2 June 2008

Hall and Degenhardt on opioid prescribing regulations: researchers suggest more research!

Lead Editorial - November Addiction journal “Regulating opioid prescribing to provide access to effective treatment while minimizing diversion: an overdue topic for research.”

These Australian authors fail in their apparent twin tasks of commenting the London General Medical Council case against several English addiction doctors and their attempt to tie it to the issue of drug diversion.

I do not understand why British journal editors would solicit opinions about opioid diversion without including a prescriber working in the field. Hall and Degenhardt’s editorial does not add clarity to this important area, but goes off into tangent and anecdote, especially on medico-legal aspects. They also fail to emphasise the major impact of treatment quality and availability on the market for diverted opioids.

Following the laws of supply and demand, improving both access to and the quality of addiction treatments would seem to be the most logical ways to reduce drug diversion. These authors call for more research in their title (they ARE researchers themselves), yet they fail to give the current state of knowledge on the subject. We need to define “best practice” and determine how closely it is followed in the various jurisdictions being described. It is pointless to alter regulations or clinical recommendations if current ones are ignored as they are in the UK, for example. Despite well publicised 1999 treatment guidelines recommending a minimum dose of 60mg daily for methadone patients, Strang found that 90% of prescriptions were for less than this with a mean of 37mg published in 2004 (there have been some reported improvements since then).

Hall and Degenhardt seem to discount the major ‘naturalistic’ experiments between jurisdictions with different regulations. For example, the state of Victoria had by far the most restrictive policy on take-away doses of methadone and buprenorphine, yet they had the highest reports of diversion. This must have some relevance scientifically, even though not ‘hard evidence’ or a RCT. While excessive supervision (eg 7 day attendance) is known to be counter-productive, we also know that easy availability and a lack of dose supervision may also lead to problems (Denmark; UK; France; USA; Ireland; NZ). Increased restrictions may not always be the best way to reduce diversion (Ritter).

A policy which frequently jails doctors who prescribe too many narcotics (as in the US) does not ensure a drug free society. Quite the contrary, and now, as if to codify bad medical practice, buprenorphine is freely available to be prescribed without supervision, urine testing or counselling on doctors prescription for up to 6 months at 32mg daily! And this is only for patients who can manage to afford the very high costs of American doctors and then pharmacy dispensing.

Rhoades and Grabowski reported substantial and significant improvements to several important outcomes, including less HIV risk behaviour, when methadone was supervised twice weekly when compared with five times (weekdays), even in early treatment. Other American open-label studies have shown successful results using once weekly or even less frequent attendance (Yancowitz; Senay; Schwartz). Hence the ideal proportion of supervised doses is still not certain, but it is at least twice weekly in new and unstable patients and possibly less often in those who have shown consistent progress in treatment. The British GP’s guidelines are still very weak on this matter, assuming that many patients can do without supervision but without details on how to choose such subjects, nor how to diagnose relapse with any degree of certainty.

In the context of minimizing diversion, it is not clear why Hall and Degenhardt would bring up two British malpractice cases, one from the 1960s and one more recent. Like many or even most British maintenance prescribers, Dr Colin Brewer was found to have been ‘too trusting’ and overly generous with take-away or dispensed doses, a matter which he conceded in his GMC hearing which took over 2 years. The authors of this editorial misconstrue Brewer’s testimony and therefore his motives regarding patient assessments. They say that Brewer stated that restrictions were ‘bureaucratic’ yet in context he clearly used the term to mean medical record documentation. Hall and Degenhardt also overlook some aspects of his practice which were found to be commendable in the case. Despite being found to have erred in some serious matters (he was deregistered), over 50 of the malpractice charges against him were found to be “not proved”. Of the other charges “proved” in the case, 6 referred to an inadequate assessment of the patient’s financial ability to pay for private treatment, a matter which would be irrelevant or even laughable in other jurisdictions, most notably America. From the evidence in the transcripts, Brewer was clearly committed to GP shared care (where this was feasible in a climate of over-worked NHS GPs). Uniquely, he used hair shaft testing for drug use history corroborations. He was also one of the first to describe post-dose physical examinations for titration of methadone and other dosages. Finally, flexible treatment regimens were instigated for stable patients (and some were found to be too flexible). Some of these particular facets of treatment might well be incorporated into dependency practice to advantage elsewhere, while other lessons learned regarding documentation and supervision. The Jarndycian case against Brewer and colleagues (both in fact exonerated) also raised some important deficiencies in the NHS system of addiction treatment whereby nearly all of their British patients were indeed ‘refugees’ from the official Government treatment agency, the NHS (the clinic also treated patients from overseas including itinerant Australians).

