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Report on Rapid Results Initiative of Post Market Surveillance of Selected Health Products and Health Technologies in Kenya

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Report on Rapid Results Initiative of Post Market Surveillance of Selected Health Products and Health Technologies in Kenya

The post market survey of selected health products and technologies was a collaborative study between the Pharmacy and Poisons Board (PPB), the National Quality Control Laboratory (NQCL) and the Kenya Medical Supplies Authority (KEMSA), under the auspices of Ministry of Health, through a rapid results initiative approach. The survey targeted health products and technologies with high public health impact, and those that are widely used by the public. The products chosen were male latex condoms, syringes, antibiotics, analgesics, anti-hypertensive, anti- diabetics, anti-helminthic, contraceptives, hematinic and erectile dysfunction products.

The main objective of the survey was to assess the quality of selected health products and technologies circulating in the Kenyan market. Specifically to determine registration status, storage conditions at the site of collection and conduct laboratory analysis.

This was a descriptive cross-sectional survey that employed quantitative data collection methods. Products sampled were drawn from eleven (11) different active pharmaceutical ingredient (API) categories as well as two (2) medical device categories. The study covered both public and private health facilities including KEMSA main supply chain center, hospitals, distributors/wholesalers and retail pharmacies in seventeen (17) counties. The counties included the four pilot counties earmarked for universal healthcare coverage (UHC) rollout.

A total of 785 samples were collected, which represented 250 registrable products of which 215 (86%) were found to be registered.

The storage conditions of the products was analysed and 530 of the collected samples were found to be stored within manufacturers‟ recommended storage temperature conditions while 108 were found to be stored in facilities where the recorded temperatures were outside the manufacturers‟ specifications. The remaining 147 samples did not have explicit manufacturers‟ storage specifications.

Two hundred and eighteen (218) out of the 243 secondary samples that were subjected to laboratory testing complied with all the test parameters evaluated. The number of pharmaceutical samples analysed was 203 while 40 were medical devices. Out of the 203 pharmaceutical product samples, 98.2% complied with the specifications for uniformity of weight; 92.6% complied with dissolution test requirements while 96.1% samples met specifications for content of active ingredient. All the samples complied with the test requirements for identification and pH (where applicable).

For medical devices, 90% complied with all the various test parameters evaluated while 5% did not meet at least one of the requirements for the dimensions tests and a further 5% failed to comply with specifications for the freedom from holes test.

Attached Files

RRI PMS final June 2019.pdfDownload



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