Mid essex area

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:
ƒ 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). ƒ 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. ƒ 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. ƒ 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 PAGE: 16 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
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

Source: http://www.northeastessexpct.nhs.uk/Prescribing-Policies/Guidelines4Clinic+PrescResponsibilityTrafficLightDoc+-++reviewupdate+Dec09.pdf