Dorset
NHS Dorset Clinical Commissioning Group
Dorset County Hospital NHS Foundation Trust
Dorset Healthcare University NHS Foundation Trust
Poole Hospital NHS Foundation Trust
Royal Bournemouth and Christchurch Hospitals
NHS Foundation Trust
PROVIDER TRUST DRUG & THERAPEUTICS COMMITTEES and DORSET MEDICINES ADVISORY GROUP
New Drug Assessment / Traffic Light Allocation
Guidance notes:
 This form should be used to propose a medicine for inclusion on the pan-Dorset formulary.
 It should be completed by consultants making an application via their local Drug & Therapeutics
Committee (D&TC) – the local D&TC will review the application; if considered appropriate they will
forward to DMAG to consider the implications of inclusion across the Dorset healthcare community.
 It should be completed by a clinical working group making an application following discussion.
 Medicines should only be considered “approved” once recommended for inclusion by DMAG and
taking into account relevant CCG priorities.
 Where a NICE Technology Appraisal or other national / regional guidance is available this can be used
to supply the clinical and cost-effective evidence and section 2 and 3 may reference these sources.
Where national / regional information is not available, section 2 and 3 should be completed in full.
Submission contact details:
1. Consultants making an application to their local trust Drug & Therapeutics Committee via their
local contact(s):
Trust
Royal
Bournemouth
& Christchurch
Hospitals NHS
FT
Main contacts
Laura Granger
(Pharmacist)
laura.granger@rbch.nhs.uk
Poole Hospital
NHS FT
Linda Porter
(Pharmacist)
Dorset County
Hospital NHS FT
Medicines
Information
Tel.
Address
01202 70 4098
Medicines Information
Pharmacy Dept
RBH
BH7 RDW
Post Point C20
Linda.Porter@poole.nhs.uk
01202 44 2394
Poole Hospital
BH15 2JB
Debbie Waite
(Administrator)
Deborah.Waite@poole.nhs.uk
01202 44 2684
Martin Shepherd
(Pharmacist)
Martin.Shepherd@dchft.nhs.uk
01305 25 5294
Sue.Baggott@dchft.nhs.uk
01305 25 5294
richard.bradshaw@dhuft.nhs.uk
01202 49 2429
adam.hocking@dhuft.nhs.uk
01305 36 1417
Sue Baggott
(Administrator)
Dorset
Healthcare
University NHS
Foundation
Trust
Email
Mental Health:
Richard Bradshaw
Community Services:
Adam Hocking
medsinfo@rbch.nhs.uk
07500074395
Dorset County
Hospital
Dorchester
DT1 2JY
Pharmacy
St Anne’s Hospital
69 Haven Road
Poole
BH13 7LN
Medicines
Management
Forston Clinic
Herrison Road
Dorchester
DT2 9TB
2. Applications to CCG DMAG contacts via: formulary.applications@dorsetccg.nhs.uk
1
GENERAL INFORMATION
Generic (approved) name of medicine:
Proprietary (brand) name of medicine:
Therapeutic class :
Manufacturer :
Formulation(s) :
Route(s) of administration :
Proposed indication(s)
National/regional guidance related to the medicine for this indication (see Appendix one):
Has this drug or topic been discussed within a Clinical Commissioning Programme?
What benefits does this drug offer over other therapy options in the same class?
2
EVIDENCE OF CLINICAL EFFICACY AND SAFETY
Please list the pivotal studies that demonstrate the medicine’s safety and efficacy & what the
principal outcome measures were, (copies of key papers should be provided – maximum of 3):
Please state the number needed to treat (NNT) and number needed to harm (NNH) – if known :
NNT=
NNH=
What are the known side effects? :
Are there any safety issues regarding this medicine in comparison to existing medicines? :
Are there any groups of patients in which this drug is contraindicated or where it should be used
with caution? :
Is there any long term safety data (if applicable)? :
Are/should there be any restrictions on who should initiate treatment or administer the medicine?
