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Processes for the Managed Entry and Use of Medicines in NHS Highland

NHS Highland

Warning – Document uncontrolled when printed

Policy Reference: id1274 Date of Issue: March 2011Prepared by: Consultant in Pharmaceutical Public Health

Date of Review: March 2013

Lead Reviewer: Consultant in Pharmaceutical Public Health

Version: 1

Authorised by: Chairman – NHS Highland Area Drug and Therapeutics Committee

Date: 31 March 2011

Distribution Chief Executive Highland Area Drug and Therapeutics Committee Highland Area Drug and Therapeutics Committee General managers

Consultant Physicians and Surgeons

General Practitioners Clinical pharmacists CHP Lead Pharmacists

MethodCD Rom E-mail Paper Intranet

Warning – Document uncontrolled when printedPolicy Reference: id1274 Date of Issue: March 2011Prepared by: Consultant in Pharmaceutical Public Health Date of Review: March 2013Lead Reviewer: Consultant in Pharmaceutical Public Health Version: 1Authorised by: Chairman – NHS Highland Area Drug and Therapeutics Committee

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Across NHSBoards

OrganisationWide

Directorate Clinical Service Sub DepartmentArea

YESThis controlled document shall not be copied in part or whole without the express permission of the author or the author’s representative.

Author: Consultant in Pharmaceutical Public HealthSubject GuidanceKey word(s): Guidance, SMC, unlicensed, non-formulary, off-licence, Scottish

Medicines Consortium, medicines

Policy application:

NHS Highland

Purpose: NHS Highland recognises that there will be times when prescribers may wish to prescribe a medicine that either has not been licensed, is awaiting SMC advice, SMC has advised should not be used in NHSS, or is contrary to NHS Highland’s policy. The processes and associated guidance in this document describe NHS Highland’s policies for the prescribing of medicines in such circumstances

Responsibilities for implementation:

Organisational: Chief ExecutiveCorporate: Highland Area Drug and Therapeutics CommitteeDepartmental: Heads of serviceHospital/Interface services:

General managers

Operational Management Unit:

Consultant physicians and surgeons, General Practitioners, Clinical pharmacists

Policy statement: The implementation of national advice from the SMC and, in some circumstances the National Institute for Clinical Excellence (NICE), where ratified by Quality Improvement Scotland, is dealt with through the Formulary Subgroup of NHS Highland Area Drug and Therapeutics Committee. Local processes of decision making are in place to provide NHS Highland with the relevant guidance and policies to support clinicians’ prescribing decisions and to manage the use of medicines in Highland

Review: This policy will be reviewed at least every two years or sooner if current recommendations change.


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This policy is also available in large print and on computer disk, audiotape and different languages. Other formats can be supplied on request from the Pharmacy

Medicines Information Department (01463 704288 or Communication Team (01463 704775)

It is also available on the internet at http://www.nhshighland.scot.nhs.uk/Publications/Pages/ManagedEntryandUseofMedi

cines.aspx and NHS Highland Intranet

Responsible for review of this document:

Consultant in Pharmaceutical Public Health

Responsible for ensuring registration of this document on the NHS Highland Policy Library

Policies, procedures and Guidelines Subgroup of ADTC

Physical location of the original of this document:

Medicines Information Department, Raigmore Hospital

Job/group title of those who have control over this document:

Highland Area Drug and Therapeutics Committee

Responsible for disseminating document as per distribution list:

Highland Area Drug and Therapeutics Committee

Revision History:

Date of change

Approval date of guidance that is being superseded

Summary of Changes (Descriptive summary of the changes made)

Changes Marked*(Identify page numbers and section heading )


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With thanks to NHS Grampian for collaborative work.

Processes for the Managed Entry and Use of Medicines in NHS Highland

Approved by: Highland Area Drug and Therapeutics Committee

Review Date: March 2013

Review Group: Highland Area Drug and Therapeutics Committee


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CONTENTS

1. Background.......................................................................................................8

1.1 Purpose and scope of this guidance.............................................................8

2. Key points in the medicine processes..........................................................9

3. Local advisory structures............................................................................11

4. Prescribing of non-formulary licensed medicines.....................................11

4.1 Initiation of non-formulary licensed medicines.............................................12

5. Prescribing of unlicensed and off-licence medicines...............................13

5.1 Liability for unlicensed medicines or licensed medicines prescribed outside of their marketing authorisation.............................................................................13

5.2 Criteria to support prescribers deciding to use an unlicensed medicine or a licensed medicine prescribed outside the marketing authorisation........................14

5.3 Non-medical prescribers..............................................................................14

5.4 Specials.......................................................................................................15

5.5 Authorisation to prescribe an unlicensed or off-licence medicine for an individual patient in hospital...................................................................................15

5.6 Exemptions from completing Form B for off-licence use for individual patients..................................................................................................................16

5.7 Continuation of previously authorised unlicensed or off-licence treatment..17

5.8 Requests for the use of unlicensed medicines in primary care...................17

5.9 Requests to prescribe a licensed medicine off-licence or an unlicensed medicine for a group of patients............................................................................18

5.9.1 Formulary Subgroup process for assessing unlicensed and off-licence medicines..............................................................................................................18

5.9.2 Inclusion in Highland Formulary...............................................................19

5.10 Requests for use of an unlicensed medicine as part of a clinical trial. Where an unlicensed medicine is used as part of a clinical trial the current clinical trial policy applies..................................................................................................19


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5.11 Requests to use medicines via manufacturer supported open access schemes................................................................................................................20

5.12 Requests to use medicines via manufacturer supported market access schemes................................................................................................................21

6. Requests to prescribe licensed medicines for Individual Patient Treatment contrary to agreed local NHS Highland policies.................................21

6.1 Requests to prescribe licensed medicines which the SMC or NHSHIS have recommended should not be used in NHSS..........................................................22

6.2 Requests to prescribe licensed medicines which are awaiting SMC guidance, where there is a delay in SMC advice or SMC rejection based on non/incomplete submission by the manufacturer..................................................23

7. Monitoring of adherence to this guidance in NHSH..................................24

8. Identifying and sharing good practice........................................................25

GLOSSARY...............................................................................................................26

APPENDIX 1.............................................................................................................27

THE REGULATORY PROCESS...........................................................................27

APPENDIX 2.............................................................................................................29

GUIDE TO THE LICENSING AND ASSESSMENT OF MEDICINES IN THE UK. 29

APPENDIX 3.............................................................................................................30

Summary of request forms and their uses in relation to this guidance..................30

REQUEST FOR MEDICINES SUPPLY FORM A..................................................31

REQUEST FOR MEDICINES SUPPLY FORM B..................................................33

INDIVIDUAL PATIENT TREATMENT REQUEST (IPTR) FOR MEDICINES SUPPLY FORM C.................................................................................................37

APPENDIX 4.............................................................................................................41

GUIDE TO WHICH FORM SHOULD BE USED FOR REQUESTING MEDICINES FOR INDIVIDUAL PATIENTS USING FORMS A, B and C...................................41


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APPENDIX 5.............................................................................................................42

PRESCRIBING PATHWAYS.................................................................................42

APPENDIX 6.............................................................................................................43

Guidance for Individual Patient Treatment Requests using Form C......................43

APPENDIX 7.............................................................................................................50

Decision making framework to be used when considering requests for individual patient use of unlicensed medicines, off-licence medicines and medicines turned down for use in Scotland by SMC/NHSHIS (Forms B and C)................................50


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1. Background

The safety, effectiveness and cost-effectiveness of medicines are controlled by regulatory processes for licensing at national and international levels and by advisory processes in the UK and in NHS Scotland (Appendices 1 and 2).

1.1 Purpose and scope of this guidanceThe majority of prescribing in NHS Highland is in accordance with the Highland Formulary. However NHS Highland recognises that there will be times when prescribers may wish to prescribe a medicine that either:

has not been licensed, is to be used in clinical circumstances outside of the manufacturer’s

license, is licensed but is awaiting Scottish Medicines Consortium (SMC) advice, is the subject of SMC / NHS Healthcare Improvement Scotland

(NHSHIS) advice which does not recommend use in NHS Scotland, is contrary to NHS Highland’s local policy e.g. is accepted by SMC but

FS decision is not to include in Highland Formulary since suitable alternatives are available.

The processes and associated guidance in this document describe NHS Highland’s policies for the prescribing of medicines in all such circumstances, specifically prescribing of:

formulary medicines licensed non-formulary medicines unlicensed medicines licensed medicines prescribed outside of their marketing authorisation

(off-licence medicines) medicines which the SMC or NHSHIS have recommended should not be

used in NHSS medicines for individual patients with significantly different clinical

circumstances contrary to agreed local NHS Highland policies medicines which are awaiting SMC or NHSHIS guidance

NHS Highland makes a distinction between requests to prescribe for groups of patients which normally require a submission to the FS and individual patient treatment requests (IPTRs) for single patients where a number of different routes are available dependant on the circumstances of the request.


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2. Key points in the medicine processes

Key Points Wherever possible and clinically appropriate, all prescribers in NHS Highland

are expected to prescribe within the Highland Formulary. Requests can be made to add a non-Formulary medicine to the Highland

Formulary, particularly where it is envisaged either that its level of use will merit this, or that its use will have significant financial implications (Ref.1)

Where a hospital prescriber considers that there is no alternative but to use a licensed medicine that is not on the Formulary, they should assess its clinical and cost effectiveness, seeking medical and pharmaceutical advice (Ref.2).

