Interface Pharmacist Network Specialist Medicines Shared Care Guidelines

Interface Pharmacist Network Specialist Medicines Shared Care Guidelines Guidance on the development & maintenance of shared care guidelines for amber listed medicines June 2012

Contents Section 1 Introduction Section 2 Forming a shared care guideline development group Section 3 Running a shared care guideline development group Section 4 Identification of evidence & information sources Section 5 Writing a shared care guideline Section 6 Consultation and dealing with stakeholders comments Section 7 The final document Section 8 Evaluation Section 9 Updating the guideline and correcting errors References Appendices Appendix 1 Shared Care Guideline Development Action Plan Appendix 2 Standard letter of invitation Appendix 3 Comments sheet

SECTION 1 Introduction The purpose of this document is to facilitate the systematic development of shared care guidelines for amber list specialist medicines within the Northern Ireland HPSS. A specialist medicine is classified amber when it is deemed suitable for prescribing responsibility to transfer from secondary to primary care. The transfer process is dependant on an agreement between the initiating consultant and an individual GP. The aim of a shared care guideline is to optimise patient care. Objectives include: Defining the shared responsibilities of practitioners involved in the patient s care. Meet clinical governance requirements by recommending best care practice. Provide appropriate information to ensure patient safety. Ensure efficient use of resources and expertise. The Interface Pharmacist Network Specialist Medicines (IPNSM) will be responsible for: Identifying and prioritising guideline development. Co-ordinating the guideline development process. Managing the introduction of new shared care guidelines. The Regional Group on Specialist Medicines will be responsible for overseeing the introduction of shared care guidelines within the Northern Ireland HPSS. 2

SECTION 2 2.1 Forming a Shared Care Guideline Development Group (SCGDG) A workable size for the SCGDG is 10 to 12 people. The SCGDG members should be drawn from different Trust areas across Northern Ireland. All SCGDG members are expected to attend all meetings/ link in to virtual meetings/ engage in electronic correspondence and to have a commitment to guideline development. The key constituents of the SCGDG are: The chair Professional members Interface pharmacist for specialist medicines task co-ordinator The composition of the SCGDG will vary according to the topic covered by the guideline. 2.1.1 Selecting the Chair The chair should have enough expertise in co-ordinating groups of health care professionals. The chair is usually expected to have a good understanding of the guideline topic and is therefore likely to be a clinician. On occasion, however, he or she may be someone with facilitative skills who is not an expert in the topic area. Although clinical knowledge is not essential, it is usually advantageous in understanding the scope of the guideline and discussions surrounding its content. The nominees are formally approached by the IPNSM and are asked at this stage if they would wish to be considered as chair. From the positive replies received the task coordinator interviews and selects the chair. 2.1.1.2 Key roles and functions of the Chair The chair needs relevant background knowledge, including: In-depth knowledge or appreciation of the scope of the guideline and the topics to be covered during the meeting Good knowledge of the skills mix within the group To facilitate the group process, the chair: Assists with the planning of the meetings Ensures that the group has relevant information Provides opportunities for all members to contribute to the discussions In meetings the chair: Has a directive role in steering the discussions according to the agenda Keeps the group discussion unified and avoids the disruption of sub-conversations and dominance by some members Encourages constructive debate, without forcing agreement Winds up repetitive debate Summarises the main points and key decisions from the debate. 3

2.1.2 Professional members Interface Pharmacist Network Specialist Medicines - Developing SCGs June 2012 Professional members should be representative of the healthcare workers involved in the care of patients affected by the guideline topic. Professional members may include: Hospital specialist/ consultant GP Medicines Management Advisor Clinical Governance lead Clinical pharmacist Community pharmacist Specialist nurse (Primary and secondary care) Practice nurse/ district nurse/ treatment room nurse 2.1.2.1 Selecting professional members The professional members should be representative of the healthcare workers involved in the care of the patients affected by the shared care guideline. Appropriate professional members can be identified by writing to key stakeholder organisations for nominations or from individual expressions of interest. Potential members should be invited to complete a declaration of interest form and return this to the Interface Pharmacist Specialist Medicines co-ordinating the SCGDG. 2.1.2.2 Key roles of professional members SCGDG members are expected to: Contribute constructively to meetings and have good communication and team working skills; this should include commitment to the needs of service users Use background knowledge and experience of the management of the topic being covered Read all relevant documentation and make constructive comments and proposals at SCGDG meetings and in the interim Use their own networks to augment their contribution to the group They are not expected to: Search for literature Write the guideline Ideally 2 or 3 nominations to represent each healthcare professional should be requested so the most appropriate person for the group can be selected. If there is a professional nominee who cannot be included (because there are too many nominees) that person may be asked to comment on the draft guideline as part of the consultation process. The membership of the group will be finalised by the chair and task co-ordinator. At the first meeting, the make-up of the group is examined to ensure complete representation has been achieved. 4

