Public Comments

The Pharmacy Access to Resources and Medication for Opioid Use Disorder Guideline

After the public comment period has concluded, these comments will be analyzed thematically. Then, a panel of experts who were not involved in the initial guideline creation process will be convened to review the aggregated comments and discuss potential changes to the guideline document.

Public Comment Period: April 15 – May 31, 2024

CommentsEntry creation date

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.

April 17, 2024 at 7:45 am

Excellent document! Just a few suggestions:
1. Suggest removing 50% dose increase as a red flag. As you outlined later in the paper, there are MANY MANY legitimate medical reasons for dose increases of this kind, particularly in the first few weeks of BUP therapy.
2. Under “Telehealth” section, I would specifically have one of the “supporting recomendations” be “Removing Provider-Patient Distance requirements.” You elaborate on this later, but since it is the number one reason pharmacists currently give for not filling BUP, I would specifically include it under “Supporting Recommendations” to be very clear
3. Under “Red flags/Green flags” section, I sugget making the point that NOT having a BUP prescription on file when checking PDMP should NOT be a red flag. I’ve had several pharmacists refuse to fill new start BUP patient scripts bc PDMP did not show it listed. This logic makes sense with stimulants, but not BUP.

April 17, 2024 at 9:41 am

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.

April 18, 2024 at 3:33 pm

To the Committee:
I am a nurse practitioner, dually certified as an adult and a psychiatric mental health NP. I have been an NP for 25 years and was a registered nurse prior to that. Currently I am employed in a private pain management practice where I care for the majority of patients treated with buprenorphine whether for OUD, chronic pain or both. I also provide primary care and mental healthcare primarily psychopharmacologic medication management. I hear over and over again how difficult it is for persons with OUD to access care and the overdose rate continues to climb. Having said that, I recently saw a new patient. I prescribed two week’s of buprenorphine-naloxone films of the 8mg/2mg strength to be taken BID. I sent them electronically to a chain pharmacy and shortly after received a call from the patient that they did not have the medication in stock. I should also add that this person was in withdrawal at the time of their visit. They requested I send the RX to a local “big box” store pharmacy which I did while also cancelling the RX to the chain pharmacy. I did, of course check the PDMP and found no issues there. I received yet another call from this patient that the pharmacist at the big box store wanted to speak with me. After being placed on the line with the pharmacist I was subjected to a litany of questions: Did I see the patient face-to-face, was this an in-person visit, was this my first time seeing the patient, had I seen the patient before. I was annoyed that my patient’s RX was delayed. Patients with SUD experiencing withdrawal are not known for their patience and this type of delay could certainly cause someone to give up and go use. My state is currently auditing pharmacies to make sure the don’t have too high a percentage load of patient on chronic opioid therapy and that those patients are not exceeding recommended MMEs. One concern is that buprenorphine will get lumped into this scenario with conventional opioid analgesics. When I did speak to the pharmacist, they didn’t seem to understand why I was annoyed with the delay in the patient’s prescription. I agree with the one recommendation that if a pharmacist truly feels they need to speak with a provider, at least provide a partial fill so the patient is not left in withdrawal. Also it would have been helpful if the pharmacist had said “I’m sorry Nurse Beebe but my company requires me to ask all these questions when a new patient prescription comes through.” I would have been less annoyed if I had had some sort of explanation but at the time it seemed to be a random inquisition. I also would have understood if there was something irregular about the prescription such as a high dose or increased dosing frequency but that wasn’t the case.

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

April 26, 2024 at 5:32 pm

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!

April 29, 2024 at 11:34 am

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!

