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GOVERNING BODY MEETING Wednesday 27 March 2013 Agenda Item 2.5 Name of Paper / Report Lead Author Contributors Governing Body Sponsor Service Level Agreement between NHS Vale Royal CCG NHS Eastern Cheshire CCG NHS South Cheshire CCG for Medicines Management Services Mark Dickinson Head of Prescribing and Medicines Optimisation Executive Prescribing Team Jerry Hawker Supporting healthy lifestyles and reducing health inequalities Reducing premature mortality Focussing on local needs Managing our resources Corporate development Purpose of Paper / Report Exec Summary For agreement At the informal Governing Body Meeting on 27 February 2013 it was agreed, based on historic excellent service provided by the Central and Eastern Cheshire PCT Medicines Management Team, that NHS Eastern Cheshire CCG would enter into an arrangement with NHS South Cheshire CCG and NHS Vale Royal CCG to retain a shared medicines management service across the area. Medicines Management is critical to the continuous improvement in the quality of care provided to patients and in ensuring that medicines are prescribed in the most effective and productive manner, retaining a balance between local expertise and economies of scale. The annual value of the contract will be 826,391. The funding for the whole service has been agreed by all parties; NHS Eastern Cheshire CCG, NHS South

EC CCG Governing Body Meeting 27 March 2013 Agenda Item 2.5 Cheshire CCG and NHS Vale Royal CCG based on a capitation weighting. NHS Eastern Cheshire s funding level will therefore be 349,500 (subject to final validation of capitation numbers). The contract start date will be 1 st April 2013. Recommendations The Governing Body is requested to: Note the final service level agreement Delegate authority to the Chief Officer to sign on behalf NHS Eastern Cheshire CCG Next steps On going monitoring of the SLA will be undertaken by the CCG Leadership Team. Author Name and Job Title Mark Dickinson Head of Prescribing and Medicines Optimisation Date 18 th March 2013 Contact details (phone 07900 691 858 and email address) Mark.Dickinson@cecepct.nhs.uk Page 2 of 2

SERVICE LEVEL AGREEMENT BETWEEN NHS Vale Royal Clinical Commissioning Group And NHS Eastern Cheshire Clinical Commissioning Group NHS South Cheshire Clinical Commissioning Group For Medicines Management Services Service Level Agreement between NHS Vale Royal Clinical Commissioning Group And NHS Eastern Cheshire Clinical Commissioning Group NHS South Cheshire Clinical Commissioning Group 1

1. Purpose of this Service Level Agreement To set out the arrangements for the provision of a Shared Medicines Management Service by NHS Vale Royal CCG to NHS Eastern Cheshire and NHS South Cheshire CCG. Medicines Management is critical to the continuous improvement in the quality of care provided to patients and in ensuring that medicines are prescribed in the most effective and productive manner, retaining a balance between local expertise and economies of scale. The cost of Medicines represents over 15% of CCG total commissioning budget. The CCGs and MMT understand the complexity of delivering a high quality cohesive medicine management function, given the complexity of patient pathways (multiple hospitals and networks) and differential practice performance, and the contrast between local excellence and opportunities for improvement. 2. The Service 2.1 Overall Aim The Medicines Management Team (MMT) will deliver the prescribing and Medicines Optimisation support to the CCGs using the following elements Clinical Leadership / Ownership Managerial / practical support Clear evidence base Excellent data/ true benchmarking Incentives and penalties. NHS Vale Royal, NHS South Cheshire & NHS Eastern Cheshire have agreed to collaborate in the development and provision of Medicines Management. The MMT will be hosted by NHS Vale Royal CCG on behalf of the three CCGs. 2.2 Values and principles of Service delivery The parties have agreed to adopt the following principles of a collaborative arrangement for medicines management; a. To ensure that local medicines management skills and expertise are protected and developed for the benefit of our local practices, communities and patients. b. To ensure no local detrimental impact in the quality, performance and value for money of existing medicines management. c. To recognise the autonomy of individual CCGs, but agree to maximising resource and expertise to the benefit of the collaborative. d. To communicate openly about concerns issues and opportunities related to the collaborative. e. To ensure that the provision of medicines management is clinically led, and locally owned. f. To retain the resource allocation previously transferred from the PCT ( 826,391). g. To formally review the total resource for the team on an annual basis and to apportion by CCG on a patient population basis. h. Individual CCG will be free to vary funding levels above their base allocation to meet local priorities 2

