A proposed amendment to TCA Title 53 Chapter 10 limits buprenorphine prescribing

For consideration in January, 2014, there is a proposed amendment to TCA Title 53 Chapter 10.  The proposed legislation is problematic on several levels. The first of which has to be recognized as a state-sponsored restraint of trade that prohibits qualified specialists in the field of addiction from using an effective medication appropriately.  The question of how long a patient “should” be on buprenorphine for addiction management is not an appropriate legislative issue.  A banner on the www.TnSAM.org website reads, “Treatment decisions on the use of FDA-approved medications for addiction should be made only by skilled physicians.”  A proposed top dose and forced taper is inappropriate. The issue of requiring the naloxone combination is flawed. These issues are fundamental to the proposed bill and therefore there is no acceptable amendment.  The proposed amendment to TCA Title 53 Chapter 10 is redundant with existing laws in many areas.  It appears to conflict with and violate several areas of Federal law, ranging from FDA regulations to the Mental Health Parity and Addiction Equity Act of 2008, which specifies that visit limits cannot be more restrictive for treatment of mental health and substance abuse disorders than they are for medical and surgical care, and also mandates that mental health and substance abuse care can be no more limited than they are for other types of care.

Senator Kelsey pulled the initial bill, but Senator Joey Hensley (a family physician) and Representative Tony Shipley are the new sponsors with minor modifications. The response to the bill’s new sponsor was as follows:

Dear Sen. Hensley and Rep. Shipley,
Joey,

My name is Dr. John Standridge. Perhaps you remember me from our work together at the TAFP where I was president-elect.  I remember you fondly and with respect.  I am now President of the Tennessee Society of Addiction Medicine, and a practicing addiction medicine and family physician from Chattanooga, Tennessee. I am very concerned about a proposed amendment to TCA Title 53 Chapter 10 that would severely hamper my ability to treat my opioid-addicted patients and their ability to get well. I am also surprised at your sponsorship of a bill initially written by Reckitt Benckiser; Orexo came in later to advise. Still it is the state who is practicing medicine, and in a complicated field at that. Surely your values think that this is abhorrent.

Tennessee has been hard-hit by the prescription drug epidemic. Moreover, Tennessee has seen a 10-fold increase in neonatal abstinence syndrome, since 2000. As you are aware, more Tennesseans die annually from prescription drug over dose than from any other cause, including motor vehicle accidents. This comes with tremendous social and economic costs, not to mention tremendous suffering, shame and loss on the part of the patient and their family. Fortunately, there are highly effective medications, like buprenorphine, that when used appropriately can reduce cravings to these drugs and enable patients to get back to school, work, and family.

I and my colleagues at the TN Society of Addiction Medicine agree that abuse of buprenorphine is a problem, and one that demands solution. However, state-directed micro-management of addiction medicine, or of any field of medicine, is an egregious action with easily foreseeable unintended consequences. Educating more physicians how to treat their opioid-dependent patients with medication and counseling would be far more effective and have a more lasting impact. Your goal should be to improve upon addiction treatment and a Tennesseans’ ability to access good treatment, rather than to make it harder for them to get it.

Action to promote recovery efforts for opioid dependent patients while curbing the abuse potential of buprenorphine is a laudable effort, one that the members of the Tennessee Society of Addiction Medicine, and our parent organization ASAM, will continue to vigorously pursue. As a staunch advocate for my patients, and as an expert in the field of addiction medicine, I would gladly meet with you to discuss ways to curb abuses and promote recovery.

Sincerely,

John Standridge, MD, FAAFP, FASAM

Medical Director, Council for Alcohol and Drug Abuse Services, Inc.

President, Tennessee Society of Addiction Medicine

Medical Director, Alexian Health Care Center

Physician, Private Practice, Personal Medicine LLC

Clinical Professor, Department of Family Medicine

Clinical Professor, Department of Internal Medicine

University of Tennessee College of Medicine Chattanooga

 

Joey,

Here is some medical information that others might not understand:

Compared to methadone, buprenorphine resulted in similar maternal and fetal outcomes, yet had lower severity of NAS symptoms, thus requiring less medication (1.1 versus 10.4 milligrams) and less time in the hospital for their babies (10 versus 17.5 days). The Maternal Opioid Treatment: Human Experimental Research (MOTHER), published in the New England Journal of Medicine, was the first study to identify a medication (buprenorphine ) that lessens the withdrawal distress to newborns, and gets them out of the hospital more quickly.

Although buprenorphine has some abuse potential, albeit limited relative to full opiate agonists, my addiction medicine colleagues and I feel strongly that it offers far more benefit than harm. Buprenorphine is a life saving intervention that is the best option available for many properly chosen people afflicted with opiate dependency. Harm reduction therapy is not a cure, but by turning off the craving for opiates, buprenorphine mitigates against a compulsive, destructive behavioral pattern that makes addiction such a terrible disease. My colleagues and I have witnessed the majority of our patients “get their life back”, and pursue counseling, education, employment and family life goals that are gratifying to witness. Treatment with buprenorphine is not just substituting one opiate drug for another. There are distinct properties that make buprenorphine uniquely beneficial and efficacious in the treatment of opiate dependency.

Overdose deaths with buprenorphine are rare with monotherapy, and commonly involve concomitant use of benzodiazepines or other polydrug abuse settings. The partial agonist effect of buprenorphine is unique to buprenorphine, and means that at a dose that effectively relieves craving, a ceiling effect prevents the euphoria associated with drug abuse and protects against overdose deaths. The user cannot abuse buprenorphine to get “high”, only to prevent being “drug sick”. Buprenorphine protects the individual from relapse because it binds tighter to the mu-opioid receptor sites and will not let another opiate attach, preventing abuse of all other opiates.