NHS Hampshire (South East) NHS Portsmouth Portsmouth Hospitals NHS Trust Southern Health NHS Foundation Trust Solent NHS Trust AREA PRESCRIBING COMMITTEE ANNUAL REPORT 2012-13 Katie Hovenden Director Clinical and Professional Development NHS Portsmouth Clinical Commissioning Group Chair Janet Brember Formulary Pharmacist Secretary CONTENTS
1. Chair’s Foreword Appendices
1. Membership and attendance record of members
2. Additions to the Portsmouth District Prescribing Formulary
2(a). Business cases or external guidance considered without change to the Portsmouth 11 District Prescribing Formulary 3. Terms of Reference 1. Chair’s Foreword
As outgoing Chair of the Area Prescribing Committee (APC), I am delighted to introduce this Annual Report for the year April 2013 - March 2013. The APC continues to fulfill a vital role in overseeing the entry of new drugs into the Portsmouth and South East Hampshire health economy and acting as the guardian of the Portsmouth District Prescribing Formulary. This joint primary and secondary care formulary continues to contribute to the effective management of a combined drug budget in excess of £100 million. As Clinical Commissioning Groups (CCGs) establish themselves, the Area Prescribing Committee continues to ensure a consistent approach to decision-making on access to medicines across the local health economy. The three local CCGs (Portsmouth, Fareham and Gosport and South Eastern Hampshire) operate as part of a COMPACT and each of these three CCGs are now represented on the committee, with both GP and medicines management representation from each. Continuing to place the health economy at the heart of the work undertaken by the APC has meant that the committee has been able to continue to work effectively and to develop and increase its influence. As well as overseeing the introduction of new drugs, the APC also has an important role in terms of medicines safety and agreeing health economy wide actions to reduce risks arising from medicines use. Each of the three CCGs have their own websites and are making the Portsmouth District Formulary available to the public. The APC continues to review all NICE Technology Appraisals involving medicines, assessing the local financial impact and ensuring these agents are added to the formulary if recommended by NICE. The APC is therefore effectively contributing to assurance of compliance with the requirement to include NICE-recommended medicines on the formulary in a timely fashion. The Committee will continue to review its effectiveness and to work closely with the Basingstoke, Winchester and Southampton District Prescribing Committee to improve efficiency and also to build consistency of decision-making on medicines and treatments across Hampshire. It is with great pleasure that I now hand over the Chair of the Area Prescribing Committee to Dr Alastair Bateman, GP Prescribing lead for South Eastern Hampshire CCG I commend this Annual Report to the Boards of all the constituent member organisations and hope that it provides a helpful overview of the work we have undertaken over the year. Katie Hovenden Director Professional and Clinical Development NHS Portsmouth Clinical Commissioning Group.
2. Activity and Achievements The Area Prescribing Committee (APC) met every two months in 2012-13 in rotation with the Portsmouth Hospitals Trust Formulary and Medicines Group (FMG). The formulary pharmacist acts as secretary for both the Formulary and Medicines Group and the Area Prescribing Committee and is able to triage items for presentation to the appropriate committee. Applications for new products that will be used entirely within PHT and have no financial implications for commissioners will be approved by FMG and noted at APC. There has been a standing agreement with the Basingstoke, Southampton and Winchester DPC for the APC to act as lead for mental health medicines and guidance. The DPC will accept recommendations from APC on mental health medicines and guidance without further review except under very exceptional circumstances. This reduces bureaucracy for Southern Health NHS Foundation Trust who only need to apply to a single committee to gain approval across Hampshire. Increased collaboration between Southern Health and Solent NHS Trust (providers of mental health services in Portsmouth City) is also leading to increased consistency and a reduction in duplication. The APC is responsible for approval of drug therapy guidelines that include recommendations on drug treatment of conditions that may be managed in primary care. The APC also approves shared care guidelines to support the transfer of ongoing treatment from secondary to primary care and to provide an information resource for clinicians. In addition the APC considers the impact on the local health economy of recommendations from NICE and the SHIP Priorities Committee. All relevant external guidance published since the previous meeting is considered as a standing agenda item and any necessary actions agreed. The anticipated financial impact of new NICE recommendations is considered annually on a Hampshire-wide basis as part of the planning process. The role of the APC is therefore to ensure that new medicines recommended in a NICE Technology Appraisal (TA) are made available on the Portsmouth District Prescribing Formulary for prescribing in accordance with NICE criteria and that the impact on the Portsmouth and South East Hampshire local health economy is assessed in the light of the