PROPOSED RULE AMENDS FEDERAL OPIOID TREATMENT PROGRAM REGULATIONS REGARDING DISPENSING OF BUPRENORPHINE

The Substance Abuse and Mental Health Services Administration (SAMHSA) requested comments on the proposed rule ammendment regarding the Federal OTPs dispensing requirements for buprenorphine and combination products. My comments are outlined below.

“Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction; Buprenorphine and Buprenorphine Combination; Approved Opioid Treatment Medications Use”

Current regulations demand of all patients receiving buprenorphine in OTPs (Outpatient Treatment Program) daily attendance for several months followed by rigidly defined criteria for less frequent visits thereafter. In marked contrast, patients receiving buprenorphine outside an OTP setting can receive at the first physician visit a prescription to be filled at any pharmacy for a month’s supply of the medication. The proposed rule-making change eliminates this arbitrary and unwarranted disparity by providing that precisely the same flexibility will apply to OTPs as has governed “waivered” physicians for several years; it is to be welcomed!

The proposed regulatory change, however, is exceedingly narrow in scope, focusing exclusively on the administration, dispensing and prescribing of buprenorphine. In stressing that buprenorphine providers and patients in OTPs shall be obliged to “adhere to all other Federal treatment standards established for methadone” the proposed rule-making notice calls attention to these “other standards,” and they demand comment. To say they are extraordinary would be an understatement; they would appear to be unique in American medicine.

For complete comments click here .

NIMBY IN CANADA:

A tale of 2 cities: two stories on 23 Sept, one from Bracerbriudge, 120 miles north of Toronto, the other from Oakville, 20 miles southwest of Toronto. The former: reportedly very favorable response to news of a new methadone clinic to open in a mall. The manager of a store next door to the site is quoted as saying, “I don’t have any concerns about it. We need places like that. People need help.” And a local outreach and support organization promised to provide its services “in any way we can.”

On the other hand, the site in which a new clinic is expected to open in Oakville generated major opposition. “It’s the right business, but the wrong location.” The President of a local Residents’ Association worried because “When my daughter goes down to catch the bus at 8AM, there may be people lining up before the clinic opens.” According to her, “There’s got to be somewhere better.”

Bracebridge story

Oakville article

UK EXPERTS CALL FOR NATIONAL NETWORK OF 'SHOOTING GALLERIES' AFTER HAILING SUCCESSFUL TRIALS:

“A group of government-appointed drug experts will call for a nationwide network of ‘shooting galleries’ to provide injectable heroin for hardened drug addicts across the country. A pioneering trial programme prescribing heroin to long-term addicts has shown ‘major benefits; in cutting crime and reducing street sales of drugs.” A positive accompanying editorial was headlined, “An injection of common sense.” Full story in the Independent (London)

ANTIDEPRESSANT MEDICATION DURING PREGNANCY:

A just published article (Clin OBGYN, 52(3):469-482) concludes: "The decision to expose the fetus to anti-depressant medication during pregnancy must be weighed against the risks of untreated maternal depression to both mother and fetus." Precisely the same orientation should apply to treatment of opioid dependent pregnant women, but in those cases all too many judges and probation officers and child welcome authorities and others (including some physicians!!!!) have only one position: JUST SAY NO TO METHADONE!

PERCEPTIONS OF METHADONE TREATMENT FROM AN IRISH GP:

In the Irish Medical Times, 9/9/09, a GP, Dr. Cathal O’Sullivan, notes the absurdity of the officially recommended Irish urine toxicology schedule – "at least once weekly" for a total annual cost of approximately $US 10 million.

Some of Dr. O'Sullivan's other observations:
“Relatively new to the drug treatment world, I was struck by the difference in the relationship between the patients and the treatment service and the staff, including doctors, who were treating them. Supervised collection of urine samples seemed to me, at the very least, an undignified process, both for the patient and the person supervising the sample collection. Even the language used around urinalysis was different. Positive opiate tests were called ‘dirty’, negative were ‘clean’. One can still hear doctors working in the addiction service today, referring to a patient, say, ‘he’s dirty this week’. Raised a strict Freudian, I found this very strange (but very interesting).”

Most significant is his summation: “Compared to patients in general practice, where I had worked for the previous twenty years, drug users were seen and treated as a completely different category of customer. They were considered to be inherently untrustworthy, and incapable of telling the truth about their drug use.”

The same must be said of methadone treatment in the US and many other countries.

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