Public Comments
The Pharmacy Access to Resources and Medication for Opioid Use Disorder Guideline
A public comment period was held from April 15 to May 31. These comments were analyzed thematically, and a panel of experts who were not involved in the initial guideline creation process convened to review the aggregated comments and discuss potential changes to the guideline document.
Public Comment Period: April 15 – May 31, 2024
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Many pharmacist have experienced abusive statements and threatening behavior from patients collecting their suboxone. Suboxone users tend to purchase small amounts (2-3 strips) at a time, due to cost. Pharmacy staff sees the Suboxone user more then the prescriber. Patients often exhibit signs of abuse and addiction during these encounters. Since the majority of pharmacist practice in corporate run environments that do not encourage boundaries for pharmacist, I suggest a behavior contract at the beginning of each relationship with a pharmacy. The behavior contract can provide an opportunity for the pharmacist to go over the requirements for a prescription, future roadblocks that could occur (prior authorization, wholesale limits, no refills etc). The pharmacist can explain what they are willing to do and what is the patient and prescriber’s responsibilities. If patients yell at staff, use inappropriate language, or request multiple early refills the patient will be referred back to the prescriber with a request to find another pharmacy. If you EMPOWER pharmacist to feel like they have a choice with the way they practice that honors THEIR needs as well as the patient, I believe the “buy-in” will be greater among said pharmacist. Lastly, I have grave concerns about the length of therapy on Suboxone. In my 6 years of community practice, I never witnessed a patient titrated off the drug. I would like to see this addressed. |
Excellent document! Just a few suggestions: |
I have been a licensed pharmacist for over 20 years. I believe that increasing access to OUD medications, specifically buprenorphine at the pharmacy level, will have a tremendous impact on getting individuals into treatment and recovery from OUD. Pharmacists should be permitted to prescribe and dispense buprenorphine, and should be compensated fairly for doing so. This is a critical public health matter that pharmacists are best positioned to address. Many individuals with OUD are not equipped with the resources to obtain access to MAT. This move would align with the DEA’s recent activity to increase access to buprenorphine and other medications to treat OUD. |
To the Committee: As I already mentioned in this scenario, the first pharmacy “did not have the medication in stock”. We practice a harm reduction model whereby we don’t automatically discharge pain management patients for using illicit substances but instead work with them to obtain appropriate treatment. What we also do is offer them buprenorphine therapy for their pain. I had a new pain management patient who had a history of using cocaine and had been discharged from at least two other pain management practices. I attempted to order buprenorphine-naloxone tablets at a pharmacy in the patient’s county and I contacted a pharmacy in a chain grocery store to see if they had the medication in stock. The pharmacist informed me “we don’t do THAT here” i.e. stock buprenorphine-naloxone formulations. I inquired about other formulations and the indication was that this particular pharmacy wanted nothing to do with buprenorphine. It was again stigma, which is very hard to combat but I have several patients on Suboxone, Zubsolv and the generic equivalents for chronic pain. They are happier with this medication than conventional opioid analgesics because they experience better pain control and their dose remains stable. The physician who owns the practice is triple certified in anesthesia, interventional pain management and addiction medicine so I have expert consultation immediately available in addition to continually educating myself. I was encouraged to post these comments by a pharmacist but again my concerns are the delay of life-saving medication to patients particularly if they are in withdrawal and pharmacies being reluctant to stock buprenorphine products so they can avoid serving persons with SUDs. Thank you, Janet Beebe, DNP. ANP-BC, PMHNP |
This is one of the best set of guidelines regarding buprenorphine that I’ve seen. Bravo! After 20 years of prescribing buprenorphine to patients, my patient population was made up of individuals who had been seeing me, on average, for 7 years and were quite stable. Most of them followed me when I moved my practice to RI from MA. But that set off alarms at pharmacies, and several cut my patients off because they were now “traveling” (albeit about 45 minutes) to see the doctor. That’s when the fact that they were paying cash (because they didn’t want employers finding out that they had addictive disease) hadn’t already gotten them in trouble at the pharmacy. I hope the pharmacists on Cape Cod read this closely! |
This is a very important document that will have a positive impact on evidence-based opioid use disorder treatment access. As a registered nurse at a telehealth opioid use disorder treatment organization, I can speak to the many barriers patients with OUD face when seeking treatment with buprenorphine and how this leads many patients to end their OUD care. One of the most frequent and demoralizing barriers I see patients with OUD experience is at the pharmacy level. It is not uncommon for patients with OUD to drop out of buprenorphine treatment because they are denied their prescription. Common reasons patients are denied their prescription include: 1) prescription is from a telehealth provider, 2) the patient lives far away from the pharmacy, 3) patient lives far away from provider, and 4) pharmacy not accepting new bupnorphine prescriptions due to fear of over-prescribing. I am glad to see the document address many of the aforementioned barriers. Notably, I am glad to see the document highlights that pharmacists should dispense buprenorphine prescriptions issued by telehealth providers. I would like to see additional context in this section around patients who live far from providers and when patients live far from the pharmacy. These situations often happen in telehealth; the lack of proximate OUD care is a big part of why patients seek care via telehealth. Thank you for this document! |
Thank you for this opportunity to submit comments. Specific suggestions for Background section: Recommendation 2) Recommendation 4) Recommendation 5) Recommendations 6-10) Recommendations 11-15) Recommendation 16) Recommendation 17) |
This is a very good article, well-reasoned. Our job as healthcare providers is to help our patients not put up roadblocks to their care. OUD patients will become “Dope Sick” without the medication and end up in the hospital, jail, or dead. This is a way to help your patients as long as they are doing the right thing, mutual respect. If they are caught selling or snorting in the parking lot, they need a in house treatment program. |
Thank you for this guideline to our pharmacy colleagues. Access to buprenorphine is much better than what it was years ago. I am an addiction medicine specialist certified by the ABPM. I treat opioid use disorder, chronic pain and opioid dependence, stimulant use disorder, benodiazepine use disorder, alcohol use disorder, cannabis and tobacco use disorders. I also treat co-occuring disorders as ADHD, anxiety, and depression. Some pharmacies refuse to fill my prescriptions when benzodiazepines or CNS stimulants are prescribed together with buprenorphine. I urge the board to review the current literature and guidelines in the field of addiction medicine for other substance use disorders than OUD and come up with guidelines for community pharmacists so that they are free and enpowered to fill legitimate prescriptions by trained addiction medicine physicians. Mark Norleans, MD, PhD, FASAM |
As an owner and pharmacist, I understand the importance of carrying life enhancing medications, but current insurance practices are not sustainable for our business. The insurances pay me $20 for $60 worth of buprenorphine or buprenorphine/naloxone combo. Sometimes I’m able to get the “cheap” one from mckesson, but it’s often out of stock since everyone wants it. I have been losing hundreds of dollars filling this medication with insurnace but we are done doing that. I refused to fill one this week due to insurance reimbursement. I called the doctor and the patient but it took a week for the doctor to call me back. There’s needs to be a requirement for insurances to pay more than they currently are for these medicines or it will be a cash only prescription. Even for medicaid patients who already struggle with costs. |
Pharmacists are highly trained healthcare professionals with deep expertise in medications and their effects. Allowing pharmacists to initiate treatments for opioid use disorder (OUD) can significantly improve access to care, particularly in underserved communities where healthcare resources may be limited. Pharmacists can offer timely interventions, including medication-assisted treatments like buprenorphine, which have been shown to reduce opioid cravings and withdrawal symptoms, ultimately aiding in recovery and reducing the risk of overdose. Their accessibility and knowledge make them valuable allies in combating the opioid crisis, providing holistic care alongside other healthcare providers. A big missing piece is after-hours care from a lot of stake holders we have spoken to. Most practices are open from 9-5. A lot of these dire critical moments occur after hours. We can save a lot of lives. |
There’s nothing in here about the Medicaid guidelines we’re all trying to follow. This basically deals with the Mono and Dual therapy. Certain Medicaid’s will not cover the monotherapy. Leaving only the dual therapy or the patient paying out of pocket due to a PA never rarely getting approved. Also on the patient side, there’s a lot more street value for the Monotherapy. Patients are consistently getting the doctor to document allergy to Naloxone on the script. This is always a red flag for us. From what I’m gathering the DEA is still looking at the Monotherapy a little differently than the dual. |
Buprenorphine is a necessary medication in the treatment of Opioid Use Disorder. Many of our patients receiving buprenorphine are either uninsured or underinsured. Buprenorphine provides a more cost effective treatment. Alternative therapies can easily be over 300 to 400 dollars. Although buprenorphine may not be the most ideal medication option for OUD, I appreciate role that it plays in OUD treatment. |
I believe these guidelines will be very beneficial to help improve access to providers for treatment and pharmacies that stock buprenorphine containing products. My pharmacy is located on the campus of a mental health and recovery facility and in a medical building that houses physicians that specialize in those areas. Being in the metro Atlanta area, there is an increased number of providers that treat OUD and we have patients that drive a significant distance to use one of these providers in our area and use us as their pharmacy because we keep generally keep these products in stock and we do not judge them for their past and need for a buprenorphine containing product. Our largest barrier is the limitations by our wholesaler on how much we may order at a time due to controlled substance ratios and quotas. We try to care for as many patients with OUD as possible, but often have to turn someone away due to the product being out of stock. We have relationships with these providers. We know them. We know their prescribing patterns and policies in place at their offices. Having to turn someone always makes me worry if they will relapse if they are unable to find a pharmacy that has it in stock and is willing to care for the patient. Hopefully this will help decrease the stigma around these products and improve access more locally for these patients. |
