Monitoring quality, safety and efficacy of medical products and technologies is critical in detection and prevention of substandard products.
Pharmacy and Poisons Board (PPB) Chief Executive Officer, Dr Fred Siyoi, said strengthening of pharmacovigilance and market surveillance of health products functions were key as they impacted on patient safety and health of the public.
Speaking during Kenya pharmacovigilance and post-marketing surveillance stakeholders’ forum virtual workshop, Dr Siyoi said that PPB has established a robust pharmacovigilance and post-marketing surveillance system with one of the components included being Pharmacovigilance Electronic Reporting System (PvERS) that provides a platform to both members of the public and healthcare professionals to report medical products suspected to be of poor quality.
PvERS that PPB has been processing information on suspected Adverse Drug Reactions (sADRs) and Medicinal Products of Poor Quality tendancies.
“We need pharmacovigilance and post-marketing surveillance now more than ever as we experience the COVID 19 pandemic,” he said noting that the deployment of multiple types of vaccines in Kenyan population requires heightened safety monitoring and efficacy of the vaccines.
To this end, Dr Siyoi said that the PPB in collaboration with National Vaccines and Immunization Programme and development partners has initiated targeted spontaneous reporting (TSR) activity in fourteen (14) Counties aimed at accelerating detection and reporting of Adverse Events following immunization with COVID 19 vaccines.
The Counties are Kiambu, Kakamega, Kisumu, Kilifi, Kajiado.Nairobi, Uasin Gishu, Nyeri, Meru, Garissa, Mombasa, Nakuru Machakos, and Turkana.
“We live in the era of big data, artificial intelligence and machine learning which heralds immense opportunities for safety data collection and analysis and use of data for decision making,” the CEO said.
He urged all stakeholders and key players in Pharmacovigilance and Post-Marketing Surveillance to utilize information technology and innovation for strengthening of PV/PMS activities.
Dr Siyoi further called upon the experts to generate ideas and innovations that would help move Pharmacovigilance and Post-Marketing surveillance to the next level.
He said some of the focus areas should include strengthening collaborations with Public Health Programmes, County Health Departments and other key organizations to facilitate awareness creation on adverse drug reaction and adverse events detection, reporting and management, evaluation of the current reporting system and its effectiveness and new strategies that can be employed to increase the reporting rates.
In addition, Dr Siyoi said targeting of the public for awareness through Information, Communication and Education (IEC) materials is equally important for risk and safety communication.
“Research on consumer reporting medium preferences will be useful in order to target reporting tools and pharmacovigilance messaging based on reporter preferences”, he added.
The Pharmacovigilance (PV) and Post-Marketing Surveillance (PMS) stakeholder engagement meeting PPB comes at a crucial time when the world is grappling with effects of the COVID 19 Pandemic.
World Health Organization (WHO) has also introduced a dashboard to support regulatory processes for the introduction and the monitoring of COVID-19 vaccines safety through consolidating in a single tool information on the various components such as dosage and administration schedule, indications and contraindications, storage and logistics, clinical studies and effectiveness, pre- and post-authorization safety, monitoring, and references.
By Wangari Ndirangu
