Implementation of the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act:  Dispensing and Administering Controlled Substances for Medication-Assisted Treatment
2021-01-04 2020-11-10 2020-12-22 2021-01-05 2021-01-04 2021-01-04 2020-11-23 2020-11-12 2020-12-22
DEA-2020-0031-0045 DEA-2020-0031-0002 DEA-2020-0031-0031 DEA-2020-0031-0055 DEA-2020-0031-0039 DEA-2020-0031-0046 DEA-2020-0031-0011 DEA-2020-0031-0008 DEA-2020-0031-0033
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https://api.regulations.gov/v4/comments/DEA-2020-0031-0045 https://api.regulations.gov/v4/comments/DEA-2020-0031-0002 https://api.regulations.gov/v4/comments/DEA-2020-0031-0031 https://api.regulations.gov/v4/comments/DEA-2020-0031-0055 https://api.regulations.gov/v4/comments/DEA-2020-0031-0039 https://api.regulations.gov/v4/comments/DEA-2020-0031-0046 https://api.regulations.gov/v4/comments/DEA-2020-0031-0011 https://api.regulations.gov/v4/comments/DEA-2020-0031-0008 https://api.regulations.gov/v4/comments/DEA-2020-0031-0033
Emily Rick Representative wayne Christopher William Ricquitta Michaela Nathan Angela
Zadvorny Chavez Sasser Von zwehl Santoro Johnson Jackson Trueger Williamson
To Whom it May Concern,The Colorado Pharmacists Society, a 501c(6) organization representing pharmacy professionals (pharmacists, technicians and interns) in the state of Colorado would like to take the opportunity to SUPPORT the following with respect to the Interim Final Rule:Administration of long-acting injectables by non-data waived practitioners.  Ask for the DEA to confirm that non-data waived health-care practitioners (HCPs) can administer long acting injectable forms of controlled substances subject to having a prescription data waived HCP.Pharmacists ability to administer long-acting injectables.  Ask the DEA to confirm that pharmacists are considered HCPs and that they can (subject to state laws) administer long-acting forms of injectable controlled substances subject to having a prescription from a data waived HCP for the patient.   This confirmation is especially import for rural patients who are more likely close to a pharmacy than a data waived HCP.  This also makes sense given the rise of telemedicine that has taken place during the COVID19 pandemic Thank you,Emily Zadvorny, PharmD, BCPSExecutive DirectorColorado Pharmacists Society 11 / 02 / 2020 COMMENTS:  I have practiced medicine for 37 years and currently, I am the Chief Medical Officer at Urgent Point in Los Angeles, CA.  I have been a DATA 2000 provider since 2001 and I have successfully treated thousands of patients over 20 years who suffer with chronic pain disorders and opioid use disorder.  Over 20 years, my perspective on the treatment of opioid use disorder utilizing MAT has become more realistic because I have observed a dysfunctional medical system misunderstand the general approach to the treatment of opioid addiction.There is no doubt that we do not have enough providers to treat opioid addiction.  However, the problem is more complex and just allowing more providers to treat more patients will not necessarily reduce our countries epidemic of opioid use disorder.  Currently 4% of the worlds populations in the United States consumes 80% of the opioids produced by our world.   Unfortunately, many of the providers who undergo training on the use of MAT do not fully understand that opioid use disorder is a condition that requires at minimum 6 months treatment and often requires a longer period of time.  Unfortunately, opioid addiction treatment has been treated as though opioid addicts are similar to alcoholics and residency training and AA oriented treatment programs in the United States have resulted in the emphasis being that addicts must approach their opioid addiction from an AA behavioral emphasis and this has caused many opioid addicted individuals to be undertreated because providers insisted on rapid tapering off BUPRENORPHINE early in treatment or forced patients to use lower doses of BUPRENORPHINE early in therapy.   It is this emphasis that has resulted in opioid addicts early relapse and re-addiction to opioid drugs. MAT should be offered as chronic therapy, like we treat all other chronic disorders ie. Diabetes, hypertension, heart disease, headaches, etc.  The average treated individual is on 16 mg daily of BUPRENORPHINE to reduce 90% or more of opioid craving.  It is only while opioid craving is extinguished that addicts are able to change behavior over time.  The danger in the DEA changes is that more providers will be created and it will be easier to provide therapy but, if attitudes remain the same, we may say increased misuse and diversion.  Our system of addiction treatment spends more money on keeping patients in residential treatment than to just treat people and monitor them as outpatients.  In Europe, providers treat patients for years and rigidly control the use of prescriptions with the primary care physician in control.  In the U.S. the only drug that needs to be dispensed from the office is SUBLOCADE.  In residential treatment, physicians can prescribe SUBOXONE for dispensing under rigid prescription controls.  At discharge, the pharmacy should be the dispensing entity, not the physician provider.  