(if ‘yes’ please specify) e.g. No restrictions, Consultant only, Specialist Only, Use only according to
guidelines :
Has it been widely used elsewhere? (if ‘yes’ please specify) :
Are there any clinically important drug interactions? (if ‘yes’ please specify):
Are there any monitoring requirements? (if ‘yes’ please specify):
Is this preparation part of a formal research project or clinical trial? (if ‘yes’ please give details) :
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3.
COST-EFFECTIVENESS
Are there any published cost effectiveness analyses for the new medicine?
Please provide information on the cost effectiveness of this medicine in terms of absolute risk
reduction (ARR) and cost per QALY (if known/applicable)? :
4.
FINANCIAL AND COMMISSIONING IMPLICATIONS OF ADDING TO FORMULARY
Are there any other service implications? e.g. new equipment or processes (if ‘yes’ please specify
which):
What are the financial implications for the Dorset population?
Are there off-set costs to be considered if this is added to formulary?
What are the commissioning implications for provider Trusts and the CCG?
Where does the balance of
prescribing lie (see appendix 2)
5.
BALANCE IN
SECONDARY CARE
PROPOSED TRAFFIC LIGHT CLASSIFICATION (see appendix 3)
Green
6.
BALANCE IN
PRIMARY CARE
Red
Amber
Not
recommended
DECLARATION OF INTEREST
The lead clinician(s) responsible for completing this form, and/or providing information to the
Medicines Advisory Group, are asked to declare and describe any involvement that they may have
with the relevant pharmaceutical company, or with the manufacturers of any comparator products.
Please declare any personal interests over the last 12 months. This involves payments (or other
support) from any one company to an individual member or their spouse/partner/co-habittee or
close relative. The main examples are consultancies, fee-paid work, travel grants or
pharmaceutical company shares. (The amount of money involved does not have to be declared).
If you have nothing to declare please type ‘None’:
Please declare any non-personal interests over the last 12 months. This implies support from
any one company for your unit or place of work. It may be financial or in kind, e.g. funding of a
nurse, colleague, building or piece of equipment. (The amount of money involved does not have
to be declared).
If you have nothing to declare please type ‘None’:
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7.
DETAILS OF APPLICANT
Name of requestor :
Contact details (email address, telephone number, secretary etc.) :
Speciality :
Directorate :
Trust:
Date of submission :
8.
DIRECTORATE SUPPORT – Supportive of application and aware of potential budgetary impact to
directorate
General Manager :
Name (print)
Signature
Date
Clinical Director :
Name (print)
6.
Signature
Date
APPROVAL
Recommendation of local drug and therapeutics committee:
Date of recommendation:
Detail support of the D&TC:
Are Provider Trusts or Primary Care supportive of this approach (where applicable)?
Sponsor from local drug and therapeutics committee for this application:
9.
OUTCOME OF MEDICINES ADVISORY GROUP DISCUSSIONS
Notes:
Date:
Appendix 1 - Example of Organisations providing relevant resources on medicines
All Wales Medicines Strategy Group
Cochrane Library
Drugs and therapeutics Bulletin
Midlands Therapeutics Review and Advisory Committee
National Institute for Health Research – Horizon Scanning Centre
NICE
NICE Medicines Information
North East Treatment Advisory Group
Regional Drug & Therapeutics Centre
Scottish Intercollegiate Guidelines Network
Scottish Medicines Consortium
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Appendix 2 - Balance of responsibility – to assist with section 4
Criteria
Primary Care
Secondary Care
(a)
The disease/condition
Familiar/common
(b)
Efficacy &
effectiveness
Initiation
No special requirements
Maintenance
Benefit – measurable in
primary care
Dose titration
Simple
Withdrawal
Lack of benefit –
measurable in primary care
Adverse events
Predictable Chronic
Knowledge base
Monitoring-skills
equipment
Skill Equipment
Training
Large
Specialist diagnosis required
Intense initial monitoring
Benefit measurable with
specialist skills/equipment
Complex depending on factors
which can only be assessed in
secondary care
Lack of benefit – Requires
specialist skills/equipment,
close monitoring required
Unpredictable adverse events
Acute and life threatening
Limited
Available in primary care
Specialised
Available in primary care
Available in primary care
Specialist skills
(c)
(d)
Safety
Administration
Unfamiliar/rare
Appendix 3 - Definitions of traffic light categorisations in Dorset
The “traffic light” system defines where responsibility for prescribing between primary and
secondary care should lie through categorising individual drugs as red, amber or green.