i. The budget and out-turn for prescribing and medicines use will be the responsibility of each CCG and not shared in any way unless the three CCG Governing Bodies formally agree to any risk pooling arrangements. j. Each CCG will be able to invest and disinvest in the Service. Human resources should be reviewed no more frequently than annually as part of the planning cycle. In particular, disinvestment requires a notice period agreed between the three CCGs. Any CCG voluntarily withdrawing from the service is responsible for its full allocation of the associated redundancy costs. k. NHS Vale Royal CCG will be the employer of all MMT team members, and take responsibility for all legal and statutory matters. 2.2 Service Description The MMT will provide a complete medicines management service, including both strategic and practicebased support varying by CCG as required. The benefit of integration of both strategic and operational functions include; efficiencies from practicebased work being planned at scale; robust staff training, performance management and retention; and avoiding the duplication and isolation known to be a disadvantage of individual GP practice-employed support. Relationships are at the heart of service delivery to support commissioners manage medicines across each health economy; including access to new treatments, formulary, contract and performance management. The points below outline the core functions to be delivered by the MMT on behalf of the 3 CCGs. More detail is provided in the Service Specification. a) Each CCG will establish its own annual plan working with the MMT to agree objectives and reporting schedule. b) This service provides expert advice to CCGs and prescribers on all aspects of medicines use; from strategic planning, commissioning and service development to operational support and patient interventions agreed at appropriate pan-ccg, individual CCG and individual practice / patient level. c) The MMT will host a Local Area Prescribing Committee to support development of the Local Health Economy Formulary, prescribing guidance and policy to maximise resources and offer patients appropriate medicines including implementation of NICE Technology Appraisal Guidance. d) The MMT will provide practice-based support to facilitate adoption of best practice, involving prescriber and patient interventions. The range of activities to be undertaken and the relative priority of each will be agreed with individual CCGs each financial year. The following is a list of examples but is not exhaustive Interpretation of clinical evidence and data Local guidance and formulary choices Medication review Quality, Innovation, Productivity and Prevention projects Safety alerts and drug withdrawals Process improvement, including repeat prescribing processes Clinical audit Responding to queries and general support Education and training. 3

e) The MMT will manage the provision of tailored prescribing data, including agreeing arrangements with the Commissioning Support Unit business intelligence function and other providers as appropriate. f) The MMT will agree joint working arrangements with MM colleagues, locally, regionally and nationally. g) The MMT will provide strategic advice and support and operational management for Payment by Results Excluded medicines and other high cost drugs to the CCGs. h) The MMT will provide medical and pharmaceutical support to the Individual Funding Request process on behalf of the CCGs. i) The MMT will support arrangement to improve access to medicines including the use of Non- Medical Prescribing arrangements and Patient Group Directions in accordance with relevant legislation. j) The MMT will develop and support the implementation of incentive and penalty schemes for providers as appropriate and agreed with the CCGs. k) The MMT will support CCGs to ensure that providers and services comply with relevant legislation and statutory duties relating to medicines l) The MMT will respond to safety alerts, incidents and complaints to increase the safety of medicines use and safeguard against substandard or unsafe practice. m) The MMT will provide pharmaceutical advice and support to emergency planning forums n) The MMT will support the management of contracts for medicines, appliances, medical gases and services to optimise prescription and non prescription routes of supply. o) The MMT will support CCGs to set, monitor and manage prescribing budgets. 3. Governance a) Each CCG will appoint a GP Prescribing lead who will sit on the Executive Prescribing Committee (EPC) together with the Head of Prescribing and Medicines Optimisation and their deputies to agree strategic and operational issues and oversee governance of the service. The EPC will be chaired by the Head of Prescribing and Medicines Optimisation. b) Decisions within the GP Prescribing Leads individual delegated limits as specified by their CCG will be made within the EPC and those outside will be referred up to their respective committees; Quality and Performance Committee / ECCCG Leadership Team. c) On a quarterly basis the EPC will produce a report to the respective reporting committees (Quality and Performance Committee/ ECCCG Leadership Team ). These Committees will also receive the minutes of joint medicines committees for information. d) The Head of Prescribing and Medicines Optimisation will be accountable for the delivery of objectives and for having in place appropriate systems for risk identification eradication or mitigation relating to financial targets. e) All three CCGs have a responsibility to support service delivery by arranging appropriate access to systems, staff, resources and accommodation. The CCGs will undertake to ensure that any risks, protocols or guidance issues identified by the MMT in relation to the services delivered are communicated to and followed by all relevant parties. 4

