Medicines Management Guidance

Transcription

1 Medicines Management Guidance Status Final Version 1.0 Author Jon Boyd Version date 05/12/2016 Agreed by the following North West London CCGs: Central London West London Hammersmith and Fulham Hounslow Ealing Brent Harrow Hillingdon

2 Amendment history: Version Date Amendment history /11/2016 Medicines Management Guidance updated Related documents: These documents will provide additional information. Ref no Title Version 1 NWL Medicines Schedule 2017/ NWL Integrated Formulary NWL Integrated Formulary 3 NWL Red List NWL Red List 4 NWL Shared Care Guidance NWL Shared Care Page 2 of 21

3 Table of contents 1. Introduction General principles Admission arrangements In-patients Discharge arrangements Out-patients/day case Dressings and appliances Patients attending Accident and Emergency Unlicensed medicines Medicines used outside of their licensed indications Red List - when responsibility for prescribing remains with the Hospital Trust Consultant Transfer of prescribing medicines requiring specialist monitoring Tertiary care referrals and prescribing medicines requiring specialist monitoring Clinical trials and Ethics Committees PbR-excluded drugs commissioned by CCGs Individual Funding Requests Research Homecare medicines Appendix 1 - Standard dataset for information on medicines required on admission to hospital Appendix 2 - Standard dataset for information on medicines required on discharge from hospital Appendix 3 - North West London Red List Appendix 4 - Framework for the production and use of Shared Care for medicines in NW London Page 3 of 21

4 1. Introduction 1.1 The aim for this document is to outline NWL wide good practice recommendations for medicines management to be adopted by commissioners and used to support high quality safe-effective and cost-effective use of medicines in commissioned services across the board. 1.2 The objectives of the document are: To underpin good quality medicines management in all service providers To ensure best value for money from the drugs budget To promote implementation of national and local guidance To promote increased understanding of the resource impact of medicines in relationship to other service changes. 2. General principles 2.1 CCGs and local Providers should work to optimise medicines use to improve health outcomes by enabling timely, safe and effective medicines related care, tailored to the needs of individual patients throughout the local health economy 2.2 Providers should ensure they have a Drug and Therapeutics Committee (or equivalent) in place to co-ordinate medicines use. The Drug and Therapeutics Committee should develop an up to date formulary with the involvement of GPs and CCG prescribing advisers. 2.3 Prescribing should be from the Provider formulary and prescribers should not seek to avoid restrictions by asking GPs to prescribe non-formulary medicines. Prescribers should adhere to the NWL Integrated Formulary across the interface. The current formulary and guidance can be accessed at NWL Integrated Formulary 2.4 Providers will contribute to the local arrangements for the managed entry of new medicines. This should consider the clinical and cost-effectiveness of new medicines and the impact on primary as well as secondary care. 2.5 Apart from specific exclusions, all medicines are included in the National Tariff. For all nationally-defined PbR-excluded medicines, commissioners and providers will agree local prices and arrangements for commissioning and monitoring. 3. Admission arrangements 3.1 CCGs and local Providers should ensure that written guidance is in place covering information flow on admission, as recommended by the Care Quality Commission (CQC). 3.2 The recommended minimum dataset for information provided on patient admission to provider is listed in Appendix 1 and should be agreed locally between CCGs and Providers. 3.3 CCGs should develop a standard template letter that GP practices can use to ensure all information required is readily available. Page 4 of 21

5 3.4 Information on prescribed medicines should be available to the provider as soon as possible and ideally within 24 hours of admission where possible. 3.5 An agreement should be made between the provider and CCG to enable audits to be undertaken by the Provider to monitor the quality and timeliness of information provided on admission and ensure compliance with CQC recommendations. 3.6 Health economies should support the use of Green Bags as a way of reminding and encouraging patients to bring all their own medicines into provider with them. 3.7 Medicines management arrangements on admission should include: Provision of information to patients before planned admissions about the arrangements in the provider, for example: bringing in own medicines, self-administration, use of patients own medicines, dispensing for discharge. Arrangements for medicines history taking and pharmacist review of medication (medicines reconciliation should be the gold standard where possible). 4. In-patients 4.1 The Provider is responsible for the supply of any new medicine started or continuation of existing medicine for in-patients. Patients at risk of experiencing problems managing their medicines should be identified and, if appropriate, a referral made for pharmaceutical support. 5. Discharge arrangements 5.1 Contractual requirements for discharge include: a minimum of 14 days supply or original patient pack, whichever is higher, unless the full course of treatment is less, a smaller supply is deemed appropriate on mental health or patient safety grounds, or after assessment it is clear the patient already has appropriate supplies at home. use of a recommended minimum dataset for information provided on patient discharge (see Appendix 2). discharge notifications should be sent electronically to the GP within 24 hours of discharge. 5.2 CCGs and local Providers should ensure that written guidance is in place covering information flow on discharge, as recommended by the Care Quality Commission (CQC). 5.3 Providers should review templates for discharge systems (including electronic where applicable) and adapt where necessary to ensure the fields comply with the required minimum dataset. 5.4 An agreement should be made between provider and CCG to enable an audit to be undertaken by CCGs to monitor the quality and timeliness of information provided on discharge and ensure compliance with CQC recommendations. 5.5 Patients should be provided with appropriate written information about the medication prescribed, duration of treatment and obtaining further supplies of medicine. Page 5 of 21

