US Food and Drug Administration’s Risk Evaluation and Mitigation Strategy for Extended-Release and Long-Acting Opioids

摘要: Prescriptions for opioid analgesics to manage moderate-to-severe chronic non-cancer pain have increased markedly over the last decade. An unintentional consequence of greater prescription utilization has been parallel increase in misuse, abuse and overdose, which are serious risks associated with all analgesics. In response disturbing rises abuse, US Food Drug Administration (FDA) proposed implementation aggressive Risk Evaluation Mitigation Strategies (REMS). While REMS could dramatically change development, release, marketing extended-release opioids, questions remain on how these programmes may influence prescribing practices, patient safety ultimately access agents. The extent availability misuse opioids Europe is difficult assess from data currently available, due large part considerable differences patterns regulations between countries. Balancing those patients who pain, while discouraging illicit use, a complex challenge requires effective efforts many levels, particularly where policies quite different