Provision of Near-Patient Testing Service Service Level Agreement 2016-2019 Contents: 1. Financial Details 2. Service Aims 3. Criteria 4. Ongoing Measurement & Evaluation 5. Accreditation 1. Background Originally commissioned in 2004, the Near Patient Testing was aimed at monitoring those patients currently being prescribed a range of drugs particularly focussed in the field of Rheumatology following an agreed shared care plan with secondary care as evidence shows the incidence of side effects can be reduced if shared care plan monitoring is carried out in a well organised way, close to the patients home 1. In the guidelines 2, the British Society for Rheumatology (2008) discussed various DMARD s, all of which are included in this service (excluding Hydroxychloroquine) due to minimal use and minimal monitoring respectively. 2. Financial Details This agreement is to cover the 36 months commencing 1 April 2016. Each practice contracted to provide this service will receive a monthly payment in line with prior year activity. Payment adjustments will be made quarterly based on actual activity levels calculated as 25% of the annual contract value detailed below times the number of patients in each quarter. For example 5 patients on Leflunomide (only) in Q1 will generate a payment of 5 (patients) x 10 (i.e. a quarter of the 40pa payment). Where a patient is receiving shared care across multiple drugs; only one monitoring payment at the highest level relevant to those drugs will be made. For example, if a patient is on Azathioprine (level 3) and Denosumab (level 1) payment will be at level three. 1 British Society for Rheumatology (2008) BSR/BHPR Guideline for Disease-modifying Anti-rheumatic Drug (DMARD) Therapy in Consultation with the British Association of Dermatologists, Oxford University Press 2 British Society for Rheumatology (2008) BSR/BHPR Guideline for Disease-modifying Anti-rheumatic Drug (DMARD) Therapy in Consultation with the British Association of Dermatologists, Oxford University Press
Shared Care Drugs Monitoring Intensity Levels Payment per patient Per Annum Azathioprine Ciclosporin Mercaptopurine Dronedarone Methotrexate Year 1 Denosumab Sodium Aurothiomalate Dronedarone Sulfasalazine Leflunomide Mycophenolate Penicillamine Sulfasalazine Level One Level One Level One - Year 2 onwards Level One - Year 2 Level Two Level Two Level Two Level Two Year 1 Practices will be requested to complete quarterly activity returns in 2016/17 which the CCG will reconcile against activity reports run centrally from TPP SystmOne and equivalent clinical systems. Through discussion with practices differences will be identified and agreed in order to eliminate future differences throughout 2016/17. Quarterly payment adjustments will be made based on agreed actual activity levels. From 2017/18 onwards it is envisaged that the CCG will run central searches in order to make quarterly payment adjustments based on actual activity, following the alignment of activity reporting within 2016/17. In signing up to this service the practice agrees to recording patient activity using the read codes above, and agrees for the CCG to reconcile quarterly activity returns to central reports run based on these read codes, for payment and audit purposes. Practices will be paid where they have accepted responsibility for monitoring patients according to locally agreed shared care guidance or a care plan agreed with secondary care for that patient. The CCG reserves the right to make changes to, add, amend or cancel this service with three months given notice. 3. Service Aims The treatment of several diseases within the fields of medicine is increasingly reliant on drugs that, while clinically effective, need regular blood monitoring. This is due to the potentially serious side-effects that these drugs can occasionally cause. It has been shown that the incidence of side-effects can be reduced significantly if this monitoring is carried out in a well-organised way, close to the patient s home. The near patient testing service is designed to be one in which: (i) Therapy should only be started for recognised indications for specified lengths of time (ii) Maintenance of patients first stabilised in the secondary care setting should be properly controlled (iii) The service to the patient is convenient (iv) The need for continuation of therapy is reviewed regularly
(v) The therapy is discontinued when appropriate (vi) The use of resources by the National Health Service is efficient. 4. Criteria All practices are expected to provide essential services as well as additional services they are individually contracted to provide to all their patients. This enhanced service specification outlines the more specialised services to be provided. The specification of this service is designed to cover the enhanced aspects of clinical care of the patient all of which are beyond the scope of essential services. No part of the specification by commission, omission or implication defines or redefines essential or additional services. Different amber drugs require different levels of monitoring. There are three levels of monitoring intensity levels being proposed within the proposed contract: high intensity blood monitoring required. A shared care drug monitoring service including frequent blood testing, in respect of the following drugs: Drug Azathioprine Ciclosporin Mercaptopurine Methotrexate Dronedarone (Year One only) Indication Arrhythmias Level Two medium/low intensity blood monitoring. Monitoring including blood testing, in respect of the following drugs: Drug Leflunomide Mycophenolate Penicillamine Sulfasalazine (Year One only) Indication Level One routine monitoring only, in respect of the following: Drug Sulfasalazine (Year Two only) Denosumab Sodium Aurothiomalate Dronedarone (Year Two onwards) Indication Osteoporosis Arrhythmias This service will fund: (i) A shared care drug monitoring service in respect of the following specified drugs: Azathioprine Ciclosporin Leflunomide Mercaptopurine Mycophenolate Denosumab Dronedarone Penicillamine
