Pharmacovigilance System in Zambia
The Zambia Medicines Regulatory Authority (ZAMRA) is mandated by law to undertake pharmacovigilance activities in Zambia. The National Pharmacovigilance Unit (NPVU) under ZAMRA manages the day-to-day activities of the pharmacovigilance programme. The Unit receives reports from healthcare workers, the pharmaceutical industry as well as members of the general public.
What is pharmacovigilance?
Pharmacovigilance – Monitoring, assessing and understanding side effects, or other drug related problems. It can also be defined as a science relating to detection, assessment, understanding and prevention of adverse effects or any other medicine related problems.
Passive and Active Pharmacovigilance
Passive Pharmacovigilance is largely based on voluntary spontaneous reporting of ADRs with limited information on patient characteristics where as active Pharmacovigilance involves electronic records containing detailed information about patient population. The Ministry of Health through ZAMRA has been conducting active pharmacovigilance in relation to antiretroviral drugs (ARVs) that are introduced in Zambia.
Why pharmacovigilance in Zambia
- To monitor new specific toxicities
- To identify signals of previously unidentified ADRs to medicines
- To estimate rates of events so that safety of medicines can be compared and informed choices made
- To determine safely in children and pregnancy
- To identify events that are likely to affect adherence to treatment
How and where to report
The Adverse Drug Reaction Reporting Forms may be obtained from ZAMRA offices, health facilities, District and Provincial Health Offices. A copy of the form can also be downloaded from the ZAMRA website. The completed report form should be sent to ZAMRA with copies to the district or provincial health offices. Reports can be sent using the following:
- Hard-copy ADR Report Forms available at the health facility
- Telephone +260 211 432 356 / 50; WhatsApp: +260 956 521 094
- Online e-reporting form on the ZAMRA website and select report online.
- Mobile App (“Med Safety” available on Play Store®️ (Android devices) or iStore ®️ (iOS devices)
- Email to npvu@zamra.co.zm (preferably with attachment of a copy of the completed ADR report form).
- Forms can be downloaded from the ZAMRA website
When to report
ANY suspected ADR should be reported AS SOON AS POSSIBLE. Report even if you are not certain the product caused the suspected ADR or do not have all the details. If possible, report while the patient is still in the health facility as this gives a chance to the reporter to clear any ambiguity by further probing, re-questioning or examining the patient.
Contact Details for the National Pharmacovigilance Unit
For any queries or clarifications that you may have concerning pharmacovigilance please contact the NPVU with your comments/questions at:
National Pharmacovigilance Unit (NPVU)
Zambia Medicines Regulatory Authority (ZAMRA)
P O Box 31890
Lusaka
Zambia
Tel: +260 211 432 356 / 50
WhatsApp: +260 956 521 094
Email:npvu@zamra.co.zm or pharmacy@zamra.co.zm
Website: www.zamra.co.zm