NHS Fife WORKING WITH THE PHARMACEUTICAL INDUSTRY AND HEALTHCARE EQUIPMENT SUPPLIERS GUIDANCE FOR NHS STAFF

NHS Fife WORKING WITH THE PHARMACEUTICAL INDUSTRY AND HEALTHCARE EQUIPMENT SUPPLIERS GUIDANCE FOR NHS STAFF This guidance relates to all staff employed by NHS Fife (including staff within the Health & Social Care Partnership), Clinical and Non-Clinical, and should be viewed as good practice by independent contractors. 1. REQUIREMENTS OF NHS STAFF WHEN MEETING WITH INDUSTRY REPRESENTATIVES 1.1 Meetings between NHS staff and representatives of the Pharmaceutical and the Healthcare Equipment industries can provide an opportunity for awareness raising and information sharing, such as advance notification of new medicines/products, education/training and support for clinical research. The benefits of this exchange are recognised for both parties. However, interactions must follow the Association of the British Pharmaceutical Industry (ABPI) Code, http://www.abpi.org.uk/ for medicines and the relevant company specific Code of Ethics and Business Standards. Within Fife: Awareness of and training in the application of this Guidance is included in induction training for consultants and mandatory training for all other staff Meetings must only involve those whose roles justify their participation. Individuals must obtain prior approval from their Line Manager/Clinical Director or equivalent before participation in any meeting. Only senior staff will participate in meetings with representatives - consultants, senior pharmacy staff and for nursing staff, a limited register of staff meeting the above criteria delegated through the relevant Associate Director of Nursing are included. This register will be reviewed annually by the Associate Nurse Directors. The Research & Development (R&D) Manager must develop and hold a register of those staff authorised to meet with representatives as part of the work of the R&D Department. Staff taking part in such meetings will ensure there is a clear understanding of the purpose of the meeting, including the aims and the potential outcomes which benefit the NHS and patients. Approved on behalf of NHS Fife by the Fife Drugs & Therapeutics Committee Date: June 2016 Review Date: June 2019 Version 2 Amended April 2017

Employees must complete a Record of Meeting with or Hospitality Received from the Pharmaceutical Industry or Healthcare Equipment Suppliers Form (Appendix 1) for each meeting and submit these when requested as part of the monitoring arrangements. 1.2 DISCLOSURE OF PAYMENTS TO HEALTHCARE PROFESSIONALS BY PHARMACEUTICAL COMPANIES From June 2016, pharmaceutical companies are required to publish details of payments they make, in cash or in kind, to individual healthcare professionals for services they provide. These services include sponsorship, consultancy and associated fees relating to their participation in events e.g. Advisory Boards, conferences etc. Information will be publicly available through a publicly searchable database on the Association of British Pharmaceutical Industry (ABPI) website. Regular review of NHS Fife records on the ABPI website will be undertaken. Any information provided at such meetings must be critically evaluated. In the case of pharmaceuticals, the ABPI Code governs the approval of promotional materials and directs that statements should be evidence based and restricts distribution to persons who can reasonably be assumed to have a need or interest in the information. 2. DECLARATIONS OF INTEREST 2.1 For medicines: The health care professional who: proposes a change to the Fife Formulary; is a member of any of the medicines governance groups within Fife, including the Fife Area Drug &Therapeutics Committee, the Formulary Committee, Formulary Review groups, Clinical Guideline Development groups, Managed Clinical Network Prescribing Groups, Managed Service Drug & Therapeutics Committee etc; will declare any interest in the pharmaceutical industry - both personal and nonpersonal interests and complete an annual Declaration of Interests form. 2