The “traffic light” system provides a framework for defining where clinical and therefore
prescribing responsibility should lie through categorisation of individual drugs. The “traffic light”
system is intended to provide a framework to consider the clinical responsibility and
competency associated with the prescribing of a medicine and is not based on the cost of a
medication.
The list is advisory only (and can be changed by Dorset Medicines Advisory Group (DMAG) on
request) but its existence should clarify expectations of prescribing responsibility.
The DMAG recognises that there are some medicines with unresolved ‘traffic light status’ and
others where prescribers may have concerns or disagreements arising from the reclassification of
medicines. Please raise these issues with the formulary pharmacists of the employing Trust or the
CCG senior pharmacists. The formulary pharmacists and DMAG will aim to resolve the issues in a
timely manner.
Following review of clinical data on efficacy, safety and cost-effectiveness by the DMAG and its
sub-groups, drug treatments will either be recommended, following which they will receive a
“traffic light” category as follows:

Red
- for secondary or tertiary care initiation and long-term maintenance of
prescribing;
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
amber with shared care
– drugs which are appropriate to be initiated and
stabilised by a specialist in secondary or tertiary care, once stabilised the drug may be
appropriate for responsibility to be transferred from secondary to primary care with the
agreement of a GP and a formal ‘shared care’ agreement.
o Initiation, prescribing, & monitoring until drug is stabilized is the responsibility of
the specialist.
o Specialist to request GP to take part in ongoing prescribing & associated clinical
responsibility according to a ‘shared care guideline’, this may be prior to or
following initiation of therapy
o GP to respond to the specialist
o Ongoing communication between primary and secondary care

amber without shared care
– drugs which may be initiated within a specialist
service, which may be situated in primary, intermediate or secondary care, the drug may
require stabilisation in the specialist service before transfer of prescribing to a primary
care practitioner OR drugs which may be recommended by a specialist following a face-to
face assessment or a telephone conversation with the patient’s GP and initiated by the GP
o Initiation with 28 day supply (where possible) or recommendation is the
responsibility of the specialist. Additional information regarding dosing and
monitoring to be supplied by the specialist.
o GP to respond to the specialist (where necessary).
o Ongoing communication between primary and secondary care

green
- drugs which may be initiated, stabilised and maintained in a primary,
secondary or tertiary care setting

or, not recommended
, that is where prescribing is not generally recommended in
primary or secondary care. This category may be assigned to a drug where there is a lack of
good clinical evidence for the drug, due to concerns over safety or due to the availability
of more cost effective alternatives. This list will be reviewed regularly. Clinicians should
not prescribe these drugs. This category includes all new black triangle ▼ drugs until they
have been requested and formally assessed.
For unlicensed medicines the prescriber, patient and GP should be aware of the unlicensed
nature of the drug and reference to the protocol on the use of unlicensed drugs should be made.
Commissioning issues may also need to be considered, for example, the prescribing of unlicensed
medications should not generally be transferred to primary care, however off-label use may be
suitable for transfer.