Some of the writing in this guidance document may be misconstrued to mean a pharmacist does not have the right to refuse to fill a prescription. The wording may want to be adjusted as not to imply a requirement to fill if there is not a “red flag” as outlined exactly in this document. Also, in order to properly provide a Drug Utilization Review it is imperative that the pharmacist has the entire drug profile for a patient. While stigma and autonomy may be a driving factor for the patient to only fill their OUR prescription at a pharmacy, providing proper and accurate patient care should be the most important. It is understood about the balance of noncontrolled substance to controlled substance for a wholesaler/dispensing balance, but also having a complete patient profile helps ensure patient safety and fulfillment of a pharmacist’s duty. |
The medication works, the need is tremendous! Counselling, educating, encouraging and monitoring will be required! Pharmacists can do this! |
Wholesalers are not flexible in ordering arrangements because DEA is not flexible. We as community pharmacists feel as though the DEA is publicizing in the media the expansion of MAT services, but behind the curtain telling wholesalers to watch out for increases in ordering. We are told repeatedly by Compliance departments to “know our customer”, which can only be accomplished from a patient interview. Patient interviews are crucial to us remaining in good standing with our wholesaler. Compliance departments tell us that we are dispensing too high a percentage of controls or too high a percentage of buprenorphine compared to other medications. This forces us to require transfers of other meds to keep some balance between control and non-control dispensing totals. Most wholesalers have ex-DEA agents in their compliance departments, who are uniquely qualified on this subject. I must assume that these folks know the inner workings of the DEA, thus what could potentially get me in trouble, and that their suggestions should be followed or I will get in trouble. Some of my personal frustration comes from the media, DEA, DOJ, manufacturers, and doctors blaming the opioid crisis on pharmacists and then telling us to keep access open. A DEA audit could potentially be catastrophic for pharmacy. My business can not suffer sanctions, loss of DEA license, or a million dollar fine and it is my responsibility to make sure that we stay in line with dispensing patterns or at least our own status quo. We are currently not accepting new patients for MAT because of a wholesaler cap. |
Comments on Behalf of the American Association of Psychiatric Pharmacists (AAPP) The Pharmacy Access to Resources and Medication for Opioid Use Disorder Guideline We thank the entire Steering Committee and Expert Panel for their efforts in addressing a complex, multi-faceted gap in the care of patients with opioid use disorders (OUD). Despite the varied sources of these barriers, pharmacists and pharmacies are uniquely positioned to affect change and advance the care being provided. We stand with our community pharmacy colleagues who practice through these challenges on a daily basis. Although evidence suggests that stigma plays a role in pharmacy access to buprenorphine1, we recognize this to be a small contributor to the intricate nature of the issue. Far more concern stems from unnecessary administrational and legal burden interfering with pharmacists’ clinical decision making. We recognize that in absence of these barriers, the vast majority of our pharmacist colleagues stand ready and willing to help patients with OUD as originally committed to upon embracing the Oath of a Pharmacist. These guidelines lay the groundwork for overcoming these barriers and re-establishing pharmacists as the experts in determining the safety and appropriateness of the prescription orders they fulfill. At present, the written tone could be suggestive that pharmacist stigma is prompting many of the recommendations within. The Steering Committee may wish to explicitly acknowledge the existence of data surrounding stigma in our profession, while ensuring to separate this phenomenon from the language used within each of the recommendations. Introduction and General Comments Maintenance Pharmacotherapy with Buprenorphine Red Flags and Prescription Drug Monitoring Programs Early Refills Providing Care to Persons Utilizing Telehealth Buprenorphine Monotherapy Recommendations to Protect Patient Safety Care Coordination and Provider Communication Stigma toward Persons with OUD References |
On behalf of the Vital Strategies Overdose Prevention Program, we write in support of the National Association of Boards of Pharmacy (NABP) and National Community Pharmacists Association (NCPA) Joint Consensus Pharmacy Access to Resources and Medication for Opioid Use Disorder Practice Guideline (Guideline). Vital Strategies is a registered 501(c)(3) nonprofit organization headquartered in the United States with a mission to support strong public health systems around the world. The Overdose Prevention Program works in various U.S. states and nationally to catalyze data-driven solutions for an equitable and sustainable reduction in overdose deaths and access to care for people with SUD. The country’s overdose crisis continues unabated, with data from the Centers for Disease Control and Prevention (CDC) showing that overdose deaths surpassed 100,000 last year alone. Treatment for opioid use disorder (OUD) with agonist medications buprenorphine and methadone is most effective at reducing overdose and serious opioid-related acute care relative to other treatments, such as naltrexone or inpatient detoxification or residential services. Agonist medications for OUD are associated with an estimated mortality reduction of 50% among people with OUD, supporting the conclusion of the National Academies of Sciences, Engineering, and Medicine in 2019 that “[t]he verdict is clear: effective agonist medication used for an indefinite period of time is the safest option for treating OUD.” The development, publication, and future implementation of the Guideline is a major milestone for advancing access to buprenorphine, a lifesaving medication for OUD, in pharmacies. Vital Strategies commends NABP, NCPA, and other contributors to the Guideline, and offers the following comments and recommendations to further clarify and strengthen the Guideline. I. Global comments (1) Avoid use of the phrase “opioid crisis.” See, e.g., Page 3. This language implies that opioids themselves are the problem and can result in disproportionate focus on the drug itself rather than the underlying causes and consequences (i.e., substance misuse and addiction), potentially leading to ineffective or even harmful policy responses. We recommend “overdose crisis” or “opioid overdose crisis.” (2) Avoid unnecessary specificity with respect to the type of prescribing practitioner. In multiple locations, the draft Guideline refers to specific types of practitioners. See, e.g., Page 7 (“Pharmacists should generally dispense buprenorphine in response to prescriptions issued by licensed physicians, physician assistants, or nurse practitioners with an active Drug Enforcement Administration (DEA) registration.”); Page 8 (“All physicians, physician assistants, and advanced practice nurses with prescriptive authority can issue valid prescriptions for buprenorphine.”); Page 26 (“Pharmacists should work closely with physicians and patients to ensure that the most appropriate buprenorphine product is used to support the patient’s recovery.”). As the draft Guideline acknowledges, the elimination of the X-waiver means that any DEA-registered practitioner with Schedule III prescriptive authority may prescribe buprenorphine for OUD in accordance with state laws. The final Guideline should take care not to suggest that only specific types of practitioners may prescribe buprenorphine for OUD as this varies among states (e.g., in some states, certain pharmacists themselves may have prescriptive authority). (3) Similarly, the draft Guideline includes multiple references to a practitioner’s “state medical board.” See, e.g., Page 7, 12 (“The pharmacist can verify that the prescriber is in good standing with their state medical board and maintains an active DEA registration.”); Page 13 (“the pharmacist can verify that the prescriber is in good standing with their state medical board and the DEA”); Page 24 (“prescribers in good standing with DEA and their state medical board.”). We recommend the final Guideline use a more generic term as not all buprenorphine prescribers are regulated by their state medical board. (4) Include a general acknowledgement about the potential application of state laws. In some instances, the draft Guideline notes that certain practices may be constrained by state laws. See, e.g., Page 10 (“Pharmacy technicians can provide valuable support to the process of care. Where not otherwise prohibited by state law, technicians can improve the efficiency of care by extracting information from prescription monitoring programs, contacting providers, reminding patients to refill their prescriptions, and assisting with reimbursement issues.”). In other instances, the draft Guideline remains silent as to the potential effects of state law, such as on prescribing authority. We recommend the final Guideline include a general acknowledgement that state laws may impose additional requirements or limitations rather than selectively including such qualifiers throughout the document. II. Vital Strategies strongly supports the following provisions (non-exhaustive list): (1) The acknowledgment on Page 4 that “assuming that buprenorphine is being prescribed inappropriately and wrongly denying care for persons with OUD can have disastrous consequences for patients. Delaying the initiation of care or refusing care to an established patient dramatically increases a patient’s risk of death due to opioid overdose.” (2) The Guideline’s overarching recommendation, included on pages 4-5, “that pharmacists should make a good faith effort to provide high quality care to persons with OUD by always maintaining an adequate supply of buprenorphine and filling legitimate prescriptions in a timely manner.” (3) The statements on Page 7 that “[p]harmacists should not decline to dispense buprenorphine solely due to the duration of maintenance treatment,” and that “[d]eclining to dispense buprenorphine is a measure of last resort and should only be considered after discussion with the patient and their prescriber when the pharmacist strongly suspects prescription forgery, prescription alteration by the patient, misuse, or diversion.” (4) The statement on Page 8 that pharmacists should not refuse to dispense buprenorphine based on the “[d]istance from the patient’s address or the provider’s address to the pharmacy,” nor to cash-paying patients. (5) The recognition on Page 9 that telehealth prescriptions “are not more likely to be fraudulent or illegitimate than prescriptions from face-to-face encounters and should not be subjected to a higher level of scrutiny than other buprenorphine prescriptions.” (6) The statement on Page 13 that “[w]hen a patient with no known history of pharmacotherapy for OUD presents to a community pharmacy with a new buprenorphine prescription, this is an opportunity for a pharmacist to provide, rather than deny, care. In most circumstances, pharmacists should favor dispensing buprenorphine to patients new to their pharmacy.” (7) Emphasizing on Page 13 that “[g]iven the risks of morbidity and mortality associated with buprenorphine discontinuation, there are very few circumstances in which the potential benefits to the patient of refusing to dispense outweigh the risks of early discontinuation.” (8) The recommendation on Page 16 that pharmacists should not automatically decline to dispense a prescription of buprenorphine based solely on the presence of red flags (“In no circumstance should the presence of red flags immediately disqualify a patient from filling a prescription for medication for OUD. Rather, red flags should lead to a patient centered discussion on the appropriateness of the course of therapy with both the patient and the provider. Both parties should be provided the opportunity to explain the presence of red flags.”) (9) Underscoring the lack of benefit and clear risk of