Where the annual (or course of therapy) cost per patient exceeds £10,000 the hospital prescriber is required to discuss the budgetary implications with senior Pharmacy staff and with clinical service management prior to completion of Form A (Ref.3).

Where a primary care prescriber or out-patient prescriber considers that there is no alternative but to use an unlicensed medicine that is not on the Formulary, they should assess its clinical and cost effectiveness, seeking medical and pharmaceutical advice (Ref.4).

The licensing of medicines is covered by Parts One and Two of the Medicines Act 1968, as amended. The regulatory process for licensing and assessment of medicines in the UK is summarised in Appendices 1 and 2 of this document (Refs 5 and 6).

Prescribers and dispensers of unlicensed medicines, or medicines prescribed out with their marketing authorisation (‘off-licence’), have a personal liability for their prescription and supply that cannot be transferred to the manufacturer or importer of the medicine. Where such use has been authorised and agreed by NHS Highland, the Highland NHS Board carries a liability for the actions of its, employees, provided that local policies and procedures are adhered to (Section 5.1).

Where a licensed medicine is available, it should be prescribed in preference to any unlicensed equivalent according to the MHRA Risk Hierarchy (Section 5.2).

Nurse and Pharmacist Independent Prescribers must take full clinical and professional responsibility for their prescribing and should only prescribe ‘off-licence’ or unlicensed medicines where it is best practice to do so (Section 5.3).

Where a request is made to use an unlicensed or off-licence medicine in a single patient, as opposed to a group of patients or the first of a group of patients, Form B should be used to request authorisation to prescribe such medicines within the hospital service (Ref.7).

Local protocols should be in place to support any off-licence use in specialties and wards which are currently exempted from using Form B due to the volume of off-licence prescribing undertaken.


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http://www.nhshighland.scot.nhs.uk/Publications/Documents/Policies/Managed%20Entry%20and%20Use%20of%20Medicines/Request%20for%20Medicines%20Supply%20Form%20B.doc


http://www.nhshighland.scot.nhs.uk/Publications/Documents/Policies/Managed%20Entry%20and%20Use%20of%20Medicines/Request%20for%20Medicines%20Supply%20Form%20A.doc

Where a hospital prescriber wishes to hand over the prescription of an unlicensed medicine to a primary care prescriber, there must be agreement to do so and clear arrangements regarding specific responsibilities.

Local protocols should be in place for the use of a licensed medicine off-licence or an unlicensed medicine for a group of patients. Requests to add an unlicensed medicine (for a group of patients) to the Formulary should be made using Form B (Ref.7).

Where an unlicensed medicine is used as part of a clinical trial, the current trial policy applies.

Where SMC advises that a medicine should be made available as part of a patient access scheme, the process of local decision making as to whether that medicine is made available on the Formulary is the same as for all other SMC advice.

An Individual Patient Treatment Request (IPTR) can only be made where the clinician responsible for the patient fully supports the request and is in agreement with the patient as to the most appropriate course of clinical treatment.

Requests to prescribe in significantly different clinical circumstances those licensed medicines which the SMC or NHSHIS have recommended should not be used in NHSS should be made using Form C (Ref.8), according to the IPTR Policy in Appendix 6 (Ref.9). The same applies to requests to prescribe licensed medicines which are awaiting SMC guidance, where there is a delay in SMC advice or SMC rejection based on non/incomplete submission by the manufacturer.

References1. NHSH Flowchart: Process for addition of medicines to the Highland Formulary 2. NHSH Policy: Supply of non-Formulary medicines for hospital in-patients 3. NHSH Form A: Non-Formulary medicine request form (initiation or

continuation in hospital)4. NHSH Flowchart: Non-Formulary medicine use in primary care and out-patient

settings5. Appendix 1: The Regulatory Process 6. Appendix 2: Guide to the Licensing and Assessment of Medicines in the UK 7. NHSH Form B: Request for use of an unlicensed medicine or off-licence use

of a medicine for a group of patients.8. NHSH Form C: Individual Patient Treatment Request (IPTR) For Medicines

Supply.9. Appendix 6: Guidance for Individual Patient Treatment Requests using Form

C.

3. Local advisory structures


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http://www.nhshighland.scot.nhs.uk/Publications/Documents/Policies/Managed%20Entry%20and%20Use%20of%20Medicines/Individual%20Patient%20Treatment%20Request%20(IPTR)%20for%20Medicines%20Supply%20Form%20C.doc




http://www.nhshighland.scot.nhs.uk/Publications/Documents/Policies/Managed%20Entry%20and%20Use%20of%20Medicines/Primary%20care%20and%20outpatient%20flowchart%20of%20non-Formulary%20medicine%20supply%20process.pdf




http://www.nhshighland.scot.nhs.uk/Publications/Documents/Policies/Managed%20Entry%20and%20Use%20of%20Medicines/Hospital%20request%20form%20for%20non-Formulary%20medicine%20supply.pdf

http://www.nhshighland.scot.nhs.uk/Publications/Documents/Guidelines/Highland%20Formulary.pdf#page=11



The Formulary Subgroup of NHS Highland ADTC (FS) considers the national advice from the SMC and, in some circumstances the Multiple Technology Assessments (MTAs) developed by the National Institute for Health and Clinical Excellence (NICE), where ratified by NHSHIS.

The overarching aim of FS is to develop and manage a Highland Formulary which is evidence based, takes account of both clinical and cost effectiveness and reflects local priorities, population needs and local affordability. The FS takes a population perspective and only considers requests to use medicines in groups of patients. It produces the Highland Formulary.

The FS reviews all SMC advice on publication to assess the place of SMC recommended medicines in the Highland Formulary. On receipt of SMC advice the FS approaches appropriate local clinicians and pharmacists to help assess the local clinical need for the new medicine in the context of other available medicines. Where local clinical opinion is that the new medicine has a place in local care a submission is made to the FS to have the medicine added to the Highland Formulary.

There are also occasions where national advice from SMC or from NICE is not available, e.g. consideration of using medicines that were licensed prior to SMC being established. In these instances local clinicians may request addition of such medicines to the Highland Formulary.

In some circumstances the FS puts in place specific plans for the hospital introduction of medicines accepted for inclusion into the Highland Formulary. These may include restrictions relating to financial, administrative or clinical criteria. Members of any of the panels or committees involved in local decision-making are expected to declare any interests which could have an impact on impartiality in decision-making.

4. Prescribing of non-formulary licensed medicines

Prescribers are expected to prescribe within the Highland Formulary whenever clinically appropriate

It is recognised that no formulary can cover one hundred percent of prescribing but whenever possible and clinically appropriate prescribers in NHS Highland are expected to prescribe within the Highland Formulary. Where a prescriber believes that a non formulary medicine should be considered for addition to the HF they may request such addition following the flowchart “Process for the addition of medicines to the Highland Formulary” and completing the appropriate forms (‘Medicines Assessed by SMC – Request Form or ‘Medicines Not Assessed by SMC – Request Form’).


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http://www.nhshighland.scot.nhs.uk/Publications/Documents/Policies/Managed%20Entry%20and%20Use%20of%20Medicines/Medicines_not_assessed_by_SMC_-_Request_Form.doc

http://www.nhshighland.scot.nhs.uk/Publications/Documents/Policies/Managed%20Entry%20and%20Use%20of%20Medicines/Medicines_assessed_by_SMC_-_Request_form.doc




4.1 Initiation of non-formulary licensed medicines

Where there is no alternative but to use a non-formulary medicine the prescriber should refer to the flowchart ‘Supply of non-Formulary medicines for hospital in-patients’ and associated ‘Non-Formulary medicine request form (initiation and continuation in hospital)’ and in primary care follow the flowchart ‘Non-Formulary medicine use in primary care and outpatient settings’.

It is recognised that there will be occasional circumstances where a prescriber considers that there is no alternative but to use a licensed medicine that is not on the formulary and where that medicine has not been turned down by SMC / NHSHIS or is awaiting assessment by SMC.

On these occasions it is essential that the prescriber considers the clinical and cost effectiveness of such use and where appropriate seeks advice from appropriate medical and pharmacy colleagues, taking note of any previous FS advice.

Requests for the initiation or continuation of non-Formulary medicines in individual patients in hospitals follow the flowchart ‘Supply of non-Formulary medicines for hospital in-patients’ and associated ‘Non-Formulary medicine request form (initiation and continuation in hospital)’ and in primary care follow the flowchart ‘Non-Formulary medicine use in primary care and outpatient settings’.

Where such non formulary licensed medicines are over £10,000 per annum per patient there should be discussion within the service with pharmacy and service management as to the budgetary implications of such use prior to completion of Form A.

For patients who reside in other health boards, agreement should be sought from a nominated individual in the home board before treatment begins, unless it is considered that the delay to treatment will adversely affect the clinical outcome. This applies to all medicines where the cost of the course of treatment will be greater than £1000 and is irrespective of the medicine’s licensed, formulary or SMC status.Systems are currently in place for the retrospective quarterly provision of NHS Highland reports on hospital non-Formulary medicines issues data and primary care non-Formulary prescribing data.

Where use of a non formulary licensed medicine is likely to have significant financial implications or take place more than on rare occasions prescribers will be requested to make a Formulary submission to have the medicine assessed locally by the FS for addition to the Highland Formulary.


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5. Prescribing of unlicensed and off-licence medicines

The licensing of medicines is covered by Parts One and Two of the Medicines Act 1968, as amended and detailed previously in Appendices 1 and 2.