2.1.3 Interface Pharmacist Specialist Medicines (IPSM) The role of the IPSM will be as task co-ordinator and will encompass the following: Seeking nominations for professional members including the appointment of a chair Forming the group Organising meetings Identifying and providing evidence/information Providing administrative support Writing guideline Maintaining version control as appropriate Facilitating consultation Taking the final shared care guidelines to the Regional group on Specialist Medicines for ratification Disseminating and implementing of the shared care guidelines 5

SECTION 3 Running a Shared Care Guideline Development Group (SCGDG) As Task Coordinator, the Interface Pharmacist Specialist Medicines (IPSM), in consultation with the chair, has the following core responsibilities: seeking agreement of the development group members the method of running the group, face to face meetings, video-linked meetings, or electronic correspondence i.e. via email setting meeting dates planning agenda items sending out papers keeping a record of all meetings As task co-ordinator, the IPSM produces, in conjunction with the chair, an action plan in advance of the first meeting. This should be disseminated to the group at the first meeting. (See Appendix 1) 3.1 General principles As the SCGDG is multidisciplinary, its members will bring with them different beliefs, values and experience. It is important that all these perspectives are listened to and that each member has an equal voice in the process. It is important to check that the terminology members use is understood by all and that the group obtains clarification when needed. The chair should ensure there is sufficient discussion to allow a range of possible approaches to be considered, whilst making sure the group remains focused on the guideline remit and the timescale of the project. The chair needs to allow sufficient time so that all members can express their views without feeling intimidated or threatened and should check that all the members in the group agree to endorse the share care guideline. Decision-making methods used to come to a consensus should be documented by entering these into the SCGDG database as appropriate. 6

SECTION 4 Identification of Evidence and Information Sources 4.1 Sources It is important to ensure that the SCG development process is as thorough and unbiased as possible. It is equally important to determine the best practice to be recommended and what is the best evidence to support the information in the shared care guidelines. Not acting on or implementing best practice can affect patient outcomes. Sources of acceptable information should be evidence based and recognised within the NHS. Acceptable information may come from 2 main sources and should be considered until date of publication of guideline: a) Information from the stakeholders or members of the guideline development group. b) Information from literature or database searches. 4.2 Documentation of evidence All evidence or information submitted for consideration by the SCG development group should be documented including any material submitted but not used. Results of database searches and methods used to search should be recorded as part of the audit trail for guideline development. 4.2.1 Stakeholder evidence Stakeholders and the development group may submit information or evidence individually, this should be considered for use based on the same principles as information found by gathering evidence by systematic searches. 4.2.2 Suitable sources of information Systematic reviews Randomised controlled trials Other shared care guidelines National service frameworks Guidelines issued by professional bodies NICE guidelines Local practice guidelines Relevant websites 4.2.3. Information less suitable for inclusion: Studies of weak design Promotional literature Editorials interpreting trial results Representations or experiences of individuals Commercial In confidence material 7

SECTION 5 5.1 Writing a Shared Care Guideline 5.1.1. Principles for writing guidelines 5.1.1.2 Guideline Structure Arrange the information within the fixed template using the: standard titled sections, and bold the headings within these sections. 5.2 Presentation Using lists Use a bulleted list rather than a numbered one, to avoid implying a ranking or preference. Using tables and figures Tables need to be readily understood and have a clear informative title. Limit footnotes unless essential. Number tables sequentially Obtain permission to use tables or figures reproduced from published sources. Using abbreviations If it is thought that general readers will be familiar with an abbreviation, use it throughout after defining at first use. Font Use Arial 14 where possible. Limit bold print to section titles and headings within sections (See template). In text, apply bold only to agreed key statements. 5.3 Produce first draft document The IPSM on each SCG development group produce an initial document prior to the groups first meeting (Meeting 1) this is referred to as the skeleton document This document is sent out in advance of Meeting 1 as an initial starting point in the development process, to initiate discussion, and clarify relevant areas etc. Explain its purpose before and at the beginning of the first group meeting. If the SCGDG have agreed to carry out the process via email, this is emailed to the group for comment by an agreed date. Note agreed recommendations made by the group Prepare the first draft SCG using the agreed structure and style Distribute the first draft SCG for first consultation 5.4 Produce final draft document At Meeting 2,discuss comments received from first consultation and action if necessary Complete final draft of SCG If the SCGDG have agreed to carry out the process via email, the comments received are emailed to the group for agreement of a final draft of the SCG. Distribute the final draft of the SCG for second consultation 8

