Pharmacovigilance (PV), also known as drug safety, is the pharmacological science that is related to the detection, collections, assessment, monitoring, and prevention of adverse drug effects with pharmaceutical products or any drug-related problem. The word “pharmacovigilance” is derived from two Greek words; Pharmakon (for drug) and Vigilare (to keep watch). As such, pharmacovigilance heavily focuses on the detection of adverse drug reactions associated with the use of medicinal products, Adverse drug reactions ADRs, which is defined as any response to a drug which is noxious and unintended, including lack of efficacy.
Why there is a need for Pharmacovigilance?
Pharmacovigilance is all about the safer and more effective use of medicines for everyone, young and old. Therefore, before the drug is being approved for marketing authorization, clinical trials are employed as a gold standard method in evaluating the safety of the drug, efficacy of the drug on a particular disease, monitor and identify side effects associated with the drug. Due to the nature of clinical trials, it is impossible to determine the complete safety profile of the product in pre-marketing studies as still some of the adverse reactions may remain undetected during studies due to varying reasons, some of which are;
- Clinical trials are often carried out on a limited number of subjects (Patients) usually Less than 10,000 compared to the end number of potential users of the medications.
- Limited periods of the trials allow only the detection of short terms ADRs and left long term manifested ADRs to be undetected.
- Vulnerable people (pregnant women and childbearing age individuals) are also excluded even though they may be potential users of the medicine.
- People of extreme ages (children and old aged) are often excluded during clinical trials unless the drug is to be used for such populations.
- People with multiple diseases (comorbidity) are also excluded.
- In clinical trials, only a single medication is given at a time compared to the multiple drugs a patient might take at the hospitals’ settings.
- Clinical trials are done in a controlled environment with constant monitoring compare to when the drug is released to the market, in which various factors including the environmental factors that could affect the drug.
Aims of Pharmacovigilance:
The objective of pharmacovigilance is the reduction of the frequency and the severity of adverse effects of drugs while maintaining or, better, improving their efficacy. The aims include but not limited to;
- Ensure the rational and safe use of medical drugs
- Encourage their safe, rational, more effective, and cost-effective use.
- Educating and informing patients.
- Assessment and communication of risks and benefits of the drug.
- Promote understanding, education and clinical training in Pharmacovigilance and its effective communication to the public.
- Improve patient and public healthcare and safety concerning the use of medicines.
- Contribute to regulatory assessment of benefit, harm, effectiveness, and risk of medicines.
Abubakar Mukhtar BPharm, MSc. (In view)