Skip Page Header

Home > Proposed regulatory framework for buprenorphine/naloxone products in Ireland.

Lyons, Suzi (2013) Proposed regulatory framework for buprenorphine/naloxone products in Ireland. Drugnet Ireland, Issue 47, Autumn 2013, pp. 22-23.

[img] PDF (Drugnet Ireland 47) - Published Version

The drug Suboxone, a combination of buprenorphine and naloxone, was licensed for use in 2006 in Ireland as an alternative to methadone for opiate dependency. In 2007 the Department of Health set up an expert group to examine the regulatory framework for products containing buprenorphine/naloxone and buprenorphine-only.1 The expert group considered a number of relevant documents, including the evaluation of a feasibility study on the use of Suboxone in Ireland.2 (That evaluation is reviewed on p. 19 of this issue.)The report of the expert group is now available.3  The terms of reference of the group are outlined below, with a summary of its deliberations and associated recommendations. 

1. In the context of the product authorisation for Suboxone issued by the European Medicines Agency, to consider and make a recommendation as to whether the general regulation of relevant professions provides a sufficient regulatory framework for the prescription and dispensing of buprenorphine/naloxone, or buprenorphine-only products in Ireland. 

The group concludes that the regulations and guidelines for the prescribing and dispensing of methadone can also apply to buprenorphine/naloxone, or buprenorphine-only products.
2. To consider and make recommendations if appropriate as to which if any elements of the methadone protocol should apply to Suboxone, and if so how they could apply in practical terms. 
The group concludes that the Methadone Protocol Scheme can also apply to the prescribing and dispensing of buprenorphine/naloxone or buprenorphine-only products, and that the details of patients receiving these products should be recorded on the Central Treatment List. Other general recommendations include having consistent and uniform guidelines for prescribing and dispensing these products, that the current methadone prescription form should be adapted for them, the need for co-ordinated multi-disciplinary training, and a system of clinical governance and audit for GPs and pharmacies.  
3. To consider and make recommendations if appropriate as to whether and if so how Suboxone should be made available to particular client groups and/or settings in an Irish context, taking into account the work done by the NACD and taking into account the cost of this treatment.
The group concludes that methadone is the drug of first choice for treating opiate dependency, but that buprenorphine/naloxone may be appropriate for some patient cohorts in certain circumstances, as follows: 
  • patients already receiving treatment with buprenorphine/naloxone;
  • patients with a specific medical condition where methadone is contraindicated, for example prolonged QT interval;
  • patients who have never been prescribed methadone before, especially young patients, where detoxification is a primary goal of treatment;
  • patients whose main problem drug is codeine or another pharmaceutical opiate;
  • patients who the prescriber believes to be stable for at least six months, particularly in regard to employment or education, and committed to compliance with the treatment. 
After individual patient risk assessment, less-than-daily dosing can be considered, with frequency down to every second day or even to three times per week after a satisfactory level of stabilisation. The total amount of Suboxone given on any one day must not exceed the maximum of 24mg authorised by the European Medicines Agency. 
The group states that the economic factors involved were outside the scope of their deliberations but were relevant to the establishment of a buprenorphine/naloxone treatment protocol and should be considered. These included: 
  • findings of the economic evaluation done by the National Centre of Pharmacoecomomics in 20074 which found that Suboxone and buprenorphine-only could not be considered cost effective when compared to methadone in clinics or in the community;
  • generic pricing discussions between the HSE and the manufacturer;
  • issues around HSE clinics which have their own budgets and consistency of treatment; and
  • contractual implications in relation to prescribing and dispensing for both GPs and pharmacists. 
The group advises that the recommendations be reviewed within two years of the date on which they were given to the Minister, to allow for new research and evidence to be taken into account.
4. To consider and make recommendations if appropriate as to whether and if so in what way buprenorphine-only products should be available in Ireland. 
The group is not aware of any buprenorphine-only products being marketed in Ireland to treat opiate dependence. They acknowledge that, while not authorised in Ireland, buprenorphine-only products may be prescribed for pregnant women in certain circumstances, and with appropriate advice and warning. They advise that if a buprenorphine-only product were to be prescribed and dispensed in Ireland, it should be done with extreme caution due to the high risk of diversion and potential for use by injection.  
5. To consider any legal advices received in relation to the above matters.
After taking legal advice, the group decided that if buprenorphine/naloxone or buprenorphine-only products were to be used in Ireland then the appropriate changes will have to be made to the misuse of drugs legislation and the regulations for the prescription and supply of methadone. 
1. Long J (2007) Suboxone licensed in Europe. Drugnet Ireland, (22): 25.
2. Fitzgerald N (2011) Evaluation of Suboxone feasibility study in Ireland. Dublin: Department of Health.
3. Expert Group on the Regulatory Framework (2011) Recommendations of the Expert Group on the Regulatory Framework for products containing buprenorphine / naloxone and buprenorphine-only for the treatment of opioid dependence. Dublin: Department of Health.
4. National Centre for Pharmacoeconomics (2007) Economic evaluation of the use of Suboxone for opiate addiction. Dublin: National Centre for Pharmacoeconomics.

Repository Staff Only: item control page