harm associated with higher dosages of naloxone. See Pages 27-28 (“It should be noted that there are currently no known benefits to higher dose, 8 mg, naloxone preparations compared to conventional 4 mg preparations. Higher doses of naloxone may increase the severity of precipitated withdrawal symptoms, including severe acute pain.”) (10) Endorsing the dispensing of partial quantities of buprenorphine to ensure treatment continuity while a pharmacist attempts to communicate with a prescriber. See Page 32 (“Delays in care due to the inability of a pharmacist to quickly reach a prescriber are unacceptable in the current era of communication and are a direct threat to continuity of pharmacotherapy for OUD. If a pharmacist cannot reach a prescriber quickly, it is strongly recommended that, where possible, the pharmacist consider dispensing a partial quantity of buprenorphine (1-3 days, as appropriate) to ensure that the patient is not without medication possession.”) III. Vital Strategies recommends the final Guideline clarify or correct the following legal statements: (1) On page 3, the draft Guideline notes that “In 2019, the SUPPORT Act required that all DEA registrants that distribute controlled substances report suspicious orders to DEA.” This statement reflects a common misunderstanding. Although the SUPPORT Act codified the suspicious order reporting requirement into statute and required centralized reporting, DEA registrants have always had a legal obligation to identify and report suspicious orders. Indeed, the Controlled Substance Act’s original 1971 implementing regulations specified that “[t]he registrant shall design and operate a system to disclose to the registrant suspicious orders of controlled substances. The registrant shall inform the Regional Office of the Bureau in his region of suspicious orders when discovered by the registrant. Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.” 36 Fed. Reg. 7785; 21 CFR § 301.74(b) (1971). The final Guideline should clarify that the SUPPORT Act provisions merely reinforced and modified longstanding suspicious order reporting obligations. (2) The draft Guideline makes several assertions that provisions of the Ryan Haight Act were “suspended” or “overturned” to enable telehealth prescribing of buprenorphine without an in-person evaluation. See, e.g., Page 4 (“In March 2020, DEA and the Department of Health and Human Services overturned provisions of the Ryan Haight Act that previously prevented prescribers from initiating buprenorphine without an in-person office visit.”); Page 23 (“In March of 2020, DEA, along with the department of Health and Human Services (HHS), temporarily suspended provisions of the Ryan Haight act allowing providers to initiate patients on buprenorphine products indicated for the treatment of OUD through an audio only or audio-visual telehealth encounter.”); Page 24 (“The DEA has not only endorsed the legitimacy of telehealth prescribing but has repeatedly extended the suspension of the Ryan Haight Act that allows for the issuance of buprenorphine prescriptions without an in-person encounter.”). This is an inaccurate description. DEA and HHS did not suspend or overturn provisions of the Ryan Haight Act, but rather exercised authority granted by the Ryan Haight Act itself to establish an exemption to the generally applicable requirement of an in-person evaluation. See 21 USC 802(54)(D). (3) The draft Guideline conflates the Mainstreaming Addiction Treatment Act (MAT) Act and Medication Access and Training Expansion (MATE) Acts in certain sections, suggesting that both played a role in elimination of the X-waiver. See, e.g., Page 4 (“In December 2022, the Mainstreaming Addiction Treatment (MAT) Act and Medication Access and Training Expansion (MATE) Acts were signed into law. This legislation allows any DEA registered practitioner with prescribing authority, including Advanced Practice Registered Nurses and Physicians Assistants, to prescribe buprenorphine for the treatment of OUD. The MAT and MATE acts, therefore, eliminated the need to register under the Drug Abuse Treatment Act of 2000 (DATA-2000) and obtain an X-Waiver from DEA to prescribe buprenorphine.”); Page 8 (“The implementation of the MAT and MATE acts extends prescribing authority for buprenorphine to all DEA registered providers.”); Page 14 (“The provisions of the MAT and MATE acts therefore eliminate the need for providers to complete requisite training and obtain a Drug Abuse Treatment Act of 2000 waiver, commonly known as an X-waiver, to dispense buprenorphine.”). Although adopted concurrently, only the MAT Act – not the MATE Act – addressed the X-waiver. We recommend the final Guideline more clearly delineate between the two laws, as there is no need to refer to the MATE Act when focused solely on elimination of the X-waiver as opposed to the new one-time education requirement applicable to most controlled substance prescribers. (4) On Page 13, the draft Guideline states “In July of 2022, in their decision on Ruan vs United States, the Supreme Court found that controlled substance prescribing is authorized unless the prescribers have “knowingly and intentionally” acted in an unauthorized manner.” However, the referenced federal statutory provision, 21 USC § 841(a), is disjunctive, requiring a prescriber to have acted knowingly OR intentionally. 21 USC § 841(a) (“Except as authorized by this title, it shall be unlawful for any person knowingly or intentionally…”). See also Xiulu Ruan v. United States, 142 S. Ct. 2370 (2022) (“We hold that the statute’s ‘knowingly or intentionally’ mens rea applies to authorization.”) (5) On Page 16, the draft Guideline notes that “In the context of OUD treatment, it is important to note that federal law prevents Opioid Treatment Programs (e.g., methadone clinics) from reporting dispensation to PDMPs.” The final Guideline should clarify this statement. Federal law does not categorically prohibit OTPs from reporting dispensation to PDMPs. Rather, federal SUD privacy regulations provide that such reporting may occur if required by state law and the patient consents. 42 CFR § 2.36. See also 89 Fed. Reg. 12486 (“Under § 2.36, opioid treatment programs (OTPs) may report methadone dispensing information to PDMPs, but only if the reporting is mandated by state law and authorized by a part 2-compliant consent form.”) A revised statement could, for example, read “federal law permits Opioid Treatment Programs (e.g., methadone clinics) to report dispensing only with patient consent.” (6) On Page 16, the draft Guideline states that “while all states except Missouri require dispensers to report data to the PDMP, most states do not require emergency departments and inpatient facilities to report data to the PDMP.” Missouri adopted a PDMP law in 2021, and the requirement that dispensers report data to the PDMP in real time went into full effect as of January 1, 2024. See 2021 MO SB 63; Mo. Rev. Stat. § 195.600(5). (7) The draft Guideline makes multiple statements suggesting that recent DEA guidance encourages wholesalers to monitor buprenorphine separately from other controlled substances. See Page 14 (“On March 8, 2024, the DEA released guidance to registrants clarifying that wholesalers should monitor buprenorphine separately from other controlled substances.”); Page 34 (“This practice is unnecessary in light of recent clarification from the DEA encouraging pharmaceutical wholesalers to disentangle buprenorphine from other opioid medications in suspicious order monitoring programs.”). Although we agree that wholesalers should monitor buprenorphine separately, the current draft Guideline overstates the cited DEA guidance, including the March 8 letter, which merely recommends that “[d]istributors should carefully examine quantitative thresholds they have established to ensure that individuals with OUD who need buprenorphine are able to access it without undue delay.” The letter does not address how distributors should monitor buprenorphine in relation to other controlled substances or make any specific recommendations as to how distributors examine buprenorphine thresholds. IV. Additional recommendations to strengthen the Guideline: (1) On Page 3, the draft Guideline states that “Still, around half of all pharmacies in the United States are unable to dispense buprenorphine products for the treatment of OUD.” Although some pharmacies are truly unable to dispense buprenorphine because they, for example, are unable to obtain enough of the medication from their distributors, other pharmacies are merely unwilling to do so. We recommend rephrasing the sentence accordingly (e.g., “around half of all pharmacies in the United States are unable or unwilling to dispense buprenorphine products for the treatment of OUD.”) (2) On Page 3, the draft Guideline describes the regulatory treatment of buprenorphine as “reasonable in light of the financial liability pharmacy organizations and pharmaceutical wholesalers have faced through multidistrict opioid litigation.” Although pharmacy organizations and wholesalers may have legitimate concerns about potential future liability, we disagree that how they’ve opted to address those concerns is “reasonable” with respect to buprenorphine, especially given the current state of the overdose crisis. We recommend replacing the word “reasonable” with “understandable.” (3) We request the final Guideline clarify the statement on Page 4 that “[i]f buprenorphine is subjected to the same limits on controlled substance purchase as other medications, then pharmacies will be forced to limit the amount of buprenorphine they dispense to avoid wholesaler ‘caps’ on controlled substance supply established by SORS.” It is unclear whether this is intended to suggest that subjecting buprenorphine to the same constraints as other controlled substances raises unique concerns or that a pharmacy’s ordering of buprenorphine would affect its orders for controlled substances other than buprenorphine. (4) On Page 9, the draft Guideline recommends that “Pharmacists should continue to dispense buprenorphine to telehealth patients who are adherent to a stable plan of care even if they change providers.” We believe that the phrase “adherent to a stable plan of care” introduces too much discretion and invites greater scrutiny of telehealth prescriptions, the latter of which contradicts the Guideline’s statement on Page 9 that telehealth prescriptions “are not more likely to be fraudulent or illegitimate than prescriptions from face-to-face encounters and should not be subjected to a higher level of scrutiny than other buprenorphine prescriptions.” Telehealth patients may opt to change providers for any multitude of reasons and at any stage of treatment, and it is critical that their access to medication not be interrupted as a result. When a telehealth patient changes providers, a pharmacist should continue to fill the patient’s buprenorphine prescription regardless of whether the patient is stable so long as there is no compelling evidence of diversion or other serious issues. Put simply, a pharmacist should apply the same standards of review to the prescription in this scenario as they would to any other prescription. This approach is consistent with other statements in the draft Guideline. See, e.g., Page 24 (“Pharmacists are encouraged to evaluate telehealth prescriptions in the same manner and to the same standard that they would prescriptions originating from in-person encounters.”). (5) The draft Guideline states that pharmacists should initiate a discussion on appropriate use if there is a more than 50% increase in a patient’s maintenance buprenorphine dose between prescriptions. See Page 15 (“An increase in a patient’s maintenance buprenorphine dose of more than 50% between prescriptions.”). The Draft Guideline later acknowledges on Pages 16-17 that “[e]arly in treatment, patients may titrate their dose upwards rapidly” and clarifies that the dosage increase flag applies only “[a]fter the patient’s dose is stable.” However, we are concerned that the recommendation’s reference to “maintenance buprenorphine dose” may not adequately convey this important context (i.e., what constitutes initiation vs. maintenance) and could result in the denial of prescriptions while