Prescribers may wish to access the GMC guidance on prescribing off-label or unlicensed
medications:
http://www.gmc-uk.org/guidance/ethical_guidance/14327.asp
Further detail of classifications
Criteria for “Red” classification
1. Requiring specialist assessment to enable patient selection and initiation and continuation of
treatment
2. Requiring long-term, on-going specialist monitoring of efficacy
3. Requiring long-term, on-going specialist monitoring of toxicity (because the side-effect profile
necessitates rigorous supervision by the hospital consultant or, the full range of possible sideeffects, particularly long-term effects needs to be established (e.g cancer drugs)
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4. Specifically designated as ‘hospital only’ by product licence
(e.g. isotretinoin (Roaccutane®))
5. That are new, or a new indication for an existing drug, that needs evaluation to be undertaken
to establish place in therapy, with a recommendation that a formal review process be
undertaken.
6. That are hospital indicated clinical trial materials
7. Use restricted by national guidance e.g NICE
8. Unlicensed / Off Label Drugs this includes unlicensed or named patient drugs, unlicensed doses
or unlicensed indications for new▼drugs / drugs unfamiliar to primary care.
Criteria for the “Amber with shared care” classification
1. Requiring specialist assessment to enable patient selection and initiation of treatment
2. Requiring specialist monitoring of efficacy, or that responsibility is clearly transferred to
primary care
3. Requiring specialist monitoring of toxicity, or that responsibility is clearly transferred to
primary care
4. That is rarely used, such that individual GPs are unlikely to see sufficient patients and acquire a
working knowledge of the drug
5. NICE guidance
6. Products without a UK product licence would normally be classified as ‘red’ but may, in
exceptional circumstances, be classified as ‘amber’.
Shared Care Template
A template for shared care agreements for drugs listed in the Shared care category of the panDorset formulary is available (link to be added). Shared care category drugs should be prescribed
by a secondary care specialist or competent clinician to establish the patient on treatment, i.e. to
monitor the patient’s response (efficacy, safety and appropriateness), adjust dosage and treat
side effects. The patient needs to be stabilised and reviewed before asking the GP to take over
clinical and prescribing responsibility. Each ‘shared care agreement’ will be individualised
according to specific requirements of the drug. Shared care guidance should be sent and transfer
agreed at least 2 weeks before the GP needs to prescribe the next period of treatment. The GP
should consider the competencies required to manage and prescribe for the patient.
Please note that primary care prescribers should not assume that drugs listed in the shared care
group would attract “Near Patient Testing” payments under GMS Enhanced Services. This
decision in relation to individual drugs is subject to local discussion with the CCG.
Criteria for the “Amber without shared care” classification
1. Requiring an assessment by a specialist service, which may be situated in primary,
intermediate or secondary care, to enable patient selection and initiation of treatment (this may
be face to face or a telephone conversation with the patient’s GP)
2. Monitoring of efficacy can be undertaken in primary or secondary care
3. Monitoring of toxicity can be undertaken in primary or secondary care
4. Often used, such that individual GPs are likely to see sufficient patients and acquire a working
knowledge of the drug.
Criteria for the “Green” classification
1. Routinely used drugs with a high degree of universal familiarity
2. Initiation may be appropriate in primary, intermediate or secondary care
3. Offers significant benefit over existing treatment and that its use as a first, second or thirdline drug has been defined
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Criteria for Not Recommended classification
1. Lack of data on effectiveness compared with standard therapy.
2. Lack of data on safety compared with standard therapy.
3. Known increase in risk of adverse events compared with standard therapy.
4. Lack of data on cost-effectiveness compared with standard therapy.
5. Less cost-effective than current standard therapy
6. NICE guidance which does not recommend the use of the drug
7. An interim measure pending review of the drug treatment
It should be noted that there may be occasions where the use of a drug treatment that has been
categorised as “not recommended” is considered appropriate. This should be managed by NHS
Trusts and the Clinical Commissioning Group on an individual patient basis and with regard to
appropriate commissioning arrangements.
Second version: July 2014
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