6 5.6 Monitored Dosage Systems and other Compliance Aids - Providers are encouraged to develop discharge planning arrangements for vulnerable patients. Where these include supply of monitored dosage or other similar systems there should be a policy in place for their use, including assessment of need and making appropriate arrangements for continuity after discharge. This arrangement should reflect guidance on support to people with disabilities, compliance with the Disabilities Discrimination Act (see Primary Care Commissioning for a resource tool) and include community pharmacies, where appropriate. 6. Out-patients/day case 6.1 Contractual requirements for out-patient/day case include: medicines required immediately should be supplied by the provider acute prescriptions that are required for a short term should be supplied by the provider. for prescriptions that are required on an ongoing basis, it is appropriate to complete an Out-patient Medication Proforma or equivalent use of patient packs when a medicine is supplied. 6.2 If the provider doctor is recommending that the GP prescribes, the GP cannot make an informed decision before receiving sufficient clinical information (including information required in section 6.3) via outpatient letter/electronic discharge note (EDN). If the patient requires any medicine before the provider can guarantee that the practice will receive such a letter/edn, it is the responsibility of the provider to supply the prescription. 6.3 It is the responsibility of the provider to supply medicine on an on-going basis if it is unavailable in the community (excluding manufacturer supply problems), if it is unlicensed (see section 9) or where a GP feels they do not have sufficient experience of the medicine to take clinical responsibility for prescribing it (see also Appendices 3 and 4 relating to red list and shared care agreements). There will be a clear mechanism for the GP to refer the patient back to the provider for a prescription. 6.3 Information provided to the GP should include details of any medicines that have been stopped or changed, the reason why the medicine has been prescribed and the intended duration of any new medicine. It is recommended that providers and CCGs agree an outpatient template letter/electronic note to ensure this information is communicated effectively. This should include appropriate contact details where the GPs can communicate any issues. 6.4 GPs should not be asked to prescribe medicines and dressings which are intended to be used/administered in provider out-patient clinics or day-care surgery, (e.g. intrauterine levonorgestrol, implants), or courses of antibiotics that are to be taken pre/peri-operatively. (Note: this does not apply to those medicines which have been prescribed by the GP for patient's use at home and which the patient has brought in as a "patients own medicine" for an in-patient stay - see section 3). Page 6 of 21

7 7. Dressings and appliances 7.1 Suitable local arrangements should be in place for the supply of dressings and appliances. Sufficient information about a patient s dressing and appliance treatment should be supplied to ensure continuity of care in the community. 7.2 Providers should not make arrangements with appliance contractors for ongoing supplies of dressings or appliances in the community without involving patients in the decision about where their prescriptions are dispensed. 8. Patients attending Accident and Emergency 8.1 Contractual requirements for accident and emergency include: supply of a minimum of 7 days of necessary medicines, unless the full course of treatment is less electronic communication of attendance at A&E to GP within 24 hours of discharge. 8.2 If not included in electronic communication above, medicines related information should follow and include: any medication dispensed dose, route, frequency, formulation (where relevant) and length of course for all medications the reasons for any medications started or stopped any adverse reactions or allergies to medications or treatments observed in the patient during attendance. 9. Unlicensed medicines 9.1 Prescribing of unlicensed medicines should usually remain the responsibility of the clinician initiating treatment. The Provider will accept full responsibility for the continued sourcing, quality and supply, which should be under the control of the Provider pharmacy department. 9.2 Informed consent for the use of unlicensed medicines should be obtained from patients before the prescription is written. 9.3 GPs should not be asked to prescribe unlicensed specials when an alternative, more cost effective dosage form/licensed product is available that meets the individual needs of a patient. 9.4 Where there is a substantial body of evidence to support the use of an unlicensed medicine or special, for example: indicated in current BNF for children, the GP may be asked to prescribe. 10. Medicines used outside of their licensed indications Ideally, informed consent for the use of licensed medicines outside of their licensed indications should be obtained from patients before the prescription is written. Page 7 of 21