a patient is still titrating their dosage. If the final Guideline maintains this recommendation, we recommend rephrasing the recommendation to address these nuances and specify a duration of dose stability before the flag applies. A revised recommendation could read, for example, as: “An increase in a patient’s buprenorphine dose of more than 50% between prescriptions when the patient was on a stable buprenorphine dose for at least [X] days immediately preceding the prescription.” (6) On Page 15, the draft Guideline states that “In addition to ‘red flags’, pharmacists should review the PDMP for potential ‘green flags’, or indicators that a patient is actively engaged in therapy and using their medication as directed. These may include a history of timely buprenorphine refills, receiving sequential prescriptions from the same prescriber or prescriber group, the absence of concurrent opioid agonist prescriptions, and a long-term history of buprenorphine pharmacotherapy.” See also Page 19 (“It is therefore recommended that the pharmacists’ approach to reviewing the PDMP be expanded to support the inclusion of ‘green flags’ in the decision-making process. The presence of any of these indicators should reaffirm the pharmacist’s decision to dispense buprenorphine to the patient.”). We have two recommendations. First, the final Guideline should explicitly state that the absence of one or more “green flags” does not constitute sufficient grounds to decline to fill a prescription. Second, the phrase “actively engaged in therapy” should be modified or excluded from the final Guideline. The word “therapy” could be understood to mean psychosocial therapy, which evidence demonstrates is both unnecessary for successful OUD treatment with buprenorphine and may pose a barrier to treatment engagement for some individuals. If retained, alternative phrasing could specify “a patient is actively under the care of a medical professional and using their medication as directed.” (7) On Page 16, the draft Guideline notes that “ASAM and the Center for Substance Abuse Treatment (CSAT) both support the use of buprenorphine at daily doses of up to 32 mg for maintenance treatment of opioid use disorder.” Although we appreciate the draft Guideline’s recognition of support for higher dosages of buprenorphine, we recommend the final Guideline clarify that 32mg does not constitute an absolute cap on daily doses for maintenance treatment of OUD. Prescriptions for daily doses exceeding 32mg must be evaluated on an individualized basis and subject to the same review standard as any other prescription. (8) On Page 23, the draft Guideline states, “Pharmacists may legitimately question the patient provider relationship developed or the quality of care delivered in telehealth encounters.” This statement unnecessarily singles out telehealth for greater scrutiny and is inconsistent with the surrounding paragraphs, which outline the quality and efficacy of telehealth-based care. We recommend rephrasing the sentence to read, “Pharmacists may legitimately question the patient provider relationship developed or the quality of care delivered in any setting, including telehealth, but evidence does not suggest that telehealth encounters are inferior to in-person encounters.” (9) We appreciate the draft Guidance noting on Page 33 that there is no evidence or guidance to support requiring a patient interview prior to dispensing buprenorphine. See Page 33 (“In the formative focus groups used to lay the groundwork for this guidance, participants reported that they felt the need to interview persons with OUD prior to dispensing buprenorphine to ensure that their intentions in filling buprenorphine were legitimate. There is no evidence to support this practice or to guide the interpretation of a patient interview in this manner.”). We recommend the final Guideline also explain that such practices may constitute unlawful disability-based discrimination under federal civil rights laws, including the Americans with Disabilities Act and Section 504 of the Rehabilitation Act. (10) On Page 37, the draft Guideline suggests that large pharmacy corporations can leverage their purchasing power and wholesaler relationships to eliminate caps on buprenorphine purchases. See Page 37 (“Rather than creating inhibitory policy, large pharmacy corporations should leverage their wholesaler relationships and purchasing power to negotiate the terms of suspicious order monitoring programs with wholesalers to ensure that pharmacies under their management can continuously be able to purchase buprenorphine. Doing so may eliminate ‘caps’ on buprenorphine purchase.”). We recommend deleting the sentence “Doing so many eliminate ‘caps’ on buprenorphine purchase.” Although pharmacy chains may be able to negotiate sufficient thresholds to ensure a consistent supply, they cannot negotiate the true elimination of ordering thresholds, which are mandated by settlement agreements with the three largest distributors. Only the parties to those settlement agreements – state governments and the distributors themselves – could agree to modify its terms. Vital Strategies thanks NABP and NCPA for their consideration of our input. Please do not hesitate to contact us should you have any questions. We are also happy to provide a formatted PDF of our comments upon request. |
In addition to the buprenorphine guideline document as published, there needs to be a recognition of the specific documents that lead to many of the problems with buprenorphine distribution. While we all have seen the DEA “Dear Registrants” letter in support of MOUD and the guidance document regarding thresholds https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-065)(EO-DEA258)_Q_A_SOR_and_Thresholds_(Final).pdf it is important that The Pharmacy Access to Resources and Medication for Opioid Use Disorder Guideline recognize these tools and documents as well as the federal injunctive relief that was entered into by most states that has phrasing identifying buprenorphine products in the list of Highly Diverted Controlled Substances as well as identifying “red flags” in the injunctive relief to include single-ingredient buprenorphine, out of area patients, cash prescriptions and prescriber activity which cause supply issues for distributors and pharmacies alike in conflict with DEA guidance on MOUD. Having heard several practitioners blame DEA for these issues it is important to help educate readers to the full scope of contributing factors in order to work on solutions. |
I appreciate the time, thought and effort put into these guidelines. It’s a great roadmap for how practice should be. I sure hope it gains some traction with pharmacy stakeholders and regulatory agencies. However, I think it’s overly optimistic given today’s community pharmacy landscape. I’ve got several opinions and initial reactions to things covered here. Nothing with any evidence, just experience and opinion, so take that for what its worth. In regard to a pharmacy’s concerns about being cut off from controlled substances: It’s a valid concern. Cardinal, McKesson and AmerisourceBergen just tightened their limits on controlled substances (including buprenorphine) as a result of that opioid lawsuit settled in 2022. Smaller drug wholesalers have followed suit in reining back on controlled substances as well. Anytime a pharmacy reaches its monthly limit on a controlled substance, the wholesaler has to let the local DEA office know that they’ve declined a ‘suspicious order’. Additionally, that monthly limit is unknown until it is reached, and it may change from month to month. As long as buprenorphine remains a controlled substance [which given current data regarding its ability to cause psychological and physiological dependence, it should], quotas and requirements around ordering it will not change. In regard to a clinical preference for Suboxone over Subutex: It’s been repeated over and over to us by regulatory agencies, wholesalers and other guidelines that Suboxone should be the treatment of choice and Subutex should only be reserved for pregnancy and documented naloxone allergies. You argue that there’s no preference for one over the other in patients who may snort it, but I’d only ever been told it was IV use we were deterring with the presence of naloxone. Sure, you’re not deterring all abuse with the addition of naloxone, but you’re deterring some abuse. Price may be an issue some places but in my experience in recent years, price for generic Suboxone tabs and generic Subutex tabs is roughly the same. And in 2022 Subutex’s package insert was updated with a warning for dental carries as well, so I don’t think that’s an argument for Subutex over Suboxone either. In regard to telemedicine: While telemedicine limitations have been relaxed since covid and reinforcing them has been pushed off for some time, I don’t think that’s because the DEA is interested in expanding access via telemedicine, I think they just didn’t want to deal with it yet after the public outcry when they discussed reinforcing them. They’ve already abolished the NADEAN requirements and any prescriber with a DEA number is allowed to prescribe buprenorphine for OUD now – that expands access. Maybe the upper echelons of the DEA have voiced some sort of support for access via telemedicine, but I don’t think a field agent is going to care if the prescriber is from telemedicine or not. They’re just going to see the script is from an out of state prescriber and base their conclusions on that. In regard to requiring a profile transfer: Look, polypharmacy is a concern for us with non-controlled medications. It’s a much greater concern when the patient has controlled substances. Sure, patients have the ability to use a pharmacy of their choosing, but they also have the ability to choose a pharmacy that would not require them to transfer their non-controls. That’s a policy that most pharmacists will have with any controlled substance and is not limited solely to buprenorphine products. |
I appreciate the time, thought and effort put into these guidelines. It’s a great roadmap for how practice should be. I sure hope it gains some traction with pharmacy stakeholders and regulatory agencies. However, I think it’s overly optimistic given today’s community pharmacy landscape. I’ve got several opinions and initial reactions to things covered here. Nothing with any references, just experience and opinion. In regard to a pharmacy’s concerns about being cut off from controlled substances: It’s a valid concern. Cardinal, McKesson and AmerisourceBergen just tightened their limits on controlled substances (including buprenorphine) as a result of that opioid lawsuit settled in 2022. Smaller drug wholesalers have followed suit in reining back on controlled substances as well. Anytime a pharmacy reaches its monthly limit on a controlled substance, the wholesaler has to let the local DEA office know that they’ve declined a ‘suspicious order’. Additionally, that monthly limit is unknown until it is reached, and it may change from month to month. As long as buprenorphine remains a controlled substance [which given current data regarding its ability to cause psychological and physiological dependence, it should], quotas and requirements around ordering it will not change. In regard to a clinical preference for Suboxone over Subutex: It’s been repeated over and over to us by regulatory agencies, wholesalers and other guidelines that Suboxone should be the treatment of choice and Subutex should only be reserved for pregnancy and documented naloxone allergies. You argue that there’s no preference for one over the other in patients who may snort it, but I’d only ever been told it was IV use we were deterring with the presence of naloxone. Sure you’re not deterring all abuse with the addition of naloxone, but you’re deterring some abuse. Price may be an issue some places but in my experience in recent years, price for generic Suboxone tabs and generic Subutex tabs is roughly the same. And in 2022 Subutex’s package insert was updated with a warning for dental carries as well, so I don’t think that’s an argument for Subutex over Suboxone either. In regard to telemedicine: While telemedicine limitations have been relaxed since covid and reinforcing them has been pushed off for some time, I don’t think that’s because the DEA is interested in expanding access via telemedicine, I think they just didn’t want to deal with it yet after the public outcry when they discussed reinforcing them. They’ve already abolished the NADEAN requirements and any prescriber with a DEA number is allowed to prescribe buprenorphine for OUD now – that expands access. Maybe the upper echelons of the DEA have voiced some sort of support for access via telemedicine, but I don’t think a field agent is going to care if the prescriber is from telemedicine or not. They’re just going to see the script is from and out of state prescriber and base their conclusions on that. In regard to requiring a profile transfer: Look, polypharmacy is a concern for us with non-controlled medications. It’s a much greater concern when the patient has controlled substances. Sure, patients have the ability to use a pharmacy of their choosing, but they also have the ability to choose a pharmacy that would not require them to transfer their non-controls. That’s a policy that most pharmacists will have with any controlled substance and is not limited solely to buprenorphine products. |
