§ Dr. Brian Iddon (Bolton, South-East)Rehabilitation centres have relied on methadone as the primary treatment for drug addiction from the national health service for almost 30 years. I believe that there is a place for methadone in the clinic. However, although it is commonly used in the treatment of opiate addiction, and its use is endorsed in "Drug Misuse and Dependence: Guidelines on Clinical Management", it is now widely recognised as a street drug in its own right. It was solely responsible for 48 deaths in a six-month period in 1998. Nearly 59 per cent. of those who died had obtained the drug illegally, demonstrating clearly the view that methadone now has its own street currency.
Methadone is implicated as a drug of misuse, often associated with other drugs, in more than 400 deaths a year in the United Kingdom. Many addicts have reported that they find methadone harder to give up than heroin.
In Scotland, the use of methadone as a treatment for opiate addiction has been hailed as a state-sponsored drugs plague. It appears that methadone has been misused and over-used as the only pharmaceutical method of treating opiate addiction. Therefore, why is methadone widely advocated in this country as the optimum method for the treatment of opiate addiction? There are a number of reasons, and cost is not among them.
First, an inadequate appraisal has been made of the research evidence available on methadone. Secondly, we are too accustomed to the drug. It has been prescribed for more than 20 years for the treatment of opiate addicts, and doctors are not encouraged to prescribe alternatives. There is a lack of will to change prescribing habits in the United Kingdom. If we are to reduce the number of deaths each year in which methadone is cited as the sole drug used, those habits must change.
In France, where Buprenorphine has been widely prescribed since 1996, the experience is different. Buprenorphine is the generic name for a drug branded as Subutex by Schering-Plough, which distributes the drug in the United Kingdom. It is a partial opioid agonist, unlike heroin and methadone, which are full agonists. The effect of that difference is realised in the treatment of opiate addiction. As a partial agonist, Buprenorphine decreases cravings for street heroin, tempers withdrawal symptoms and, importantly, negates any effect if street heroin is used simultaneously. It also carries a significantly lower risk of overdose, especially in polypharmacy cases.
By prescribing methadone alternatives, it is possible to save lives and encourage the rehabilitation of addicts. Since Buprenorphine was licensed in 1996 in France, the number of deaths from heroin overdoses has fallen year on year—from 336 in 1996 to 92 in 1998. Clearly, any pharmaceutical treatment must be given in the context of other therapy that helps addicts to sustain their treatment and find a new life for themselves. Even if the drug was administered in a multi-therapeutic context, a degree of success must still be attributed to the use of Buprenorphine.
206WH However, the use of Buprenorphine is not clearly endorsed in the Department of Health clinical guidelines to which I referred. That is because of previous research highlighting the potential for its abuse, especially as the analgesic Temagesic. Although a degree of risk exists, it is comparatively less than that associated with the use of methadone. In France in 1997, six deaths occurred among the 49,000 people treated with Buprenorphine. There were more deaths in the same period among only 2,350 patients treated with methadone.
An economic gain can also be realised indirectly from the wider use of Buprenorphine, through a reduction in the need for health care and a reduction in the impact on the criminal justice system. Schering-Plough estimates the cost to the state as nearly £10,000 per addict per year, but the annual cost of treatment with Buprenorphine would be £2,000, with some added cost for additional suppport.
In France, 300 heroin addicts who were treated with Buprenorphine took part in a longitudinal study that demonstrated a 70 per cent. reduction in heroin use, a 25 per cent. improvement in housing and a 15 per cent. improvement in employment. Other indicators are available that demonstrate a shift to social reintegration—there was a 14 per cent. decline in drug dealing, a 7 per cent. decline in criminal activity and more than 40 per cent. of those who took part in the study reported improved personal relationships. Such a relatively small study easily demonstrates how effective treatment of opiate addicts can provide real benefits to the individuals concerned and society at large.