8 10.2 Where there is a substantial body of evidence to support the use of a licensed medicine outside of its licence, the GP may be asked to prescribe. 11. Red List - when responsibility for prescribing remains with the Provider Consultant (see Appendix 3) 11.1 The Provider is expected to retain prescribing responsibility where: Medicine has been commenced by the provider and specialist ongoing intervention and monitoring is needed (see Appendix 3 for the NWL red list) Medicine is used as systemic chemotherapy, including oral or intracavitary cytotoxic chemotherapy for the treatment of malignant disease. EXCEPT in the following cases; (i) GPs who are acting for that part of their practice under contract to a Provider; (ii) the prescription of oral hydroxycarbamide, for cases under the overall care of a consultant haemato-oncologist; (iii) the prescription of topical cytotoxic agents used for the treatment of some skin malignancies or premalignant conditions. Medicines are unlicensed see section 9. Medicines are only available through NHS Trusts. Medicines are part of a Provider initiated clinical trial. Medicines are not available on FP10. Medicines have not been approved by the Drugs and Therapeutics Committee (or equivalent) If there is disagreement about where prescribing of a patient s treatment should best take place the case should be referred to the CCG, via the Chief Pharmacist who will seek resolution. 12. Transfer of prescribing medicines requiring specialist monitoring (see Appendix 4) 12.1 Increasingly, patients with continuing specialist clinical needs can be cared for at home or in the community. There are medicines which could be prescribed by GPs if sufficient support, review and information is shared between the GP and consultant It is the responsibility of the consultant to ensure that the GP is willing to prescribe before mentioning the possibility of shared care to the patient. In no circumstance should the patient be used as the vehicle for informing the GP that prescribing could be transferred to the GP A GP should not decline to prescribe a medicine solely on the basis of cost. Likewise, if the patient is to receive the majority of their ongoing care through the provider then prescribing must remain with the provider and must not be transferred solely on the basis of cost The following conditions should be met before the shared care takes place: The patient's condition is stable; and The agreement of the patient's GP is sought prior to the transfer of prescribing; and The GP is sufficiently informed and able to monitor treatment, identify medicine interactions and adjust the dose of any medicines as/if required by shared care; and Page 8 of 21

9 Resources are available to ensure (where required) the safe administration of any specialist medication in the community e.g. IV therapy. This would usually be agreed with the community nursing services All prescribers should be aware of their responsibilities to develop their expertise and the expertise of others in the managed introduction of new medicines A framework for the production and use of shared care guidelines for medicines in NW London is detailed in Appendix It is essential that a copy of the shared care guideline including the baseline monitoring information is provided to the GP in order to facilitate the shared care transfer. 13. Tertiary care referrals and prescribing medicines requiring specialist monitoring 13.1 Where it is clinically appropriate for the patient to be cared for at home, under the supervision of the tertiary centre, the centre should make appropriate arrangements for prescribing and supply of specialist medicines (e.g. High tech home health care schemes EL(95)5 or using FP10 (HNC)) In some circumstances it may be appropriate to transfer prescribing to a more local Provider or more rarely to a GP. In all situations there should be robust processes in place between the tertiary centre, Provider and GP to ensure timely and accurate transfer of a patient s medication details to appropriate professionals responsible for his/her care The principles outlined in Section 12 should be applied. 14. Clinical trials and Ethics Committees 14.1 All clinical trials must have been subject to Ethical Committee approval, in line with the prevailing guidance from DH. CCGs should be consulted if any trial has any anticipated impact on primary care Prescribing and supply of clinical trial medicine is the responsibility of the Provider. Standard out-patient or in-patient treatment costs will be met for patients on a trial as required by HSG (97)32; this will not include the cost of the trial medicines either during or after the trial NWL CCGs will only fund provision of medicines used in clinical trials (which must have appropriate Ethics Committee approval) in line with prevailing guidance from the DH. NWL CCGs will not provide funding for continuation of treatment with a medicine after free stock provided by a company in an expanded access scheme or on compassionate grounds ceases to be available. Patients offered participation in a clinical trial of a medicine must be made aware that there is no guarantee that the commissioning organisation will fund continued provision of the medicine after the patient exits the trial, irrespective of the results In line with The Medicines for Human Use (Clinical Trials) 2004 Regulations (and amendments 2006 and 2008) and the Declaration of Helsinki, the responsibility for ensuring a clear exit strategy from a trial, and ensuring that those who have benefited from the trial drug will have continued access to it, rests with those conducting the trial. Providers will be Page 9 of 21