As recently as 2007, Strang reported that a majority of UK prescriptions for methadone still involve no doses being witnessed. While supervision at pharmacies is now slowly being introduced, following Strang’s committee’s 1999 recommendations, there are still major problems in maintenance treatments in the UK (the average dose is still well below optimal levels and a high proportion of prescriptions are for ‘new’ patients). Hall and Degenhardt dismiss these gross and long-standing failings by quoting this very review despite its positive findings being very modest compared to its negative ones.

In my view, the situation is one of the most scandalous episodes in British medical history with the sorry consequences of increased HIV, hepatitis C, crime and overdose all reflecting these deficiencies. And most of this toll could have been prevented with an evidence based approach as was used in British Hong Kong, a sorry lesson for those at home in the UK.

Could it be that the Addiction editorial board wanted to highlight this case to take the spotlight off the real issue of poor treatment standards across the country (with some notable and commendable exceptions, including Sheffield, Manchester, Portsmouth and some parts of London and Scotland)? This is an area the editors have neglected for decades which is regrettable. To my best knowledge, Addiction has never covered this quite fundamental matter, despite its overwhelming importance to public health in the UK. In the past I have suggested it to editor Griffith Edwards who accepted its importance but then completely ignored the matter for years in the journals over which he has ruled for a generation.

Drug diversion is also covered is several other recent prominent articles. Readers interested in this field will learn much by reading some of the items below while passing over the pusillanimous November Addiction editorial by Hall and Degenhardt.

Comments by Andrew Byrne .. http://www.redfernclinic.com/

Hall W, Degenhardt L. Regulating opioid prescribing to provide access to effective treatment while minimizing diversion: an overdue topic for research. Addiction 2007 (November)

Drug Misuse and Dependence – Guidelines on Clinical Management. Working Group Chair: Strang J. Department of Health, London, United Kingdom. 1999 ISBN 0113222777

Strang J, Sheridan J, Hunt C, Kerr B, Gerada C, Pringle M. The prescribing of methadone and other opioids to addicts: national survey of GPs in England and Wales. Brit J General Practice 2005 55; 515: 444-451

Robinson GM, Dukes PD, Robinson BJ, Cooke RR, Mahoney GN. The misuse of buprenorphine and a buprenorphine-naloxone combination in Wellington, New Zealand. Drug Alcohol Dependence (1993) 33;1:81-6

O'Connor JJ, Moloney E, Travers R, Campbell A. Buprenorphine Abuse Among Opiate Addicts. British Journal of Addiction 1988 83:1085-1087

Rawson RA, Maxwell J, Rutkowski B. OxyContin Abuse: Who Are the Users? American Am J Psychiatry 164:11, 1634-6

Carise D, Dugosh KL, McLellan AT, Camilleri A, Woody GE, Lynch KG. Prescription OxyContin Abuse Among Patients Entering Addiction Treatment. Am J Psychiatry 164:11:1750–1756

Smith MY, Bailey JE, Woody GE, Kleber HD. Abuse of Buprenorphine in the United States: 2003-2005. Journal of Addictive Diseases 2007 26;3:107-111

Stimmel B. Buprenorphine Misuse, Abuse, and Diversion: When Will We Ever Learn. Journal of Addictive Diseases 2007 26;3:

Frazer J, valentine k. Comparison of take-away policies in NSW and Victoria. Conference presentation(s); monograph, UNSW 2007.

Rhoades HM, Creson D, Elk R, Schmitz J, Grabowski J. Retention, HIV Risk, and Illicit Drug Use during Treatment: Methadone Dose and Visit Frequency. 1998 Am J Public Health 88:34-39

Ritter A, Di Natale R. The relationship between take-away methadone policies and methadone diversion. Drug Alcohol Rev (2005) 24;4:347-352

Yancovitz SR, Des Jarlais DC, Peyser NP, Drew E, Friedmann P, Trigg HL, Robinson JW. A randomised trial of an interim methadone maintenance clinic. (1991) American Journal of Public Health 81:1185-91

Senay EC, Barthwell AG, Marks R, Bokos P, Gillman D, White R. Medical Maintenance: A pilot Study. J Addictive Diseases; 1993: 12(4): 59-76.

Strang J, Manning V, Mayet S, Ridge G, Best D, Sheridan J. Does prescribing for opiate addiction change after national guidelines? Methadone and buprenorphine prescribing to opiate addicts by general practitioners and hospital doctors in England, 1995–2005. Addiction 2007 102:761-770