Pharmacovigilance risk mitigation plans: action in public health to promote the safe use of medication

Abstract

Risk mitigation plans (RMP) are an innovative and important strategy for monitoring the sanitary risks of medication. The scope of the study was to identify RMPs for drugs registered with the Food and Drug Administration (FDA) and the actions to minimize risks established by the Brazilian Health Surveillance Agency (Anvisa) and the manufacturers of these drugs. This is a quantitative and descriptive study including a survey together with the pharmaceutical industries and research on sites and databases of Anvisa, the FDA and pharmaceutical industries. Forty drugs with RMPs filed with the FDA were also registered with Anvisa. Only 4 laboratories (10f%) reported RMPs developed in Brazil. Safety information for 15 drugs (37.5%) were located on the Anvisa site. In 91.4% of Brazilian user package leaflets there is safety information equivalent to actions to promote safe use described in RMPs available on the FDA website. The actions of communication on drug safety and sanitary risk of drugs needs to be expanded by Anvisa. The RMP is an important strategy in public health for managing new risks, monitoring known risks and, especially, for promoting the safe use of medication.