PHARMACEUTICAL REPRESENTATIVE POLICY VEMBER 2017 This policy supersedes all previous policies for Medical Representatives
Policy title Pharmaceutical Representative Policy Policy PHA39 reference Policy category Clinical Relevant to All clinical staff Date published November 2017 Implementation November 2017 date Date last November 2017 reviewed Next review November 2020 date Policy lead Lucy Reeves, Chief Pharmacist Contact details Accountable director Approved by (Group): Approved by (Committee): Document history Email: lucy.reeves@candi.nhs.uk Dr Vincent Kirchner, Medical Director Drugs and Therapeutic Community (DTC) Quality Committee Date Version Summary of amendments Nov 2013 2 Review Nov 2015 3 Review and update Nov 2017 4 Routine Review Membership of the policy development/ review team Lucy Reeves, Chief Pharmacist Consultation Drugs and Therapeutic Committee members DO T AMEND THIS DOCUMENT Further copies of this document can be found on the Foundation Trust intranet. I PHARMACEUTICAL REPRESENTATIVE POLICY_PHA39_VEMBER 2017
Contents Page 1 Introduction 1 2 Aims and objectives 1 3 Summary points 1 4 Scope of the policy 1 5 Duties and responsibilities 2 6 General points 2 7 Visits by Pharmaceutical Representatives 2 8 Access to information 3 9 Educational meetings conducted by Pharmaceutical Representatives 3 10 Gifts, hospitality and meetings 4 11 Further Points 4 12 Dissemination and implementation arrangements 4 13 Training requirements 5 14 Monitoring and audit arrangements 5 15 Review of the policy 5 16 References 6 17 Associated documents 6 Appendix 1: Equality impact assessment 7 II PHARMACEUTICAL REPRESENTATIVE POLICY_PHA39_VEMBER 2017
1 Introduction 1.1 The Association of British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry includes standards of conduct for pharmaceutical representatives. Pharmaceutical representatives visiting any premises from which the trust operates must act in accordance with the ABPI code of practice and this policy. 1.2 In 2017 NHS England published guidance for staff and organisations: Managing conflicts of interest in the NHS. In addition a joint statement on conflicts of interest from the chief executives of statutory regulators of health and care professionals was published. This joint statement sets out the expectations of health and care professionals in relation to avoiding, declaring and managing conflicts of interest across all healthcare settings. It is intended to support the standards or code for each profession and any additional guidance they may have. 1.3 By adhering to both codes of practice and trust policy it is hoped the association between NHS staff and the pharmaceutical companies will be constructive. This policy should be read in conjunction with the Trust Corporate Policy Gifts and Hospitality 2 Aims and objectives 2.1 The aim of this policy is to give clear guidance to trust staff and pharmaceutical representatives on appropriate conduct within the Trust. 3 Summary Points To give clear guidance to trust staff and pharmaceutical representatives on appropriate conduct within the Trust. Pharmaceutical representatives must contact the Chief Pharmacist at first instance prior to contact other members of staff. Representatives will be expected to comply with the ABPI standards. Representatives should aim to educate staff, not to promote company medical products. Educational sessions should be about medicines included in the Trust formulary. Leaflets and posters produced by the pharmaceutical company must be approved by the Chief Pharmacist. Clinical trial medicines are not within the scope of this policy. 4 Scope of the policy This policy is applicable to all pharmaceutical representatives and trust staff who may come into contact with pharmaceutical representatives. 1 PHARMACEUTICAL REPRESENTATIVE POLICY_PHA39_VEMBER 2017
5 Duties and responsibilities 5.1 Senior trust staff who meets with pharmaceutical representatives are responsible for ensuring the representative is made aware of this policy and receives a copy. They are also responsible for ensuring this policy is adhered within their services and report any deviations to the Chief Pharmacist. 6 General points 6.1 All pharmaceutical representatives are expected to comply with the ABPI code of practice. Non adherence should be reported to the Chief Pharmacist. 6.2 The trust operates a Medicines Formulary and Formulary Policy. All prescribing must be in accordance with the trust formulary/formulary policy and any trust guidelines or other agreed recommendations. The introduction of new medicines for use in the trust is managed through the Drug and Therapeutics Committee. Contact with the Committee should be made via the Chief Pharmacist. 