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Pharmacovigilance Requirements in Botswana

Pharmaceutical companies and practitioners have specific obligations with regards to pharmacovigilance. BoMRA ensures patient safety by communicating with healthcare professionals and by monitoring the activity of Marketing Authorization in order to assess whether they are compliant with pharmacovigilance obligations.

What should be reported?
  • All side effects should be reported. Report any side effect of ANY medicines and/or vaccines, whether prescribed by a doctor or bought without a prescription

  • You can also report problems with; suspected pharmaceutical defect, lack of efficacy, counterfeits/fake medicines, medication errors etc

  • Report all suspected ADRs associated with drug-drug, drug-food or drug-food supplements (including herbal and complementary products) interactions

  • Report when there is a lack of efficacy or when suspected pharmaceutical defects are observed

How to Report Side Effects

  • Contact your healthcare provider e.g. doctor, nurse, pharmacist, vet etc

  • Your healthcare provider will fill out the ADR form and send it to BoMRA on your behalf

Report Adverse drug reactions (ADR) online

Contacts Details Postal Address Botswana Medicines Regulatory Authority Private Bag 2 Gaborone Station Botswana

Email: reportadr@bomra.co.bw Tel: +267 373 1753 Fax: +267 318 6254 Toll-Free: 0800 600 216

 

 

Guidelines on Good Distribution Practices of Pharmaceutical Products - IL-IL-P01-G03 - Iss1

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Risk Management Plan

This is designed to identify, characterize, prevent, or minimize risks related to the medicinal products; assess the effectiveness of those interventions; and communicate those risks to health care professionals and patients.

Routine pharmacovigilance include includes safety evaluations within clinical trials and the monitoring and reporting of spontaneous adverse events post-authorization. Routine risk management activities include ensuring that suitable warnings are in all product information and careful labelling/ packaging of the medicine.

Additional pharmacovigilance activities involve:

  • Active surveillance
  • Epidemiology studies
  • Further clinical studies
  • Drug utilization studies

Additional risk minimization measures could include: educational materials about the medications and their indications (patient information brochures, visual aids, doctors' prescribing guides/checklists, pharmacist dispensing guides/checklists, direct healthcare professional communication letters), training programs (for patients, pharmacists or doctors) and restricting the use of the medicine for example by restricting access to prescription only.