The new Orange Book guidelines provide extensive practical advice for GPs on managing drug misusers, as Professor John Strang explains

In April 1999, in London, the Minister of Public Health Tessa Jowell launched the new Orange Book guidelines Drug Misuse and Dependence – Guidelines on Clinical Management with simultaneous launch of the same document at equivalent events in Scotland, Wales and Northern Ireland.1

The new guidelines are much more substantial than their predecessors, and give a greater scope and depth of practical advice for the doctor in general practice or hospital practice who is involved in clinical management of the drug misuser.

Clinical governance will require identification of the elements of treatment for which there is a strong evidence base. The new guidelines will substantially meet this need and will also stand as a benchmark for the measurement of suitability and competence of treatment, as highlighted in the recent BMJ editorial.2

For the first time, the guidelines are available in electronic form and can be downloaded from the website www.doh.gov.uk/drugdep.htm.

The guidelines have been written primarily for doctors, while recognising that modern-day practice functions within a multidisciplinary context. Consequently the Working Group convened by the Department of Health comprised mostly doctors working in drug dependence treatment or general practice, although there was also important representation from non-medical colleagues in nursing, pharmacy and the voluntary sector. (The full membership is reported on the above website address.)

The guidelines have been prepared with a particular focus on the challenges facing many generalist practitioners who have not received significant training in substance misuse but who nevertheless find an increasing number of drug misusers in their caseload.

For such generalist practitioners, the Working Group considered it particularly important to try to address those elements of care that can reasonably be provided in a typical primary healthcare or general hospital setting, and how the generalist practitioner should judge when it is appropriate to refer the patient to specialist drug dependence services.

In order to address the types of care that can reasonably be provided by different doctors, we found it helpful to consider qualified doctors as having one of three possible levels of expertise in this field (Table 1, below).

Table 1: Levels of expertise

Level 1: the generalist

Generalists are medical practitioners who may be involved in the treatment of drug misuse, although this is not their main area of work. They should be able to demonstrate relevant competence to underpin their practice and care for a number of drug misusers, usually on a shared-care basis. Services to be provided would be expected to include the assessment of drug misusers and, where appropriate, the prescribing of substitute medication.

All these services would normally be carried out with the provision of support from a shared-care scheme or following the advice from a more suitably experienced medical practitioner (specialist or specialised generalist). Practitioners would be encouraged to enter into a locally agreed treatment scheme or guideline to ensure consistent standards and integrated care.

Such doctors would undergo regular training and have knowledge of prescribing issues and options, approaches to the development and understanding of dependence, policy issues and the management of drug treatment.

Level 2: the specialised generalist

A specialised generalist is a practitioner whose work is essentially generic or, if a specialist, is not primarily concerned with drug misuse treatment, but who has a special interest in treating drug misusers. Such practitioners would have expertise and competence to provide assessment of most cases with complex needs.

Examples of a specialised generalist would be a GP or a prison medical officer who deals with large numbers of drug misusers in their practice and who, with other professionals and agencies, provides many of the services that are necessary. Their drug mØsuse practice would possibly involve prescription of specialised drug regimens. Additionally, they can potentially act as an expert resource in shared-care arrangements for GPs and professional staff operating at level 1.

Such doctors would be required to undergo appropriate training to enable them to maintain this level of competence.

Level 3: the specialist

A specialist is a practitioner who provides expertise, training and competence in drug misuse treatment as their main clinical activity. Such a practitioner works in a specialist multidisciplinary team, can carry out assessment of any case with complex needs and provide a full range of treatments and access to rehabilitation options.

Most specialists would normally (but not always) be a consultant psychiatrist who holds a Certificate of Completion of Specialist Training (CCST) in psychiatry, and is therefore able to provide expertise, training and competence in drug misuse treatment as their main clinical activity.These data would be held on the specialist register of the General Medical Council. Such doctors would be required to maintain their level of specialist competence by attending appropriate training events

Their practice would probably involve prescription of injectable and other specialised forms of prescribing, which will require appropriate Home Office licences. They can act as an expert resource in shared-care arrangements for other practitioners and professional staff.

Specialists in addiction would hold a higher qualification with a CCST in psychiatry, and would be required to maintain their level of specialist competence by attending appropriate training events.

Most practitioners will probably consider themselves to be operating at level 1 – the 'generalist'.