f) The CCGs will inform the MMT, with a reasonable period of notice, of service developments, timetable or other changes that impact on delivery of services under this SLA. 4. Insurance and Liability The Medicines Management team will be covered by NHS vicarious liability held by NHS Vale Royal CCG covered by the NHSLA. 5. Amendments, Disputes, Termination of Contract and Recovery of Funds 5.1 Amendment to the Agreement This agreement may be amended at any time so long as such amendments are agreed by all the signatories. 5.2 Disputes Any dispute or disagreement arising between a CCG or the CCGs and the MMT should be resolved by the parties involved. Any dispute or disagreement not resolved locally will be escalated to the NHS Vale Royal CCG Governing body for resolution or an external body who will act as an independent arbiter. Failure to reach resolution may lead to one or more parties withdrawing from the agreement. 6. Funding for the Service 6.1 Contract start 01 April 2013 6.2 Notice Period If any party wish to terminate the contract during the contract period they should give 1 years actual notice in writing. The appropriate allocation of real redundancy and other termination costs should the Shared Service be terminated by one or more party. 6.3 Agreed funding level The annual financial allocation for the whole service has been agreed by all parties; NHS Eastern Cheshire CCG, NHS South Cheshire CCG and NHS Vale Royal CCG. The annual value of the contract will be 826,391. The apportionment of costs and MMT resources to each CCG, (NHS Eastern Cheshire CCG, NHS South Cheshire CCG and NHS Vale Royal CCG), is determined by their individual unweighted capitation level on the 1 st of January in each year that the service is provided. Payments will be made to NHS Vale Royal CCG monthly on 15 th of each month. Slippages and deficits will be shared by all three CCGs on a proportionate basis. 5

7.0 Equality and Diversity Equality and diversity will be embedded into the work of the medicines management delivery programme. The service will be delivered in a way that it is accessible to all protected characteristics including: Age Sex Disability Sexual orientation Gender re-assignment Marriage and civil partnership Pregnancy and maternity Race Religion and belief We will work with patients, practices and pharmacists to foster good relations and to ensure services are delivered to meet the needs of local people and communities. Services will be free from discrimination and we will ensure patients have equal access to medicines in accordance with the Equality Act 2010. 8. Signatories to the Agreement 8.1 On behalf of NHS Vale Royal Clinical Commissioning Group: Name: Position: Lynda Risk Finance Date: Signature: 8.2 On behalf of NHS South Cheshire Clinical Commissioning Group Name: Position: Date: Signature: 10.3 On behalf of NHS Eastern Cheshire Clinical Commissioning Group Name: Position: Date: Signature: 6

7

SECTION B PART 1 - SERVICE SPECIFICATIONS Service Specification No. V 0 1 Service Medicines Management Commissioner Lead Provider Lead Period Date of Review 1. Population Needs 1.1 National/local context and evidence base- 2. Scope 4 elements 1) Regulatory and Statutory Compliance We will support CCGs to enable commissioned and provider services to comply with the Medicines Act and other relevant legislation e.g. Patient Group Directions are robust and have appropriate organisational sign off. We will support practices to comply with CQC standards for medicines use for CQC registration. We will ensure CCGs comply with the Association of British Pharmaceutical Industry (ABPI) code of conduct and standards for engagement with the pharmaceutical industry. We will provide advice on any proposals for sponsored projects and events to ensure compliance with the ABPI code of conduct and maintain sponsorship registers on behalf of the CCGs. We will co-ordinate the dissemination and of drug and safety alerts. We will support reporting of and shared learning from serious incidents and near misses related to medicines. We will co-ordinate responses to Freedom of Information requests related to medicines. We will support the CCGs to respond to medicines related MP s letters, PALs enquiries and media enquiries. We will support CCGs with regards to medicines related organisational requirements to ensure 8