Lemrey “Al” Carter, MS, PharmD, RPh B. Douglas Hoey, Pharmacist, MBA Dear Mr. Carter and Mr. Hoey: On behalf of the physician and medical student members of the American Medical Association (AMA), I am writing to provide comments on the “Pharmacy Access to Resources and Medication for Opioid Use Disorder (PhARMOUD) Guideline: A Joint Consensus Practice Guideline from the National Association of Boards of Pharmacy (NABP) and the National Community Pharmacists Association (NCPA)” (PhARMOUD proposed guideline). The AMA strongly agrees with the overarching theme in the PhARMOUD proposed guideline that, without significant changes to increase access to buprenorphine in the nation’s pharmacies, the overdose epidemic will have little chance of substantially improving. The AMA and the nation’s pharmacists have for years worked together to ensure access to care for patients with pain, opioid use disorder (OUD), and other conditions that might require a prescription for a controlled substance.1 The AMA strongly supports the physician-pharmacist-patient therapeutic triad and commends the NABP and NCPA for outlining key actions that will help improve access to buprenorphine for individuals with an OUD. Physicians and patients continue to experience barriers to accessing buprenorphine at pharmacies,2 and implementation of the recommendations in the PhARMOUD proposed guideline can help remove many of those barriers. The AMA strongly agrees, for example, that when pharmacists have questions about a prescription for buprenorphine for the treatment of OUD, it is essential for the pharmacist and physician to discuss the situation—and not automatically deny the patient access to the life-saving medication. Buprenorphine is the gold standard for OUD treatment because it improves patient outcomes, including helping patients with OUD maintain recovery, reducing the risk of overdose, and improving the quality of lives. Unfortunately, as the PhARMOUD proposed guideline also makes clear, it is with increasing regularity that some pharmacies deny access to buprenorphine because of stigma, fear of law enforcement3 investigation, fear of distributors’ inflexible quotas, or corporate pharmacy policies that limit the ability of community pharmacies to stock or dispense this life-saving medicine for patients with OUD. The AMA commends the NCPA and NABP for making clear that denying a buprenorphine prescription “is a measure of last resort and should only be considered after discussion with the patient and their prescriber.” The AMA also commends the NCPA and NABP for shining a light on the challenges community pharmacies and pharmacists face—calling for action to stop harmful practices that delay or deny access to buprenorphine for OUD, including the concerning use of inflexible quotas that distributors are using to limit buprenorphine supply.4 The AMA looks forward to continuing to work with you to remove these barriers to care. The AMA generally supports the discussion around state prescription drug monitoring programs (PDMP) for pharmacists, where the use of a PDMP is a supplement for decision-making and should not be used as the sole justification to deny dispensing buprenorphine or other medication. The AMA strongly supports the recommendation that, “Chain pharmacies and pharmacy owners should immediately retire policies that prohibit employee pharmacists from filling buprenorphine prescriptions solely due to the pharmacy’s distance from the provider or patient home address.” Furthermore, the AMA supports the discussion that distance from the physician or other prescriber, use of telehealth, cash payments, early refills, and other potential concerns should be discussed rather than used to justify stigma or denial of care. The AMA has long maintained that PDMPs may be a helpful tool as part of the clinical decision-making process, but that they are never a substitute for individualized, patient-centered clinical decisions. There are a few areas in the PhARMOUD proposed guideline that could benefit from additional clarification. For example, we urge further clarification that there should be concern when there is, “An increase in a patient’s maintenance buprenorphine dose of more than 50% between prescriptions.” The PhARMOUD proposed guideline appropriately notes that when starting on buprenorphine, the dose may increase at regular intervals, which may be up to or greater than 50% depending on the dose strength. The AMA understands that the Controlled Substances Act requires pharmacists to exercise their corresponding responsibility, but we highlight that if the PhARMOUD proposed guideline uses a specific numeral threshold to indicate concern, that will become a default threshold some will use to deny buprenorphine dispensing. The AMA, therefore, urges removal of numerical thresholds for decision-making. The AMA also urges additional attention to the discussion of when buprenorphine monotherapy may be appropriate. As the drug supply in the country shifts to higher potency, synthetic opioid products, such as fentanyl, the need for higher doses (>24mg daily) of buprenorphine may be warranted for adequate therapeutic effect.5 Using the combination buprenorphine/naloxone product for these higher doses may increase adverse events from systemic naloxone absorption and decrease the potential for continued utilization for treatment.6 Limiting the indications for buprenorphine monotherapy to pregnancy, breastfeeding, and dental lesions inserts unwarranted stigma for buprenorphine treatment and hampers access to these medications. In addition, the AMA is concerned that by specifying only a few situations where buprenorphine monotherapy is appropriate, some policymakers, pharmacy chains, or distributors may use the PhARMOUD proposed guideline as justification to deny access to buprenorphine monotherapy in all other situations. The AMA strongly agrees with efforts to increase access to naloxone. We have been strong supporters of laws and practices to authorize pharmacists to dispense naloxone directly to patients through standing orders. While the PhARMOUD proposed guideline highlights the importance of naloxone, this document would be strengthened by describing the broader impact pharmacists can have to increase access to evidence-based harm reduction initiatives. Pharmacists are well-positioned to increase access to additional harm reduction measures, such as sterile syringes for purchase to help stop the spread of blood-borne infectious diseases. Pharmacists also are well-positioned to help increase access to fentanyl test strips and other drug checking supplies to reduce the risk of drug-related overdose. We commend the NABP and NCPA for the open dialogue about stigma and the barriers placed on pharmacists by some employers. We hope that the forthcoming recommendations will motivate those employers to take necessary actions, including stocking over the counter naloxone in prominent locations; making sterile syringes available for purchase; and helping with education and access about fentanyl test strips and other drug checking supplies. The AMA wants to also emphasize that we have long appreciated the invaluable role pharmacists play on the clinical care team. It is widely known that the integration of pharmacist care into physician-led clinical care models can result in greater continuity of care, improved care coordination, improved patient outcomes, and better care management—particularly for patients with chronic conditions. As such, we support the PhARMOUD proposed guideline’s inclusion of physician-led collaborative practice models as a means of increasing patient access to OUD treatment and supporting patients in adhering to the treatment plan. We agree that patients seeking treatment for OUD would benefit from pharmacy services similar to those available to patients experiencing other chronic diseases and support collaborative practice agreements that require meaningful involvement by a physician. The AMA would be pleased to have further discussions on how to achieve high-functioning, patient-centered collaborative practice models to achieve the goals set forth in the PhARMOUD proposed guideline. Thank you for your consideration of these comments. If you have any questions, please contact Jennie Jarrett, PharmD, MMedEd, PhD, BCACP, FCCP, Director, Science and Drug Policy, at jennie.jarrett@ama-assn.org or Daniel Blaney-Koen, JD, Senior Attorney, at daniel.blaney-koen@ama-assn.org. Sincerely, James L. Madara, MD [References available upon request] |
Excellent guidance. The establishment of a state hotline for pharmacists that are trying to stock and dispense buprenorphine but are experiencing barriers from wholesalers/distributors (which is currently happening) and are receiving undue attention from the DEA due to supporting practitioners who are newly prescribing buprenorphine, and therefore appear to have an increased opioid ordering/dispensing pattern or are considered statistical outliers is E,EXTREMELY necessary to support and intercede for pharmacists that are trying to do the right thing. |
Please include in the arbitrary pharmacy policy section, the requirement for a urine drug screen at bup initiation prior to dispensing. This is not evidence based and presents a major barrier – needlessly increasing patient suffering and OD risk – to patients initiated on bup via telemedicine who have not yet received their drug tests in the mail or presented to a facility in person. I have argued with a pharmacist over this exact “policy,” and I think it deserves explicit mention as an example of what NOT to do. |
