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Changes in methadone prescribing in England - competing interpretations
- Gerry V. Stimson, Nicola Metrebian, Matthew Hickman (13 August 2003)
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Anticipating methadone related paediatric poisonings: ignorance or inertia?
- Thein T Ohn, Mr D Burke, Accident & Emergency Consultant, SHeffield Children Hospital (23 August 2003)
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Methadone policy in primary care
- Clive L Morrison (19 September 2003)
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Changes in methadone prescribing - rival hypothesis
- George Dowswell, Stephen Harrison (26 September 2003)
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Gerry V. Stimson, Director of the Centre for Research on Drugs and Health Behaviour Imperial College London, W6 8RP, Nicola Metrebian, Matthew Hickman
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We welcome the analysis of methadone prescribing data before and after the introduction of guidelines [1] but are sceptical about the interpretation of the data and the conclusion that changes in methadone prescribing in England are due to the effect of national guidelines. Guidelines issued in 1996 and 1999 recommended that the prescribing of methadone in tablet form should cease, and that methadone ampoules should not be mainstream treatment (the authors take 1996 as the turning point). The data show that proportionally more of the increase in methadone prescribing after 1996 was for oral mixture and visual examination suggests a downward trend in the prescribing of tablets and ampoules. The analysis would have been helped by statistical trend analysis – for example, the decline for ampoules commenced before the guidelines and appears to be a secular trend. Further, the absolute number of prescriptions for tablets and ampoules did not decline but remained high. Indeed prescribing of tablets did not cease: the mean annual number of prescriptions for tablet methadone was 60,400 in the six years before the guidelines, and 75,000 in the six subsequent years. By 2001, in the sixth year of the guidelines, the annual total NHS prescriptions for methadone tablets was 52,600, remaining higher than for three of the six years before the recommendations were introduced (1990 - 41,800; 1991 - 38,300; 1992 - 47,700). Similarly, the 2001 figure for methadone ampoules at 51,300 was higher than 1990 and 1991 and the mean annual number of prescriptions for ampoules was higher in the six years of the guidelines (at 72,000) than in the six preceding years (60,800). Interpretation of the impact of single historical whole coverage events is difficult, and plagued by confounding factors. Rival hypotheses about changes in prescribing should explore the role of other events, such as major changes in drug policy and resource allocation for treatment (starting from 1998) and the broader impact of the GMC in disciplining aberrant methadone prescribers. Research evidence indicates that guidelines alone have little impact on clinical practice [2], and it is unlikely that methadone is the exception. While Strang and Sheridan present a plausible interpretation, the evidence is insufficiently robust to support their certainty of a causal link between guidelines and changes in prescribing. 1. Strang J, Sheridan J. Effect of national guidelines on prescription of methadone: analysis of NHS prescription data, England 1990 -2001. BMJ 2003; 327: 321-322. 2. Bero LA, Grilli R, Grimshaw J et al Getting research findings into practice: Closing the gap between research and practice: an overview of systematic reviews of interventions to promote the implementation of research findings BMJ 1998; 317: 465-468 Competing interests: None declared |
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Thein T Ohn, Post graduate research School of Health and Related Research, Sheffield UNiversity, Mr D Burke, Accident & Emergency Consultant, SHeffield Children Hospital
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From Porfessor Strang's report there is evidence that methadone use is increasing as professionals turned to this effective drug to tackle the rising addiction problems in the society. In the UK deaths attributable to methadone poisoning fell from 37% in 1997 to 18% in 1999 according to a study based in Yorkshire(1). Also this report described that the proportion of deaths involving methadone fell despite increased prescribing. These are positive evidence for the use of methadone. On the other hand, methadone has been implicated in child accidents and this indicates a need for thorough examination of methadone related child accidents. Evidence has been gradually increasing in terms of what works in injury and poisoning prevention for children (2). According to the latter review, prevention of childhood injuries is possible but requires multidisciplinary and multi-prong efforts. Thus a challenge exists for the public health professionals and injury control professionals to stop these accidental methadone poisonings in children. Recent death in the UK(3), reports from the EU (4,5), and the USA(6), have described methadone as a causal agent in paediatric poisoning over the past decades(see table below). Given that this is not a one-off problem nor restricted to one region, there is an urgent need to explore the lessons learnt from the past and to formulate pragmatic interventions. Reports from different countries have reiterated the problem and this can be seen in this selective review: A toddler took 40 mls of methadone. The boy’s mother was on methadone. The child later died (www.guardian.co.uk -Guardian accessed 2002, UK). (3) A report from Merseyside described cases of methadone poisoning deaths in children. (4) A two-year-old girl was found dead in her bed after taking methadone. The girl’s parents were both taking part in the methadone substitution scheme.