其 他 安 全 警 示
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| The United States: Opioid pain relievers or medicines to treat opioid use disorder: FDA recommends health care professionals discuss naloxone with all patients when prescribing (English only) |
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The US Food and Drug Administration (FDA) announces that it 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.
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.
Health care professionals are recommended to:
- Discuss the availability of naloxone with all patients when prescribing or renewing an opioid analgesic or medicine to treat OUD.
- Consider prescribing naloxone to patients prescribed medicines to treat OUD and patients prescribed opioid analgesics who are at increased risk of opioid overdose.
- Consider prescribing naloxone when a patient has household members, including children, or other close contacts at risk for accidental ingestion or opioid overdose.
- Additionally, even if the patients are not receiving a prescription for an opioid analgesic or medicine to treat OUD, consider prescribing naloxone to them if they are at increased risk of opioid overdose.
- Educate patients and caregivers on how to recognize respiratory depression and how to administer naloxone. Inform them about their options for obtaining naloxone as permitted by their individual state dispensing and prescribing requirements or guidelines for naloxone. Emphasize the importance of calling 911 or getting emergency medical help right away, even if naloxone is administered.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/medical-product-safety-information/opioid-pain-relievers-or-medicines-treat-opioid-use-disorder-medwatch-safety-alert-fda-recommends
http://www.fda.gov/drugs/drug-safety-and-availability/fda-recommends-health-care-professionals-discuss-naloxone-all-patients-when-prescribing-opioid-pain
In Hong Kong, there are registered pharmaceutical products which are opioid pain relievers or medicines used to treat opioid use disorder. There are also registered pharmaceutical products containing naloxone. So far, the Department of Health (DH) has received cases of adverse drug reaction related to opioid pain relievers (such as pethidine and tramadol), or medicines used to treat opioid use disorder (such as methadone). The DH has not received any case of adverse drug reaction related to naloxone. In light of the above FDA’s announcement, letters to inform local healthcare professionals will be issued. Healthcare professionals are advised to balance the risk of possible adverse effects against the benefit of treatment. The DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities.
Ends/Friday, Jul 24, 2020
Issued at HKT 17:00
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