Importance of Pharmacovigilance

Some of the terms used in drug safety can vary in how the terminologies are interpreted and used. For instance:

Adverse Drug Reaction

In the pre-approval Pharmacovigilance institute of the drugs’ clinical experience with a fresh medicinal product or its usages, specifically as the therapeutic dose or doses might not be established, all unintended and noxious responses to the medicinal product associate with any of the does should be considered as the adverse drug reaction.

Adverse event

An adverse event or AE can be any unintended and unfavourable sign, including the abnormal laboratory finding, symptom or the disease temporarily related to the medicinal product’s use whether or not considered associated with the medicinal product.


Assessment of the favourable or beneficial and unfavourable outcomes of undertaking a particular course of action the medicinal action can contribute to the final evaluation of the perks of the drugs.

Causal relationship

Causal relationship or assessment is the method for assigning the probability of the causation to a suspended adverse reaction of the drug.

Clinical trial

Clinical trial or study is the investigation into the human subjects that is intended with the purpose to verify or discover the pharmacological, clinical or pharmacodynamics of an investigational product or to identify any of the adverse reactions of the investigational product.

Control group

Control group or cohort studies usually identify and compare the exposed patients to the unexposed patients or to the patients that receive different exposure from the use of the drug.

Dechallenge and Rechallenge

Dechallenge refers to the stopping of the drug generally after the adverse event or at the termination of the planned treatment. Rechallenge refers to the re-commencement of the similar drug after its usage has been stopped generally for adverse event.


The effectiveness of drugs examines the trends in the disease events over the time across the various geographical locations and then correlates them with the trends in the putative exposures like the rates of the utilisation of drug.