Special Bulletin (July 2000)
Support for Clinicians Following GP Arrests
Information for GPs Who Work With Drug Users
Comment and advice drawing on the Drug Misuse and Dependence - Guidelines on Clinical Management 1999 ('Clinical Guidelines'), intended for GPs and those supporting the development of shared care arrangements and the management of drug users in primary care.
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Concern is now widespread for the need for protection and support for clinicians involved in the care of drug users following GP arrests in connection with patient overdose. Concern follows in the wake of the Shipman episode - with a shifting media and police focus on GP responsibility for deaths in relation to substitute prescribing. Unfortunately situations may occur, as in any area of medicine, where there is evidence of unhelpful and very occasional 'abusive' prescribing and clinical practice. Appropriate and stepped responses are needed. However, a 'witch hunt' climate, with GPs having to look over their shoulder for fear of suspension or arrest, is unlikely to encourage widespread uptake of the work.
Reassurance and support for GPs - What primary care does not need is fear of knee jerk police involvement in what may often, and certainly initially, be a clinical governance issue (quality monitoring, review, support, training, extending to stepped disciplinary measures). GPs need to be reassured by local Directors of Public Health, DATs and Shared Care Monitoring Forums, that they are valued and supported around their involvement in caring for drug users. This reassurance should include: local guidance fitting in with the national 'Clinical Guidelines'; assurance that support, training and formalised shared care structures are being put in place; and assurance of an understanding climate of partnership working with the police around treatment and clinical issues.
Police partnership in treatment - Enforced partnership working and the criminal justice interventions now mean that police are closer to local treatment issues than previously. We have a situation of an increasingly politicised agenda of drugs, and a post Shipman media and police scrutiny of certain clinical activities. However, for the police, Home Office and treatment agencies to establish useful partnership working (and have some of the criminal justice agenda met through treatment), it is important that any fear of inappropriate and hasty police interventions is quelled.
Patient and clinician responsibility - A GP has a duty to take due care and attention and follow clinical guidelines. This will include advising the patient as to the contra-indications of a medication. Without responding to specific instances that have been recently highlighted by the media, there is evidence that many deaths associated with prescribing are partly or wholly attributable to other drug or alcohol use additional to substitute prescribing. We want to ensure the best possible clinical practice for all patients groups, but drug use is a risky business, with a high client-group morbidity. Clinicians have a duty to do their best and be responsible, as do patients. There needs to be understanding and acknowledgement however, that when working with this client group, even with the most responsible clinical practice in place, that deaths may still occur.
"The Drug Misuse Clinical Guidelines, published in April 1999, stressed the importance of the provision of safe treatment in the care of drug misusers. They were targeted at GPs and emphasized the importance of good assessment, urine testing before prescribing, shared care, supervised ingestion (where available) and training."
"Shared care means GPs working in the context of a local network of services, supported by specialist service provision. Medical practitioners should not prescribe in isolation and health authorities must ensure appropriate services are in place to support GPs."
"The Government attach importance and welcome the recent announcement from the General Practitioners Committee and Royal College of General Practitioners [see below] emphasizing and supporting the important role that GPs have in providing care for drug misusers and also their emphasis on shared care."
See 'Main Page' on www.doh.gov.uk/drugdep.htm
"The RCGP and GPC believe that General Practitioners should offer appropriate care to all patients on their lists. Where patients have problems with substance abuse, appropriate care will include aspects of primary care normally provided by the practice primary health care team, shared care with other care services and referral to other appropriate services."
"Certain GPs may develop particular expertise in the care of substance abusers, and the number and location of these doctors should, ideally, be sufficient to prevent substantial workload falling onto only a few GPs. In supporting the development of this expertise, the Health Departments must ensure the provision of appropriate training in this field; facilitate professional support; resource the adequate provision of support services including specialist services and offer appropriate additional remuneration for this work."
Recent concerns should not undermine the fact that there is substantial evidence for the effectiveness of methadone maintenance, more so than many other common types of treatment. To obtain maximum effectiveness, correct dosing is paramount. This is acknowledged by the 'Clinical Guidelines':
"The use of methadone maintenance now has a strong evidence base, 5, 6 Methadone Maintenance is one of the most researched of the available treatment modalities and an overall assessment of its effectiveness can be made with more confidence than for other treatments. If practitioners are properly trained, methadone maintenance can be effectively delivered in a wide range of settings, including primary care."
(Clinical Guidelines p53)
"Taken over two decades, the randomised studies of methadone maintenance demonstrate consistent, positive results over vastly different cultural contexts... The one-year follow up of the National Treatment Outcome Research Study, which is monitoring the progress of 1075 clients recruited into either residential or community treatment services over five years, also supports these findings."
(Clinical Guidelines p53)
Dosing (also see below for starting dose and risk of overdose/dosing)
"After careful dose induction... (See commencement dose in 'Clinical Guidelines' p45-6) and dose stabilisation, there is a consistent finding of greater benefit from maintaining individuals on a daily dose between 60mg and 120mg. In some instances, due to a patient's high tolerance, higher doses may be required but this is exceptional..."
(Clinical Guidelines p54)
Clinicians need reassurance and development of better local support. This should include:
- Formalised primary care/shared care support schemes or GP facilitation
These would offer training and peer support; local clinical audit/guidelines in line with the national clinical guidelines; access to clinical supervision, advice and support through specialised generalists (lead GPs with training and competence) or specialists. This should form part of a review and development of shared care arrangements, and provision of accessible specialist services or other mechanisms for primary care support.
"Primary Care Groups (Local Health Co-operatives in Scotland) introducing more formalised shared care arrangement, including local protocols, as outlined in these guidelines, will need to review existing local service configuration, contracts and researching arrangements for primary and secondary care services."
(Clinical Guidelines p13)
A local quality control group
A local quality control group (Shared Care Monitoring Group) with links to local Public Health Departments and possibly the central and regional offices of the Home Office Drugs Inspectorate. Links should exist with both providers and treatment consumer groups. Such bodies which could be part of the DAT structure, could be more effective in responding to the full range of quality issues that go with prescribing treatments, and provide forums for the resolution of local differences on clinical practice. They could manage both the instances of 'unhelpful' prescribing, as well as the rare instances of 'abusive' prescribing. Such groups could assist in a death review process where there is police involvement, help manage any media interest, and cascade information on lessons learnt from drug related deaths to practitioners.
"It is therefore recommended that a local shared care monitoring group be set up. This should relate to the Drug Action Team, and should comprise the Director of Public Health (or deputy), representatives from specialist treatment agencies, general practice, the Local Medical Committee (GP Sub Committee of the Area Medical Committee in Scotland) and other members as required. The monitoring group should agree to approve local agreements and protocols, review training needs, clarify performance indicators and monitor the delivery and effectiveness of shared care service provision in the area."
(Clinical Guidelines p14)
Reassurance of support
Primary care needs reassuring communication by local Directors of Public Health, DATs and Shared Care Monitoring Forums, that primary care is valued and supported around its involvement in caring for drug users. Communication should include reassurance on the development of:
- Local guidance fitting in with the national 'Clinical Guidelines'.
- Support and training for primary care.
- Formalised shared care with accessible specialist, specialist generalist or other model of support.
- An understanding climate of local partnership working with police around treatment and clinical issues.
- Primary care involvement in the planning and delivery of the above.
- Can generalist GPs initiate prescribing and still be within the 'Clinical Guidelines'?
Generalist GPs can initiate prescribing (only after confirming dependency, including a positive urine). This is usually but not exclusively expected to be within shared care arrangements. The 'Guidelines' require that they can:
"...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"
(Clinical Guidelines p5)
See also 'The Minimum responsibilities of the prescribing doctor' (Clinical Guidelines p28)
Whose responsibility is the prescription in shared care arrangements?
"Prescribing is the particular responsibility of the doctor signing the prescription. The responsibility cannot be delegated."
(Clinical Guidelines p28)
Should there be supervised consumption for all patients, all of the time?
No, but the 'Guidelines' recommend this for some patients, normally for a limited period; as good practice for new prescriptions, those restarted after a break, and vulnerable patients. No blanket recommendations are made about all patients or permanent supervised consumption. Pragmatic clinical judgement and flexibility around individual patient circumstances are recommended. The 'Guidelines' acknowledge that not all areas will have access to this service, as not all pharmacists will provide it, and that those that are willing will require training and guidance which may not yet be in place. Urine testing, daily pick-up and instalment prescribing are highlighted as other practices that can help improve, but not guarantee, compliance.
[The 'Guidelines' cover these areas in key recommendations (p27), the minimum responsibilities of the prescribing doctor (p28), dispensing (p32-33), supervised consumption (p61) and community pharmacists (p67)]
"Supervised consumption is recommended for new prescriptions for a minimum of three 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 consumption 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." (Clinical Guidelines p28)
Do generalist GPs have to be working within formalised shared care?
No, but they are not encouraged to work in isolation. They should have some form of supervision and support (a multidisciplinary approach) to be within the 'Clinical Guidelines'. Whilst the establishment of formalised shared care is a central priority, specialist services may not exist or may not take a shared care lead in all areas. Other forms of primary care support (specialised generalist model, other or independent agencies) may develop.
"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 specialist generalist [GP]). Practitioners would be encouraged to enter into a locally agreed treatment scheme or guideline to ensure consistent standards and integrated care."
(Clinical Guidelines p5)
"Where there are no local specialist services with which shared care agreement can be developed, it is the responsibility of the health authority to ensure that appropriate services are in place. This might mean for example, developing a shared care arrangement with a service in the independent or private sector or providing support for primary care practices to develop as secondary providers i.e. specialist generalists"
(Clinical Guidelines p9)
What competencies do generalist GPs have to demonstrate?
This is somewhat of a grey area as at present there is no standard or acknowledged accreditation or diploma. Additionally many areas do not have schemes or facilities offering formal training. The guidelines state:
"They [doctors] should be able to demonstrate relevant competence to underpin their practice... 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."
(Clinical Guidelines p5)
What training and support for primary care and whose responsibility is it to provide it?
Training should be appropriate to the needs of the whole primary health care team, but involve local specialist providers, be delivered locally and be based on national guidance. Around three days of cumulative training time is suggested, with some form of accreditation and continuous audit overseen by a senior medical figure. (For delivery of training see the Clinical Guidelines, annexe 2 p69-72)
"Health Authorities, Primary Care Groups and future Primary Care Trusts… all have a duty to provide treatment for drug misusers. All GPs treating individuals for drug misuse have a right to support from their health authority or relevant primary care organisation."
(Clinical Guidelines p2)
"The health authority or health board is responsible for ensuring the availability of support for primary health care teams. Training is a crucial element of that support."
(Clinical Guidelines p69)
What is the role of the specialised generalist?
"Such practitioners would have expertise and competence to provide assessment of most cases with complex needs...Their drug misuse practice would possibly involve prescription of specialised drug regimens. Additionally, they can potentially act as an expert resource in shared care arrangements for general practitioners and professional staff operating at level 1."
(Clinical Guidelines p5)
- It is best not to initiate prescribing but seek support and advice from specialist services or a specialised generalist GP. Never initiate prescribing without confirming dependency - including a positive urine.
- Where possible have the patient assessed and any prescribing initiated by specialist services or a specialised generalist GP. If you are confident you can receive on-going advice and support you can consider taking the prescribing on once the patient is stable.
Assessment - Conduct an assessment to help confirm drug dependency and keep clear and concise notes, signed, named and dated. If you do not have time for a full assessment or if you feel pressured to prescribe, ask the patient to come back to complete a full assessment. The patient will feel that they are receiving care and being taken seriously. It will also allow you time to take advice, confirm any given patient history with other providers and arrange support for you and the patient - a planned response. Set treatment goals.
Urine - Take a urine prior to prescribing to inform you that the patient is dependent, and for your own medical legal protection. Only prescribe if the urine tests positively for methadone or morphine.
Seek advice and support for you and patient - a multidisciplinary approach - If available locally, ask for help or advice on prescribing from a local specialist service or specialised generalist. However, "Remember, prescribing is the particular responsibility of the doctor signing the prescription. The responsibility cannot be delegated." (Clinical Guidelines p28) Arrange non-prescribing/therapeutic input for the patient where required.
Responding to pressure for a script - While substitute prescribing may be a preferable early option, there is no need to be rushed into it by the patient's apparent desperation. Most patients in this situation have been obtaining and using drugs, and managing 'living in crisis' for some time. The patient need not come to any additional harm by having to wait a short time for a planned response. The drug user will want to know that they have been listened to, that they will receive care and that something is underway.
Prescribe a low starting dose on daily dispensing (10-40mg see below). If this is not sufficient to hold the patient this can be reviewed at the next consultation. Titrate the dose against withdrawal symptoms (see Clinical Guidelines p32)
Risk of overdose/dosing:
"Deaths have occurred following the commencement of a daily dose of 40mg methadone... In general, the initial daily dose will be in the range of 10-40 mg. If neuroadaptation (ie tolerance to opiates) is present then the usual daily dose is 25mg. If tolerance is low, or uncertain, then 10-20mg is more appropriate. Care is needed in starting a dose greater than 30mg because of the risk of overdose. If a low starting dose of 10mg is used, supervision after a few hours and further small doses can be given depending on the severity of the withdrawal symptoms. In cases where dose assessment is undertaken, the patient should be re-assessed about 4 hours after the administration of an initial dose."
(Clinical Guidelines p45)
Review daily dispensing conservatively/clinical reviews - Only when the patient is clearly making satisfactory progress on a daily dispensing regimen, should the dispensing intervals be reduced gradually to thrice then twice weekly, etc. Unless exceptional circumstances, no more than one weeks drugs should be dispensed at one time. Clinical reviews should be undertaken regularly, at least every 3 months (see Clinical Guidelines p33 and p28).
Storage - ask patient about daily safe storage and consumption facilities at home regarding children etc.
Contra-indications - Advise the patient on the contra-indications of their medication, particularly the interactions with alcohol and benzodiazepines.
Pharmacist/Supervised consumption - Liaise regularly with the pharmacist about the patient. Supervised consumption can be considered for new and vulnerable patients where this facility exists.
Notify the patient to the regional database.
Three levels of expertise have been described on pages 5 and 6 of the 'Clinical Guidelines', and are referred to in this Bulletin. These are generalist, specialised generalist and specialist. These three levels represent a continuum by which the development of shared care arrangements, training, and resources can be targeted. Training verses experience for 'accrediting' these levels is not altogether clear. The guidelines state that a doctor must be able to "demonstrate relevant competence" (Clinical Guidelines p5), and also state the need to be "trained to a competence commensurate with their level of activity" (Clinical Guidelines p4). Some judgement is needed together with local guidelines, 'accreditation' and training opportunities which take into account existing experience. Experience is important, but activity alone does not necessarily equate to competence. All three levels can apply to GPs although specialists are normally consultant psychiatrists.
What can GPs do to protect themselves? Read and follow the 'Clinical Guidelines' or agreed local guidelines based on these. The 'Clinical Guidelines' represent a consensus view of good clinical practice and can serve as a reference point for performance review or Clinical Governance. The following may be useful:
If you have little or no training, support or experience:
If you are initiating prescribing independently as a GP or as part of a shared care arrangement, as a minimum you should always:
See also 'The minimum responsibilities of the prescribing doctor' in the Clinical Guidelines (p28).
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