final recommendations in the TA. The formulary pharmacist attends the Basingstoke, Southampton and Winchester Medicines Evaluation Committee (MEC) and has access to evidence-based evaluations produced for the MEC and DPC. This link also contributes to collaborative working between the Basingstoke, Southampton and Winchester DPC and the APC and supports consistent decision-making across Hampshire. A common application form for evaluation of new products is available and both the APC and DPC have standing agenda items to note each others recommendations and identify any actions arising from these. In June 2011 agreement was reached for the Portsmouth and South East Hampshire local health economy to adopt the Basingstoke, Southampton and Winchester Wound Formulary. The proposal to adopt a common wound formulary was driven by organisational change and the need to promote a consistent approach to wound management across Hampshire. The joint Wound Formulary is now used by all NHS organisations in Hampshire and a common process for evaluation of new products is in place. The formulary was subject to a comprehensive review in October 2012 and has been relaunched in both hard copy and on local websites. The DPC is the lead committee for the approval of changes to the Wound Formulary proposed by the Wound Formulary Group and the APC will normally ratify any changes agreed by the DPC without further discussion. PCTs and Portsmouth Hospitals NHS Trust are represented on the Joint Wound Formulary Group. 2.1 Portsmouth District Prescribing Formulary The Portsmouth District Prescribing Formulary is well established and acceptance is generally high. In Portsmouth Hospitals the formulary is monitored by the pharmacy department and
Medicines Management teams in primary care are active in encouraging adherence to the formulary by all medical and non-medical prescribers. The Portsmouth District Prescribing Formulary is available on an extranet site for primary care prescribers and through the PHT Intranet. Updating the formulary is a continuous process. Changes are made following APC meetings and as required in response to product withdrawals or new safety information. In addition there is a rolling programme of review by BNF chapter to ensure that the content is accurate, up-to –date and refers to local and national prescribing guidance where applicable. Within Portsmouth Hospitals there is a system for approving requests to use non-formulary medicines on a case-by-case basis. There have been 25 non-formulary requests during 2012-13, a considerable reduction on the previous year. The non-formulary application route is also used in some cases to allow access to medicines that are the subject of a positive NICE Final Appraisal Determination (FAD) in the short period prior to publication of the final Technology Appraisal guidance (TA). The rule that only two non-formulary requests are allowed before a business case is required is generally accepted and the manageable number of requests reflects improved horizon-scanning and more pro-active preparation of business cases for new medicines. Advice is also available for clinicians on when an application to commissioners for individual patient funding is necessary (exceptional requests for Payment by Results tariff exclusions). 2.2 Introduction of new medicines All medicines require a written proposal for addition to the Portsmouth District Prescribing Formulary. For hospital-only, in-tariff products an abbreviated submission is usually sufficient. This will include evidence of effectiveness for the proposed use, costs, estimated annual usage and place in the treatment pathway. If the proposal is supported by FMG it will be referred to APC for ratification prior to listing on the District Formulary. New products that will be prescribed in both primary and secondary care settings require a full submission to assess clinical and cost- effectiveness and estimate the impact across the local health economy in terms of costs, place in treatment pathways, patient safety and any additional service costs (administration, monitoring etc.). Implementation advice is prepared for drug interventions that have a positive recommendation in a NICE TA. This consists of a summary of the NICE guidance plus an estimate of the impact on the local health and any actions required. Estimates of financial impact will be taken from the NICE costing template or costing statement usually published together with the TA. The principal action is to ensure the recommended medicines are added to the District Formulary for prescribing in line with the criteria in the TA in order to fulfill the statutory obligation to make NICE-recommended medicines available within three months of publication of the TA. Partly due to the publication of NICE costing templates and the increasing availability of budget impact data from both pharmaceutical companies and independent sources the majority of proposals now contain accurate estimates of costs for the local health economy or on a per 100,000 population basis. Where relevant, primary care (ePACT) and secondary care (JAC) prescribing data on existing medicines use is taken into account as part of the evaluation process. The APC considered and approved 49 business cases or other requests for new medicines during 2012-13. In addition 20 items of external guidance were considered that did not require any change to the Portsmouth District Prescribing Formulary. (For example the drug was already on the formulary, or was the subject of a negative recommendation from NICE.) Refer to Appendix 2 for details. There is already pro-active consideration of medicines on the NICE Technology Appraisal programme as well as significant new products that will not be assessed by NICE. During 2012 a standing item on horizon scanning was introduced onto the APC agenda. This highlights recently launched products, new licenses and license extensions and new drugs that have a positive opinion from the EMA meaning that they have been recommended for licensing. This assists with identifying new products that are a priority for a formulary application and enables the APC to issue interim advice to prescribers as necessary. The aim is to avoid new medicines being adopted into