10 responsible for managing patients and their expectations throughout the clinical trial process The GP should be adequately informed if a patient is participating in a clinical trial, in order to respond appropriately to any suspected adverse events that occur outside provider setting Provider organisations should ensure that the financial implications of trials and exit strategies are considered and any problems resolved before approval to recruit patients to a trial is given. 15. PbR-excluded drugs commissioned by CCGs 15.1 All medicines are included within the National Tariff unless they are specifically stated to be excluded. Those medicines subject to commissioning by NHS England are not covered by this guidance NHS Improvement and NHS England guidance on PbR-excluded drugs will be followed. The Trust and host commissioner will agree the process to be followed for each specific PbR excluded drug NOT funded by NHS England. This will be documented on a provider-byprovider basis and be included as the 2017/18 Medicines not reimbursed through national tariff prices funded by NWL CCGs. Available: NWL CCGs use a series of standard tick box forms (TBFs) for drugs commissioned by CCGs. These forms must be used to request drugs indicated as TBF on the Medicines not reimbursed through national tariff prices funded by NWL CCGs There are four ways in which routinely commissioned PbR-excluded drugs are processed in NWL: I. Prior approval: Provider must submit a tick box form prior to starting treatment and await CCG approval before commencing. A response will be sent within 5 working days of receiving full information. II. Notification: Provider must submit a tick box form within two weeks of starting treatment. A response will be sent within 5 working days of receiving full information. III. No form: Provider does not need to submit an application for defined indications. IV. Local arrangement: Provider to follow application process and give details as required of criteria agreed with CCGs. A response will be sent within 5 working days of receiving full information. The tick box forms for initial request and continuation are available via Blueteq online system. PbR excluded drugs which do not fall under I - IV above are not funded unless approved following submission of an individual funding request (IFR). IFR policies and procedures can be found at Providers must assure NWL CCGs that drug charges reflect actual acquisition costs, except where a local agreement has been reached. Local agreements that will deliver net savings Page 10 of 21

11 over the health economy will be actively encouraged. A process will be developed to capture and monitor any local exception agreements The Provider commits to using all reasonable endeavours to ensure that the best prices are attained from suppliers of any drug or device supplied for use in the services under this agreement. E.g. uptake of contract prices negotiated by London Procurement Programme 15.7 The Provider and Commissioner will work together to contain the costs associated with PbR excluded drugs as far as possible as indicated within NHS North West London s Commissioning Intentions The Provider is expected to make full use of patient access schemes in order to acquire medicines at the lowest cost. Commissioning organisations will be charged the net price the Provider pays for medicines (i.e. the price after any rebates or discounts). The Provider must have standard operating procedures in place for all patient access schemes In line with guidance from the Department of Health drugs and devices should not be exported by providers Providers must ensure that auditable data is collected to provide evidence that the drugs budget is being used in the most cost-effective way on the request of commissioners Payment can only be made for PbR-excluded drugs on receipt of the following minimum data set for PbR-excluded drugs:- Mandatory Information Schedule Section Patient s hospital number Local_Patient_ID / PAS Number Patient s NHS number NHS number Drug name Treatment_Function_Name / Drug/Device Drug strength TBC Quantity supplied TBC Date drug supplied (or processed by pharmacy for Homecare medicines) Activity_Start_Date / Date of Issue Cost of the quantity supplied in month Activity Cost / Cost of drugs Indication for the medicine; AND/OR Primary diagnosis Service area e.g. renal, rheumatology Treatment function code Preferred Cost of the quantity supplied cumulative CCG reference number (TBF/IFR) for the funding request Whether a patient access scheme applies to use of the drug 16. Individual Funding Requests 16.1 Individual funding requests (IFRs) for PbR excluded drugs are subject to the NHS NWL Individual Funding Request policy available at NWL Individual Funding Requests 17. Research Page 11 of 21

