Dr Fixit's FAQs:
Dr Fixit on Suboxone (Oct 2009)
[Note: This is the full version of a Dr Fixit article by Jack Leach which appeared in Network 27.]
I am a GP in a shared care scheme. My local specialist drug service has decided to change all their patients on buprenorphine to Suboxone. The local commissioner is now saying all GPs have to do this as well. I have 6 patients very settled on buprenorphine. None of them want to change and in fact I don't want to change them. Three of these people are on weekly pick-up, two on three times a week pick up, and one daily pick up. Four of them work and are reluctant to make any change that could damage their recovery. Do I have to change them to Suboxone? If I do make this change, do the properties of Suboxone vary from buprenorphine? Finally, can you crush Suboxone to aid the time it takes to absorb?
This is an interesting question that raises issues relevant to many drug treatment services in this country. In answering, I am first going to discuss the context to the introduction of Suboxone in this country before giving my own opinion about your case.
Suboxone is a combination of buprenorphine and naloxone in a sub-lingual tablet licensed for the treatment of opiate dependence in the United Kingdom (UK) since November 2006. In the United Sates of America it has been licensed for use in office based practice since 2003 and is the first opiate replacement treatment in the country that can be prescribed by physicians outside licensed opioid treatment programmes. Buprenorphine alone (Subutex) has been licensed in the UK since 1999.
The introduction of the combination product seems to have arisen from concerns about the misuse of buprenorphine by injecting or snorting it as it is easily dissolvable, and concerns prior to this about the misuse of Temgesic® (the low dose analgesic formulation of buprenorphine) during the 1970s. A survey conducted in France, where Subutex was being prescribed to around 70,000 patients by the end of the 1990s, estimated around 10% had injected their Subutex at some time. During the last few years there appears to be increasing illicit use of Subutex in British prisons. The worries about prescribing buprenorphine are thus that the person to whom it is prescribed either snorts or injects it themselves or gives or sells it to others, particularly if the others then use it in this way.
The inclusion of naloxone with buprenorphine seeks to deter misuse by injecting and snorting and reduce the diversion of buprenorphine to the illicit drug market. If the combination is taken orally, naloxone is not absorbed from the gastro-intestinal tract. If the combination is injected or perhaps if it is snorted, naloxone is then available in the body to exert its opiate antagonist effect, causing an unpleasant reaction from precipitated withdrawal despite the presence of buprenorphine or other opiates. The effects of naloxone are short lived, 2-3 hours, but are not readily reversed by taking more opiates.
This is the theory, and there is evidence that it works in practice. The combination has been trailed and field tested in Australia (Ref 1) and the United States (Ref 2) and the following conclusions can be drawn:
- Taken sublingually the combination has the same treatment effectiveness, side-effects and safety profile as buprenorphine at similar doses to the buprenorphine alone formulation.
- Injecting the combination has a antagonistic effect, causing a precipitated withdrawal state, which is unpleasant but not dangerous.
- For some, use by intra-nasal snorting causes a precipitated withdrawal state.
The randomised controlled trial in Australia compared outcomes in a group of patients on supervised consumption of buprenorphine and a group prescribed the combination on take home doses. The authors found equivalent illicit drug use, retention in treatment and other outcomes measure levels at three month follow up.
There are differences in the costs of the treatment programmes. The drug costs of Suboxone are the same as Subutex but from early 2009 a generic buprenorphine has been available which is marginally cheaper. Both remain considerably more expensive than methadone. The main difference in price arises from the frequency of dispensing and whether the drug is taken supervised in the community pharmacy. The cheapest alternative is take home buprenorphine followed closely by take home Suboxone.
There seems to be considerable variation in the introduction of Suboxone across the country. National Institute for Clinical Excellence guidance (Ref 3) and the 2007 Clinical Guidelines (Ref 4) advise about the use of buprenorphine but not the combination. They suggest that unless there are clear benefits of buprenorphine, including consideration of patient choice then methadone should be prescribed and they suggest that patients have supervised consumption for at least the first three months of treatment.
Getting back to the question! If a patient is new into treatment for their opiate dependence, or has had a gap in treatment and is suitable for buprenorphine rather than methadone, national guidelines suggest this should be initially taken supervised. Now there is a potential alternative of Suboxone which may allow supervision to be removed sooner, although its overall extent on reducing misuse and diversion is not clear. It seems that your local specialist drug service have decided on Suboxone rather than buprenorphine as a general policy, probably to discourage misuse and diversion.
However, the patients you mention are different. They are established in treatment, stable and not on supervised consumption. I would suggest clarifying with your commissioner and local specialist service whether their policy also includes patients already stable on take home buprenorphine. If this is the case it would increase overall cost, and, as you point out, could be unnecessary and disruptive to some patients. If there are reasons to doubt that a patient is not taking their buprenorphine as prescribed and they are continuing to use illicit drugs then it would seem reasonable to undergo a reassessment and change them to supervised buprenorphine or Suboxone or even methadone and/or consider a dose increase. If they are doing well and there are no suspicions of this, it seems unnecessary and draconian to change them against their and your wishes.
Finally both buprenorphine and Suboxone can be crushed to speed up sub-lingual absorption, but in the case of Suboxone it is probably unnecessary as it dissolves more quickly than Subutex. However, it is worth noting that crushing of buprenorphine and Suboxone is outside of the SPC (summary of product characteristics) so would be a use outside of the product licence when crushed. The National Pharmacy Association (NPA) has agreed that its Professional Indemnity Insurance policy will cover its members if they crush buprenorphine according to the joint Royal Pharmaceutical Society of Great Britain (RPSGB)/NPA protocol. Full guidance on crushing is available from the Royal Pharmaceutical Society of Great Britain (RPSGB)
1. Bell, J et all (2004), "A pilot study of buprenorphine - naloxone combination tablet (Suboxone®) in treatment of opioid dependence", Drug and Alcohol Review, 1465-3362, Volume 23, Issue 3, 2004
2. Amass L et al, "Bringing Buprenorphine-Naloxone Detoxification to Community Treatment Providers: The NIDA Clinical Trials Network Field Experience", American Journal on Addictions: The official Journal of the American Academy of Addiction Psychiatry, 1521-0391, Volume 13, Issue 5, Supplement 1, 2004, Pages S42 - S66
3. National Institute for Clinical Excellence (2007) Drug misuse: methadone and buprenorphine Technology Appraisal 114
4. Department of Health and devolved administrations (2007) Drug Misuse and Dependence: UK guidelines on clinical management London, DH.