Opioid abuse

The U.S. Drug Enforcement Agency has released its notice of proposed rulemaking for a framework to permit medically necessary controlled substances without an in-person visit without violating the Ryan Haight Online Pharmacy Consumer Protection Act. WHY IT MATTERS The NPRM comes two months after the DEA and U.S. Health and Human Services announced they extended the pandemic-era virtual prescribing of controlled substances a third time . The most recent extension of COVID-19 flexibilities for prescribing runs through 2025. "DEA has determined that the best course of action to ensure patient access to care, while maintaining sufficient safeguards to prevent and detect diversion of controlled substances, is to establish and maintain a regulatory scheme," the agency said in the notice published Wednesday. To prevent patients from losing access to their telehealth-prescribed medications, the DEA is offering three types of special registration: Telemedicine Prescribing Registration: authorizes qualified clinician practitioners to prescribe Schedule III-V controlled substances. Advanced Telemedicine Prescribing Registration: authorizes qualified specialized clinician practitioners to prescribe Schedule II-V controlled substances. Telemedicine Platform Registration: authorizes qualified covered online telemedicine platforms – in their capacity as platform practitioners – to dispense Schedule II-V controlled substances. "Once properly registered under the Special Registration framework, clinician practitioners would be considered clinician special registrants and covered online telemedicine platforms, in their capacity as platform practitioners, would be considered platform special registrants," DEA explained. While DEA has been "diligent" in its efforts, getting the framework "right for the millions of patients impacted by these actions" is critical, Kyle Zebley, senior vice president of public policy for the American Telemedicine Association and executive director of ATA Action, said in a letter Tuesday. The letter, to DEA Administrator Anne Milgram and Tom Prevoznik, assistant administrator for diversion control, calls on the agency to establish a workgroup to create the framework. "While we are still digesting the DEA’s Special Registration framework, and will have a comprehensive analysis shortly, it is clear that these updates carry significant implications for the telehealth community," Zebley said in a written reaction to the NPRM Wednesday. "Early indications suggest the proposed rule includes elements that represent significant operational challenges," he noted. DEA said in the notice that registering covered online telemedicine platforms under the third special registration "is necessary given the pivotal role they sometimes play in the delivery of healthcare through telemedicine." The agency, concerned about "doctor shopping," said that "the lack of proper oversight and verification of clinician practitioners’ credentials" can open a door "bad actors" could take advantage of. "While these covered online telemedicine platforms may improve healthcare accessibility by connecting patients with clinician practitioners, their emergence also brings more, and sometimes easier, avenues to divert or abuse controlled substances, particularly when such entities have financial incentives tied to prescriptions and/or do not adequately screen the clinician practitioners utilizing their system or platform." The Alliance for Connected Care said in a statement that it is "very concerned to see language in the proposed rulemaking mandating what portion of patient care can be offered through telemedicine" and deemed it an inappropriate guardrail. "Limiting the proportion of Schedule II prescriptions issued through telemedicine would help to manage the risks associated with the prescribing of Schedule II controlled substances by ensuring that a significant portion of these prescriptions are issued following in-person medical evaluations, which can provide a more comprehensive assessment of the patient’s medical history and condition than can be done remotely," DEA said in the NPRM. "Restricting the geography in which telemedicine can be offered undermines the value of creating virtual access for those patients who need it most," the alliance said. DEA is accepting comments on the proposed telehealth prescribing registry framework through March 15. THE LARGER TREND Without a third extension before the end of 2024 , the expiration of telehealth prescribing flexibilities would have required patients to have an in-person visit with a provider within 30 days or lose access to medications. Lawmakers urged the agency to act in an October letter addressed to Milgram. Along with numerous industry groups, lawmakers have also been concerned that restrictions would result in a return to access barriers many patients experienced before the pandemic. DEA's initial 2023 draft rule to make some telehealth prescribing flexibilities permanent would have required affected patients to have in-person exams, but a litany of healthcare industry groups and observers argued a return to pre-pandemic prescribing rules would risk patient harm. Industry groups and lawmakers have also long questioned why a registry for telemedicine providers similar to the existing prescribing of controlled substances system had not already been created. They have said that the agency has a responsibility to create one under the 2018 Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act. In 2023, the agency held Telemedicine Listening Sessions to facilitate stakeholder engagement centered on what would be needed to create a special registration for telehealth prescribers and held a second comment period on its draft rule. According to DEA’s docket, Telemedicine Prescribing of Controlled Substances has received 35,470 comments. On Friday, DEA said it will also publish a rulemaking on Expansion of Buprenorphine Treatment via Telemedicine Encounter . According to the American Hospital Association, the final rule will allow providers to prescribe a six-month initial supply to treat opioid use disorder via audio-only telemedicine interaction without a prior in-person evaluation. "Requirements for the special registration proposed rule would not apply to clinicians prescribing buprenorphine for OUD," AHA said in a statement . ON THE RECORD "DEA’s goal is to provide telehealth access for needed medications while ensuring patient safety and preventing the diversion of medications into the illicit drug market," said Milgram Thursday in a statement. "We understand the difficulties some patients have accessing medical providers in-person, and we want to ease this burden while also providing safeguards to keep patients safe. "These rules also mark a significant step forward for patient safety by requiring online telemedicine platforms to register with DEA and taking steps to establish a nationwide Prescription Drug Monitoring Program," she added. Andrea Fox is senior editor of Healthcare IT News. Email: afox@himss.org Healthcare IT News is a HIMSS Media publication.

