Microsoft word - rag list feb 2013 version 5 0

Mersey & Warrington Guidelines on
Prescribing Responsibility for “Red – Amber” Drugs
Version 5.0
February 2013
This list is intended to apply across Merseyside and Warrington. However
there may be individual differences in some localities and these are noted in
the following tables.
AIM: It is important for patient care that there is a clear understanding of
where clinical and prescribing responsibility rests between Secondary and
Primary Care Prescribers.
These guidelines reinforce the basic premise that:
“When clinical and / or prescribing responsibility for a patient is transferred
from secondary to primary care, the primary care prescriber should have the
appropriate competence to prescribe the necessary medicines. Therefore, it
is essential that a transfer of care involving medicines that a primary care
prescriber would not normally be familiar with, should not take place without
the “sharing of information with the primary care prescriber and their mutual
agreement to the transfer of care.”
Inherent in any shared care agreement is the understanding that participation
is at the discretion of the GP subject to their clinical confidence.
These are not rigid guidelines. Where necessary, secondary and primary
care prescribers should discuss the appropriate management of
individual patients personally. On occasions both parties may agree to
work outside of this guidance.

Criteria for the inclusion of medicines on these lists, or the moving of
medicines between the traffic light groups will be primarily based on clinical
issues:
 Evidence
 Ensuring efficient use (clinical and cost)  Willingness to provide agreed shared care information  Availability of suitable monitoring mechanisms in primary care RED: Primary care prescribing of these medicines is NOT recommended
unless there is a specific reason and a specific protocol and service set up to
support this.
These treatments should be initiated by specialists only and prescribing
retained within secondary care. They require specialist knowledge, intensive
monitoring, specific dose adjustments or further evaluation in use. If however,
a primary care prescriber has particular specialist knowledge or experience of
prescribing a particular drug for a particular patient it would not always be
appropriate for them to transfer that prescribing responsibility back to
secondary care. Primary care prescribers may prescribe RED medicines in
exceptional circumstances to ensure continuity of supply while arrangements
are made to obtain usual supplies from secondary care, but should be mindful
of the responsibilities they accept in doing this.
GPs must ensure that details of any RED drugs prescribed by the hospital are
recorded in individual patient records on computer systems. It is advisable to
do so under the READ code 8B2D (hospital prescription), or add to patients
medication list as a hospital drug.
NB: Inclusion of drugs on the RED list does not mean that the drug is
approved for use, or it will be commissioned (this is a local decision).
The list merely states where the clinical responsibility for prescribing
should lie if it were approved for use.


AMBER

AMBER – SHARED CARE: These medicines are considered suitable for GP
prescribing following specialist initiation of therapy, with on-going
communication between the primary care prescriber and specialist.
Primary care prescribers are advised not to take on prescribing of these
medicines unless they have been adequately informed by letter of their
responsibilities with regards monitoring, side effects and interactions and are
happy to take on the prescribing responsibility. There will normally be locally
approved guidelines (shared care protocol) that should accompany this letter
which outlines these responsibilities; otherwise they should ensure they have
been provided with adequate information in order to undertake shared care
safely. Primary care prescribers should then inform secondary care of their
intentions within 14 days by letter so that arrangements can be made for the
transfer of prescribing.
GMC Good practice Guidance on share care should be followed as
stated below:
Responsibility for Prescribing Medicines for Hospital Outpatients
Where a patient's care is shared between clinicians, the doctor with the
responsibility for the continuing management of the patient must be fully
competent to exercise their share of clinical responsibility. They also have a
duty to keep themselves informed about the medicines that are prescribed for
their patient. They should take account of appropriateness, effectiveness and
cost when prescribing any medicine. They should also keep up to date with
any relevant guidance on the use of the medicine and on the management of
the patient's condition.
If you are the doctor signing and issuing the prescription you bear
responsibility for that treatment; it is therefore important that, as the
prescriber, you understand the patient's condition as well as the treatment
prescribed and can recognise any adverse side effects of the medicine should
they occur.
There should be full consultation and agreement between general
practitioners and hospital doctors about the indications and need for particular
therapies. The decision about who should take responsibility for continuing
care or treatment after initial diagnosis or assessment should be based on the
patient's best interests rather than on the healthcare professional's
convenience or the cost of the medicine.
AMBER – ENHANCED SHARED CARE: These medicines are considered
suitable for GP prescribing following specialist initiation of therapy, with on-
going communication between the primary care prescriber and specialist as
per AMBER – SHARED CARE above.
However in addition they require significant blood test or other monitoring for
which a Local Enhanced Service (LES) may be available that pays a fee for
prescribing and monitoring. Prescribers should check the existence and terms
of any LES that applies in their locality.
AMBER – INITIATED: These medicines are considered suitable for GP
prescribing following specialist initiation or recommendation.
Patients should ideally be initiated on therapy with a minimum of 28 days
supply before transfer to primary care, and should definitely be prescribed a
supply if it is clinically necessary for them to commence therapy before
adequate information to allow safe transfer of prescribing to the GP in the
form of a full clinic letter can be received by the GP.
Specialists should provide sufficient information as to the indication, dose,
monitoring requirements and any necessary dose adjustments to allow the
GP to confidently prescribe.
The primary care prescriber must use their professional discretion to decide
whether they feel confident to prescribe therapy themselves on the advice of a
specialist.
GREY: These medicines are still being evaluated by local processes and
a decision on whether to commission their use has not yet been made.
They should not be prescribed in any setting.
Any drug may be prescribed in exceptional circumstances in specific
individuals where an individual funding request (IFR) for this has been agreed
by the commissioner.
BLACK: These medicines are not recommended / commissioned and
should not be prescribed in any setting.
Any drug may be prescribed in exceptional circumstances in specific
individuals where an individual funding request (IFR) for this has been agreed
by the commissioner.