practice in an ad-hoc fashion and to provide early advice on the position of new products for the benefit of local prescribers. 2.3Prescribing responsibility
There is a well-established system for categorizing medicines in terms of prescribing responsibility as secondary care only, secondary care initiated or suitable for prescribing in both primary and secondary care (this category also includes medicines that may be recommended for GP prescribing via the outpatient referral process). A small number of medicines are considered to be primary care only as they are not normally prescribed in the secondary care setting. Where a medicine will be initiated by a specialist prior to transfer of prescribing responsibility to primary care, a shared care agreement is usually required and this should be presented as part of the application for formulary inclusion. The Area Prescribing Committee will ensure that it meets the needs of primary care prescribers and once approved it will be published on local websites. Published shared care agreements that reach their review dates are revised and republished as necessary. 2.4 Drug therapy and shared care guidelines The APC is responsible for reviewing and giving final approval to drug therapy guidelines that are applicable to primary care. The APC will also approve guidance on drug treatment of psychiatric conditions developed by the Hampshire Partnership Foundation Trust or Portsmouth City mental health services prior to dissemination in the local health community. The APC approved the following new or updated drug therapy guidelines during 2012-13: Anxiety Treatment Guidelines (Southern Health FT) Paliperidone Depot Guidelines (Southern Health FT) Switching from quetiapine XL to quetiapine immediate release (Southern Health FT) Bipolar Guidelines (Southern Health NHS Foundation Trust) New Oral Anticoagulants (NOACs) guidance for primary care SHIP Guidance on the use of biologic agents for the treatment of rheumatoid arthritis Guidelines for the Pharmacological Management of Chronic Pain in Primary Care Management of Chronic Obstructive Pulmonary Disease (review) The APC approved the following shared care guidelines during 2012-13: Management of patients receiving acetylcholinesterase inhibitors (donepezil, rivastigmine and galantamine) and memantine (Solent NHS Trust) Growth hormone in paediatrics Acamprosate tablets for the maintenance of abstinence in alcohol dependence
2.5 Plans for 2013-14 NICE published Good Practice Guidance on Developing and Updating Local Formularies in Decenber 2012. This guidance was developed to provide good practice recommendations for the systems and processes needed to ensure NHS organisations develop and update local formularies effectively and in accordance with statutory requirements. A number of recommendations have been identified that will require action to ensure that the local APC and formulary processes are in line with this good practice guidance.
• The range of healthcare treatments to be included on the formulary needs to be reviewed to
clarify the types of medical devices that will be included.
• The guidance suggests that the committee should include a locally-defined mix of members
from partner organisations and key stakeholders, such as patients and the public. A suitable patient representative needs to be identified.
• Ensure corporate governance arrangements are firmly established with clear lines of
accountability for each partner organisation.
• Prioritise medicines not subject to a NICE technology appraisal for consideration using
explicit criteria. Ensure these prioritisation criteria are well known, clear and transparent. Current horizon scanning activities will help to identify these medicines and there needs to be a process to ensure that those with potential for the most significant impact are considered promptly.
• Use of a multi-criteria decision-making tool should be considered in order to clearly define
and consistently apply standard criteria when making decisions.
• Engagement with commissioning and financial managers at an appropriate level of seniority
needs to be strengthened in order to align local formulary decisions within the framework of clinical commissioning. A finance representative for the committee needs to be identified.
• All relevant local formulary information should be published online, in a clear, simple and
transparent way, so that patients, the public and stakeholders can easily understand it. This includes formulary policies, minutes of meetings, decision outcomes and associated decision outputs. The preferred option to fulfil this recommendation would be to develop a dedicated APC internet site accessible to healthcare professionals and the public.
