Microsoft word - drug monitoring les 2012 - coastal only.doc
Practice Name: Practice Address: Specification for a Locally Enhanced Service (LES) Drug Monitoring in Primary Care 2012/13
Introduction This LES is based on the National Enhanced Service framework for near patient testing and takes into account the local situation. All practices are expected to provide essential and those additional services they are 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. Background The treatment of several diseases, is increasingly reliant on medicines that, whilst clinically effective, need regular blood and other monitoring, due to the potentially serious side effects that these medicines can occasionally cause and to monitor effectiveness. It has been shown that the incidence of side effects and risk to patients and prescriber can be reduced significantly if this monitoring is carried out in a well-organised way. This particularly applies to medicines with
Responsibility for follow-up transfer from secondary care to primary care
This Locally Enhanced Services takes account of the historic case of need for a LES, and reflects the increasing responsibility being requested of primary care prescribers, and is intended to complement, but not duplicate, prescribing responsibility covered under GMS QOF. This LES is an important vehicle to support appropriate use of medicines that would otherwise require continued prescribing responsibility by specialists and consequent increased secondary care out-patient activity and costs. Aims The drug monitoring 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 thereafter (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. Drug Monitoring in CWS
This LES will apply to all patients who are prescribed the medicines listed in primary care regardless of the departments in secondary care involved in the initiation of therapy. This LES will encourage prescribing to continue in primary care in recognition of the advantages of the entire prescribing record being held in primary care. However, it is expected that primary care teams will implement systems to further ensure safe prescribing. Responsibility for therapeutic monitoring of medicines initiated in secondary care remains in secondary care. The primary care phlebotomy element of monitoring these medicines has been included in the LES for phlebotomy services.
Immunosuppressants (NB excluding post-renal transplant patients under care of BSUH for whom prescribing of immunosuppressants has been repatriated to BSUH) It is recognised that certain medicines used post transplant may have a narrow therapeutic margin, may carry a high risk of side-effects, need a high level of support for critically important patient compliance and /or require a complicated monitoring regime. Such medicines are initiated in tertiary care and may have been agreed as suitable for prescribing by specialist clinicians only, therefore may not have agreed shared care guidelines in place. Where appropriate, arrangements may be made for a local secondary care clinician to continue prescribing of such medicines. However, as the tertiary care centres are often distant, it can be impractical for patients to collect repeat prescriptions from them, or local secondary care clinicians may not be able to assume prescribing responsibility. GPs may therefore decide to prescribe such medicines in order to assure continuity of care for patients. Monitoring, however, remains the responsibility of the tertiary care centre. The PCT recognises that this situation is imperfect but that, in practical terms, it is likely to continue. Therefore these medicines are included in this LES to ensure that prescribing GPs have a system in place to check that satisfactory monitoring does occur. Communication is usually made from tertiary to primary care by letter and should contain details of drug monitoring where appropriate. If this is not occurring in an acceptable manner, we would encourage GPs to contact the tertiary care centre to that effect. Shared care medicines The PCT recognises that some ‘amber’ medicines, initiated in secondary care but prescribed in primary care under shared care arrangements, are appropriate for payments under this LES as an element of monitoring is the responsibility of primary care to ensure safe prescribing. In these cases these medications are included and the shared care guideline, where available, is published on the GP website. Service Outline
This local enhanced service will fund a shared care drug monitoring service in respect of the following specified medicines: DMARDS – the following medicines, and only where an element of monitoring is the responsibility of primary care a) Methotrexate b) Leflunomide c) Gold preparations d) Penicillamine e) Ciclosporin f) Sulphasalazine 26/06/2012
g) Hydroxychloroquine h) Azathioprine Immunosuppressants a) Tacrolimus (oral) b) Sirolimus c) Mycophenolate d) Ciclosporin Shared care medicines with an element of monitoring responsibility in primary care a) somatropin b) dronedarone Enhanced Services Group may add to or remove medications from the above list from time to time depending on changes to monitoring requirements and use of new therapies. Any changes to this list will be notified to GP practices. Clinical responsibilities will be clearly defined between primary and secondary care, where practicable, as follows: PRIMARY CARE RESPONSIBILITIES
Initiation of appropriate therapy only in line with any current NICE TAG. Normally to prescribe initial 28 days of medication, and to ensure all information
To inform the consultant if unwilling to enter
relevant to transfer of prescribing responsibility
into shared care arrangements according to
To ensure that all newly treated patients (and / or their carers) receive appropriate education and advice regarding their medicine. This should include written information where appropriate
To provide and monitor repeat prescriptions and take responsibility for ongoing monitoring
To ensure and take responsibility for baseline
of parameters that relate to safe prescribing
and ongoing monitoring and act on the results
(mainly blood tests). A demonstrable system
appropriately and to ensure that any blood
should be in place to ensure that prescribing
is reviewed by the GP if there is no record of
communicated promptly and in full to the
the fact that monitoring has taken place within
the agreed time-scales. To record any changes in therapy in the
communication from secondary care To monitor the patient’s overall health and well being and to report any adverse drug reactions
Clinical review at appropriate agreed intervals.
or interactions to the appropriate secondary care clinician.
