Prescription Opioids: Risk Management and Strategies for Safe Use _ _________________________________ 19.5% were positive for an illicit drug/unreported opioid [130]. However, a negative UDT result for the prescribed opioid does not necessarily indicate diversion; it may indicate the patient halted its use due to side effects, lack of efficacy, or pain remis- sion. The increasingly stringent climate surrounding clinical decision-making regarding aberrant UDTs is concerning. In many cases, a negative result for the prescribed opioid or a positive UDT serves as the pretense to terminate a patient rather than an impe- tus to guide him or her into addiction treatment or an alternative pain management program [129]. In principle, and ideally in practice, UDTs are a worthwhile element of effective pain management and pharmacovigilance when used to enhance the diagnostic and therapeutic objectives of pain ther- apy. However, when UDT use is motivated by fear, coercion, or profiteering, patients may be offended or feel intimidated by the practice [129]. • Product-specific information • Taking the opioid as prescribed • Importance of dosing regimen adherence, managing missed doses, and prescriber contact if pain is not controlled • Warning and rationale to never break or chew/crush tablets or cut or tear patches prior to use • Warning and rationale to avoid other central nervous system (CNS) depressants, such as sedative-hypnotics, anxiolytics, alcohol, or illicit drugs • Warning not to abruptly halt or reduce the opioid without physician oversight of safe tapering when discontinuing • The potential of serious side effects or death • Risk factors, signs, and symptoms of overdose
and opioid-induced respiratory depression, gastrointestinal obstruction, and allergic reactions • The risks of falls, using heavy machinery, and driving • Warning and rationale to never share an opioid analgesic • Rationale for secure opioid storage • Warning to protect opioids from theft • Instructions for disposal of unneeded opioids, based on product-specific disposal information Disposal of Opioids There are no universal recommendations for the proper disposal of unused opioids, and patients are rarely advised of what to do with unused or expired medications [131]. According to the Office of National Drug Control Policy, most medications that are no longer necessary or have expired should be removed from their containers, mixed with undesirable substances (e.g., cat litter, used coffee grounds), and put into an impermeable, nondescript container (e.g., disposable container with a lid or a sealed bag) before throwing in the trash [132]. Any personal information should be obscured or destroyed. The FDA recommends that certain medications, including oxycodone/acetaminophen
As a side note, cannabis use by patients with chronic pain receiving opioid therapy has traditionally been viewed as a treatment agreement violation that is grounds for termination of opioid therapy. However, some now argue against cannabis use as a rationale for termination or substantial treatment and moni- toring changes, especially considering the increasing legalization of medical use at the state level [24]. PATIENT AND CAREGIVER EDUCATION Safe Use of Opioids Patients and caregivers should be counseled regard- ing the safe use and disposal of opioids. As part of its mandatory Risk Evaluation and Mitigation Strategy (REMS) for ER/LA opioids, the FDA has developed a patient counseling document with information on the patient’s specific medications, instructions for emergency situations and incomplete pain control, and warnings not to share medications or take them unless prescribed [114]. A copy of this form may be accessed online at https://www.fda.gov/ media/86281/download. When prescribing opioids, clinicians should pro- vide patients with the following information and instructions [114]:
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MDMS1526
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