PROPOSED MORTALITY REPORTING TO SAMHSA BY OPIOID TREATMENT PROGRAMS (OTP): Need Answers Before Being Able to Comment...

The following was sent to SAMHSA in response to its request for comments on the proposed new reporting system.

Re: OTP MORTALITY REPORTING PROPOSAL (Fed Reg 2 Jan 08, vo.73, no.1)

Before being able to comment a bit more information is important:

1. To your knowledge, is anything comparable being considered by FDA, which as you note has authority over methadone prescribing for pain? It's been consistently reported by SAMHSA, CDC, national panels of experts and others that the majority of methadone-related deaths do not, in fact, involve patients, providers or medication associated with OTPs. While recognizing and respecting different responsibilities and lines of authority, one would certainly expect that two parts of the same Federal Department would very closely coordinate their efforts in this important matter. Is that happening? (The same question applies to patients receiving buprenorphine for addiction treatment from non-OTP sources - apparently the vast majority of the total buprenorphine-for-addiction recipients - and those receiving it for analgesia).

2. Your "estimated annual reporting requirement burden" indicates two "responses per facility," and shows nationwide a total of 1150 such facilities. Do I correctly infer that SAMHSA/CSAT anticipates approximately 2300 deaths yearly of patients enrolled in OTP methadone facilities? If so, I imagine you must be seeking reports on every death, regardless of cause – e.g., patients known to have had AIDS unresponsive to treatment, terminal cancer, victims of homicide, etc. Is that the case? Not criticizing – just seeking clarification.

3. It is difficult to comment on the proposed reporting system without seeing even a draft form that reflects the data elements to be captured and analyzed. Can you provide such a draft form?

4. The relevance of data is to a large extent determined by their timeliness. Have you considered the system for collecting and analyzing the information submitted, and do you have estimates of how much time - for instance - between the end of a calendar year and the public release of the findings?

5. Finally, given the importance of this effort (even though it is directed at patients and providers clearly identified as NOT being the primary contributors to the marked increase in reported methadone-deaths), why is SAMHSA proposing to make this reporting system voluntary? The data are deemed important, and the reporting process is estimated by you to involve a "burden" of no more than a half hour per mortality. So why leave it up to each OTP to decide whether or not to report? Government – at all levels – has shown very little reluctance over the course of the past 40 years to demand, as a prerequisite of continued license to operate, compliance with myriad rules and regulations.

Thank you for considering these questions (I am taking the liberty of also sharing these questions with readers of our website - www.opiateaddictionrx.info; hopefully it will serve your goal of getting more comments and suggestions regarding your proposed reporting system - and if you wish us to post your response, we'll be happy to do that, with no editing of whatever you wish us to post)

robert newman, MD, MPH (NYC)

PREVALENCE OF BUPRENORPHINE “ABUSE” – IT’S ALL IN THE DEFINITION:

A recent article entitled, “Abuse of Buprenorphine in the US: 2003-2005” did not consider any indicators of the extent of abuse, but merely tabulated those instances in which the “abuse” caused adverse reactions severe enough to lead someone to contact a poison control center. This would seem to be a particularly misleading approach in dealing with buprenorphine, whose key appeal to regulators and clinicians alike is the high degree of safety attributed to its “ceiling effect.” Smith et al. J Addict Dis 2007; 26(3):107-111.

WAR ON MARIJUANA:

Dollars and lives going up in smoke! A Jan. 9 article in the Wisconsin State Journal quotes FBI sources as stating some 2,200 people are arrested every single day in the US for “marijuana violations” - almost 90% for possession alone. In the state of Wisconsin, over 14,000 arrests were for possession of marijuana in 2003 - and $83 million was spent by the state in "imprisoning such offenders... ". It is difficult to comprehend fully the impact that this has on lives of individuals and families, and costs for the community as a whole. Surely there is a better way!

METHADONE AND CARDIAC ARRHYTHMIAS – THERE’S CAUSE FOR FEARING FEAR ITSELF!

What do we really know about the cardiac “risks” of methadone maintenance? There have been many reports of prolonged QT intervals on electrocardiograms – but what does this mean? Consider a very recent report in the French Revue de Medicine Interne (vol 28, 2007, pages 709-710), which describes a single case – a 51 year-old man who had been on methadone maintenance for nine years and on hospitalized for alcohol-induced cirrhosis and complications, but apparently without cardiac symptoms of any kind. He was found to have a prolonged QT interval on admission, which appears t have necessitated no treatment, and did not prompt change in the methadone regimen.

One of the references cited in the paper also deserves mention – a 2003 report in the form of a letter published by Annals of Internal Medicine (vol. 139, no. 2, pages 154-155). That publication described a study of 132 patients for two months following induction on methadone maintenance. They demonstrated prolonged QT intervals, but there was no mention of any signs or symptoms of cardiac illness, and none of the patients apparently had the treatment plan modified as a result of the EKG changes. The authors concluded by noting that “A critical question . . . is whether the QTc prolongation is clinically significant … [and] whether changes in QTc interval in patients receiving methadone are in fact associated with adverse cardiac outcomes.” Yes indeed – those are the questions! And while they are being considered and answers sought, we must keep in mind the caution of the authors of the 2003 paper: “Any potential risk associated with [methadone’s] use must be weighed against its substantial demonstrated benefits.”

DWI LEADS TO ABRUPT DISCONTINUATION OF METHADONE TREATMENT

An article in The Olympian (Washington State) on 01 Jan stated that a woman with a 3-year old child in the car was cited for drunk driving while on her way to her methadone clinic. The clinic "told her she had to find someplace else for treatment soon." A social worker has been trying in vain to find an alternative provider and indicates that if she's not successful soon the woman will have to "go cold turkey."

Can one imagine any other medical care provider abruptly discontinuing treatment - especially treatment for a condition known to have a significant risk of death - because s/he was cited for drunk driving? Would a diabetes clinic tell a patient on insulin s/he had to find another provider or else simply do without insulin? Or a provider of care for cardiac disease or hypertension or prenatal care or . . .? Unthinkable, and if a provider for whatever reasons were to threaten to do that it would be deemed therapeutic abandonment and subject the physician in charge to possible revocation of medical licenses as well as God knows what civil actions. How incredibly ironic that this particular medical care provider, whose raison d'etre is caring for chemical dependence, should have such policies and practices!

An additional issue raised by the article: narcotic dependence is a medical condition with the most severe consequences for the individual and the community. For the former there is the risk of getting and spreading HIV, hepatitis and other illnesses, arrest and incarceration and loss of child custody, and death from overdose. For the community, there are enormous social and also financial costs. While to date no one has been able to make a credible claim for a cure for narcotic addiction, effective treatment exists - and no form of treatment is recognized as being as effective as methadone maintenance. So . . . shouldn't some voices be raised demanding the State explain what is being done to eliminate the irrationality and inhumanity of requiring those seeking help to languish on waiting lists? The social worker quoted in this article reports that waiting times routinely are 1-1.5 months. Indeed, someone should be demanding to know what consideration is being given to increasing capacity sufficiently to allow the state to take the initiative with public service announcements urging more narcotic dependent people to seek help.