FDA requires naloxone info on opioid labels, patient medication guides

Abstract

FDA announced that labeling for opioid analgesics and medications to treat opioid use disorder must now include information about naloxone. Drug manufacturers will be required to add the new recommendation to the prescribing material of all opioids as well as medications—such as buprenorphine, methadone, and naltrexone—used to treat opioid use disorder. Patient medication guides will be updated as well. The labeling changes, which were unveiled in an FDA Drug Safety Communication in late July, advise health professionals to prescribe naloxone in conjunction with medications for opioid use disorder or when prescribing opioids to patients who are at an increased risk of an overdose. Additionally, clinicians should consider prescribing naloxone to patients prescribed opioids who have household members, including children, or other close contacts who are at risk for accidental ingestion or opioid overdose. Anita Jacobson, PharmD, clinical professor at the University of Rhode Island School of Pharmacy, said she was pleased to see that labeling changes will be required not just on the package insert for opioids and medications to treat opioid use disorder, but also for patient medication guides—the component patients see. “That's important because as we coprescribe or recommend naloxone, there is often some resistance when the person gets to the pharmacy,” she said. “Having it come from FDA adds credit and additional support. The new information in the patient medication guide should not diminish the direct communication about naloxone between patient and pharmacist—it should only support it more, Jacobson said. In fact, many patients never read the patient medication guide, which only reinforces the need for pharmacists to provide education about naloxone. Jacobson advises pharmacists to specifically tell patients—based on other medications they are taking or underlying medical conditions they may have—why they are at risk and should have naloxone on hand. “Would it be okay to give you more information about naloxone and why it's important for you?” is a good approach and tone pharmacists can take, said Jacobson. Someone in that patient's immediate circle should know how to respond to a bad reaction from opioids. In addition, pharmacists can educate patients and caregivers about recognizing respiratory depression and how to administer naloxone, and they should stress the importance of calling 911 even if naloxone is given. Pharmacists can also educate themselves about the common myths surrounding naloxone. Pharmacists need to be able to let patients know the options they have for acquiring naloxone as allowed by their state (see map). Some states, including Arizona, Florida, Rhode Island, Virginia, and Vermont, have laws mandating that clinicians coprescribe naloxone with opioids. However, financial and insurance coverage issues remain a barrier, according to Jacobson. Even if a patient has a prescription for naloxone, when they get to a pharmacy, they might not be able to afford the copayment—that is, in the case when insurance covers it. Insurance in many states may not cover naloxone or may not cover the most accessible dosage forms. Jacobson said the question remains as to whether the new FDA labeling information will help with more widespread coprescribing of naloxone. “That will be interesting to see and something to eventually look at with the data,” she said.