu, Kirinyaga, Kisumu, Kwale, Machakos, Makueni, Meru, Migori, Mombasa, Muranga, Nairobi, Nyeri, Samburu, Siaya, Tharaka-Nthi, Turkana, Uasin-Gishu and Wajir. The facilities were drawn from public, private, faith-based and NGO sectors.

A total of three hundred and thirty-four (334) samples were subjected to level one screening which entailed product information review, visual and physical inspection of the products. A total of two-hundred and three (203) samples were subjected to compendial analysis at the NQCL.

The screening (level 1 testing) revealed that all the samples complied with physical appearance and labeling requirements as per their market authorization specifications while all the samples subjected to compendial testing complied with all specifications for the test parameters analyzed.

The continuous monitoring of the quality of HPTs used in public health programs 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.