Is that the case? The following was sent to SAMHSA in response to its demand for comments on the proposed new reporting system.

3. Is that happening? The notes are deemed vital, and the reporting process is estimated by you to involve a “burden” of no more than a half hour per mortality. 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? The relevance of goods is to a large extent determined by their timeliness. While recognizing and respecting different responsibilities and lines of authority, one would certainly expect that two parts of the same Federal division would very closely coordinate their efforts in that fundamental matter. Not criticizing – just seeking clarification. It is difficult to comment on the proposed reporting system without seeing even a draft anatomy that reflects the details elements to be captured and analyzed. whether 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 murder, etc. So why leave it up to each OTP to decide whether or not to report? To your knowledge, is anything comparable being considered by FDA, which as you note has authority by methadone prescribing for pain?

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

Before being able to comment a bit more knowledge is vital:

1. (The same

question applies to patients receiving buprenorphine for addiction treatment from non-OTP sources - apparently the huge majority of the total buprenorphine-for-addiction recipients - and those receiving it for analgesia). Can you supply such a draft design? 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.

Thank you for considering these questions (I am taking the liberty of additionally 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 whether 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) Have you considered the system for collecting and analyzing the info submitted, and do you have estimates of how much moment - for instance - amoung the end of a calendar year and the public release of the findings?

5.

2.

4. Finally, given the importance of that 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 assemble that reporting system voluntary? Government – at all levels – has shown very little reluctance by the course of the past 40 years to demand, as a prerequisite of continued license to operate, compliance with myriad rules and regulations.

Original post by RGNewman, MD