UNLICENSED PRODUCTS AND UNLICENSED INDICATIONS
A product containing a completely unlicensed molecule will be assumed to be
classified as Red unless agreed otherwise by Area Medicines Management
Committees. This does not automatically include reformulated versions of
licensed medicines e.g. liquid formulations of a licensed medicine supplied as
a “Special”, or unlicensed uses of licensed medicines, many of which may be
prescribed by GPs.
Unlicensed indications for products that are licensed in the UK are not
automatically classified as Red, but should be agreed between specialist and
prescriber on a case by case basis.
In the case that a request is made to a GP to prescribe a medicine for an
unlicensed indication, in line with GMC Guidance on good medical practice
the following details should be included to assist the primary care prescriber in
considering whether it is appropriate for them to take on prescribing
responsibility:
The Consultant should state in writing that they are satisfied that:
 An alternative, licensed medicine would not meet the patient's needs
 They are satisfied that there is a sufficient evidence base and/or experience of using the medicine to demonstrate its safety and efficacy  They have explained, to the patient’s satisfaction and understanding, the
Mid Mersey = Halton, St Helens, Warrington, Knowsley excl. Kirkby.
North Mersey = Liverpool, South Sefton, Kirkby

NS&WL = North Sefton and West Lancashire = Southport & Formby,
West Lancashire
Abbreviation: NSCAG (National Specialised Commissioning Advisory Group)
Generic Name
Brand Name
Indication BNF
A
Abacavir Ziagen®
Acetazolamide Diamox® Epilepsy & glaucoma Ambrisentan Volibris® Pulmonary hypertension (services are nationally commissioned through NSCAG at specialist centres who undertake all prescribing), digital ulceration Amisulpride Solian® Licensed indications arrangements or service in place that allow this Apomorphine APO-go® Parkinson’s disease A - Shared Care (Shared Care Protocol not implemented in Knowsley, Halton, St Helens, Warrington) sub lingual tablets Atomoxetine Strattera® Care (Shared Care Protocol not implemented in Sefton, Halton, St Helens, Knowsley and adults only in Warrington) A - Enhanced Shared Care (Shared Care Protocol not implemented in Halton, St Helens, Knowsley outside Kirkby, Warrington) Shared Care (Shared Care Protocol not implemented in Sefton, Knowsley, Halton, St Helens, Warrington) Shared Care(Shared Care Protocol not implemented in Sefton, Knowsley, Halton , St Helens, Warrington) R (A - Shared Care where funding not provided to acute Trust (Warrington)) B
Balsalazide
specialist centres who undertake all prescribing), digital ulceration Bocouture® Botox® Dysport® Vistabel® Xeomin® Neurobloc® C
Cabergoline Dostinex®
A - Shared Care (Shared Care Protocol not yet implemented) Capecitabine Xelodal® Breast, colorectal and (Shared Care Protocol for rheumatology not St Helens, Knowsley outside Kirkby, Warrington. Shared Care Protocol for dermatology not implemented in Sefton, Knowsley, St Helens, Halton, Warrington) R (A - Shared Care where funding not provided to acute Trust (Warrington)) Shared Care (Shared Care Protocol not yet implemented) D) 800unit caps Colesevelam Cholestagel® Hyperlipidaemia R (A - Initiated Mid Mersey & NS&WL) Care (Shared Care Protocol not yet implemented) and solid tumours Vasculitis (unlicensed indication) Vasculitic Leg Ulcer (unlicensed indication) D
Dabigatran Pradaxa®
systemic embolism in non-valvular AF. Reserved for use where warfarin is not suitable due to contra-indication, intolerance or where a stable INR within the range 2 - 3 cannot be achieved service set up) (Shared Care Protocol not yet implemented in Knowsley, Halton, St Helens, Warrington) A - Shared Care (Shared Care Protocol not yet implemented) Denosumab Prolia® Prevention of osteoporotic A - Shared Care (Shared Care Protocol not yet implemented) (unlicensed special) Donepezil Aricept® Dementia Care (Shared Care Protocol not yet implemented in Sefton, Knowsley, Warrington = Altrincham only) E
Efavirenz Sustiva®
service set up) (Shared Care Protocol not yet implemented in Knowsley, Halton, St Helens, Warrington) NeoRecormon® Binocrit® Eporatio® Retacrit® licensed combinations, unlicensed combinations at GP discretion in N. Mersey & NS&WL) F
