Pharmacovigilans

Pharmacovigilance, also known as pharmacovigilance, is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It is a critical component of drug safety and is regulated by various international organizations, including the World Health Organization (WHO) and the European Medicines Agency (EMA). The primary goal of pharmacovigilance is to ensure that the benefits of a drug outweigh its risks and to minimize the occurrence of adverse drug reactions (ADRs).

Pharmacovigilance activities typically involve the collection, analysis, and reporting of information on suspected ADRs. This information can come from various sources, including healthcare professionals, patients, and spontaneous reports. The data is then evaluated to determine the relationship between the drug and the adverse event, and appropriate actions are taken to manage the risk. These actions may include changes to the drug's labeling, withdrawal of the drug from the market, or additional monitoring.

Pharmacovigilance is an ongoing process that begins with the development of a new drug and continues throughout its lifecycle. It is essential for maintaining the safety of drugs and protecting patients from potential harm. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has established guidelines for pharmacovigilance to ensure consistency and quality in the reporting and management of ADRs.

In summary, pharmacovigilance is a vital field that plays a crucial role in drug safety. It involves the systematic collection, evaluation, and management of information on adverse drug reactions to ensure that the benefits of a drug outweigh its risks.