Opioid Safety: Balancing Benefits and Risks _ _____________________________________________________
FEDERAL AND STATE LAW In response to the rising incidence in prescription opioid misuse, dependence, diversion, and overdose, in 2018 the FDA mandated opioid-specific REMS (i.e., Opioid Analgesic REMS or OA REMS) to reduce the potential negative patient and societal effects of prescribed opioids. Other elements of opioid risk mitigation include the FDA partnering with other governmental agencies, state professional licensing boards, and societies of healthcare professionals to help improve prescriber knowledge of appropriate and safe opioid prescribing and safe home storage and disposal of unused medication [18]. Several regulations and programs at the state level have been enacted in an effort to reduce prescription opioid abuse, diver- sion, and overdose, including [19]: • Physical examination required prior to prescribing • Tamper-resistant prescription forms • Pain clinic regulatory oversight • Prescription limits • Prohibition from obtaining controlled substance prescriptions from multiple providers • Patient identification required before dispensing • Immunity from prosecution or mitigation at sentencing for individuals seeking assistance during an overdose CONTROLLED SUBSTANCES LAWS/RULES The U.S. Drug Enforcement Administration (DEA) is respon- sible for formulating federal standards for the handling of controlled substances. In 2011, the DEA began requiring every state to implement electronic databases that track prescrib- ing habits, referred to as PDMPs. Specific policies regarding controlled substances are administered at the state level [19]. According to the DEA, drugs, substances, and certain chemi- cals used to make drugs are classified into five distinct categories or schedules depending upon the drug’s acceptable medical use and the drug’s abuse or dependency potential [20]. The abuse rate is a determinate factor in the scheduling of the drug; for example, Schedule I drugs are considered the most dangerous class of drugs with a high potential for abuse and potentially severe psychologic and/or physical dependence. STATE-SPECIFIC LAWS AND RULES Most states have established laws and rules governing the prescribing and dispensing of opioid analgesics. It is each prescriber’s responsibility to have knowledge of and adhere to the laws and rules of the state in which he or she prescribes.
Visit the NetCE website to view excerpts from specific state rules and regulations relating to the regulation of controlled substances, electronic PDMPs, enacted state legislation, and prescribing guidelines. https://www.netce.com/learning.php?page=activities&co urseid=3207. inter active activity
PATIENT EDUCATION ON THE USE AND DISPOSAL OF OPIOIDS Patients and caregivers should be counseled regarding the safe use and disposal of opioids. As part of its manda- tory OA REMS for extended-release/long-acting opioids (discussed later in this course), the FDA requires a patient counseling document with information on the patient’s spe- cific medications, instructions for emergency situations and incomplete pain control, and warnings not to share medica- tions or take them unprescribed. A copy of this form may be accessed online at https://www.opioidanalgesicrems.com/ Resources/Docs/patient_counseling_document.pdf [21]. When prescribing opioids, clinicians should counsel patients on the following [18]: • Importance of adherence to prescribed dosing regimen • Patients should use the least amount of medication necessary to treat pain and for the shortest amount of time • The risk of serious adverse events that can lead to death • The risk of addiction that can occur even when product is used as recommended • Known risk factors for serious adverse events, including signs and symptoms of overdose and opioid-induced respiratory depression, GI obstruction, and allergic reactions, among others • The most common side effects, along with the risk of falls, working with heavy machinery, and driving • When to call the prescriber (e.g., managing adverse events, ongoing pain) • How to handle missed doses • The importance of full disclosure of all medications and supplements to all healthcare professionals and the risks associated with the use of alcohol and other opioids/benzodiazepines
47
PAPA2126
Powered by FlippingBook