AREA DRUG AND THERAPEUTICS COMMITTEE
GUIDANCE NOTES FOR COMPLETION OF
SMC NOT RECOMMENDED SUBMISSION FORM
This form is for use for request to use a medicine within NHS Fife where the SMC has not
recommended its use.
You may find it helpful to contact Ishtiaq Mohammed, Principal Pharmacist Clinical Effectiveness
Tel: 01592 226915 e-mail: email@example.com before starting the application process.
COMPLETING THE SUBMISSION FORM
The form can should preferably be completed electronically or can be done by hand.
All sections of the form MUST be completed.
Where you do not have the relevant data please explain why in that section.
SECTION A DRUG OVERVIEW
Copies of the Summary of Product Characteristics and SMC Recommendation MUST be
submitted. You may also add any additional information not included in the SPC that may be
SECTION B CLINICAL JUSTIFICATION
This section defines where this drug fits into therapy and estimates of the number of people in Fife
who might receive this drug.
A summary of the advantages and disadvantages of the drug and substitution for current therapy
should be identified here.
Service implications besides drug cost are required - this may be laboratory tests, staffing (medical,
nursing, pharmacy), or equipment.
SECTION C IMPACT ON PRIMARY CARE
This section deals specifically with any impact on Primary Care. It will allow the committee to
assess whether or not a Shared Care Protocol is required.
SECTION D FINANCIAL IMPACT
This section will allow the committee to assess the net cost of the drug therapy and additional
service costs. Please base any costs/savings on the information given in section B.
SECTION E OTHER COMMENTS
Any other information not requested that you feel is relevant to the decision making process.
SECTION F SUPPORTING CLINICIAN
Please include the names of all the supporting clinicians, but only one signature is required.
SECTION G DECLARATION OF INTERESTS
Please include a declaration of interests. Guidance is included at the end of the submission form.
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AREA DRUG AND THERAPEUTICS COMMITTEE
Request to use a medicine Not Recommended by Scottish Medicines Consortium
This form should be completed by a Consultant or Group of Consultants or General Practitioner.
Once completed the form and copies of supporting literature should be forwarded to:
Ishtiaq Mohammed, Principal Pharmacist Clinical Effectiveness, Cameron House, Cameron
Bridge, KY8 5RG e-mail: firstname.lastname@example.org
Information on requested drug
Indications applied for and
summary of SMC
NB (1) Indications must be included on the Summary of Product Characteristics (SPC).
(2) Drugs accepted for use are approved for 12 months initially but their usage will be
ADTC Use Only:
Approved for Use: YES / NO Date of Approval:
a) General Use
b) Hospital Only
Referred to MRG YES / NO Date……………….
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Submission for Use of SMC Not Recommended Medicine
A. Drug overview
Information supplementary to SPC e.g. routine dosage regime, important differences from other
B. Clinical Justification
Define the indication for use and criteria for patient selection.
Define the place of this medicine in relation to existing therapy.
What are advantages in comparison to other medicines within therapeutic class?
What are disadvantages in comparison to other medicines within therapeutic class?
Define how clinical efficacy will be evaluated including timescales.
Estimate of total number of patients in Fife with condition for which this medicine will be prescribed
and specify source of estimate.
Are there any implications for service provision associated with use of this medicine?
E.g. need for specialist assessment, laboratory tests, medicine administration.
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C Impact on Primary Care
Should prescribing of this product be restricted to secondary care?
Should treatment be initiated by a specialist and continued in primary care under a shared care
D Financial Data (Drug/Service Costs)
Estimated cost per day (range and average)
Anticipated duration of therapy (range and average if appropriate)
Estimated annual cost based on number of patients specified in B.
Estimated reduction or increase in annual cost of alternative Formulary agents based on number of
patients specified in B.
Estimated costs arising from additional service provision specified in B.
Summary of costs New Therapy Displaced Therapy Net budget impact
Cost/day Annual Cost Cost/day Annual Cost Total cost (+) or
Total saving (-)
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E Additional comments in support of application
F Name(s) of supporting clinician(s)
Signature (one is sufficient): __________________________________________
G Declaration of Interests
See attached sheet for guidance. Information in this section will only be made available to
members of Fife Area Drug and Therapeutics Committee.
G1. Current Personal Interests (e.g. shareholding, consultancy fees, salary, grants)
G2. Non-Personal Interests (which have arisen during the last 12 months)
Nature of Interest
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AREA DRUG AND THERAPEUTICS COMMITTEE - DECLARATION OF INTERESTS
The Fife Area Drug and Therapeutics Committee operates a policy of requiring members to declare
any interests relevant to the matters under consideration at its meetings.
This paper aims to provide a guide to different kinds of interests which should be declared.
DIFFERENT TYPES OF INTEREST
A personal interest involves payment to a clinician personally.
The main examples are:-
Consultancies: any consultancy, directorship, position in or work for the pharmaceutical
industry which attracts regular or occasional payments in cash or kind.
Fee-paid Work: any work commissioned by the pharmaceutical industry for which the clinician
is paid in cash or kind.
Shareholdings: any shareholding in or other beneficial interest in shares of the pharmaceutical
industry. This does not include shareholdings through unit trusts or similar arrangements
where the clinician has no influence on financial management.
A non-personal interest involves payment which benefits a department for which a clinician is
reasonable, but is not received by the clinician personally.
The main examples are:-
Fellowships: the holding of a fellowship endowed by the pharmaceutical industry.
Support by the Pharmaceutical Industry: any payment, other support or sponsorship by the
pharmaceutical industry which does not covey any pecuniary or material benefit to a clinician
personally but which does benefit his/her position or department.
i) A grant from a company for the running of a unit or department for which a clinician is
ii) A grant or fellowship or other payment to sponsor a post or a member of staff in the
unit for which a clinician is responsible. (this does not include financial assistance for
iii) The commissioning of research or other work by, or advice from, staff who work in a
unit for which the clinician is responsible.
Clinicians are under no obligation to seek out knowledge of work done for or on behalf of the pharmaceutical
industry within departments for which they are responsible if they would not normally expect to be informed.
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