To review the appropriateness of prescribing
Notify the GP of patient’s failure to attend for
for patients who have not been seen by a
Shared Care
Shared care guidelines are available, or will be available in due course, for each medicine on the LES giving more information and details of monitoring requirements. These shared care arrangements are a result of collaboration between primary and secondary care through the CWS CCG medicines management team, Area Prescribing Committee and the relevant specialists. Register
Practices should be able to produce and maintain an up-to-date register of all shared care drug monitoring service patients, indicating patient identifier, date of birth, medicine prescribed, the indication for treatment, monitoring undertaken and most recent hospital appointment. Individual management plan and monitoring
Secondary / tertiary care should ensure that the patient has an individual management plan, which gives the reason for treatment, the planned duration, the monitoring timetable and, if appropriate, the therapeutic range to be obtained, together with any other relevant patient information. •
National guidance about monitoring required at baseline, during initiation, during maintenance,
actions required when faced with an abnormal result, other relevant information, and BNF-listed significant drug interactions is available on the National electronic Library for Medicines website www.nelm.nhs.uk/en/NeLM-Area/Evidence/Drug-Monitoring/Suggestions-for-Drug-Monitoring-in-Adults-in-Primary-Care/?query=primary+care+monitoring&rank=100 (large pdf reference document – recommend search on generic name or drug group). If unsure of action required when faced with an abnormal result, it is acceptable for GP to seek advice from or refer patient back to consultant or specialist team. •
link to national monitoring guidance will also be published on the CWS GP website by end
June www.westsussexgp.com/index.php?menuItem=21&area=0&page=137
Prescribers should also refer to the relevant Summary of Product Characteristics published by
the manufacturer at www.medicines.org.uk/emc (search on generic name)
Where a prescribed medicine is covered by an Effective Shared Care Arrangement (ESCA),
prescribers should also refer to the relevant ESCA published on GP website (NB – ESCAs will be published by end June 2012) Professional links
All involved have a responsibility to work together with other professionals when appropriate. Any health professionals involved in the care of patients covered by this LES should be appropriately trained 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 Record keeping
To maintain adequate records of the service provided, incorporating all known information relating to any significant events e.g. hospital admissions, death, side-effects necessitating cessation of therapy, etc of which the practice has been notified Training
Each practice must ensure that all staff involved in providing any aspect of care under this scheme have received the necessary training and professional development, and have the required competencies and skills to provide the primary care responsibilities. Annual review
All practices involved in the scheme may be asked to provide information which could include: (a) details of training, education and professional development relevant to the drug monitoring service (b) details of the clinical standards used for the control of the relevant condition, e.g. NICE (c) assurance that any staff member responsible for prescribing must have developed the necessary skills to prescribe safely. (d) audit of activity claimed under the service specification Untoward events It is a condition of participation in this LES 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 medicine(s) in question. We encourage all participants to report any ‘near miss’ event through the normal local clinical governance reporting procedure. Costs Each practice contracted to provide this service will receive: £6.08 per patient monitored (NB including patients on more than one medicine covered by this LES) and on the register at the end of each month (equivalent to £72.96 per patient per annum) Claiming Claims should be made monthly via the multi-claim form. Termination
This Enhanced Service may be terminated by either the PCT or the contractor through the service of 3 months written notice. Application Practice Name:
GP Provider Application for Locally Enhanced Scheme : Drug Monitoring in Primary Care 2012/13 How will you meet the aims of the scheme? Briefly describe the service to be provided and facilities available. Will providing this service adversely affect the practice’s ability to provide essential or additional services? Who will be providing the service? Do you have evidence of appropriate staff qualifications, if appropriate? How will you ensure staff providing the service remain suitably qualified? How will you monitor and audit service provision (refer to any requirements within the scheme). Please outline any other details relevant to your ability to provide this service Monitoring/audit information for this scheme can be sent to the Commissioning Support Service Primary Care Team from 1st April 2012 until 31st March 2013
The practice has understood the terms of the scheme and is seeking to provide a service on this
basis. If commissioned the practice will adhere to the terms of the scheme.
Signed: ____________________________________ As GP principal representative of the practice Date: _____________________________________
Breach Breach of conditions of this contract will be referred to the CCG Enhanced Services Group. Signed on behalf of Practice…………………………………………. Name of Practice ……………………………………………………… GP Name (Print)……………………………………………………
GP Signature…………………………………………………………. GP Name (Print)……………………………………………………
GP Signature…………………………………………………………. GP Name (Print)……………………………………………………
GP Signature…………………………………………………………. GP Name (Print)……………………………………………………
GP Signature…………………………………………………………. Signed on behalf of the PCT
……………………………………………………………. Date ………………………… Ruth Frost Lead for Primary Care Contracting and Commissioning on behalf of NHS Sussex (CSU) N.B. This form must be completed in full for your application to be accepted and will be used as part of the monitoring information for the scheme.
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