17/03/2021
Nairobi, March 17, 2021 – Health CAS, Dr Rashid Aman, today launched an upgraded version of the Pharmacovigilance Electronic Reporting System (PvERS II) to strengthen safety and quality monitoring of Health Products and Health Technologies in Kenya.
The new system hosted by the Pharmacy and Poisons Board (PPB) is a suite of software applications for collecting and processing of information on suspected Adverse Drug Reactions (sADRs), suspected Poor Quality Medicinal Products (sPQMPs), Adverse Events following Immunization (AEFIs), Medication errors, Incidences following use of a Medical device, and suspected Blood and Blood Products reactions.
Dr Aman said the new system will be able to receive reports from all products regulated by the PPB, & see improved quality of reports to ensure causality assessment and signal detection are performed promptly to provide data for evidence-based decision making at policy level.
“This system is timely and I call upon all stakeholders to support this initiative as we strive to ensure that Mwananchi is using quality, safe and efficacious Health Products and Health Technologies,” said Dr. Rashid Aman, when he launched the system in a virtual meeting today.
He said the government is committed to providing Kenyans with safe, quality and efficacious Health Products and Health Technologies and is looking forward to great outputs from the upgraded system especially during this time when the country is still fighting the COVID-19 pandemic.
“The country is set to roll out the COVID-19 vaccines, through the Emergency Use Authorization program, this underscores the need to have a system that can quickly and effectively detect and respond to any safety concerns that may arise,” he said and lauded the Pharmacy and Poisons Board for achieving such a milestone, notwithstanding that PPB is the Regional Centre of Excellence in Pharmacovigilance in the Region.
He added that with the increasing access to Health products and Health technologies, there is greater need to develop/strengthen the vigilance and surveillance systems for patient safety and thus collaborative efforts between different stakeholders is key.
The PPB Chief Executive Officer, Dr. F. Siyoi, revealed that through the support of the Management Sciences for Health, the Pharmacovigilance Electronic Reporting System (PvERS) has been in operation since the year 2013 and has seen the collection of over 14,000 reports on individual case safety reports and over 1000 suspected quality defect reports.
“These reports have been used to inform policy change, review of treatment guidelines and various regulatory actions,” he noted and acknowledged the Management Science for Health for their technical and financial support in the development of the first version of the PvERS and the World Health Organization for availing the seed fund to support part of the PvERS II particularly the vaccines safety monitoring component.
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