May 9, 2024 at 12:40 pm

Thank you for this opportunity to submit comments.
Please note – all formatting was lost when copied and pasted comments from a Word document. Happy to email a Word document if preferred.
Drs. Ostrach & Carpenter
__________________________________

Specific suggestions for Background section:
On Pg. 4 of Background: in addition to increasing overdose risk please note dispensing delays lead to withdrawal symptoms and reluctance to continue MOUD/regret over initiating MOUD (Ostrach et al. “Ensuring Buprenorphine Access in Rural Community Pharmacies to Prevent Overdoses.” Journal of the American Pharmacists Association 62, no. 2 (2022): 588–97.)
Throughout Background, when need for pharmacist training/education mentioned consider citing Carpenter et al. “A Brief Online Training to Address Pharmacists’ Willingness to Dispense Buprenorphine.” Journal of Addiction Medicine, 2023, 10–1097.
Overall feedback for whole document:
Document very repetitive and long; would be too long for most practicing pharmacists to read.
All recommendations should be bulleted and have language like, “pharmacists should” or “employers should” to be consistent. Rationale for the recommendation shouldn’t be included in the main bullet
Reformat Recommendations sections to start with the recommendation; followed with rationale and supporting evidence (inconsistent formatting – some sections intersperse these, some have no evidence or rationale). For example, move the most compelling rationale for a recommendation to a sub-bullet under each recommendation. You could include a lengthier rationale at the end of the section.
Make sure each recommendation has a rationale to help sway pharmacists’ opinion on the topic.
Some of the ‘Supporting Recommendations” language is evidence or opinion, not worded as specific recommendations to practicing pharmacists
Some recommendations lack practical steps and are vague; while others are very specific but in ways not supported by current evidence-based clinical guidelines for treatment of OUD (specifics below)
Suggest reformatting whole document to have shorter Background, then list Recommendations sooner, in more directive language, with bullet points for rationale and supporting evidence under each one, rather than repeating similar sections with portions of each in different places
Specific feedback on numbered Recommendations:
Recommendation 1)
Suggest changing wording to “no *maximum* recommended length of treatment” as evidence-based OUD treatment guidelines do in fact offer guidance for minimum length of treatment (varies based on pregnancy status). More importantly, emphasize that pharmacists should not second-guess prescribers’ and patients’ treatment plans; treatment duration is a decision between the patient and prescriber.
What about offering proactive guidance for pharmacists anticipating increased need for bupe stock, and how to advocate with wholesalers to increase order sizes? (e.g., such trainings piloted and in further development by Hill, Carpenter, etc.)
Broad language about stocking enough bupe doesn’t help very much if pharmacists don’t know how to overcome ordering barriers.

Recommendation 2)
What is a pharmacist supposed to do when they can’t reach the prescriber while the patient is in the pharmacy? In rural settings a patient may have traveled an hour or more to reach a pharmacy; if they are turned away they may not have gas money or transportation to come back later. (e.g. Major et al. “Factors in Rural Community Buprenorphine Dispensing.” Exploratory Research in Clinical and Social Pharmacy, December 26, 2022, 100204.)
If the pharmacist is considering not filling a bupe prescription, recommend they fill a bridge script until they can get more information from the patient’s provider
Consider adding a recommendation that pharmacists proactively communicate with prescribers; need guidance for establishing relationships with prescribers ahead of time to facilitate communication when questions do arise (e.g. Major et al. “Factors in Rural Community Buprenorphine Dispensing.” Exploratory Research in Clinical and Social Pharmacy, December 26, 2022, 100204.)
The guidance offered about when not to dispense is problematic, potentially dangerous, and inconsistent with current clinical guidelines for treatment of OUD. For example:
An increase in dosage of 50% (or more) would be common and appropriate during bupe induction; a day to day doubling of dosage during a few days or a week is now standard in some protocols when inducting a person that has been using fentanyl. Discouraging pharmacists from dispensing bupe as prescribed could disrupt an evidence-based prescriber’s carefully planned induction protocol at a critical time when a patient has just decided to transition from non-prescribed substances to MOUD, and is experiencing withdrawal; such a denial could directly increase overdose death risk.
Patients receiving OBOT in a medical education setting are typically seen by medical residents, APP trainees, etc. (often expected to learn and begin prescribing MOUD by second year of residency) who are on different rotations every few weeks. Thus such OBOT patients routinely see a different provider at every appointment, or even in standalone weekly OBOT clinics where multiple providers rotate through. Therefore it would be typical for the Rx to be sent by a different provider each time. This should not be a reason to not dispense. Seeing the same provider every time may be out of the patient’s control.