5.5 Produce final document of SCG At Meeting 3, discuss comments received from second consultation and action if necessary Complete final document of SCG If the SCGDG have agreed to carry out the process via email, the comments received are emailed to the group for agreement of final document of the SCG. 9

SECTION 6 6.1 The Consultation process The consultation process, and dealing with the comments produced, can be complex and lengthy, due to the production of different versions of the relevant SCG. Two consultation phases will normally occur and the comments noted. Realistic dates must be given by which the comments should be received. 6.1.1 First consultation A first draft version of the SCG will be sent electronically to a limited number of agreed stakeholders identified at the first meeting for comment. The comments should aim to ensure that: The SCG is clinically relevant Any major areas of concern are identified The SCG is realistic in practice. The comments should be dealt with according to section 6.2.2. Once any changes have been made to the document in response to the comments received, the SCG is distributed for a second consultation. Points to consider in the first consultation are: Points/areas that are not covered but which appear to fall within the scope of the guideline Potential inconsistencies or any disagreement with the detail included 6.1.2 Second consultation The second consultation is a wider consultation of the final draft of the SCG to relevant stakeholders. Any new issues raised must be responded to in the standard way. The Chair should revise the guideline and cross-check the changes against the comments received and the responses made. The overall purpose is to: Identify major areas of concern for discussion with GDG Identify any minor changes that may be required. These may be submitted either by a written report or annotated on the submitted SCG. At the end of the second consultation, a meeting will take place to discuss major areas of concern. If appropriate, the document should be amended again, still maintaining the audit trail. 6.2 Principles of responding to comments 6.2.1 Format of comments All comments received regarding the SCG using Appendix 3 should be entered into the SCG database. A report will be produced containing the following information: Commentator name of organisation/body/person submitting comments Section highlighting which section comment relates to Comments specific comment (without editing) Response blank column for GDG to complete It may be necessary to request additional information from the commentator in order to assess the comment. 10

6.2.2 Responding to comments The following should be taken into account when responding to comments. Each comment must be acknowledged and answered as fully and as factually as possible. Some comments may be presented generally but should still be noted. If changes are made to the SCG, this must be made clear in the response. If no changes have been made, a full explanation must be given as to why it was not thought necessary. Comments made on draft guidelines: - responses and changes must be made with the agreement of the whole SCGDG. The best method is by a meeting, which should be arranged very early in the process to ensure full attendance. - any subsequent changes to guideline documents need to be reflected in each version and an audit trail of changes must be maintained. 6.3 Stakeholders Stakeholders include Medical colleagues Nursing colleagues All prescribers Drug & Therapeutic Committees/ Area Prescribing Fora Director of Public Health Interface Pharmacist Network Specialist Medicines Head of Medicines Management within Trusts Clinical pharmacy networks Professional bodies (Northern Ireland) e.g PSNI Patient Client Council Local Commissioning Groups Pharmaceutical Contractors Committee LMC GPC Medical advisors Medicines Management Advisors 6.4 Editing and final check prior to publication The IPSM will edit the SCG document to ensure that: The style and format are according to the standard The information is unambiguous The information is clear and appropriate for the intended audience. 6.5 Signing off the guideline Once the second consultation has been completed and comments addressed, the documents are returned to the SCGDG to be signed off. 11

SECTION 7 The Final Document The final, agreed document should be tabled as a full agenda item of the Regional Group of Specialist Medicines. The purpose of this is to give the final endorsement of the document prior to final publication and distribution. The document is then to be disseminated as agreed. 12

SECTION 8 Evaluation 8.1 Desired outcome The completed SCGs should be used to produce seamless care for patients receiving an amber listed medicine across the secondary/ primary care interface. The IPNSM need to be able to assess the effectiveness of SCGs at doing this. 8.2 Types of evaluation Informal feedback Formal feedback Audit Measure outcomes Focus Group 8.3 Methods of evaluation Surveys Questionnaires Case note reviews Audit Routine monitoring 8.4 Outcomes from evaluation How to raise profile of SCG if required How to collate comments for review purposes How to replace redundant SCGs How changes in organisation structure might affect SCGs 8.5 Timescale Dependant on medication and uptake of SCG If rarely prescribed in primary care, the timeframe may be upwards of 12 months If frequently prescribed, timeframe may be three-six months 13

