Actiq is not for sore throats! A hospital reported three events in which providers attempted to order ACTIQ (fentaNYL citrate oral transmucosal lozenge) to treat sore throats, mistaking the powerful opioid as a typical throat lozenge. In two cases, the pharmacist identified the error and contacted the provider. In the third case, the provider caught his own error. In each case, the patients did not have other opioids on their profiles, or a history of opioid use. Use of this product in opioid-naive patients could have resulted in serious harm. The hospital is implementing safeguards to prevent further occurrences, including limitations on prescribing to pain management specialists, anesthesiologists, hematologists, oncologists, palliative care, and hospice providers. Strict limitations on prescribing, dispensing, and distributing this drug are required by the Transmucosal Immediate Release FentaNYL (TIRF) Risk Evaluation and Mitigation Strategy (REMS), an FDA-required program designed to ensure informed risk-benefit decisions before initiating treatment, and appropriate use while patients are treated. Before enrollment in the TIRF REMS Access program, prescribers and pharmacists must review an education program (http://www.ismp.org/sc?id=357), successfully complete a knowledge assessment with a score of 100%, and sign acknowledgment statements on the enrollment form. The hospital where these events happened is also implementing an automatic medication order form that includes criteria for use of the product that can't be bypassed without completing the form. Due to the risk of fatal respiratory depression, Actiq is contraindicated in opioid-naive patients.
Close call with wintergreen oil. The Drug Facts label on bottles of wintergreen oil (methyl salicylate) (Figure 1) indicates that it is used for "temporary relief of muscular aches and pains due to overexertion or fatigue." When a hospital set up its new computer system, this product was available on the formulary. However, the primary hospital formulary indication did not match the Drug Facts label. The product is actually used by surgical staff for application to their paper face masks to make surgical smells less noxious, such as during bowel surgeries. When building the new computer system, it was not recognized that this product should not be available for ordering by the prescriber, so it was added to the order entry system without limits on the dose, route, or frequency. A prescriber found the product on the drug list and ordered it to be used at the patient's bedside as an air freshener. Directions were provided by the prescriber using the comment field of the order entry screen. A bottle of wintergreen oil was dispensed and placed in the patient's room. The concentration of this product is 89% and it comes in a small (59 mL) bottle. Because the bottle is so small, this could easily be mistaken as an oral unit dose liquid. Fortunately, the product was not used inappropriately and did not result in patient harm. However, we have had a number of other incidents where other topical products left at the bedside were swallowed by a confused patient. Hospitals should either remove the product from use or limit where it is available. Air fresheners from environmental services in spray form are generally available for use in patient rooms. This product should not be included as an option on computerized order entry systems. If it is stocked in the pharmacy, where it may be used as an ingredient for compounding topical products, it should be segregated from items that may be dispensed to patient care areas. This product can be purchased without a prescription and may also pose risks in patient's homes.
Use of "NoAC" abbreviation. A pharmacy student on a hospital rotation had a patient admitted to the coronary care unit with atrial fibrillation. The patient had been taking warfarin prior to hospitalization. A new order was written for amiodarone for the arrhythmia, but this drug can interact with warfarin and enhance its anticoagulation effect. Upon review of the patient's medical record, the student and other team members saw a cardiology note that stated, "Patient is taking Coumadin and was placed on amiodarone. There is an interaction. Instead of adjusting the Coumadin dose, consider NoAC." The entire medical team, the pharmacy preceptor, and the student, all assumed that this meant "Due to the potential interaction between warfarin and amiodarone, consider using no anticoagulation (i.e. discontinue the warfarin)." The cardiologist was contacted to confirm this interpretation. To everyone's surprise, the physician said he was actually using the abbreviation "NoAC" instead of writing out the words "new (or novel) oral anticoagulant." He meant that instead of warfarin, one of the direct thrombin inhibitors, such as dabigatran, should be considered. A quick search of the Internet revealed frequent use of the abbreviation "NoAC," and its use has become more popular with the introduction of the newer anticoagulants. We will be adding "NoAC" to our "do not use" list of potentially dangerous abbreviations and strongly suggest cautioning providers not to use it clinically. It should be noted that drug interactions can occur between amiodarone and direct thrombin inhibitors, decreasing clearance and thus increasing plasma levels of the anticoagulant. Still, the dabigatran label does not recommend a dosage adjustment (http://www.ismp.org/sc?id=281) although it is probably wise to use the drugs together with caution until more is learned. The apixaban label recommends a dose reduction to 2.5 mg or to avoid concomitant use (http://www.ismp.org/sc?id=282), and the rivaroxaban label states that combined use should be avoided (http://www.ismp.org/sc?id=283).
Imbruvica is okay to repackage. IMBRUVICA (ibrutinib) is a medication that was approved by the U.S. Food and Drug Administration (FDA) in February 2014 for treatment of mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) in patients who have had at least one prior therapy. The drug is available only through specialty pharmacies. This new oral chemotherapy medication has shown encouraging results for patients who previously had limited therapeutic options. Its use will likely continue to rise. There has been some confusion involving Imbruvica dosing and packaging. First, dosing depends on the specific condition being treated. A dose of 420 mg (3 capsules) once daily is given to patients who have CLL. For those with MCL, 560 mg (4 capsules) is given once daily. However, there have been two reported instances where a dose of only 420 mg was prescribed for a patient with MCL. Surveillance is in order if this drug is being prescribed by oncology practitioners in case dose clarification is needed. Another issue is with Imbruvica packaging: the drug is available only in 140 mg capsules in bottles of 90 (for CLL patients) or 120 (for MCL patients). Current labeling states that the medication must be "dispensed in original package." This would be a problem for patients taking a moderate CYP3A4 inhibitor (e.g., atazanavir, fluconazole, darunavir, erythromycin, diltiazem, aprepitant, crizotinib, imatinib, verapamil, ciprofloxacin, grapefruit products), as the labeling calls for a dose reduction to just one 140 mg capsule daily (30 capsules a month). (The drug should not be given at all if a strong CYP3A4 inhibitor is being used.) Patients requiring a dose reduction would be forced to purchase a 3-month supply (90 capsules) rather than a 1-month supply (30 capsules) of the medication. In addition to increasing drug costs, this could result in patients taking more than the intended dose. When asked for clarification, the U.S. FDA representative told us that the product must be retained in its original packageuntil dispensing. FDA indicated there is no problem repackaging Imbruvica in smaller amounts at the time of dispensing.