Additional requirements are enshrined in European Law. A medicine holding a full marketing authorisation will do so after a full evaluation by the MHRA or EMEA of all data required for the medicine. The marketing authorisation holder is required to ensure that full product information is supplied to both the prescriber and dispenser of the product. The marketing authorisation confers liability upon the Holder for the medicine in use when the terms of the licence are complied with.

The majority of medicines prescribed within NHS Highland are covered by marketing authorisations and the manufacturer is held liable for any harm caused where the cause can be solely attributed to a defect in the medicine, and it can be proved that the product was prescribed and used in accordance with the terms of the marketing authorisation.

5.1 Liability for unlicensed medicines or licensed medicines prescribed outside of their marketing authorisation.

Prescribers and dispensers of unlicensed medicines, or medicines prescribed out with their marketing authorisation (off-licence), have a personal liability for their prescription and supply that cannot be transferred to the manufacturer or importer of the medicine.

NHS Highland carries a liability for the actions of its employees and may accept liability for the prescription of unlicensed medicines, or medicines prescribed out with their marketing authorisation (off-licence), where such use has been authorised and agreed, provided that local policies and procedures are adhered to.

Where it is intended that such prescribing of an unlicensed medicine or off-licence medicine will be continued after patient discharge from hospital, clear arrangements require to be agreed between primary and secondary care regarding clinical and prescribing responsibilities, using appropriate processes such as shared care arrangements. Prescribers are referred to section 5.8. There may be some occasions where retention of prescribing responsibility within secondary care may be the only option.


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5.2Criteria to support prescribers deciding to use an unlicensed medicine or a licensed medicine prescribed outside the marketing authorisation.

Where a licensed medicine is available, it should be prescribed in preference to any unlicensed equivalent alternative according to the MHRA Risk Hierarchy below.

The following criteria should be applied prior to the decision to prescribe, or requesting authorisation to prescribe, a medicine that is not licensed, or is for use off-licence.

1. There is no suitable licensed alternative.2. The risk-benefit assessment for the patient is in favour of prescription of the

unlicensed medicine.3. There is an acceptable clinical and economic evidence base to support use.4. Prescribing is supported by multi-professional opinion.5. The patient/carer has been fully informed and has consented or will consent to use

of the medicine.

5.3 Non-medical prescribers

Nurse and Pharmacist Independent Prescribers must take full clinical and professional responsibility for their prescribing and should only prescribe ‘off-licence’ or unlicensed medicines where it is best practice to do so.

Nurse and Pharmacist Independent Prescribers can prescribe unlicensed medicines for their patients, on the same basis as doctors and provided that they are competent and take responsibility for doing so.Nurse and Pharmacist Independent Prescribers must take full clinical and professional responsibility for their prescribing and should only prescribe ‘off-licence’ or unlicensed medicines where it is best practice to do so. Unlicensed medication


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can be prescribed by a supplementary prescriber but only as part of a patient specific clinical management plan for patients who have first been clinically assessed by an independent prescriber.

5.4 Specials

In NHSH, policies for the use of unlicensed medicines exclude medicines manufactured by the Specials Suppliers. Prescribers and dispensers of medicines obtained as “specials”, have a personal liability for their prescription and supply that cannot be transferred to the manufacturer or importer of the medicine. Due consideration should be given to use of alternative licensed products (licensed in either in the UK or aboard) or products used “off-licence” before a “special” medicine is prescribed.

5.5 Authorisation to prescribe an unlicensed or off-licence medicine for an individual patient in hospital

Where a request is made to use an unlicensed or off-licence medicine in a single patient, as opposed to a group of patients or the first of a group of patients, Form B should be used to request authorisation to prescribe such medicines within the hospital service. It is particularly important to assess whether the medicine offers an acceptable balance of clinical benefit and risk of medicine related harm.

Prescribers should consider carefully whether the request is truly for a single patient or whether in fact the patient is the first of a group of patients likely to require treatment with the unlicensed or off-licence medicine in which case a Formulary application should be completed – see 5.9. (‘Medicines Assessed by SMC – Request Form or ‘Medicines Not Assessed by SMC – Request Form’).

Requests for use of an unlicensed or off-licence medicine for a single patient using Form B will be considered by a group from within the service consisting of the requesting clinician, Specialist Pharmacist, Divisional Manager and the Lead Clinician for the speciality / unit. Decision making by the in-service panel uses the framework for IPTRs provided in Appendix 7. For unlicensed medicines, it is particularly important for the decision making panel to assess whether the medicine offers an acceptable balance of clinical benefit and risk of medicine related harm. The panel must also consider the budget impact on the service of using the medicine. The panel may authorise use where members consider the benefit / risk of use to be acceptable, the total cost of use for the individual patient does not exceed £10,000 per annum and the funding of such use is affordable within the service. Where anticipated use of the medicine will incur an individual patient treatment cost of £10,000 per annum or more, authorisation will be needed via the board based panel.


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Where a request is approved, agreement should be made with the treating clinician and patient as to how success of individual treatment will be defined in terms of clinical outcomes and timescales. These outcomes will be a written part of the authorisation and should explicitly define when the treatment with the medicine will cease.

Once completed and signed, one copy of Form B will be added to the patient notes, one copy will be retained by the requesting clinician and the original will be stored in the Procurement Department, Pharmacy at Raigmore Hospital.

Form B is NOT required when a licensed medicine is administered in a different route / way to which it was intended, e.g. injection given orally or tablet/capsules crushed or dispersed in a liquid to administer via a naso-gastric tube for the licensed indication, and this is in accordance with recognised good clinical practice. Advice should be sought from Medicines Information Department (01463 704288) on suitability and stability of the specific medication to be used. When administration via a different route is to be used in more than one patient there should be a local peer reviewed protocol in place.

5.6 Exemptions from completing Form B for off-licence use for individual patients

Local protocols should be in place to support any off-licence use in specialities and wards which are currently exempted from using Form B due to the volume of off-licence prescribing undertaken

Formulary submissions will be required in due course for unlicensed medicines

The Paediatric service, Neo-natal Unit, Theatres, Intensive Care Unit and High Dependency Unit are currently exempted from making individual patient requests to use licensed medicines off-licence, using Form B, due to the high levels of use of medication off-licence. However, there must be local protocols in place to support any off-licence use.

A number of other areas and specialities have been identified as having a high proportion of off-licence usage. Mental Health Services, ophthalmology, dermatology, acute pain team and palliative care have time-limited exemptions due to the volume of off-licence prescribing undertaken in these areas. Clinicians in these areas are requested to develop protocols and guidelines to support off-licence use. There is an expectation that these exemptions will continue through 2011 but that these areas and specialities should have completed their development of local protocols by April 2012.


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Where these areas are currently using unlicensed medicines they will be required to make a Formulary submission for their inclusion in the NHS Highland Unlicensed Medicines List as detailed in 5.9.

5.7Continuation of previously authorised unlicensed or off-licence treatment

It is accepted that patients will be transferred between units within hospital and continuation of previously authorised unlicensed or off-licence treatment will be required. In these circumstances Form B should be completed but an entry made to detail the originating ward and the form should be signed by the clinician or pharmacist. It is good practice to ensure that a review date for review of the unlicensed or off-licence treatment is included in the notes. Reference to the authorisation using Form B should be included in the patient notes.

5.8 Requests for the use of unlicensed medicines in primary care

Where a hospital prescriber wishes to hand over the prescription of an unlicensed medicine to a primary care prescriber there must be agreement to do so and clear arrangements regarding specific responsibilities

Medicines are frequently used off-licence in all specialities in hospital and there are a large number of unlicensed medicines also in common usage. The dosage, side-effects, monitoring etc of these drugs for each indication will be well known to hospital staff and be documented in the patients’ notes. However, the primary care team may not be familiar with the use of the medicine at all or not in the setting in which it is being used. Unless adequate information is supplied to the primary care team errors in dosing, response assessment etc can be made, particularly where drugs are used off-licence as, although information will be readily available from sources such as the BNF it may not be applicable to the current setting.

Where it is intended that either unlicensed or off-licence treatment will be continued after patient discharge, clear arrangements MUST be agreed between primary and secondary care regarding clinical, prescribing and dispensing responsibilities using appropriate processes such as shared care arrangements. There may be some occasions where retention of prescribing responsibility within secondary care may be considered as an option.

A decision on final responsibility should depend primarily on the best interests of the patient in terms of safety and convenience. However, General Practitioners are at liberty to refuse to prescribe within primary care if they have not been given sufficient information to prescribe safely or that this is out with their level of expertise.


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Where initiation of treatment with an off-licence medicine / unlicensed medicine occurs in hospital, the consultant recommending the medicine is responsible for ensuring that appropriate information is provided to the GP and arrangements are made, in conjunction with the hospital pharmacy, for relevant information to be passed on to community pharmacists. This must include a delineation of responsibilities for monitoring, side effects, review and dose alteration between the initiating prescriber and the primary care prescriber who writes the prescription and thus is liable in law.

5.9 Requests to prescribe a licensed medicine off-licence or an unlicensed medicine for a group of patients

Local protocols should be in place for the use of unlicensed medicines

Requests to add an unlicensed medicine, for a group of patients, to the Formulary should be made using Form B.

Where off-licence use of a licensed medicine for a group of patients has developed historically or has a good evidence base, is limited to a single ward or speciality and does not exceed an individual patient treatment cost of £10,000 per annum, prescribers should develop a local ward based, peer reviewed protocol to provide guidance on when and how such off-licence use should take place.