3. REQUIREMENTS OF INDUSTRY REPRESENTATIVES WHEN MEETING NHS STAFF 3.1 Industry representatives are advised of the following requirements: Representatives must not visit wards, departments or theatres without a specific invitation from, or an appointment with, the relevant senior member of staff; Representatives must complete a Pharmaceutical Industry and Healthcare Equipment Representative Appointment Request Form (Appendix 1) and submit it when making a request for an appointment to the relevant individual making it clear the reason for the request; Representatives must only see Consultants, senior pharmacy staff or nursing staff referred to in 1.1 bullet point four, Heads of Nursing, R&D authorised staff or above and by appointment only; For any medicine, NHS Fife representatives will describe the status of the product (in relation to the Scottish Medicines Consortium, NHS Fife Area Drug &Therapeutics Committee, the Fife Formulary or local/national guidance) both when arranging the meeting and at the outset of the discussion. Cognisance must also be taken when products are restricted to use or initiation by specialist clinical staff; Representatives must be made aware that medicines are prescribed in NHS Fife within the context of the Fife Formulary and relevant local and national guidance, therefore promotion out with such guidance is not supported. Distribution of promotional materials should be in accordance with the ABPI Code; No medicine samples must be left in clinical areas, the Supplies Department or the Pharmacy Department. 4. PRINTING OF GUIDELINES, LEAFLETS etc 4.1 On occasion, the industry may offer to sponsor the printing of clinical guidelines, leaflets etc. This is acceptable where the following criteria are met: The funding will be restricted to printing costs only; More than one supplier, where appropriate, has the opportunity to give support through an unrestricted educational grant; Clinical and editorial matters must be under NHS Fife control and 3

developed by and approved by relevant local NHS Fife groups, involving relevant clinicians; Recommendations for medicines in these documents must only be in line with local NHS Fife Area Drug and Therapeutics Committee decisions and Fife Formulary recommendations; Generic names for medicines must be used throughout, unless otherwise specified in the NHS Fife Formulary; Only NHS and Health & Social Care Partnership logos must appear on printed documents; Acceptance of the sponsorship may be acknowledged on the printed document, for example Supported by an unrestricted educational grant from.. The declaration of sponsorship will be sufficiently clear that readers are aware of it at the outset. Approval of such documents should proceed through the agreed NHS processes. 4.2 Financial donations to a departmental fund are acceptable provided they are in line with the NHS Fife Endowment policy. 5. INDUSTRY SPONSORSHIP OF CONFERENCES, MEETINGS, PROTECTED LEARNING TIMES (PLT), COURSE FEES etc 5.1 On occasion, the industry may offer to sponsor the costs associated with the running of a conference, Protected Learning Time session, training event etc. This is acceptable when the following criteria are met: The funding is restricted to the venue and hospitality costs only, and speaker/presenters costs where appropriate More than one supplier contributes to providing this support, preferably two or more through an educational grant Promotional stands and materials must relate only to medicines and formulations approved for use through the NHS Fife Area Drug and Therapeutics Committee and listed in the Fife Formulary for the indication being advertised. The form in Appendix 3 should be completed for each event and sent to the delegated Senior Manager for the particular area/service for approval etc. 5.2 Sponsorship to cover the costs for a member of staff to attend a 4

clinical/scientific meeting/undertake training can be acceptable but is restricted to course fees, reasonable hospitality and travel and must be deemed reasonable and agreed by the member of staff s Line Manager. 5.3 Staff may accept modest hospitality, provided that it is normal and reasonable in the circumstances, e.g. lunches in the course of working visits may be acceptable, though they should be similar in scale to hospitality that the NHS as an employer would be likely to offer. Staff will decline all other offers of hospitality. If in doubt, staff will seek advice from their Line Manager. All hospitality accepted by NHS employees must be declared to their Line Manager who will keep an appropriate record of the circumstances. http://www.nhsfife.org/nhs/index.cfm?fuseaction=publication.pop&pubid=ec7b0c 65-C982-2DCD-A714CBF4E47C4A8A Section G, Appendix 2 5.4 Gifts which could place an individual in a position of conflict between their private interests and that required in the execution of their NHS duties should be politely but firmly declined. On no account should gifts of alcohol be accepted. If in doubt, staff must contact their Line Manager before acceptance. 6. SAMPLES 6.1 Samples will not be accepted within NHS Fife, as NHS Fife then becomes liable for the quality of items utilised in patient care. 6.2 For medicines, this is equally applicable to dressings, sundries and products for wound care and stoma care. 6.3 There are limited specific exemptions from the above restrictions Medicines/items provided as part of a clinical trial; Where local co-ordinated assessment of certain products (e.g. equipment or devices) is being carried out or for supply of a single sample for demonstration purposes; Supply of clinical monitoring equipment (eg. glucometers, glucose testing strips, insulin pen devices or insulin pumps for use by newly diagnosed diabetic patients, enteral feeding pumps etc) only as part of an individual evaluation of patient acceptability Emollients samples for use in Dermatology Oral Nutritional Substances only where patients are being assessed for tolerability and palatability 5

