To The Ohio State Medical Board,

It has come to our attention that the Board is proposing some very significant changes on the requirements for Buprenorphine prescribing. The intent of this letter is for us to review some of the concerns we have and how we believe they will harm patient care, reduce access to treatment and lead to more deaths from the true problem, Heroin and prescription opioid addiction.

First and foremost the premise that these dramatic recommendations are based on, which is that the Board contends there is a serious problem of medication diversion is not supported by the facts. However most importantly it is the end result where we take issue. No one would deny that diversion of this medication takes place. However, research has demonstrated that almost all diverted Buprenorphine regardless of formulation is used on the street by persons already addicted to a mu opioid to self-treat withdrawal and as a substitute for more dangerous opioids such as Heroin. (1)(2) Low levels of abuse have been detected since the medications’ introduction, with buprenorphine and buprenorphine/naloxone generally ranked as the least-abused or misused opioid among those studied (examples of other opioids with higher rates of abuse in the U.S. include heroin, oxycodone, hydrocodone, methadone, morphine, and fentanyl) [3,4]. Buprenorphine/naloxone diversion has been limited and illicit buprenorphine/naloxone—which is frequently acquired from individuals with prescriptions—is commonly used in a therapeutic, non-medically supervised manner.

We are not saying that Buprenorphine has no potential for diversion or misuse. What we are saying is the facts support that the State Board is placing too much emphasis on the problems associated with Buprenorphine use while the real problem rages on and worsens in the state of Ohio. In every community the death rates from opioid OD both prescription and non-prescription are skyrocketing. The benefits of medically assisted treatment with Buprenorphine are well established.

We ask the Board and its experts, where are all the dead bodies from Buprenorphine diversion and abuse? Since its introduction in the US somewhere around 420 deaths related to Buprenorphine have occurred according to the F.D.A. The F.D.A. information does show that more than half the American buprenorphine deaths involved other substances and that only two of 224 cases specifying “route of administration” indicated injection — the primary concern of regulators.

Fifty deaths are listed as suicides, and 69 involve unintentional overdoses, drug abuse or drug misuse. Data compiled by the U.S. Food and Drug Administration has linked as many as 980 deaths in a year to drugs containing acetaminophen.

To clarify, twice as many people die each year from Tylenol than have been linked to Buprenorphine over 10 years of use in the United States. Given the far greater morbidity and mortality related to Tylenol it would seem in some respects Tylenol would be a better choice for the Medical Board to have concerns over than Buprenorphine.

IMS HealthTM National Prescription Audit Plus indicates that 9.3 million Buprenorphine prescriptions were dispensed in the U.S. in 2012’. More than 300,000 people died from drug poisoning in the U.S. between 1999 and 2009. That first year, opioid analgesics—drugs like methadone, oxycodone, and hydrocodone—were responsible for 21 percent of drug poisoning deaths. By 2009, that number had increased to 42 percent, or 15,597 dead, making prescription painkillers the leading cause of drug-poisoning deaths. Again we remind you although there may be problems with diversion and occasional misuse of Buprenorphine, it is not what is killing people in our communities!

More recently the actual benefit of Naloxone as a deterrent to IV use has been called into question. (5) Generic buprenorphine provides considerable cost savings over brand name Suboxone and generic as well.  Some prescribers are reluctant to prescribe the generic, however, out of fear that the patient will dissolve and inject the buprenorphine.  This is unlikely for a number of reasons.

First, the large majority of opioid addicts ingest substances by insufflations. It is unlikely that addicts who avoided needles when using oxycodone or heroin would cross that barrier and take up injecting for the sake of using buprenorphine, an opioid with a far-lesser reward  than that of other mu agonists.

Second, buprenorphine injected intravenously would precipitate withdrawal in anyone using more than 60 mg of oxycodone per day.

Third, again studies of diversion demonstrate that most cases consist of self- medication by addicts attempting to treat their own opioid dependence, to break free of their addictions.

Heroin is much more plentiful, and much less expensive, than diverted generic buprenorphine.  If an addict is looking for a high, he/she will unfortunately have less trouble finding an agonist such as Heroin than finding Buprenorphine.

For many individuals who are 100% self pay generic Subutex, as replacement therapy is the difference between treatment and no treatment. We know that without substitution therapy and with only traditional psychosocial treatment over 90% of opioid addicts relapse within the first 6 months after such treatment. (6) We feel it would be a grave error to restrict self-pay patients from the use of generic Subutex nor are such restrictions supported by medical science.

Other proposals by the Board, which lack scientific support, include the demand that all patients take part in routine behavioral therapy. Repeated studies have not consistently shown that such TX improves outcomes. (7,8) It is not at all our position that none of our patients need or benefit from such treatment. It is our position that it is neither beneficial nor morally correct to coerce all patients into such treatment irrespective of their wishes or individual needs. We ask The Medical Board; in what other chronic disease with such high morbidity and mortality do we withhold lifesaving medication unless the patient attends our recommended counseling? If we were to withhold insulin from a diabetic who refused to see our dietician on a regular basis it is likely we would have our medical license revoked. The current rules are quite appropriate in that they encourage the physician to act as primary lead in educating the patient on behavioral interventions and to refer those who are in need of more intensive treatment to a qualified therapist.