Where a request needs to be made to use an unlicensed medicine for a group of patients, or for the first patient amongst a group of patients (existing or anticipated) or where off-licence use is likely to be needed in a group of patients and evidence is lacking, then prescribers should request such use through an application to the FS using Form B on NHS Highland Intranet. Such applications should be supported by appropriate evidence and include any protocols or guidance to support such medicine usage. It is unlikely that such use cannot be anticipated and it is appropriate that such use is supported by advice from the FS.

5.9.1 Formulary Subgroup process for assessing unlicensed and off-licence medicines

The purpose of the FS in assessing requests on Form B to use unlicensed medicines in a group of patients or off-licence medication across a number of wards is to satisfy itself that the correct process has been undertaken for prescribing to expand beyond individual patients / a single ward.

The FS will assess requests to use unlicensed medicines in a group of patients or off-licence use across a number of wards on the basis of the following criteria:


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Has the requesting clinician / group of clinicians provided:

1. Appropriate evidence to support the requested use?2. A clear explanation as to why alternative licensed medicines or use of

medicines within their license will not be as effective as the medicine requested?

3. Adequate information as to the protocol or guidance that is available or will be developed and provided to support the use of the medicine requested?

4. Evidence as to the safety of the medicine (in the case of unlicensed medication in particular)

5. Evidence that the requested use for all potential need is affordable within the existing service budget.

The focus of the FS decision making will be whether the request satisfies these criteria i.e. it will be the requesting clinician’s responsibility to assess the clinical effectiveness, safety of the medicine or quality of the protocol or guideline or affordability, although FS may obviously raise any concerns it may have regarding the clinician’s assessment of these with the requesting clinician(s).

Subject to the request meeting these criteria the requested use will be recorded on the NHS Highland Unlicensed Medicines List on the Formulary webpage; i.e. the usage will not have full Highland Formulary status. Where off-licence or unlicensed medicine use has been recorded by the FS on the above approved list, or is within a local ward / speciality protocol, future use of medicines for the indications and patients defined within the local guidance or protocol is covered, i.e. once a protocol or guideline is in place for a specified use of the medicine, further authorisation for individual patient use is not required.

5.9.2 Inclusion in Highland Formulary

The addition of unlicensed and off-licence medicines to the Highland Formulary itself will not normally be considered; such use should be limited and, therefore by its nature, not for widespread or common use. If clinicians wish the off-licence use to be included in the Highland Formulary document this should be discussed with the Formulary Pharmacist. A clinician wanting an unlicensed medicine included in the Highland Formulary should follow the existing process for the Formulary inclusion of products not assessed by SMC – see process and Highland Formulary request form for medicines not assessed by SMC. If accepted by FS, the Highland Formulary will then include a link to the above approved list on the Formulary webpage.

Requests for use of unlicensed medicines for a group of patients should not be seen as a mechanism to pre-empt SMC advice.


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http://www.nhshighland.scot.nhs.uk/Publications/Documents/Guidelines/Highland%20Formulary.pdf

5.10 Requests for use of an unlicensed medicine as part of a clinical trial. Where an unlicensed medicine is used as part of a clinical trial the current clinical trial policy applies

The patient must be advised of the exit strategy

Where the unlicensed use is part of a clinical trial the existing processes to authorise this use are applied. Prescribers are reminded of their responsibilities to advise the patient as to the exit strategy at the end of such trials and explain their impact on the individual patient. In particular, patients should be advised that unless specific arrangements have been made, at the end of the trial there is no ongoing commitment from NHS Highland to provide the medicine made available through the trial, regardless of individual response to treatment; i.e. their unlicensed medicine provided during the trial will stop at the end of the trial. Patients need to be advised of how their treatment will be handled at the end of the trial as part of their recruitment to such studies. Prescribers, lead clinicians / investigators and service managers are reminded that where pharmaceutical companies offer extensions to open-label / open access arrangements the funding may not necessarily fully cover the costs of these medicines or treatment of side effects between licensing, the SMC guidance being issued and a decision being made whether or not to use the medicine in NHS Highland.

5.11 Requests to use medicines via manufacturer supported open access schemes

NHS Highland has in the past supported the use of open access schemes as part of prospective planning to provide exit strategies for clinical trials. Under these arrangements NHS Highland has accepted manufacturer funded medicines for patients who have been part of a clinical trial which has ended and for which the medicine has either not yet been licensed or has been turned down by SMC. The important proviso in these arrangements is that funding continues for the length of time that the patient requires the medicine or the time at which that medicine becomes recommended for use by the SMC or NHSHIS, whichever is the sooner. As this use is for a group of patients prescribers are required to make a FS submission. Prescribers are reminded that consideration should be given to all costs associated with treatment, e.g. acquisition costs, monitoring costs and any costs associated with managing adverse events.

More recently such schemes have been offered to non clinical trial patients prior to licensing of the medicine or between licensing and assessment by the SMC. The NHS Highland policy in these situations is not to support these open access arrangements, the exception being, those specific situations where in the clinician’s clinical judgement the patient’s condition will significantly deteriorate without access to treatment.


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Where no alternatives exist, and the medicine is unlicensed, prescribers may use the Form B authorisation route for individual patients or make a FS submission for treatment of a group of patients.

N.B. Where the open access scheme is for a licensed medicine awaiting SMC assessment NHS Highland policy is not to use the medicine unless the manufacturer is supporting all treatment costs up to the time when an approval decision is made by SMC, i.e. acquisition costs, monitoring costs and any costs associated with managing adverse events. If a situation arose where SMC advised that the medicine should not be used in NHS Scotland the manufacturer would be expected to support the ongoing costs until the treatment was no longer clinically appropriate. This must be agreed at the beginning of treatment.

5.12 Requests to use medicines via manufacturer supported market access schemes

Where SMC advises that a medicine should be made available as part of a patient access scheme the process of local decision making as to whether that medicine is made available on the local formulary is the same as for all other SMC advice.

The pharmaceutical industry has begun to explore the use of novel pricing strategies in order to facilitate market access to some high cost new licensed medicines. In general, these schemes have been proposed for medicines with a high acquisition cost in situations where the cost-effectiveness ratio submitted by the company has been greater than that normally considered acceptable by SMC. Companies have stated that they are unable to reduce the acquisition price to NHS Scotland due to global pricing issues. The schemes are finance based and offer an alternative strategy allowing healthcare providers to access the treatment at a lower than ‘list’ price across all patients treated or for sub groups of patients e.g. those responding to treatment.

A national Patient Access Scheme Assessment Group (PASAG) has been set up in 2009 to assess such schemes and advise SMC as part of its assessment process. SMC advice for medicines for which a patient access scheme is available in Scotland now includes the access scheme in its advice to NHS Boards.

Where SMC advises that a medicine should be made available as part of a patient access scheme the process of local decision making as to whether that medicine is made available on the local formulary is the same as for all other SMC advice. Local decision making will be required to ensure that any required record keeping and subsequent claims for financial adjustment are undertaken.


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6. Requests to prescribe licensed medicines for Individual Patient Treatment contrary to agreed local NHS Highland policies

An Individual Patient Treatment Request (IPTR) can only be made where the clinician responsible for the patient fully supports the request and is in agreement with the patient as to the most appropriate course of clinical treatment.

There may be occasions where a prescriber feels that his/her patient will benefit from a licensed medicine that has been recommended not to be used in NHSH. The most common example will be for medicines either awaiting SMC guidance or for which the SMC has recommended should not be used in NHSS.

An Individual Patient Treatment Request (IPTR) can only be made where the clinician responsible for the patient fully supports the request and is in agreement with the patient as to the most appropriate course of clinical treatment. Where an IPTR is under consideration, the clinician making the request will provide the patient or their representative with the leaflet “New medicines in Scotland- who decides what the NHS can provide?” available at http://www.hris.org.uk/patient-information/information-about-health-services/new-medicines-in-scotland---who-decides-what-the-nhs-can-provide/

Decisions on such requests will be made by the ADTC or its subgroups on behalf of the Chief Executive.

6.1 Requests to prescribe licensed medicines which the SMC or NHSHIS have recommended should not be used in NHSS

In these circumstances an individual patient treatment request to use a licensed medicine in significantly different clinical circumstances should be made using Form C according to the Individual Patient Treatment Request Policy in Appendix 6.

Where SMC recommends that a licensed medicine is not used in NHSS, NHSH follows this guidance, i.e. such medicines should not be prescribed. However, there may be occasional circumstances where a prescriber believes that:

The patient’s clinical condition or characteristics are significantly different to the general population of patients for the NHS Highland policy is not to use the medicineand

The patient is likely to gain significantly more benefit from the intervention than might normally be expected from patients for whom NHS Highland policy is not to use the medicine

This includes situations where a prescriber wishes to use a medicine out with a restriction placed on recommended usage in Scotland.


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http://www.hris.org.uk/patient-information/information-about-health-services/new-medicines-in-scotland---who-decides-what-the-nhs-can-provide/



In these circumstances an individual patient treatment request to use a licensed medicine in significantly different clinical circumstances should be made using Form C according to the Individual Patient Treatment Request Policy (Appendix 6).

Decision-making takes place in two stages to answer the following:

1. Are significantly different clinical circumstances demonstrated?2. If significantly different clinical circumstances are demonstrated should the

request for treatment be supported and funded?

Only where requests to prescribe such medicines are deemed to meet criteria 1 above will the decision making panel move on to consider whether authorisation of the treatment should be provided. N.B. Meeting criteria 1 does not automatically result in authorisation to use the medicine.

Where a request is approved, the treating clinician should communicate with the patient as to how success of individual treatment will be defined in terms of clinical outcomes and timescales and when the treatment will cease. These outcomes will form a written part of the authorisation and should explicitly define when the treatment with the medicine will cease.

