title: Pharmacovigilance and communicating safety information.
abstract: Safe and effective prescribing can only happen when the prescriber has sufficient current knowledge of the potential harms and likely benefits of the drug. When a new drug is first marketed, knowledge about its adverse effects profile is limited to what has been learned from its use in a relatively small number of people (who may be unrepresentative of the general population) for a limited amount of time in preclinical and clinical trials.(1) Rare, but serious unwanted effects may emerge only after a drug is marketed, sometimes years later.(1) It is therefore crucial to continue monitoring the safety of drugs after marketing and that healthcare professionals have access to timely communication about any safety concerns. The activity of monitoring the safety of medicines in clinical use and taking appropriate action to minimise risk is known as pharmacovigilance, and is governed by a range of complex UK and European regulations.(2) Background information relating to drug safety issues and pharmacovigilance decisions are not always easy to find. Here we explain the pharmacovigilance process and how new information on adverse effects is communicated to healthcare professionals.
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence / Q000458:organization & administration; D003142:Communication; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods; D004346:Drug Information Services; D064420:Drug-Related Side Effects and Adverse Reactions; D005062:European Union; D006801:Humans; D060735:Pharmacovigilance; D006113:United Kingdom