12 17.1 NWL CCGs are committed to supporting non-commercial research through for example National Institute Health Research (NIHR) portfolio studies in accordance with DH guidance on attributing costs of research and development issued in May 2012 and guidance on funding Excess Treatment Costs issued in April Treatment Costs (including Excess Treatment Costs) are funded through normal arrangements for commissioning patient care and are included in reference costs used to calculate PbR tariffs. Providers are expected to cover research related treatment costs through existing commissioning arrangements. In exceptional circumstances when there has been a material increase or decrease in Excess Treatment Costs between financial years, commissioners may be approached for an adjustment to funding. Where Trusts have made savings on research related patient care costs because industry has donated drugs or devices, the Trust should use these savings to offset ETCs incurred by other research studies. 18. Homecare medicines 18.1 If providing medicines to patients through homecare arrangements, Providers should be able to demonstrate that they are working towards compliance with policy or guidance published in response to the findings of the Hackett Report on homecare medicines including professional standards issued by the Royal Pharmaceutical Society of Great Britain Supply of no more than 2 months high cost medication per homecare delivery to avoid unnecessary wastage due to treatment modification. A maximum of 3 months may be delivered in exceptional circumstances. Page 12 of 21

13 Appendix 1 - Standard dataset for information on medicines required on admission to provider setting Introduction In October 2009 the Care Quality Commission (CQC) published a report on a national study which raised concerns about the quality and timeliness of information on patients medicines transferred between acute trusts and general practitioners and vice versa when patients are admitted to and discharged from providers. This paper lists the minimum dataset for information which should be provided on admission to provider, adapted from the CQC self-assessment tool. 1 The CQC recommends that written guidance be in place covering information flow at admission. Minimum dataset for information provided on admission Complete patient details (full name, date of birth, NHS number, GP, date of admission) Presenting condition plus co-morbidities A list of all medicines currently prescribed for patient (furthermore, it is good practice for this to additionally include those bought over the counter) Dose, frequency, formulation and route of all medicines listed An indication of medicines not intended to be continued Known allergies Major side effects / sensitivities / adverse reactions to previously taken medicines (if relevant) Other recommendations This information should be available to provider when a patient is admitted for planned admissions and as soon as possible (ideally within 24 hours of admission) for unplanned admissions. Guidance may set out schemes / systems for ensuring that a patient s medicine is brought with them into provider setting this could apply to either elective or emergency admissions (or both). An example of this would be the Green Bag scheme. This will assist the reconciliation process. This recommendation is considered good practice and not an expectation. References 1. Care Quality Commission. Managing patients medicines after discharge from hospital - A Self Assessment Tool. October Accessed essionals/nhstrusts/specialreviews/2008/09/managingmedicines.cfm Page 13 of 21

14 Appendix 2 - Standard dataset for information on medicines required on discharge from provider Introduction In October 2009 the Care Quality Commission (CQC) published a report on a national study which raised concerns about the quality and timeliness of information on patients medicines transferred between acute trusts and general practitioners and vice versa when patients are admitted to and discharged from providers. This paper lists the minimum dataset for information on medicines which should be provided on discharge from provider setting, adapted from the CQC self-assessment tool 1 and National Prescribing Centre recommendations. Minimum dataset for information on medicines provided on discharge This information is also included in the NHS standard contract. complete patient details (full name, date of birth, NHS and hospital number, GP, date of discharge) key diagnosis made during the patient s admission, plus co-morbidities, and any procedures carried out medication prescribed at the time of discharge, including any medication not dispensed dose, route, frequency, formulation (where relevant) and length of course for all medications, with details of any variable prescriptions the reasons for any medications started or stopped any adverse reactions or allergies to medications or treatments observed in the patient during admission, and any previous reactions the name of the responsible Consultant at the time of the patient s discharge any immediate post-discharge requirement from the primary healthcare team any planned follow-up arrangements whether the patient has any relevant infection, for example MRSA who should be contacted in the event of a query (e.g. responsible doctor and their contact details) Other recommendations Discharge summaries should be issued electronically within 24 hours The patient should be given a copy of the discharge letter The CCG should have considered how community pharmacists can be included in the flow of discharge information. References 1. Care Quality Commission. Managing patients medicines after discharge from hospital - A Self Assessment Tool. October Accessed ecialreviews/2008/09/managingmedicines.cfm Page 14 of 21