6.3 No medicines may be promoted by representatives. Representatives may seek to inform or educate, but not promote. Representatives must only discuss the products marketed by their company. 6.4 Medical representatives should not be allowed direct contact with patients, to attend ward rounds, clinics or any other meeting where confidential information is discussed. 6.5 Conversations between medical representatives and staff members must not take place in public places such as corridors or waiting areas. 6.6 Representatives are not permitted to use C&I treatment guidelines or other documents for promotional purposes outside the trust, unless written permission has been obtained from the Chief Pharmacist or Medical Director. 6.7 Representatives should not, in support of their product, cite or quote verbally stated opinions of NHS clinicians from this or other trusts. 6.8 Representatives should carry identification on them whilst visiting the trust. 6.9 Product samples are not permitted. 7 Visits by Pharmaceutical Representatives 7.1 Representatives of pharmaceutical companies must make contact through the Chief Pharmacist at first instance. The Chief Pharmacist will then make contact with the Divisional Clinical Lead or consultant for the specialist area to discuss the appropriateness of the visit. 7.2 Visits to medical and professional staff may only be made by appointment after approval has been given by the Chief Pharmacist. When requesting an appointment, the purpose of the visit must be explained and product information provided. Visits should be limited for discussion on significant product changes/information. Notification of minor changes should be made by post. 7.3 Representatives are not permitted access to any clinical unit unless the Chief Pharmacist has given approval following agreement with the consultant and team/ward 2 PHARMACEUTICAL REPRESENTATIVE POLICY_PHA39_VEMBER 2017
manager. Each unit has the right to refuse appointments or visits from pharmaceutical representatives. Representatives must not wander around wards. 7.4 Junior medical, pharmacy or nursing staff must not be contacted directly by representatives. 7.5 It is not acceptable for pharmaceutical company representatives to seek an interview or arrange meetings with nursing staff. However in order to organise an education session for nursing staff, the representative must obtain approval from both the Chief Pharmacist and Deputy Director of Nursing. The content of the training session must be sent to the Chief Pharmacist and Deputy Director of Nursing before approval is considered. 8 Access to information 8.1 Representatives are not permitted access to any individual patient information 8.2 Medical representatives may not attend ward rounds, clinics or any other meeting where confidential information is discussed. 8.3 Staff must ensure that patient confidentiality is maintained at all times during meetings with representatives. 8.4 Representatives are not permitted to access financial data relating to medicine usage or to receive information about usage of competitors medicines. 8.5 Representatives must not be given access to the trust intranet. 9 Educational meetings conducted by Pharmaceutical Representatives 9.1 Any educational activities undertaken within the Trust by representatives must be approved by the Chief Pharmacist and carefully controlled by senior managers. Content of the presentation / educational material must be sent to the Chief Pharmacist before any decision is made. Where the training is directed at nursing staff the Chief Pharmacist will discuss with the Deputy Director of Nursing before approval is granted. 9.2 A senior member of staff should be present at the meeting to ensure the information delivered is appropriate and that concurrent hospitality is modest and inducement absent. 9.3 Pharmaceutical representatives are not permitted to deliver educational sessions about medicines that have not been approved by the Drug and Therapeutics Committee or Chief Pharmacist. 3 PHARMACEUTICAL REPRESENTATIVE POLICY_PHA39_VEMBER 2017
