______________________________________________________ Opioid Safety: Balancing Benefits and Risks
• Product-specific concerns, such as not to crush or chew ER products; transdermal systems and buccal films should not be cut, torn, or damaged before use, etc. • How to safely taper dose to avoid withdrawal symptoms • Safe storage and disposal, risks of theft by family members and household visitors • Never share any opioid analgesic with another person • How and when to use naloxone products and their various means of administration • Seeking emergency medical treatment if an opioid overdose occurs • How to report adverse events and medication errors to FDA In addition, in July 2025, the FDA announced that all opioid manufacturers must change safety labels (within 30 days) with new evidence regarding long-term use of opioids. The change is intended to assist healthcare professionals and patients to make fully informed treatment decisions when considering or already taking opioids for an extended period of time. The labeling changes must include the following [22]: • Clearer risk information: A summary of study results showing the estimated risks of addiction, misuse, and overdose during long-term use. • Dosing warnings: Stronger warnings that higher doses come with greater risks and that those risks remain over time. • Clarified use limits: Removing language which could be misinterpreted to support using opioid pain medications over indefinitely long duration • Treatment guidance: Labels will reinforce that long- acting or extended-release opioids should only be considered when other treatments, including shorter- acting opioids, are inadequate. • Safe discontinuation: A reminder not to stop opioids suddenly in patients who may be physically dependent, as it can cause serious harm. • Overdose reversal agents: Additional information on medications that can reverse an opioid overdose. • Drug interactions: Enhanced warning about combining opioids with other drugs that slow down the nervous system—now including gabapentinoids. • More risks with overdose: New information about toxic leukoencephalopathy—a serious brain condition that may occur after an overdose. • Digestive health: Updates about opioid-related problems with the esophagus. There are no universal recommendations for the proper disposal of unused opioids, although efforts toward patient education on what to do with unused or expired medications
have increased in recent years. According to the FDA, the best way to dispose of most types of unused or expired medications (both prescription and over-the-counter) is to immediately use a take-back option, such as a designated take-back location or by mailing medications back using a prepaid drug mail-back envelope. As of April 2025, the FDA began requiring OA REMS Program Companies to provide prepaid mail-back envelopes upon request to pharmacies and other dispensers of opioid analgesics to improve proper and equitable disposal of this class of drugs [23]. If these options are not available, it is recommended to consult the list of medications recommended for disposal by flushing down the toilet. For example, the FDA recommends that certain medications, including oxycodone/acetaminophen (Percocet), oxycodone (OxyContin tablets), and transdermal fentanyl patches (Duragesic Transdermal System), be flushed down the toilet instead of thrown in the trash. Patients should be advised to flush prescription drugs down the toilet only if the label or accompanying patient information specifically instructs doing so. If medication is not on the flush list, it is recommended to mix the medication with an undesirable substance (e.g., cat litter, dirt, used coffee grounds), and put it into an impermeable, nondescript container (e.g., disposable container with a lid or a sealed bag) before throwing in trash at home. Any personal information should be obscured or destroyed [23; 24].
CONSIDERATIONS FOR NON-ENGLISH- PROFICIENT PATIENTS
For patients who are not proficient in English, it is important that information regarding the risks associated with the use of opioids and available resources be provided in their native language, if possible. When there is an obvious disconnect in the communication process between the practitioner and patient due to the patient’s lack of proficiency in the English language, an interpreter is required. Interpreters can be a valu- able resource to help bridge the communication and cultural gap between patients and practitioners. Interpreters are more than passive agents who translate and transmit information back and forth from party to party. When they are enlisted and treated as part of the interdisciplinary clinical team, they serve as cultural brokers who ultimately enhance the clinical encounter. In any case in which information regarding treat- ment options and medication/treatment measures are being provided, the use of an interpreter should be considered. Print materials are also available in many languages, and these should be offered whenever necessary. DISPARITIES IN PAIN MANAGEMENT At greatest risk of unrelieved pain from stigma and bias are children, the elderly, racial and ethnic minorities, active duty or military veterans, and those with cancer, HIV, or sickle cell disease. Pain undertreatment in Black patients is
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