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Managing medicines across a health community — Making area prescribing committees fit for purpose May 2007

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Page 1: Managing medicines across a health community Medicines.pdfyour APC against the fitness for purpose framework SEE how other APCs are addressing practical day-to-day issues through illustrative

Managing medicines across a

health community —Making area prescribing committees fit

for purpose

May 2007

Page 2: Managing medicines across a health community Medicines.pdfyour APC against the fitness for purpose framework SEE how other APCs are addressing practical day-to-day issues through illustrative

Project Team

Catherine Picton is a consultant with extensive experience of healthcare delivery and management. As a

qualified pharmacist, she has managed a wide range of projects for the NHS and other healthcare

organisations. Her areas of expertise include the development of health policy and its implementation

locally, and competency and organisational development. Catherine can be contacted by email at

[email protected] or on 07747 862688.

Steve Morris is Director of Strategic Development and Operations at the NPC. He was previously Director of

Primary Care at South East Sheffield PCT. As a qualified pharmacist, he has held numerous roles in

primary care, community and hospital pharmacy. Steve was chair of the Faculty of Prescribing and

Medicines Management of the College of Pharmacy Practice until 2006. Steve can be contacted at

[email protected].

Written by: Catherine Picton Production and layout: Annette Donougher

Publications / Marketing Manager

National Prescribing Centre

NPC materials may be downloaded / copied freely by people employed by the NHS in England for purposes that

support NHS activities in England. Any person not employed by the NHS, or who is working for the NHS outside

England, who wishes to download / copy NPC materials for purposes other than their personal use should seek

permission first from the NPC. Email: [email protected] Copyright 2007

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Managing medicines across a health community —Making area prescribing committees fit for purpose

© National Prescribing Centre, May 2007 1

Medicines are the most common healthcare intervention. Patients generally have their care delivered by more

than one healthcare organisation, for example, many medicines are initiated in acute / specialist hospitals and

subsequently prescribed in primary care. Ensuring that medicines are well managed across a health

community, in terms of entry of new medicines and interventions, safe and effective choices, and equitable

access for patients, requires the input of all stakeholder organisations.

The clinical and financial risks and benefits associated with medicines are best managed using a collaborative,

area wide approach to medicines management. Commissioner and provider organisations have traditionally

worked together to address these issues in Area Prescribing and Medicines Management Committees (APCs)

or equivalents. These committees were originally established in an attempt to manage more effectively the entry

of new drugs into the NHS, however the functions of many APCs goes far beyond this remit.

The environment in which APCs are operating has changed considerably

over the last few years with the introduction of practice-based

commissioning, payment by results, the creation of foundation Trusts and

policy imperatives such as increased patient choice in providers. With the

boundary and organisational restructures for Primary Care Trusts and

Strategic Health Authorities the most recent change.

There is considerable variation in the extent to which APCs are active, the

influence they have and the ways in which they operate. However a recent

National Audit Office report1 concluded that a co-ordinated approach to

prescribing across the primary and secondary care sectors is one of the

key ways to improve the value-for-money of prescribing. An active and

effective APC can also support the implementation of NICE guidance,

National Patient Safety Agency (NPSA) guidance and the medicines

management aspects of National Service Frameworks. All of which are part

of the Healthcare Commissions’ annual health check.

The key to ensuring that APCs effectively support the local medicines

management agenda lies in each of their stakeholder organisations gaining

benefit from working in a co-ordinated manner. Only then can networks

develop to encourage information sharing, liberate decision-making and

inspire innovation. APCs’ depend strongly on members working voluntarily

together to innovate, solve problems of mutual concern, and co-ordinate

solutions and implementation plans.

Executive summary

Use this guide to:

1 National Audit Office. Prescribing Costs in Primary Care. May 2007 (www.nao.org.uk)

DIAGNOSEhow your APC is currently

functioning with a quick

assessment tool

REVIEWyour APC against the fitness

for purpose framework

SEEhow other APCs are

addressing practical day-to-

day issues through illustrative

shared practice examples

CHECKthat your APC has addressed

the key success factors for

future performance

This web-based guide contains hyperlinks to other pages within the

document. Hyperlinks are highlighted in green.

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Managing medicines across a health community —Making area prescribing committees fit for purpose

2 © National Prescribing Centre, May 2007

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Managing medicines across a health community —Making area prescribing committees fit for purpose

© National Prescribing Centre, May 2007 3

Contents

Executive summary ..........................................................................................................................................1

1 Introduction .................................................................................................................................................4

1.1 Purpose of this guide ..........................................................................................................................4

1.2 Main audiences for this document .....................................................................................................5

2 Context .......................................................................................................................................................6

3 APC fitness for purpose framework ............................................................................................................7

3.1 Scop, functions and cross check .......................................................................................................8

3.1.1 Scope .......................................................................................................................................8

3.1.2 Functions ...............................................................................................................................10

3.1.3 Cross check ...........................................................................................................................11

3.2 Structure ............................................................................................................................................11

3.2.1 Recognition and reporting ......................................................................................................11

3.2.2 APC membership ...................................................................................................................12

3.2.3 Individual committee members ..............................................................................................14

3.2.4 Key links .................................................................................................................................14

3.2.5 Resources ..............................................................................................................................14

3.3 Processes ........................................................................................................................................17

3.3.1 Setting the agenda .................................................................................................................17

3.3.2 Decision-making .....................................................................................................................18

3.3.3 Communication ......................................................................................................................19

3.3.4 Implementation and monitoring ..............................................................................................19

4 Examples of sharing practice ....................................................................................................................21

5 Abbreviations ............................................................................................................................................45

6 How the guide was developed .................................................................................................................46

7 Acknowledgements ...................................................................................................................................47

Appendix 1 A quick diagnosis exercise to identify your APCs strengths and weaknesses ......................50

Appendix 2 Key success factors checklist .................................................................................................62

Appendix 3 Useful information sources for APCs .....................................................................................66

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Managing medicines across a health community —Making area prescribing committees fit for purpose

4 © National Prescribing Centre, May 2007

1.1 Purpose of the guide

The purpose of this guide is to help Area Prescribing and Medicines Management Committees

(APCs) review their role and functions and to ensure that they are fit for purpose.

This guide can be used to help establish an APC where none exists or to help existing APCs to

review and reinstate their roles by ensuring that they are fit for purpose.

An Area Prescribing and Medicines Management Committee is essentially a ‘strategic’ committee whose

‘member’ organisations are primary and secondary care commissioners and providers working together to

ensure a consistent health community approach to medicines management. There are a wide range of local

names for Area Prescribing and Medicines Management Committees, so for the purpose of this document

the abbreviation APC will be used.

The use of medicines by patients needs to be co-ordinated throughout the patient’s journey. Most patients

have their care delivered by more than one healthcare organisation. Many medicines are initiated in acute /

specialist hospitals and subsequently prescribed in primary care. Medicines management and prescribing

are key elements of both Primary Care Trust (PCT) and acute Trust business. Issues relating to medicines

and technologies also interface with a number of other areas including commissioning, finance, clinical

networks, clinical effectiveness and public health.

Problems with medicines often occur at the interface between healthcare organisations, and health and

social care. This risk needs to be managed both clinically and financially, and a co-ordinated area wide

approach to medicines management can help organisations do this.

Traditionally, APCs have provided an area wide forum for NHS and other organisations within a health

community to address issues relating to prescribing and medicines management. There are clear benefits to

patients and organisations of having an effective and influential APC, for example, an APC can:

• Promote co-operation and consistency of approach in the commissioning process

• Prevent duplication of professional and managerial effort by ensuring local joint working

• Ensure that robust standards and governance underpin community wide decision-making

• Enable key stakeholders, working in the NHS locally, to exert an influence on the prioritisation,

improvement and development of healthcare delivery

• Co-ordinate the safe and effective use of medicines across a health community.

1 Introduction

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The recent NHS changes in primary care organisations and the development of practice-based

commissioning (PBC) (see section 2) provide the ideal opportunity for APCs to re-evaluate their activities

and functions, and their role in providing leadership on joint, strategic medicines management across their

health communities. This guide aims to help APCs reinstate their role and to ensure that they are fit for

purpose by reviewing established practice in terms of their scope and functions, and the structures and

processes they have in place to support their activities. The guide addresses practical day-to-day issues

APCs face through illustrative shared practice examples.

1.2 Main audiences for this document

This document is of relevance to all organisations and individuals involved in the management of medicines

across a health community including:

• PCT commissioner and provider services

• PBC consortia

• Acute, foundation, and tertiary and specialist Trusts

• Strategic Health Authorities (SHAs)

• Existing APCs

• Any organisation with a role which impacts on strategic medicines management across a health

community, e.g. cancer networks, private contractors for NHS services, independent sector treatment

centres, social services

• Doctors, pharmacists and nurses

• Patient representatives.

Managing medicines across a health community —Making area prescribing committees fit for purpose

© National Prescribing Centre, May 2007 5

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Managing medicines across a health community —Making area prescribing committees fit for purpose

6 © National Prescribing Centre, May 2007

APCs evolved following ‘Purchasing and Providing’ EL (94) 72, Department of Health (DH) guidance which

was issued primarily in an attempt to manage the entry of new drugs into the NHS. In 2000, after the

establishment of PCTs, the National Prescribing Centre (NPC) published guidance for APCs which was

designed to act as a ‘health check’ in the then new environment. Since 2000, however, the environment in

which current APCs are operating has again changed considerably.

PCTs and SHAs have been restructured and their roles re-defined. In general, PCTs and SHAs now cover

larger populations with SHAs having a more strategic development and oversight role. PCTs have both a

commissioner and a provider function, with the latter potentially able to split from the PCT. These boundary

and organisational restructures, plus new policy imperatives such as increased patient choice in, and the

plurality of, providers, present new challenges for organisations managing the use of medicines across a

health community.

Our Health, Our Care, Our Say (DH 2006) and Commissioning a patient led NHS (DH 2005) re-affirmed the

key role of PBC. PBC consortia are now working in practice, and PCT Professional Executive Committees

have a responsibility to ensure alignment and co-ordination across practices and groupings. APCs are likely

to have an ongoing and developing role in helping to ensure consistency in medicines management across

PBC consortia.

Payment by results (PbR) has brought another new dimension to the role of APCs with, for example,

reimbursement for PbR non-tariff medicines a new area of risk which needs to be managed across

healthcare organisations.

Foundation Trusts represent a profound change in the way in which hospital services are managed and

provided. The greater freedom that foundation Trusts have to manage their own affairs will continue to

impact on local health communities.

The role and functions of national organisations have also increased in scope. For technology appraisals

from the National Institute for Health and Clinical Excellence (NICE), Trusts have a statutory duty to identify

funding within three months of issue. Further, the Healthcare Commission now includes the implementation

of NICE guidance, National Patient Safety Agency (NPSA) guidance and National Service Frameworks

(NSFs) as part of their annual health check.

Each health community has a complex and interdependent range of local and national; public, private, and

independent; and voluntary ‘third sector’ organisations all needing to deliver care to patients in integrated

patient pathways. In this complex environment, a robust and effective APC has a clear opportunity to help

consistency of patient experience across diverse services by providing a lead on the full spectrum of

medicines management issues across a health community.

2 Context

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Managing medicines across a health community —Making area prescribing committees fit for purpose

© National Prescribing Centre, May 2007 7

This section of the guide outlines a fitness for purpose framework. The framework provides a

structure to help existing APCs, or organisations considering restructuring / creating an APC, work

through the key factors likely to contribute to its success.

