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)