The National Institute on Drug Abuse reports that in 2021 (the most recent data available) there were 80,411 deaths from opioids, 16,706 of which were from prescription opioids.1 Although the overall national dispensing rate of opioid prescriptions has declined from 2012 to 2020, the Centers for Disease Control and Prevention reports that in 2020 more than 142 million opioid prescriptions were dispensed in the United States.2

Revised label warnings. In a continuing effort to decrease the number of deaths from opioid pain medications, the Food and Drug Administration (FDA) is revising the language used in product labeling and patient guidance. The labeling for all opioid pain medications, whether immediate release, extended release, or long acting, will now warn that the risk of opioid overdose increases as the dose increases. The labeling for immediate-release opioids will state that the drugs should not be used for an extended period unless the pain is so severe as to require continuing them and other forms of treatment have not been effective. The prescribing information for extended-release and long-acting opioid pain medications will warn that these drugs should be reserved for severe, persistent pain when other types of pain treatment have been inadequate. The boxed warnings for opioids will also be revised to more prominently display the risk of life-threatening respiratory depression and the risks associated with the combined use of opioids and benzodiazepines and other central nervous system (CNS) depressants.

Also being added to all opioid labels is a new warning about opioid-induced hyperalgesia, a state of nociceptive sensitization where a paradoxical response to opioids occurs, making the patient more sensitive to certain painful stimuli. This new warning will include information differentiating opioid-induced hyperalgesia from opioid tolerance and withdrawal.

After assessing a patient's pain, nurses and NPs should offer alternatives to opioids when indicated. NPs who prescribe opioids should educate patients on the risks of opioid use, especially long-term use, and discuss treatment plans that include alternatives to opioids and how to balance the risks and benefits of opioid use. Nurses and NPs should educate patients on the risks of respiratory depression and overdose and encourage the purchase of naloxone at the same time the opioid prescription is filled. Patients who are also taking benzodiazepines or other CNS depressants should receive education on the potential additive risk of respiratory depression. NPs prescribing pain medication for acute episodes of pain should consider limiting the number of pills in a prescription, as patients with acute pain are frequently prescribed a larger number than needed-extra pills that can lead to overdose or misuse. When pain assessments indicate that a patient requires opioids for pain relief, the lowest effective dose should be prescribed for the shortest duration. NPs should only prescribe extended-release and long-acting opioids for severe, persistent pain that has not been controlled by other treatments.

Nurses and NPs should suspect opioid-induced hyperalgesia if there is increased pain intensity despite increasing opioid doses, decreased pain intensity in response to a decrease in opioid doses, or hypersensitivity to nonpainful stimuli (in the absence of opioid tolerance or withdrawal). Nurses, NPs, and patients should report adverse effects from opioid pain medication to the FDA MedWatch program at http://www.accessdata.fda.gov/scripts/medwatch/index.cfm.

To read the full Drug Safety Communication on the opioid labeling changes, see http://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-prescribing-in.

Patient education. One strategy for decreasing the incidence of opioid abuse is to keep opioids away from people who do not have a prescription for them. Nurses and NPs should tell their patients who are prescribed opioids about the national campaign from the FDA called "Remove the Risk." The website includes information on home use and safe disposal of opioids, and a toolkit of free resources such as public service announcements, social media images and posts, and fact sheets that can be used in outreach campaigns. To access these resources, go to http://www.fda.gov/drugs/buying-using-medicine-safely/fda-health-playbook; under the heading "Remove the Risk," click on the links for "Remove the Risk Outreach Toolkit" and "Safe Disposal of Medicines."

Safety considerations for Vivitrol. Prescribed opioids can be a gateway to misuse or abuse of opioids, including illegal opioids. Abuse of illegal opioids increases the risk of overdose, as street drugs are more likely to contain fentanyl or other highly potent drugs. An important strategy for decreasing opioid overdose deaths is to decrease the number of people who abuse or misuse opioids. Drug therapy is part of the treatment plan for those who wish to overcome opioid abuse. Intramuscular naltrexone extended-release injectable suspension (Vivitrol) is indicated for patients who wish to prevent relapse into opioid dependence (the drug is also prescribed to prevent relapses into alcohol abuse).

Naltrexone extended-release injectable suspension is an opioid antagonist. Patients prescribed this medication must have completed opioid detoxification. The drug comes with equipment to dilute, draw up, and administer it, including unique needles. Because the microspheres in the medication tend to clot, multiple needles are included in the packet. The Institute for Safe Medication Practices warns of reported problems with medication clogging in the syringe, preventing administration.3 To prevent this, nurses must follow the directions for preparation of the naltrexone injection in the product's labeling. Using the needle designed for preparation, nurses should thoroughly mix the room temperature microsphere and diluent vials and shake vigorously to create a suspension. Properly prepared, the product is milky white without clumps and moves freely in the vial. Nurses should then withdraw the suspension into the syringe, replace the preparation needle with one of the administration needles, and administer immediately to prevent the suspension from separating. The product should be administered only into a deep gluteal muscle.

For full prescribing information for naltrexone extended-release injectable suspension, including directions for mixing and administration, see http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021897s015lbl.pdf.

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