Since APCs were created, they have evolved in a variety of ways to suit their local environments. Whilst

some APCs are perceived as being highly effective, others are viewed as having had little impact2. The

experiences of existing APCs3 indicate that there are a range of key issues that APCs need to consider in

order to function effectively. These key issues have been used to develop the fitness for purpose framework

(illustrated below). The framework provides a structure to help existing APCs, or organisations considering

restructuring / creating an APC, work through the key factors likely to contribute to its success.

The framework considers first the importance of defining the SCOPE and FUNCTIONS of the APC

(see section 3.1). Then it looks at a range of STRUCTURES (see section 3.2) and PROCESSES

(see section 3.3) that, if in place, can help APCs to function effectively.

Figure 1 — A framework for assessing fitness for purpose

3 APC fitness for purpose framework

2 Department of Health, Association of British Pharmaceutical Industry. Qualitative analysis of variation in uptake of medicines across

the NHS in England, February 2007

3 Appendix 1 outlines how this document was developed. The results of the survey of APCs baseline activities (December 2006 /

January 2007) which informed development of the fitness for purpose framework can be found at www.npc.co.uk

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3.1 Scope, functions and cross check

This section of the fitness for purpose framework will help APCs to:

• Identify the SCOPE of their activities using a stakeholder map

• Outline the potential FUNCTIONS of APCs

• CROSS CHECK which organisations or groups are responsible for which issues and identify

gaps in decision-making.

In general, APCs can provide a strategic lead on the full spectrum of medicines management issues in the

‘local’ health community. An APC may not consider all medicines management issues, however, it can help

to ensure that systems are in place to deliver consistent decisions across the health community. Acting in

this way APCs will help to minimise duplication of effort and maximise the use of resources across a given

area.

3.1.1 Scope

Local health communities vary widely. A stakeholder map of all the

organisations and committees involved in medicines management will

help an APC to define its natural health community. It will also highlight

stakeholder relationships relative to each other in the process of

medicines management and focus efforts on ensuring appropriate

membership and representation on an APC (see APC membership

section 3.2.3 and key links section 3.2.4).

A health community is usually a natural grouping of one or more PCTs

along with one or more providers. Factors influencing the scope of an

APC include:

• Demographics

• Size and number of PCTs and acute Trusts

• Presence of a mental health Trust and / or a specialist Trust and

• Where a care Trust exists, social services and local authorities.

Pre-existing advisory and / or decision-making groups including, for example, commissioning groups

configured along previous SHA boundaries should also be included in stakeholder mapping; as should new

commissioning groups such as PBC consortia.

It may also be useful to produce a stakeholder map at SHA level to identify the potential for joint work

programmes across a SHA. APCs have potentially large work programmes (see functions section 3.1.2)

and duplication of effort could be minimised by neighbouring, or SHA-wide APCs sharing workloads.

Managing medicines across a health community —Making area prescribing committees fit for purpose

8 © National Prescribing Centre, May 2007

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Local authorities and social services

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This stakeholder map plots out how a range of different organisations / committees

are linked by medicines management decisions.

Section 3.2.4 gives more information about key links for APCs.

Managing medicines across a health community —Making area prescribing committees fit for purpose

© National Prescribing Centre, May 2007 9

Figure 2 below gives an example of a stakeholder map.

Figure 2 — Example of a stakeholder map

APC A

PBC Consortia

‘PCT A’

Prescribing / Medicines

Management Committee

Acute Trust

DTC

Sub-groups, e.g.

formulary / NICE

implementation

‘PCT B’

Prescribing / Medicines

Management Committee

LMC / LPC

Neigbouring

APC B

Mental Health Trust

DTC

Tertiary Foundation

Trust DTC

Boundary between neighbouring APCs

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Managing medicines across a health community —Making area prescribing committees fit for purpose

10 © National Prescribing Centre, May 2007

3.1.2 Functions

APCs have expanded their activities considerably from the new medicines remit initially proposed for them. However,

there is variation in the range of issues which APCs consider. The following functions illustrate the range of roles that

APCs have, grouped broadly into four areas (overarching functions, core business, extended activities and wider

context). Some of these many APCs do, others have developed in some APCs due to environmental / locality

drivers. It is unlikely that an APC will be able to undertake all of these functions, to be effective an APC will need to

prioritise its activities depending on its local environment.

OVERARCHING FUNCTIONS

• Provide a forum for informed discussion between clinicians from both primary and secondary care; structured to

ensure that the implications of any significant changes in practice on the management of healthcare resources

overall, are defined and understood

• Ensure that robust standards and governance arrangements underpin area wide decision-making / advice

related to medicines

• Develop effectiveness measures against the main priorities of the APC

CORE BUSINESS

• Plan for and manage the introduction of new medicines and new indications for existing medicines into the local

health economy (see processes 3.3 and sharing practice 6)

• Plan and facilitate local implementation of national policy, e.g. NICE guidance (see sharing practice 1), NPSA

patient safety alerts (see sharing practice 2) and other national guidance, e.g. Better Care, Better Value

Indicators (see appendix 3 useful information resources for APCs)

• Develop and / or approve shared care protocols, treatment and / or prescribing guidelines and care pathways

between different care environments; help to decide who prescribes and where prescribing occurs

• Provide guidance on medicines management issues that have an effect on clinical practice and the overall

delivery of healthcare in the local health economy, e.g. developing and keeping a formulary up-to-date;

agreement of prescribing policies

• Ensure that its advice, once agreed, is implemented and / or endorsed by relevant organisations, for example,

by an implementation and monitoring plan

• Ensure patient safety is incorporated as a specific issue in all decisions and recommendations made by the

APC, including the safety aspects of the way medicines are used in practice

EXTENDED ACTIVITIES

• Make recommendations to commissioners about medicines linked to new interventions, e.g. bariatric surgery for

morbid obesity, peripheral DEXA scanning

• Management of the financial resource allocated for medicines across the health community, e.g. an in year

budget allocated to support decisions on new drugs (see sharing practice 14 and sharing practice 16)

• Co-ordinate community-wide initiatives, e.g. safety campaigns, patient awareness, medicines related admissions

• Advise on non-medical prescribing issues

• Health community-wide patient group direction development

WIDER CONTEXT

• Consider funding pathways and work with commissioners and contractors to ensure that systems are in place

to manage high cost medicines and / or interventions within the context of existing (and future) financial

frameworks (for example PbR tariff exclusions — see sharing practice 25)

• Highlight to commissioners potential impact (cost saving or cost generation) of approved medicines

• Provide guidance for appropriate working with the pharmaceutical industry including guidance for PBC

consortia and non-medical prescribers (see key links section 3.2.4)

• Consider changes in service delivery that impact on medicines management across the interface

• Consider social and local authority issues relating to medicines management

• Develop relationships with new and emerging organisations / groups who will have an impact on medicines

management in the heath community, e.g. PBC consortia, Independent Sector Treatment Centres (ISTCs),

foundation Trusts (see key links section 3.2.4)

• Monitor medicines use in the health community and feedback to local organisations

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© National Prescribing Centre, May 2007 11

3.1.3 Cross check

Whilst the APC may not perform all medicines management functions locally, it is important that they are

done. The stakeholder map can be cross checked against the functions identified to help decide the most

appropriate local group / organisation to take responsibility. Some committees may be decision-making for

some of their functions but may have an advisory role in others.

A key factor in the cross check is to decide whether APCs (or any of the other stakeholder groups) are

decision-making groups with members having delegated responsibility from their organisations (see sharing

practice 3), or whether decisions are guidance for member organisations to consider (see sharing practice 4).

Clearly when mapping functions to organisations it is important to be clear about the status of decisions. It is

also important to understand the relationship the APC has to similar decision-making committees in the

individual organisations (see structures 3.2).

3.2 Structures

This section of the fitness for purpose framework outlines the key issues to consider when

structuring an APC, under the following headings:

• Recognition and reporting

• APC membership

• Members’ responsibilities

• Key links

• Resources.

Shared practice examples are included throughout.

APCs have a range of structures to facilitate the delivery of their functions. There is no single right way of

structuring an APC. The most important thing is to ensure that whatever structure is decided upon, it can

deliver the APC’s goals locally. For an APC to function effectively the organisations involved need to feel that

they own the decisions that the APC makes. In order to create this environment it is important for an APC to

be robustly and transparently structured.

3.2.1 Recognition and reporting

APCs are essentially supra-organisational committees with individual

committee members representing their own organisations (to whom they

remain ultimately accountable). To be recognised in the wider locality as

the ‘key committee’ through which strategic decisions and / or advice

around medicines management issues are sought, key stakeholders

should have confidence in the authority, membership and decision-making

processes, as well as the implementation and monitoring of decisions.

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APCs need to consider:

• Acute Trust boards and PCT boards ‘formally recognising’ the APC, e.g. by making it accountable to a

joint forum of chief executives (see sharing practice 3), and any other member organisations, e.g. mental

health Trusts, tertiary Trusts. It is important that this 'formal recognition' is followed up with robust

communications to keep the Trust boards fully informed and engaged in the work of the APC

• A defined reporting procedure for APC decisions and / or endorsement procedure for APC advice in all

‘member’ organisations (see sharing practice 23)

• Terms of reference outlining the committee’s accountability, roles, responsibilities, reporting mechanisms,

frequency of meeting, membership, selection of the Chair and quoracy should be agreed by all the APCs

member organisations. The terms of reference should be reviewed when organisational changes occur

• Clarity at Board level about the status of APC decisions and the relationship the APC has to similar

decision-making committees in the individual organisations, e.g. acute Trust Drug and Therapeutics

Committee (DTC), PCT medicines management committees (see box 1 below)

• Clarity about who is responsible for implementation and monitoring of decisions

• The APC Chair, or another designated representative, to have a mechanism for direct access, where

necessary, to the relevant Boards of all stakeholder organisations.

3.2.2 APC membership

The number of APC committee members depends on a range of local factors, for example, the number and

size of its member organisations, the structure of the APC and its functions. A stakeholder map will help to

identify relevant stakeholders (see scope section 3.1.1). It is important that relevant organisations have

involvement in the APC process (see key links section 3.2.4) at the same time the committee has to be

workable. Generally, APC membership is multidisciplinary (although there are exceptions; see sharing

practice 3) but by definition it needs an agreed balance of primary and secondary care representation.

The committee’s chairperson must be committed and able to command the professional respect of his / her

peers locally. Strong leadership from the committee’s chairperson is seen as one of the key success factors

for an APC (see sharing practice 26).

Box 1: Some examples of how APCs relate to Trust DTCsIt is important for APCs to be explicit about how they relate to existing Trust DTCs. APCs and DTCs have developed a range ofdifferent relationships depending on local circumstances. Some examples include:

• The APC and Trust DTC have been combined with all decisions being made by a joint APC (see sharing practice 5)• Trust DTCs are effectively a sub-group of the APC, considering, for example, formulary issues or evaluating new drugs for

the APC (see sharing practice 6)• The acute Trust DTC considers the APCs recommendations but remains the decision-making group for its organisation

(see sharing practice 4).

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Members are generally experienced healthcare professionals and / or managers who can most effectively

represent a body of opinion, not just their own. Often members are board level and / or other senior

individuals who exert a direct influence on prescribing matters within their organisations.

Inclusion of a lay representative will help APCs to ensure that the public’s interests are addressed. APCs

have a poor record of including lay representation. Sharing practice 7 gives hints from APCs who have had

successful lay representation on their APCs. APCs should also consider other ways of encouraging lay

input, for example, via patient and public engagement forums.

Membership will always reflect the local needs and functions of the APC and as such cannot be unduly

rigid, however, as a guide, box 2 below gives examples of core APC members and examples of the wider

membership that some APCs have.