Thank you for the opportunity to submit commentary to the “The Pharmacy Access to Resources and Medication for Opioid Use Disorder Guideline.” We appreciate the inclusion of several mentions of expanded naloxone access in the guidelines and as leading subject matter experts, we are submitting recommendations for a crucial expansion of this section that could be impactful for harm reduction programs working on the frontlines of the overdose crisis. We are encouraged by the FDA’s guidance (https://www.fda.gov/media/161750/download) that provides regulatory flexibility under the DSCSA to support supplying harm reduction programs with affordable injectable naloxone during the opioid public health emergency. This guidance has successfully reduced barriers for distribution of low-cost naloxone to harm reduction programs and saved lives. Since 2022, Remedy Alliance has provided over two million doses of injectable naloxone to over 400 harm reduction programs for distribution in their communities in 45 states, the District of Columbia and Puerto Rico, as a direct result of this guidance. Unfortunately, access to this life-saving medication is still hindered by other challenges, including the prescription-only status of injectable naloxone and lack of clarity at the state-level around layperson distribution of naloxone. The FDA guidance provides a framework for expanded access via the supply chain, but harm reduction programs on the frontlines of the overdose epidemic still face regulatory barriers at the state level that hinder or prevent the distribution of naloxone to their communities. For example, one harm reduction program who only has access to injectable naloxone for distribution was recently prohibited from distributing their supply by the State Pharmacy Director of their state’s Health Department, and threatened with possible fines and criminal sanctions. This program is located in a US state with the most restrictive naloxone access in the US, and operates in a county with overdose rates that are double the statewide rate. State pharmacy boards should work to remove barriers to naloxone access at the state level, both through directly removing any regulatory barriers under control of the boards, or through advocating for changes that need to be made at the legislative level. This should include, at a minimum: *Expanding standing orders to include 0.4mg/1ml injectable naloxone If you would like any additional clarification on these recommendations or sample language related to naloxone access, please do not hesitate to reach out to any of the undersigned. Sincerely, Dr. Nabarun Dasgupta, PhD, MPH, University of North Carolina and Co-Founder and Board President, Remedy Alliance For the People Eliza Wheeler, MS, MPA, Co-Director, Remedy Alliance For The People Maya Doe-Simkins, MPH, Co-Director, Remedy Alliance For The People Corey Davis, JD, MSPH, Harm Reduction Legal Project: Network for Public Health Law and legal advisor, Remedy Alliance For The People |
ASAM’s comment letter will be emailed to Dr. Varisco on 5/31/2024. |
I am a board certified addiction doctor operating an office-based buprenorphine treatment program at the same rural FQHC since 2011. I have treated 40+ patients for 10 years+ and about 150 patients 5-10 years continuously. I have had many of these patients report adverse effects from the combination product which are effectively alleviated by using the monoproduct and are completely stable in remission. They have no secondary gain for the monoproduct outside of avoiding side effects. Our drug testing is almost exclusively gas chromatography/mass spectroscopy. Their expected toxicology results as well as the complete restoration of their lives affirms this clinical reality. I was so grateful to see that, “If a patient… is experiencing adverse effects related to combination therapy, transitioning to buprenorphine monotherapy is a reasonable clinical action.” included in the section, “Safety and appropriateness of buprenorphine monotherapy” on page 26. This is affirming and very helpful! Thank you! I noticed however that even though the publication indicates that adverse effects are a reason to consider the monoproduct, it fails to include the statement on adverse effects in the section, “Indications for Buprenorphine Monotherapy” on the same page (26). Cost consideration for monoproduct use, on the other hand, is listed under both sections. It would be quite helpful for adverse effects to be listed under both sections like cost consideration. Over the past 13 years, my patients and I have experienced substantial misunderstandings and increased scrutiny for treatment with the monoproduct and it would help immensely to have the requested amendment to help deter these problems. Could there be a statement like, “Adverse effects from the combination product is consistent with an indication for an alternative treatment option such as the monoproduct.” added to the section, “Indications for Buprenorphine Monotherapy”? For consideration, is a recent Prescribers Clinical Support System (PCSS-MOUD) guidance: Newcomb A. Providers Clinical Support System-Medications for Opioid Use Disorders. Buprenorphine Prescribing Flexibility: Buprenorphine Monoproduct for Adverse Effects from Buprenorphine/Naloxone, PCSS-MOUD Guidance. March 2024. Accessed May 2, 2024. https://pcssnow.org/wp-content/uploads/2024/03/Buprenorphine-Prescribing-Flexibility.pdf. Thank you for your consideration. This is vital work and greatly appreciated! |
Dear Mr. Carter and Mr. Hoey: On behalf of the physician and medical student members of the American Medical Association (AMA), I am writing to provide comments on the “Pharmacy Access to Resources and Medication for Opioid Use Disorder (PhARMOUD) Guideline: A Joint Consensus Practice Guideline from the National Association of Boards of Pharmacy (NABP) and the National Community Pharmacists Association (NCPA)” (PhARMOUD proposed guideline). The AMA strongly agrees with the overarching theme in the PhARMOUD proposed guideline that, without significant changes to increase access to buprenorphine in the nation’s pharmacies, the overdose epidemic will have little chance of substantially improving. The AMA and the nation’s pharmacists have for years worked together to ensure access to care for patients with pain, opioid use disorder (OUD), and other conditions that might require a prescription for a controlled substance.1 The AMA strongly supports the physician-pharmacist-patient therapeutic triad and commends the NABP and NCPA for outlining key actions that will help improve access to buprenorphine for individuals with an OUD. Physicians and patients continue to experience barriers to accessing buprenorphine at pharmacies,2 and implementation of the recommendations in the PhARMOUD proposed guideline can help remove many of those barriers. The AMA strongly agrees, for example, that when pharmacists have questions about a prescription for buprenorphine for the treatment of OUD, it is essential for the pharmacist and physician to discuss the situation—and not automatically deny the patient access to the life-saving medication. Buprenorphine is the gold standard for OUD treatment because it improves patient outcomes, including helping patients with OUD maintain recovery, reducing the risk of overdose, and improving the quality of lives. Unfortunately, as the PhARMOUD proposed guideline also makes clear, it is with increasing regularity that some pharmacies deny access to buprenorphine because of stigma, fear of law enforcement3 investigation, fear of distributors’ inflexible quotas, or corporate pharmacy policies that limit the ability of community pharmacies to stock or dispense this life-saving medicine for patients with OUD. The AMA commends the NCPA and NABP for making clear that denying a buprenorphine prescription “is a measure of last resort and should only be considered after discussion with the patient and their prescriber.” The AMA also commends the NCPA and NABP for shining a light on the challenges community pharmacies and pharmacists face—calling for action to stop harmful practices that delay or deny access to buprenorphine for OUD, including the concerning use of inflexible quotas that distributors are using to limit buprenorphine supply.4 The AMA looks forward to continuing to work with you to remove these barriers to care. The AMA generally supports the discussion around state prescription drug monitoring programs (PDMP) for pharmacists, where the use of a PDMP is a supplement for decision-making and should not be used as the sole justification to deny dispensing buprenorphine or other medication. The AMA strongly supports the recommendation that, “Chain pharmacies and pharmacy owners should immediately retire policies that prohibit employee pharmacists from filling buprenorphine prescriptions solely due to the pharmacy’s distance from the provider or patient home address.” Furthermore, the AMA supports the discussion that distance from the physician or other prescriber, use of telehealth, cash payments, early refills, and other potential concerns should be discussed rather than used to justify stigma or denial of care. The AMA has long maintained that PDMPs may be a helpful tool as part of the clinical decision-making process, but that they are never a substitute for individualized, patient-centered clinical decisions. There are a few areas in the PhARMOUD proposed guideline that could benefit from additional clarification. For example, we urge further clarification that there should be concern when there is, “An increase in a patient’s maintenance buprenorphine dose of more than 50% between prescriptions.” The PhARMOUD proposed guideline appropriately notes that when starting on buprenorphine, the dose may increase at regular intervals, which may be up to or greater than 50% depending on the dose strength. The AMA understands that the Controlled Substances Act requires pharmacists to exercise their corresponding responsibility, but we highlight that if the PhARMOUD proposed guideline uses a specific numeral threshold to indicate concern, that will become a default threshold some will use to deny buprenorphine dispensing. The AMA, therefore, urges removal of numerical thresholds for decision-making. The AMA also urges additional attention to the discussion of when buprenorphine monotherapy may be appropriate. As the drug supply in the country shifts to higher potency, synthetic opioid products, such as fentanyl, the need for higher doses (>24mg daily) of buprenorphine may be warranted for adequate therapeutic effect.5 Using the combination buprenorphine/naloxone product for these higher doses may increase adverse events from systemic naloxone absorption and decrease the potential for continued utilization for treatment.6 Limiting the indications for buprenorphine monotherapy to pregnancy, breastfeeding, and dental lesions inserts unwarranted stigma for buprenorphine treatment and hampers access to these medications. In addition, the AMA is concerned that by specifying only a few situations where buprenorphine monotherapy is appropriate, some policymakers, pharmacy chains, or distributors may use the PhARMOUD proposed guideline as justification to deny access to buprenorphine monotherapy in all other situations. The AMA strongly agrees with efforts to increase access to naloxone. We have been strong supporters of laws and practices to authorize pharmacists to dispense naloxone directly to patients through standing orders. While the PhARMOUD proposed guideline highlights the importance of naloxone, this document would be strengthened by describing the broader impact pharmacists can have to increase access to evidence-based harm reduction initiatives. Pharmacists are well-positioned to increase access to additional harm reduction measures, such as sterile syringes for purchase to help stop the spread of blood-borne infectious diseases. Pharmacists also are well-positioned to help increase access to fentanyl test strips and other drug checking supplies to reduce the risk of drug-related overdose. We commend the NABP and NCPA for the open dialogue about stigma and the barriers placed on pharmacists by some employers. We hope that the forthcoming recommendations will motivate those employers to take necessary actions, including stocking over the counter naloxone in prominent locations; making sterile syringes available for purchase; and helping with education and access about fentanyl test strips and other drug checking supplies. The AMA wants to also emphasize that we have long appreciated the invaluable role pharmacists play on the clinical care team. It is widely known that the integration of pharmacist care into physician-led clinical care models can result in greater continuity of care, improved care coordination, improved patient outcomes, and better care management—particularly for patients with chronic conditions. As such, we support the PhARMOUD proposed guideline’s inclusion of physician-led collaborative practice models as a means of increasing patient access to OUD treatment and supporting patients in adhering to the treatment plan. We agree that patients seeking treatment for OUD would benefit from pharmacy services similar to those available to patients experiencing other chronic diseases and support collaborative practice agreements that require meaningful involvement by a physician. The AMA would be pleased to have further discussions on how to achieve high-functioning, patient-centered collaborative practice models to achieve the goals set forth in the PhARMOUD proposed guideline. Thank you for your consideration of these comments. If you have any questions, please contact Jennie Jarrett, PharmD, MMedEd, PhD, BCACP, FCCP, Director, Science and Drug Policy, at jennie.jarrett@ama-assn.org or Daniel Blaney-Koen, JD, Senior Attorney, at daniel.blaney-koen@ama-assn.org. Sincerely, James L. Madara, MD |