• A robust and transparent process for reconsideration or appeals of decisions needs to be
introduced. Appeals are currently allowed but there is currently no written process or criteria.
In addition the membership and Terms of Reference for the APC will be reviewed to ensure that they accurately reflect the new NHS structure and relationships with other prescribing groups. Appendix 1 Area Prescribing Committee attendance April 2012 to March 2013 Meetings Post title Represents Attended (max 6)
Head of Medicines Management NHS Portsmouth
Consultant in critical care medicine Portsmouth Hospitals
Dr Holmes continues to receive all papers and correspondence for the APC.
Appendix 2 Medicines added to the Portsmouth District Prescribing Formulary
The following medicines or new uses of medicines were given final approval by the Area Prescribing Committee. Drug External Financial impact* recommendation
£42,900 for 15 patients (SREs) in adults with bone metastases
Submacular haemorrhage (off-licence) Emollient and soap substitute for
general use Antimicrobial emollient and soap
Telaprevir tablets Boceprevir capsules Fingolimod capsules
Castration resistant metastatic prostate
First-line treatment of locally advanced
medical retinal specialist only. (May also
Higher acquisition cost than gonadorelin
analogues but no administration costs. Heart failure. Additional drug costs likely
for inhalation Glycopyrronium bromide for
inhalation Raltegravir tablets Rilpirivine tablets Ipilimumab injection Vemurafenib
agent for patients allergic to other agents. Sleep disorders associated with
neurological or neurodevelopmental disorders in children.
Drugs in bold print were excluded from the Payment by Results Tariff for 2012-13 Appendix 2(a) Business cases or external guidance considered without change to the Portsmouth District Prescribing Formulary Drug
Type 2 diabetes. Approved for addition to the
Reheumatoid arthritis. (Update of TA 198)
Venom anaphylaxis. Specialist centres only. Not recommended for advanced breast cancer – no
action required. Not recommended for prostate cancer – no action
required. Not recommended for breast cancer – no action
required Chronic migraine. Botulinum toxin is already on the
formulary for other indications. DVT treatment. Rivaroxaban is already on the
formulary for other indications. Not recommended for metastatic breast cancer- no
action required. Acute ischaemic stroke. Review only - no action
required Bone metastases from solid tumours (added to the
formulary April 2012) Cystic fibrosis (adults). Highly unlikely to be
prescribed locally. Acute myeloid leukaemia. Terminated appraisal -
no action required To improve walking ability in multiple sclerosis –
low priority for funding –no action required. Lambert-Eaton Myasthenic Syndrome. Low priority
Not recommended for diabetic macular oedema- no
action required. Benign prostatic hyperplasia. Terminated appraisal
– no action required Urothelial carcinoma. Terminated appraisal – no
*SHIP - Southampton, Hampshire, Isle of Wight and Portsmouth Priorities Committee Policy Recommendation Appendix 3
Terms of Reference Portsmouth and South East Hampshire Area Prescribing Committee Membership CCG GP Prescribing Lead (Chair) Director of Professional and Clinical Development, NHS Portsmouth Clinical Commissioning Group (Vice chair) General Practitioner appointed by NHS Portsmouth CCG General Practitioner appointed by South Eastern Hampshire CCG General Practitioner appointed by Fareham and Gosport CCG Medicines Management Lead for South Eastern Hampshire CCG Medicines Management Lead for Fareham and Gosport CCG Medical Director of Portsmouth Hospitals NHS Trust PHT Director of Medicines Management and Pharmacy Specialist Pharmacist for Commissioning Three clinician representatives from Portsmouth Hospitals NHS Trust nominated by the Medical Director to include the chair of the PHT Formulary and Medicines Group Clinical Pharmacy Manager nominated by PHT Director of Medicines Management and Pharmacy Formulary Pharmacist (secretary) Chief Pharmacist Southern Health NHS Trust (or nominated deputy) Chief Pharmacist Solent NHS Trust (or nominated deputy) Local Pharmaceutical Committee Chief Officer or nominated deputy Public Health representative nominated by Portsmouth City Council or Hampshire County Council Lay member Nursing representative Finance representative Accountability The Committee will be accountable to the Boards of the constituent organisations through their respective Chief Executives or CCG Accountable Officer. Reporting arrangements The Committee shall report to all constituent organisations by way of an Annual Report produced by 30th June annually. Purpose To promote evidence-based, safe and cost-effective use of medicines within the local health economy To promote a consistent approach to prescribing and medicines management within the local health economy. To provide advice and guidance to NHS organisations and health professionals within the local health economy on prescribing and medicines-related issues. To provide a forum for informed discussion between primary and secondary care; structured to ensure that the implications of any significant changes in practice related to medicines are defined and understood. Functions
Plan for and manage the introduction of new medicines and new indications for existing
medicines into the local health economy including advising on appropriate prescribing responsibility within primary and secondary care and advising commissioners and/or providers as appropriate about the cost implications of such new medicines or indications.
