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Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Notices
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Issue: DEA received numerous comments expressing concerns that DEAs reduction of quotas for painrelieving controlled substances does not correlate to a reduction in overdose deaths. According to the commenters, DEA and CDC data show that illicit fentanyl and heroin are responsible for the majority of overdose deaths. The commenters state that overdose deaths in the U.S. continue to rise because of illegal fentanyl, heroin, and illegally manufactured pain pills, not from pharmaceutical medications prescribed to chronic pain patients.
DEA Response: In establishing the APQ, DEA considers the legitimate medical need in the United States. DEA
strives to ensure that the APQs are sufficient to provide for the legitimate controlled substance prescription requirements while limiting the potential for diversion of controlled substances. DEA also considers changes in currently accepted medical use in treatment as part of the determination of legitimate medical need, and establishes the APQ for specific controlled substances accordingly. 21 CFR
1303.11b7.
Use of PDMP Data in Identifying Potential Diversion Issue: DEA received numerous comments that raised questions regarding DEAs use of prescriptions filled for the five covered controlled substances in dosages exceeding 240
morphine milligram equivalents MME
daily as a potential indicator of diversion. The commenters noted that CDC has published guidelines that recommend prescribers consider the medical necessity of exceeding a daily dosage limit of 90 MME. The State Attorneys General also asked whether, in flagging prescriptions that exceed 240
MME daily, DEA considered individual prescriptions, or considered combined prescriptions for patients at any given time.
DEA Response: DEA did not consider prescriptions written for the five covered controlled substances in quantities lower than 240 MME daily because some patients, including oncology patients in particular, have legitimate medical needs for covered controlled substance prescriptions in excess of 90 MME daily. DEA did not wish to inadvertently include legitimate prescriptions for these patients in its calculation of diversion. Daily dosages higher than 240 MME place individuals at a higher risk of overdose and death, and correlate with a heightened risk of diversion. DEA received aggregated data from state PDMPs that reflected only individual prescriptions.

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Issue: Commenters asked whether the PDMP data responses from the states covered all time periods requested. If they did not, how did DEAs calculations account for missing data?
DEA Response: All responding states provided summarized PDMP data for 20182020, the entire time period requested by DEA.
Issue: Some commenters, including the State Attorneys General, expressed concerns that the PDMP data obtained from responding states that DEA used to identify diversion does not represent the entire U.S. population accurately.
DEA Response: DEA requested data through the National Association of State Controlled Substances Authorities NASCSA, which includes the fortynine member states that utilize PDMPs.
As indicated in the proposed APQ, DEA
did not receive PDMP data from all queried states for use in its determination of diversion. The sixteen states and one county providing PDMP
data represent a geographically diverse cross-section of 78.5 million people, or 24 percent of the United States population. Based on publicly available, established statistical methods for sampling very large populations, polling approximately 10 percent of a given large population provides enough statistical power to draw reliable inferences about the population. A
sample size of 24 percent therefore is large enough to accurately generalize that data outcome to the whole population of the United States and to be used in the calculation of estimated national levels of diversion of the covered controlled substances.
Issue: Commenters raised questions regarding patient privacy issues relating to the PDMP data provided to DEA by states.
DEA Response: DEA requested and received anonymized, aggregated PDMP
data from the states. No individual patient names, addresses, or other discrete, personally identifiable information was shared with DEA.
Issue: The State Attorneys General commented that DEA should have used patient address information from the PDMP data to determine a metric for potential diversion based on geographic distances between patient, prescriber, and pharmacy.
DEA Response: DEA did not request, nor did it receive, any state PDMP data that included individualized identifying data such as patient addresses.
Issue: DEA received comments that raised questions about the accuracy of PDMP data regarding patients current and discontinued use of opioid prescriptions containing the covered
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controlled substances within discrete time periods.
DEA Response: DEA requested aggregated PDMP data for filled prescriptions containing the five covered controlled substances. In many instances, prescriptions that are filled but not used by patients create the potential for diversion because of the opportunity for misuse by non-patients.
The most common sources of misused pharmaceutical opioids are family and friends. The Substance Abuse and Mental Health Services Administrations 2019 National Survey on Drug Use and Health Annual National Report published data demonstrating that more than half 50.8
percent of people who self-reported misusing prescription pain relief medicine obtained their most recent pain reliever from a friend or relative, either for free, by purchase, or by taking without asking. Such misuses of prescriptions constitute diversion.
Issue: One commenter questioned whether it is appropriate to use data showing instances of patients receiving specific controlled substance prescriptions issued by three or more doctors within a 90-day period as a metric to determine potential diversion.
DEA Response: DEA developed the metric of patients prescribed covered controlled substances from three or more prescribers in a 90-day period to identify potential doctor shopping, a common technique used to obtain large amounts of controlled substances for the purpose of abuse or diversion. Federal administrative and criminal case law demonstrates that multiple prescriptions from multiple prescribers in a short timeframe is a reliable indicator of diversion.2
Issue: DEA received comments from the State Attorneys General and the general public questioning whether DEA
derived its diversion estimates from individual prescriptions paid for with cash, and if entire classes of prescribers or pharmacies with large cash transactions were excluded.
DEA Response: DEA received reports from state PDMP administrators which were designed by NASCSA to respond to DEAs request for aggregated information. The reports contained the number of patients and prescriptions that met each of the diversion metrics DEA identified. These reports did not include individualized information that would be contained on prescriptions.
DEA did not consider whether this data 2 The Medicine Shoppe, 29 FR 59504, 59507, 5951213 2014; Holiday CVS, LLC, d/b/a CVS
Pharmacy Nos. 219 and 5195, 57 FR 62316 2012.

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