6.2 Requests to prescribe licensed medicines which are awaiting SMC guidance, where there is a delay in SMC advice or SMC rejection based on non/incomplete submission by the manufacturer.

In these circumstances an individual patient treatment request to use a licensed medicine in significantly different clinical circumstances should be made using Form C according to the Individual Patient Treatment Request Policy (Appendix 6).

NHSH policy is that medicines awaiting SMC guidance should not be used until such guidance has been published, the guidance discussed with local clinicians and the place of the medicine in local treatment decided through the FS. Where SMC accepts a medicine for use in NHSS the FS decides which of these drugs should join the Highland Formulary, with input from local clinicians.

SMC aims to provide its advice as close to licensing as possible. There are occasional delays to this, generally where the medicine manufacturer fails to submit a timeous application to the SMC. In addition there have been a number of occasions where medicine manufacturers have submitted incomplete or insufficient information for the SMC to base a decision on, often due to incomplete economic information. In these instances the SMC generally advises that the medicine is not recommended for use in NHSS and the company manufacturing the medicine makes a further submission. Where SMC advice is given NHS Highland policy will follow this advice not to use the medicine and the route for prescribers to use such medicines for individual patients is via the IPTR process (Appendix 6) using Form C.


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There are also instances when SMC delays its advice for a significant period so that a drug may be licensed for many months without accompanying SMC advice as to its use in NHS Scotland. Where such a delay occurs and there is no suitable licensed alternative available, approved by SMC or on the Highland Formulary, there may be circumstances where a clinician assesses that his or her patient would experience significant, material, irreversible deterioration or harm without using a newly licensed medicine for which the SMC has not provided advice. Where this is the case prescribers should use the IPTR process route using Form C.

The process of decision making is in two parts. The first assesses whether the request is significantly different. In this instance the significant difference relates to the case that Highland should put aside its general policy not to use a licensed medicine where SMC has yet to provide advice. In considering this significant difference the decision-making panel considers whether:

1) there is no other suitable licensed alternative, approved by SMC or on the Highland Formulary, for the indication the medicine is requested for

2) there is published, peer reviewed evidence of clinical effectiveness3) waiting for SMC to provide advice to NHS Scotland would lead to the patient

missing an opportunity for cure, long term remission (five years), a significant extension of life or avoidance of permanent disability. This would include situations where the medicine requested is a bridging treatment to other treatments that would provide these benefits and situations where the only alternative medicine would be associated with significant, permanent harm to the patient and the risk of that harm is high enough to preclude the alternative medicine as a treatment option.

If the criteria above are met then the Decision Making Panel will go on to decide whether use of the medicine for the individual patient offers acceptable cost effectiveness to NHS Highland.

Where SMC fails to provide advice for a period of more than six months and a clinician wishes to request use of a drug not yet assessed the FS will be asked to decide whether this route of access should continue for the medicine on an individual patient basis or whether a FS submission and decision is required.

7. Monitoring of adherence to this guidance in NHSH

In order to monitor adherence to this guidance in NHSH an annual report summarising use of medicines authorised through Forms A,B,C and D will be provided to the NHS Highland Area Drug and Therapeutics Committee.

To support adherence to this guidance use of particular medicines may be subject to additional recording and reporting to ensure that where particularly expensive medicines (based on either unit cost or on total cost) are authorised for use there is a clinical record assuring that use is in line with the clinical circumstances the medicine


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has been authorised for. This is of particular importance in situations where high cost licensed medicines are subject to requests for off-licence use or where SMC guidance restricts licensed use to particular patient sub groups.

Requirements for such additional recording and reporting may be made through the existing medicines management structures (Area Drug and Therapeutics Committee, FS, Policies, Procedures and Guidelines Subgroup or through operational unit Management).

8. Identifying and sharing good practice

NHS Highland works continually to identify and share good practice regarding arrangements for accessing new medicines. NHS Highland participates in the North of Scotland ADTC collaborative in which boards work together to share good practice and develop policies to promote consistency of approach. Collaboration also takes place with other boards and across other networks such as the Directors of Pharmacy to enhance learning and continually improve quality.


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GLOSSARY

Marketing Authorisation Previously medicines were described as having a “product licence”. Medicines are now more correctly described as having a marketing authorisation which defines the clinical conditions, routes of administration, dosages and precautions for which treatment has been approved.

Unlicensed Medicines and ‘Off-licence’ medicines Prescribing practice involves the use of unlicensed medicines, (products which have not been licensed for human medical use) and off-licence medicines (licensed medicines prescribed outside the terms of their marketing authorisation).

Specials A pharmaceutical special as defined is a medicine made to satisfy the needs of an individual patient. Specials are unlicensed products prepared by licensed manufacturing units. They have not been assessed for safety, quality and effectiveness by the licensing authority. They are used where a suitable formulation of a licensed product is unavailable.

Significantly Different Clinical CircumstancesThere is acceptable evidence that a patient’s clinical circumstances are significantly different in some way that would improve either the clinical or cost-effectiveness of a treatment to such an extent that a Board policy not to support / fund a particular treatment should not apply.


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APPENDIX 1

THE REGULATORY PROCESS

1.1 The regulatory process for licensing medicines available in the UK

In the UK, a pharmaceutical company who wishes to bring a medicine to the market has to apply for a marketing authorisation (license). The current relevant legislation for this approach is an area reserved to the UK Parliament.

For the purpose of this guidance, the term “licensing” will be used throughout this document to describe the granting of a marketing authorisation.

Before a medicine gets to the stage of licensing it will, typically, have undergone 12 years of research and development. Following the development and clinical trial stages, the pharmaceutical company will usually seek a licence for the medicine.

Safety, quality and efficacy are the only criteria on which legislation to control human medicines is founded. It is the responsibility of the Medicines and Healthcare products Regulatory Agency (MHRA) and the expert advisory bodies set up by the Medicines Act to ensure that the sometimes difficult balance between safety and efficacy is achieved. The purpose of the licence application is to consider whether the medicine has a measurable effect against a placebo or comparator in a clinical trial and whether, on balance, the medicine is likely to have an acceptable level of safety and quality.

There are two ways of obtaining a licence for the UK:

Applying for a UK licence through the MHRA; For more information about the process, see their website: www.mhra.gov.ukand

Applying for a European licence through the European Medicines Agency (EMEA), which relates to all EU member states. For more information about the process, see their website: http://www.emea.europa.eu/

1.2 The advisory process relating to licensed medicines used in NHS ScotlandMost mature healthcare systems have in place processes of health technology assessment to advise local healthcare providers as to the effectiveness of medicines both independently and in comparison with other available treatments. Such assessment and provision of advice generally occur at two levels; national and local.

1.2.1 National advisory structures

In NHS Scotland this assessment is provided at, or close to, the point of licensing by the Scottish Medicines Consortium (SMC). SMC considers the clinical and cost effectiveness of all newly licensed medicines and provides advice to NHS Scotland (NHSS) as to whether the medicine is recommended for use, and if so its place in treatment. Where a medicine is accepted by the SMC, NHS Boards are expected to


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http://www.emea.europa.eu/

http://www.mhra.gov.uk/

make it (or its equivalent) available. Full details of the role, remit, processes and decisions of the SMC can be found at www.scottishmedicines.org.uk

In England, clinical and cost-effectiveness of medicines is currently considered by the National Institute for Health and Clinical Excellence (NICE). The Multiple Technology Appraisal or MTA usually looks at a disease condition(s) and will appraise the different options for treatment giving a guidance type approach to its recommendations. Newer therapies are frequently compared to older more established therapies. The more rapid Single Technology Appraisal, STA, is similar in function to the SMC process looking only at one specific drug. STAs are only undertaken on medicines referred to it by UK Ministers.

NICE STA recommendations have no formal status in Scotland and the SMC remains the primary source of advice on the use of all newly licensed medicines in Scotland. For MTAs, NHS Quality Improvement Scotland (NHSHIS) decides on the applicability of the MTA guidance to Scotland. NHSHIS publishes advice on its website to advise NHS Boards on whether the MTA is valid for Scotland. NHS Boards in Scotland will then be advised to follow the advice of NHSHIS, this will then take precedence over any previous SMC decisions.


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http://www.scottishmedicines.org.uk/

APPENDIX 2

GUIDE TO THE LICENSING AND ASSESSMENT OF MEDICINES IN THE UK


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License sought by manufacturer for product via either:

Medicines and Healthcare products Regulatory Agency (MHRA)

European Medicines Evaluation Agency (EMEA)Licensed

approved

YesNo

Product goes no further or is resubmitted for license approval following further work

Medicine is assessed for cost effectiveness against current treatments (Health technology assessment)

NICE considers medicines referred to them by Ministers

NICE Multiple Technology Appraisal (MTA) (54 weeks or more)

Final NICE MTA Appraisal Guidance issued for England and Wales. There is an appeals process for negative NICE MTA decisions

NHS Quality Improvement Scotland (NHS QIS) reviews NICE MTA for applicability in Scotland

NHSQIS confirms how NICE MTA applies in Scotland

SMC Single Technology Assessment (STA) of newly licensed medicines (18 weeks)

Approved

Yes No

SMC issues advice to NHSScotland.Advice remains extant unless NHS QIS validates a subsequent NICE MTA for the same product and determination as valid for Scotland.

NHS QIS will issue advice to NHSScotland

Approved

NoYes

SMC issues advice to NHSScotland.Product goes no further or is resubmitted for SMC approval. Advice remains in force unless NHS QIS confirms a subsequent NICE MTA as valid for Scotland.

