If one were to describe the relationship between drug safety and pharmacovigilance; the most concise way of describing it is by calling them as two sides of the same coin. The aspects of drug safety and pharmacovigilance are intricately and inseparably bound together. The whole purpose of pharmacovigilance is the assurance of drug safety. It is precisely to ensure drug safety, more than anything else, that pharmacovigilance has come into being as a discipline.
Pharmacovigilance (PV in drug industry parlance) is a means to ensuring drug surveillance across the entire process, right from procuring of raw materials to consumption and the effects of consumption. So, pharmacovigilance has to be implemented right across the chain of activities that go into drug manufacturing. It has to ensure compliance with regulation at all stages, namely before the product is manufactured, during the manufacture, and after it enters the market. It is an indispensable aspect of a Quality System, and plays a central role in inspections and audits.
Drug safety and pharmacovigilance are tied together at the level of regulatory bodies. There are different PV rules for different markets. For instance, while the FDA has its own set of PV guidelines; the EU has its own. A clinician or drug company involved in drug safety and pharmacovigilance has to be aware of the regulations in the markets into which the company’s products are sold and has to abide by them.
In order to ensure drug safety, pharmacovigilance is carried out by agencies and governments across the globe in accordance with strict guidelines. Drug safety and pharmacovigilance pair together in a number of areas. These are some of them:
Clinical trial:The work of ensuring drug safety through pharmacovigilance starts at the stage of the clinical trial itself. Pharmacovigilance ensures that drug safety is built into the drug right at the clinical trial stage. PV sets out a number of processes and methods by which a pharmaceutical company involved in clinical trials has to go in order to ensure drug safety.
Marketing:PV is set out in the marketing stage of a drug, too. Drug safety brought about by pharmacovigilance is to be implemented at the marketing stage of the drug, including processes for its safe storage, handling and transit. Throughout all these stages, drug safety and pharmacovigilance guidelines are to be strictly implemented.
Governmental drug distribution:Drug safety and pharmacovigilance are also built in by governments in their interactions with each other. For instance, when the government of a country or an agency such as the UN is shipping drugs to another country to support a health program; utmost drug safety is ensured through the principles of pharmacovigilance.
Drug safety and pharmacovigilance in disease management:Several governments across the world, along with international agencies conduct disease control management or emergency handling across the globe, especially in developing countries. Pharmacovigilance is the means to ensure that the drugs administered at these programs are safe for human consumption.
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