Staff Writer
Zimbabwe is strengthening its systems for monitoring the safety of medicines and vaccines through the African Union Smart Safety Surveillance (AU-3S) Project, with the Medicines Control Authority of Zimbabwe (MCAZ) leading efforts to improve pharmacovigilance and patient safety.
MCAZ, which serves as Zimbabwe’s National Pharmacovigilance Centre, convened stakeholders from across the health sector for a consultative workshop held under the AU-3S Project, supported through an African Union Development Agency (AUDA-NEPAD) grant.
The workshop brought together stakeholders to review progress made under the project, share findings and discuss measures to further strengthen the country’s systems for monitoring, reporting, investigating and managing adverse drug reactions (ADRs) and adverse events following immunisation (AEFIs).
MCAZ said pharmacovigilance was an important component of protecting public health because it enabled authorities to continuously monitor the safety of medicines and vaccines once they were in use.
The authority said its role as the National Pharmacovigilance Centre included coordinating national pharmacovigilance activities and collecting, assessing and monitoring safety information on medicines and vaccines to support regulatory and public health action.
According to MCAZ, one of the major achievements under the AU-3S Project was the enhancement of pharmacovigilance capacity through Training of Trainers programmes conducted across all 10 provinces.
The training was intended to strengthen the capacity of healthcare professionals and other relevant personnel to monitor and report safety concerns associated with medicines and vaccines.
MCAZ said the project had also assessed barriers faced by healthcare professionals when reporting ADRs and AEFIs.
The assessment resulted in recommendations aimed at improving the quality, completeness and timeliness of safety reports submitted through the pharmacovigilance system.
“Improved safety reporting is critical to ensuring that potential safety concerns are identified, assessed and appropriately managed,” MCAZ said.
The authority also highlighted the strengthening of Hospital Medicines and Therapeutics Committees (HMTCs) as another key area of intervention.
MCAZ said functional HMTCs were an important component of medicines safety and the promotion of rational medicine use within health facilities.
A key objective of the initiative is to support the establishment of functional HMTCs in public and private hospitals and clinics, including the adoption of signed Terms of Reference (ToRs) to guide their operations.
MCAZ said strengthening these committees would help improve medicines safety and monitoring at facility level.
The project has also focused on strengthening safety surveillance at hospitals and clinics to ensure that monitoring of medicines and vaccines takes place closer to where they are prescribed, administered and used.
MCAZ said monitoring and evaluation visits were undertaken to assess the impact of project interventions. These included assessments using VigiGrade completeness scores and activities related to signal management.
The authority said the findings from the project, together with recommendations arising from the interventions, were presented for consideration and discussion during the stakeholders’ workshop.
MCAZ said the feedback from stakeholders would help inform the continued strengthening of Zimbabwe’s pharmacovigilance system.
The authority explained that pharmacovigilance remained necessary even after medicines and vaccines had undergone regulatory assessment before being placed on the market.
“Safety monitoring continues throughout the use of medicines and vaccines,” MCAZ said, noting that ongoing surveillance could help identify emerging safety concerns and facilitate appropriate regulatory and public health action.
ADRs are unwanted or harmful reactions suspected to be associated with the use of medicines, while AEFIs refer to medical events that occur following immunisation and require assessment to determine their cause.
MCAZ said timely reporting of suspected adverse events was essential because the information received from healthcare professionals, patients and other stakeholders could contribute to the detection and assessment of potential safety signals.
The authority emphasised that patient safety was a shared responsibility involving healthcare professionals, patients, caregivers, pharmaceutical companies and other stakeholders.
MCAZ urged stakeholders to play their part by reporting suspected adverse events and supporting the continuous monitoring of medicines and vaccines.
The authority said a stronger pharmacovigilance system would enhance Zimbabwe’s ability to identify potential risks, assess emerging safety concerns and support evidence-based regulatory and public health decisions.
MCAZ reaffirmed its commitment to protecting public health through effective monitoring of medicines and medical devices and strengthening systems that ensure patients have access to quality, safe and effective healthcare products.