Important Update on House Bill 788

The KYSAM Board strongly supports House Bill 788 and encourages you to do the same. We have been advocating for the repeal of the Suboxone special regulation so that Suboxone is treated as a Schedule 3 drug just like other Schedule 3 drugs. That is what 33 other states do. They don’t have a special regulation for Suboxone. Tennessee and Indiana have regulations, but they are not as stringent as ours. Even the DEA, a very conservative entity regulating prescribing of controlled substances, significantly liberalized regulations for prescribing Suboxone via Telehealth in the Final Rule (https://www.functionallawyer.com/blog/New%202025%20Telehealth%20Prescribing%20Rules) though this has not yet been signed by the President.

Representative Kim Moser has filed House Bill 788. it currently is in the Health Services Committee.

As you can see, this protects doctors and nurse practitioners who prescribe Suboxone. It gives them more flexibility in dosing without fear of reprisal. It should encourage more providers to prescribe Suboxone.

Please call your legislator (Senator and Representative) and strongly advocate for this bill. This is a short legislative session and we need to move quickly. To find your legislator go to:

https://legislature.ky.gov/Legislators/Pages/default.aspx

UNOFFICIAL COPY 25 RS BR 951

AN ACT relating to buprenorphine products.

Be it enacted by the General Assembly of the Commonwealth of Kentucky:

SECTION 1. A NEW SECTION OF KRS CHAPTER 311 IS CREATED TO

READ AS FOLLOWS:

(1) Notwithstanding any law to the contrary, a physician who is licensed in Kentucky

and meets the qualifications to prescribe, dispense, or administer Buprenorphine-

Mono-Product or Buprenorphine-Combined-with-Naloxone shall use

professional judgement to prescribe, dispense, or administer a specific dosage

regimen of Buprenorphine-Mono-Product or Buprenorphine-Combined-with-

Naloxone that best meets the treatment needs of a patient.

The Kentucky Board of Medical Licensure shall not suspend, limit, or restrict a

license or take other disciplinary action against a physician who prescribes,

dispenses, or administers Buprenorphine-Mono-Product or Buprenorphine-

Combined-with-Naloxone to a patient in accordance with subsection (1) of this

(2) section.

(3) The board shall promulgate administrative regulations in accordance with KRS

Chapter 13A to implement the requirements of this section.

SECTION 2. A NEW SECTION OF KRS CHAPTER 314 IS CREATED TO

READ AS FOLLOWS:

(1) Notwithstanding any law to the contrary, an advanced practice registered nurse

who is licensed in Kentucky and meets the qualifications to prescribe, dispense,

or administer Buprenorphine-Mono-Product or Buprenorphine-Combined-with-

Naloxone shall use professional judgement to prescribe, dispense, or administer a

specific dosage regimen of Buprenorphine-Mono-Product or Buprenorphine-

Combined-with-Naloxone that best meets the treatment needs of a patient.

The board shall not suspend, limit, or restrict a license or take other disciplinary

action against an advanced practice registered nurse who prescribes, dispenses,

(2) Page 1 of 2

XXXX 2/19/2025 9:52 AM Jacketed

UNOFFICIAL COPY 25 RS BR 951

1

2

3

(3) 4

or administers Buprenorphine-Mono-Product or Buprenorphine-Combined-with-

Naloxone to a patient in accordance with subsection (1) of this section.

The board shall promulgate administrative regulations in accordance with KRS

Chapter 13A to implement the requirements of this section.

