Aschenbrenner, Diane S. MS, RN
Diane S. Aschenbrenner recently retired as course coordinator for undergraduate pharmacology at Johns Hopkins University School of Nursing in Baltimore, MD. She also coordinates Drug Watch: email@example.com.
* The labeling of extended-release and long-acting opioid analgesics has been revised to warn practitioners that the drugs have been associated with misuse, abuse, life-threatening respiratory depression, accidental exposure, neonatal opioid withdrawal syndrome, and (with some drugs) serious drug interactions with alcohol.
* The labeling will also state that long-acting opioids should only be used if other pain relief methods aren't effective.
The introduction of extended-release and long-acting opioids, such as MS Contin in 1987 and OxyContin in 1995, improved the treatment of chronic pain in the United States. Unfortunately, because these long-acting opioids have higher concentrations of active narcotic, they've also been associated with misuse, abuse, and overdose. Concern over the safe use of these products, even at recommended doses, has grown over the last several years, and the Food and Drug Administration (FDA) has received public petitions, such as the one from Physicians for Responsible Opioid Prescribing, requesting that various limitations be imposed on the sale and use of these long-acting opioid analgesics.
After a review of the literature, meetings with petitioners and other stakeholders, and a review of public comments related to proposals, the FDA has determined that the labeling of all extended-release and long-acting opioids will be revised to emphasize to prescribers the risks and to recommend prescribing practices that promote safe use. The FDA did not set limits regarding doses, durations of therapy, or the types of chronic pain that may be treated with long-acting opioids.
The labeling changes that address the risks appear as boxed warnings in the full prescribing information (available at http://1.usa.gov/1anytgm), which will now read as follows (with language to be changed according to the specific drugs shown in brackets):
Addiction, abuse, and misuse. [Trade name] exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing [trade name], and monitor all patients regularly for the development of these behaviors or conditions.
Life-threatening respiratory depression. Serious, life-threatening, or fatal respiratory depression may occur with use of [trade name]. Monitor for respiratory depression, especially during initiation of [trade name] or following a dose increase. Instruct patients to swallow [trade name] [formulation; such as tablets or capsules] whole; crushing, chewing, or dissolving [trade name] [formulation] can cause rapid release and absorption of a potentially fatal dose of [active opioid].
Accidental exposure. Accidental consumption of even one dose of [trade name], especially by children, can result in a fatal overdose of [active opioid].
Neonatal opioid withdrawal syndrome. For patients who require opioid therapy while pregnant, be aware that infants may require treatment for neonatal opioid withdrawal syndrome. Prolonged maternal use of [trade name] during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life threatening and requires management according to protocols developed by neonatology experts.
Interaction with alcohol. (This text will only appear in the prescribing information of those products that interact adversely with alcohol.) Instruct patients not to consume alcoholic beverages or use prescription or nonprescription products that contain alcohol while taking [trade name]. The coingestion of alcohol with [trade name] may result in increased plasma levels and a potentially fatal overdose of [active opioid].
A second major change to the labeling of extended-release and long-acting opioids relates to the drugs’ indications and uses. Previously, the labels stated that the long-acting opioids were appropriate to treat moderate-to-severe pain when around-the-clock analgesia is needed. The labeling will now state that the drugs are indicated for the “management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.”
This revised language has important implications for nurses, including NPs who are authorized to prescribe opioids. Implicit in the new language is the recognition that there are more aspects to pain and pain management than just a number rating pain severity. The new wording encourages health care providers to more fully assess patients and their pain and make decisions that are patient centered and appropriate for the individual; a more detailed assessment is warranted in the case of long-acting opioids because of their potentially serious adverse effects. Nurses should take into account quality-of-life issues (such as whether the pain prevents the performance of activities of daily living, prevents the patient from being able to leave the house, or has a negative impact on the patient's interpersonal relationships).
The new language also emphasizes that these drugs are to be used only when alternative treatments are inadequate. Long-acting opioids should be prescribed only when other options have been tried and found ineffective. Prior to the start of therapy with a long-acting opioid, the nurse should determine whether the patient has previously received nonopioid analgesics or short-acting opioids for pain. Has the patient tried nonpharmaceutical treatments such as physical therapy?
Because currently cited studies of long-acting opioids haven't exceeded 12 weeks’ duration, the FDA is directing manufacturers to conduct studies that look at effects related to therapy lasting one year or longer. These studies should provide quantitative estimates of the serious risks of misuse, abuse, addiction, overdose, and death associated with the long-term use of opioid analgesics for chronic pain. Long-term safety studies must be completed and a full report submitted to the FDA between 2015 and 2018, depending on the study. And depending on the results of these studies, additional changes to the labeling might be warranted.
To help promote safety the FDA has revised its risk evaluation and mitigation strategy on long-acting opioids. Pharmaceutical companies will be required to provide educational programs for health care providers that emphasize safe prescribing practices. The medication guide for patients will be strengthened to reflect these changes and encourage patients to be active partners in their care. Nurses should encourage all patients to read the medication guide, which accompanies all filled prescriptions for long-acting opioids, and to learn the most current information on the risks associated with use of the drug and how to minimize those risks. Nurses should provide education regarding safe use of these drugs to all patients receiving them.
The FDA news release regarding the labeling changes can be found at http://1.usa.gov/15NDWsJ.
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