Those practitioners who have received some degree of additional training and have demonstrable expertise and competence in the assessment and management of drug misusers would be considered to be at level 2 – the 'specialised generalist'. Many (probably most) specialised generalists would be operating with colleagues in a primary healthcare team setting.

There will then be only a small number of doctors working at level 3 – the 'specialist': these doctors will have chosen to specialise in substance misuse and should have completed higher training in this subject (typically, but not essentially, holding a CCST in psychiatry with a substantial proportion of this training having been in drug and alcohol treatment).

We would then expect more complicated cases to be referred on to, and be managed by, doctors working at the later levels, making it more realistic for the generalist practitioner to handle the more straightforward drug misuser who may present.

Several key principles are enumerated within the new clinical guidelines.

  • Drug misusers have the same entitlement as other patients to healthcare provided within the NHS, and it is the responsibility of all doctors to provide care for both the general health needs and drug-related problems of these patients, even when the patient may not be willing to withdraw from drugs. Examples of important healthcare provision include vaccination against hepatitis B, harm minimisation advice, and the treatment of secondary infections.
  • A shared-care approach is stressed within the guidelines. Shared care is seen as a rational model to improve the quality of care provided while being mindful of the competing calls on the time of the busy doctor.3 Input from colleagues within the multidisciplinary team may effectively reduce the burden on the busy medical practitioner, and shared-care arrangements may be established with colleagues outside the immediate service if external input is considered valuable.
  • Medical practitioners should not prescribe in isolation and should liaise with other professionals in identifying factors contributing to an individual's drug misuse. A multidisciplinary approach to treatment is therefore essential.
  • The guidelines make clear that where there is no local specialist service to provide specialist back-up, or develop a shared-care arrangement, the health authority has a responsibility to establish an equivalent arrangement, e.g. with a more distant specialist service or from an adjacent primary care practice that includes practitioners with a greater level of training and established competence.

The guiding principle is that support for GPs must include the availability of expert clinical advice (including prescribing advice) and that this external advice must be grounded in an evidence-based knowledge and experience of treating more complex cases.

Improved arrangements for shared care between GPs and specialist services are central to many of the proposals within the new Orange guidelines.

With improved training and support, it should be possible to:

  • Enhance GPs' skills in the detection and management of patients with drug misuse problems
  • Reduce referrals to the specialist services for patients with less complex medical needs and problems and hence enable the patient to be treated in primary care for as long as possible
  • Encourage selected referrals to specialist services for patients with more complex needs and problems.

The facilities within specialist services should then be used more specifically to deal with more complicated drug misusers. Examples of the criteria that might indicate referral to specialist services are shown in Table 2 (below).

Table 2: Criteria that might indicate referral to specialist services

Patients with serious risk to physical or mental health or complex needs e.g. schizophrenia, liver disease, frequent relapses, polydrug use, concurrent alcohol misuse, complications of drug misuse or a chaotic lifestyle.

Patients with a serious forensic history.

Patients not responding to oral substitute prescribing, who may require less frequently used interventions such as injectable opioids, should in most circumstances be managed by a specialist service.

Patients requiring a large element of psychosocial therapy or support for housing, employment and training.
Patients requiring specialised inpatient or day care.
Patients requiring a specialist residential rehabilitation programme.

An illustration of how responsibilities for good clinical practice might be shared within a multidisciplinary team is contained within the guidelines and reproduced in Table 3 (below).

Table 3: Examples of good practice in shared care of drug misusers

Professional Role
GP

Treatment of acute episode of illness

Immunisation

HIV testing

Cervical screening

Family planning advice

Identification of drug problem*

Assessment of drug misuse*

Treatment of drug problems*

Referral to secondary drug service*

Pharmacist

Daily dispensing of methadone

Point of contact for general health information

Practice nurse

Abscess dressing, wound care

Social worker

Welfare rights, legal advice

Drug agency

Provision of injecting paraphernalia

Safer sex advice

Referral for rehabilitation

*GPs are very likely to require additional training to develop these skills

The provision of competent treatment is not synonymous with prescribing substitute drugs to the drug misuser. In some instances, substitute prescribing may be contraindicated, and the practitioner considering this should bear in mind the dangers as well as the possible benefits of this type of approach.