15 Appendix 3 - North West London Red List Medicines that Hospital Doctors should not ask GPs to prescribe 1.0 Background Hospital New Drugs Panels or Drug and Therapeutics Committees (NDP or D&TC) consider published evidence on the effectiveness of a new medicine and its costeffectiveness before deciding whether to add it to the hospital s formulary. All such committees in North West London (NWL) have representation from local Clinical Commissioning Groups (CCGs). When a medicine is added to a hospital formulary, the committee will also consider whether it is reasonable for a hospital doctor to ask a GP to prescribe the medicine, or whether it should be added to the red list. The NWL Medicines Management Pharmacy Network (NWLMMPN) is a network of Clinical Commissioning Group/ Commissioning Support Unit Senior Pharmacists from NWL, Acute and Mental Health Trust Chief Pharmacists from all Trusts in NWL and Community Health Care Pharmacists representatives from NWL. It meets at least 4 times a year to provide a mechanism for formal liaison in order: To work together to improve prescribing of medicines at the interface between primary, secondary/tertiary care and be involved in service redesign. To share ideas on cost improvement programmes (CIP) for drugs and QIPP plans To share information about the managed entry of new drugs To keep all parties informed and aligned with regard to prescribing priorities and local policies for primary and secondary care To respond to NHS policies including NICE guidance that affect prescribing and medicines management across the interface To identify ways of improving medicines management in both sectors To maintain the North West London red list and shared care tracker and make recommendations to the NWLIF NDP and to Trust New Drugs Panels To share information on medicines expenditure The NWLMMPN has an advisory role on whether medicines are suitable for addition to or removal from the red list and makes recommendations to the relevant decision making bodies. 2.0 Criteria for adding a medicine to or removing from the red list : The following criteria are used by NDPs, D&TCs and the NWLMMPN in deciding whether a change to the red list should be made: Safe or effective use of the medicine, throughout its use, requires expertise or facilities that a GP will not normally have Medicines added to the red list will normally be specialist medicines that a GP will see infrequently Relevant changes to a medicine s licensing or to national policy (e.g. NICE guidance). Page 15 of 21

16 Criteria for removing a medicine from the red list: Guidance from NICE states that it is reasonable for GPs to prescribe the medicine, perhaps in the context of a shared care agreement. New trial evidence or a change in licence has made the medicine easier to use than at the time it was added to the red list (e.g. by demonstrating that less monitoring is needed than previously thought). A medicine will not be added to the red list: If, although the medicine should only be initiated by a hospital specialist, it is reasonable for a GP to continue to prescribe it once the patient and treatment are stable (e.g. monitoring, dose changes and stopping treatment require no specialist expertise or facilities). Simply because it is expensive. There should be an annual review of the red list to incorporate any change in national policy and if a significant incident occurs in clinical practice. 3.0 Process for adding a new medicine to or removing from the red list Annex 1 is a template for requesting the addition of a medicine to or removal from the red list. When an NDP or D&TC decide a new medicine should be added to the red list, the NW London Medicines Management Pharmacy Network (NWLMMPN) will review the request and make a recommendation to the North West London Integrated Formulary Panel and to individual Trust NDPs or DTCs as to whether the medicine should be added to the red list. Any NW London CCG, Hospital or Mental Health Trust can request that a medicine is added to or removed from the red list. The trigger for consideration for the red list is normally following the review of a new medicine at a hospital NDP or D&TC. The Trust s Chief Pharmacist (or equivalent) should make the case for the change at a NWLMMPN meeting. The NWLMMPN will normally take a view on red list decisions at the first meeting to which the decision is presented. The red list document is updated quarterly and presented for review at the NWL Integrated Formulary New Drugs Panel following on from discussions held at local hospital Drugs and Therapeutics or New Drugs Panel meetings. The list contains medicines that are not on the NWL Integrated Formulary but are on hospital formularies. Owing to their speciality, safety or monitoring requirements, GPs should not be asked to continue the prescribing. The responsibility for prescribing should remain with the hospital trust consultant. 4.0 Disputes If a NDP or D&TC decision appears inconsistent with the criteria in Section 2, the NWLMMPN will check the decision against the criteria. If there still appears to be inconsistency, the NWLMMPN will recommend that the NDP or D&TC reviews its decision. If there is disagreement about where prescribing of a patient s treatment should best take place, the case should be referred to the North West London Integrated Formulary Panel. 5.0 Red List For most up to date version please see NWL Integrated Formulary Page 16 of 21