NB NICE Single Technology Assessments (STAs) do not apply in NHS Scotland

GlossarySMC = Scottish Medicines ConsortiumNHSQIS = NHS Quality Improvement ScotlandNICE = National Institute for Health and Clinical Excellence

APPENDIX 3

Summary of request forms and their uses in relation to this guidance

Form A Requests for continuation of previously prescribed or newly initiated non-

formulary licensed medicines in NHS Highland acute service for individual patient use

Form B Requests for use of an unlicensed medicine or off-licence use of a medicine for

a group of patients

Form C Requests for use of medicines in individual patients which the SMC / NHSHIS

have recommended should not be used in NHSS where a prescriber believes, following review of published evidence, that his/her patient will respond significantly differently to the medicine than the group of individuals upon which the SMC advice and NHSH policy is based

or for Requests to prescribe licensed medicines for individual patients, marketed in

the UK, for which there is a significant delay in provision of SMC advice and the clinician assesses that his or her patient would experience significant, material, irreversible deterioration or harm without using the newly licensed medicine before the SMC advice is to be made available.


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REQUEST FOR MEDICINES SUPPLY FORM A

Please use this form to request initiation of non formulary medicines in hospital or continuation of non formulary licensed medicines, initiated in primary care for use in a single patient

All sections must be completed for all initial requests.In covering a repeat hospital supply, quote original reference no. and complete Section B only.This form provides for supply to be made to the stated patient only

Date

SECTION A – TO BE COMPLETED FOR ALL REQUESTSHospital Patient NameCHI number

Ward Unit No.

CONSULTANT Address

Tel No.

Bleep No. Date of Birth Sex

This form provides for supply to be made to the stated patient only

SECTION A (to be completed for ALL requests) – TO BE COMPLETED BY PHARMACIST

Approved Name of Product

Brand Name of ProductStrength Manufacturer

Formulation Unit Cost

Reason for Request

(tick appropriate box, if continuation please state original Form A ref no)

Continuation of medicine initiated in primary care Form A Ref No .....…..

Continuation of previous hospital supply Form A Ref No .....…..

Quantity required Total Treatment Cost (this request)

Pharmacist’ Signature Date:

Bleep No Supply on Receipt Y / N* Supply to

SECTION B TO BE COMPLETED BY PRESCRIBING CONSULTANT/PHARMACIST

Formulary Status Has an application been submitted to the NHS Highland Formulary Subgroup?

Y / N


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Reason for request, include reasons for not using FORMULARY product

Has product been reviewed by SMC Y / N, if Y state outcome APPROVED/REJECTED

Hospital Treatment ONLY Y / N, if continuing into Primary Care, indicate duration

Is there an agreed treatment protocol? If so, please include.

Consultant / Pharmacist name Date:

Consultant / Pharmacist signature

SECTION C FOR PHARMACY PROCUREMENT SECTION ONLY DATE RECEIVED

New Product Record No Supplier

Therapeutic Classification Order No Ordered By

Shelf Location Expected Delivery Date

Unit Cost Quantity Ordered

Ref No. Issued Date:

Checked By Date:

*If “Supply on Receipt” indicates ‘N’ – pharmacist to be contacted on receipt


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REQUEST FOR MEDICINES SUPPLY FORM B

Please use this form for requests to use an unlicensed or off-licence medicine in a single patient*.

All sections must be completed for all initial requests.In covering a repeat hospital supply, quote original reference no. and complete Section B only.This form provides for supply to be made to the stated patient* only.

*If the unlicensed or off-label medicine is subsequently identified by the Raigmore Hospital Medicines Management and Information Pharmacist as being prescribed regularly in a group of patients then the information provided in sections B to E of this form may be used as the basis of a submission for inclusion of the medicine in the NHS Highland approved list of unlicensed medicines available on NHS Highland Intranet at: http://intranet.nhsh.scot.nhs.uk/Clinical/Formulary/Pages/Default.aspx.

Date

SECTION A – TO BE COMPLETED FOR ALL REQUESTSHospital Patient NameCHI number

Ward Unit No.

CONSULTANT Address

Tel No.


SECTION B – TO BE COMPLETED BYCONSULTANT / PHARMACIST




Reason for Request

(tick appropriate box, if continuation please state original Form B ref no.)

Continuation of previously hospital supply Form B Ref No .....…………..

New initiation

Quantity required

Treatment Cost

(this request)Cost of course/annual cost

Pharmacist’ Signature Date:

Bleep No Supply on Receipt Y / N* Supply to


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http://intranet.nhsh.scot.nhs.uk/Clinical/Formulary/Pages/Default.aspx

SECTION C TO BE COMPLETED BY PRESCRIBING CONSULTANT

Formulary Status Has an application been submitted to the Highland Formulary Subgroup? (please circle)

Y / N

SMC Status Is SMC due to consider this medicine for use as part of its work plan published on its website? (please circle)

Y / N

Indication to be used for

Is the proposed use (please tick) Unlicensed Off-licence

Is there a licensed medicine available in the UK for this indication? Y / N

Reason for not using FORMULARY product or other licensed medicine

Summary of evidence for use of the medicine in terms of safety and clinical and cost effectiveness (please attach separate sheets / quoted papers as appropriate). Please provide evidence that use of this medicines is acceptable practice within a cohort of peers.

Treatment Plan, include frequency of administration, duration of treatment and clinical circumstances when the treatment will cease

Treatment outcomes and timescales: Please note that treatment will not be authorised without explicit agreement of these outcomes for continuation. If authorised you will need to make the circumstances in which treatment will cease explicitly clear to the patient as described in NHSH policy.


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State clearly and explicitly the treatment outcomes to be achieved and timescales of achievement for continuation of this treatment. Please include any treatment milestones.

Please detail criteria for cessation of therapy.

Will treatment continue:

Only in hospital? Hospital and then primary care?

If continuation in primary care:

What is the anticipated duration of treatment? ………………………………………………


Has the patient’s GP agreed to prescribe if request is approved? Yes / No

I understand that the medicine requested is an Unlicensed Medicine and understand and accept the responsibility for the use of this medicine in the treatment indicated for this patient.

Consultants Signature Date:

SECTION D TO BE COMPLETED BY HEAD OF SERVICE

I have reviewed the request and SUPPORT/ DO NOT SUPPORT the use of the requested medicine as proposed based on the safety, clinical and cost effectiveness and the absence of a licensed alternative.

STATE REASON(S) IF USE NOT SUPPORTED

Signature Date:

SECTION E TO BE COMPLETED BY DIVISIONAL MANAGER OR CLINICAL LEAD

Where the costs exceed £10,000 per patient per annum there is a requirement for additional Board level sign off as described in the guidance.

Divisional/ operational decision making group summary

Use approved by the divisional panel / Use supported by the divisional panel but requires board level sign off due to budget impact (delete as appropriate)

Signature Date:


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Board level decision making group summary

Use approved by the board level decision making group

Signature

Title Date

SECTION F FOR PHARMACY PROCUREMENT SECTION ONLY DATE RECEIVEDNew Product Record No SupplierTherapeutic Classification Order No Ordered ByShelf Location Expected Delivery DateUnit Cost Quantity OrderedRef No. Issued Date:

For repeat requests for the same patient only Page 1 requires to be completed and forwarded to the Procurement Section, Pharmacy Department, Raigmore Hospital, Inverness, Fax: 01463 705622


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INDIVIDUAL PATIENT TREATMENT REQUEST (IPTR) FOR MEDICINES SUPPLY FORM C

Please use this form to: request a licensed medicine:

Where SMC advice is that the medicine should not be used in NHS Scotland but where a prescriber believes, following review of published evidence, that his/her patient will respond significantly differently to the drug treatment than the group of individuals upon which the SMC advice or NHSG policy is based;

OR

Marketed in the UK, for which there is a significant delay in provision of SMC advice and the clinician assesses that his or her patient would experience significant, material, irreversible deterioration or harm without using the newly licensed medicine before the SMC advice is to be made available.

All sections must be completed for all initial requests.This form provides for supply to be made to the stated patient only.

Date

SECTION A – TO BE COMPLETED FOR ALL REQUESTSHospital Patient Name

CHI number

Ward Unit No.

WARD TEL NO Address

CONSULTANT


Is the patient an NHS Highland resident Y / N If not, state home board:

SECTION B – TO BE COMPLETED BY CONSULTANT / PHARMACIST




Reason for Request

(tick appropriate box, if continuation please state original Form D ref no.)

Continuation of previously hospital supply Form D Ref No ...........

New initiation

Quantity required


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Treatment Cost

(this request)Annual Cost/Cost of course

Other additional costs e.g. tests, additional medicines

Pharmacist’s Signature Date:

Bleep No Supply on Receipt

Y / N*Supply to

SECTION C - TO BE COMPLETED BY PRESCRIBING CONSULTANT

SMC Status

Licence Status of Medicine treatment

SMC has produced guidance for the proposed indication? Y / N

SMC guidance is awaited for the proposed indication? Y / N

The medicine is licensed for use for the proposed indication in the UK Y / N

Background to Request (Please note you will need to provide a case report for the panel in addition to the information on this form)

State the indication the medicine will be used for

Identify licensed and formulary approved alternatives and explain why they are not appropriate

If SMC rejected the medicine for use in NHS Scotland, explain how the patient will respond significantly differently to the drug treatment than the group of individuals upon which the SMC advice or NHSH policy is based.

