Farmacovigilans

Farmacovigilans, often shortened to PV, is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem. It is a crucial component of pharmacoeconomics and public health, aiming to ensure that medicines are used safely and effectively once they are available to the public. The primary goal of farmacovigilans is to identify potential risks associated with drug use that may not have been apparent during clinical trials.

This field involves collecting and analyzing information on suspected adverse drug reactions (ADRs) from various sources. These sources include healthcare professionals, patients, pharmaceutical companies, and regulatory authorities. The data gathered is then assessed to determine if a causal relationship exists between a medicine and a reported event, and to evaluate the severity and frequency of such events.

The outcomes of farmacovigilans activities can lead to important regulatory actions. These may include updating the information provided with a medicine, such as adding new warnings or contraindications to its label, or in rare cases, withdrawing a medicine from the market if its risks are deemed to outweigh its benefits. Pharmacovigilans also plays a role in monitoring the effectiveness of risk management strategies and in promoting rational drug use.

Regulatory bodies worldwide, such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), have established systems for collecting and analyzing ADR reports. Pharmaceutical companies are also legally obligated to have their own farmacovigilans systems in place to monitor the safety of their marketed products and report any safety concerns to regulatory authorities. Ultimately, farmacovigilans contributes to the ongoing safety monitoring of medicines throughout their lifecycle, safeguarding public health.