Are These Buprenorphine Appropriateness Criteria Inappropriate?

Guidelines seem to have taken over the practice of medicine at the expense of physician judgement and discretion. While some can help medical decision making, we must not blindly accept their contents, some of which, like the example that follows, may border on the absurd. A recent disciplinary action against physician Michael Schorsch, MD, brought my attention to the "Vermont Buprenorphine Practice Guidelines, Appendix 2B: Guidelines for Assessing Appropriateness for Office-Based Buprenorphine Treatment provided by John R. Brooklyn, MD, May 21, 2009" (See page 10). According to this document, "The following guidelines will help in deciding whether to treat with buprenorphine in the office. They assume the person is opioid dependent." However, in reality they only purport to provide guidance as to whether OBOT or methadone maintenance is most "appropriate." Unfortuanately this vague concept of appropriateness has little or no precedent in medicine as compared to concepts like indication and predictor of success.

I can find no evidence of any evidence to validate these criteria which Dr. Brooklyn seems to have conjured up from his own experience. He did not respond to an attempt to contact him with a series of questions, so we can only guess what he might have meant by "appropriateness." Dr. Brooklyn appears oblivious to the very real possibility that a person applying for buprenorphine treatment might do better with naltrexone, counseling alone, inpatient rehab, or even no treatment. In my opinion these criteria are so poorly defined, vague, sloppily written and subjective as to be almost entirely useless.

Let us examine the items in order. A prospective patient scoring higher is more "appropriate" for a methadone program; one scoring lower is more "appropriate" for OBOT.

Item 1: "Is the person employed?" Unemployment, even if it is "possible" the patient is employed, suggests methadone maintenance is more appropriate, despite the fact that methadone programs require daily visits to take the drug. How many jobs allow for daily absences? one wonders whether Dr. Brooklyn considers freelance writers, for example, to be employed or not, not to mention homemakers.

Item 2: "Is the family intact?" Dr. Brooklyn fails to define an intact family, but even the possibility of an intact family, and certainly a family that is not intact, argues for methadone maintenance. He fails to specify whether the family "intactness" must have persisted for any minimum duration. I would like to hear the answer when he asks a prospective patient, "Is your family intact?"

Item 3: "Does the person have a partner who uses drugs or alcohol?" We must guess whether Dr. Brooklyn refers to a romantic partner vs. a business partner. We must also rely on the report of the patient, or the partner in most cases for the answer to this question. Even if it is only possible that this partner uses (or has used -- since we have no way of knowing what they will do in the future) drugs or alcohol methadone will be the more appropriate treatement as far as Dr. Brooklyn is concerned.

Item 4: "Is the person’s housing stable?" Housing that is possibly stable or not stable argues against OBOT. Does this mean a house that has weak foundations or one that seems ready to slide into a sink hole? Would Dr. Brooklyn deem a tent to be unstable? What about a doublewide? How does the OBOT physician determine stability of housing? Perhaps we should consult a building inspector.

Item 5: "Does the person have legal issues?" As opposed to illegal issues? Lawyers must have legal issues. Count them out for OBOT. The same for legislators and those who work in law enforcement. Again, if it is possible the person has legal issues, send them to a methadone clinic. Come to think of it, a lawyer once told me that in court, "Anything is possible." so maybe we should check all those boxes in the last column.

Item 6: "Does the person have any convictions for drug dealing?" Fine -- if the person tells us. Otherwise, how do we obtain this information? And I might have thought such a person would have "legal issues." Please go back to item 5. And what if it is just possible that the person has such a conviction? (Remember, anything is possible.) For that matter, are convictions the kinds of thing one "has?"

Item 7: "Is the person on probation?" On probation: methadone. Off probation: OBOT. But how do we know (unless they need a letter for the probation officer)? I guess parole leans toward OBOT, unless maybe that's a legal issue.