Identification of nominated deputies will help to ensure that a balanced complement of members is always

present. Such issues should be agreed in advance by the members and defined in the committee’s terms of

reference (see recognition and reporting 3.2.1).

Core membership of APCs• Senior medical representative from each member organisation, e.g. acute Trust medical director, PCT medical director• Senior pharmacy representative from each member organisation, e.g. acute Trust chief pharmacist, PCT head of medicines

management• Senior nurse representative• Lay representative (see sharing practice 7)• Commissioning and / or finance representatives (including representatives from PBC, see box 4)• Pharmacist facilitator / analyst / secretary.

Wider* membership of APCs• Other pharmacists, for example, acute, medicines information, formulary, community• Other medical representatives, for example, GPs, acute Trust consultants• Public health representative• Mental health representative (if not a core organisation)• Non-medical prescribing representative• Local Medical Committee (LMC) representative• Local Pharmaceutical Committee (LPC) representative• PCT professional executive committee chair • Social services • Ethics committee representative, academic representative.

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14 © National Prescribing Centre, May 2007

3.2.3 Individual committee members

Committee members need clarity about their role and responsibilities as members of the APC. Some APCs

have explicit ‘job descriptions’ for committee members. Box 3 gives an example of some of these. To

encourage effective team working some APCs have encouraged committee members to participate in

occasional ‘away days’ (see sharing practice 20).

3.2.4 Key links

Local health communities have a complex range of overlapping organisations and groups likely to have an

impact on strategic medicines management (see also scope 3.1.1). There are many ways an APC can

engage these groups, for example, inviting representatives to attend meetings when agenda points are

specifically relevant to them. What is key is that these links are defined and in place to ensure the timely

response to issues. Some key organisations / groups that APCs need to have links with include:

• Existing groups / committees

Most of the organisations who are members of the APC will already have a range of groups / committees

in their organisations where overlap might occur. It is important that the interaction between existing

groups is explicitly discussed and agreed. An APC’s credibility and ability to optimise patient care is likely

tol be damaged if its decisions are ignored and / or overruled by another committee / group. The

relationship with the acute Trust DTC was discussed in section 3.1.1, however, other committees where

overlap may occur include governance committees, commissioning and priority setting groups,

exceptional cases committees, NICE implementation groups, risk management and audit committees.

• Local mental health Trusts

Many mental health Trusts cross the boundaries of several APCs and so their input into any APC needs

to be seen in the wider context of their catchment area. In some areas, mental health Trusts are

members of the APC with their Boards committed to implementing or considering APC advice, in other

areas, mental health Trusts receive APC minutes or attend relevant meetings only.

Box 3: Examples of responsibilities of an individual APC member• Accept ownership of APC decisions• Undertake work as necessary between meetings• Promote two-way communication between the APC and relevant NHS colleagues / organisations• Take specific views, from the APC, back to your own organisation for comment, and then to feed back the responses to the

APC, as appropriate• Commit to regular attendance of APC meetings to ensure continuity and balance of input into decision-making• Be an enthusiastic, motivated and active participant in the committee• Declare prior to each meeting any outside interests, which might have a bearing on your actions, views and involvement in

discussions within the committee.

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• Neighbouring APCs

Neighbouring APCs are likely to share many of the same issues. Co-operation between APCs can help

to share resources and ensure consistency of decision-making across wider health communities when

appropriate (see sharing practice 16 and 24).

• PBC consortia

APCs are likely to have a key role in engaging PBC consortia and helping to ensure continuity of

medicines management across local health economies. There are a range of ways in which PBCs are

linking into local medicines management networks (see box 4 for some examples).

• Specialist commissioning groups and tertiary providers

These groups and organisations are often engaged as part of the APC horizon scanning process

(see sharing practice 8).

• Local clinical practitioners (see also PBC)

Via links with the LMC and LPC. Good engagement from local practitioners is crucial to the successful

implementation of any APC decisions. A good relationship with both the LMC and LPC is likely to help

the local adoption of APC decisions. To facilitate this, some APCs have LMC and LPC representatives as

committee members. In other cases the LMC and LPC receive minutes of all meetings and / or are

members of PCT medicines management committees.

• Networks, e.g. cancer, cardiac

These networks can have a major role in making / influencing decisions about medicines. The APC

should have processes in place to communicate with the networks and clarity around roles and

responsibilities. As with mental health Trusts, networks frequently span several APCs.

• Private and ‘third sector’ contractors

Increasingly these contractors can deliver services within APCs areas. Links with these organisations by

the APC and commissioners will help to ensure that their terms of service require them to follow APC

decisions / guidance (see sharing practice 9).

• Pharmaceutical industry

Clear policies will help APCs considering working with the pharmaceutical industry. The NPC and the

Association of British Pharmaceutical Industry (ABPI) hope to publish joint guidance for APCs by Autumn

2007.

Box 4: Examples of how APCs are engaging wih PBC consortia• Each of the PBC consortia have a nominated GP member of the APC and so are directly involved in area medicines

management decisions (see sharing practice 17 and 24) • PBC consortia need APC approval for any new business cases with a treatment element (see sharing practice 22) • PBC consortia have a nominated GP member of the PCT medicines management committee.

It is via these local medicines management committees that PBCs raise issues with the APC (see sharing practice 27).

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• Social and education services and local authorities

APCs will also need input from these organisations when appropriate, this type of input will become

more important as more integrated working practices evolve.

• Prison primary care groups

APCs with a prison, private or public, in its health community need to engage with the relevant prison

primary care group.

• Accountable officers

Accountable officers are responsible for ensuring the safe and effective use and management of

controlled drugs within local organisations subject to their oversight. APCs should be aware of how any

decisions taken impact on accountable officers and vice versa.

• Health Protection Units (HPUs)

Local HPUs work directly with PCTs, acute hospital Trusts and local authorities in their area and agree

with them how health protection should be delivered locally. APCs need to be aware of local HPUs and

where decisions / advice impact on a HPU and vice versa.

3.2.5 Resources

The resources dedicated to support an APC, over and above the member organisations identifying

appropriate committee members, are seen as a key success factor in the functioning of an APC. This is also

one of the most problematic areas to resolve since organisations need to take a wider view and devote hard

pressed financial resources to a community-wide committee. However, it is important to stress that investing

in these additional resources will optimise the effectiveness of an APC.

Examples of additional resources that APCs can use include:

• Dedicated professional time to co-ordinate and support the APCs functions (see sharing practice 10)

• Secretarial support for administrative processes including ensuring timely communication of decisions /

advice

• Access to critical appraisal and health economic skills, for example, via a dedicated pharmacist (see

above) or commissioning reviews from other organisations (see appendix 3 useful information resources

for APCs)

• Appropriate venue and hospitality to cover scheduled meetings and development activities, e.g. away

days (see sharing practice 20)

• Pharmacy technician time to support the committees’ functions specifically monitoring and

implementation work (see sharing practice 11)

• Locum fees where necessary to encourage clinical participation.

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3.3 Processes

This section of the fitness for purpose framework considers the APC’s processes under the

following headings:

• Setting the agenda

• Decision-making

• Communication

• Implementation and monitoring.

Shared practice examples are included throughout.

Once the functions of an APC have been outlined and its structure set up, the processes underpinning the

APC’s working can be defined. Clear processes will help the successful functioning of an APC as well as

protecting against the possibilities of legal or other challenge.

3.3.1 Setting the agenda

Several APCs have developed processes for deciding what agenda

items to consider (see sharing practice 21and 24). The APCs agenda

should be proactive as well as reacting to issues as they arise, for

example, an APCs agenda setting might include the following

components:

• Forward planning / work plan — usually APCs schedule a yearly

work programme

• Horizon scanning — using resources from national organisations to

highlight potential issues for the APC as they arise (see also

appendix 3 useful information resources for APCs) as well as local

intelligence,

e.g. from exceptional case committees

• Agenda setting — as well as being structured to deal with unexpected issues arising, an agenda will

usually include a range of standing items, for example:

• Notes of previous meeting

• Declaration of conflicts of interest

• NICE / NPSA guidance

• Replies to letters / correspondence

• New drug applications

• Guidelines in development.

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3.3.2 Decision-making

As well as a core membership, APCs frequently co-opt specialist representation for specific issues or create

sub-groups. Some groups are permanent, others are time-limited and issue related (see sharing practice 1,

2 and 12). The membership of any sub-group requires consideration and should probably include major

local stakeholders working in the specialist area under consideration, and non-specialist representation, for

example, a non-specialist chair.

APCs have a range of ways of assessing evidence and producing guidance. However, access to high

quality, independent information on medicines is vital to ensure advice is robust and based on the best

available, clinical and cost-effectiveness evidence, as is clarity about criteria for assessment.

Standardised processes and documentation are essential for APCs to help support decision-making and

communication. Examples of standardised processes include:

• Submission process for new drug and / or formulary applications and a classification system for

decisions, e.g. traffic light systems (see sharing practice 18)

• Explicit criteria to be considered when assessing a new drug / formulary submission (see sharing

practice 13 some websites include their criteria)

• Attendance of ‘applicants’ at meetings to discuss specific requests for new medicines / extensions of

indications. In some instances ‘applicants’ stay whilst the decision is made, in other cases ‘applicants’

leave the room whilst the decision is made. There are pros and cons to each approach, however, the

important thing is that the decision remains evidence-based and that the presence of an ‘applicant’

doesn’t unduly pressure the committee (see sharing practice 25)

• Pro forma letters communicating decisions to ‘applicants’ / the health community

• ‘Ethical frameworks’ to underpin decision-making (see sharing practice 16 and 23).

APCs have a range of ways of assessing evidence, these include:

• Members of the committee assess applications and conduct independent appraisals

• A dedicated individual, usually a pharmacist, a joint appointment or employed by a member organisation,

assesses applications

• Commissioned / existing reviews from national, e.g. NPC, Scottish Medicines Consortium, and / or local

organisations / groups, e.g. Medicine Information Centres, London New Drugs Group, neighbouring

PCTs, specialized commissioning (see appendix 3 useful information resources for APCs)

• Sub-committees are set up to assess evidence and bring their recommendations to the APC, e.g. a

formulary group, a new drugs group (see sharing practice 2 and 12).

However, an assessment occurs, ideally it will be a critical appraisal of the evidence, as opposed to

summaries of clinical trial data. Relevant local specialists also need to be engaged. Once a decision is

made, how the decision was made needs to be transparent. As a general principle, minutes should be

publicly available, rapidly circulated with clear action points (see communication section 3.3.3).

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Meetings should encourage open, honest and challenging debate. Decisions should be reached by

consensus and be supported by the whole of the membership. Once a decision has been finalised all

members of the APC need to present and maintain the agreed position.

3.3.3 Communication

Effective communication is crucial to the successful functioning of any APC. Irrespective of how high the

quality and relevance of an APC’s work, recognition, endorsement and active implementation of its advice is

unlikely to take place unless it is communicated in a timely and effective way to all appropriate stakeholders.

Communication is the responsibility of the committee as a whole, but is also dependent on the active

participation of individual members. Clear direction and agreement on how members link into, and report

back to, key groups and individuals within their own organisations / professions will help communication.