Page 2 of 2

XXXX 2/19/2025 9:52 AM Jack

January 2025 Update

As of Jan. 10, 2025, the Kentucky Board of Medical Licensure posted proposed updated guidelines for KAR 9:270, the Suboxone prescribing regulation, on its website. While there are a few changes, most of our requested updates are not included. The regulation does not allow physicians to make decisions which are individualized to each patient. It requires a frequency of visits and urine testing that may not be needed for every patient. It does not address the use of long acting injectables. It does not acknowledge the increased research supporting higher doses of suboxone. It requires “certification” of the need for continued care each year. We encourage continued care. Why do we need to justify it? In short, these regulations are not evidence based. KYSAM will be reviewing these regulations in detail. There is a public comment period at KBML offices on March 26 and written comments are accepted until March 31. If you scroll to the end of the proposed regulation, you can see the procedure for signing up for the public comment or submitting written comments. Let us know your opinion about the regulations by emailing admin@kysam.org. To read the proposed regulation, click here.

You may also be aware that HHS and DEA issued a final rule for telemedicine this week. The final rule says that practitioners utilizing telemedicine (video or audio) must review the prescription database for the patient in that state and then can issue up to 6 months of medication (split among several prescriptions) before an in-person visit is required. At the six-month period, the prescriber has 2 options: 1. Conduct an in-person evaluation, or if that is not possible, the practitioner can engage in other forms of the practice of telemedicine as defined in 21 U.S.C.802(54). You can review that rule here. It states that if an in- person evaluation is not possible, the evaluation can take place if the patient is in a DEA registered hospital or clinic and the prescriber has a DEA license in the state where the patient is located, or 2. The patient is being treated by and is in the physical presence of a DEA registered practitioner who is licensed in the state in which the patient is located. The pharmacist has to verify the patient’s identity before releasing the prescription.

In response to concerns about diversion, the final rule says the following:

Though, as with all transactions involving controlled substances, there is an inherent risk of diversion, DEA and HHS believe these regulatory provisions have been narrowly tailored to enable DEA and HHS to mitigate the risk of diversion associated with buprenorphine prescriptions issued pursuant to these new regulations. Moreover, considering the efficacy of treating OUD with buprenorphine when taken appropriately and subject to the additional safeguards in this rule, DEA and HHS believe that expanding access to buprenorphine through audio-only telemedicine outweighs the relatively lower risk of misuse and diversion of buprenorphine.

To read about the final rule, click here:

July 2024 Member Update

We continue to advocate for a new, diverse workgroup to make recommendations for updating 201 KAR 9:270, regulations for prescribing buprenorphine/naloxone.  We do not feel that the process utilized by KBML was open and inclusive. The proposed regulations have very few changes, and in some cases, for example the requirement for urine testing, they are even more strict than before. (To view the proposed changes, click here.)This does not incentivize physicians to prescribe suboxone. Our petition has 340 signatures. Dr. Murphy has written a resolution which we will be heard at the KMA annual meeting. If you are a KMA member, we strongly encourage you to attend the annual meeting and speak in favor of the resolution. The Greater Louisville Medical Society (GLMS) is supporting it. The resolution can be viewed at https://kyma.org/2024-kma-resolutions/.

ASAM is supporting our request. We have sent another letter to KBML which was co-signed by our ASAM President, Brian Hurley, MD, MBA, FAPA, DFASAM. See the letter here. KYSAM/ASAMletter

Important Update on Increasing Use of Tianeptine and Xylazine in Kentucky

More information is becoming available about one new “gas station” substance and a veterinary medication that are being abused. The first is Tianeptine, also known as ZaZa or Tianna Red, which is an antidepressant similar in structure to the tricylics that is approved in Europe, but not here in the US. It has a strong affinity for mu and delta opioid receptors, and it increases extracellular dopamine. Though similar in some ways to tricyclics, it is also quite different. It is more involved in modulating the glutamate system via indirect actions on NMDA and other receptors. Currently it is legal in Kentucky. Several other states have banned it. When it is abused, the withdrawal symptoms are similar to opioid withdrawal. Tianeptine was discussed at the spring 2022 ASAM meeting. It is very prevalent in states around us, particularly in larger suburban areas. Clinicians there were using short courses of suboxone to detox patients off tianeptine. Tianeptine is not new to the US. It has been available and shown abuse potential since 2000. But for whatever reason, there seems to be an increase in patients showing up in the ER exhibiting withdrawal symptoms from stopping it.