Sulfasalazine Methotrexate Sodium Aurothiomalate In accordance with local shared care agreements (SCAs) or individually agreed care plans. For the drugs included in the service, the following monitoring requirements are specified in the SCAs. GP Responsibilities: 1 Reply to the request for shared care as soon as practicable. 2 Prescribe the drug at the dose recommended. 3 Carry out monitoring according to the guideline recommendations. 4 Ensure the patient is aware of any treatment change and that where held, the monitoring booklet is up to date. 5 Report to and seek advice from the specialist on any aspect of patient care that is of concern and may affect treatment. 6 Refer patient to specialist if his or her condition deteriorates. 7 Stop treatment on the advice of the specialist or immediately if an urgent need to stop treatment arises. 8 Report adverse events to the specialist team and to the MHRA via the yellow card scheme. Monitoring should be as per local shared care agreements found at the following links: BCAP Formulary (RUH): http://www.bcapformulary.nhs.uk/includes/documents/bcap-final-shared- Care_DMARD_monitoring_guidelines-30th-Sept-2015.pdf 3Ts formulary (GWH): http://nww.extranet.gwh.nhs.uk/formulary/3t's-shared-care-agreements.aspx See Rheumatology section at bottom of page. ICID formulary (SFT): There are currently no shared care agreements available, so please use those available from 3Ts or BCAP formulary. The general responsibilities for ALL of the drugs are as follows: (ii) A register. Practices should be able to produce and maintain an up-to-date register of all shared care drug monitoring service patients, indicating: patient name date of birth indication and duration of treatment date practice accepted responsibility for monitoring last hospital appointment. (iii) Call and recall. To ensure that systematic call and recall of patients on this register is taking place. (iv) Continuing information for patients. To ensure that all patients, (and/or their carers and support staff when appropriate), are informed of how to access appropriate and relevant information. (v) Professional links. To work together with other professionals when appropriate. Any health care professionals involved in the care of patients in the programme should be appropriately trained.
(vi) Referral policies. Where appropriate to refer patients promptly to other necessary services and to the relevant support agencies using locally agreed guidelines where these exist. (vii) Record keeping. To maintain adequate records of the service provided, incorporating all known information relating to any significant events e.g. hospital admissions, death of which the practice has been notified. (viii) Training. Each practice must ensure that all staff involved in providing any aspect of care under this scheme has the necessary training and skills to do so. Staff are expected to keep up-to-date with current evidence and guidance. 5. Ongoing Measurement & Evaluation Untoward events It is a condition of participation in this service that practitioners will give notification, in addition to their statutory obligations, within 72 hours of the information becoming known to him/her, to the CCG clinical governance lead of all emergency admissions or deaths of any patient covered under this service, where such admission or death is or may be due to usage of the drug(s) in question or attributable to the relevant underlying medical condition. Annual review All practices involved in the scheme should perform an annual review, which could include: (a) Brief details as to arrangements for each of the aspects highlighted in the service (b) Details of any computer-assisted decision-making equipment used and arrangements for internal and external quality assurance (c) Details of any near-patient testing equipment used and arrangements for internal and external quality assurance (d) Details of training and education relevant to the drug monitoring service (e) Details of the standards used for the control of the relevant condition (f) Assurance that any staff member responsible for prescribing has the necessary skills to prescribe safely. Clinical System Searches Year 1 practice will continue to submit manual returns for this service. These will be reconciled on a quarterly basis with information from the central reporting unit for TPP SystmOne and equivalent searches for other clinical systems. The central reporting searches will be shared across all practices to allow identification of any anomalies and unified agreed search criteria for year 2. Year 2 and 3 Data will be collated using the central reporting unit for TPP SystmOne and equivalent searches for other clinical systems. No reporting required from individual practices. Note, the central reporting searches to allow identification of medication prescribed by a secondary care provider (e.g. hospital prescribed medication). Instructions on how to record these drugs are available here: https://prescribing.wiltshireccg.nhs.uk/?wpdmdl=8. 6. Accreditation
Those doctors who have previously provided services similar to the proposed service and who satisfy at appraisal and revalidation that they have such continuing medical experience, training and competence as is necessary to enable them to contract for the enhanced service shall be deemed professionally qualified to do so.