Prescribers' compliance is part of benefit-risk assessment of medicines and it can lead to failure of risk minimization measures and withdrawals of medicines.

Prescribers' compliance is part of benefit-risk assessment of medicines and it can lead to failure of risk minimization measures and withdrawals of medicines.
Curr Med Res Opin. 2018 Sep 25;:0-5
Authors: Puljak L
Abstract
In 2018 EMA's Pharmacovigilance Risk Assessment Committee (PRAC) recommended withdrawal of marketing authorization for flupirtine-containing medicines in European Union. The case of flupirtine is important lesson for prescribers. If prescribers are not compliant with RMMs, they are negatively affecting benefit-risk balance of a medicine, and may contribute to withdrawal of medicine from the market. Prescribers may not perceive their lack of compliance with RMMs as a potential threat to a medicine, and therefore there is a need to increase prescribers' awareness about this issue. If a medicine has adverse reactions that can be avoided or significantly reduced with RMMs, prescribers should be part of the solution, and not part of the problem.
PMID: 30252554 [PubMed - as supplied by publisher]

Source: Current Medical Research and Opinion - September 28, 2018 Category: Research Tags: Curr Med Res Opin Source Type: research