The word Pharmacovigilance is formed by combining two words, Greek and Latin. The Greek word Pharmakon means ‘medical substances’ and the Latin word Vigilaremeans ‘to keep watch’. Literally, it means scrutinizing the use of medicines, drugs and medical practices. It refers to practices, actions, and steps taken to monitor drug administration in clinical trials.
Pharmacovigilance has been defined by the World Health Organization (WHO) as “The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problem.”
Clinical trials for drugs or medicines for conducting clinical research worldwide are carried with the consent of patients called subjects. This would be impossible without the active involvement of all participants throughout the full duration of the study. It, therefore, becomes crucial for the medical community; drug specialists and clinical research companies to provide correct information to create awareness and impart knowledge about the drugs. They also need to communicate possible benefits, short-term and long-term risks and any possible adverse side-effects. Pharmacovigilance plays a significant role in lessening risks while conducting clinical trials for research or studies.
The objectives of Pharmacovigilance are enhancement of patient safety and care while using medicines, drugs or any medical interventions. The practices employed to achieve these are termed as Pharmacovigilance Practices or GVP.
History: Thalidomide Tragedy (1960)
Pharmacovigilance became crucial after Thalidomide tragedy in the year 1960. The drug ‘Thalidomide’was promoted by doctors and extensively marketed by companies in 1960 in 46 countries to prevent nausea experienced by mother’s during pregnancy. This resulted in more than 20,000 cases of deformed infants. It prompted governments all over the world to take precautionary action. After this incident, there was an amendment to Federal Food, drug & Cosmetic Act USA in 1962. World Health Organization (WHO) started the Programme for International Drug Monitoring in 1968. Both these steps were for the safety of drug and medicine administration to patients anytime for clinical trials.
Objectives of Pharmacovigilance Practices (GVP)
- Improve patient care and safety in use of medicines, and medical and paramedical interventions.
- It also aims to improve public health and safety in relation to use of medicines.
- Complete assessment of benefits, effectiveness and risk of medicines used.
- Encourage a safe, rational and effective use of medicines.
- Promote understanding, education, clinical training and effective pharmacovigilance communication to medical professionals and public.
Requirements for Effective Pharmacovigilance Practices
Here is a list of some essential elements for beneficial pharmacovigilance practices are as follows.
- Acquisition of complete data
- Adverse event reports
- Adverse reaction report
- Clinical course of events
- Baseline patient characteristics
- Details of therapy
- Diagnosis of events
Best Pharmacovigilance Practices for Optimum Results
Good Pharmacovigilance practices should consist of the following important factors.
- Evaluation of Risk Benefit Balance
- Collection of Customer Specific data
- Increase the probability of beneficial effects of a drug on subjects than the probability of adverse effects
- Maintain good reporting practices for effective risk management
- Concentrate of Signal investigation by collecting all information on any new or unknown drug effects
- Making Pharmacovigilance certificationmandatory for and companies providing clinical trial and pharmacovigilance services
- Good reporting practices
- Signal investigation via observational studies
- Interpreting safety signals
- Randomized clinical trials
- Ethical and social aspects of drug use
Pharmacovigilance target’s to protect patients by creating awareness, providing knowledge to professional communities, including drug specialists,’ patients and their families to reduce any risk by optimizing drug safety. It is a general information to topics and not legal or professional advice.