Maintain and review the Portsmouth and South East Hampshire Prescribing Formulary including
approving class reviews of medicines when necessary.
Plan for and facilitate local implementation of national policy and guidelines related to medicines
e.g. NICE and other national guidance, including assessment of the impact for the local health economy.
Ensure that medicines recommended within NICE Technology Appraisals are added to the
formulary and made available for prescribing within 90 days of the publication of the TA.
Have regard to and advise constituent organisations on the impact of medicines-related guidance
issued by local priorities committees, when established, and refer topics to these committees for consideration as appropriate.
Note recommendations issued by the Basingstoke, Winchester and Southampton District
Prescribing Committee and support collaborative working between committees.
Consider and approve mental health medicines and related guidance from mental health provider
organisations for use in the local health economy.
Ratify recommendations from the DPC on the content of the wound management formulary
without further consideration, unless specific concerns are raised that warrant referral back to the DPC.
Approve shared care protocols, prescribing guidelines and care pathways that apply to
prescribing across primary and secondary care.
Review new safety information and alerts related to medicines and advise on action to be taken
Provide guidance on medicines management issues that have an effect on clinical practice and
the overall delivery of healthcare across the local health economy.
Make recommendations to commissioners about medicines linked to new interventions.
Highlight to commissioners potential impact (cost-saving or cost-pressure) of approved
medicines including those that are excluded from the Payment by Results Tariff.
Note medicines-related commissioning policies issued by NHS England in relation to specialised
Approve audit requirements associated with introduction of new medicines or new uses of
medicines and receive audits of prescribing to ensure that any conditions associated with formulary approval are being adhered to.
Link with other existing groups with regard to medicine management issues (e.g. PHT Formulary
and Medicines Group, PHT Medication Safety Committee, PHT Patient Group Directions Group, Joint Wound Formulary Group, Solent NHS Trust, Southern Heath NHS Foundation Trust and individual CCG Medicines Management Committees.)
Develop relationships with new and emerging organisations/groups who will have an impact on
medicine management in the local health community.
Produce an annual report by 30th June each year.
Meeting to be chaired by appointed Chair or vice-Chair. In the absence of both the Chair and
Vice-chair the meeting may be chaired by a GP member or CCG pharmacist.
Formulary pharmacist to act as secretary; to agree agenda before each APC meeting in
Agenda and associated papers to be circulated to all APC members electronically one week
Clinicians may attend the meeting in support of formulary applications but will be asked to leave
before any decision is taken. The secretary will arrange a designated time for clinicians to attend in advance of the meeting.
The committee will endeavour to reach decisions by consensus where possible. If a vote is
required all full members have the right to vote.
Decisions on formulary status will be communicated to applicants within ten working days of the
committee meeting. The decision may include requirements for audit or any other conditions required by the committee.
Terms of Reference, the notes of each meeting and annual reports will be published.
Members will be required to complete an annual declaration of interests and the Chair will
request any additional declarations at the beginning of each meeting. (Relevant declarations include remuneration for work undertaken, sponsorship for attendance at meetings or other events, shareholdings or directorships, where there is a commercial relationship that may result in a conflict of interest with the work of the committee).
A meeting will be considered quorate if all of the following are present:
1. Two clinicians (one of whom must be a GP) 2. One pharmacist 3. A representative from primary care 4. A representative from secondary care 5. A representative from two CCGs and Portsmouth Hospitals NHS Trust
Terms of reference will be reviewed every two years.
Frequency of meetings The 3rd Friday of every other month (6 meetings per annum). Approved: June 2013 Date of next review: June 2015
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