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FDA Drug Safety Communication: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; January 11, 2018.
Web Resource > Government Resource
Centers for Disease Control and Prevention.
Journal Article > Commentary
Dowell D, Haegerich TM, Chou R. MMWR Recomm Rep. 2016;65:1-49.
Opioid pain medications carry high risk for adverse drug events and misuse. Due to climbing rates of opioid use and associated adverse events, the Centers for Disease Control and Prevention released new guidelines for prescribing opioid medications for chronic pain. These guidelines do not apply to patients receiving cancer treatment, palliative care, or end-of-life care. The authors recommend using opioids for chronic pain only if nonopioid medications and nonpharmacologic approaches to chronic pain are not effective and prescribing immediate-release instead of long-acting medications. For acute pain, they recommend limiting duration of therapy, stating that more than 1 week of medications should rarely be needed. The guidelines also suggest minimizing concurrent use of opioids and other sedating medications and dispensing naloxone to prevent overdoses. A previous WebM&M commentary describes an adverse event related to opioids.
Journal Article > Study
Sharek PJ, McClead RE Jr, Taketomo C, et al. Pediatrics. 2008;122:e861-e866.
This AHRQ-funded study describes the implementation of an Institute for Healthcare Improvement–style quality improvement collaborative aimed at reducing narcotic-related adverse drug events (ADEs). Fourteen participating hospitals adopted a series of recommended interventions while tracking ADE rates in a pre- and postintervention study design. Investigators discovered a 67% reduction in narcotic-related ADE rates, and also noted decreased rates of constipation and automated drug-dispensing overrides in patients receiving narcotic therapy. The authors point out several limitations to the study, including the inability to measure compliance with the intended change packages at each hospital. This study provides a nice example of the challenges in evaluating multifaceted quality improvement interventions despite its successful outcomes.
FDA Public Health Advisory [US Food and Drug Administration Web site]. March 11, 2008.
This announcement alerts parents and health care professionals about the potentially fatal dangers of Tussionex Pennkinetic Extended-Release Suspension, a prescription cough medicine that should not be used in children younger than 6 years.
FDA Public Health Advisory. Silver Spring, MD: US Food and Drug Administration; December 21, 2007.
This Food and Drug Administration public health advisory alerts health care professionals, patients, and their caregivers to the possibility for overdoses of fentanyl in patients using fentanyl skin patches for pain control.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; September 13, 2007.
This announcement provides specific instructions on safe prescribing of a cancer pain medication in response to several patient deaths associated with off-label use.