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After the thalidomide disaster, WHO set up regulations to monitor the quality, efficacy, and safety of drugs as a few drugs were harmful to the patients. Pharmacovigilance (PV) is the science of detecting, assessing, understanding, and preventing adverse effects or any other drug-related problem. The drugs are monitored based on the ADR reports from healthcare professionals to ensure patient safety.
In the early days of drug development, there were no regulations monitoring the quality, efficacy, and safety of drugs. In the late 1950 and early 1960, it became evident that drugs were not only treating diseases but had a negative impact.
Adverse drug reactions (ADRs) were acknowledged as a problem related to drug use. After the thalidomide disaster, authorities all over the world began to set up systems to monitor the safety of drugs. These spontaneous reporting systems were based on the collection of reports of ADRs from healthcare professionals.
The World Health Organization (WHO) recognized the need for global drug monitoring, and in 1968, the WHO Pilot Research Project for International Drug Monitoring started its operation with 10 participating countries to develop a system for the detection of adverse effects of drugs.
Pharmacovigilance (PV), defined by the WHO, is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. The emergence of PV activities and the awareness would play a vital role in ensuring that doctors, healthcare professionals, and the patients have enough information to make an educated decision regarding choosing a drug for treatment and eventually achieving patient safety at large. Every pharmacist or medical professional should know about PV and the methods used to keep up with society’s demands.