I should stress that Buprenorphine is not the only currently available alternative to methadone to combat opiate addiction. Indeed, two other drugs have been shown to be effective—laevo-alpha-acetylmethadol, which is commonly known as LAAM, and laevo-methadone. Unfortunately, those drugs are not licensed for such use in this country, although their efficacy is acknowledged in the clinical guidelines. LAAM is now licensed for use in Australia and the United States of America. Because the two drugs are longer-acting, it is claimed that they are much safer. They can also be administered orally, thereby minimising the injection culture and the consequent risk from hepatitis and HIV. As the new biotransformation process proposed by a north-west research laboratory now significantly reduces the cost of production of LAAM and laevo-methadone, the two drugs offer not only a clinically effective but a cost-effective alternative to methadone. One thing is clear: we must stimulate primary research and clinical trials in this area. I ask the Minister to give his attention to that.
The French experience is remarkable but not unique. Another large study in New South Wales showed that LAAM and Buprenorphine are at least as effective as methadone, and safer. In the United States of America, a study of the two drugs conducted at the John Hopkins School of Medicine showed that heroin use could be reduced by 80 per cent. The market for methadone alternatives is improving all the time. In two years' time, Buprenorphine will be available in a form that includes Naloxone, which will greatly reduce any risk of overdose. It is estimated that 1,000 lives could be saved by the wider prescription of methadone alternatives such as Buprenorphine.
207WH To prescribe Buprenorphine for the treatment of an opiate addict within the guidelines, however, a doctor must write 14 separate prescriptions for a fortnight's supply—one every day. That is because Buprenorphine, while licensed under the UK Medicines Control Agency and recognised by the clinical guidelines, is not included on the FPIO form used by general practitioners. Until it is included on that form, use of Buprenorphine will be unnecessarily hindered in this country. I ask the Minister to examine that issue urgently.
I applied for this debate in order to urge the Minister to widen the choice of drugs available for the treatment of opiate addiction, and to ask him to stimulate research into the discovery and use of other opiate substitutes that are safer than methadone. If the Government are to succeed in reducing drug misuse and associated criminal behaviour, they must take the issue of drug rehabilitation seriously. They must remove any barriers to choice, in a safe and supportive way, for addicts and health professionals who treat them. I look forward to the Minister's reply.
§ 12.38pm
§ The Minister of State, Department of Health (Mr. John Hutton)I congratulate my hon. Friend the Member for Bolton, South-East (Dr. Iddon) on raising such serious issues, and on his thoughtful comments. I am aware of his personal interest in the issues and of the good work that he does as chairman of the all-party group on drugs misuse.
My hon. Friend will be aware that the Government take the issue of drugs misuse seriously. One of the key objectives of the Government's 10-year strategy, set out in "Tackling Drugs to Build a Better Britain", is to enable people with drug problems to overcome them and live healthy and crime-free lives. That is why we will have allocated, over the next three years, an additional £50 million to health authorities and more than £20 million to social services departments for the provision of effective treatment services. The aim of any treatment, ultimately, is to enable the patient to achieve the goal of abstinence. We recognise, however, that drugs dependence is a chronic, relapsing condition, and that patients will need support, at times, when they relapse into drugs misuse after periods of abstinence. As my hon. Friend recognised, long-term methadone maintenance may help the patient to reduce or stop using illicit opiates.
Methadone is used internationally in the treatment of people who are dependent on opiates such as heroin. A substantial body of research supports the use of drugs such as methadone in managing dependence. For example, the national treatment outcome research study showed that both in-patient and community methadone programmes dramatically reduced patients' involvement in crime, and use of heroin and other illicit drugs. Furthermore, about one fifth of those on methadone abstained from opiates after two years' treatment. That shows that some drug misusers who enter methadone substitution programmes can abstain and are not necessarily maintained on the medication for long periods without reduction.
Prescribing should be seen as an enhancement of other medical and social interventions, rather than the sole treatment component. Support and advice on issues 208WH such as housing, education and training are important elements in enabling people to improve their lives and end dependence on illegal drugs.