THURSDAY, Jan. 16, 2025 -- For individuals reporting cannabis use, the odds of opioid misuse are reduced among individuals in states with medical cannabis legalization (MCL), according to a study published in the February issue of the International Journal of Drug Policy . Silvia S. Martins, M.D., Ph.D., from the Columbia University Mailman School of Public Health in New York City, and colleagues used data from the National Survey on Drug Use and Health from 2015 to 2019 to estimate cannabis law associations with opioid misuse and use disorder. The researchers observed no associations for MCL or recreational cannabis legalization (RCL) with changes in the odds of any opioid outcome overall. Decreased odds of past-year opioid misuse were seen among individuals in states with MCL versus those without cannabis laws, after restricting the analyses to respondents reporting past-year cannabis use (adjusted odds ratio, 0.57). There was no association seen for RCLs with changes in the odds of any opioid outcome beyond MCL adoption. "One important issue to consider is that compared to MCLs, relatively fewer states have adopted RCLs+MCLs, and most laws have been adopted within the past decade," Martins said in a statement. "Therefore, the impact of RCLs+MCLs may become clearer as more states adopt these laws and as post-law observation time accumulates."

MONDAY, Jan. 13, 2025 -- Fifteen candidate genetic variants account for only 0.40 percent of variation in opioid use disorder (OUD) risk, according to a study published online Jan. 9 in JAMA Network Open . Christal N. Davis, Ph.D., from the Crescenz Veterans Affairs Medical Center in Philadelphia, and colleagues examined the utility of 15 genetic variants from an algorithm intended to predict OUD risk in a case-control study using electronic health record data, which were accrued from 452,664 participants with opioid exposure in the Million Veteran Program across the United States. The researchers found that the 15 candidate genes accounted for 0.40 percent of the variation in OUD risk, while age and sex accounted for 3.27 percent of the variation. Using the 15 variants as predictive factors, the ensemble machine learning model correctly classified 52.83 percent of individuals in an independent testing sample. "Findings of this case-control study suggest that candidate genetic variants from the approved genetic risk algorithm do not meet standards of reasonable clinical efficacy in assessing risk of opioid use disorder," the authors write. "Because genetic risk models in psychiatry will continue to emerge and could prove clinically useful, it is crucial that researchers and regulatory agencies adopt rigorous standards for developing and evaluating them prior to their application in clinical settings." Several authors disclosed ties to the biopharmaceutical industry; several authors reported holding relevant patents or having patents pending. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.