Some practical issues for APCs to consider:

• Active engagement with applicants and / or specialists throughout the APC decision-making process

• Rapid dissemination of decisions in a high quality, concise format to GPs, clinical directors, pharmacists

and other relevant professionals and managers

• Clear and well publicised mechanisms should be in place for individual healthcare professionals, e.g.

prescribers, affected by APC decisions / advice to communicate with the APC

• Many APCs produce a monthly newsletter and more are using email and the inter- and intranet (see

sharing practice 13 for a list of APCs with accessible websites and sharing practice 23 for an email alert

system)

• Individual communication by medicines management teams in primary care and the hospital pharmacy

team in secondary care

• Sometimes APC decisions / advice will have a significant effect on other NHS organisations outside its

locality. These organisations, and their APC(s), should be informed of / involved in discussions at an

early stage. This process will require suitable communication processes to be in place beyond a

committee’s area of responsibility

• An Annual Report on the APC’s work and processes sent to all relevant Boards for information.

3.3.4 Implementation and monitoring

APCs need to consider developing and monitoring systems to evaluate the outcomes of an APC’s advice.

Approaches to the monitoring and implementation of APC decisions / guidance include:

• Monitoring of prescribing in primary care via ePACT and in acute Trusts by hospital prescribing data

(see appendix 3 useful information resources for APCs and sharing practice 18)

• Individual follow-up by PCT advisers or hospital pharmacy team where practice differs from

recommendations

• Policy for onward referral where practice continues to differ, e.g. back to APC, or to Trust or PCT medical

director, chief pharmacist

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• Specific activities, e.g GP incentive schemes to support APC recommendations, hospital pharmacies not

stocking non-formulary drugs (see sharing practice 18)

• Local practitioners, e.g. GPs, encouraged to query prescribing they see outside APC guidance

(see sharing practice 15)

• Service delivery changes, guidelines, shared care protocols evaluated and / or audited and results

reviewed (see sharing practice 19)

• Access to decisions / formulary on a web resource accessible by both primary and secondary care and

in some cases the public (see sharing practice 13)

• Meetings to launch specific initiatives.

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4 Examples of sharing practice

Sharing practice 1 APC responds to NICE guidance Page 22

Sharing practice 2 APC responds to NPSA guidance Page 23

Sharing practice 3APC has responsibility for making decisions on behalf of its member

organisations Page 24

Sharing practice 4APC makes recommendations for acute Trust DTC / PCT medicines

management committees to decide uponPage 25

Sharing practice 5 Combined APC and Trust DTC make decisions together Page 25

Sharing practice 6 Acute Trust DTC makes decisions on new drugs for the APC Page 26

Sharing practice 7 Successful lay representation on APCs Page 27

Sharing practice 8An APC obtains information from its partner organisations and

tertiary care providersPage 28

Sharing practice 9 APC input into model contracts for private service providers Page 29

Sharing practice 10 Dedicated pharmacist supports APC activities Page 30

Sharing practice 11 Pharmacy technician supports APC activities Page 30

Sharing practice 12 APC utilises ‘task and finish’ and formulary sub-groups Page 31

Sharing practice 13 APC websites for communicating decisions Page 31

Sharing practice 14 APC aligns clinical and financial responsibility Page 32

Sharing practice 15 GP non-formulary reporting scheme Page 33

Sharing practice 16 Neighbouring APCs share agendas Page 34

Sharing practice 17 Moving forward: an APC engages PBC clusters Page 35

Sharing practice 18 Monitoring an APCs’ traffic light system Page 36

Sharing practice 19 Auditing the APCs’ decisions Page 37

Sharing practice 20 APC team building Page 38

Sharing practice 21 An APCs’ agenda setting process Page 39

Sharing practice 22 APC engages PBC consortia using a governance structure Page 40

Sharing practice 23 APC uses an email alert system to inform stakeholders about decisions Page 40

Sharing practice 24 An APC restructures following mergers and engages PBC consortia Page 41

Sharing practice 25 An APC and its’ role in PbR Page 42

Sharing practice 26 Expert advice and clear chairmanship at APC meetings Page 43

Sharing practice 27APC engages PBC consortia via PCT Medicines Management

Committees Page 44

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APC responds to NICE guidance

Organisation: Winchester and Southampton District Prescribing Committee

Member organisations: Five consultants, three specialist registrars, two specialist nurses and

the medical directorate pharmacist

The Southampton University Hospitals NHS Trust gastroenterology team met to establish the

current practice for prescribing infliximab in patients with crohn’s disease, within the acute Trust.

There was some variation within the group, however, a consensus as to how infliximab should be

used in patients with crohn’s disease was reached.

The agreed proposal was presented by two members of the gastroenterology team to the

Winchester and Southampton District Prescribing Committee (DPC). The DPC members include

GPs, hospital clinicians, PCT pharmaceutical advisers, practice pharmacists and hosptial

pharmacists. The DPC approved the use of infliximab locally for crohn’s disease, but only if in

line with the NICE recommendation. It was therefore necessary to introduce a system to ensure

that the prescribing of infliximab for patients with crohn’s disease was in line with NICE.

A specialist registrar and the medical directorate pharmacist designed a double-sided infliximab

form. The first side included the patient details together with tick box sections for diagnosis,

indication and the patient’s current immunomodulating therapy. The doctor was also required to

indicate that the exclusion criteria had been satisfied and to calculate the patient’s Harvey

Bradshaw Index. Completing the first side of the form ensured that the patient fulfilled the NICE

criteria.

The second side of the form comprised of the infliximab prescription. The prescriber was also

required to record the necessary safety monitoring on this side. The response to therapy and

reason for stopping therapy also needed to be recorded on the second side of the form.

The clinicians within the gastroenterology team were made aware that it was necessary to

complete an infliximab form in every case, before a patient could receive infliximab treatment.

The pharmacists and nurses were also reminded that infliximab could not be supplied or

administered until the infliximab form had been completed satisfactorily.

The information on the infliximab forms is also entered onto the hospital information database.

The infliximab prescribing information is then easily accessible and auditable. The database is

also linked to the acute trust’s pathology results system and therefore enables the safety

monitoring data to be downloaded directly into the information database of our gastroenterology

patients.

All the clinicians, pharmacists and nurses involved in the use of infliximab in patients with crohn’s

disease were kept informed throughout the process. The final infliximab form was emailed to all

the gastroenterology clinicians. Additionally, copies were made available in the outpatient

department and on the medical wards.

For further details contact: Caron Weeks, Medical Directorate Pharmacist, Southampton

University Hospitals NHS Trust

Email: [email protected]

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APC responds to NPSA guidance

Organisation: Sutton and Merton PCT Medicines Management Committee

Member organisations: Two PCTs and acute Trust

We established a joint methotrexate working group consisting of GPs and pharmacists from two

PCTs and clinicians and pharmacists from our local acute Trust.

We initially organised a one-off meeting involving all the different specialties within the acute

Trust to establish current practice with regards to methotrexate prescribing. There was a lot of

variation in terms of tests that were conducted and whether GPs were prescribing or not. After

this meeting two clinicians (a consultant rheumatologist and consultant dermatologist)

represented all the acute Trust clinicians at the working group.

The working group developed:

• A reference guide on the process to be followed when initiating methotrexate

• A form to facilitate communication of essential information between primary and secondary

care

• A shared care prescribing guideline for methotrexate

• An information leaflet for all hospital staff

• Adaptation of the national methotrexate book for local use.

The group also sought agreement from neighbouring PCTs and acute Trusts, not to prescribe

and dispense 10mg methotrexate.

Clinicians on the working group liaised with other clinicians in the Trust and kept them informed

throughout the process. Guidance was launched in primary care and secondary care at the same

time and widely publicised through our PCT prescribing bulletin and by practice support

pharmacists.

To ensure implementation we included a methotrexate audit in the quality and outcomes

framework (QOF) medicines management targets. When conducting community pharmacy

contract monitoring visits in our PCT, we also check and remind pharmacists that 10mg

methotrexate should be discouraged and not to store 2.5mg and 10mg methotrexate tablets

together to minimise the risk of any dispensing errors.

For further details contact: Brigitte van der Zanden, Chief Pharmacist, Sutton and Merton PCT

Email: [email protected]

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APC has responsibility for making decisions on behalf of its member

organisations

Organisation: Winchester and Southampton District Prescribing Committee

Member organisations: Acute Trust, acute Teaching Trust, two PCTs, mental health Trust

The APC considers strategic medicines management decisions which concern all the member

organisations. The APC is a decision-making organisation and the chief executives of all the

member organisations have agreed that APC advice will 'normally be implemented'. The APC

reports directly to the chief executives. Member organisations maintain their own DTC

committees which deal with ‘internal’ medicines management issues and help disseminate,

implement and monitor APC decisions and guidance.

In the hospital Trusts, prescribers not following APC policy are asked about it by their directors of

service. Reports from primary care are also passed onto the hospital chief pharmacist. In general

this is getting rarer but we do occasionally still have some issues.

In primary care, because prescribers aren't directly employed, other ways are used to influence

them. We have been giving supportive, patient-centred medicines management assistance since

1999 and so our team is known and respected. We provide practice level prescribing data on all

the things that the APC is keen to change, benchmarked against national and SHA averages. We

also get groups of GPs from different practices together regularly so that those who are slower to

change can learn from, and be reassured by, the early adopters.

The bottom line is that most of the GP community trusts us not to recommend an inferior product

and we are honest about the need to save money. We also link prescribing cash savings with the

ability to keep open other services, e.g. district nurses or community hospital facilities, and GPs

tend not to think of money as being in different pots. When carrying out agreed medication

switches we put the PCT prescribing team's phone number on letters to patients so that they can

ring us to discuss it if they wish. This reduces the work and hassle for the practice and means

the switch does not get in the way of the doctor patient relationship.

For further details contact: Brian Curwain, Chief Pharmacist, Hampshire (West) PCT

Email: [email protected]

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APC makes recommendations for acute Trust DTC / PCT medicines

management committees to decide upon

Organisation: North Central London Pharmacy and Medicines Management

Operations Committee

Member organisations: Five acute Trusts, five PCTs, two mental health Trusts

Currently the APC is a pharmacy only forum with recommendations taken to individual PCT /

acute Trust DTC committees for broader discussion, agreement and implementation.

The committee discusses and agrees area prescribing policy, implements area cost-effectiveness

projects, e.g. statins prescribing; and discusses and agrees arrangements for shared care (in

progress).

Challenges faced include: reassuring local GPs that their views are taken on board when policy

originates from a pharmacy only group; gaining agreement across large teaching acute Trusts for

important cost-effectiveness policies, e.g. statins; gaining representation and 'buy-in' from large

number of Trusts and PCTs.

For further details contact: John Farrell, Chair, North Central London Pharmacy and Medicines

Management Operations Committee or Allan Karr

Email: [email protected] or [email protected]

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Combined APC and Trust DTC make decisions together

Organisation: Wirral Drug and Therapeutics Committee

Member organisations: PCT, acute Trust, mental health Trust, tertiary Trust

Since November 2003 the DTC has been a joint decision-making group for primary and

secondary care. Previously a joint PCT / Trust Committee alternated with separate ones within

each organisation. The Wirral geography, with one PCT and one acute Trust, and regular

collaborative working across the health economy, enable the joint DTC to be effective.

The Chair, PCT head of medicines management and the acute Trust director of pharmacy /

deputy director: formulary services have a pre meeting to ensure that implications for primary

and secondary care are shared. This is a key success factor in the operation of the joint

committee.

For further details contact: Julia Simms, Head of Medicines Management, Wirral PCT or

Pippa Roberts, Director of Pharmacy and Risk, Wirral Hospitals NHS Trust

Email: [email protected] or [email protected]

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Acute Trust DTC makes decisions on new drugs for the APC

Organisation: Sandwell Medicines Management Committee

Member organisations: Two PCTs, acute Trust

Two PCTs and an acute Trust work in partnership to produce a Consolidated Health Economy

Formulary. Decisions relating to which drugs to include are made at the acute Trust's DTC. The

DTC’s decisions are accepted by both PCTs. Membership of the DTC includes the PCTs' senior

pharmaceutical advisers and GPs.