7. INDUSTRY SPONSORED RESEARCH/CLINICAL TRIALS 7.1 In general the NHS does not require confidentiality agreements (Non Disclosure Agreements) for clinical studies sponsored by third parties, unless the study is of a commercially sensitive nature. Such documents are primarily intended to protect the interest of the Sponsor. NHS confidentiality will normally be covered in the main contract where appropriate. Any confidentiality agreements requested by a Sponsor must be referred to Research & Development for review. Once an agreeable form of confidentiality agreement has been agreed, the Research & Development (R&D) Manager will arrange for the contract to be signed on behalf of the organisation. 7.2 NHS Fife, in collaboration with its academic partners, wishes to enhance patient care through advancement in clinical practice. NHS Fife recognises the support that industry provides to research, with the resultant benefits of interaction between NHS staff and their scientific counterparts representing companies who supply medicines. 7.3 Research partnerships need to meet the rigorous requirements of clinical relevance and governance as set out in current guidelines and legislation. All projects must be formally approved by the relevant NHS Medical Research Ethics Committee(s) and by NHS Fife, which is organised by the R&D Team. 7.4 In the Post-Study management of patients in clinical trials, researchers should take note of the NHS Fife Area Drug and Therapeutics Committee view of not recommending the prescribing of new medicines until they have been evaluated and approved by the Scottish Medicines Consortium (SMC). Therefore, where patients are treated with new medicines in clinical trials, the following post study options should apply. The R&D Department will ensure that the R&D study review and set up procedures include checking that the study arrangements comply with NHS Fife s guidance. 7.4.1 Post study management options: Treatment with an unlicensed medicine should only be continued for an individual patient where it is provided free of charge by the manufacturer/supplier; A licensed medicine that has been approved for use by the SMC can continue to be prescribed where indicated*; A licensed medicine not yet submitted for evaluation by the SMC should not be prescribed at the end of a study. See appeal mechanism below**; 6

A licensed medicine that has been submitted but not yet evaluated by the SMC may continue to be prescribed subject to review once SMC advice is available*; A licensed medicine not approved for use by the SMC should not be prescribed at the end of a study. See appeal mechanism below**; Cancer chemotherapy and other agents e.g. Rheumatology/General Practice may continue to be prescribed where supplied free of charge for use within a named patient programme by arrangement with the manufacturer or supplier. *The GP will make decisions about the continued use of a trial drug where it is to be prescribed. The researcher should provide sufficient information on the outcome of the study to inform such a decision. Also, the GP should be advised of the continued use of specialist drugs prescribed in secondary care and be party to any decision to continue trial drugs as part of a shared care agreement. **Requests to allow the consideration of exceptional treatment of individual patients funded from existing budgets should be made using the agreed submission form on the Area Drug &Therapeutics Committee website www.fifeadtc.scot.nhs.uk/ and submitted to the Clinical Effectiveness Pharmacist, Lynebank Hospital, Dunfermline Tel no: 01383 565374. 7.5 NHS Fife cannot guarantee that a new medicine will be available in clinical practice following clinical trial activity, compassionate use prescribing or expanded access programme (or equivalent). Such availability is dependent on marketing authorisation and national guidance (e.g. Scottish Medicines Consortium and/or National Institute of Health and Clinical Excellence (NICE), in addition to individual patient circumstances. Trial subjects/patients should be informed of this. 7.6 Market research activities, post marketing surveillance studies, clinical assessments and the like must be conducted with a primarily scientific or educational purpose and must not be disguised promotion. In the event that this activity involves a non-formulary medicine, NHS prescribing should be conducted in line with accepted NHS Fife policies and guidelines. 7