(5) Children admitted to hospital with methadone were described in a report from USA. These were severe poisonings and the report focused on those who died at hospital in Maryland. ( 6) All these indicate that children are at risk from dangerous medications and in particular from methadone if the these are available inside their home. Thus there is a need for the injury control professionals to join up with parents, health care professionals and community in an effort to curb these avoidable accidents. A simple strategy to prevent these kinds of accidents will be to promote the use of child resistant containers (CRC). Legislation might help as evidence has been mounting from the effective prevention of accidental poisoning for certain medication, which has been successfully addressed by the use of regulations and child resistant containers (7,8). Community pharmacist will play a crucial role in the utilisation of these also. Moreover Krug’s and colleagues argued that a properly focused intervention could be successful against poisoning (8). Other possible methods might be to reduce the dose of methadone supplied to the patient or supervised methadone administration. The poisoning deaths of children appeared imminently avoidable. Unless campaigns and efforts are initiated now these is a possibility that these might be repeated in the future. It is long overdue for the public health policy makers to identify preventive factors to contribute towards averting another unnecessary child death from methadone. Poisoning prevention is complex where different players are required to interrupt the chain of causal events leading to poisoning. These players will range from the parents, pharmacists, public health doctors to the primary care team. Perseverance is required by professionals as well as parents to enhance children’s safety in the home. It would be naïve to say that we could prevent all poisonings in children by following certain preventive interventions. But the following might be a good step towards redressing the balance. Primary prevention - To abolish the use of ordinary bottles and legislate the use of child resistant container for methadone (for families with young children). - To educate the parents/carers to keep the medications safe. - To initiate multi-sectoral preventive programmes and research (eg. RCT for the use of safety container). - To conduct supervised administration(of methadone). - Health authority, emergency physicians, pharmacists, social departments and the professionals concerned with child safety should undertake annual childhood safety audit (into dangerous medications) and disseminate the findings. Also they should highlight the use of CRC. Secondary prevention - First aid knowledge - to decrease the severity of the event by reducing the dose given to the parent. Tertiary prevention - Paramedics and acute care management - Hospital emergency management – consensus guidelines for Naloxone use for methadone poisoning in children. Reference 1. Oliver P, Keen J, Mathers N. Deaths from drugs of abuse in Sheffield 1997-1999: what are the implications for GPs prescribing to heroin addicts? Fam Pract. 2002 Feb;19(1):93-4 2. Towner E Dowswell T. 2001 Community-based childhood injury prevention interventions: what works? Health Promot Internation. 2002 Sep;17(3):273-84. 3. Guardian 8th Oct 2002 (www.guardian.co.uk accessed 18/11/02) 4. Binchy JM, Molyneux EM, Manning J. Accidental ingestion of methadone by children in Merseyside. BMJ. 1994. May 21;308(6940):1335-6 5. Klupp N, Risser D, Stichenwirth M, et al. Fatal methadone poisoning of a child . Wien Klin Wochenschr 2000 Apr 21;112(8):365-7 6. Li L, Levine B, Smialek J. Fatal methadone poisoning in children: Maryland 1992-1996. Subst Use Misuse. 2000 Aug;35(9):1141-8. 7. Lawson GR, Craft AW, Jackson RH . Changing pattern of poisoning in children in Newcastle, 1974-81 Br Med J (Clin Res Ed). 1983 Jul 2;287(6384):15-7 8. Krug A. Ellis J, Hay IT et al. The impact of child-resistant containers on the incidence of paraffin (kerosene) ingestion in children. S Afr Med J 1994 Nov;84(11):730-4 Competing interests: None declared |
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Clive L Morrison, General Practitioner Pendyffryn Medical Group, Prestatyn, Denbighshire. LL19 9DH