The same goes for demanding individuals attend AA as an alternative. According to The Cochrane Review published in 2009’ “No experimental studies unequivocally demonstrated the effectiveness of AA or TSF approaches for reducing alcohol dependence or problems.” Why would we assume it to be more effective for opioid addicts? In addition courts have repeatedly ruled that compelling individuals to attend AA is a violation of their First Amendment rights. (9) It is certainly not our position that AA is unhelpful to all. However, all one need do is go to a meeting to see how many are there simply to get a signature and have zero interest in actually taking part in the process of AA. Patients often remark that the meetings are not consistent with their personal beliefs and do little more than increase cravings for them and expose them to unstable addicts. All they want is to reintegrate into the mainstream of life. Not to go on forever in the role of chronic addict. Not all can do this and need the chronic support of a program. However, many are successful in this process and their prior failures are driven purely by attempts to relieve prolonged sickness from opioid withdrawal. Not a spiritual or psychological deficit. Many patients can neither afford weekly psychotherapy nor do they have the ability to attend AA three times a week. Such demands may make it easier for them to stay addicted to street drugs rather than seek treatment that could ultimately result in taper and discontinuation of all medications.

We talk at great lengths about respecting patient rights and autonomy. Do these people who suffer from opioid addiction have no right whatsoever to hear the facts about all forms of treatment from their doctor and then make a choice themselves as to which treatment they will participate in? These rules would appear to single out the opioid addict and deprive them of such rights.

Some of your recommendations such as monthly OARRS reports, all observed urine tox screens, mandatory lab work and a physical exams should be discussed at great length one by one to determine some middle ground between improving care or if they simply drive up cost. We as a program are already doing regular OARRS reports and observed urines as well as random saliva testing. Random pill counts are also an important approach to maintaining compliance. Our patients are made aware of this at the start of treatment and remain compliant with that knowledge.

That being said we humbly ask the Board to be very careful and considerate, as we believe some of these recommendations will be overly demanding for those practitioners who do not specialize in the care of opioid addicts alone. For most doctors there is already low motivation to care for this group of individuals. This will undoubtedly drive some good doctors out of the practice of providing care to opioid addicts meaning death tolls from opioid use will increase. According to authors at the National Institutes of Health in a 2011’ review paper on use and diversion of Buprenorphine (10), “Tighter controls on buprenorphine will likely increase barriers encountered by opioid-dependent individuals as they seek treatment, may force “black market” sales of Buprenorphine into more reclusive and dangerous settings, and may result in the sale of tainted or counterfeit medications to individuals who are seeking illicit Buprenorphine for therapeutic purposes. Thus, any increases in control or monitoring should be considered in parallel with efforts to increase access to affordable and sustainable opioid substitution therapy for dependent individuals.”

In conclusion, we do not feel the Boards recommendations fully take into account take the grave risk of reducing access to treatment compared to the reasonable desire to reduce illegal diversion. Regardless of what decisions are made by the Board they should be made with great care one recommendation at a time and only after full hearings and testimony by numerous patients and providers. One need only look at the recent KORTOS Report released by the state of Kentucky to see the overwhelming benefits to both patients health and emotional well-being and the huge amount of cost savings to the state reaped by providing opioid replacement therapy to those in need. I would also refer you to the timely editorial in JAMA calling for wider access to medically assisted treatment of opioid addiction and an end to the stigma of treatment. I have included copies of both.

We applaud the Boards desire to address the unscrupulous use of any medication but ask that we refocus on the real problem in the state of Ohio, Heroin and prescription opioid abuse. The facts do not support that Buprenorphine diversion is part of this problem.

We look forward to the Boards response and our ability to exercise our right to discuss these issues with the Board before any such important rules are passed. It is critical for the welfare of the people of this state and not just our patients that we act not based on hysteria or preconception about addiction but scientific and statistical facts.

 

Respectfully,

John Sorboro MD ABPN

Medical Director Addiction Outreach Clinics.

 

1) Schuman-Olivier Z, Albanese M, Nelson SE, et al. Self-treatment: illicit

buprenorphine use by opioid-dependent treatment seekers. J Subst Abuse

Treat. 2010;39(1):41–50. [PubMed]

 

2) Monte A, Mandell T, Wilford B, Tennyson J, Boyer E. Diversion of

Buprenorphine/Naloxone Coformulated Tablets in a Region with High

Prescribing Prevalence. J Addict Dis. 2009;28(3):226–31. [PubMed]

 

3) Cicero TJ, Inciardi JA, Muñoz A. Trends in abuse of Oxycontin and other

opioid analgesics in the United States: 2002–2004. J Pain.

2005;6(10):662–72. [PubMed]

 

4) Hughes AA, Bogdan GM, Dart RC. Active surveillance of abused and misused

prescription opioids using poison center data: A pilot study and descriptive

comparison. Clin Toxicol. 2007;45(2):144–51. [PubMed]

 

5)Buprenorphine: Effective Treatment of Opioid Addiction Starts in the Office

DAVID A. FIELLIN, M.D., Yale University School of Medicine, New Haven,

ConnecticutAm Fam Physician. 2006 May 1;73(9):1513-1514

 

6)Expert Opin Pharmacother. 2009 Oct;10(15):2537-44. doi:

10.1517/14656560903213405.The clinical efficacy and abuse potential of

combination buprenorphine-naloxone in the treatment of opioid

dependence.Mammen K1, Bell J.

 

7) http://yaledailynews.com/blog/2013/01/22/therapy-ineffective-for-

 

8)http://www.drugaddictiontreatment.com/addiction-in-the-news/addiction-

news/combined-use-of-buprenorphine-and-behavioral-therapy-for-opioid-

addiction-treatment/

 

9)https://ffrf.org/faq/state-church/item/14012-court-ordered-participation-

in-aa

 

10)Curr Drug Abuse Rev. Mar 1, 2011; 4(1): 28–41.

Buprenorphine and Buprenorphine/Naloxone Diversion, Misuse, and Illicit Use: An

International Review

Michael A. Yokell,1,2 Nickolas D. Zaller,*,1,2,3 Traci C. Green,2,3,4 and Josiah D. Rich1,2,3