Drugs are classified as:

• Available for use by all prescribers — the majority of the commonly used drugs in primary

care, e.g. simvastatin, armorial, aspirin, salbutamol inhalers, metformin

• Restricted use — drugs to be initiated by named departments or specialities, e.g. combined

long-acting bronchodilator / steroid inhalers for asthma / COPD

• Very restricted use — drugs must be initiated by named consultants, e.g. rosuvastatin.

The hospital pharmacy does not stock non-formulary drugs so if patients are admitted with

non-formulary drugs, they are switched to a formulary choice if clinically appropriate. Where

non-formulary drugs are clinically necessary, a process is in place to allow supply. The DTC

monitors the use of non-formulary drugs at each meeting and the 2007 review process is just

starting.

The implementation process is slightly different in the two PCTs. One PCT has its own formulary

and prescribing guidelines which include the agreed consolidated formulary drugs, the other uses

the acute trust formulary for PCT guidance. Both PCTs monitor adherence to the formulary in

primary care and any concerns are raised at the DTC.

We have had a few issues with implementing the formulary. For example, GPs being asked to

prescribe restricted or non-formulary drugs by hospital consultants or patients being admitted to

hospital who have been initiated on non-formulary drugs by GPs. Generally, however, the

decision-making process is working well and the main issue that acted as the driver for the

consolidated formulary (the pharmacies on the two hospital sites used different formularies

neither of which was compatible with primary care choices), has been resolved.

For further details contact: Jenifer Harding, Assistant Director, Medicines Management,

Sandwell PCT

Email: [email protected]

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Successful lay representation on APCs

Very few APCs have lay representation. Here are some hints from APCs that have made it work.

Selecting a lay member

• Use patient and public involvement groups to help selected members, they have a good

network of interested people

• Individuals with an educational background, not necessarily health professionals, can make a

good contribution

• It can be helpful if the lay member has some level of background knowledge, for example,

some lay members have already been non-executive members of PCTs, lay representatives

of SHAs or are retired healthcare professionals

• Ideally a lay representative shouldn’t represent a specific advocacy group. If they do, make

sure that the patient is clear on their role, i.e. they are representing patients in general not just

those with a particular disease.

Supporting lay members

• To encourage more active participation, provide support for lay members in terms of coaching

/ an induction so that they can be prepared and have a chance to find out what the issues are

and get more out of meetings

• Do a pre-briefing to give some technical background and make sure they are included in the

discussion by checking on understanding and asking for opinions

• Try and find a network for your lay member to tap into

• A written / verbal ‘job description’ can help the lay representative understand their role.

• Try not to let the professionals over-power the confidence of the lay person.

Benefits of having lay members

• “Our lay member asks the naïve and simple questions in considering how to handle new

drugs or shared care issues, this leads to more simple issues often buried under technical

knowledge”

• “The lay representative looks at issues from a different perspective and asks things like; what

will be the impact on patients? How do they find out about this?”

For further details contact: Alaster Rutherford, Bristol PCT; Sue Lunec, Redditch and

Bromsgrove PCT; Brigitte Van der Zanden, Sutton and Merton PCT; Eleanor Mitchell, Berkshire

PCT; Rasila Shah, Hertfordshire PCT or Liz Butterfield, East Sussex Downs and Weald PCT

Email: [email protected]

[email protected]

[email protected]

[email protected]

[email protected]

[email protected]

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An APC obtains information from its partner organisations and

tertiary care providers

Organisation: Hertfordshire Medicines Management Committee

Member organisations: Two acute Trusts, two PCTs, one mental health Trust, one cancer

network (Bedfordshire PCT currently remain members and make a

significant contribution to the work agenda)

As part of the commissioning process, we request our local partners and some of our tertiary

care providers, who have significant contracts with us, to share the agendas and minutes from

relevant medicines management committees with us.

This enables us to express our interest in topics that will impact on us and request relevant

papers. Where we feel it is helpful, we may use this documentation as a starting point for any

paperwork we are preparing, to help inform our APC and the organisation whose information is

utilised will be acknowledged.

Not all health systems and tertiary care centres share information in this manner. Sometimes, if

the decision taken in another area is not what you believe is good use of NHS resources, it can

be tricky but not insurmountable.

Sharing requires confidence on both sides as well as a culture of transparency. We are happy to

share our information with our partner organisations.

For further details contact: Rasila Shah, Lead Pharmacist, Hertfordshire PCTs

Email: [email protected]

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APC input into model contracts for private service providers

Organisation: East Lancashire Medicines Management Board

Member organisations: Two PCTs, acute Trust, mental health Trust

The East Lancashire Medicines Management Board had previously agreed a health economy

‘Prescribing Specification’ written from a commissioner perspective to specify standards from

providers in relation to prescribing and medicines management. This document has recently

been updated as a ‘Prescribing and Medicines Management Specification’ to incorporate new

sections on major incidents and dealing with excluded drugs under the PbR framework.

Traditionally, the specification has been aimed at local NHS providers with whom it had been

developed in partnership. However, with the introduction of policy developments such as Patient

Choice and plurality in provision, where patients may not necessarily receive their healthcare

intervention at the local NHS hospital, it has been recognised that the PCTs (through the

Medicines Management Board) need to engage with a wider range of providers, including

foundation Trusts and the private sector. As a result, it has been agreed that the specification will

be shared with local private providers. There is also the desire to share it across a wider

geographical NHS footprint to promote a consistent approach in relation to medicines

management across a variety of commissioning and provider units.

The specification can be located on the East Lancashire Medicines Management website

www.elmmb.nhs.uk

For further details contact: Catherine Harding, Head of Medicines Management,

East Lancashire PCT

Email: [email protected]

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Dedicated pharmacist supports APC activities

Organisation: North Staffordshire Area Prescribing Committee

Member organisations: Two PCTs, acute Trust, mental health Trust

The PCTs and acute Trust jointly fund a full time equivalent band 8a pharmacist. The pharmacist

is actively involved in the APC and the new medicines sub-group of the APC. Key responsibilities

include preparing new medicines reviews, promotion and regular updating of the Joint Formulary,

production of a bi-monthly newsletter, and establishment of shared cared agreements.

To date this post has been key in establishing a joint primary and secondary care formulary and

in ensuring that applications to include new medicines in the joint formulary are reviewed

thoroughly and in a timely manner.

The pharmacist is based at the acute Trust and has a purely secondary care background,

inevitably some of the work undertaken could be viewed as having a secondary care slant. One

of the greatest challenges faced is being able to fully understand, appreciate and meet the

individual needs of the PCTs, the acute Trust and the mental health Trust.

For further details contact: Andrew Riley, Head of Medicines Management, Stoke-on-Trent PCT

or Angela Davis, Medicines Management Interface Pharmacist, University Hospital of North

Staffordshire

Email: [email protected] or [email protected]

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Pharmacy technician supports APC activities

Organisation: North Staffordshire Area Prescribing Committee

Member organisations: Two PCTs, acute Trust, mental health Trust

The PCTs and acute Trust jointly fund a full time equivalent band 8a pharmacist. The pharmacist

supports the APC and the new medicines sub-group of the APC. The pharmacist is supported by

a 0.6fte band 6 pharmacy technician, based at the acute Trust.

The technician role was established to support the formulary within the acute Trust, but as the

formulary is now a joint primary and secondary care formulary her role has expanded. The

technician was key in setting up the Joint Formulary and is now responsible for its continuous

updating. The technician provides cost and usage information for the new medicine reviews,

monitors formulary compliance and contributes to the bi-monthly new medicines committee

newsletter. The technician has also started to become involved in the new medicines reviews by

undertaking literature searches and collating information.

For further details contact: Andrew Riley, Head of Medicines Management, Stoke-on-Trent PCT

or Angela Davis, Medicines Management Interface Pharmacist, University Hospital of North

Staffordshire

Email: [email protected] or [email protected]

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APC utilises ‘task and finish’ and formulary sub-groups

Organisation: East Sussex Health Economy Medicines Management Committee

Member organisations: Acute Trust, two PCTs, mental health Trust

The APC uses specific ‘task and finish’ sub-committees to look at, for example, high cost drugs,

shared cared guidelines, NICE, PbR exclusions. The sub-committees have tight terms of

reference and are time limited. They usually take three months to report, with interim progress

reports given. The APC then takes a decision based on the groups’ recommendations. The

formulary sub-group makes decisions on all formulary issues across the health economy,

including managed entry of new drugs. Once the APC has made a decision the local medicines

groups (DTCs / prescribing committees) take responsibility for implementation.

Having a joint formulary sub-group has helped to engage clinicians and encourage a health

community perspective. Setting up this decision-making process also secured commitment from

chief executives, the acute Trust medical director and the clinical management Board to a joint

process and the implementation of decisions.

The major challenge with this process has been ensuring joint working across two acute Trust

sites. We have also needed a consistent communication strategy to healthcare professionals and

patients across the patch.

For further details contact: Liz Butterfield, Pharmacist Facilitator, East Sussex Downs and

Weald PCT

Email: [email protected]

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3 APC websites for communicating decisions

Many APCs are now using inter- and intranet sites to communicate their decisions and / or

advice to their health communities. Here is a list of websites which are easily accessible:

• East Lancashire Medicines Management Board www.elmmb.nhs.uk

• Cambridgeshire Joint Prescribing Group www.cambsphn.nhs.uk and follow the link to

Cambridgeshire Joint Prescribing Group

• Mid Essex Area Prescribing Committee and Bedfordshire and Luton Joint Prescribing

Committee www.eastern.nhs.uk

• North Derbyshire Priorities and Clinical Effectiveness Forum

nww.nodyis.nhs.uk/guidelines/pacef%20web.htm

• Southampton and Winchester District Prescribing Committee

www.suht.nhs.uk/extranet/index.cfm?articleid=1927

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APC aligns clinical and financial responsibility

Organisation: Worcestershire Area Prescribing Committee

Member organisations: Acute Trust, PCT, mental health Trust

The APC holds an annual horizon scanning meeting and produces a spreadsheet of drug

pressures and likely costs for the following year which is used to inform the local delivery plan

process within the PCT. Once allocated the budget is essentially given to the acute Trust to

manage. The process for management is via the APC with all committee members involved but

led by the director of pharmacy who holds the resource. The process is slightly complicated by

PbR as the new drug resource allocated by the PCT largely relates to the excluded elements and

the included elements are determined within the acute Trust (from available growth monies). The

APC monitors total expenditure at the monthly meeting. When requests for new drugs are

assessed, and subsequently supported, the APC determines how much of the resource it needs to

/ can afford to allocate to the new drug.

The APC has been operating in this capacity (alignment of clinical and financial resources) for

three to four years now and it works well, with financial balance achieved. It was particularly

effective when there were three PCTs linking into the process as it ensured agreement and equity.

It is much simpler now as we are just one merged PCT. Holding the budget also gives the APC

extra credibility and has raised the APCs profile within the acute Trust. It means that the clinicians

know exactly where they stand and that prompt decisions can be made on clinical appropriateness

that are not separate to the financial approval process.

One of the weaknesses of the committee has been in the area of oncology because the area links

into three cancer networks and achieving consistency has been difficult. With the merger of the

PCTs it is hoped that this will be easier to manage. The committee has recently reviewed its terms

of reference and is looking to mirror the budgetary management process with the mental health

trust also. Finally the committee is looking to extend its remit into non-drug technologies. It is felt

that this will assist the local process for implementation of NICE guidance and assessment of non-

drug technologies in a manner consistent with drug developments.