17 Annex 1 Template Request for the North West London Medicines Management Pharmacy Network to Consider Adding a Medicine to the Red List of Medicines The following criteria are used to decide whether a change to the red list should be made: Criteria for adding a medicine to the red list Safe or effective use of the medicine, throughout its use, requires expertise or facilities that a GP will not normally have. Medicines added to the red list will normally be specialist medicines that a GP will see infrequently. Relevant changes to a medicine s licensing or to national policy (e.g. NICE guidance). Criteria for removing a medicine from the red list Guidance from NICE states that it is reasonable for GPs to prescribe the medicine, perhaps in the context of a shared care agreement. New trial evidence or a change in licence has made the medicine easier to use than at the time it was added to the red list (e.g. by demonstrating that less monitoring is needed than previously thought). A medicine will not be added to the red list: If, although the medicine should only be initiated by a hospital specialist, it is reasonable for a GP to continue to prescribe it once the patient and treatment are stable (e.g. monitoring, dose changes and stopping treatment require no specialist expertise or facilities). Simply because it is expensive, if the criterion for adding a medicine to the red list (above) is not met. Name of medicine Presentation Indication Specialist expertise needed to prescribe safely Special facilities required to prescribe safely Details of recent change to license or national policy Form completed by Date of completion Please completed forms to Monika Chowdhury, Secretary to the North West London MOPN, Monika.Chowdhury@nwlcsu.nhs.uk Page 17 of 21

18 Appendix 4 - Framework for the production and use of Shared Care for medicines in NW London 1. Background Red lists list medicines that provider doctors should not ask GPs to prescribe. The NWLMMPN has considered the red lists that existed in NW London in 2002 and used them as the basis of a single NW London red list. Most medicines that were considered were not controversial (CCG and provider Chief Pharmacists readily agreed which should appear on the red list). It was not possible to reach agreement on some medicines however, with some advocating and some opposing inclusion of the medicine on the red list. One way of achieving effective and efficient use and supply of some of these medicines might be for Consultants to seek agreement with GPs relating to individual patients. In such instances shared care documents are produced and agreed across the provider and CCG to ensure the responsibilities of the Consultant and the GP are clearly defined. Transfer of prescribing arrangements is never an emergency and continuity of supply should be ensured to prevent the need for urgent transfer of care. In order for such shared care to work well it is essential that the following principles are applied. 2. Essential features of effective shared care agreements Best interests of the patient Any shared care arrangement should never be detrimental to the patient. Individual, patient by patient arrangements Shared care documents should be accompanied by information about the patient in question, outlining all relevant aspects of that patient s care. The provider doctor and GP must agree which elements of the patient s care each will undertake. If the GP agrees to undertake a specific element of care subject to receiving appropriate support the onus is on the provider to provide this support. The GP should never be asked to initiate prescribing for shared care medicines Reasonably predictable clinical situation Sharing care with primary care should only be considered where a patient s clinical condition is stable or predictable. Willing and informed consent of all parties, including patients and carers All parties must have sufficient accurate and up-to-date information in a form they can understand. Consent must be given voluntarily. Consultants and GPs are encouraged to communicate directly when questions arise around shared care for a particular patient. If issues about prescribing remain after these discussions, the Chief or Senior Pharmacist at the CCG or Provider should be contacted for advice. Page 18 of 21

19 Clear definition of responsibility The areas of care for which each party has responsibility must be clearly defined and should be patient specific. The documentation should include details of any specialist resources that may be available. Communication network and emergency support A telephone contact number, fax number and address must be provided so that the GP can access advice and information if problems arise. Out-of-hours contact numbers must be provided so that the GP can contact an appropriate hospital doctor out-of-hours. The documentation should state how often the patient will be reviewed and must detail a route of return should the patient s condition become less predictable (e.g. return of symptoms, development of adverse effects). Progress reports should be produced to an agreed timescale. Clinical information Shared care documentation should not duplicate information that is available in the BNF; it should direct the reader to the BNF when appropriate. It may be appropriate to include the following: A brief overview of the disease A note of relevant NICE or other guidance (and a web link to the full guidance) Intended duration of treatment Common and important adverse effects (incidence, identification, importance and management) Clear information regarding monitoring requirements (e.g. LFTs, renal function), who is responsible for this, frequency of testing and what to do when adverse test results occur. It is envisaged that all prescribers will want to keep reasonably up-to-date with important developments in therapeutics. Practitioners have a duty to keep themselves informed of the medicines that are recommended for their patients. Review Shared care documentation must be reviewed by the authors, every two years or sooner if indicated (e.g. when NICE guidance is reviewed or updated). 3. Circumstances in which shared care is not appropriate Providers must normally retain responsibility for prescribing in the following instances: When the GP does not feel competent to take over responsibility for prescribing. Where patients receive the majority of care, including monitoring, in provider setting and the only benefit achieved by sharing care would be a reduction in provider expenditure. Where the medicine is unlicensed, only available through provider or being used as part of a provider-initiated clinical trial. Page 19 of 21