We also recognise the other benefits of taking medications orally. As my hon. Friend noted, injecting behaviour, which is physically damaging, is reduced. In turn, that can reduce the spread of blood-borne diseases such as HIV and hepatitis B and C, which can be spread through sharing injecting equipment. Regular appointments with prescribing doctors and drug workers also keep drug misusers in contact with treatment services, and provide a better opportunity to meet their general physical and mental health needs. The 1993 update report by the Advisory Council on the Misuse of Drugs concluded that
the benefit to be gained from oral methadone maintenance programmes both in terms of individual and public health and cost effectiveness has now been clearly demonstrated".Much good work is being undertaken around the country to improve prescribing and dispensing practice. For example, we are aware of the four-way agreement in Berkshire, which links general practitioner, pharmacist, community drugs team and patient through a contract agreed by all the parties before any methadone is prescribed. The contract includes dispensing details such as supervised consumption and frequency of dispensing. The scheme is based on clear, commonly agreed protocols and a real partnership. It has at heart the needs of patients, but does not compromise the safety of the community and the professionals involved.Although schemes such as this are very encouraging, we recognise that methadone is a powerful drug that, like any opiate, has addictive properties. Prescribing should not be undertaken without full assessment and regular reviews of the patient. Naturally, treatment should be tailored to the specific clinical needs of individual patients. That is why, in April, the Department of Health published "Drug Misuse and Dependence: Guidelines on Clinical Management", which guides all doctors on appropriate clinical interventions for drug misuse, including assessment, management of withdrawal and dependence, and prevention of relapse.
Those guidelines were drawn up by an expert working group and are based on a number of sources, including expert committee reports. We also took written evidence from professional bodies such as the Royal College of General Practitioners, the Royal College of Psychiatrists and the Royal Pharmaceutical Society of Great Britain. The guidelines were also peer reviewed, and all incorporated research was extensively examined.
The guidelines lay out the principles of safe and responsible prescribing to ensure maximum safety and benefit for the individual and the community. They state that, as a general principle, substitute drugs should initially be dispensed daily, which reduces the possibility of accidental overdose. In addition, they recommend the supervision of methadone consumption, which will help to prevent leakage on to the illicit market.
My hon. Friend referred to deaths linked to methadone and the percentage of people who obtain it illicitly, rather than on prescription. Although the figures are worrying, better prescribing and dispensing practices, informed by the clinical guidelines, will help to 209WH bring about improvements. Nevertheless, I assure my hon. Friend that we are not complacent about what is a serious problem.
In addition to the advice given in the clinical guidelines, £12 million was distributed to health authorities earlier this year from the drug misuse special allocation element of the modernisation fund. In using that money, priority was given to the introduction of supervised consumption schemes, particularly in community pharmacies. The nationwide implementation of those measures should substantially reduce methadone-related deaths.
There are also difficulties associated with attributing drug-related deaths to specific substances. As my hon. Friend will know, many deaths involve a mixture of drugs and alcohol, and it is not easy always to determine the relative quantities of different substances, or which was responsible for the individual's death. The reduction in injecting behaviour resulting from the use of such prescribed substitute drugs will help to reduce deaths from blood-borne diseases such as hepatitis B and C, in conjunction with other harm-minimisation measures such as needle and syringe exchange programmes. The Advisory Council on the Misuse of Drugs prevention working group is producing a report on reducing drug-related deaths. Its findings will form the basis of a comprehensive action plan to reduce such deaths, which is a target of the drug strategy.
As my hon. Friend said, although liquid methadone is currently the most commonly used drug in maintenance prescribing, it is important that a full range of effective medications is available to doctors. We welcome the introduction and use of appropriate and effective new drug treatments, and we will carefully review evidence of their effectiveness. The clinical guidelines provided information on alternative opiates and other drugs used in treating drug dependence that were available at the time of publication, including Lofexidine, Naltrexone, LAAM and Buprenorphine.