Or

Explain how the patient would experience significant, material, irreversible deterioration or harm without using the newly licensed medicine before the SMC advice is to be made available

Summarise the peer reviewed evidence for clinical and cost


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effectiveness for the proposed use (you may wish to attach relevant papers)

Treatment outcomes and timescales: Please note that treatment will not be authorised without explicit agreement of these outcomes for continuation. If authorised you will need to make the circumstances in which treatment will cease explicitly clear to the patient as described in NHSH policy.

State clearly and explicitly the treatment outcomes to be achieved and timescales of achievement for continuation of this treatment. Please include any treatment milestones.

Please detail criteria for cessation of therapy.

Proposed treatment plan

Dose

Frequency

Duration of treatment

Will treatment continue:

Only in hospital ? Hospital and then primary care?

If continuation in primary care:

What is the anticipated duration of treatment? ………………………………………………


Please indicate how many NHSH patients you would anticipate this medicine should be used for in its licensed indication for NHS Highland if SMC had approved the medicine for use in Scotland. Please note any decision of the panel will only apply to the individual patient requested for.

Consultant’s Signature Date:

Do you have any declarations of interest to make in respect of this product applicationYes/No - If yes please complete a full declarations of interest statement & submit with the request.


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SECTION D - TO BE COMPLETED BY THE DIVISIONAL MANAGER or CLINICAL LEAD REPRESENTATIVECan the medicine requested be funded within this year’s service budget? Y / N

Signature Date:

SECTION E - TO BE SIGNED BY THE CHAIR OF IPTR DECISION-MAKING PANEL

Following review of the above information the decision making panel AGREE / DO NOT AGREE* that this treatment should be approved for use as described. (please outline the reasons for the decision in the space provided).

Can this expenditure be accommodated within the Divisional budget? Y / NIf N state where extra resource is to be found

Decision and supporting statement

Panel Chair Name …………………. Signature …………………………….. Date ………………..

SECTION F - FOR PHARMACY PROCUREMENT SECTION ONLY DATE RECEIVED

New Product Record No. Supplier

Therapeutic Classification Order No. Ordered by

Shelf Location Expected Delivery Date

Unit Cost Quantity Ordered

Ref No. Issued Date:

A signed copy to be forwarded to the Procurement Section, Pharmacy Department, Raigmore Hospital, Inverness, Fax: 01463 705622 and to the requesting clinician for the patient’s notes.


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APPENDIX 4

GUIDE TO WHICH FORM SHOULD BE USED FOR REQUESTING MEDICINES FOR INDIVIDUAL PATIENTS USING FORMS A, B and C


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Is the drug licensed?

Yes NoForm B for unlicensed use.

Has SMC provided advice on the licensed medicine?

Yes NoForm C for pre SMC licensed medicines (where cases can be made for use in exceptional circumstances)

Does the SMC advice include the indication for which you are planning to use the medicine?

Yes NoForm B for off-licence use.

Is the medicine on the NHS Highland Formulary?

Yes No Form A for limited non formulary initiation or continuation use.

Prescribe as normal.

APPENDIX 5

PRESCRIBING PATHWAYS


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Clinician submits non-formulary request (Form A) guidance

Clinician provides a suitable equivalent medicine approved by SMC/NHS QIS which is on the local formulary

Are the patient’s clinical circumstances significantly different to the patient group that the policy / guidance applies to or is based on?

Clinician explains the IPTR route to the patient.

No

No

Patient / requesting clinician may appeal against decision if suitable grounds

Appeal upheld?Yes

No

No

Does patient wish to pursue IPTR process?

Yes

Does patient still wish to pursue treatment with the non NHSH/ SMC/ NHSQIS recommended medicine?

No

No

Clinician prescribes an alternative treatment approved by SMC/NHS QIS and on the local formulary

Yes

NHS and private care should be kept as clearly separate as possible. Subject to satisfying clinical governance requirements, patient can receive concurrent treatment from the independent sector and the NHS. Private care should be carried out at a different time and place to NHS care being provided.

SMC issues advice to NHSScotland.Advice remains extant unless NHS QIS validates a subsequent NICE MTA for the same product and determination as valid for Scotland.

NHS QIS will issue advice to NHSScotlandEP considers

case againNB NICE Single Technology Assessments (STAs) do not apply in NHS Scotland

GlossarySMC = Scottish Medicines ConsortiumNHSQIS = NHS Quality Improvement ScotlandNICE = National Institute for Clinical Excellence

Is medicine recommended for use by SMC or NHS QIS?

Yes

Clinician prescribes medicine in accordance with current guidance

Clinician discusses treatment options with patient

Yes

Clinician advises patient that the IPTR process is not viable and discusses other treatment options

Clinician and patient agree that their preferred option is to use the medicine not recommended for use in NHS Scotland the criteria used to make decisions about exceptional cases.

Clinician makes a case for patient to be considered under IPTR process

Case considered via IPTR process

IPTR approved for individual patient use of non NHSH /SMC/NHS QIS approved treatment

Yes

Yes

Does patient wish to purchase treatment from the independent healthcare sector?

No

Clinician prescribes an alternative treatment approved by SMC/NHS QIS and on the local formulary

Yes

NHS and private care should be kept as clearly separate as possible. Subject to satisfying clinical governance requirements, patient can receive concurrent treatment from the independent sector and the NHS. Private care should be carried out at a different time and place to NHS care being provided.

Clinician prescribes the non SMC/NHS QIS medicine via NHS

If local clinicians wish to use the medicine the Formulary Group decides whether it should be on the Formulary

Yes

No

No

APPENDIX 6

Guidance for Individual Patient Treatment Requests using Form C

Form C should be used for:

Requests to use a medicine for an individual patient with significantly different clinical circumstances where the requested licensed medicine has been recommended not to be used IN NHS Scotland by SMC / NHSHIS –

Or

Requests to use a medicine for an individual patient with significantly different clinical circumstances where the licensed medicine is marketed in the UK and there is a significant delay in provision of SMC advice

1. Initiation of the request1.1 It will be for the treating clinician to make a request to prescribe a medicine

through this process and demonstrate that the patient concerned does meet the following criteria:

The patient’s clinical circumstances and potential response to treatment with the medicine are significantly different to the general population of patients for the NHS Highland policy is not to use the medicine

and The patient is likely to gain significantly more benefit from the intervention than

might normally be expected from patients for whom NHS Highland policy is not to use the medicine.

1.2 Clinicians are required to fully complete sections A to C of Form C. Particular attention is drawn to the questions relating to significant differences and the patient report section. Providing insufficient information will lead to delays in decision-making.

1.3 The completed request (Form C), patient report and systematic review of published evidence should be submitted to the designated Area Clinical Pharmacist who will copy it to the IPTR process coordinator by secure NHS e mail.

Once completed by the requesting clinician a copy of Form C (including the required patient report) should be sent to the process coordinator who will initiate the process of decision making once satisfied that the request is complete. Once completed, one copy of Form C will be added to the patient notes, one copy will be sent to the requesting clinician and the original will be stored in the Procurement Department at Raigmore Hospital. These Forms should be updated once the decision of the panel has been ratified.


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1.4 The process coordinator in conjunction with the NHS Highland Medicines Information Department will assess Form C for completeness and liaise with the requesting clinician to address any gaps in information provided.

1.5 Decision-making should be supported by robust scientific evidence. Once a fully completed request (Form C) has been accepted by the process coordinator the NHS Highland Medicines Information Department will be requested to undertake a systematic review of the published evidence undertaken to the standards used by UKMI to support decision-making.

1.6 The NHS Highland Medicines Information Department review of evidence will be provided to both the process coordinator and requesting clinician for comment prior to completion of the review and circulation to the decision making panel.

2. Decision-making

Prior to the start of any discussions members of panels involved in local decision-making will be expected to declare any interests which could have an impact on impartiality in decision-making.

2.1 The first decision to be made by the panel is whether the individual patient’s clinical circumstances are significantly different, i.e. that there is acceptable evidence that the clinical circumstances of the patient under consideration are significantly different in some way:

The patient’s clinical circumstances and potential response to treatment with the medicine are significantly different to the general population of patients for the NHS Highland policy is not to use the medicine

and The patient is likely to gain significantly more benefit from the intervention than

might normally be expected from patients for whom NHS Highland policy is not to use the medicine.

2.2 If the panel concludes that significantly different clinical circumstances are not demonstrated then the NHS Highland policy for that medicine applies, e.g. if SMC or NHSHIS has recommended that the medicine should not be used the patient and his/her prescriber would be advised that treatment will not be made available.

2.3 If the panel concludes that significantly different clinical circumstances have been shown then the panel must go on to consider the second stage of decision-making, i.e. whether the medicine should be authorised for this individual patient.


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2.4 The second stage of decision-making, for those patients deemed to have significantly different clinical circumstances, i.e. whether the medicine should be authorised for this individual patient, should be undertaken by the panel using a decision-making framework to include consideration of clinical effectiveness, cost effectiveness, health gain, disbenefits, service impact and the implications of the request on the equity of service provision in Highland.

Individual Patient Treatment Requests for medicine use in significantly different clinical circumstances where the licensed medicine is marketed in the UK and there is a significant delay in provision of SMC advice

1. Initiation of the request

1.1 It will be for the treating clinician to make a request to prescribe a medicine through this process and demonstrate that the patient concerned does have significantly different clinical circumstances.

1.2 Clinicians are required to fully complete sections A to C of Form C. Particular attention is drawn to the questions relating to alternative treatments, significant differences, summary of peer reviewed evidence and goals of treatment. Providing insufficient information will lead to delays in decision-making.