10 Gifts, Hospitality and meetings Representatives must not offer gifts or benefits to health professionals or administrative staff as an inducement to prescribe, supply, administer or purchase any medicine. 10.1 Companies are permitted to provide appropriate hospitality to trust staff in association with scientific educational meetings or seminars. Meetings must have a clear educational content and agreed by the relevant senior manager beforehand. 10.2 The hospitality must be secondary to the purpose of the meeting and must not be out of proportion to the occasion. 10.3 Promotional stands must not be set up at such meetings. The support of the pharmaceutical industry will be acknowledged appropriately. 10.4 Staff must exercise judgement when accepting a gift or hospitality. Where it is not easy to decide, the offer should be declined or advice sought from a line manager. It is the responsibility of members of staff to ensure that neither their role nor the Trust s reputation is compromised. Staff should not accept or provide any gifts or hospitality if it gives the impression that they have been influenced or could influence decisions in the future. 10.5 Refer to the Trust Corporate Policy Gifts and Hospitality for more detailed information. 10.6 Staff must declare any interest which may lead to a conflict with the interests of C&I and the public for whom they provide services in relation to a decision to be made by C&I or which may affect, or appear to affect, the integrity of the decision. Declarations must be made to the Trust Secretary in line with trust policy and at relevant groups and committees. 10.7 Advice on the acceptability, hospitality or any aspect of a representative s operation may be sought from the Chief Pharmacist. 11 Further points 11.1 Comprehensive information on new medicines is essential e.g. product monographs, papers published in reputable journals. In addition, it is helpful to receive updates on existing medicines e.g. new licensed indication, recently published comparative trials, product discontinuation, future developments and cost changes. 11.2 Leaflets and posters produced by the pharmaceutical company may not be distributed or displayed in clinical areas unless approved by the Chief Pharmacist. 11.3 Medical representatives should be well informed about the medicines they are presenting including the standard technical and clinical data and the specific place the medicine is expected to have in therapy. 11.4 Commitment to contract for or purchase medicines can only be entered via the Pharmacy department. 12 Dissemination and implementation arrangements 4 PHARMACEUTICAL REPRESENTATIVE POLICY_PHA39_VEMBER 2017
12.1 This document will be circulated to all managers who will be required to cascade the information to members of their teams and to confirm receipt of the procedure and destruction of previous procedures/policies which this supersedes. It will be available to all staff via the Trust intranet. Managers will ensure that all staff are briefed on its contents and on what it means for them. 13 Training requirements None 14 Monitoring and audit arrangements Elements to be monitored Lead How trust will monitor compliance Frequency Reporting arrangements Acting on recommendations and Lead(s) Change in practice and lessons to be shared Information / education meetings Chief Pharmacist Review of content On going Drugs and Therapeutics Committee Required actions will be identified and completed in a specified time frame Required changes to practice will be identified and actioned within a specified time frame. Lessons will be shared with relevant stakeholders. 15 Review of the policy 3 years from date of ratification 5 PHARMACEUTICAL REPRESENTATIVE POLICY_PHA39_VEMBER 2017
16 References NHSE managing conflicts of interest in the NHS: Guidance for staff and organisations Feb 2017 (accessed November 2017) https://www.england.nhs.uk/publication/managingconflicts-of-interest-in-the-nhs-guidance-for-staff-and-organisations/ Association of British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry, February 2016. http://www.abpi.org.uk/ourwork/library/guidelines/pages/170216.aspx 17 Associated documents Gift and Hospitality Policy. Medicines Management Policy. Unlicensed medicines and unlicensed use of licensed medicines (off-label) policy. Trust formulary policy 6 PHARMACEUTICAL REPRESENTATIVE POLICY_PHA39_VEMBER 2017
Appendix 1 Equality Impact Assessment Tool Yes/No Comments 1. Does the policy/guidance affect one group less or more favourably than another on the basis of: Race Ethnic origins (including gypsies and travellers) Nationality Gender Culture Religion or belief Sexual orientation including lesbian, gay and bisexual people Age Disability - learning disabilities, physical disability, sensory impairment and mental health problems 2. Is there any evidence that some groups are affected differently? 3. If you have identified potential discrimination, are any exceptions valid, legal and/or justifiable? 4. Is the impact of the policy/guidance likely to be negative? 5. If so can the impact be avoided? 6. What alternatives are there to achieving the policy/guidance without the impact? 7. Can we reduce the impact by taking different action? N/A N/A N/A N/A 7 PHARMACEUTICAL REPRESENTATIVE POLICY_PHA39_VEMBER 2017