With regard to reducing illicit drug misuse, criminality and risk behaviour, such as sharing injecting equipment, LAAM's results have been comparable to methadone. However, as my hon. Friend, who has a relevant professional interest and expertise, will know, it is a longer acting drug and can be dispensed less frequently. So far, it has not been licensed for use in the UK for opioid dependence, but it shows promise as an alternative form of treatment. Buprenorphine, however, was licensed in the UK last year for the treatment of opioid dependence. Trials suggest that it may have an efficacy similar to methadone 50 to 60 mg, and we are sure that it has a valuable place in the overall treatment of opioid dependence.
The Department of Health is actively considering including Buprenorphine in the list of drugs on the special prescription form to which my hon. Friend referred. That form enables doctors to prescribe the dispensing of drugs on one prescription in daily instalments for up to a fortnight. My hon. Friend asked 210WH me to consider prescription on an instalment basis, and the measure may lead to that. We anticipate a decision in the near future.
Like methadone, Buprenorphine is a powerful drug and not without its problems. It has potential for diversion and misuse, and it will not be suitable for all patients. It must be used carefully for patients with higher levels of opiate use, because it may precipitate partial withdrawal. It is also readily soluble, so dispensing must be carefully supervised to minimise the risk of injection. There is literature to suggest that, in other parts of the world, it has been used for injection.
My hon. Friend referred to the French experience with Buprenorphine. We understand that, on its introduction in France, there was considerable leakage on to the illicit market and substantial intravenous use. Furthermore, its use in the UK during the early 1980s resulted in similar concerns about safety and suitability. It is likely that only a relatively small percentage of patients who are currently treated with methadone would be treated instead with Buprenorphine, although some patients who are thought unsuitable for methadone may be suitable. However, we are pleased that another medication is now available to doctors in the treatment of drug dependence.
I assure my hon. Friend that we are not unaware of the importance of the issues that he has raised today, and we are looking at them carefully. He also asked for further research into other substitute medications in this country. There is a research base for LAAM and Buprenorphine, but most research has been conducted in north America, and we recognise the need for further research in this area in the UK. The United Kingdom deputy drugs tsar, Mike Trace, has confirmed that he will seek a meeting with the Medical Research Council to discuss research into alternative drug substitutes.
Although substitute prescribing has an important role, it should not be pursued in isolation. Drug dependence is a complex issue, and a full range of services should be available to meet all needs, including those of non-opiate users. Those services should include giving advice and information, needle exchange programmes, counselling, prescribing services and residential rehabilitation. Treatment should be carried out in a shared care scheme, involving specialists, general practitioners and other professionals such as community psychiatric nurses, pharmacists and general drug workers. That should ensure that all patients receive appropriate treatment and care, although we are aware that there are gaps in service provision in some areas of the country. That is why we have made an additional £70 million available to health authorities and local authorities over the next three years to enable the development of important new services across the country.
We are also concerned to maintain the quality of all treatment types. In addition to the clinical guidelines, the Department of Health has funded the substance misuse advisory service to produce a document entitled "Commissioning Standards for Drug and Alcohol Treatment and Care", which was published earlier this 211WH year. We have also assisted the Standing Conference on Drug Abuse in producing a set of quality standards for treatment services.
Providing good quality all-round treatment is key to the success of our strategy. It is probable that substitute prescribing will remain a key part of treatment for many drug misusers who are currently dependent on heroin. Methadone's effectiveness is proven, and we are taking seriously and acting on the problem of deaths linked to 212WH its use. Although methadone is currently the most commonly used drug, and will probably remain so, we appreciate the importance of making available a wide range of effective drugs, including Buprenorphine. We remain open-minded, and would welcome other new substitutes that are shown to be effective in the management of drug dependence.
Question put and agreed to.
Adjourned accordingly at eight minutes to One o'clock.