1.3 The completed IPTR Form C should be submitted to the designated Principal Pharmacist, Acute Services or CHP lead pharmacist who will liaise with the Unit Operations Manager / Finance Representative to complete Section D and initiate arrangement of the Sector based decision making panel. The designated principal pharmacist will assess Form C for completeness and liaise with the requesting clinician to address any gaps in information provided.

1.4 The timescale for the decision making process will be established in accordance with the patient’s clinical needs and be communicated to the patient by the clinician responsible for their care, following discussion with those involved in dealing with the request.

2. Decision-making

Prior to the start of any discussions members of panels involved in local decision-making will be expected to declare any interests which could have an impact on impartiality in decision-making.

2.1 The first decision to be made by the panel is whether the individual patient’s clinical circumstances are significantly different. In this instance the significantly difference relates to the case that Highland should put aside its general policy not to use a licensed medicine where SMC has yet to provide advice. In considering this significantly difference the decision-making panel considers whether:


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1. there is no other suitable licensed alternative, approved by SMC or on the Highland Formulary, for the indication the medicine is requested for.

2. there is published, peer reviewed evidence of clinical effectiveness

3. waiting for SMC to provide advice to NHS Scotland would lead to the patient missing an opportunity for cure, long term remission (five years), a significant extension of life or avoidance of permanent disability. This would include situations where the medicine requested is a bridging treatment to other treatments that would provide these benefits and situations where the only alternative medicine would be associated with significant, permanent harm to the patient and the risk of that harm is high enough to preclude the alternative medicine as a treatment option.

2.2 If the panel concludes that significantly different clinical circumstances are not demonstrated then the NHS Highland policy not to use a licensed medicine where SMC has yet to provide advice would stand and for that medicine applies and the prescriber would be advised that treatment will not be made available.

2.3 If the panel concludes that significantly different clinical circumstances have been shown then the panel must go on to consider the second stage of decision-making, i.e. whether the medicine should be authorised for this individual patient.

2.4 The second stage of decision-making, for those patients deemed to have significantly different clinical circumstances, i.e. whether the medicine should be authorised for this individual patient, should be undertaken by the panel using a decision-making framework to include consideration of clinical effectiveness, cost effectiveness, health gain, disbenefits, service impact and the implications of the request on the equity of service provision in Highland (Appendix 7).

3. Decision-making panel

The Decision Making Panel for individual patient treatment request via Form C will include Group Clinical Lead, Senior Pharmacist, Public Health representative, Clinical Ethics representative, Divisional Manager and a senior doctor from another area (i.e. a chronic disease area such as rheumatology / gastroenterology for haematology and oncology requests and vice versa).

The requesting clinician and the representative from the Highland Medicines Information Department will attend and be requested to remain during decision-making to provide additional information where required but will not take part in the decision-making itself.


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3.2 Quorum: No business will be transacted unless the Chairman, or in his absence the person acting as Chairman, and one senior medical representative, one senior pharmacist and a manager or their deputies are present.

4. Patient representation

Patient or patient representative involvement should be through discussion with the requesting clinician who will present the case for the medicine to be used as part of the IPTR process and will represent the patient’s interests. Patients (or their representatives) who wish to and are able to make a statement to the panel, should be advised that they may do so. However, they should not feel under any pressure to do so and the absence of such a statement will not present a disadvantage. Such statements are not a necessary addition to the information to be considered by the panel and will not form part of the evidence.

Patients will be offered information about the process, access to meeting papers and a copy of the final decision panel report should they so wish.

5. Reporting

5.1 Prior to the meeting the method of informing the patient, their family or carer of the panel decision will be agreed. Subsequent reference in this document will be to the patient. This will normally be either via the patient’s clinician. In most instances the decision of the panel will be communicated to the patient within 24hrs of the decision being made. Where communication is made by telephone or face to face meeting this should be followed by a written communication from the process coordinator. Where there is a delay, contact will be made with the patient to explain the reasons for such delays and the revised timescale of reporting.

5.2 Following the meeting the Chair of the decision making panel will liaise with the Head of Pharmacy / Head of service / requesting clinician and finance as appropriate to communicate the decision and make the medicine available to the requesting clinician.

5.3 A summary of the decision made by the panel and statements supporting the decision will be completed by the Chair of the Decision Making Panel and sent to the clinician by the process co-ordinator.

5.4 The report summarising the decision-making panel’s decision will be presented to the next meeting of the NHS Highland Area Drug and Therapeutics Committee for recording of the decision.

5.5 Once the Chair has signed IPTR Form C a copy will be provided for the clinician to include in the patient’s notes and a copy sent to the Pharmacy Office at Raigmore Hospital for storage. Where appropriate and requested the clinician may provide a copy of the form to the patient.


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5.6 In the event of the decision-making panel turning down a request to use a medicine the Chair of the decision making panel will arrange for the patient and requesting clinician to be informed about the appeals process.

5.7 In the event of the decision-making panel turning down a request to use a medicine the significantly different process coordinator will provide information to the patient and requesting clinician about the appeals process and other associated information. The clinician should also provide information on how the patient can seek a second opinion on proposed treatment.

5.8 The significantly different process coordinator will coordinate any appeal lodged by the patient or the requesting clinician.

6. Appeals of the panel decision

6.1 An appeal can be referred where the clinician supports his/her patient’s decision to appeal under the terms described in 6.2. An appeal cannot be accepted solely because the patient or clinician does not agree with the views or conclusions reached.

6.2 Appeals will only be accepted on the following grounds: the NHS Board failed to act fairly (this would be where it was felt that due

process had not been followed) The NHS Board has reached a decision which cannot be justified in light of

the evidence submitted.

6.3 Patients or requesting clinicians wishing to appeal should write to the Chief Executive of NHS Highland Board identifying the grounds of their appeal. Appeals should be made within three calendar months of the original panel decision being communicated to patients / requesting clinicians.

6.4 Appeals will normally be heard, subject to the availability of panel members, representatives and any reports / information within fifteen working days of the appeal being received.

6.5 Appeal Panel MembershipAppeal panel membership should not include individuals previously involved in the decision-making panel. The composition should include relevant expertise to review the original process and decision and reach an independent conclusion.


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They should include the following post-holders or their representatives:

- Non-executive Board Member (Chair of the Appeal Group)- Chair, Area Clinical Forum or their designated deputy- Senior Clinical Manager – Medical Director or Nursing Director- NHSH Legal Advisor- Director of Pharmacy

6.6 Patient / requesting clinician representation

6.7 The patient (or guardian where applicable) and / or the requesting clinician will be offered the opportunity to make representation to the appeal group, either in person or through their chosen representative (this representative may be a solicitor but should not be acting in a legal capacity during the panel meeting) regarding the grounds of their appeal. The IPTR Appeals Panel will be expected to consider the following evidence:

NHS Board policy on PTRs

The written evidence submitted in respect of the IPTR

The written account of the rationale for the IPTR decision reached

6.8 ReportingA report of the appeal panel will be made to the Chief Executive, NHS Highland and to the requesting clinician who should communicate it to the patient. There will be an accompanying letter from the Chair of the Appeal Panel to provide a brief summary and rationale for the decision. The letter will signpost the patient/ patient representative to an appropriate source of advice and support such as Independent Advice and Support Service.

6.9 Successful appeals will normally result in a direction that the decision should be made again.

6.10 Successful appeals will result in a new decision being made (N.B. Not necessarily a different outcome).

6.11 Decision-making following a successful appeal will be coordinated as laid out in this guidance.

6.12 An unsuccessful appeal means that options within NHS Highland processes have been exhausted, with the medicine not being made available to the patient in NHS Highland.

7. Review of the decision in the light of new evidence

It is accepted that new evidence may well be published that may mean that a decision may need to be reviewed.


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7.1 Where a clinician believes that the weight of the new evidence is such that it may affect a new decision they should reapply using Form C, initiating the decision-making process again including review of the new evidence.


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APPENDIX 7

Decision making framework to be used when considering requests for individual patient use of unlicensed medicines, off-licence medicines and medicines turned down for use in Scotland by SMC/NHSHIS (Forms B and C)

Dimension In assessing a medicine for individual use the decision making panel should consider:

Clinical effectiveness

1. The strength of the available clinical effectiveness evidence. 2. The likely response rate and / or attributable risk reduction for the patient.3. The nature of the benefit e.g. on a continuum from life saving to short term prolongation of life with poor quality.

Cost effectiveness

1. The strength of the available cost effectiveness evidence.2. The cost effectiveness in comparison to either the most appropriate comparator (using appropriate economic outcome

measures) or more generally the prevailing cost/QALY thresholds used by national health technology assessment groups such as the SMC.

Health gain 1. The expected benefits of treatment in terms of mortality and morbidity2. When such benefits occur3. The likely duration of benefit

Disbenefits 1. Potential disbenefits are there for the patient using the medicine2. Likelihood of these disbenefits occurring (e.g. attributable risk increase)

Service impact 1. Whether the service can use the medicine immediately or there is additional service development that needs to be put in place first e.g. clinic spaces, diagnostic equipment.

2. The budget impact. 3. Whether the medicine quantifiably and significantly contributes to local NHS priorities e.g. waiting time reduction,

shifting the balance of care, HEAT targets etc.

Equity 1. The opportunity cost in investing funds into a particular medicine versus other medicines that might require funding by the service / sector during the remainder of the year.

2. The impact on equity of access relative to other health boards i.e. will funding bring NHSH in to line with other health boards / care routinely available on the NHS in Scotland.


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