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PPB upgrades system for reporting adverse effects of medicines and vaccines – March 17, 2021

PPB upgrades system for reporting adverse effects of medicines and vaccines

Nairobi, March 17, 2021 – The Pharmacy and Poisons Board today launched an upgraded version of thePharmacovigilance Electronic Reporting System (PvERS II) to strengthen safety and quality monitoring of Health Products and Health Technologies in Kenya.

The new system 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.

The new system is able to receive reports from all products regulated by the PPB, it will 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, the Chief Administrative Secretary, in the Ministry of Health, 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.

He added that in order to continuously align with best international standards and offer better usability to the stakeholders, there was need to upgrade the system to ensure it is able to collect data on all Health Products and Health Technologies that are given Market Authorisation by PPB.

“The new system will also be more interactive and allow users at a snap shot to view summaries of what is reported to PPB,” he noted.

The old system had two reporting forms; one for suspected ADRs (yellow form) and one for poor quality products (pink form). The scope of pharmacovigilance has expanded globally to include safety monitoring of other health products and technologies and more forms have been incorporated to capture information on; Medication Errors (blue form), Adverse Events Following Immunizations (white form), Incidences following use of a Medical Devices (green form) and Haemovigilance reactions due to Blood and Blood Products i.e. (cream-off white form).

The added function of user access rights allows reporters to monitor the progress of their reports, see trends across various counties and seek quick basic summary statistics of the Individual Case Safety Reports Submitted to PPB. One of the key new features is a provision for patient/consumer reporting which is critical to ensure that each and every person is keen on their health and are able to report any concerns that they may have in regards to Health Products or Health Technologies they are exposed to.


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