Pharmacovigilance
Department of Pharmacovigilance and Clinical Trials (PVCT)
Overview
The Department of Pharmacovigilance and Clinical Trials (PVCT) is tasked with monitoring the safety of all medical products registered for use in Botswana. The department ensures that approved medicines, medical devices, and other regulated products continue to meet safety and quality standards throughout their lifecycle.
Pharmacovigilance
Pharmacovigilance deals with safety monitoring of medical products that have been approved for use in the market.
Responsibilities
Ensure the safety and efficacy of products to protect public and animal health.
Evaluating the benefit-risk of medical products.
Risk management and implementation of safety measures such label changes, or public warnings, to protect public health.
Promoting medicine safety through stakeholder engagement, education and communication.
Scope
Processes
Scope
The scope of pharmacovigilance activities includes monitoring of the safety of:
- Human medicines
- Vaccines
- Biological products
- Veterinary medicines​
- Medicals Devices​
- Cosmetics
Process Automation
The following are available on our brims public portal:
- Adverse Event Reporting (report any discomfort from use of a medical product)
- Promotional Materials (submit your advert application here for review and approval by the Authority)
- Periodic Safety Benefit-Risk Assessment (Submit your annual safety report here)
- National Medicines Information Center (Curious about your medication? Pose a question here)
Frequently Asked Questions FAQ
What is pharmacovigilance?
Pharmacovigilance is the science and activities used to monitor the safety of medicines and vaccines. It helps identify, assess, and prevent harmful effects that may occur when medicines are used.
What is an adverse drug reaction (ADR)?
An adverse drug reaction is an unexpected or harmful effect that happens after taking a medicine. It can happen even when the medicine is used correctly or if taken in the wrong way such as taking too much or by accident.
What types of medicines are monitored through pharmacovigilance?
BoMRA monitors the safety of all registered medicines, including prescription medicines, over-the-counter medicines, vaccines, herbal medicines and traditional medicines.
Who can report a suspected adverse drug reaction?
Anyone can report a suspected adverse drug reaction, including patients, caregivers, doctors, nurses, pharmacists, and other healthcare professionals.
What is reported?
All suspected adverse events including known and unknown adverse events, serious and non serious events, common side effects, severe events, events that resulted from medication errors, lack of efficacy and abuse/misuse of medication.
Why should I report a suspected adverse reaction?
Reporting helps BoMRA identify medicine safety problems early and take action to protect patients. Your report may help prevent harm to others.
Can I report a reaction even if I am not certain the medicine caused it?
Yes. You do not need to be certain that the medicine caused the reaction. If you suspect a medicine may have caused a problem, you should report it.
What happens after I submit an ADR report?
BoMRA reviews the information provided and may contact you if additional details are needed. The report is assessed and added to the medicine safety database for monitoring and analysis.
Will my personal information remain confidential?
Yes. All personal information is treated confidentially and is protected in accordance with applicable laws and regulations.
How does BoMRA use ADR reports?
BoMRA uses ADR reports to identify safety concerns, monitor medicine risks, investigate potential safety signals, and take appropriate regulatory actions when necessary.
How does BoMRA communicate new medicine safety information to the public?
BoMRA communicates important safety information through safety alerts, Dear Healthcare Professional Letters and the Pharmacovigilance-Newsletter published on the website and social platforms.
How do I report a suspected adverse drug reaction?
You can report a suspected adverse drug reaction by completing the e-reporting form available on the BoMRA website or by submitting a report through your healthcare professional. You can also report using the downloadable Mobile App (MedSafety App)
What if I do not have all the information when submitting a report?
You should still submit the report. BoMRA can assess the information available and may contact you if additional details are needed.
Can I submit follow-up information after making a report?
Yes. If you receive new information after submitting a report, you can provide additional details to BoMRA as a follow-up report.
Should I report known side effects that are already listed in the package insert?
Yes. Reporting known side effects helps BoMRA monitor how often they occur and identify any changes in their frequency or severity.