Responsible and Effective Opioid Prescribing _ ____________________________________________________
CONTROLLED SUBSTANCES LAWS/RULES The U.S. Drug Enforcement Administration (DEA) is responsible for formulating federal standards for the handling of controlled substances. In 2011, the DEA began requiring every state to implement electronic databases that track prescribing habits, referred to as PDMPs. Specific policies regarding controlled substances are administered at the state level [62]. According to the DEA, drugs, substances, and certain chemicals 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 [63]. 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.
All treatment approaches share the common goal of improving health outcomes and reducing drug-related criminality and public nuisance [64]. CRISIS INTERVENTION In response to acute overdose, the short-acting opioid antagonist naloxone is considered the criterion standard. Naloxone is effective in reversing respiratory depression and coma in patients who have overdosed. There is no evidence that subcutaneous or intramuscular use is inferior to intravenous naloxone. This prompted discussion of making naloxone available to the general public for administration outside the healthcare setting to treat acute opioid overdose, and in 2014, the FDA approved naloxone as an autoinjector dosage form for home use by family members or caregivers [65]. The autoinjector delivers 0.4 mg naloxone intramuscularly or subcutaneously. The autoinjector comes with visual and voice instruction, including directs to seek emergency medical care after use [65]. In 2015, the FDA approved intranasal naloxone after a fast-track designation and priority review. Intranasal naloxone is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. It is available in a ready-to-use 2-mg, 4-mg, or 8-mg single-dose sprayer [66; 67; 68]. In 2023, the FDA approved Narcan, the first over-the-counter naloxone nasal spray [69]. Narcan is available as a 3-, 4-, or 8-mg single dose, administered in one nostril [70]. HARM REDUCTION Harm reduction measures are primarily employed to minimize the morbidity and mortality from opioid abuse and to reduce public nuisance [38; 71]. As a part of this effort, measures to prevent and minimize the frequency and severity of overdoses have been identified. Enrollment in opioid substitution therapy, with agents such as methadone and buprenorphine, substantially reduces the risk of overdose as well as the risk for infection and other sequelae of illicit opioid use [38; 71]. DETOXIFICATION AND WITHDRAWAL The process of tapering patients with opioid dependence from agonist therapy is often referred to as detoxification, or more accurately, medically supervised withdrawal [72; 73]. Its purpose is to eliminate physical dependence on opioid medications. It can be considered the medically supported transition to a medication-free state or to antagonist therapy. A careful and thorough review of the risks and benefits of detoxification should be provided, and informed consent obtained from patients prior to choosing this option [73; 74]. Detoxification alone should not be considered a treatment and should only be promoted in the context of a well-planned relapse-prevention program [64; 73]. Studies have shown that most patients with opioid use disorder who undergo medically supervised withdrawal will start using opioids again and will not continue in recommended care [75; 76; 77; 78; 79].
MANAGEMENT OF OPIOID USE DISORDER
Management of opioid dependence entails different methods to achieve different goals, depending on the health situation and treatment history of the patient. These treatment approaches include [64]: • Crisis intervention: Directed at immediate survival by reversing the potentially lethal effects of overdose with an opioid antagonist. • Harm reduction: Intended to reduce morbidity and mortality associated with use of dirty needles and overdose. • Detoxification/withdrawal: Aims to remove the opioid of abuse from the patient’s body, either through gradual taper and substitution of a long-acting opioid or through ultra-rapid opioid detoxification. • Maintenance treatment or opioid (agonist) replacement therapy: Aimed at reduction/elimination of illicit opioid use and lifestyle stabilization. Maintenance follows detoxification/withdrawal, whereby the patient is tapered from short-acting opioids and introduced to a long-acting opioid agonist, such as methadone or buprenorphine. Patients remain on agonist therapy short-term, long-term, or indefinitely depending on individual needs. • Abstinence-oriented therapy: Treatment directed at cure. The patient is tapered off of short-acting opioids during the detoxification/withdrawal process and may be placed on an opioid antagonist with the goal of minimizing relapse.
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MDTX1625
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