Dear NABP, UH, and NCPA: On behalf of the American Society of Addiction Medicine (ASAM), a national medical specialty society representing more than 7,500 physicians and associated health professionals who specialize in the prevention and treatment of addiction, I am grateful for the opportunity to provide suggested changes to the draft document titled, “The Pharmacy Access to Resources and Medication for Opioid Use Disorder (PhARMOUD) Guideline.” All page number references correspond to the pages in the PDF found here. According to the Substance Abuse and Mental Health Services Administration (SAMHSA), more than 48 million people met the diagnostic criteria for having a substance use disorder (SUD) in the U.S. in 2022.1 Increasing access to buprenorphine for the treatment of opioid use disorder (OUD) is fundamental to addressing this daunting statistic. To that end, ASAM offers the following comments: Global change: “Issuers of prescriptions” are often referenced as “providers;” consider replacing that term with the term, “clinicians.” Page 3: Irrespective of treatment adherence, if risk of treatment dropout is high, evidence favors the use of agonist medication to retain patients with OUD in treatment; consider noting this with respect to “retaining individuals in OUD treatment.”2 Consider the following change in the first sentence in paragraph 2: “Still, around half of all pharmacies in the United States are not prepared unable to dispense buprenorphine products for the treatment of OUD.” In paragraph 3, second sentence, consider explicitly noting that evidence suggests that buprenorphine diversion rates are highest in areas with greater buprenorphine access challenges, and as people with OUD gain access to legal prescriptions, misuse decreases. 3,4 Page 5: With regard to pharmacists’ “corresponding responsibility,” there is a “knowledge” requirement in § 1306.04 that is critically important to acknowledge so that it is made clear that pharmacists are not responsible for determining the legitimacy of a prescription.5 Accordingly, under “Interpreting the Recommendations,” consider the following suggested changes to the current text: At many points in this document, pharmacists are recommended to dispense medication for OUD if they are able to verify that a prescription is legitimate and fulfill their corresponding responsibility. In the context of this document, that corresponding responsibility is defined as the pharmacist’s obligation to resolve any concerns that the pharmacist knows or should have reason to know about the validity of the prescription, exercising his or her independent professional judgment. To be effective, ensure that a prescriptions for controlled medications must be has been issued for a legitimate medical purpose consistent with in the usual course of a practitioner’s professional practice; “knowingly filling” a purported prescription not so issued is subject to penalties. 20 If the pharmacist cannot verify, and document, that these criteria have been met, then they have not fulfilled their corresponding responsibility. Pharmacists are, first and foremost, autonomous practitioners and should be encouraged to use their professional judgement in a way that most effectively addresses the health needs of their patients. In the rare case that a pharmacist feels that dispensing buprenorphine would not benefit their patient, would not be appropriate, or would otherwise cause harm, pharmacists should carefully document their decision and explain their rationale to the patient and prescriber as appropriate. In general, however, if, in their professional judgement, the prescription is legitimate and the patient is expected to benefit from treatment, pharmacists should dispense buprenorphine in a manner that is consistent with the recommendations of this guidance as long as, in their professional judgement, the prescription was issued for a legitimate medical purpose. Page 7: Consider revising the first sentence of recommendation 1 as follows: “Declining to dispense buprenorphine can lead to interruptions in opioid use disorder (OUD) treatment, force patients into withdrawal, and increase risk of recurrent opioid use and opioid overdose deaths.” Page 8: Throughout the document, a clarifying, global change is needed to address PDMP functionality and accessibility. For example, consider revising recommendation 2’s last sentence as follows: “Pharmacists should query the PDMP when operational and available prior to dispensing all buprenorphine prescriptions.” ASAM further recommends deleting the first red flag pertaining to an increase in a patient’s maintenance buprenorphine dose of more than 50% between prescriptions, as a 50% increase in dosing between buprenorphine maintenance prescriptions is rather typical early in treatment. Additionally, higher doses of buprenorphine are becoming more routine given the continued presence of fentanyl in the unregulated drug supply.6 Finally, consider modifying the red flag in “c” as follows: A patient has received or is receiving buprenorphine from multiple providers (who are not part of the same medical practice) with no consistent plan of care. Page 10: Some prescribers do not have the ability to respond immediately to phone calls from pharmacists attempting to resolve concerns/verify prescriptions; some practices report each week receiving hundreds of pharmacy calls on behalf of patients needing to fill their prescriptions. Consider encouraging pharmacists to use alternate methods of real-time communication, such as email, to save time, and preserve efficiency and patient flow. Accordingly, ASAM recommends the following revision to the relevant sentence: “If a pharmacist needs to clarify a buprenorphine prescription for whatever reason, they should make every effort to promptly contact the prescriber directly (e.g., by phone, email, pager, or other through direct phone methods of communication) rather than rely solely on fax, while following federal and state privacy rules. Page 12: Considering pending federal legislation that would allow addiction specialist physicians to prescribe methadone for pharmacy dispensing and naltrexone, ASAM recommends the following revisions to the first sentence under the subsection titled “Long-term Maintenance Pharmacotherapy”: “Buprenorphine is widely accepted as safe and effective for the treatment of OUD and is currently the only agonist medication for OUD that can be dispensed directly to patients in community pharmacies in all fifty states.” Page 14: Consider the following revisions to make the MATE Act description more precise: “The MATE act requires that all DEA registrants complete a one-time, eight-hour training requirement on SOUD treatment prior to renewing their DEA license. The provisions of the MAT and MATE acts therefore eliminate the need for providers to complete requisite training and obtain a Drug Abuse Treatment Act of 2000 waiver, commonly known as an X-waiver, to dispense buprenorphine.” Page 16: For accuracy, consider the following revisions to the relevant sentences: “In the context of OUD treatment, it is important to note that federal law prevents Opioid Treatment Programs (e.g., methadone clinics) from reporting dispensation to PDMPs without patient written consent. Furthermore, while all states except Missouri7 require dispensers to report data to the PDMP, most states do not require emergency departments and inpatient facilities to report data to the PDMP. Page 18: For accuracy, consider the following revision to the relevant sentence: “This means that if patients consent to share their information once, future disclosures do not always require consent.” Page 26: Under the subsection titled “Indications for Buprenorphine Monotherapy,” ASAM recommends that you highlight additional, relatively overlooked, literature that questions the utility of buprenorphine combination products, relative to buprenorphine monoproduct.8 ASAM also recommends the following revisions following the second sentence in the first paragraph under said subsection: “For pregnant and breastfeeding individuals with OUD seeking treatment, buprenorphine formulations without naloxone are preferred to combination products due to concerns about naloxone’s potential to cross the placenta and cause harm to the developing fetus. Of note, however, in a systematic review of the use of buprenorphine naloxone combination product, pregnant individuals undergoing treatment for OUD with buprenorphinenaloxone did not experience significantly different pregnancy outcomes than women undergoing treatment with other forms of opioid agonist medication treatment.9 . . . Transdermal10 or Llong acting injectable products should be considered in patients suffering from dental carries or other oropharyngeal adverse effects associated with the use of buprenorphine/naloxone11 sublingual transmucosal products. Also consider making a global change from “sublingual” to “transmucosal,” where appropriate. Page 27: In the last full paragraph, which begins with: “In addition to monitoring for incidence of adverse events…,” consider aligning the tone and level of concern in this document with the tone and level of concern exhibited in SAMHSA’s statement on the topic of tooth decay risks and the importance of good oral hygiene. 12 As currently written, the concern appears overstated, which could have unintended consequences, such as proliferating misguided beliefs about the safety of buprenorphine. In conclusion, ASAM greatly appreciates this important effort by your organizations to establish consensus-based guidelines for pharmacy access to buprenorphine. Your collective work represents a significant contribution towards advancing our shared goal of saving and improving the lives of individuals with SUD. Please contact Kelly Corredor, Chief Advocacy Officer at ASAM (kcorredor@asam.org), with any questions. Sincerely, Brian Hurley, MD, MBA, FAPA, DFASAM President, American Society of Addiction Medicine |
To Whom It May Concern, The Healthcare Distribution Alliance (HDA) submits these comments in response to the “Joint Consensus Practice Guideline from the National Association of Boards of Pharmacy (NABP) and the National Community Pharmacists Association (NCPA)” (the “guidelines”).1 HDA represents primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and pharmacies, hospitals, long-term care facilities, clinics, and others nationwide. Since 1876, HDA has helped members navigate regulations and innovations to get the right medicines to the right patients at the right time, safely and efficiently. It is HDA’s understanding that the purpose of these guidelines is to suggest ways in which pharmacists2 can increase access at the pharmacy counter to medications for opioid use disorder (MOUD) treatment, specifically with respect to buprenorphine. We also understand that later this summer the authors of the guidelines intend to disseminate the final guidelines “nationwide through accredited continuing professional education and a hybrid digital, print, and social media campaign in collaboration with [the University of Houston], University of Southern California, University of Texas at Austin, NCPA, and NABP.”3 HDA agrees with the guidelines’ statement that pharmacists can play a critical role in protecting the health and safety of persons with opioid use disorder by stocking and dispensing buprenorphine. To that end, HDA appreciates the guidelines’ intended purpose because it aligns with our goal to help ensure a safe supply of medicines while minimizing the potential for their abuse or misuse. 