We heard from a long-term-care (LTC) pharmacy about an increase in the prescribing of transdermal fentaNYL patches for elderly patients. In most cases, the pharmacists determined the fentaNYL patches had been inappropriately prescribed for opioid-naive patients, sometimes to treat acute pain rather than chronic pain. Sometimes fentaNYL patches had been prescribed because of a documented allergy to another analgesic, such as codeine. However, further investigation showed that the "allergy" was a minor intolerance to the analgesic, usually gastrointestinal. The more common underlying cause of prescribing fentaNYL patches inappropriately is a knowledge deficit about the dangers of prescribing this potent opioid analgesic to opioid-naive patients. FentaNYL is a powerful opioid that is 50 to 100 times more potent than morphine. Several of these events began in a hospital, with opioid-naive patients receiving prescriptions for fentaNYL patches after treatment in an emergency department or upon discharge home and/or transfer to an LTC facility.
Background
In 1990, DURAGESIC (fentaNYL transdermal system) was approved by the U.S. Food and Drug Administration (FDA). Years later, generic fentaNYL patches became available. Today, the official prescribing information recommends use of fentaNYL patches only in opioid-tolerant patients 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. According to the prescribing information, patients considered opioid-tolerant are those taking, for 1 week or longer, at least one of the following:
* 60 mg of oral morphine per day
* 60 mg of oral HYDROcodone per day
* 30 mg of oral oxyCODONE per day
* 25 mg of oral oxyMORphone per day
* 8 mg of oral HYDROmorphone per day
* 25 mcg of transdermal fentaNYL per hour
* An equianalgesic dose of another opioid
In 2012, FDA approved an extended-release (ER) and long-acting (LA) opioid analgesic Risk Evaluation and Mitigation Strategy (REMS) to ensure the benefits of prescribing opioids outweigh the risks (http://www.ismp.org/ext/508). In 2018, that was modified to reduce the risk of abuse, misuse, addiction, overdose, and death due to all prescription opioid analgesics (http://www.ismp.org/ext/509). The REMS strongly encourages training on risks and safe use of opioids for all healthcare providers involved in the management of patients with acute or chronic pain. FDA believes that, with training, the proper analgesic will be selected and used with appropriate clinical oversight and monitoring. The agency has even created a blueprint to specify the content of an opioid educational program for healthcare providers (http://www.ismp.org/ext/510). However, there is no mandatory federal requirement for REMS-compliant education about opioids, including fentaNYL patches, as a precondition to prescribing, as FDA concluded that monitoring compliance would be unduly burdensome.
Inappropriate Prescribing of FentaNYL Patches
Prescribing a fentaNYL patch to elderly, opioid-naive patients can result in life-threatening or fatal respiratory depression and overdose. Additionally, with the elderly population, there are a number of risk factors, including age-related comorbidities, polypharmacy, and drug-drug interactions, which can further contribute to an unintentional overdose if opioids are inappropriately prescribed.
Event 1
An 80-year-old hospitalized patient with persistent pain from a recent fall was discharged with orders for HYDROmorphone 1 mg by mouth every 4 hours as needed for pain, which he had received during his 3-day hospitalization. Before the patient was transferred to a facility for rehabilitation, the physician also prescribed a 50 mcg/hour fentaNYL patch to be applied at discharge for pain management. When reviewing the transfer orders, a pharmacist noticed the patient did not have a history of taking opioids prior to his hospitalization and was concerned about the fentaNYL patch that had been applied prior to transfer, particularly in combination with the prescribed HYDROmorphone. The pharmacist contacted the LTC physician, who initially did not want to discontinue the fentaNYL patch since the hospital physician had recommended it. The pharmacist was persistent and convinced the LTC physician that the fentaNYL patch was unsafe in the elderly, opioid-naive patient. The patch was removed and discarded.
Event 2
A 70-year-old man with back pain had been taking HYDROcodone with acetaminophen 5 mg/325 mg once or twice daily for the past week. When he was hospitalized for a different reason, he mentioned taking this oral analgesic periodically for back pain when asked about his medication history. The patient was concerned that his back pain would worsen during hospitalization and asked the nurse if he could try a "pain relieving narcotic patch." The nurse documented this request. When the patient was discharged the next day to a facility for rehabilitation, the physician noticed the patient's request and prescribed a fentaNYL patch 25 mcg/hour every 72 hours for back pain. The pharmacist reviewing the transfer orders contacted the prescriber, who realized the patient was not an appropriate candidate for a fentaNYL patch and instead ordered oral HYDROcodone with acetaminophen 5 mg/325 mg every 4 hours for back pain.
Recommendations
In 2018, we called for the elimination of prescribing fentaNYL patches for opioid-naive patients and/or patients with acute pain in the ISMP Targeted Medication Safety Best Practices for Hospitals (http://www.ismp.org/node/160). This Best Practice has incorporated into a new Best Practice (#15) to verify and document the patient's opioid status and type of pain before prescribing and dispensing ER or LA opioids. The most recent stream of reports is associated with a knowledge deficit about pain management, end-of-life care, and proper prescribing of fentaNYL patches. Reliance on product labeling and practitioner education alone will not solve this life-threatening problem. Thus, system safeguards must be established to avoid the risk of harm.
When entering orders for fentaNYL patches, interactive alerts requiring confirmation that the patient is opioid-tolerant and experiencing chronic pain might help prevent inappropriate prescribing, as might hard stops if patients do not meet prescribing criteria. Similarly, pharmacy computer systems should help pharmacists ensure that a fentaNYL patch is appropriate for the patient. Home care clinicians also play a key role in identifying opioid-naive patients who are inappropriately prescribed fentaNYL patches. In addition, pharmacists and clinicians must ensure patients and/or caregivers receive education regarding safe and proper use, storage, and disposal of fentaNYL patches.
Finally, distinguishing between true allergies and drug intolerances is critical to the proper selection of analgesics. When allergy information is collected, document the reaction type (e.g., side effect, intolerance, toxicity, immune response) and description (e.g., nausea, rash, pruritus, swelling, anaphylaxis). Before prescribing medications, allergy information without a documented reaction type and description should be reconciled with the patient or family so crucial medications are not avoided simply due to mild intolerances.