For further details contact: Fiona Bates, New Drug and Technology Adviser, Worcestershire PCT

Email: [email protected]

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GP non-formulary reporting scheme

Organisation: North Staffordshire Area Prescribing Committee

Member organisations: Two PCTs, acute Trust, mental health Trust

A reporting scheme is being piloted to monitor requests to prescribe non-formulary medicines

arising through hospital consultant letters to GPs and out-patient prescriptions.

GPs are able to complete a form (either by hand or electronically) which includes patient details,

hospital doctor and / or out-patient clinic details, and details of the non-formulary medicine

requested. Completed forms are returned directly to the Interface pharmacist. Information

obtained is for monitoring purposes and is used to identify trends in non-formulary

recommendations so that these can be addressed. Reports are not replied to individually unless

the GP has specifically requested this.

For further details contact: Andrew Riley, Head of Medicines Management, Stoke-on-Trent PCT

or Angela Davis, Medicines Management Interface Pharmacist, University Hospital of North

Staffordshire

Email: [email protected] or [email protected]

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Neighbouring APCs share agendas

Organisation: Berkshire Priorities Committee

Member organisations: Two acute Trusts, two PCTs, mental health Trust

Berkshire Priorities Committee is a countywide priorities committee with a diverse membership

including patient representatives, a non executive director chair, legal adviser, finance director and

commissioning members, public health, pharmaceutical advisers and GPs. The committee is an

overarching committee which makes policy decisions on a wide array of health issues, including

review of NICE guidance. It covers the whole of the Berkshire economy and has links with the two

acute Trusts and the mental health drug and therapeutics committees. This ensures continuity of

policy across the economy.

We work to an ethical framework in all our policy decisions, which includes testing for clinical

effectiveness and cost effectiveness of all treatments / procedures being reviewed. The diverse

membership ensures a wide range of views are considered fully and the committee is given

delegated responsibility from all the membership organisations to make decisions on their behalf.

At the beginning of each financial year all member organisations ‘top-slice’ funds to allow funding

of in-year new developments and treatment which we approve at the committee.

We work to a work plan which is shared and co-ordinated with Buckinghamshire and Oxfordshire,

in order to avoid duplication of effort and as much consistency across neighbouring counties as

possible. A central public health resource unit is responsible for carrying out the ‘work up’ of the

topics and this will involve extensive liaison with key clinicians in the particular topic field.

Challenges ahead include how we work effectively over large reconfigured health authority areas

— now South Central, yet retain local buy in and commitment to the decisions.

Implementation of APC policies remains the responsibility of the member Trusts.

For further details contact: Eleanor Mitchell, Senior Pharmaceutical Adviser, Berkshire East PCT

Email: [email protected]

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Moving forward: an APC engages PBC clusters

Organisation: Sandwell Medicines Management Committee (SMMC)

Member organisations: Two PCTs, acute Trust, mental health Trust

The first Sandwell Area Prescribing Committee (SAPC) was set up by Sandwell Health Authority

(HA) about 10 years ago. In 2002, the HA devolved into three PCTs and the SAPC developed

new terms of reference based on NPC guidance so the main focus of interface partnership

working continued. In 2004, single management partnership arrangements between the three

PCTs were formed and the SAPC became the SMMC with the terms of reference becoming

more primary care focused in preparation for PBC. Our three PBC clusters are loosely based on

the three PCT areas. The core membership of the SMMC is being redesigned to include

designated representatives from each of the three PBC clusters, namely, GP leads, senior

pharmacists and prescribing leads.

The SMMC is one of the more successful and stable committees in Sandwell with both decision

making and advisory powers. Between 2002 and 2005, the medicines management groups in

each PCT focused on different things, but the strength of the SAPC meant that interface

decisions, e.g. shared care agreements, community pharmacy initiatives, affecting the whole of

the Borough, were managed consistently thus avoiding fragmentation and confusion.

Key lessons from our experience are that inclusion and representation from all partners is

essential to ensure that decisions can be implemented and feedback discussed. The chair of the

committee needs to be a senior manager to ensure the status of the committee and allow

reporting directly to the PCT Board and governance committee. The acute Trusts' medical

directors and chief pharmacists are members of SMMC for similar reasons.

For further details contact: Jenifer Harding, Assistant Director, Medicines Management,

Sandwell PCT

Email: [email protected]

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Monitoring an APCs’ traffic light system

Organisation: Northamptonshire Prescribing Advisory Group (NPAG)

Member organisations: Two acute Trusts, PCT, mental health Trust

Our traffic light system was initiated about two years ago. We have six categories for drugs,

green, amber 1 and 2 (depending on the monitoring requirements), red (hospital only), double

red (not to be prescribed as lack of evidence of effectiveness) and grey (awaiting a decision by

NPAG). All amber 1 drugs should have a shared care protocol, and we are working our way

through these, whereas amber 2 need to be initiated by a consultant but can then move to GP

prescribing, e.g. duloxetine for depression.

We monitor double red drugs via ePACT.net and this will be one of the standards in our incentive

scheme for next year (some examples include desloratidine, levocetirizine, duloxetine for stress

incontinence and Tramacet).

We seem to have good buy-in from most of our GPs and our use of double reds is low. We

monitor double reds via a tag on ePACT.net.

The scheme works well as long as prescribers are aware of the status of drugs (the full list is on

the PCT intranet site with copies of the existing shared care protocols). The meeting also

provides an excellent forum for interface discussions between the acute Trusts, mental health

Trusts and PCTs.

The biggest challenge is getting good attendance at the meetings, as we need at least two

doctors in attendance to be quorate. We also need to try and anticipate the launch dates of new

drugs so that we can categorise them before their launch to prescribers.

For further details contact: Sue Maguire, Deputy Head of Pharmacy Policy and Prescribing,

Northamptonshire Teaching PCT

Email: [email protected]

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Auditing the APCs’ decisions

Organisation: South Devon Joint Formulary Group

Member organisations: One care Trust, two PCTs, mental health Trust

The South Devon Joint Formulary provides consistent prescribing advice across South Devon.

Our prescribing data shows that formulary drugs appear to be prescribed more than (and non-

formulary drugs less than) the national average in a number of areas including statins, ACE

inhibitors and coxibs.

As part of the implementation and monitoring of the joint formulary, Torbay Care Trust, one of the

APCs’ member organisations, has developed audit tools for a number of prescribing areas as

part of their local enhanced service — cost-effective prescribing and has shown the following:

1. Reduced prescribing of clopidogrel outside of the joint formulary (based on NICE advice)

clopidogrel prescribing is considerably lower than national average

2. Reduced prescribing of sip feeds outside of joint formulary guidance — more patients with

documented nutritional reviews.

Audits in 2006/2007 (results not available at time of writing) included NSAIDs in the over 75s and

appropriate monitoring of shared care drugs, and have shown areas for action which are

currently being worked on.

For further details contact: Shivaun Gammie, Pharmaceutical Adviser, Torbay Care Trust

Email: [email protected]

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APC team building

Organisation: City and Hackney Teaching PCT / Homerton University Hospital NHS

Foundation Trust Joint Prescribing and Medicines Management

Group

Member organisations: One foundation Trust, one PCT

At least annually, the APC holds an away-day at a 'neutral' venue, such as a conference centre.

The agenda for the day is set by the Group during their monthly meetings. The away-day

provides committee members with an opportunity to reflect on current ways of working, and to

identify when and how the committee is effective and the main barriers to effective working.

The away-day aims to develop skills in constructively using differences of perspective to improve

decision-making and to identify specific proposals to take forward — for the group as a whole

and for individual group members — to improve effectiveness. Such days also provide an

opportunity to regularly assess whether the committee is still required, whether the right people

are on the committee, and to plan for the coming year.

Holding the away-day at a 'neutral' venue works well because there is less temptation for

participants to leave for a couple of hours to attend to administrative work; attendees are more

likely to participate all day. Also, all attendees have the opportunity to provide input into the

agenda which leads to ownership by the group as a whole.

It has been a challenge to ensure that committee members understand the need for away-days

and the importance of attending for the whole day.

For further details contact: Jonathan Mason, Head of Prescribing and Pharmacy, City and

Hackney Teaching PCT or Jasbinder Khambh, Interface Pharmacist, City and Hackney Teaching

PCT / Homerton University Hospital NHS Foundation Trust

Email: [email protected] or [email protected] or

[email protected]

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An APCs agenda setting process

Organisation: City and Hackney Teaching PCT / Homerton University Hospital NHS

Foundation Trust Joint Prescribing and Medicines Management

Group

Member organisations: One foundation Trust, one PCT

The APC meets monthly; dates are set in December for the coming year. The agenda for the

next meeting is set at the end of each meeting and in general this is the structure:

• Standing items, e.g. discussion of the latest NICE guidance, new drug applications for

inclusion on the Joint Formulary, etc.

• Additional items for the next meeting are agreed by the Group before the close of the meeting

• Items not agreed at the previous meeting will only be included on the agenda if agreed by the

chair and secretary prior to the meeting

• Urgent 'any other business' (AOB) will only be discussed if the chair and secretary are notified

prior to the meeting.

What works particularly well is having standing items on the agenda and keeping AOB to a

minimum. Urgent AOB is only included if agreed by the chair and secretary. Also, taking AOB at

the beginning of the meeting helps to ensure that discussion is brief. If an item of AOB requires

extensive discussion then it will be postponed to the next meeting, or dealt with outside the

meeting. A challenge has been that many group members are used to taking AOB at the end of

meetings, the chair has to be firm and ensure that AOB is only taken at the start of the meeting,

and then only if the chair and secretary are notified prior to the meeting.

Not all group members actively participate in the agenda setting process, so we need to ensure

that there is no feeling that agendas are set mainly by the chair and secretary, and those who

are most vociferous.

For further details contact: Jonathan Mason, Head of Prescribing and Pharmacy, City and

Hackney Teaching PCT or Jasbinder Khambh, Interface Pharmacist, City and Hackney Teaching

PCT / Homerton University Hospital NHS Foundation Trust

Email: [email protected] or [email protected] or

[email protected]

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APC engages PBC consortia using a governance structure

Organisation: Croydon Prescribing Committee

Member organisations: Acute Trust, PCT, mental health Trust

Historically, our APC has had a very good relationship with GPs. The APC is seen as the

decision making group for medicines management issues across our health community. With the

PBC consortia the PCT has an arrangement whereby any new business cases need to be

submitted to a business case panel for agreement. Our governance process stipulates that any

new business cases / patient pathways with a treatment element, need to be approved by the

APC before they go to the business case panel.

This process is still in its’ infancy but because we have good relationships with all our GPs and

the new consortia it has been well accepted. Although it may introduce another level of

committee approval into the process the APC is prepared to consider a business case ‘virtually’

where urgent consideration is required.

For further details contact: Eileen Callaghan, Chief Pharmacist, Croydon PCT

Email: [email protected]

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APC uses an email alert system to inform stakeholders about decisions

Organisation: East Lancashire Medicines Management Board

Member organisations: Two PCTs, acute Trust

All decisions are posted on our medicines management board website once the decisions are

up, an email is sent out within the hospital Trust and across primary care to highlight new

additions to the website. This includes web links to new drug reviews, shared care protocols,

new prescribing guidelines, new newsletters or any other addition to the website.

The advantage of this system is that only web links to documents need to be sent out, rather

than sending out large documents. Individuals with non-NHS addresses or outside the region can

also register for the update allowing us to share practice with other localities.

This does have resource implications because all information has to be placed online which is

time consuming and requires someone to do this consistently.