4 However, despite the intended purpose, we have concerns that the guidelines misstate and misinterpret current legal requirements for distributors registered with the Drug Enforcement Administration (DEA) (“DEA Registrants”). In some instances, the guidelines directly contradict applicable statute, regulation, or other legal requirements. As we detail below, the guidelines should accurately describe that distributors must comply with overall security requirements including maintaining effective controls against diversion per 21 C.F.R. § 1301.71 and identifying and reporting suspicious orders under 21 U.S.C. § 832(a); 21 C.F.R. § 1301.74(b), as well as guidance that DEA has provided to the industry and separately, related terms and requirements of the 2021 National Opioid Settlement Agreement (the “Injunctive Relief”), 5 which nearly every state in the country has adopted. Compliance with these legal requirements cannot be negotiated between supply chain actors and any language within the guidelines that suggest otherwise should be removed. Accuracy on these points is critical to the effectiveness of these guidelines, especially as the authors intend to disseminate the final guidelines to practitioners throughout the country. Without accurate information, the intended purpose of these guidelines will be undermined, causing confusion, conflict and possible risk of non-compliance for pharmacists and pharmacies. In addition to our comments provided below, HDA looks forward to its continued support of efforts to fight against the ongoing public health risks of drug abuse, misuse, and diversion associated with controlled substances. 1. The guidelines should accurately describe that distributors must identify and report suspicious orders. Distributors that are DEA Registrants must create and administer suspicious order monitoring (SOM) programs to comply with statutory and regulatory requirements.6 The DEA recently summarized these requirements as follows: The [Controlled Substance Act], as amended by the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment Act (SUPPORT Act) requires each DEA registrant to: 1) design and operate a system to identify suspicious orders for the registrant; 2) ensure that the system complies with applicable Federal and State privacy laws; and 3) upon discovering a suspicious order or series of orders, notify the Administrator of the DEA and the Special Agent in Charge of the Division Office of the DEA for the area in which the registrant is located or conducts business. 21 U.S.C. § 832(a). Suspicious orders may include, but are not limited to, orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency. 21 U.S.C. § 802(57). Furthermore, all applicants and registrants must maintain effective controls and procedures to guard against theft and diversion. 21 C.F.R. § 1301.71(a). DEA, Suspicious Orders (SORS) Q&A, DEA-DC-065, EO-DEA258 (Jan. 20, 2023). As part of their SOM program, some distributors use thresholds to identify and then report suspicious orders of controlled substances, including those orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency (all factors enumerated in the Controlled Substance Act).7 Certain legislative and regulatory initiatives have modified and reinforced distributors’ suspicious orders reporting responsibilities. Further, distributors subject to the Injunctive Relief8 are required to use thresholds and specify methods, established around suspicious order requirements, which must be applied to their development and use. However, the guidelines contain inaccurate information with respect to SOM programs. First, the guidelines suggest that pharmacists can simply negotiate different terms and conditions for buprenorphine ordering that would not be subject to the same requirements as other controlled substance ordering9 . State and federal law, as well as the Injunctive Relief terms, require that suspicious orders be reported for all controlled substances, including buprenorphine. The guidelines also imply that distributors have implemented policies that effectively limit a pharmacist’s ability to dispense buprenorphine.10 The current regulatory landscape requires that distributors employ long-identified dispensing “red flags” like distance between the patient’s home and their provider, the distance between their home and the pharmacy, or the distance between provider and pharmacy.11 The Injunctive Relief further identifies a pharmacy’s disproportionate filling of controlled verses non-controlled prescriptions, cash payments, and other actions as red flags. 12 Statements within the guidelines that lead pharmacists to conclude actions like those identified in the Injunctive Relief are not a red flag may be oversimplistic and are likely to steer pharmacists in the wrong direction. 2. The guidelines should accurately describe that distributors can and do update customer thresholds. When distributors set thresholds, distributors are complying with their obligations under 21 C.F.R. § 1301.71 to maintain effective controls against diversion and 21 C.F.R. § 1301.74 to identify suspicious orders. Most distributors have established threshold methodologies that have been developed using statistical methods and computerized models whereby one or more thresholds are used as a base of comparison for every controlled substance order a distributor receives. Still, ordering patterns for controlled substances may change for various reasons, and there are many legitimate reasons for increasing customer thresholds like an increase in new patients. Thus, most distributors have processes in place to amend and change customer thresholds. Threshold changes must be supported by documentation and may take time to approve. Distributors subject to the Injunctive Relief also have a multi-prong process, detailed within three pages of directives, mandating specific methods that must be applied for adjusting thresholds. For instance, under the Injunctive Relief, a “[d]istributor may increase or decrease a [c]ustomer [t]hreshold as set forth in its [Controlled Substance Monitoring Program] policies and procedures, subject to Sections XII.C.3.b through XII.C.3.e [of the Injunctive Relief].”13 Many, if not most, of the distributors not subject to the Injunctive Relief maintain similar processes for adjusting thresholds.14 While distributors can and do adjust thresholds, the guidelines contain inaccurate information on that process. First, the guidelines do not accurately describe how distributors subject to the Injunctive Relief evaluate threshold changes.15 Prior to approving any threshold change request by a customer, a distributor subject to the Injunctive Relief must conduct extensive due diligence to determine whether an increase to the threshold is warranted.16 For example, pharmacists can request an increase to their thresholds for a specific drug if they plan to take on a new patient population that will cause the ordering of specific controlled substances to increase. However, beyond the basis for the threshold change request, under the Injunctive Relief, a distributor must review dispensing data and/or pharmacy customer data, and as needed, conduct an on-site visit to the customer to increase a threshold.17 The guidelines also suggest that pharmacists should be able to know when thresholds are exceeded.18 Under the Injunctive Relief, and a practice generally employed as a good security practice by the industry, distributors cannot tell customers what their thresholds are; therefore, pharmacists cannot know when those thresholds are exceeded.19 Specifically, the Injunctive Relief reads in relevant part: Injunctive Relief Distributors shall not provide Customers specific information about their Thresholds or how their Thresholds are calculated. Distributor Settlement Agreement, Exhibit P-16, Term XII.C., PDF p. 516. Importantly, however, exceeding a buprenorphine threshold would not necessarily lead a distributor to bar a customer from purchasing controlled substances absent other concerns about the order. The overall concerns with a customer’s ordering pattern and/or a customer’s dispensing practices are what could lead to termination. The guidelines also mistakenly imply that buprenorphine thresholds are entangled with other thresholds, which is not accurate.20 While methodologies may differ among distributors, thresholds are set at the drug family level (e.g., for buprenorphine) and are independent from each other. The guidelines mischaracterize the DEA’s letter to DEA Registrants on March 8, 2024, with respect to access MOUD medications. The guidelines state that the letter “clarifies that wholesalers should monitor buprenorphine separately from other controlled substances.”21 This is incorrect. Instead, the DEA stated in part: DEA supports collaboration amongst all DEA registrants to ensure there is an adequate and uninterrupted supply of MOUD products when these products are appropriately prescribed. Distributors should carefully examine quantitative thresholds they have established to ensure that individuals with OUD who need buprenorphine are able to access it without undue delay. Drug Enforcement Administration, Dear Registrant Letter (Mar. 8, 2024). Finally, the guidelines imply that distributors are not already considering the legitimate need for buprenorphine when setting thresholds.22 Distributors account for legitimate needs of all controlled substances, including buprenorphine, when setting thresholds. Moreover, if a customer experiences an increase in MOUD patients that need buprenorphine to the point where the customer’s orders are being cancelled by the distributor, the customer can provide its supplier with information regarding its legitimate need for a threshold adjustment. Importantly, it is HDA’s general understanding that distributors have not reported seeing an increase in threshold change requests for buprenorphine. 3. The guidelines should use relevant terms of the Injunctive Relief. The Injunctive Relief is a critical document for the guidelines to accurately reference to avoid misinterpretation and inaccurate standards. In addition to the above legal requirements, we recommend that the authors reflect the language of the Injunctive Relief, such as using the term “distributors” instead of “wholesalers.” Finally, we caution the authors to not use incorrect phrases when describing the 2021 National Opioid Settlement Agreement that would incorrectly imply admissions outside of those in the Agreement.23 Conclusion Thank you for the opportunity to provide these educational comments to the guidelines, as we continue to support initiatives aimed at combating the ongoing public health crisis related to the abuse, misuse, and diversion of controlled substances. Should you have any questions, please contact me at kshankle@hda.org. Sincerely, /s/ Kala Shankle Kala Shankle Vice President, Regulatory Affairs |
The Pharmacy Access to Resources and Medication for Opioid Use Disorder Guideline We thank the entire Steering Committee and Expert Panel for their efforts in addressing a complex, multi-faceted gap in the care of patients with opioid use disorders (OUD). Despite the varied sources of these barriers, pharmacists and pharmacies are uniquely positioned to affect change and advance the care being provided. We stand with our community pharmacy colleagues who practice through these challenges on a daily basis. Although evidence suggests that stigma plays a role in pharmacy access to buprenorphine1, we recognize this to be a small contributor to the intricate nature of the issue. Far more concern stems from unnecessary administrational and legal burden interfering with pharmacists’ clinical decision making. We recognize that in absence of these barriers, the vast majority of our pharmacist colleagues stand ready and willing to help patients with OUD as originally committed to upon embracing the Oath of a Pharmacist. These guidelines lay the groundwork for overcoming these barriers and re-establishing pharmacists as the experts in determining the safety and appropriateness of the prescription orders they fulfill. At present, the written tone could be suggestive that pharmacist stigma is prompting many of the recommendations within. The Steering Committee may wish to explicitly acknowledge the existence of data surrounding stigma in our profession, while ensuring to separate this phenomenon from the language used within each of the recommendations. Introduction and General Comments Maintenance Pharmacotherapy with Buprenorphine Red Flags and Prescription Drug Monitoring Programs Early Refills Providing Care to Persons Utilizing Telehealth Buprenorphine Monotherapy Recommendations to Protect Patient Safety Care Coordination and Provider Communication Stigma toward Persons with OUD References |