Minireview of drug safety and pharmacovigilance

Nawaf Almuntashiri

doi:10.48185/jcnb.v1i1.91

Abstract

Pharmacovigilance or drug safety is defined as science and actions related to diagnosis, evaluation, understanding and avoidance of harmful effects or any other problems related to drugs. Adverse drug reaction (ADR) may be caused by intrinsic factors, extrinsic factors, underlying medical conditions, interactions and wrong usage. Adverse drug reaction (ADR) may be caused by intrinsic factors, extrinsic factors, underlying medical conditions, interactions and wrong usage. ADR causing intrinsic factors include the active ingredients in the drug itself. In Saudi Arabia, the National Pharmacovigilance Center (NPC) was established in March, 2009 as a semi-autonomous department of Saudi Food and Drug Authority (SFDA). The purpose of NPC was to perform early detection of ADR and safe use of drugs. We need pharmacovigilance because animal experiments and clinical trials performed before marketing are insufficient evidence of drug safety.

Highlights

Pharmacovigilance or drug safety is defined as science and actions related to diagnosis, evaluation, understanding and avoidance of harmful effects or any other problems related to drugs
Adverse drug reaction (ADR) causing intrinsic factors include the active ingredients in the drug itself
We need pharmacovigilance because animal experiments and clinical trials performed before marketing are insufficient evidence of drug safety

Summary

Definitions and history

Pharmacovigilance or drug safety is defined as science and actions related to diagnosis, evaluation, understanding and avoidance of harmful effects or any other problems related to drugs. It started on Jan 29, 1848 when a young girl died after administration of chloroform as an anesthetic prior to surgery of an infected toenail. When sulfanilamide elixir caused 107 deaths in USA in 1937, the Federal Food, Drug and Cosmetic Act was created in 1938. According to this Act, the public health system was modernized and protocols for drug safety were established. In 1961, congenital malformations of babies (>20,000 cases) due to thalidomide was reported and debated and this changed the system of Pharmacovigilance as reporting of adverse drug reactions became very systematic and regulated (Fornasier et al, 2018)

Adverse drug reaction

The possible cause of adverse drug reaction

The establishment of Saudi Pharmacovigilance

Why do we need a Pharmacovigilance?

Pharmacovigilance cycle

Causality assessment and the Naranjo algorithm