8. PARTNERSHIP WORKING WITH THE PHARMACEUTICAL INDUSTRY AT CORPORATE LEVEL 8.1 The Scottish Executive guidance A Common Understanding Guidance on Joint Working with the Pharmaceutical Industry (2003) http://www.scotland.gov.uk/publications/2003/12/18625/29956 acknowledges that: A governing ethos of NHS Scotland is the acceptance and recognition that a modern and dependable NHS will be built on effective joint working with others. All joint working, if properly managed, should be of mutual benefit to the organisations concerned and to patients. The relationship with the Pharmaceutical Industry should not be any different and should be built on mutual respect and trust. 8.2 In developing joint working agreements consideration should be given to the following: The costs and benefits of any arrangement; Likely impact on purchasing decisions across the NHS structure, with such decisions being based on best clinical practice and value for money; The need for an open and transparent tendering process where joint working is linked to the purchase of particular products or services. In particular, no sponsorship, funding or resources should be accepted from a supplier who is actively engaged or shortly (within 6 months) to be engaged in a tender or commercial review of the services they provide; A requirement that all participants observe Data Protection legislation to respect and preserve patient confidentiality; The employment or seconding of any person as a result of the agreement is covered by relevant NHS regulations, for example MEL(1994) 48, NHS Fife Standards of Business Conduct for NHS staff, NHS Fife Secondment Policy and other relevant HR policies and procedures; Participants are made fully aware of the duration of the project with a clear definition of the exit strategy and the implications for both patients and the service once the project comes to an end. 8.3 A Common Understanding presents an outline framework to guide parties through the formation of a partnership agreement. Any possible partnerships should always be discussed with the relevant Line Manager, Head of 8

Profession/Clinical Director or equivalent and local Pharmacy and Finance personnel before proceeding beyond the initial stages. Appendix 2 outlines the areas to be considered and agreed when entering into a partnership agreement. 8.4 Finance and Pharmacy will work with suppliers to establish the best arrangements for the supply of medicines, in line with established partnership principles, business standards, purchasing law and NHS Fife s Code of Corporate Governance. 8.5 No commercial relationships can be entered into other than by staff with formal delegated powers as set out in NHS Fife s Code of Corporate Governance. Any discussion on commercial matters should be referred to the relevant Finance or Pharmacy Teams Area Drug & Therapeutics Committee April 2017 9

Appendix 1 Pharmaceutical Industry or Healthcare Equipment Representative Appointment Request Form Meeting with representatives of the pharmaceutical or healthcare equipment industries should carry potential benefits for the NHS and the representative should present a clear agenda for the meeting in advance. All representatives must complete this form when requesting an appointment with a senior clinician. A decision will be made based on the information provided. The duration of a meeting should not last more than 30 minutes without prior agreement. A meeting will not be agreed if any details are omitted or incomplete. Section 1: To Be Completed By The Person Requesting The Meeting: Name / Job Title: Company: Contact number / Address: The visit is regarding: Trade name: Generic name: Indication(s): Tick applicable boxes New product: Reviewed by SMC: Yes No New indication: New formulation: Other Reason (Please state) Meeting aims (agenda) these should be beneficial for the NHS 1. 2. 3. Please feel free to enclose a copy of any promotional material or references Section 2: For Office Use Only Make next available appointment Request information by post/email Request phone call on.. Do not make appointment Approved on behalf of NHS Fife by the Fife Drugs & Therapeutics Committee Date: June 2016 Review Date: June 2019 Version 2 Amended April 2017

Appendix 2 DECLARATION FORM OF STAFF INTERESTS AND GIFTS/HOSPITALITY Title(Mr/Mrs/Miss/Ms/Dr/Other) Name Job Title/Capacity Location Email Declared Item Details Interest (e.g. other employment, directorships, ownership of interest in a business, shareholdings, position in another body) Give details whether the interest is declared on behalf of another Offer of Gift/Hospitality Date Offered. Estimated Value I have accepted this offer Y/N I have notified my Line Manager and been given approval Y/N Give details of gift/hospitality and donor Signature: Date: 11

Appendix 3 A Common Understanding Guidance on Joint Working with the Pharmaceutical Industry (2003) http://www.scotland.gov.uk/publications/2003/12/18625/29956 1. Joint Working Project Summary 1. NAMES OF THE PARTNERS ENTERING THE JOINT WORKING AGREEMENT 2. NAMES OF THE LEAD REPRESENTATIVE OF EACH PARTNER 3. SUMMARY OF INTENDED AIMS/OBJECTIVES 4. SUMMARY OF EXPECTED OUTCOMES 5. EXACT NATURE OF THE JOINT WORKING PROPOSAL 6. START DATE 7. FINISH DATE 8. EXIT STRATEGY 2. Resources and Costs: 1. OVERALL COST OF THE JOINT WORKING PROJECT 2. WHAT ARE THE DIRECT AND INDIRECT RESOURCE / COST COMMITMENTS BY EACH PARTNER? 3. HOW WILL THE RESOURCES/COSTS BE MONITORED AND RECORDED? 4. LIST VALID AND RELEVANT INFORMATION ON COST EFFECTIVENESS (has value for money been shown?) 12