Recommendation 4)
This needs to be more nuanced – it is chain pharmacies tjat should not set company-wide policies that prohibit pharmacists from dispensing buprenorphine prescribed via telehealth. Pharmacists may wish to dispense to telehealth bupe patients, but if their employer has established a policy prohibiting this (as at least one large corporation did in 2023) their hands are tied.

Recommendation 5)
Take out the guidance to discuss risks and experiences with monoproduct patients each time they dispense; this would single them out and stigmatize them in a way that does not occur with other patients. They could ask at every refill whether the patient has questions about their medications.
Recommendations should encourage pharmacists to trust the treatment plan prescriber and patient have made, which may include a decision for monoproduct
Bottom line – Pharmacists should dispense buprenorphine monoproduct when prescribed

Recommendations 6-10)
Not all the items listed are recommendations
Naloxone should be offered to any patient dispensed any opioid medication
An additional safety recommendation would encourage pharmacists to identify local harm reduction organizations and have referral resources available (for free naloxone, test strips, etc.)

Recommendations 11-15)
What is a pharmacist supposed to do when they can’t contact the prescriber while the patient is in the pharmacy? In rural settings a patient may have traveled an hour or more to reach a pharmacy; if they are turned away they may not have gas money or transportation to come back later. (Ostrach et al. “Ensuring Buprenorphine Access in Rural Community Pharmacies to Prevent Overdoses.” Journal of the American Pharmacists Association 62, no. 2 (2022): 588–97.)
What about specific guidance for how best to communicate with prescribers? Templates? Recommendations for establishing relationships with prescribers ahead of time to facilitate communication when questions arise? (e.g. Major et al. “Factors in Rural Community Buprenorphine Dispensing.” Exploratory Research in Clinical and Social Pharmacy, December 26, 2022, 100204.)
Dedicated dispensing agreements? (Ostrach et al. “Ensuring Buprenorphine Access in Rural Community Pharmacies to Prevent Overdoses.” Journal of the American Pharmacists Association 62, no. 2 (2022): 588–97.)
Pharmacists should also be ready to refer to harm reduction organizations
Bridge scripts should be mentioned sooner, and in multiple other places (early fills, ‘red flags,’ maintenance, etc.); also need to provide guidance on careful documentation of bridge scripts to prevent return to use/withdrawal/overdose and efforts to reach prescriber

Recommendation 16)
Very general; make specific recommendations re: pharmacist training and education for stigma reduction

Recommendation 17)
Remove the bullet point about transferring non-controlled Rxs, as this isn’t a practice pharmacists do punitively or out of stigma, rather it’s a proactive attempt to manage CS ratios so that wholesalers will continue allowing them to stock sufficient CS so that they can order and stock enough bupe to meet increasing demand. The recommendation should instead be geared toward supporting pharmacists to work with their wholesalers to increase order sizes, or otherwise thinking about how to advocate with wholesalers to stop requiring the ratios
Strengthen the second bullet to be more specific and actionable
Third bullet should be more nuanced – this could go poorly if the person in that role is misinformed or stigmatizing toward MOUD (such as establishing corporate policies that prohibit dispensing of telehealth Rx); if a recommendation is going to be made that practicing pharmacists influence corporate policy this should include that it be a pharmacist that has received training on evidence-based OUD treatment and stigma reduction (as with anyone else in such a role); not to mention incorporating people with lived experience (MOUD patients) into policy formation

May 13, 2024 at 3:38 pm

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.

May 14, 2024 at 6:54 am

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

May 15, 2024 at 9:55 pm

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.

May 18, 2024 at 6:30 am

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.

May 18, 2024 at 12:19 pm

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.

May 20, 2024 at 2:54 pm

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.

May 20, 2024 at 5:51 pm

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.

May 21, 2024 at 12:01 pm