I am glad that the DEA is changing the dynamics of access to treatment but, the overall approach to treatment must undergo a coordinated management approach that includes provider education and a focus that emphasizes necessary therapeutic approaches rather than to add cost to treatment  by forcing unneeded cookie cutter AA management requirements.  It is important to remember that Methadone is a form of MAT and the only requirement is to present to the clinic daily.  AA management is not required.  Buprenorphine is a better alternative because it is one of the safest medications ever produced.  The insistence on AA philosophy over medication therapy has resulted in rigid treatment.  Patients on an average of 16 mg daily will have opioid craving blocked and can change behavior without having to fight the opioid craving that drives addictive behavior.  Providers should focus on monitoring of care and maintaining sobriety over forcing AA attendance.   The primary point is that BUPRENORPHINE dispensing really doesnt require inpatient or residential treatment for the most part.  As Methadone treatment has proven, it is the blocking of opioid craving that is the primary effect of MAT.  I hope that my comments are helpful and provide a rationale observation regarding how opioid use disorder treatment should be viewed.  Opioid addiction treated from the primary care office, like we treat most chronic disease is how we will successfully address our current epidemic of opioid addiction.  It will be much less costly and more effective if we focus on how MAT should be instituted.  The Residential treatment and addiction treatment center political lobby are focused on the most-costly therapies and will only perpetuate the current ineffectual opioid treatment approaches.  Any changes in the prescribing of MAT must include an aggressive education program for providers that is uniquely mandated for the treatment of opioid use disorder. Thank you and I am happy to continue this in-depth discussion in the future.Sincerely,Rick Chavez, M.D. As the only pharmacist in the North Carolina General Assembly I believe North Carolina is on the frontline of the opioid crisis. One proven solution is the use of long acting injectable formulations of buprenorphine. It is vital that all individuals diagnosed with opioid use disorder have the necessary access to important forms of medication for treatment. The interim final rule currently contains unnecessary restrictions that would hinder patient access. First, the fourteen-day rule does not take into account that it may take longer than 14 days to arrange for a patient to visit a clinic to receive the injection or that currently medications obtained via buy-and-bill options are permitted to be stored for periods far exceeding 14 days. In order to ensure proper access, the ability to store injectable medications should be extended to at least 60-days.Secondly, in many instances, data 2000 waived practitioners, while able to prescribe injectable buprenorphine, may not have a facility to administer the injections. To accommodate this, non-data waived practitioners should be permitted to administer injections ordered by a data waived provider. This should include pharmacists who may administer injections ordered by data waived providers. This can ensure that patients in rural areas, residential care facilities, and those receiving regular treatment via telemedicine can receive life-saving medication to treat their opioid use disorder.  January 4, 2021Drug Enforcement AdministrationAttn: DEA Federal Register Representative/DPW8701 Morrissette DriveSpringfield, VA  22152-2639 RE: Notice of Proposed Rulemaking Request for Comments-Implementation of the Substance Use Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018: Dispensing and Administering Controlled Substances for Medication Assisted Treatment (SUPPORT Act of 2018)RIN 1117-AB55/Docket No. DEA-499Scripps Safe, a leader in pharmaceutical and controlled substance anti-diversion solutions, fully supports expanded access to opioid recovery and treatment for patients and communities.  Scripps Safe is concerned that the proposed regulations do not require adequate physical security to prevent controlled substance diversion for OTPs (Opioid Treatment Providers, one of our largest markets), so we offer some specific recommendations.  By considering and implementing our recommendations, the Drug Enforcement Administration (DEA) will provide greater control, transparency and accountability by OTPs storing, inventorying, dispensing, administering, and disposing of the controlled substances they handle. Overall, many of the applicable regulations (21 C.F.R.  1301.72-.76) governing controlled substance security are outdated and subject OTP facilities to increased risk for diversion as stated.  We have found that diversion is common in the OTP space due to lack of guidance and codification of requiring current available sophisticated technologies by over 20 vendors.  Currently diversion occurs among 12-14% of healthcare practitioners, mid-level practitioners and non-practitioners costing our nation countless lives and some $78.5 + billion a year.   Employee pilferage accounts for roughly 48% of pharmacy thefts.   DEA should enhance controlled substance security requirements through a robust program utilizing the latest technologies for OTP services and for all registrants security handling requirements. Updating simple, very low-cost, widely and commercially available solutions would strengthen the proposed regulations by protecting against diversion.  