Nevertheless, prescribing medication to assist in withdrawal from drugs can sometimes be highly appropriate and confer major health benefits for patients, while also relieving the distress of family and other carers. If prescribing to a drug-dependent patient, the doctor should 'e particularly mindful of key elements of practical advice in the associated decision-making (Table 4, below).

Table 4: Key principles of prescribing for opiate dependence

Prescribing should be seen as an enhancement to other psychological, social and medical interventions.
As newer 'addiction' drug treatments are developed, clinicians are advised to request specialist advice to support the benefits of the pharmacological intervention they are either considering or being requested to prescribe.
Keep good, clear, written or computerised records of prescribing.
It is good practice for all new prescriptions to be taken initially under daily supervision for a minimum of 3 months – supervision should thereafter be continued or reinstated at any stage if considered appropriate.
Methadone has to be clearly labelled and all bottles should have child-proof tops. The patient should be told that methadone and other prescribed drugs must be kept out of reach of children.
Where the parent is opiate-dependent, and in receipt of a substitute drug prescription, their children should not be authorised to collect their medication from the pharmacy.

Setting goals: Before prescribing a supply of substitute drugs (e.g. oral methadone to an opiate addict), the doctor and the patient should be clear, and have reached agreement, about the objectives of treatment. In agreeing the therapeutic goals, the doctor and patient should identify:

  • What changes the patient will be endeavouring to make in his pattern of drug use
  • What lifestyle changes the patient will be endeavouring to make
  • How the prescription will be managed and will help the patient to achieve these changes.

It is often helpful also to identify agreed short-term objectives and realistic goals to be achieved within a period of 4–12 weeks, for example. Thus it might often be reasonable to identify that, within this period, the patient would:

  • Make major reductions or stop completely the use of non- prescribed drugs
  • Reduce any excessive alcohol consumption or use of other drugs such as benzodiazepines
  • Reduce the frequency of, or stop, injecting
  • Participate in the broader treatment programme provided perhaps by paramedical colleagues, or members of the local drug team
  • Begin to tackle other problem areas within their life (e.g. legal, financial, accommodation or relationship problems).

The doctor considering prescribing in the treatment of drug dependence would be wise to restrict himself to drugs that are recognised for this purpose, and for which, in most instances, a licence has been obtained by the pharmaceutical company approving its status for the treatment of drug dependence.

Table 5 (below) lists the drugs sometimes considered for prescribing to, or sometimes requested by, the dependent drug misuser.

Table 5: Drugs sometimes considered for prescribing to, or requested by, the dependent drug misuser

Drug of dependence Drug used for, or requested as, treatment Licence status for the treatment of drug dependence
Opiates, (e.g. heroin) Methadone mixture or oral methadone in a liquid form (such as methadone mixture 1mg/ml) Licensed
  Lofexidine Licensed
  Naltrexone Licensed for relapse prevention
  Buprenorphine Licensed
  Dihydrocodeine, codeine Not licensed
  Levo-alpha-acetylmethadol (LAAM) Not licensed (not yet available in the UK)
  Diamorphine (heroin) Not licensed
Benzodiazepines Diazepam Licensed for withdrawal
  Chlordiazepoxide Licensed for alcohol withdrawal
Stimulants    
Amphetamines Dexamphetamine

Not licensed

Cocaine Antidepressants (e.g. fluoxetine)

Licensed for depression only

Dose assessment and induction: The prescribing doctor has a particular responsibility to ensure that the patient receives a safe but adequate dose of the appropriate drug.

The doctor must also ensure that sufficient effort is made to secure a safe 'chain of custody' from prescription pad to the patient's stomach, ensuring that the drug is used appropriately (e.g. in daily doses under supervision instead of the unregulated provision of a week's supply) and is not available for diversion to the illegal market.4

Methadone is the most commonly prescribed substitute opiate used in the treatment of opiate addicts. In the 1995 National Survey of Community Pharmacists in England and Wales, 96% of prescriptions for controlled drugs in the treatment of opiate addiction were for methadone.5

Whenever possible, methadone should be prescribed as an oral liquid or syrup since there is a greater risk that the tablets, although intended for oral use, may be crushed and injected, with much greater associated dangers.

The first 2 weeks of methadone treatment is associated with a greater risk of overdose mortality than the later stages, by which time stable plasma levels have been achieved.

