Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems, generates knowledge to facilitate the rational use of medicines.
When a medicine is first marketed, there is limited information on adverse drug reactions (ADRs), especially in pediatrics, where medicines are less likely to have been extensively studied. Knowledge in drug safety is built up over time when more (in number, and more heterogeneous) patients are treated than were studied in the randomized controlled trials preceding the marketing of a medicine.
A well-organized system of pharmacovigilance is essential to ensure the safety of medicinal products. Before recommending the granting of a marketing authorization the BOMRA ensures that a system of pharmacovigilance is in place through scrutiny of the pharmacovigilance system, After granting an authorizations the Authority scrutinizes procedures, assesses safety reports and conducts pharmacovigilance inspections in order to:
- Regulate and provide drug information to the public and to coordinate and implement pharmacovigilance
- Receive, capture, analyses and recommend action on suspected adverse drug reactions reports
- Carry out post market surveillance on drugs
- Approve advertising and clinical trials of new, current and variant medicines and related medical products
- Train, mentor and help mentor health workers on Pharmacovigilance
- Develop thorough knowledge of medicines and flag up early warning signs of adverse effects of medicines
- Carry out and complete safety audits
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.
Benefits and Risks of Medicines
Most people take medicines without suffering any unwanted side effects; however, all medicines can cause problems. For a medicine to be considered safe, its expected benefits should be greater than the risk of harmful reactions (side effects).
This is known as a positive Benefit-Risk balance. Information on the risks and safety of medicines often becomes known after the product is placed on the market (for more information visit our offices of contact BoMRA PV team on how we monitor the safety of medicines and therefore the Benefit-Risk balance may change throughout a product marketed life.
Risk Management Plan
Our PV has got a a Risk Management Plan in place, this is designed to identify, characterize, prevent, or minimize risks related to the medicinal products; to assess the effectiveness of those interventions; and to communicate those risks to health care professionals and patients.
Routine pharmacovigilance include includes the 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 Additional Risk Minimization Measures could include: educational materials about the medications and its 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.
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A side effect means a response to a medicine in humans or animals, which is unwanted and unintended. It includes lack of efficacy and can occur at any dosage and can also result from overdose, misuse or abuse of a medicine.
Important Reporting Information
If possible, you should provide the following information when making your report:
- Information on the person who has had the side effect (such as age and sex)
- The description of the side effect
- The dose and the name of the medicine suspected to have caused the side effect (brand
name as well as active ingredient)
- The batch number of the medicine (found on the packaging)
- Any other medicines being taken around the same time (including non-prescription medicines, herbal remedies and contraceptives)
- Any other health conditions that the person who experienced the side effect may have
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