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Problem: Despite warnings from the FDA, drug manufacturers, and patient safety agencies, fentanyl transdermal patches continue to be prescribed inappropriately to treat acute pain in opioid-naive patients, sometimes in large doses or in combination with oral or intravenous (IV) opioids. Some of these prescribing errors have occurred in hospitals; other mistakes have originated in physicians’ offices or ambulatory surgery centers, where well-meaning but misinformed primary care physicians or surgeons have prescribed the drug for opioid-naive patients with contraindications such as acute postoperative pain.
Unfortunately, pharmacists have often filled fentanyl prescriptions without questioning whether the dose was correct, and nurses have applied the patches to patients without recognizing various possible prescribing errors. The Institute for Safe Medication Practices (ISMP) has been troubled by the steady stream of reports of adverse events associated with the patches, including fatalities, resulting from inappropriate prescribing, dispensing, and administration.
As noted last year in one of my columns in P&T,1 Ortho-McNeil/Janssen, the maker of Duragesic, issued a “Dear Health Professional” letter to bring attention to new boxed warnings in the product label related to improper prescribing.2 The FDA also issued a Public Health Advisory to alert health care providers that deaths and overdoses had occurred in patients using both the brand-name product Duragesic and the generic product.3 Despite these warnings and label changes,4,5 some practitioners still seem unaware of the proper prescribing guidelines for this potent narcotic. Following are two scenarios involving improper prescribing.
Case 1. A patient who had been given a morphine infusion immediately after surgery was discharged the next day. A nurse applied a prescribed fentanyl patch, at a dose of 75 mcg/hour, to the patient’s skin before discharge and gave the patient three patches to take home. The patient also received a prescription for oxycodone (OxyContin, Purdue Pharma), as needed, every four to six hours. Unfortunately, the patient died within 12 hours of discharge.
The coroner attributed the patient’s death to application of the patch. Not only was this patient opioid-naive and his pain not chronic; he was also being treated for sleep apnea and bronchopneumonia at the time of the surgery. Existing respiratory compromise is another contraindication to fentanyl administration.
Case 2. An elderly patient was admitted to the hospital after application of a fentanyl transdermal patch at a dose of 100 mcg/hour. A family member had called the clinic where the patient had been receiving periodic epidural injections for back pain. The relative asked a nurse to arrange for an ambulance to transport the patient to the next visit. Because this represented a change in the patient’s status, the nurse questioned the family and learned that a fentanyl patch had been prescribed and that the patient had continued taking two tablets of oxycodone 5 mg/acetaminophen 325 mg (Percocet 5/325, Endo) three or four times per day.
After calling the patient’s pharmacist to confirm his prescribed medications, the nurse advised the patient’s relatives to remove the patch immediately and to take the patient to the emergency department. The patient was admitted to the step-down unit. During the call to the patient’s family, the nurse also confirmed that the patient and family had not been counseled when they picked up the prescription and that they were not aware of the drug’s potency. Fortunately, this patient did not experience any permanent adverse consequences.
Safe Practice Recommendations: These scenarios reflect a knowledge deficit about the proper prescribing of fentanyl patches. Relying on product labeling and instructing health care practitioners alone does not do enough to solve this life-threatening problem. Some clinicians will always remain unaware of the great risks they take when they prescribe fentanyl patches to treat acute pain in opioid-naive patients. To help avoid the risk of patient harm from this high-alert medication, clinicians and prescribers might benefit from establishing the following procedures:
The reports described in this column were received through the ISMP Medication Errors Reporting Program (MERP). Errors, close calls, or hazardous conditions may be reported on the ISMP Web site (www.ismp.org) or communicated directly to ISMP by calling 1-800-FAIL-SAFE or via e-mail at gro.pmsi@ofnipmsi.