Thus the prescribing doctor needs to be particularly vigilant and cautious during the first few weeks. The risk of overdose is greater when opiates are being taken in conjunction with other drugs such as benzodiazepines or alcohol.

Supervised consumption: The prescribing doctor needs to balance the anticipated benefits from prescribing drugs such as methadone against the potential dangers of overdose by patients (e.g. if they take an excessive quantity of the prescribed supply or if they mix their methadone with other non-prescribed drugs), by children (if surplus supplies are provided to be kept at home), or by other drug users (if supply of the drug is so lax that it leaks onto the black market).

To ensure compliance and avoid the risk of diversion to the black market, the Guidelines Working Group considered it good practice for all new prescribed drugs to be taken initially under daily supervision (either by arrangement with the relevant local community pharmacist or collaboratively through the local drug treatment services) for at least the first 3 months of treatment.

This requirement may be relaxed once there is clear evidence that the patient is progressing well and can confidently be expected to continue to show good compliance, despite the lower degree of supervision.

Since the 1980s, special prescription pads have existed so that all doctors can now include instructions about the dispensing arrangements, e.g. 'dispense methadone daily and on Saturday for Sunday'.

Supervision of consumption of prescribed methadone by the community pharmacist is a development that has been introduced with great success in Glasgow and is now being more widely implemented. However, the arrangements for setting up such supervision (and the associated reimbursements to the pharmacist, etc.) vary between areas.

Review: As with other areas of clinical practice, the doctor needs to review regularly the progress that the patient is making towards the agreed treatment goals.

Minor forms of failure to achieve fully the original objectives set usually indicate that some further adjustment or change of emphasis of the treatment plan may be required. This may be a good point at which to undertake a joint reassessment with local specialist services as part of improved shared-care arrangements.

Major failure to progress towards the agreed treatment goals is a reason for a more substantial review of the objectives and methods of treatment: there is little point in continuing a treatment that is failing to deliver any benefit. Indeed, methadone prescribing carries dangers of dependence upon the methadone itself as well as an associated overdose risk.

It is often possible to clarify the aims and objectives and get a failing treatment package back on track through the incorporation of greater structure and additional ancillary support and monitoring. This may be a very suitable point at which to inclfde a larger input from more specialist services in the context of the new shared-care arrangements.

Minimum responsibilities of the prescribing doctor: The Guidelines Working Group also considered the particular responsibilities associated with prescribing in this context. Even though the prescribing doctor will be working with other colleagues within the multidisciplinary team, and often with other doctors within shared-care arrangements, the responsibilities associated with prescribing cannot be delegated.

In deciding whether or not to prescribe, and the manner in which prescribing should be undertaken, the doctor must obviously bear in mind the particular problem with which the patient has presented, their assessment of the risks and benefits of a particular course of treatment, the guidance contained within national documents such as the Orange guidelines, as well as additional local agreements.

The doctor will also need to bear in mind his/her own personal degree of expertise, prior training and experience in this field.

A decision to prescribe substitute drugs to an opiate addict should only be contemplated if the doctor has already established that:

  • Opiates are being taken on a regular†daily basis and there is convincing evidence of current dependence (including evidence of withdrawal symptoms when supply is interrupted)
  • The patient is motivated to change at least some aspects of his/her drug use and associated behaviours
  • Assessment (history, urine toxicology, drug diary etc.) clearly substantiates the need for treatment
  • The doctor is satisfied that the patient will cooperate sufficiently and demonstrate adequate compliance with the agreed treatment plan.

There can be substantial benefits from providing such a prescription:

  • Reduction or prevention of withdrawal symptoms
  • Providing an opportunity for the patient to stabilise his/her drug intake and lifestyle while breaking with previous illicit drug use and associated harmful behaviours
  • Stimulating healthy change and reduction in drug taking and risk behaviour
  • Maintaining contact and opens up the opportunity for fuller work with the patient.

Some of the essential responsibilities of the prescribing doctor are listed in the new Orange guidelines (Table 6, below).

