The first training seminar in Ireland in the use of buprenorphine by general practitioners for opiate-dependent patients was held at the Irish College of General Practitioners on 23 November 2005.

Participants included the general practitioner co-ordinators and liaison pharmacists from the Health Service Executive drug services, as well as a small number of general practitioners and pharmacists who are preparing to use buprenorphine for selected patients in the primary care setting. Two experts from the Royal College of General Practitioners (RCGP) in London facilitated the seminar.

According to the Irish College of General Practitioners, after the introduction of buprenorphine on a pilot basis in the primary care setting, best practice guidelines will be developed for the Irish context and, following that, further training will be provided to Level 2 general practitioners. Plans are now being progressed for the development of a pilot programme with a small group of interested general practitioners and pharmacists. During this pilot programme, the RCGP publication, Guidance for the use of buprenorphine for the treatment of opioid dependence in primary care,1 will be used until experience is gained in the context of primary care in Ireland.

The National Medicines Information Centre conducted a review of the use of buprenorphine as an intervention in the treatment of opiate dependence syndrome.2 This examined the effectiveness of buprenorphine as a treatment option, its safety in use, as well as the practical and pharmaco-economic considerations associated with its use. Where appropriate, the authors compared the treatment outcomes, safety issues and costs to those of methadone – the mainstay of treatment for opiate dependence in Ireland. The methods employed in this analysis were: literature reviews, systematic reviews, case histories and an economic evaluation.

The key findings of the review were:

• In terms of its use in managed withdrawal, the studies were too heterogeneous to enable formal meta-analysis, but a systematic review suggested that buprenorphine had potential in this area.
•  The results of a formal meta-analysis on its use in treatment as an opiate substitute using six-randomised controlled trials, with methadone as comparator, showed that high-dose buprenorphine was similar to high-dose methadone in terms of treatment retention, with a small increase in positive urinalysis relative to methadone. Although the latter was statistically significant, it was not felt to be clinically relevant. It was not possible, from the data, to determine the optimal dosing regimen, although it was noted that less than daily dosing was feasible in clinical practice.
• From the data available, it was not possible to determine whether buprenorphine was more suitable for specific sub-groups. There is some evidence to suggest that those with higher psychosocial and global functioning are more likely to respond to buprenorphine, but more studies are required to substantiate this.
• Data available to date on its use in pregnant women showed that buprenorphine was efficacious and safe for both the woman and the foetus, but definitive recommendations on dosing regimens could not be deduced from the results of studies undertaken.
• The safety data available to date suggest that buprenorphine has a known and predictable toxicity profile, related to its opioid agonist pharmacology and its interactions with other medicines. Although causality has not been proven, there is a warning regarding possible hepatotoxicity associated with its use and it is recommended that liver function tests are regularly performed for patients receiving buprenorphine. The biggest problem to date appears to be the risk of interaction with alcohol or benzodiazepines.
• The results from the pharmaco-economic evaluation show that use of buprenorphine appears to be less cost-effective than the current methadone system. It may prove to be a cost-effective treatment option in selected Irish settings (such as general practice), but further studies are needed to identify these settings.
• Buprenorphine has a known potential for abuse, because of its opioid effects. Studies from France suggest that abuse may occur in up to 30% of treatment subjects. Research findings indicate that abuse is more likely in those subjects not closely supervised by either a physician or a dispensing pharmacist.

 In Ireland, buprenorphine (mainly Temgesic) misuse among the treated population is rare. Of the 44,767 cases reported to the National Drug Treatment Reporting System (NDTRS) between 1998 and 2003, 56 (0.1%) reported that buprenorphine was a problem drug. Between 1998 and 2003, the number of cases reporting buprenorphine as a problem drug decreased considerably, from 18 in 1998 to 5 in 2003 (Table 1).

Table 1   Number (%) of treated cases reporting problem buprenorphine use and reported to the NDTRS, 1998–2002

Source: Unpublished data from the NDTRS

There are no data available on buprenorphine-related deaths in Ireland.

In August 2002, the Irish Medicines Board authorised the use of Subutex (a buprenorphine preparation specifically for treatment of opiate dependence) in Ireland.2 The licence for the use of Subutex in opiate dependency was amended in November 2005, and states

Treatment with SUBUTEX sublingual tablets must be by physicians who have specialist training in its use and all treated patients must be on a central register according to Drug Misuse Programme guidelines. These physicians can be consultants, and/or Level I or Level II GPs who have received special training. All patients will be reviewed and reassessed regularly.3

In order for this programme be operationalised, a system similar to that existing for methadone, including a protocol and a central register, needs to be established. This is an opportunity to provide choice of treatment to problem opiate users as well as to identify which substitute is most suitable to different groups of patients.

1. Ford C, Morton S, Lintzeris N, Bury J and Gerada C (2004) Guidance for the use of buprenorphine for the treatment of opioid dependence in primary care. 2nd edition. London: Royal College of General Practitioners.

2. National Medicines Information Centre (2002) Report to the National Advisory Committee on Drugs on use of buprenorphine as an intervention in the treatment of opiate dependence syndrome. Dublin: Stationery Office.

3. Summary of Product Characteristics Point 4.2 November 2006 http://www.medicines.ie/emc/assets/c/html/DisplayDoc.asp?DocumentId=1658.

.