FDA Recommends Discussing Naloxone With All Patients Prescribed Opioid Pain Relievers or Medicines to Treat OUD

In the United States, the opioid epidemic is a public health crisis that affects millions of Americans every year. To address the crisis, in a recent statement, the FDA explained that it is now recommending all pharmacists discuss naloxone with patients when prescribing opioid pain relievers or medicines to treat opioid use disorder (OUD). Additionally, the FDA is requiring drug manufacturers of all opioid pain relievers and medicines that treat OUD to add new recommendations about naloxone to the prescribing information.

In 2018, an estimated 1.7 million Americans had a substance use disorder involving prescription pain relievers and 0.5 million had a substance use disorder involving heroin. During the 19-year period from 1999 to 2018, approximately 450,000 people died from an overdose involving opioids, including both prescription and illicit opioids. However, 46,802 people from that 19-year period died from an opioid-related overdose in 2018.

In the statement, the FDA explained that it is critical that all health care professionals are aware of naloxone when prescribing and dispensing opioid pain relievers or medicines to treat OUD.

The FDA also explained that there are certain patients who are most at risk and health care professionals should specifically be sure to discuss and/or prescribe naloxone to them when prescribing and dispensing opioid pain relievers or medicines to treat OUD. These patients include those with an increased risk of opioid overdose, including those who are also using benzodiazepines or other medicines that depress the central nervous system, have a history of OUD, or have experienced a previous opioid overdose.

Additionally, health care professionals should also consider prescribing naloxone if the patient has people in their household, including children or others they are in close contact with, who may be at risk of accidental ingestion or an opioid overdose.

The FDA is advising health care professionals to strongly consider prescribing naloxone for all patients who are prescribed medicines to treat OUD. They also advise considering prescribing naloxone for patients being prescribed methadone and buprenorphine-containing products who have any household members, including children or others close to them, who may be at risk for accidental ingestion or opioid overdose.

The FDA noted that other patients with an increased risk of opioid overdose, including people with a current or past diagnosis of OUD or who have had a previous opioid overdose, may also need to have naloxone available even if they are not receiving a prescription for an opioid pain reliever or medicine to treat OUD. These individuals may still need to be prescribed naloxone by a health care professional in order to reverse an opioid overdose and prevent death in the future.

Naloxone can be used when a person either takes too much of an opioid or takes it with certain medicines or substances, such as alcohol. Naloxone is able to block the effects of opioids and temporarily reverse the breathing problems caused by an overdose, which allows it to prevent death.

Additionally, naloxone is safe even when someone is not experiencing an opioid overdose. This means that if an individual expects someone may be overdosing but is not certain, it will not damage that person’s health if they are not actually experiencing an overdose. Naloxone is also safe for people of all ages, from infants to elderly adults.

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 July 29, 2020.