__________________________________________________ Responsible Prescribing of Controlled Substances
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 [60]. 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 [60]. The abuse rate is a determinate factor in the scheduling of the drug. Schedule I controlled substances have no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse. Some examples of substances listed in Schedule I are: heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), peyote, methaqualone, and 3,4-methylenedioxymethamphetamine (“Ecstasy”) [60; 61]. Schedule II/IIN substances have an accepted medical use but also a high potential for abuse, which may lead to severe psy- chologic or physical dependence. Examples of Schedule II/IIN narcotics include amphetamine, hydromorphone, methadone, meperidine, methylphenidate, oxycodone, fentanyl, morphine, opium, codeine, pentobarbital, and hydrocodone [60; 61]. Schedule III/IIIN controlled substances have a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psycho- logic dependence. Examples of Schedule III/IIIN narcotics include products containing not more than 90 mg of codeine per dosage unit (e.g., Tylenol with Codeine), buprenorphine, benzphetamine, phendimetrazine, ketamine, and anabolic steroids [60; 61]. Schedule IV controlled substances have a low potential for abuse relative to substances in Schedule III. Examples include alprazolam, carisoprodol, clonazepam, diazepam, lorazepam, midazolam, temazepam, and triazolam [60; 61]. Schedule V controlled substances have a low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics. Examples of Schedule V substances include ezogabine and cough preparations containing not more than 200 mg of codeine per 100 mL or 100 g [60; 61].
Patients with chronic pain found to have an ongoing substance abuse problem or addiction should be referred to a pain special- ist for continued treatment. If drug diversion has occurred, the activity should be documented and a report to law enforcement should be made. The DEA requires that registrants notify the Field Division Office of the Administration in his/her area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. This is followed by completion of DEA Form 106 and submission of that report to the DEA and the Board. With respect to the initial notification to the DEA, the New Orleans Field Division has established an email address to facilitate that report. Please direct your initial report of theft/loss of controlled substances to NOFD.theftorloss@DEA.gov. DEA 106 reports may also be submitted to the DEA electronically at https://www.deadiversion.usdoj.gov/21cfr_reports/theft/ theft-loss.html [57].
COMPLIANCE WITH STATE AND FEDERAL LAWS
In response to the opioid crisis and associated incidence in prescription opioid misuse, addiction, diversion, and overdose, in 2018 the FDA mandated 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 [45]. Several regulations and programs at the state level have been enacted in an effort to reduce prescription opioid abuse, diver- sion, and overdose, including [59]: • 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
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