In layman’s term Pharmacovigilance is drug safety. It is defined as the study and prevention of adverse effects caused due to pharmaceutical products.
Pharmacovigilance was officially introduced in December 1961, with the publication of a letter (case report) in the Lancet by W. McBride, an Australian Doctor who first suspected a causal link between serious fetal deformities (phocomelia) and thalidomide, a drug used during pregnancy.
In view of Pharmacovigilance many drugs are withdrawn from the market or not even brought into circulation for use. The Pharmacovigilance makes it possible to implement quality systems in all pharmaceutical industries that manufacture large quantities of pharmaceutical products. The World Health Organization (WHO) has defined Pharmacovigilance as “The Science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problem”.
Pharmacovigilance plays an important role in the healthcare system by assessment, monitoring and discovery of interactions amongst drugs and their effects in humans. The main object of medicines produced by biotechnical and pharmaceutical companies are to cure, prevent and treat the diseases but there are also risks of adverse drug reactions (ADRs) which may cause serious harm to patients. It is therefore required to monitor each medicine against adverse drug reactions throughout its life cycle, during development of drugs such as pre-marketing including early stages of drug design, clinical trials, and post marketing surveillance.
Why is pharmacovigilance important?
The science of collection, monitoring and evaluating information from healthcare providers and patients is known as pharmacovigilance. It also deals with the adverse effects of medications, biological products, blood products, herbals, vaccines, medical devices, traditional and complementary medicines with a view to recognize information about hazards associated with the products and preventing impairment to patients. The biggest challenge is to maximize drug safety and maintain the confidence level of the users. It should be the responsibility of Pharmaceutical and biotechnical companies to monitor, and also proactively estimate and manage drug risk throughout a product’s lifecycle, starting from development to post-market.
The Pharmaceutical companies invest millions of rupees for the development of drugs that help the patients for better medical treatment as well as bring revenue for the company. Where such huge money is involved to produce drugs for human use, the company will also ensure its safety norms. Once the drug is approved by the regulatory board for marketing it becomes more important for the company to keep monitoring its safety so that any adverse reports can be evaluated and needful action can be taken as per the applicable regulations. The various drug companies have their own dedicated team of professionals who are responsible to track adverse reports on drug utilization, entering the information in various databases, identifying signals and reporting adverse events to regulatory agencies. In the last decade this sector has developed immensely due to strict observance for safety of drugs by various regulatory agencies; which has also resulted in a huge demand for pharmacovigilance professionals.
The Government supports and helps to implement courses in Pharmacovigilance as they are concerned with the detection, assessment, understanding as well as prevention of Adverse Drug Reactions. The research focuses towards the use of data generated from platforms outside the conventional framework such as electronic medical records, biomedical literature, and patient reported data in health forums.
Drug safety is a crucial aspect in the development of new drugs as well as continued marketing of drugs available in the market. The area of drug safety is coming up in a big way in developing countries while scopes are also growing in developed countries. The data management staff works closely with the clinical operations team, biostatisticians, medical writers, regulatory affairs teams and many other functional teams. Data management professionals ensure that the data is managed by means of specialized software such as Oracle Clinical, Medidata Rave etc so that the data is error free, accurate and ready for analysis by biostatisticians. Candidates with qualification in data management can explore careers in contract research organizations, pharmaceutical companies, pharma IT companies etc.
Commonly Used Pharmacovigilance Terms/Definitions
- Adverse drug events (ADEs): Any “untoward medical occurrence” that occurs alongside a drug that has not been conclusively attributed to the use of the drug itself. ADEs encompass side effects and laboratory results.
- Adverse drug reactions (ADRs): Any “noxious and unintended responses” attributed to a drug. ADRs are side effects that are directly caused by the use or discontinuation of a medicine.
- Serious adverse events (SAEs): Adverse drug events that are particularly serious, including those that are life-threatening, lead to congenital abnormalities, result in extended or unexpected inpatient hospitalization, or cause disability. Newly discovered SAEs for drugs on the market require expedited reporting by pharma companies to regulatory authorities.
- Suspected unexpected serious adverse reactions (SUSARs): Adverse reactions that occur which do not line up with the adverse reactions currently outlined in the investigator brochure (before marketing) or product information including the SmPC and PIL (after marketing). Also called unexpected drug reactions.