As an example, allowing a currently DEA approved Group 1R combination dial lock on a UL Listed narcotics boxes carrying multiple units of Suboxone, Methadone, Ketamine or Buprenorphine with access by several medical professionals as outlined in this proposed rulemaking, lacks adequate accountability and control.  We suggest that DEAs outdated regulations be enhanced by requiring the following to support robust treatment access to patient care program while minimizing the risk of diversion:Purpose-built pharmacy and narcotics safes with UL Type 1 electronic access control systems with cloud or PC based software for managing and auditing all lawful users for reporting and accountability. Records should be pulled monthly and kept for two years.Low-cost electronic inventory control that complies with the Drug Supply Chain Security Act (Track  Trace/ Chain of Custody Control) and state laws to prevent adulteration and/ or substitution. Records should be pulled monthly (or as per updated state regulations) and kept for two years. Additional security features such as constant supervision video surveillance and monitoring to meet most state health codes. Video storage for up to two years. To ensure a seamless transition, we recommend that these additional measures be temporarily exempt for facilities that currently have an existing dial combination locking security safe in place and allow them to keep those storage and/ or dispensing units until they fail or up to twelve months after implantation of the proposed regulation, whichever occurs first. The combination Group 1R locks can inexpensively be swamped out onsite in less than one hour with a new electronic UL Type 1 by over 3,500 licensed locksmiths throughout the USA for only a few hundred dollars in total. In addition, OTPs should be required within the next 12 months to transition over to electronic record keeping with monthly audit logs to track inventory and administration of controlled substances. If utilizing a hub (pharmacy or central narcotics storage) and spoke model (treatment facilities), especially those with multiple locations, this information should be centralized with the responsible individual on the DEA registration or the authorized designee.  Such IP technology is readily available to push/pull this data via an IP/ WiFi network to provide greater constant supervision and oversight when licensed healthcare professionals constantly move around facilities as needed. Safe Scripps appreciates the opportunity to comment on DEAs proposed OTP regulations. We look forward to working with the DEA in the future on this and CSA security issues. Respectfully Submitted,Christopher von Zwehl, MASVP/ RX Security Expert1-844-4Safe-Rx (472-3379)chrisvz@scripps-safe.com www.4SafeRx.com The united States is no doubt in the middle of an opioid crisis.  The acceptance of medication assisted therapy by providers, patients, insurance companies and the general public is long overdue.  We now have several excellent options including naltrexone, buprenorphine and methadone.  The most recent advance is the availability of long acting injectable buprenorphine.  The restriction known as the 14 day rule puts undue burden on the use of this valuable product.  Often times a patient is unable to be scheduled in the 14 day window of opportunity.  Further complicating this situation is the soon to be available weekly injectable product.  It is my understanding that this product will be shipped with 4 (four) separate weekly injections.  The 14 day rule would hinder all but the use of the first injection in this situation. A reasonable solution would be to extend the allowance to 60 days.  Most patients are transitioned from sublingual to the injectable buprenorphine and a stable patient is commonly given anywhere from 7 to 60 days worth of medication until the next appointment.  By extending the 14 day rule to a 60 day rule, there would be sufficient time for the patient and provider to arrange a regular follow up after the product is received by the provider.Furthermore, for the past several years pharmacists have successfully administered multiple other medications prescribed by physicians.  The administering of injectable buprenorphine by pharmacists appropriately trained should be considered for this as well.  There are many physicians who are DATA-2000 wavered who do not have the staffing to administer the medication.  Others will find that it is much more convenient for the patient to receive their medication at the pharmacy and continue with their follow up at their physicians office for care of their opioid use disorder.We should be exploring ways to remove barriers to care for this disease while maintaining excellent and appropriate service and follow up by well trained providers.   