2014—2015
The Challenge
To protect its citizens from falsified, substandard, and unapproved medicines, Kenya's Pharmacy and Poisons Board (PPB) established its first program to monitor the quality of antimalarial medicines in 2010 with PQM's support. Based on its success, the PPB wished to expand the MQM program to other high-risk sites, including its ports of entry.
Our Strategy
To help PPB accomplish this, PQM provided extensive quality control training to health workers at PPB, the National Quality Control Laboratory, and the National Malaria Control Program. The trainings enhanced skills and knowledge in post-marketing surveillance of medicines and use of innovative, field-based technologies, called GPHF-Minilabs™, to evaluate medicines quality at the additional sentinel sites.
Results
PPB increased the number of sentinel sites from 5 to 11 sites, including ports of entry. PPB evaluated the quality of antimalarial samples collected at 11 sites and took regulatory actions on failed samples.
Anticipated Outcomes
Expanded post-marketing surveillance will enable PPB to more effectively monitor the quality of essential medicines and reduce the amount of falsified, substandard and unapproved medicines in circulation. This will strengthen PPB’s core regulatory function of ensuring medicines are quality, safe and effective, as well as strengthen Ethiopia’s overall health system and improve public health.
About PPB
The Pharmacy and Poisons Board is the national regulatory authority of Kenya responsible for regulating the manufacture, trade, distribution, sale, and use of medicines intended for public use. The PPB aims to protect citizens by implementing regulatory measures that ensure all medicines, chemical substances, and medical devices meet the highest standards of quality, safety, and efficacy.