According to the article cited below from Practical Pain Management, there is not a POC or gas chromatography urine test available for Tianeptine. There is only a blood test. The article was written in 2020, so perhaps that has now changed.

A second substance being increasingly abused is Xylazine. A PowerPoint presentation, sent to KYSAM from ASAM and put together by Kelly Ramsey, MD,MPH,MA, FACP, DFASAM has been prepared. Since this newsletter format will not allow a file of that size to be downloaded, our administrative coordinator, Miranda Sloan, will send it separately, so watch for the email. It is a great overview of the history, pharmacology, and abuse potential of Xylazine. Xylazine is a non-opioid sedative, analgesic, muscle relaxant used by veterinarians for procedures. It is an alpha 2-adrenergic receptor agonist. It is not a controlled substance. It is not manufactured illicitly, but it is probably diverted from the veterinary supply chain. It has been used to extend the effects of fentanyl. It is also known as “tranq." It is increasingly involved in opioid overdoses. If you look at Dr. Ramsey's slide 31, you will see that the role of benzodiazepines in overdoses has declined somewhat while the role of Xylazine has increased. There is an increased incidence of skin ulcers when Xylazine is used as an adulterant with fentanyl or heroin.

Slide 55 lists signs of a Xylazine overdose. Those include BP and heart rate instability, heavy sedation, respiratory depression, and elevated glucose with rebound hypoglycemia. Avoid CNS depressants when treating Xylazine overdoses. Xylazine cannot currently be detected via point of contact, office based, testing, but it can be detected via gas chromatography (GC/MS or LC/MS or Thin Layer Chromatography). However, those results take several days to come back.

Obviously, a pure Xylazine overdose won’t respond to Narcan because Xylazine is not an opioid. However, most overdoses are from polysubstance use, so the standard of care when the substances are not known, is still to use Narcan.

Of course, Kratom, an herbal supplement, is still available in gas stations as well. Historically, the FDA has regulated it as an herbal. The FDA did consider banning it but held off because of public outcry from users who felt it was beneficial. It has opioid like effects, and users can become physiologically dependent on it if they use it regularly. Recently there has been an increase in adulterated Kratom with reports of seizures, tachycardia, and liver damage. Several states have banned it, but it is still legal in Kentucky.

Here are some links to articles about tianeptine.

From the University of Alabama. Toxicologist unravels the dangerous medical mystery of ZaZa, Alabama’s ‘gas station dope’. click here

Bettinger J, Cleary J. The Rise in Tianeptine Abuse: Our Next Kratom Problem?. Pract Pain Manag. 2020;20(2). click here.

Springer J, Cubała WJ. Tianeptine Abuse and Dependence in Psychiatric Patients: A Review of 18 Case Reports in the Literature. J Psychoactive Drugs. 2018 Jul-Aug;50(3):275-280. doi: 10.1080/02791072.2018.1438687. Epub 2018 Mar 1. PMID: 29494783.

Trowbridge P, Walley AY. Use of Buprenorphine-Naloxone in the Treatment of Tianeptine Use Disorder. J Addict Med. 2019 Jul/Aug;13(4):331-333. doi: 10.1097/ADM.0000000000000490. PMID: 30550394.

Devastating Flood in Eastern Ky Impacts our Members and Patients

Please remember our members and patients in Eastern Kentucky. A devastating flood hit the area on Thursday, July 28, 2022. Currently there is no internet operating. At least one of our providers has been able to make contact with a couple of pharmacies that are operating. Many people are homeless and living in temporary shelters. They have lost everything and access to medication may not be utmost on their minds. This will obviously be a major disruption in treatment for many patients in that area. One of our members in that area is Jonathan Hatton, MD. There are several funds set up for donations including through Team Kentucky. This can be accessed by going to the Ky.gov website. Dr. Hatton would be happy to answer any questions about needs in the area. He can be reached at 606-253-1974.