Table 6: The minimum responsibilities of the prescribing doctor

It is the resposibility of all doctors to provide care for general health needs and drug-related problems, whether or not the patient is ready to withdraw from drugs.
Medical practitioners should not prescribe substitute medication, such as methadone, in isolation. A multidisciplinary approach to drug treatment is essential.
Prescribing is the particular responsibility of the doctor signing the prescription. The responsibility cannot be delegated.
A doctor prescribing controlled drugs for the management of drug dependence should have an understanding of the basic pharmacology, toxicology and clinical indications for the use of the drug, dose regimen and therapeutic monitoring strategy if they are to prescribe responsibly.
A full assessment of the patient, in conjunction with other professionals involved, should always be undertaken and treatment goals set.
The clinician has a responsibility to ensure that the patient receives the correct dose and that appropriate efforts are taken to ensure that the drug is used appropriately and not diverted onto the illegal market. Particular care must be taken with induction on to any substitute medication, especially where self-reporting of dosage has been significantly influential.

Supervised consumption is recommended for new prescriptions for a minimum of 3 months, and should be relaxed only when the patient's compliance is assured. However, the need for supervised consumption should take into account the patient's social factors, such as employment and child care responsibilities. If supervised ingestion clashes with these and is still felt necessary, it must be made available at a time that allows the patient to attend without putting their job or families at risk.

The prescribing doctor should liaise regularly with the dispensing pharmacist about the specific patient and the prescribing regimen.

No more than one week's drugs should be dispensed at one time, except in exceptional circumstances.
Clinical reviews should be undertaken regularly, at least every 3 months, particularly inpatients whose drug use remains unstable.
The patient should be told that methadone and other prescribed drugs must be kept out of reach of children.
Thorough, clearly written or computer records of prescribing should be kept.

Drug misusers have the same rights to healthcare from the NHS as other patients, but the provision of this treatment is often complicated by the behaviour problems displayed by some drug misusers, by the bad reputation that this patient group consequently acquires, and by prejudice against this patient population on account of the apparent self-inflicted nature of their addiction problems.

These problems undoubtedly present challenges for the organisation and provision of services to this patient group, but there are now treatments of demonstrated effectiveness which can produce great health gain for the individual patients, comfort and relief to their families and loved ones, and an enormous cost saving to society in terms of reduced criminality and avoidance of long-term complications such as chronic viral hepatitis.

Healthcare provision within the NHS is now substantially centred on the GP. Hence it is particularly important to look for examples of good working practice in which the GP's greater knowledge of the locality and the context of the patient's problems can be used productively while providing the necessary support, training and pathways of ongoing referral for more difficult cases.

In this context, shared-care arrangements have offered particular promise3 and hence feature prominently in the new Orange guidelines.

It is important to find the right balance between unreasonable expectations on the busy diverse practice of the GP and primary healthcare team, while ensuring relevant prompt local access to treatments of proven effectiveness. A balance is also required between an approachable empathic therapeutic style on the part of the GP while still incorporating necessary safeguards against abuse of the service and caution against drift into careless or dangerous practice.2

The new Orange guidelines provide a framework for the coordinated provision of care to the varied population of drug misusers who may present seeking treatment for either their general medical needs or their specific drug dependence problems. The adequacy of the treatment response at a national level will depend greatly on the extent to which the described collaborative arrangements are properly supported by the health purchaser, the specialist and the GP.

  • Drug Misuse and Dependence: Guidelines on Clinical Management is published by The Stationery Office and available from The Publications Centre (mail, tel. and fax orders only) PO Box 276, London SW8 5DT; tel. 020 7873 9090; fax 020 7873 8200.

  1. Department of Health, Scottish Office Department of Health, Welsh Office, Department of Health and Social Services, Northern Ireland. Drug Misuse and Dependence: Guidelines on Clinical Management. London: The Stationery Office, 1999.
  2. Keen J. Managing drug misuse in general practice: new Department of Health guidelines provide a benchmark for good practice. Br Med J 1999; 318: 1503-4.
  3. Gerada C, Tighe J. Review of shared-care protocols for the treatment of problem drug use in England, Scotland and Wales. Br J Gen Pract 1999; 439: 125-6.
  4. Fountain J, Griffiths P, Farrell M, Gossop M, Strang J. Diversion tactics: how a sample of drug misuers in treatment obtained surplus drugs to sell on the illicit market. Int J Drug Policy 1997; 9: 159-67.
  5. Strang J, Sheridan J, Barker N. Prescribing injectable and oral methadone to opiate addicts: results from the 1995 national survey of community pharmacies in England and Wales. Br Med J 1996; 313: 270-2.

Guidelines in Practice, July 1999, Volume 2
© 1999 MGP Ltd
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