Currently the alert is sent out to all staff across primary and secondary care, so we do target a lot

of people unnecessarily. Initially we tried to compile a list of interested stakeholders, but it was

impossible to keep up to date, so we send out to all staff. The hospital only send out as part of a

larger document once a week that includes lots of non-clinical information so sometimes the alert

does get lost.

For further details contact: Catherine Harding, Head of Medicines Management,

East Lancashire PCT or Richard Lee, East Lancashire New Drugs Pharmacist

Email: [email protected] or [email protected]

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An APC restructures following mergers and engages PBC consortia

Organisation: Hertfordshire Medicines Management Committee (HMMC)

Member organisations: Two acute Trusts, two PCTs*, one mental health Trust, one cancer

network (*Bedfordshire PCT currently remain members and make a

significant contribution to the work agenda)

In our new health economy area (one management team for two PCTs) we are aiming for a

managed entry structure of two ‘local’ APCs around each district general hospital (one is an

established APC [secondary care and PBC leads], the other is a secondary care prescribing

committee which primary care attend, at the moment), as well as a cancer and mental health

new drugs groups. All these have representation from PCT and secondary care pharmacists.

Across the health system, we have developed quality standards on how these committees

operate, criteria for prioritising work programme for similar committees and an ethical framework

by which recommendations from each committee would be assessed against. These committees

put forward any recommendations that are likely to have cost implications in any part of the

health system to the over-arching HMMC.

HMMC ensures robust processes followed in local ‘expert’ committees, consistency and

affordability for the health system and ratify the recommendations HMMC is responsible for

managing entry of all tertiary care commissioned treatments; agree / approve protocols for PbR

exclusions, implications of NICE, etc. and uses an ethical framework to arrive at its

recommendations.

HMMC reports to a clinical executive group comprising of primary and secondary care

representation / commissioning / finance to make final decision on affordability.

Potential pros of this system are: robust processes and consistency across the county; shared

workload; develop common understanding in primary and secondary care clinicians; empower

PBC groups / Trust clinicians to jointly agree value-for-money for health system; evidence on

existing treatments to be considered.

Potential cons of this system: too many committees; dis-engagement of clinicians if final decision

to be ratified across the county and / or affordability considered instead of just clinical

effectiveness.

Challenges we face: changing the functioning of current committees; developing confidence to

enable shared workload across the county; moving to a consistent process; getting engagement

and attendance from local groups to the over-arching committee.

For further details contact: Rasila Shah, Lead Pharmacist, Hertfordshire PCTs

Email: [email protected]

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An APC and its’ role in PbR

Organisation: Winchester and Southampton District Prescribing Committee

Member organisations: Acute Trust, acute Teaching Trust, two PCTs, mental health Trust

The APC already discusses the expected funding mechanisms for decisions made that affect

secondary care — this will be either via the tariff uplift (items within the healthcare resource

group) or via the high cost drug exclusion mechanism. Though at an early stage we plan to use

the APC as a place to discuss and agree additions of new drugs to the PbR exclusion list (the

Annex B agents such as cytokine inhibitors). It will allow us to consider broader indications of

drugs on the list and new agents where they become available. The latter is provided for in the

technical guidance (under paragraph 34). The agreed approach may well be taken as advice to

commissioning bodies rather than a final decision, but it seems a good way to ensure expert

advice on the subject.

What works well is that discussion helps to clarify for PCT and Trust members the funding

consequences of decisions, but it is too early to be sure this will works satisfactorily.

What isn't so good is that these mechanisms are not straightforward and are evolving, it is hard

for members of the APC to understand the detail on this.

For further details contact: Martin Stephens, Director of Clinical Effectiveness,

Southampton University Hospitals NHS Trust

Email: [email protected]

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Expert advice and clear chairmanship at APC meetings

Organisation: Winchester and Southampton District Prescribing Committee

Member organisations: Acute Trust, acute Teaching Trust, two PCTs, mental health Trust

The APC does accept personal attendance of experts who wish to advocate a particular

medicine or guideline. Discussion of the product and a final decision is taken with them there.

This is accepted as a difficult issue to get right — the committee needs to be prepared to say NO

if that’s the consensus based on evidence of clinical and cost-effectiveness.

What works well is that as all appraisals of medicines are developed, the local experts’ views are

sought, this ensures the more technical interpretative issues are dealt with prior to the meeting.

Experts attending are given a clear brief on what is expected, and understand that the APC may

reject their request. Members have access to the detailed reviews and therefore know the key

discussion points, the chair has a responsibility to understand these and be prepared to give a

strong lead to the meeting whilst reflecting the consensus view in summing up for decision.

What isn't so good is that it is not easy to turn down a well passionately argued case, and there

can be a tendency to ‘accept expert advice’, this is countered by the use of evidence.

The chair needs to ensure that behaviours of all present are appropriate for the meeting; there is

an argument that presentation should be allowed by an expert, but then discussion and decision

takes place without them, this would be less challenging for chair and members, but has been

rejected as less transparent and a less mature approach than that currently followed.

For further details contact: Martin Stephens, Director of Clinical Effectiveness,

Southampton University Hospitals NHS Trust

Email: [email protected]

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7

APC engages PBC consortia via PCT Medicines Management Committees

Organisation: Redbridge PCT Medicines Management Committee

Member organisations: Acute Trust, PCT, mental health Trust

The PCT Medicines Management Committee (MMC) membership consists of a number of

clinicians, including prescribing leads from each of the Clusters (three in total). They work closely

with the prescribing team to monitor and manage the prescribing budgets, for the member

practices of the Cluster.

There is no direct PBC representation on the APC, however, we ensure that the PBC prescribing

leads on the PCT MMC are aware of the PCT’s agenda and the status of APC decisions.

The relationship with the Cluster PBC prescribing lead and the medicines management team

works effectively, facilitating joint working with all practices and providing support as appropriate.

This includes regular Cluster Prescribing Educational meetings, for all clinicians, which provides

the opportunity for disseminating APC decisions.

The PCT is geographically situated between two acute Trusts; one of which involves working with

two PCTs, whilst the other working with a third different PCT. We have secured engagement of

the leads at the local DTC meetings and have initiated joint working with acute care clinicians in

a number of specialities to implement service re-design. We are currently developing processes

to ensure any impact on prescribing and related protocols is identified at the service re-design

stage.

For further details contact: Kiran Shah, Chief Pharmacist / Assistant Director Service

Reconfiguration, Redbridge PCT

Email: [email protected]

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ABPI Association of British Pharmaceutical Industry

APC Area Prescribing and Medicines Management Committee

DEXA Dual energy X-ray absorptiometry

DH Department of Health

DPC District Prescribing Committee

DTC Drug and Therapeutics Committee

HPU Health Protection Unit

ISTC Independent Sector Treatment Centres

LMC Local Medical Committee

LPC Local Pharmaceutical Committee

NHS National Health Service

NICE National Institute for Health and Clinical Excellence

NPC National Prescribing Centre

NPSA National Patient Safety Agency

NSFs National Service Frameworks

PACT Prescribing Analysis and Cost Data

PbR Payment by Results

PBC Practice-based commissioning

PCT Primary Care Trust

SHA Strategic Health Authority

5 Abbreviations

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In December 2006, a questionnaire was sent to prescribing advisers in all PCTs as a baseline assessment

of APC activities. A summary of the questionnaire and its findings can be found at www.npc.co.uk. At the

same time, a literature review was conducted to identify developments in APCs and their working

environments since the publication of the original APC guide in 2000. The project steering group also

reviewed the original APC document and identified which areas were still relevant in the current

environment.

The questionnaire results, literature search and steering group review informed the development of a first

draft of the guide which included the fitness for purpose framework and the key success factors checklist,

and identified initial sharing practice examples.

The early draft guide was tested by a focus group (see acknowledgements) of individuals actively involved

in APCs in order to further develop key themes and ideas, see if anything had been missed and to identify

more sharing practice examples and potential support tools for APCs.

Following on from the focus group, a user-testing group (see acknowledgements), ensured all key points

had been covered and tested the document in practice. The document was then widely circulated and

further refined prior to the steering group’s final review.

6 How the guide was developed

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Steering group members

Martin Anderson Director of NHS Policy and Partnerships, Association of British Pharmaceutical

Industry

Gill Arr-Jones Senior Professional Advisor Pharmacist, Healthcare Commission

Nigel Barnes Programme Consultant — Medicines Management, NHS West Midlands

Nicola Bent Associate Director, Implementation Systems, National Institute for Health and

Clinical Excellence

Rebecca Blessing Senior Business Manager, Medicines, Pharmacy and Industry Group,

Department of Health

Katrina Cleary GP Consortia Commissioner, South Sheffield PBC Consortia

Fred Faller Prescribing Lead, North Yorkshire and York PCT

Janet Hattle Pharmacy Services Manager, Gateshead Health NHS Foundation Trust

David Jenner GP and NHS Alliance PBC Lead

Jonathan Mason Head of Medicines Management, City and Hackney Teaching PCT

John McIvor Chief Executive, Lincolnshire PCT

Steve Morris Director of Strategic Development and Operations, National Prescribing Centre

Colin Pearson Medicines, Pharmacy and Industry Group, Department of Health

Catherine Picton Consultant in healthcare delivery and management

Dave Roberts Unit Manager, Prescribing Support Unit, Information Centre

Andrew Scott-Clark Deputy Director of Public Health, Eastern and Coastal Kent PCT

Martin Stephens Director of Clinical Effectiveness, Southampton University Hospitals NHS Trust

Bruce Warner Senior Pharmacist, Safe Medication Practice, National Patient Safety Agency

7 Acknowledgements

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Focus group members

Sarah Alton Pharmacy Adviser, NHS Yorkshire and The Humber

Rebecca Blessing Senior Business Manager, Department of Health

Angela Davis Senior Medicines Management and Interface Pharmacist,

University Hospital North Staffordshire

Jonathan Hall Critical Evaluation Pharmacist, Southampton University Hospital Trust

Catherine Harding Head of Medicines Management, East Lancashire PCT

Jenny Harding Assistant Director of Medicines Management, Sandwell PCT

Jonathan Mason Head of Medicines Management, City and Hackney Teaching PCT

Neill McDonald Assistant Director of Medicines Management, North Kirklees PCT

Helen Stubbs Pharmaceutical Adviser in Public Health, Sefton PCT and North West Specialised

Commissioning Team

Val Shaw Chief Pharmacist, Peterborough and Stamford Hospitals NHS Foundation Trust

User testing / review

Michele Cossey Prescribing and Pharmacy Lead, NHS Yorkshire and The Humber

Andrea Loudon Head of Pharmacy and Medicine Management, South Cumbria PCT

Bridget Nisbet Lay representative, Worcestershire APC

Gail Thomas Associate Director Medicines and Pharmacy, Central and Eastern Cheshire PCT

Fiona Williamson Head of Medicines Management — Commissioning, Doncaster PCT

The document (in draft) was circulated for comment to a range of individuals / organisation. Comments

received were used to refine the content and presentation of this document.

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Appendices

Appendix 1 A quick diagnosis exercise to identify your APCs’ strengths and weaknesses Page 50

Appendix 2 Key success factors checklist Page 62

Appendix 3 Useful information resources for APCs Page 66

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The recent NHS changes in primary care organisations provide the ideal opportunity for APCs to re-

evaluate their activities and functions, and their role in providing leadership on joint, strategic medicines

management across their health communities. The NPC has recently published a guide for APCs which

aims to help them reinstate their role and to ensure that they are fit for purpose by reviewing established

practice in terms of their scope and functions, and the structures and processes they have in place to

support their activities.