20 Where the medicine is included on the NW London red list of medicines that hospital doctors should not ask GPs to prescribe (see Appendix 3). 4. Checklist for GPs when considering sharing care GPs should only agree to prescribe if, after reading the shared care document, they can answer YES to the following questions: Is the patient s condition predictable or stable? Do you have the relevant knowledge, skills and access to equipment to allow you to monitor treatment as indicated in this shared care document? Have you been provided with relevant clinical details including monitoring data? Have the document and BNF provided sufficient information for you to feel confident in accepting clinical and legal responsibility for prescribing? If the answer is NO to any of these questions the GP should write to the consultant, within 14 days, outlining his or her reasons for NOT prescribing. Refusal to prescribe must ONLY be on the grounds of clinical responsibility. The cost of the medicine should not be a barrier to sharing care nor should a provider seek to transfer prescribing on the grounds of cost alone. 5. Involving the patient The consultant should only obtain the consent of the patient (and his or her carers if appropriate) after the GP has agreed in principle to share care. Patients should never be used as a conduit for informing the GP that prescribing is to be transferred. Nor should they ever be placed in a position where they are unable to obtain the medicines they need because of lack of communication between primary and secondary care. 6. Process for development and approval of shared care arrangements 6.1 There are two possible mechanisms for identifying a need for shared care: When the NWL Integrated Formulary New Drugs Panel (IFNDP) adds a drug to the Integrated Formulary, it will express a view on whether a shared care document for the drug should be developed; OR Consultants should work with their Chief Pharmacist and their prescribing committee to seek agreement in principle from their local CCG s Medicines Committee (or equivalent) before commencing any work on developing a document. 6.4 Development of a shared care document requires participation from two sponsoring organisations: a CCG and an acute or mental health trust. 6.3 The Consultant or Chief Pharmacist is invited to check whether there is an existing shared care document covering the medicine(s) in question. Providers are encouraged to adopt existing documents that are being used successfully elsewhere in NW London to improve Page 20 of 21

21 consistency, avoid duplication and streamline the review process. All IFNDP supported shared care documents will be published at NWL Shared Care Documents. 6.4 A standard template for shared care documents will be available for use in NWL at NWL Shared Care Documents. 6.5 The sponsoring organisations are and remain responsible for the accuracy and currency of the content - this must be clearly stated on the shared care document. At least two pharmacists, or a doctor and a pharmacist, from these organisations must sign to confirm they have checked that the content is in line with relevant summaries of product characteristics and NICE guidance. Documents must have been approved by appropriate committees in each of the sponsoring organisations before they are sent to the IFNDP. 6.6 If a CCG and trust are intending to develop a shared care document, one of their Medicines Optimisation Pharmacy Network (MOPN) representatives should MOPN members to inform them. The risk that others will want to amend the document should be minimised by enabling input at the outset from any interested trust or CCG. 6.7 If the IFNDP is to be asked to support a shared care document, the content must be aligned with recommendations in relevant NICE technology appraisals and guidelines. 6.8 Once a shared care document has been approved locally the CCG s Chief Pharmacist should submit to the IFNDP as Word files. If supported by the Panel the words Noted by the NWL Integrated Formulary New Drugs Panel [date] will be added at the top of the document and it will be published as a pdf on the website. 6.9 If the IFNDP supports a shared care document that complies with the requirements outlined here and that it has been sent, it will add the document to a repository of shared care documents on the Integrated Formulary internet pages A CCG or trust Medicines Committee may decide not to support use of a shared care document however when the IFNDP has supported a shared care document, the initial assumption will be that all trusts and CCGs in NWL will be willing to use it. Individual GPs can decline to take over responsibility for prescribing a drug if they feel that doing so would be outside their competency Review of shared care documents, at least every two years or sooner if indicated, is the responsibility of the sponsoring organisations. Unless reviewed and updated shared care documents are presented to the IFNDP at the first meeting following 24 months since the IFNDP s support was obtained, the document will be removed from the IFNDP internet page. Page 21 of 21