SECTION 9 Updating Guidelines and Correcting Errors 9.1 Scheduled review of existing SCGs invite some members of the original group to join the review group for continuity invite new members to bring a fresh perspective aim for the same mix of professionals, patient/carers as the original group follow the development process used originally although electronic communication may be possible depending on the complexity of the process. 9.1 For a new amber list medicine in a specialty where SCGs already exist for other amber list medicines: follow the procedure for development of a SCG using electronic communication and/or meetings as appropriate. 9.3 Updating guidelines before a scheduled review Responsibility for updating the guideline will rest with the IPNSM In updating guidelines IPNSM should consult with the original SCGDG and if necessary the Regional Group on Specialist Medicines use the records of the previous SCGDG obtain relevant post-publication information decide the new scope, and whether an update is needed as a result of emerging evidence and comments from the original SCGDG, and other stake-holders. 9.4 Correcting Errors 9.4.1. Criteria for a issuing a correction Corrections or changes will be made when: an error undermines the conclusions on which a recommendation has been based an error may result in harm to patients 9.4.2 Issuing a correction The guideline development group will consider the proposed error If no error is considered to have been made this will be communicated to the individual or organisation who reported it. If a correction is to be made stakeholders will be notified either by the website only, or in writing and through the website. The Chair will decide which is more appropriate based on the nature and significance of the error. The web version will be corrected and this will be highlighted on the relevant first page. 14

REFERENCES NICE SIGN Appraisal of Guidelines for Research & Evaluation. AGREE Instrument. The AGREE Collaboration Sept 2001. Red/Amber list 15

APPENDICES Appendix 1 Shared Care Guideline Development Action Plan ACTION TO BE TAKEN OUTCOMES SUGGESTED TIMEFRAME Meeting 1 1. Establish group 2. Prepare skeleton document and email to group in advance of meeting 1 3. Arrange meeting 1 4. Define remit & review membership of group 5. Introduce what an amber medicine is and what a SCG is 6. Agree decision making methods 7. Based on comments of group, agree first draft Remit First draft 8 weeks Between Meetings Meeting 2 Between Meetings Meeting 3 8. Distribution of first draft for first consultation 9. Prior to Meeting 2 send collated comments to group 10. Arrange Meeting 2 11. Discuss consultation comments & action if necessary 12. Complete final draft of SCG 13. Distribution of final draft for second consultation 14. Prior to Meeting 3, send collated comments to group 15. Arrange Meeting 3 16. Discuss comments & action if necessary 17. Complete final document of SCG 18. Bring final SCG to Regional Group on Specialist Medicines Final draft SCG 8 weeks 8 weeks Next appropriate meeting 19. Launch 16

Appendix 2 Standard letter of invitation Interface Pharmacist Network Specialist Medicines - Developing SCGs June 2012 Interface Pharmacist Network Specialist Medicines Dear Colleague, Re Development of shared care guideline for <drug> The Interface Pharmacist Network Specialist Medicines (IPNSM) is facilitating the development of a Shared Care Guideline (SCG) for < drug > in the treatment of < condition > A SCG details the respective clinical responsibilities of the consultant and G.P thus ensuring the management of a particular medicine may be transferred into the community. The medications that are suitable for SCG development are termed "Amber list medicines" and, whilst not falling into the Red list of specialist medicines, cause particular monitoring difficulties and responsibilities for GPs. Examples of guidelines already published for other Amber medicines can be found at: http://www.ipnsm.hscni.net/library/shared%20care%20guidelines.html. As a colleague with an interest in this field, I would be very grateful if you would consider being part of a development group to draw up a Shared Care Guideline for this drug. Please reply by< date> if you would consider participating in this process. The expected workload for you is not prohibitive as I will act as task co-ordinator and provide the group with administrative and organisational support. We would also hope to carry out most of the development work electronically by email, only resorting to face to face meetings if the group feel it is necessary. A document detailing the SCG development process is available on the website listed above for your information. We are also seeking one of the development group members to undertake the role of Chairperson for this group - please indicate also if this is a role you would be interested in undertaking. Please do not hesitate to contact me on the number below if you would like to discuss this request further. Yours sincerely, XXXXXXXXXX IPSM 17

Appendix 3 Comments sheet Comments sheet for: SCG section Comments Introduction Hospital specialist responsibilities GP responsibilities Adverse effects and contraindications Drug interactions Communication Footnotes Name: Contact details: 18