Kenya Launches Mobile Reporting Tool to Improve Medical Product Safety Monitoring
By Ndinda Kusu, MTaPS Kenya
Establishing pharmacovigilance (PV) is critical for determining a medical product’s safety and efficacy profile. Although the role of PV lies largely within the national medicines regulatory authority, it requires participation and awareness across a wide spectrum of actors from consumers for reporting suspected adverse drug reactions to regulatory bodies for using safety data to inform regulatory actions, policy decisions, and clinical care. Most low- and middle-income countries (LMICs) struggle with weak regulatory capacity, leading to challenges with functional systems to effectively monitor, mitigate, and avert adverse effects of medical products and health technologies.
On April 13, 2022, the Kenya Pharmacy and Poisons Board (PPB) launched a mobile PV electronic reporting system (mPvERS), developed with the support of USAID MTaPS to the PPB Regional Centre of Regulatory Excellence to enhance Kenya’s PV electronic reporting system for stronger safety monitoring in the country. The system developed as an application for both android and iPhone operating systems leverages the extensive and growing use of mobile devices in Kenya, which is higher than in the rest of Sub-Saharan Africa.
The virtual launch attended by Dr. Rashid Aman, the Chief Administrative Secretary for Health and Dr. Fred Siyoi, PPB Chief Executive Officer, drew approximately 400 participants from the Ministry of Health, public health programs, the PPB, the pharmaceutical industry, counties, hospitals, the private sector, faith-based organizations, supply agencies, distributors, the community sector, the Nigeria National Medicines Regulatory Authority, WHO, USAID-funded PQM+ program, and MTaPS.
“This is another great milestone achieved by the Pharmacy and Poisons Board towards the monitoring of quality, safety, and efficacy of health products and technologies in Kenya,” said Dr. Aman lauding the value of the mPvERS tool, which will be used by health workers and the public. Dr. Aman emphasized that consumer reporting is a useful tool in empowering consumers and improving their involvement in managing their own health.
Chief Administrative Secretary for Health Dr. Rashid Aman gives his remarks.
Dr. Siyoi thanked MTaPS for its technical and financial support in the development of the mPvERS platform, saying “The Pharmacovigilance electronic reporting system will go a long way in strengthening reporting and vigilance on safety quality issues for health products and technologies in Kenya both by healthcare providers and the general public. I sincerely thank the USAID MTaPS Program for their technical and financial support in the development of the mPvERS platform.”
The launch of the mPvERS—an integrated, innovative solution to promote patient safety and protect public health—is a significant milestone in the effective use of data for decision making at all levels. The tool leverages mobile solutions and an unstructured supplementary service data (USSD) code, for reporting adverse drug reactions, suspected poor quality medical products and technologies, transfusion reactions, incidents from medical devices, medication errors, adverse events from medical products and health technologies, and adverse events following COVID-19 and other immunizations. The USSD code makes the service more widely accessible with a basic mobile device and has both English and Kiswahili functionality.
The assistance to PPB to strengthen PV is part of MTaPS’ wider support to LMICs to build or strengthen PV systems and develop their capacity to generate, analyze, and use safety data to improve health outcomes and quality of care. The program implements the World Health Organization (WHO) Global Benchmarking Tool as a guiding framework to help countries strengthen their regulatory systems, including establishing a functional PV system.