medicines optimisation is met. The CCGs, as commissioners, will be responsible for ensuring all commissioned services operate in a safe manner to protect patients. All policies and procedures relating to medicines procurement, use and storage need to comply with relevant legislation e.g. Medicines Act, Waste Regulations. Controlled Drug regulations. Prescriptions pads, as controlled stationery, need to be ordered, used and stored in a secure manner ensuring audit trails are in place. The Department of Health is encouraging more joint ventures between NHS organisations and the pharmaceutical industry. It is essential any such ventures are conducted in accordance with the ABPI code of conduct and a register of interests in maintained. CCGs will be responsible for the dissemination and implementation of drug and safety alerts. Where implementation information is needed (e.g. patient level re-calls of drugs) we will provide this so that the relevant members of staff can ensure implementation is robust. CCGs will be responsible for responding to FOI requests, MP letters, PALs enquiries and media enquiries. We will provide appropriate response in conjunction with the relevant CCG(s). Often these request come into multiple organisations so we can support the CCGs to respond consistently and efficiently. 2) Support to ensure CCGs comply with principles of NHS Constitution with regards to strategic decisions regarding medicines We will provide a professional secretary function and advice to the local Area Prescribing Committee (APC), to ensure the principles of the NHS constitution are upheld, so reducing the possibility of post code prescribing and judicial review. We will facilitate the managed entry of new drugs, formulary and guideline development, shared care protocol development, and commissioning agreements with provider organisations by leading and coordinating the working groups. We will support the process to enable consistent decision making across the Local Health Economy in order to support the delivery of the QIPP agenda, NICE compliance and budgetary management. We will produce medicine policy statements, shared care protocols, joint formularies and lead on the production and review of the Red/Amber/Green (RAG) list. We will lead the annual horizon scanning process in relation to new drug developments in conjunctions with relevant stakeholders. We will lead on ensuring public and patient involvement in shaping the recommendations of the APC. We will lead on sharing learning from safety incidents related to medicines, on co-ordinating National Patient Safety Alert implementation plans across the Health Economy, or other joint work across the health economy promoting medicines safety and assurance We will represent the CCGs on the provider Drug & Therapeutic Committees/Medicines Management Committees/Clinical Networks e.g. JMMC, MMG We will lead and co-ordinate QIPP meetings with Secondary Care Chief Pharmacists across the Health economy. We will professionally manage the local Health Economy Formulary website to ensure all output is communicated and available to clinicians and the public. CCGs need to ensure they comply with the requirements of the NHS constitution when making decisions about the use of medicines. Decisions need to be made in a robust way in order to be able to withstand challenge and potential judicial review. We will lead the process to produce and review policy statements, shared care protocols, the joint formulary and produce and review the Red/Amber/Green (RAG) list in conjunction with secondary care colleagues and the joint formulary pharmacists. 9

We will ensure potentially controversial or significant decisions e.g. drug not recommended for use (and not within NICE technology appraisal work plan) or NICE recommended as a treatment option with significant financial impact, are discussed at the EPC prior to being sent to the CCG Boards for approval. In order for the CCGs to plan resources effectively we will lead and manage the annual horizon scanning process across primary, secondary and tertiary care to feed into budgetary and service planning/commissioning processes. The output from this process will then be built into the new drugs introduction. The CCGs are responsible for dealing with Individual Funding Requests when a clinician treating a patient deems them to be exceptional and seeks funding approval for a drug not routinely commissioned. We will manage the medicine-related IFR decisions on behalf of the CCGs and ensure all decisions are supported by evidence. All provider organisations have Drug & Therapeutics Committee/Medicines Management Committee and it is important there is a representative from primary care in attendance to ensure primary care views are considered. We will ensure there is consistent representation at the provider DTCs/MMCs and feedback any relevant issue to the CCGs. There are many opportunities to work with secondary care colleagues to deliver the QIPP agenda. We will lead and co-ordinate regular joint QIPP meetings to develop and implement any CCG joint QIPP plans with secondary care and identify new areas where work is necessary. 3) Provide medicines management input into secondary care and other provider contracts We will lead in the development and monitoring of the medicines elements of provider contracts, e.g. quality schedules and CQINs including agreement of audits as required e.g. compliance with NICE TAs. We will manage Payment by Results excluded (PbRe) drug budgets to ensure monitoring of expenditure, identification of spending trends, examination of causality and implementation of solutions as agreed through the APC. This includes advising on the data to be provided by service providers to do this and its appropriate reporting and manipulation by them. We will ensure secondary care Chief Pharmacists are monitoring homecare provider contracts for appropriateness of care, duration and charges and also ensuring value for money when negotiating provider contracts. We will identify joint opportunities for QIPP across primary/secondary/tertiary care and facilitate implementation. We will represent the local health economy with regards to cancer commissioning of medicines. We will provide a financial overview with regards to the total spend on medicines PbRe, high cost drugs and primary care prescribing. We will work with finance and business intelligence colleagues to provide a pharmaceutical link between the CCGs and specialised commissioning, Out of Hours providers and the voluntary sector including charities (hospices) to ensure CCG interests are accounted for in all medicine-related decisions. The quality schedule and CQINs in provider contracts are an opportunity to ensure medicines are used in a safe and cost-effective manner and are in line with NICE/National guidance. We will work with the CCGs to ensure issues of concern or where assurance is needed are built into the quality schedules or CQINs. We will liaise with the secondary care Chief Pharmacists to ensure measurement is appropriate and can be provided in a timely manner. The PbRe drug budget across the health economy amounts to approximately Xm when taking into account what is included in block contracts and what is invoiced separately. The budget is growing rapidly due to increased use of cytokine inhibitors for an increasing range of conditions in dermatology, rheumatology and gastroenterology especially. We will monitor this budget to ensure all treatments are in line with NICE or locally agreed pathways. Many patients have their therapy delivered by homecare providers and again this budget is increasing rapidly. We will ensure secondary care Chief Pharmacists monitor homecare provider contracts to 10

