Prescription Opioids: Risk Management and Strategies for Safe Use _ _________________________________ Clinicians should provide physically dependent patients with a safely structured tapering protocol. Withdrawal is managed by the prescribing physician or referral to an addiction specialist. Patients should be reassured that opioid discontinuation is not the end of treatment; continuation of pain management will be undertaken with other modalities through direct care or referral.
FDA AMENDMENTS ACT OF 2007 The FDA Amendments Act (FDAAA) of 2007 gave the FDA authority to require REMS from manufac- turers to ensure that benefits of a drug or biological product outweigh risks. REMS replaced the previ- ously existing risk management programs, termed Risk Minimization Action Plans (RiskMAPs). An important distinction between the two programs is that the FDA did not have authority to require or enforce a RiskMAP after product approval. The FDA now has the authority to require REMS as part of the approval process for a new medication or post- approval if the agency becomes aware of new safety information pertaining to serious medication-asso- ciated risks following approval for marketing [114]. As defined by the FDAAA, REMS may include a medication guide, a patient education package insert, a communication plan, and other elements to assure safe use (ETASUs). ETASUs must address the goals to mitigate a specific serious risk listed in the labeling of the drug and may include [114]: • Prescriber training, experience, or certification • Distributor or dispenser training or certification • Restricted distribution or dispensing • Dispensing limited to patients with evidence of safe use conditions, such as laboratory test results • Patient monitoring • Patient enrollment in a registry • Physician and/or pharmacist enrollment in a registry The FDA maintains a list of current opioid analgesic REMS at https://www.accessdata.fda.gov/scripts/
The American Society of Interventional Pain Physicians recommends advising patients undergoing dosage titration in a trial of opioid therapy to avoid engaging in dangerous activities, such as driving a motor vehicle or the use of heavy machinery, until
a stable dosage is established and it is certain that the opioid dose does not cause sedation, as well as when taking opioids with alcohol, benzodiazepines, or other sedating drugs. (https://painphysicianjournal.com/current/pdf?article= NDIwMg%3D%3D&journal=103. Last accessed August 15, 2023.) Level of Evidence : Expert Opinion/Consensus Statement
COMPLIANCE WITH FEDERAL AND STATE LAWS OPIOID RISK EVALUATION AND MITIGATION STRATEGIES (REMS)
In response to the rising incidence in prescription opioid abuse, addiction, diversion, and overdose since the late 1990s, the FDA has mandated opioid- specific REMS to reduce the potential negative patient and societal effects of prescribed opioids. Another element of opioid risk mitigation is FDA partnership with other governmental agencies, state professional licensing boards, and societies of healthcare professionals to help improve prescriber knowledge of appropriate and safe opioid prescrib- ing and safe home storage and disposal of unused medication [123].
cder/rems/index.cfm [134]. SPECIFIC OPIOIDS WITH A REMS REQUIREMENT
In 2011, the FDA announced the components of REMS that would apply to all ER/LA opioid for- mulations. The decision to not include short-acting formulations was based on the substantially greater opioid amount in ER/LA formulations and the cor-
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MDMS1526
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