Fentanyl citrate
G
Galantamine Reminyl® Dementia
Care (Shared Care Protocol not yet implemented in Sefton, Knowsley, Warrington = Altrincham only) Care (Shared Care Protocol not yet implemented in Liverpool, Knowsley, Warrington, Halton, St Helens) A - Shared Care (Shared Care Protocol not yet implemented) H
Haloperidol depot
therapies and treatments for HIV-associated infections Sefton, Liverpool, Knowsley, Halton , St Shared Care (Shared Care Protocol not implemented in Halton, St Helens, Knowsley outside Kirkby, Warrington) Eye Drops
I
Ibandronic acid oral Bondronat®
(services are nationally commissioned through NSCAG at specialist centres who undertake all prescribing) (IVF) and oral subfertility treatment Iron dextran i.m. K
Ketamine - oral
L
Lacosamide - oral
solution Leflunomide Arava® Rheumatic disease A - Enhanced Shared Care (Shared Care Protocol not implemented in Halton, St Helens, Knowsley outside Kirkby, Warrington) A - Shared Care (Shared Care Protocol not yet implemented in Liverpool, Knowsley, Warrington, Halton, St Helens) licensed combinations, unlicensed combinations at GP discretion in N. Mersey & NS&WL) (Shared Care Protocol not yet implemented in ritonavir L-Tryptophan Optimax® Depression M
Macrogols Klean
A - Shared Care (Shared Care Protocol not yet implemented in Sefton, Knowsley, Warrington = Altrincham only) Shared Care (Shared Care Protocol not yet implemented in Sefton,Knowsley, Halton, St Helens, Warrington) Mercaptopurine Puri-Nethol® Leukaemia's Shared Care (Shared Care Protocol not implemented in Halton, St Helens, Knowsley outside Kirkby, Warrington) A - Enhanced Shared Care (Shared Care Protocol not yet implemented in Sefton, Knowsley, Halton, St Helens, Warrington) A - Enhanced Shared Care (Shared Care Protocol not yet implemented) (Shared Care Protocol not yet implemented in Knowsley outside Kirkby, Halton, St Helens, Warrington) Halton & St Helens, Knowsley and adults only in Warrington) oxidase inhibitors non-reversible Moviprep® (A - Shared Care where funding not provided to acute Trust (Warrington) except rheumatic disease Rheumatic disease (Shared Care Protocol not implemented in Halton, St Helens, Knowsley outside Kirkby, Warrington) N
N-acetylcysteine
(A Initiated- Mid Mersey & NS&WL) O
Octreotide Sandostatin®
medoxomil/ amlodipine besilate Olmesartan medoxomil/ amlodipine besilate/ hydrochlothiazide Omalizumab Xolair® Severe (May be prescribed in restricted circumstances Mid Mersey) (Red NS&WL) P
Paliperidone long
acting injection Paliperidone tablets Invega® A - Enhanced Shared Care (Shared Care Protocol not implemented in Halton, St Helens, Knowsley outside Kirkby, Warrington) A - Initiated Mid Mersey & NS&WL only Q
Quetiapine Seroquel® Licensed indications
R
Racecodotril Hidrasec®
Isoniazid & pyrazinamide Rifaximin Xifaxanta® systemic embolism in non-valvular AF. Reserved for use where warfarin is not suitable due to contra-indication, intolerance or where a stable INR within the range 2 - 3 cannot be achieved DVT 2.8.2 Care (Shared Care Protocol not yet implemented in Sefton, Knowsley, Warrington = Altrincham only) S
Saquinavir Fortovase®,
solution or injection Sevelamer Renagel® R (A - Shared Care where funding not provided to acute Trust (Warrington)) (Shared Care Protocol not implemented in Halton, St Helens, Knowsley outside Kirkby, Warrington) sulphate bladder instillation Sodium oxybate Shared Care (Shared Care Protocol not implemented in Halton, St Helens, Knowsley outside Kirkby, Warrington) T
Tacrolimus (topical) Protopic® Psoriasis
(services are nationally commissioned through NSCAG at specialist centres who undertake all prescribing) immediate release Tegafur/uracil Uftoral® Colorectal Virormone® patch or gel Sustanon® Testogel® Testim® Striant® Tostran® Restandol ® practical or transport issues - only NHS pts. e.g. Erfa thyroid Unlicensed preparation (Shared Care Protocol not yet implemented in Knowsley, Halton, St Helens, Warrington) Care (Shared Care Protocol not yet implemented) A - Shared Care (Shared Care Protocol not yet implemented) U
Ursodeoxycholic
injection
V
VAC Dressing
Z
Zidovudine Retrovir®

Source: http://www.northmerseyammc.nhs.uk/Library/new_meds_recommendations/RAG/RAG_V5.pdf