ensure policies and procedures are robust, care is appropriate and invoices are accurate. Due to the rapid increase in the PbRe budget and high cost drugs we will work with secondary care colleagues to identify opportunities for QIPP and facilitate implementation. It is important that the CCGs monitor all medicines expenditure not just primary care prescribing as a considerable amount of money is spent in other areas. We will provide a monthly report on the total spend on medicines and update the CCGs regarding any additional pressures they may expect e.g. from NICE approved medicines. Some services are commissioned by Specialised Commissioning and we will provide a pharmaceutical link to this process and report back to the CCGs. 4) Pharmaceutical Public Health advice and support We will support the development of strategies to minimise the pharmaceutical elements contributing to health care associated infections (HCAIs). We will develop strategies to enable antibiotics to be used appropriately (Not Liverpool). We will support the medicines aspects of pandemic flu planning We will support the planning, implementation or monitoring of pharmaceutical public health schemes e.g. waste medicines disposal, needle exchange, supervised methadone, drugs misuse and sexual health services (some may be NCB or Local Authority responsibility). (Not Liverpool) We will follow up root cause analysis of whether medicines may have contributed to HCAIs for individual patients 3. Applicable Service Standards 3.1 Applicable national standards eg NICE, Royal College 3.2 Applicable local standards 4. Key Service Outcomes To 1) Commissioned services have been checked to ensure they have safe systems in place for medicines procurement, use and storage. All CCGs have a sponsorship policy and register of interests in place. All drug and safety alerts will be disseminated within the required timeframe. All responses to medicines related FOI requests will be collated within the necessary timescales. All responses to medicines related MP letters, PALs enquiries and media enquiries will be provided within the necessary timescales. 11

2) Local Area Prescribing Committee Meetings are held every 2 months Provider D+T/MMG meetings are held monthly or 2-monthly. APC outcomes are presented to the EPC where appropriate for further discussion before being presented to CCG Boards/Governing Bodies. Reports are produced regarding APC output quarterly to key stakeholders. Health economy formulary is updated monthly. Attendance is monitored to ensure organisations are adequately represented. NICE timescales are adhered to e.g. recommendations will be discussed at the EPC to ensure decisions to fund within 3 months of technology appraisals being released are made. All amber shared care drugs have agreed shared care protocols within 3 months of the need for a SCP being identified, subject to co-operation from key stakeholders e.g. L.M.C., secondary care clinicians, CCGs. The Red/Amber/Green (RAG) is produced and reviewed on an ongoing basis, with an overview on an annual basis. The annual horizon scanning process will begin in October with feedback on the potential budgetary impact being provided to CCGs by the end of January each year. All IFRs relating to medicines undergo an evidence review. A pharmacist representative attends all provider Drug & Therapeutic Committees/Medicines Management Committees/Clinical Networks and feedback is provided to the CCGs. QIPP meetings are held with the Secondary Care Chief Pharmacists across the Health economy on a regular basis at least quarterly. 3) All provider medicines management quality schedules are agreed by 31st March for the next financial year All provider medicines management CQINs are agreed by all parties by 31 st March for the next financial year. All medicines management elements of the contract quality schedule and CQINs are monitored as agreed. Cancer commissioning meetings are attended and feedback provided to CCGs within 1 week of the meeting. All homecare provider invoices are checked and challenged if inappropriate charges are made. At least one joint primary/secondary/tertiary QIPP project is identified and delivered each year Monthly reports on PbRespend, high cost drugs spend and prescribing spend to be reported to the CCGs. All meetings with the NCB regarding specialised commissioning will be attended where required and issues fed back to the CCGs as agreed with Business Intelligence and Finance. We will oversee the medicines management aspects of the OOH provider contracts and ensure OOH medicines supplies are in line with DH guidance 4) Vaccination and Immunisation PGD templates produced and maintained in accordance with national policy (Green Book) Production of a pandemic flu medicines plan. Strategy for HCAI management produced. Strategy for antimicrobial use produced. Antibiotic guidance updated annually 12

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Governing Body Governing Body Governing Body ECCCG Leadership Team Quality and Performance Committee And Commissioning Advisory Board GP Prescribing Lead (EC) GP Prescribing Lead (VR) GP Prescribing Lead (SC) Senior Medicines Management Team Executive Prescribing Committee Appendix 2