INOPP Forum
Pharmacovigilance Requirements in Botswana
Quote from VigiServe Admin on November 28, 2020, 8:38 AMPharmaceutical 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
https://youtu.be/zL_C9ChY3HA
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
Quote from VigiServe Admin on April 28, 2021, 2:16 PMGuidelines on Good Distribution Practices of Pharmaceutical Products - IL-IL-P01-G03 - Iss1
Guidelines on Good Distribution Practices of Pharmaceutical Products - IL-IL-P01-G03 - Iss1
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Quote from VigiServe Admin on April 28, 2021, 2:23 PMRisk 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.
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.
Quote from VigiServe Admin on April 7, 2022, 10:32 AMRisk Based Post Market Surveillance Guideline of Medicines in Botswana PCT-PMS-P03-G01 Iss1
Risk Based Post Market Surveillance Guideline of Medicines in Botswana PCT-PMS-P03-G01 Iss1
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Quote from VigiServe Admin on April 7, 2022, 10:34 AMPV HCPs Reporting PCT-PV-P01-G01 Iss 1
PV HCPs Reporting PCT-PV-P01-G01 Iss 1
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