Responsibilities and Requirements of Prescribing Schedule II Opioid Drugs _ ___________________________
available, it is also best practice to periodically request a report from the state’s prescription reporting program to evaluate the prescribing of opioids to your patients by other providers [49]. When dealing with patients suspected of drug seeking/diver- sion, first inquire about prescription, over-the-counter, and illicit drug use and perform a thorough examination [43; 49]. Pill counting and/or UDT may be necessary to investigate possible drug misuse. Photo identification or other form of identification and social security number may be required prior to dispensing the drug, with proof of identity documented fully. If a patient is displaying suspicious behaviors, consider prescribing for limited quantities [43]. If a patient is found to be abusing prescribed opioids, this is considered a violation of the treatment agreement and the clinician must make the decision whether or not to continue the therapeutic relationship. While dentists have the option of withdrawing from a case, they should notify the patient (or authorized decision maker) long enough in advance to permit the patient to secure another care provider and facilitate transfer of care, when appropriate [42]. Patients may also be given resources and/or recommendations to help them locate a new dentist. Patients with chronic pain found to have an ongoing substance abuse problem or addiction should be referred to a pain spe- cialist for continued treatment. Theft or loss of controlled substances is reported to the DEA. If drug diversion has occurred, the activity should be documented and a report to law enforcement should be made [38]. CONSIDERATIONS FOR PATIENTS UNDERGOING TREATMENT FOR OPIOID USE DISORDER Medication-assisted therapy for the treatment of opioid use dis- order often includes the use of buprenorphine, which reduces withdrawal symptoms and the desire to use opioids without causing the cycle of highs and lows associated with opioid misuse. The comprehensive approach of buprenorphine com- bined with counseling and other behavioral therapies is often one of the most effective ways to treat opioid use disorder [27]. However, buprenorphine is highly acidic, and dental problems have been reported with orally dissolving buprenorphine- containing formulations, including increased risk for tooth decay, cavities, oral infections, and loss of teeth. These complications can be serious and have been reported even in patients with no history of dental issues. Despite these risks, buprenorphine is an important treatment option for opioid use disorder and pain, and the benefits of these medicines clearly outweigh the risks. The American Dental Association recommends instruct- ing patients taking oral buprenorphine therapy should be instructed to rinse their mouths 30 minutes after use of a strip/tab [30]. After one hour, patients should brush their teeth. These patients should also be instructed to adhere to good oral hygiene practices and to drink more water to combat potential xerostomia. Sugary beverages and smoking/vaping
should be limited or avoided, if possible. Prescription fluoride toothpaste or trays should be considered [30]. It is also essential to consider the impact of medication- assistant opioid use disorder treatment on dental pain man- agement. Naltrexone is an opioid antagonist and will block the action of opioids used to manage dental pain. In addition, buprenorphine/methadone therapy increases patients’ toler- ance for other opioids. Any dental pain management plans should take these potential issues into account.
REGULATORY REQUIREMENTS FOR PRESCRIBERS AND DISPENSERS
COMPLIANCE WITH STATE AND FEDERAL LAWS
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. Other elements of opioid risk mitigation include 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 [24]. Several regulations and programs at the state level have been enacted in an effort to reduce prescription opioid abuse, diver- sion, and overdose, including [37]: • 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 [36]. 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 [35]. The abuse rate is a determinate factor in the scheduling of the drug; for
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