FDA Guidance for Health Care Professionals When Prescribing Treatment for Opioid Use Disorder

The opioid epidemic affects millions of Americans every year. To address this public health crisis, in a recent statement, the FDA provided some guidelines for health care professionals when prescribing or renewing an opioid analgesic or medicine to treat opioid use disorder (OUD).

In the statement, the FDA noted that it is important for health care professionals to routinely discuss the availability of naloxone with all patients when prescribing or renewing an opioid analgesic or medicine to treat OUD. Additionally, it may also be important to consider prescribing naloxone to patients who have been prescribed medicine to treat OUD previously or patients who may be at an increased risk of opioid overdose.

Although patients already receiving medicines to treat OUD may have a lower risk of opioid overdose than those not receiving such treatment, there remains the risk of relapse, which has the potential of resulting in an overdose.

Additionally, the FDA explained that prescribing naloxone may also be necessary if a patient lives with anyone who is at risk of accidental ingestion or overdose, which includes children and other close contacts.

Patients and caregivers may also need to receive education on how to recognize a potential overdose and how to subsequently administer naloxone successfully in such cases. Some states provide this information online via training videos that describe the signs of overdose and the appropriate administration of naloxone.

However, it may still be necessary to provide patients with general information in order to ensure they understand the signs and symptoms of an overdose, as well as the appropriate steps to take when administering naloxone, according to the FDA.

States also provide specific guidelines regarding the dispensing and prescribing requirements for naloxone, making it helpful for health care professionals to consult their individual state’s information for further guidance regarding whether patients in fact need a prescription to obtain naloxone.

The FDA made note that under all circumstances, it is important to let a patient know that if they believe an overdose is occurring, it is necessary to call 911 or get emergency medical support immediately, even if naloxone is administered. Naloxone’s effects are temporary, meaning that the individual it was administered to may still need medical support following its administration.

Upon the prescription of naloxone, the FDA recommends that health care professionals let patients know to inform all family and friends that they have naloxone, where it is stored, and how to properly use it in the event of an overdose. Additionally, it’s important to keep it in a place that is easily accessible to family and friends.

It is also helpful to encourage patients and caregivers to read the educational materials and instructions for use that come with naloxone before an opioid emergency happens so that they are aware.

With an estimated 1.7 million Americans experiencing a substance use disorder involving prescription pain relievers in 2018, 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.

REFERENCE

Federal Drug Administration. FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder. FDA PDF. Published July 23, 2020. Accessed August 4, 2020.