T he fentanyl transdermal system (FTS) is designed to deliver a continuous dose of fentanyl, a potent opioid analgesic. Adverse events related to toxicity include sedation and respiratory depression, particularly in the opioid-naïve patient and when the FTS is abused or misused. To minimize the risk of severe and potentially fatal adverse drug events (ADEs), national warnings and guidelines outlining the safe use of the FTS have been released, including a boxed warning restricting its use to moderate to severe chronic pain conditions in the opioidtolerant patient.1 The US Food and Drug Administration (FDA) also released statements in 2005 and 2007 outlining appropriate prescribing, dose selection, and safe use of the FTS.2 In 2012, the FDA approved the extended-release (ER) and long-acting (LA) opioid analgesics risk evaluation mitigation strategy (REMS), and The Joint Commission published a sentinel event alert related to the safe use of opioid analgesics, including the FTS, in the hospital setting. ABSTRACTBackground: National safety guidelines were developed to minimize the occurrence of serious adverse drug events (ADEs) associated with the use of the fentanyl transdermal system (FTS), however, reports of use in opioid-naïve patients for treatment of acute pain and associated ADEs continue to occur. Objective: To evaluate the prescribing patterns of the FTS for adherence to recent US regulatory recommendations and identify the impact of health information technology (HIT) on adherence rates. Methods: A retrospective pre-and postintervention analysis was performed in hospitalized adult patients receiving FTS. Electronic medication order instructions and text questions were incorporated into FTS electronic medication orders. The primary outcome measure was adherence of FTS medication orders to regulatory guidelines defi ned as (a) a new order in an opioid-tolerant patient for use in moderate to severe chronic pain or (b) continuation of the documented home dose in use for at least 7 days. Safety measures included respiratory rate and documented ADEs. Results: Adherence rates were signifi cantly increased in the postintervention cohort as compared to the preintervention cohort (48.7% vs 85.0%; P < .0001). Incidence of ADEs was signifi cantly lower post intervention (34.7% vs 23.3%; P = .043), including a lower incidence of respiratory depression (16.7% vs 8.3%; P = .043). Documentation was increased in the postintervention cohort (76% vs 100%). However, supporting documentation confi rmed responses in only 59.2% of records reviewed. Conclusions: Incorporation of HIT via electronic order text questions increased overall adherence rates to regulatory recommendations, increased documentation, and decreased the rate of associated ADEs.
This Hospital Pharmacy feature is extracted from Off-Label Drug Facts, a publication available from Wolters Kluwer Health. Off-Label Drug Facts is a practitioner-oriented resource for information about specific drug uses that are unapproved by the US Food and Drug Administration. This new guide to the literature enables the health care professional or clinician to quickly identify published studies on off-label uses and determine if a specific use is rational in a patient care scenario. References direct the reader to the full literature for more comprehensive information before patient care decisions are made. Direct questions or comments regarding Off-Label Drug Uses to jgeneral@ku.edu.
This Hospital Pharmacy feature is extracted from Off-Label Drug Facts, a publication available from Wolters Kluwer Health. Off-Label Drug Facts is a practitioner-oriented resource for information about specific drug uses that are unapproved by the US Food and Drug Administration. This new guide to the literature enables the health care professional or clinician to quickly identify published studies on off-label uses and determine if a specific use is rational in a patient care scenario. References direct the reader to the full literature for more comprehensive information before patient care decisions are made. Direct questions or comments regarding Off-Label Drug Uses to jgeneral@ku.edu. THERAPUETIC CONSIDERATIONSUnsupported. In a small case series and prospective review including adult patients, montelukast demonstrated a symptomatic but not histologic improvement and was not effective in maintaining steroid-induced remission of eosinophilic esophagitis.
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