3. Governance Arrangements: 1. WHO HAS BEEN CONSULTED PRIOR TO THE JOINT WORKING PROJECT AND HOW WAS THIS DONE? 2. HOW WILL PATIENTS BE INFORMED OF THE JOINT WORKING? 3. DECISION-MAKING PROCESS OF THE PROJECT 4. OPERATIONAL AND MANAGEMENT ARRANGEMENTS 5. HOW DOES THE PROJECT RELATE TO, AND MESH WITH, EXISTING SYSTEMS OF CARE IN THE PRIMARY AND SECONDARY CARE SECTORS? 6. HAS THE PROJECT BEEN PILOTED OR ARE THERE PLANS TO DO THIS? HOW WOULD THIS BE DONE? 7. HAS THE PROPOSAL BEEN COMPARED WITH OTHER JOINT WORKING PROPOSALS CURRENTLY ON OFFER? 4. Monitoring and Evaluation: 1. MANAGEMENT OF THE PROJECT FORMAT/ PROCESS 2. WHO HAS DESIGNATED RESPONSIBILITY AT EACH STAGE OF THE PROPOSAL? - PLEASE LIST 3. ON COMPLETION OF THE PROJECT HOW WILL IT BE EVALUATED IN TERMS OF PATIENT BENEFITS? 4. WHAT HAVE BEEN THE LEARNING OUTCOMES/OPPORTUNITIES? 5. AUDIT ARRANGEMENTS 13

5. Data and Patient Protection: 1. WHAT INTERESTS DO THE COMPANY AND THE NHS HAVE IN RELATION TO THE JOINT WORKING PROPOSAL - WHERE DO THESE INTERESTS COINCIDE? 2. WHAT ARE THE POTENTIAL CONFLICTS OF INTEREST? 3. WHO 'OWNS' THE DATA GENERATED BY AUDIT AND MONITORING OF THE JOINT WORKING? 4. WHO HAS ACCESS TO THE DATA AND IN WHAT FORM, I.E. AGGREGATION AND ANONYMISATION CRITERIA? (Bearing in mind the Data Protection Act) 5. HOW WILL THE DATA BE USED? 6. WHAT ARE THE RESEARCH AND DEVELOPMENT ISSUES? 7. WRITTEN CONTRACT BETWEEN PARTIES CLEARLY STATING OBLIGATIONS OF CONFIDENTIALITY, SECURITY STANDARDS AND LIMITS USE OF INFORMATION TO PURPOSE SPECIFIED IN CONTRACT 8. FOR CLINICAL SERVICES, WHAT ARE THE PROFESSIONAL INDEMNITY AND LIABILITY ARRANGEMENTS THAT THE PROVIDER HAS IN PLACE? 6. Declaration of interests (see below) YES NO If YES, Please tick one box in (A) and in one box in (B) (A) Personal Non-Personal Signature:... (B) Specific Non-Specific Date:... 14

'PERSONAL' implies that you (or your spouse) receive direct payment for services or hold shares in the relevant company concerned or a competitor NON-PERSONAL' implies that your Unit benefits by receiving funding from the company 'SPECIFIC' implies that you have undertaken work or given advice on other products made by the relevant manufacturer. This system is used by the Medicines Commission and other national drug regulatory bodies. 15

Appendix 4 PHARMACEUTICAL COMPANY SPONSORSHIP I, (pharmaceutical representative) On behalf of. (Company) wish to sponsor an educational meeting within Fife Date of meeting Venue... Title of meeting. NHS Fife policy states that when a pharmaceutical company wishes to sponsor an event held in NHS property or under the auspices of NHS Fife, advertising of the sponsoring company s products is restricted to those products listed in the Joint Formulary (available at www.fifeadtc.scot.nhs.uk/ In respect of this I will be advertising the following products Which are recommended in the Fife Formulary and will provide payment of. To...(name of account) Within 28 days of the meeting. Signature Date. Bookings for stands at Educational Events will only be confirmed upon receipt of a completed agreement. 16