title: US Food and Drug Administration's Risk Evaluation and Mitigation Strategy for extended-release and long-acting opioids: pros and cons, and a European perspective.
abstract: 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 opioid utilization has been the parallel increase in misuse, abuse and overdose, which are serious risks associated with all opioid analgesics. In response to disturbing rises in prescription opioid abuse, the US Food and Drug Administration (FDA) has proposed the implementation of aggressive Risk Evaluation and Mitigation Strategies (REMS). While REMS could dramatically change the development, release, marketing and prescription of extended-release opioids, questions remain on how these programmes may influence prescribing practices, patient safety and ultimately patient access to these agents. The extent of the availability and misuse of prescription opioids in Europe is difficult to assess from the data currently available, due in large part to the considerable differences in prescribing patterns and regulations between countries. Balancing the availability of prescription opioids for those patients who have pain, while discouraging illicit use, is a complex challenge and requires effective efforts on many levels, particularly in Europe where policies are quite different between countries.
authors.affiliation: Anesthesia and Intensive Care Unit and Pain Relief and Palliative Care Unit, La Maddalena Cancer Center, Palermo, Italy. terapiadeldolore@lamaddalenanet.it
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Mercadante
authors.forename: David
authors.initials: D
authors.lastname: Craig
authors.forename: Antonello
authors.initials: A
authors.lastname: Giarratano
mesh_terms: D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects; D059350:Chronic Pain / Q000188:drug therapy*; D003692:Delayed-Action Preparations / Q000008:administration & dosage* / Q000009:adverse effects; D005060:Europe; D006801:Humans; D009293:Opioid-Related Disorders / Q000517:prevention & control*; D018570:Risk Assessment; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations