Serving the people of north east Essex NORTH EAST ESSEX MEDICINES MANAGEMENT COMMITTEE Guidelines for Clinical And Prescribing Responsibility & “Traffic Light” Document
INTRODUCTION
This document was originally developed by the North Nottinghamshire Drugs and Therapeutics Committee and has subsequently been revised, adapted and accepted by Mid Essex and the NEEMMC. It is intended to define the process, which will apply within North East Essex for clarifying the clinical and prescribing responsibilities for individual drugs. In particular, attention will be paid to the introduction of new drugs, new users of exisiting drugs and drugs whose use is under review in terms of shifting from predominantly being a drug normally prescribed within secondary care to a drug normally prescribed within primary care. Prescribing costs should, in part, form part of discussions on clinical responsibilities between clinicians. These guidelines address the circumstances where shared care prescribing arrangements might be appropriate, and explain how the management of shared care prescribing will proceed in the future in North East Essex. They provide a mechanism to determine the most appropriate clinician responsible for prescribing a particular drug. The development of shared care prescribing guidelines for particular drugs/conditions is outlined, for use when shared clinical care of the patient is agreed between the consultant and general practitioner. This process is being addressed, at this time, alongside the new GP contract implementation process. This document should be the first point of reference for both general practitioners and consultants in the Trusts when considering the introduction of a new drug, a new use for an existing drug, the appropriateness of shared care prescribing arrangements for a particular condition, or the transfer of prescribing of an individual drug from one setting to another. Division of clinical responsibility and therefore prescribing responsibility is considered and general principles are put forward to meet the needs and concerns of all those involved. Legal responsibility for prescribing lies with the doctor who signs the prescription, and this includes the correct completion of the prescription and full or shared clinical responsibility for the treatment of the patient. Responsibilities to Patients PAGE: 1 of 17 APPROVED BY: North East Essex Medicines Management Committee July 2009 REVIEW DATE: February 2011 AUTHOR: Paul Breame, Head of Medicines Management North East Essex PCT UPDATED: August 2009 ¾ Patients should not be involved in discussions or disputes between clinicians on
clinical or prescribing responsibilities. Patients may need to be kept informed about specific problems involving “shared care prescribing arrangements”, but must not be used as intermediaries between consultants and GP’s.
The best interests and convenience of patients must be considered at all times.
¾ A “safety net” is needed for patients so that their treatment does not suffer while
decisions on clinical and prescribing responsibilities are made. Whilst a decision is awaited as to which category a drug belongs, or where shared care guidelines are being drawn up, the clinical responsibility and supply of the drug under issue to the patient will be retained by the physician who initiated the treatment. The NEEMMC will consider the drug in question at their next meeting and determine the category to which it should be allocated. If a drug is deemed to be amber and a shared care guideline needs to be produced the drugs will be classified as red until such time as a shared care guideline is produced and approved by the relevant Medicines Management Committee (MMC) and the NEEMMC.
The North East Essex Medicines Management Committee “Traffic Lights” Pathway This should be followed with reference to the NEEMMC “Traffic Lights” Pathway – Appendix 2 A drug is referred to the NEEMMC. The routes for this are through one of the constituent organisations:
− PCT via Assist. Director / Head of Medicines Management
GPs, consultants and the LMC are encouraged to raise any requests / issues through either of the above as appropriate. The NEEMMC will then follow the steps outlined below to categorise the drug. Step 1 – Consideration of Evidence of Clinical and Cost-Effectiveness The NEEMMC will firstly need to determine whether the use of a drug is supported by evidence of clinical and cost effectiveness. If evidence is not available, or the evidence available indicates that the drug in question is clinically ineffective or is not cost effective, the drug will be designated BLUE. If evidence, published in a peer-reviewed journal, is available but has not been appropriately evaluated the drug will remain in the BLUE list until such time as an evaluation of the evidence has taken place. The evaluation may be undertaken locally PAGE: 2 of 17 APPROVED BY: North East Essex Medicines Management Committee July 2009 REVIEW DATE: February 2011 AUTHOR: Paul Breame, Head of Medicines Management North East Essex PCT UPDATED: August 2009
or nationally e.g. NICE, National Prescribing Centre, London and Eastern Medicines Information Service BLUE BLUE drugs will be reviewed, along with the other traffic light categories at each meeting of the NEEMMC. Conditions may be attached to drugs within this category. If evidence becomes available to support the drug as clinically and/or cost effective the NEEMMC will proceed to Step 2. Step 2 – Determination of Drugs Appropriate for Prescribing in Secondary Care Is the GP suitably trained to undertake this specialised care with the provision of appropriate guidelines?
NEEMMC will normally make this decision after discussion with members of the organisations they represent. This decision should reflect the competency of the “average” GP to undertake this specialised care. Factors to be taken into consideration include:
Is the GP truly taking full clinical responsibility for that patient’s treatment? (e.g. if
monitoring is performed within secondary care and not by the GP it would normally be considered inappropriate for the GP to prescribe).
If the drug is a new chemical entity, and still marked with a black triangle, i.e.
there is limited experience of the use of the product and the CSM requests that all suspected adverse reactions be reported, any prescribing should remain within secondary care until the NEEMMC has had time to comment on its position in relation to the traffic lights pathway. It may be suitable for “me-too” products marked with a black triangle, where there is experience in the use of the group of drugs to which it belongs, to be prescribed in primary care.
New, specialised drugs should only move into primary care once GP’s have been
provided with sufficient information in the form of a shared care guideline approved by the NEEMMC and / or given the opportunity for training.
The financial considerations are separate and prescribing should not be initiated
as part of any policy or protocol where the PCT is expected to fund (through commissioning or by GP / non-medical prescribing) until the PCT has agreed this alongside a timetable for implementation.
If the answer is No, the drug will be added to the RED category. RED PAGE: 3 of 17 APPROVED BY: North East Essex Medicines Management Committee July 2009 REVIEW DATE: February 2011 AUTHOR: Paul Breame, Head of Medicines Management North East Essex PCT UPDATED: August 2009 For all RED drugs prescribing responsibility remains with the consultant at the hospital. This may particularly be the case for: ¾
Certain new drugs and new indications for older drugs where there is at present no experience of use in general practice.
Clinical trial drugs which are being used in the hospital
¾ Medicines which require preparation by the hospital pharmacy, unless an
acceptable procedure for supply through a community pharmacist can be arranged.
Drugs, dressings or appliances not available or prescribable in general practice.
Patients attending the hospital frequently for complicated treatments and specialist investigations, and the consultant needs to monitor progress.
¾ Drugs, unsuitable for use in primary care, covered under the shared-risk
agreement e.g. PPH, anti-tnf, where a separate funding stream is already in place. – these will remain in the BLUE drugs category.
The convenience of the patient and in the patient’s best interest.
¾ Circumstances where the GP justifiably refuses to take clinical responsibility e.g.
where he has no control over the use of the drug.
Where a drug has been classified as amber but a shared care guideline, approved by all relevant Trust MMC(s) and the NEEMMC is not yet available.
RED drugs will be reviewed, along with the other traffic light categories, at each meeting of the NEEMMC as necessary. Where there are major financial implications of the use of certain drugs, the costs should form part of the negotiation process for the Trust contract with the relevant Trust. If the answer is Yes, the drug will enter Step 3. Step 3 – Determination of the Appropriateness of Shared Care Prescribing Arrangements Is the drug normally prescribed by the majority of GP’s? If the answer is No, the drug will be allocated to the AMBER category, appropriate for shared care prescribing arrangements between secondary and primary care. The AMBER category can be split into two sections, which can be defined as follows: PAGE: 4 of 17 APPROVED BY: North East Essex Medicines Management Committee July 2009 REVIEW DATE: February 2011 AUTHOR: Paul Breame, Head of Medicines Management North East Essex PCT UPDATED: August 2009
AMBER (2) - Drugs that should normally be initiated by a specialist and prescribed by
GP’s under a shared care guideline agreed by the NEEMMC. These would normally also be covered by an additional Local Enhanced Service in primary care.
AMBER (1) - Drugs that can only be prescribed in general practice after specialist
referral and initiation. The patient would normally be stabilised before prescribing responsibility is devolved. A shared care guideline is not required.
AMBER For many drugs allocated to AMBER, a shared care prescribing arrangement is appropriate. In these circumstances: ¾ Hospital consultants and general practitioners may come to an agreement that
they will share the clinical responsibility for a patient who is being seen by both of them – a “shared care” situation.
¾ Prescribing in these circumstances is determined by the shared care prescribing
arrangement negotiated for each individual drug.
The GP must have a role in the care of the patient, which is justifiable in terms of improvement in patient care and proper use of a GP’s expertise. For drugs, which they have prescribed, GP’s should have sufficient expertise to start, stop, or alter the dosage of the drug in appropriate circumstances. The degree of control, which they have over this prescribing, will form part of the shared care guidelines.
Agreements for shared care should not be used for cost shifting purposes only, so that prescribing can be transferred to the GP.
¾ GP’s as independent contractors, have the right to decline to take clinical and
prescribing responsibilities for a patient on their medical list who is being treated elsewhere, but the reason for this action must be documented in the patient notes. In the view of the NEEMMC, it would be inappropriate for a GP to refuse to take clinical and prescribing responsibilities for an individual drug, where shared care usage for that drug has become common practice and where shared care guidelines include adequate support, education and information as approved by the NEEMMC. Where the GP refuses to take responsibility for prescribing, this should be communicated on the documentation approved by the NEEMMC.
¾ Where a dispute arises in this area, advice will be sought from the PCT Assistant
Director (Medicines Management) or hospital Chief Pharmacist as appropriate. The GP(s) involved will then be written to by the appropriate organisation, often after discussion with the hospital or PCT, advising them as to the most appropriate way forward.
PAGE: 5 of 17 APPROVED BY: North East Essex Medicines Management Committee July 2009 REVIEW DATE: February 2011 AUTHOR: Paul Breame, Head of Medicines Management North East Essex PCT UPDATED: August 2009
¾ Adequate support, education and information must be available to GP’s who
“share care” of patients with a consultant.
¾ The NEEMMC will establish a mechanism to develop a guideline for each drug
− For drugs already categorised as amber for which no shared care
agreements are available the NEEMMC will form working groups to produce guidelines for each drug, or group of drugs.
− Where consultants apply to their Trust MMC for a new drug to be entered
on to the Trust Formulary, or for an existing drug to be used in a new indication, advice will be sought from the NEEMMC as to which category that drug should fall. If the drug is categorised as amber the consultant as part of the process required by their Trust MMC or equivalent, must produce a draft shared care guideline for consideration within Primary Care.
− In some circumstances a ‘shared care guideline’ will involve a specialist or
tertiary provider. In this case the PCT will enter into discussion with the appropriate partner.
The guideline developed should reflect all of the preceding principles. The aim of the guideline is to define the role and responsibilities of the GP and the Consultants who are agreeing to share clinical and prescribing responsibility for a particular patient with a particular disease or condition. A standard format for these guidelines is given at Appendix 1.
¾ The relevant Trust mechanism and the NEEMMC must approve all shared care
guidelines produced before they can be distributed for use between primary and secondary care.
Where a drug is categorised as AMBER and a shared care guideline needs to be produced the drug will be categorised RED until such time as a shared care guideline is produced and approved by the relevant Trust MMC and the NEEMMC. This should take place within 6 months of the date of identification of the need for the shared care guideline.
¾ When legal responsibility for overall clinical care of the patient is shared, then the
manner in which it is shared will be indicated by the shared care guideline.
¾ Where appropriate, the NEEMMC will review, or return guidelines to their author
for review on a regular basis as determined for each individual drug, all shared care prescribing arrangements. The NEEMMC will consider whether AMBER drugs require re-categorisation, at each of it’s meeting, along with the other traffic light categories and in light of any further evidence of experience.
GREEN
If, after considering further evidence, a decision is made to re-categorise an AMBER drug, that drug will be allocated to the GREEN category PAGE: 6 of 17 APPROVED BY: North East Essex Medicines Management Committee July 2009 REVIEW DATE: February 2011 AUTHOR: Paul Breame, Head of Medicines Management North East Essex PCT UPDATED: August 2009 For all GREEN drugs prescribing responsibility remains with the general practitioner. In particular this is the case in circumstances where GP’s accept FULL clinical responsibility for the treatment of their patients in primary care and they also accept responsibility for prescribing all necessary drugs, dressings and appliances. ¾ GP’s, as independent contractors, have the right to decline to take clinical and
prescribing responsibilities for a patient on their medical list who is being treated elsewhere, but the reason for this action must be documented. In the view of the NEEMMC, it would be inappropriate for a GP to refuse to take clinical and prescribing responsibilities for an individual drug, where the prescribing of that drug within primary care has become common practice. Where the GP refuses to take responsibility for prescribing, this should be communicated on the documentation approved by the NEEMMC.
By default, any drug not listed under RED, AMBER or BLUE may be considered GREEN. Drugs may be listed under GREEN where advice has been sought from the NEEMMC on the categorisation of the drug within the “traffic lights” pathway and a recommendation has been made. New drugs, or drugs where there are changed indications in licences should not normally be initiated in primary or secondary care until the relevant organisation has considered this.
Acknowledgements: NEEMMC acknowledges the assistance of the following in the preparation of these guidelines: North Nottinghamshire Drugs and Therapeutics Committee Mid Essex Area Prescribing Committee PAGE: 7 of 17 APPROVED BY: North East Essex Medicines Management Committee July 2009 REVIEW DATE: February 2011 AUTHOR: Paul Breame, Head of Medicines Management North East Essex PCT UPDATED: August 2009 SHARED CARE PRESCRIBING GUIDELINE – REQUIRED FORMAT APPENDIX 1 Background information on condition to be treated Including information on the disease, diagnostic criteria and investigations, general treatment and management and patient selection for drug treatment. Drug Treatment, Licensed Indicators and Management Plan Including indications and exclusion, pharmacology, products available, dosages, reconstituting, storage, administration, adverse effects, drug interactions, costs, patient information and availability of other information. Presentation of a product and particular advice relevant for patients and / or carers on the use of that product. Procedures for Initiating shared care Prescribing Including mechanism for reaching agreement, contractual and funding implications for Trusts, PCG’s and the practices involved. Role and Responsibilities of Trust Including the role of the consultant, degree of control over prescribing, monitoring procedures, frequency of Trust attendance, emergency treatment arrangements, and exchange of information including change of treatment, special clinical and drug problems to be watched for. Role and Responsibilities of GP Including the role of the GP, monitoring procedures, frequency of attendance at GP surgery, emergency treatment arrangements, exchange of information, degree of control over prescribing, notifications of change of treatment, special clinical and drug problems to be watched for. Proforma
Details of the specific patient, Consultant and GP for which guideline is being used. Proforma for consultant to sign will list rules and responsibilities of Trust. Proforma for GP to sign will list roles and responsibilities of GP. Each party will retain a copy of the others signed proforma. (Example Proformas to be developed). Support, Education and Information Support available from Trust, meetings and other education or instructional courses which may be available, information available such as literature, video and audio tapes, films and other organisations and individuals who can provide information and support. Advice Help Line Arrangement for immediate advice and help from trust consultants and other appropriate staff. Safety Net Procedure to be followed in case of problems initiating shared care. PAGE: 8 of 17 APPROVED BY: North East Essex Medicines Management Committee July 2009 REVIEW DATE: February 2011 AUTHOR: Paul Breame, Head of Medicines Management North East Essex PCT UPDATED: August 2009 North East Essex Area ‘Traffic Lights’ Amber 1=Specialist initiation, GP to take over prescribing when patient is stabilised (Essential Services); Amber 2=Prescribe under shared-care protocol (Local Enhanced Service or NES) Red =Specialist prescribing only-usually secondary care (but could be GpwSI) Blue =Prescribe under risk sharing scheme-link with Mary Tompkins, North East Essex PCT Purple = Drugs not recommended for prescribing within North East Essex (previously double red) All other Formulary drugs not appearing on this list are considered to be ‘Green’ and freely available to be prescribed. GPs and specialists should consult their Pharmacist / Prescribing Advisor before prescribing any non- formulary drug for the first time. This list will be revised on a regular basis. Drugs may change category over time and all prescribers will be notified of any changes. December 2007 Blue - Shared-Risk
Advanced ovarian cancer (2nd line), AIDS related Karposi’s sarcoma
Rheumatoid arthritis, psoriatic arthritis.
Chronic myeloid leukeamia and gastro-intestinal stroma tumours
Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis
Viraferon, Viraferon Peg PegIntron, Roferon A) PAGE: 9 of 17 APPROVED BY: North East Essex Medicines Management Committee July 2009 REVIEW DATE: February 2011 AUTHOR: Paul Breame, Head of Medicines Management North East Essex PCT UPDATED: August 2009 Tertiary and specialized packages (Shared risk) All drugs for pulmonary (may involve LES) Chloroquine phosphate (1
or 2 depending on local agreement) Chloroquine phosphate (1
PAGE: 10 of 17 APPROVED BY: North East Essex Medicines Management Committee July 2009 REVIEW DATE: February 2011 AUTHOR: Paul Breame, Head of Medicines Management North East Essex PCT UPDATED: August 2009
Hypertension where conventional therapies have failed or are not tolerated. Augment currently available antihypertensives in renal patients – nephrologist initiation.
Open angle glaucoma, ocular hypertension
Anaemia associated with chronic renal failure and non-myeloid malignancies
Narcolepsy, adjunct in management of refractory hyperkinetic states in children
Treatment of peripheral diabetic neuropathic pain
Women between 35 and 40 with heavy menstrual bleeding where Mirena is not appropriate.
PAGE: 11 of 17 APPROVED BY: North East Essex Medicines Management Committee July 2009 REVIEW DATE: February 2011 AUTHOR: Paul Breame, Head of Medicines Management North East Essex PCT UPDATED: August 2009
receiving opioid therapy for chronic cancer pain.
Chronic stable angina intolerant or contraindicated to beta-blockers.
Symptoms associated with carcinoid tumours
Adjunctive treatment of partial seizures
PAGE: 12 of 17 APPROVED BY: North East Essex Medicines Management Committee July 2009 REVIEW DATE: February 2011 AUTHOR: Paul Breame, Head of Medicines Management North East Essex PCT UPDATED: August 2009
Alternative to exanatide in selected patients under Dr Bodmer or Diabetes Team
Low molecular weight heparin (Clexane)
Acute treatment of mild to moderate atopic eczema
To use in selected dialysis patients with high protein requirements needing supplements
To use in renal patients requiring oral supplements
To extend life or the time to mechanical ventilation in amyotrophic lateral sclerosis
Hyperphosphataemia in patients on haemodialysis
Moderate to severe eczema unresponsive to conventional therapy
Glaucoma in patients allergic to preservatives
Spasticity associated with MS or spinal cord injury
PAGE: 13 of 17 APPROVED BY: North East Essex Medicines Management Committee July 2009 REVIEW DATE: February 2011 AUTHOR: Paul Breame, Head of Medicines Management North East Essex PCT UPDATED: August 2009 PAGE: 14 of 17 APPROVED BY: North East Essex Medicines Management Committee July 2009 REVIEW DATE: February 2011 AUTHOR: Paul Breame, Head of Medicines Management North East Essex PCT UPDATED: August 2009
Pulmonary fibrosis, non-specific interstitial pneumonia, usual interstitial pneumonia & sarcoidosis
Adjunct treatment of full-thickness, neuropathic, diabetic ulcers
In place of enoxaparin in hip and knee replacements
Initiation of cervical ripening at term.
Severe sepsis with multiple organ failure
Joint lubrication in Osteoarthritis (TRIAL only)
Efavirenz/emtrictabine/tenofovir (Atripla)
Use in family planning clinics only for patients with compliance problems, GI or absorption problems.
Life and sight threatening cytomegalovirus infections
Replacement for pamidronate in skeletal events in breast and bone metastases
PAGE: 15 of 17 APPROVED BY: North East Essex Medicines Management Committee July 2009 REVIEW DATE: February 2011 AUTHOR: Paul Breame, Head of Medicines Management North East Essex PCT UPDATED: August 2009
Augment current range of topical ophthalmic corticosteroids
Candidiasis in patients undergoing head and neck radiotherapy
Control of agitation and disturbed behaviour
Replace or augment treatment for intractable nausea and vomiting.
Treatment of refractory myeloproliferative disorders
Severe respiratory sybcytial virus bronchiolitis, Hepatitis-C
Additional line of treatment for autoimmune thrombocytopenia patients refractory to current treatment
In place of enoxaparin in hip and knee replacement
nebulised acetylcysteine in severe bronchiectasis
Reverse neuromuscular blockade in emergency situations
Psoriasis treatment in patients intolerant to or not suitable for other anti-TNFs and subject to funding approval
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initiation (funding & logistical issues
Replacement for pamidronate in skeletal events in advanced bone malignancies
Banned drugs within North East Essex Locality
Memantine Substance misuse
PAGE: 17 of 17 APPROVED BY: North East Essex Medicines Management Committee July 2009 REVIEW DATE: February 2011 AUTHOR: Paul Breame, Head of Medicines Management North East Essex PCT UPDATED: August 2009
Tuesday afternoon September 4, 2007 Poster session I MAXIMUM POSTER SIZE 80 width × 100 height PI_1) Garnir, Improved energy resolution of a cyclotron beam for RBS measurements Shao, Toward high accuracy in channeling Rutherford backscattering spectrometry analysis Mallepell, Annular gas ionization detector for Heavy Ion Backscattering Spectrometry Baltateanu, Influence of so
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Serving the people of north east Essex