RIN 1117-AB55-DEA-499 Joseph DuranDirector of Policy and PlanningUS Department of Veteran Affairs 3773 Cherry Creek North DriveDenver, CO 80209RE: AQ31-Proposed Rule - Elimination of Copayment for Opioid Antagonists and Education on Use of Opioid Antagonists (Docket ID: VA-2020-VHA-0023) Thank you for the opportunity to comment on the proposal to eliminate copayments for Opioid Antagonists and Education on the Use of Opioid Antagonists. As a Masters of Public Health candidate, and a harm reduction advocate, I am writing to encourage this rule to be passed.I applaud the DVA for bringing this topic to the attention of regulators. This is an issue that is critical to public health and the future of our nation. For decades, the opioid crisis in the United States has devastated communities, and the Veteran population has not been exempt. Opioids are highly addictive and have historically been prescribed to veterans to help them manage chronic pain. Research has shown that Veterans have a higher risk of harm due to opioids and accidental poisonings when compared to non-veterans. From 2010-2016, the overdose rate from opioids rose by nearly 10% within the Veteran community. We have the tools and the power to reduce mortality and morbidity rates associated with this crisis, and they should all be fully utilized to prevent more deaths. Aligned with Federal RulesSince 2016, federal rules have allowed for the considerations in this document. The proposed amendment would simply solidify what is already agreed upon by several government agencies, and make it easier for veterans to access the care they need. By being in agreement with the current laws, DVAs proposal could eliminate a significant barrier to care while upholding their commitment to protect Veterans. Additionally, the proposed definition of a high-risk Veteran is broad, and captures a diverse range of Veterans who benefit greatly from this clarification. Current Barriers to Care - Providers Play a Role The Veterans Health Administration reports that less than 35% of patients with an opioid use disorder are prescribed treatments, including opioid antagonists, despite data that shows their effectiveness to save lives. This is due to several barriers that include a lack of education about these treatments, provider stigma, and providers perception of lack of patient interest. Providers can be considered the gatekeepers to prescription drugs, and should be properly educated on the communities they serve to minimize harm. Therefore, provider education should also be included in the amendments to the education rule. Providers who serve veterans should have mandatory education on how the Veteran community is specifically impacted by the opioid crisis, and how to assess when a person may need an opioid antagonist. Furthermore, the education component of the amendment will help patients learn how to advocate for themselves, and teach individuals how to be more comfortable with using the medication properly. Affordability Saves LivesThe elimination of copayments is a fantastic policy to make sure is followed. Data shows that poverty within the Veteran community has been steadily rising, which can impact how people can afford medications and treatments. Amongst Veterans 18-34, the poverty rate is 12% compared to 9% of Veterans ages 35-54. However, Veterans 68% and older have a poverty rate of 48% - the highest of all age groups. These two numbers are essential to highlight for several reasons. In the US, people over 26 years of age are most likely to use prescription opioids, which places them at risk for opioid use disorder. Additionally, veterans 65 and older likely have comorbidities and are at increased risk for chronic pain. Additionally, Veterans aged 50 and older have the highest suicide rates amongst the population. DVA reports that opioids played a role in over 40% of all suicide and opioid deaths in 2017.  When these facts are compounded with the growing poverty rates in these age groups, there should be significant worry about Veterans being able to afford their life-saving treatments. Ensuring that the policy to not charge a copay for opioid treatments is critical to the health of this community.  Free education and access to opioid antagonists are essential to preventing accidental deaths, and decreasing morbidity.  The barriers to medical-assisted treatment (MAT) are unfortunate and illogical. I recognize that some of this may be statutory rather than regulatory, but as a practicing emergency physician it is very odd that with standard training and a DEA license, I can prescribe opioid analgesics that lead to substance use disorder but not the substantially safer medications to help treat substance use disorder. Any regulatory barriers to MAT should be lowered as much as possible as the impact of the opioid epidemic is unfortunately vast. We see  treat many patients in the ED for substance use disorder and medications such as buprenorphine are well within our scope of practice, and safer than most other controlled substances. The potential impact in helping vulnerable patients is enormous.N. Seth Trueger, MD, MPH, FACEPAssistant Professor of Emergency MedicineNorthwestern University  Northwestern Memorial Hospital Patient care is not predictable, especially with a population suffering from OUD. A treatment plan is often delayed/disrupted by unforeseen circumstances (court/legal issues, job, relapse, family, medical provider schedule, etc).  The patient and practice should not have to bear the burden.  Starting the process over after 14 days is taxing on staff and slows down our efforts to help patients suffering from this epidemic.  Patients and practices will benefit if the period is extended or waived on this class of medication.    