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Strang and Sheridan (1) will be disappointed that limited resources in the new General Medical Services (GMS) contract will hinder their hope of more widespread methadone prescribing. Provision of drug misuse services by general practitioners will now be voluntary under a national enhanced service agreement and the four UK countries are finalising negotiations on levels of fund. The Welsh Assembly Government have agreed a ceiling of £1 million, providing the annual retainer payment for a maximum of 200 general practitioners which may be only half of those already prescribing methadone. Funding is restricted to practices that offer this service and the vast majority of doctors (2) who are aware of the inadequacies of methadone therapy are not obliged to prescribe under essential GMS. General practitioners will no longer have to practice with the burden of the blatant and Draconian threats of GMC disciplinary action contained in the first chapter of “Drug Misuse and Dependence - Guidelines on Clinical Management” (1). Those who proselytise methadone as a treatment for opiate addiction provide no balanced argument and the discussion regarding possible detrimental effects is conspicuous by its absence. An Advisory Council on the Misuse Drugs report found there had been 2,576 methadone related deaths in a five-year period (3). The Committee on Safety of Medicines have received 12 reports of fatalities with methadone, through the suspected adverse drug reactions yellow card scheme, suggesting concealment by prescribing doctors. Global surveillance of deaths associated with medicines that have been recently withdrawn, such as cerivastatin and troglitazone, pale into insignificance when compared to methadone. £447 of funding is being directed towards enrolling criminals into methadone programmes through the Criminal Justice Interventions Programme(4) in an attempt to achieve the government’s crime reduction targets. This is social control masquerading as health treatment. Strategies designed to address social exclusion become a peccant policy on the underclass. Doctors who prescribe methadone should reflect on their ethical position and those who are more obdurate may have to endure the rigours of an investigation for neglect when their prescribing proves fatal. References 1. Strang J, Sheridan J. Effect of national guidelines on prescription of methadone: analysis of NHS prescription data, England 1990 -2001. BMJ 2003; 327: 321-2 2. Brownell LW, Naik PC. Services for opiate misuse: can primary care meet government expectations? Psychiatr Bull 2003; 27: 328-330 3. Advisory Council on the Misuse of Drugs. Reducing Drug Related Deaths - A Report by the ACMD, London: Stationery Office, 2000 4. Home Office Press Releases. Home Secretary backs police drugs strategy. Reference: 246/2003 12 Sep 2003. http://www.homeoffice.gov.uk/n_story.asp?item_id=603 (accessed 19 September 2003) Competing interests: None declared |
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George Dowswell, Hallsworth Fellow Manchester University M13 9PL, Stephen Harrison
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The data on methadone prescribing presented by Strang and Sheridan1 are interesting enough and the authors are justified in asking questions about the length of time over which clinical behaviour change may occur and be sustained. However, whilst the data presented may not be inconsistent with the authors' conclusion that the prescribing changes are the impact of clinical guidelines, they certainly do not on their own justify such a conclusion. As Stimson et al2 have already noted in their response to the paper, there is large body of empirical evidence that guidelines are not self- implementing3 and that a variety of implementation methods have been evaluated, with sometimes positive and sometimes negative effect. In the context of this existing knowledge, the conclusion that the simple distribution of a guideline has led to behaviour change is implausible unless accompanied by some consideration of why this case might be different. Yet the authors neither attempt this, nor even describe the cause whose effects they posit. They merely state that the relevant guidelines were 'widely distributed' (how? to whom?) and the references that they cite provide only the further information that the guideline distribution was targeted at GPs.4 And as Stimson et al also note, nothing is said about context or potential confounding factors. Simple time series cannot on their own establish causality. To imagine that they can is to commit the ancient fallacy of post hoc ergo propter hoc. No-one would accept time series data as conclusive of the efficacy of a clinical intervention, so how can it be held as conclusive of the efficacy of a social intervention? The clue to a more plausible hypothesis is to be found in one of the articles cited by Strang and Sheridan. Gabbay comments on the potentially intimidating character of guidelines that evoke the threat of GMC action for non-compliance. So far as we are aware, this is a very unusual feature of clinical guidelines and therefore an obvious candidate as a rival hypothesis. It is also broadly consistent with our recent findings that political climate may affect guideline.5 Stephen Harrison PhD
George Dowswell PhD
1. Strang J, Sheridan J. Effect of national guidelines on prescription of methadone: analysis of NHS prescription data, England 1990 -2001. British Medical Journal 2003;327:321-322. 2. Stimson G, Metrebian N, Hickman M. Changes in methadone prescribing in England - competing interpretations. eletter 327/7410/321 ed: BMJ, 2003. 3. NHS Centre for Reviews and Dissemination, University of York. Getting evidence into practice. London: Royal Society of Medicine Press, 1999. 4. Gabbay M, Carnwath T. A cautious welcome for the new guidelines on management of drug dependence. British Journal of General Practice 2000;50:92-3. 5. Harrison S, Dowswell G, Wright J, Russell I. General practitioners' uptake of clinical practice guidelines: a qualitative study. Journal of Health Service Research and Policy 2003;8(3):149-153. Competing interests: None declared |
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