Item 8: "Does the person have psychiatric problems, e.g., major depression, bipolar, severe anxiety, PTSD, schizophrenia, personality subtype of antisocial, borderline, or sociopathy?" (I can see that Dr. Brooklyn failed to consult a psychiatrist before writing this part.) Where to start? Did he mean Major Depressive Disorder? Did he mean Bipolar Disorder? How long must the person have to suffer from severe anxiety? Is anxiety not a component of opiate withdrawal? Personality "subtype?" Hey doc, we usually call those personality disorders, except sociopathy. Where did you dig that one up? Agoraphobic? No way you get to stay home. Go to that methadone clinic every day buddy. Hypoactive Sexual Desire Disorder? No OBOT for you. Sleepwalking Disorder? Walk on down to that methadone clinic. ADHD? Bet nothing will distract you from getting that methodone hit every day.

Item 9: "Does the person have a chronic pain syndrome that needs treatment?" You say buprenorphine was approved by the FDA 30 years ago for treatment of cancer pain? No way. You need methadone. But that's only if your chronic pain syndrome (can't just be chronic pain) needs treatment. If it does not need treatment, OBOT is OK.

Item 10: "Does the person have reliable transportation?" Buy a Humvee or go get your methadone. And it had better have air in the tires and a full gas tank. You say you'll take the bus? What if you miss it? Bicycle? Taxi? Roller skates? Bring them all to your first appointment so Dr. Brooklyn can check them for reliability. Amazing that you don't need reliable transportation to get to a methadone clinic. Segue (so to speak) to

Item 11: "Does the person have a reliable phone number?" You know, like 911. Wait, when was the last time you called anyone's phone number and they actually answered? You are out of luck Dr. Brooklyn. Still waiting for you to answer my email. I hope your phone number is more reliable than your email address. No bupe for you. Please tell us whether a number like 333.123.4567 is more reliable than, say, 999.000.4321. You did say number, not phone. Here's that pesky question again: How do you determine that a phone number is reliable during your first encounter with a patient?

Item 12: "Has the person been on medicated assisted treatment before?" Possibly or no? Dr. Brookly thinks you should try methadone this time. Am I missing something here? This one actually makes sense.

Item 13: "Was the medicated assisted treatment successful?" Possibly or no: Cannot try again. Of course it might help to know what "successful" means when we take the history, or inconsequential little facts like duration of treatment and what makes the patient want to try again.

Items 14-16: "Does the person have a problem with alcohol, cocaine, benzodiazepines?" Would it not be more critical to know whether and when the person has used these substances? If I have not had a drink in ten years, because I am a recovering alcoholic, do I not "have a problem" with alcohol? Does that disqualify me from OBOT? Just asking. Dr. Brooklyn seems to think those with benzo problems can do just fine on methadone maintenance.

Item 17: "Is the person motivated for treatment in the office?" "Dr. Brooklyn, you gotta help me. I'm motivated for treatment in the office, but as soon as I walk out the door all my motivation just vanishes." Seriously Dr. B, how do you determine this, and perhaps more importantly, what what do you mean by "treatment in the office?" Does the patient take their buprenorphine in your office? My patients take theirs at home or sometimes at work.

Item 18: "Is the person currently going to counseling, AA, or NA ?" How could the person be "going to AA" when they sit across your desk fom you in your office? Do you mean to ask whether they have attended one or more counseling sessions in the past, whether they plan to attend in the future? DEA regulations relating to waivered physicians require that we have the ability to refer for counseling. Does that not at least imply that it might be acceptable for you to refer a new OBOT patient, one who has not regularly visited a counselor? Or maybe you tell them to get into counseling and come back in a month, walk to my office, preferably motivated for treatment therein, and proclaim, "I may look like I'm walking in the door to your office, Dr. Brooklyn, but believe it or not I am actually currently goint to counseling."

What scares me, and should scare the good people of Vermont even more, is that the Vermont Medical Board, in the case of Dr. Schorsch, may have deemed this very subjective guideline objective, and still found Dr. John Brooklyn, the author of this worthless inscrutable document, to be a credible judge of the work of another physician. Unless I misunderstand the board believes that OBOT physicians in their state should execute this document before inducing every patient with buprenorphine and perfunctorily record a meaningless number somewhere between 0 and 25 in the patient's record. Failure to do so means the physician is guilty of unprofessional conduct. Really.

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