US Food and Drug Administration's Risk Evaluation and Mitigationud Strategy for Extended-Release and Long-Acting Opioids Pros and Cons, andud a European Perspective

摘要

Prescriptions for opioid analgesics to manage moderate-to-severe chronicudnon-cancer pain have increased markedly over the last decade. An unintentionaludconsequence of greater prescription opioid utilization has been the paralleludincrease in misuse, abuse and overdose, which are serious risks associatedudwith all opioid analgesics. In response to disturbing rises in prescription opioidudabuse, the US Food and Drug Administration (FDA) has proposed the implementationudof aggressive Risk Evaluation and Mitigation Strategies (REMS).udWhile REMS could dramatically change the development, release, marketingudand prescription of extended-release opioids, questions remain on how theseudprogrammes may influence prescribing practices, patient safety and ultimatelyudpatient access to these agents. The extent of the availability and misuse of prescriptionudopioids in Europe is difficult to assess from the data currently available,uddue in large part to the considerable differences in prescribing patterns andudregulations between countries. Balancing the availability of prescription opioidsudfor those patients who have pain, while discouraging illicit use, is a complexudchallenge and requires effective efforts on many levels, particularly in Europeudwhere policies are quite different between countries.