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[Posted 07/23/2020]
Opioid Pain Relievers or Medicines to Treat Opioid Use Disorder: MedWatch Safety Alert - FDA Recommends Health Care Professionals Discuss Naloxone with All Patients when Prescribing (1)
AUDIENCE: Patient, Health Professional, Pharmacy
ISSUE: FDA is requiring drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder (OUD) to add new recommendations about naloxone to the prescribing information. This will help ensure that health care professionals discuss the availability of naloxone and assess each patient's need for a naloxone prescription when opioid pain relievers or medicines to treat OUD are being prescribed or renewed. The patient Medication Guides will also be updated.
BACKGROUND: Opioid pain relievers are medicines that can help manage pain when other treatments and medicines are not able to provide enough pain relief. Certain opioids are also used to treat OUD. Opioids have serious risks, including misuse and abuse, addiction, overdose, and death. Naloxone can help reverse opioid overdose to prevent death.
The misuse and abuse of illicit and prescription opioids and the risks of addiction, overdose, and death are a public health crisis in the United States. As a result, FDA is committed to encouraging health care professionals to raise awareness of the availability of naloxone when they are prescribing and dispensing opioid pain relievers or medicines to treat OUD. FDA held discussions about naloxone availability with the Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory Committees, which recommended that all patients being prescribed opioids for use in the outpatient setting would benefit from a conversation with their health care professional about the availability of naloxone.
Read more about the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at: https://reurl.cc/8nqnXg
Opioid類鎮痛藥可用於當其他治療方法和藥物無法充分緩解疼痛時，幫助控制疼痛的藥物。某些opioid類藥物也可用於治療opioid類藥物使用疾患（opioid use disorder, OUD）。Opioid類藥物有嚴重的風險，包括誤用和濫用、成癮、用藥過量和死亡。Naloxone為opioid類藥物過量的反轉劑，避免藥物過量而死亡。
美國FDA要求所有緩解疼痛的opioid類藥物和治療OUD的藥物製造商，在仿單中加入有關naloxone的新建議。此建議將有助於確保醫療專業人員在開立opioid類止痛藥或使用治療OUD藥物時，和病人討論naloxone該如何取得，並評估每個病人對naloxone處方的需求。病人用藥指南也將一併更新。
非法使用和處方opioid類藥物的誤用和濫用以及opioid類藥物成癮、服用過量和死亡的風險是美國的公共衛生危機。因此，美國FDA致力於鼓勵醫療專業人員在處方和調劑opioid類止痛藥或使用治療OUD藥物時，增加對naloxone的認識。美國FDA與麻醉止痛藥產品及藥物安全和風險管理諮詢委員會就naloxone該如何取得進行開會討論，建議所有在門診處方opioid類藥物的病人與醫療專業人員討論naloxone該如何取得。
更多相關訊息與連結請參考FDA網址：https://reurl.cc/8nqnXg
（待續）
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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