This self-assessment exercise is intended as a quick diagnostic which looks at key success factors

identified by the NPC guide and gives a visual ranking on each of the factors. Where areas of development

are identified, there are links into the APC fitness for purpose framework in the NPC guide which gives hints

and tips for APCs to help them improve their performance.

Undertaking this exercise will give you and your APC team a starting point with which to review performance

and identify potential development areas, it should be used in conjunction with the full NPC guide.

How to complete the diagnosis exercise

Listed on the following pages are a series of statements about the STRUCTURES and PROCESSES

necessary to support the FUNCTIONS of APCs. Each page relates to one of the dimensions shown on the

‘spider’s web’.

Consider each statement and tick the statement that you think most closely reflects your APCs’ activities in

each of the dimensions. It will help to read through the relevant section of the APC guide before you read

each page.

When you have completed all the dimensions, plot the score given at the end of each statement on the

‘spider’s web’.

When you have circled all of the statements that most closely reflect your APCs’ activities within each of the

dimensions plot your ‘web’ on the graph.

From the ‘spider’s web’ you will easily be able to see in which of the dimensions your APC needs to

develop.

Appendix 1 — A quick diagnosis exercise to identify

your APCs’ strengths and weaknesses

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Rating Scale:

5/6 Our APC has the structures and processes in place to enable it to deliver its existing

functions at high level and to allow further development

3/4 Our APCs structures and processes allow it to deliver its functions at a basic level

1/2 Our APCs structures and processes are not supporting the delivery of its functions

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Recognition and reporting: section 3.2.1 of APC guide

Board level commitment

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The Boards of all our member organisations are committed to supporting the APC. There are clear

reporting structures in place, APC decisions / advice are taken seriously.6

The Boards of all our member organisations are supportive of the APC and are usually willing to

listen to APC decisions / advice.5

The Boards of all our member organisations are usually supportive of the APC and will listen to APC

decisions / advice if there is time left on the agenda.4

The Boards of our member organisations do not give much support to the APC. APC advice /

decisions are expected to be listened to and / or supported by Boards but it is very difficult for the

APC to get its decisions through to them.

3

The Boards of our member organisations do not support the APC and rarely discusses its decisions

and / or advice.2

The Boards of our member organisations hinder the APC. Generally APC members feel ignored as

they try to encourage implementation of decisions.1

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Committee membership: section 3.2.2 of APC guide

Stakeholder representation

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All stakeholders, including patients, are represented at an appropriate level by our committee. Our

committee members are widely respected in the local health community. 6

The majority of stakeholders are represented, although occasionally some stakeholders are missed.

Stakeholders are effectively represented by members.5

We try to include all relevant stakeholders. Committee members effectively represent their

organisations. 4

We try to include relevant stakeholders. Committee members are sometimes unable to effectively

represent their stakeholder organisations.3

We are unable to engage some stakeholders in the health community. 2

Our committee is not representative of the stakeholders in the health community and actively

excludes some key stakeholders.1

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Members’ responsibilities: section 3.2.3 of the APC guide

Clarity of purpose

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The members of the APC are clear about their responsibilities as committee members. They are

personally committed to APC decisions and attend meetings regularly.6

The members of the APC accept all their responsibilities as committee members. Occasionally

some members do not attend because of clinical commitments. 5

We try to encourage members of the APC to accept all their responsibilities as committee members.

Getting all members to feedback to their organisations and collate views can be difficult.4

We sometimes struggle to get APC members to accept their responsibilities as committee members.

Some don’t accept ownership of decisions if they don’t agree and are not very committed to the

process.

3

We haven’t got APC members to accept their responsibilities as committee members. Participation

is patchy and the members represent themselves and their own agendas. 2

The APCs’ members actively discourage the APC from delivering its functions. They are not

committed to the process and obstruct decision-making on an area wide basis.1

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Key links: section 3.2.4 of the APC guide

Credibility with primary care practitioners

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The APC has credibility and buy-in from clinical practitioners across primary care. It is seen as the

key decision-making group for strategic medicines management locally.6

The APC has credibility with clinical practitioners in primary care and in general they follow APC

decisions. 5

The APC has some credibility with primary care clinical practitioners although decisions are followed

variably.4

The APC struggles to establish credibility with clinical practitioners in primary care, they follow APC

decisions when they agree with them.3

The APC has no credibility with clinical practitioners in primary care they either do not follow APC

decisions or are not aware of it.2

The APCs’ relationship with clinical practitioners in primary care discourages the APC from

delivering its functions, they actively undermine the APC.1

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Key links: section 3.2.4 of the APC guide

Credibility with secondary care practitioners

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The APC has credibility and buy-in from clinical practitioners in all secondary care environments. It

is seen as the key decision-making group for strategic medicines management locally.6

The APC has credibility with clinical practitioners in secondary care and in general they follow APC

decisions.5

The APC has some credibility with clinical practitioners in secondary care although decisions are

followed variably. 4

The APC struggles to establish credibility with clinical practitioners in secondary care. They follow

APC decisions when they agree with them.3

The APC has no credibility with clinical practitioners in secondary care, they either do not follow

APC decisions or are not aware of it.2

The APCs’ relationship with clinical practitioners in secondary care discourages the APC from

delivering its functions, they actively undermine the APC.1

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Resources: section 3.2.5 of the APC guide

Assessing the evidence

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Dedicated resources enable the APC to deliver its functions. The APCs functions are so important to

member organisations they actively support dedicated professional and administrative time to

support the APC.

6

Dedicated resources support the APC to deliver most of its functions. Member organisations

recognise the importance of professional time and provide some dedicated professional resource.

Sometimes administrative support is lacking.

5

Dedicated resources that the APC has are reasonably helpful in helping the APC to deliver its

functions although sometimes we are unable to respond to issues in a timely way.4

Dedicated resources don’t really support the APC’s functions, we have a few professionals that we

can call on to help but nothing is formalised.3

The availability of dedicated resources for the APC is poor. Professional time is hard to identify and

the committee members input can’t be guaranteed.2

The lack of dedicated resources to support the APC’s work hinders the APC from delivering its

functions. We are unable to consider certain issues because we have no resources to do so.1

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Setting the agenda: section 3.3.1 of the APC guide

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Agenda setting fully supports delivery of the APC’s functions. We have clear, well understood

criteria for which items we consider. We routinely forward plan and horizon scan to ensure that we

are ready to review all key issues.

6

Agenda setting is generally supportive of the APC’s functions although we sometime struggle to

keep up with the issues that we need to review. 5

We try and make agenda setting a priority although with competing demands on our committee

members’ time, sometimes we don’t manage to identify key issues or miss making a timely

decision. Our processes could be better.

4

The APC struggles to see the agenda setting process as a priority. We have a few standing agenda

items but that’s about it.3

The APC’s agenda setting does not support the APC to deliver its functions. Agenda setting

happens in an ad hoc way, we have few processes in place. 2

Our agenda setting discourages the APC from delivering its functions. It is a case of the loudest

voices get heard at any particular meeting.1

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Decision-making: section 3.3.2 of the APC guide

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The APC has a robust, systematic and transparent process for decision-making as part of its overall

governance framework. Processes are clearly documented thereby ensuring consistency in

decision-making.

6

Our systems for decision-making are generally robust, systematic and transparent. Our processes

are documented.5

Generally we have systems in place to support decision-making, however, sometimes we take short

cuts. We document most of our processes.4

We have some documented processes, however, overall our decisions are not very transparent and

sometimes seem inconsistent. 3

We don’t have clear documented processes to support our decision-making and so decisions are

often inconsistent. 2

There is no documented process for decision-making, our decisions are inconsistent and generally

governance is poor.1

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Communication: section 3.3.3 of the APC guide

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Communication from the APC is excellent. We use a range of different approaches to ensure that

our decisions reach key stakeholders as rapidly as possible.6

Communication from the APC is generally good although it does seem to rely heavily on one

medium. Sometimes it would be better if key messages were delivered via multiple routes. 5

Communication from the APC tries to be supportive of all affected stakeholders. However,

communication channels between key organisations and groups are not very strong and

occasionally messages slip through the net.

4

Communication from the APC is not very good. Within the APC committee we seem to manage but

it is very difficult to get the messages across to all our organisations.3

Communication from the APC does not support the APC in the delivery of its functions. Our

decisions are unsystematically communicated.2

Inadequate communication from the APC hinders delivery of its functions. Our decisions are poorly

communicated.1

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Implementation and monitoring: section 3.3.4 of the APC guide

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Implementation and monitoring of APC decisions / advice is excellent. We facilitate a range of

different approaches across stakeholder organisations. We always act on the results of our

monitoring activities.

6

Implementation and monitoring of APC decisions / advice is generally good although it does seem

to rely heavily on a number of individuals.5

We try to facilitate the implementation and monitoring of APC decisions / advice. However,

sometimes co-ordination is not very good with variability between primary and secondary care.4

Implementation and monitoring of APC decisions is not very good. Within the APC committee we

discuss it but nothing really ever happens.3

Implementation and monitoring of APC decisions is poor. Sometimes we don’t have time to

discuss it.2

In general, we don’t consider the implementation or monitoring of our decisions. 1

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This key success factors checklist is designed to be a practical tool for APCs to use to assess their current

fitness for purpose and to allow them to identify areas for improvement in the future. It is based on the

fitness for purpose framework outlined in section 3 of this document and questionnaire feedback from

existing APCs on current and future good practice4. It asks a series of questions that APCs should answer.

A copy of this checklist, with space for notes and observations, can be downloaded from the NPC website

at www.npc.co.uk.

Appendix 2 — Key success factors checklist

Scope, functions and cross check (section 3.1)Tick

here

Does the APC have a clear stakeholder map of its health community? ]

In relation to its community is the APC decision-making advisory or both? Is this clearly

understood by all stakeholders? ]

Are the APCs’ functions clearly defined and understood by all stakeholder organisations? ]

Have functions been reviewed in light of organisational and environmental changes in the health

community? ]

Review the functions in section 3.1.2 of the guide. Identify which your APC should be doing? Are

those that aren’t being done by your APC being done by another group? Is there any duplication

of functions that can be eliminated?]

4 Appendix 1 outlines how this document was developed. The results of the survey of APCs baseline activities (December 2006 /

January 2007) which informed development of the fitness for purpose framework can be found at www.npc.co.uk

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Structures (section 3.2)

Recognition and reporting (section 3.2.1)Tick

here

Have the Boards of all ‘member’ organisations formally recognised the functions of the APC? ]Is there commitment at the highest level in each of the organisations? Are there any incidents

which support this? How can this be strengthened? ]How does the APC work with acute / tertiary / mental health Trust DTCs? Is there clarity about

the functions of the APC and the status of its decisions in relation to local DTCs? Does a review

of recent activities support this?]

How are decisions / advice reported to ‘member’ organisations? Are any improvements

possible? ]Does the APC Chair have access to a senior executive / non-executive in member

organisations? How is this working in practice? ]

Committee membership (section 3.2.2)Tick

here

Is the committee effectively representing its stakeholders with its membership? Are there any

gaps? How can these be filled? ]Does membership cover a wide range of medical conditions in terms of specialist professional

expertise? Does this need to be increased? How can this be done? ]

Does the committee have a lay member? Are steps being taken to include one? ]Is membership reviewed in line with organisational changes? When was the last time this

occurred? ]Does the committee have commissioning representation? Are steps being taken to include /

engage commissioners? ]Does the committee have terms of reference? Are these reviewed when organisation structures

change? When was the last time they were reviewed? ]

Individual members responsibilities (section 3.2.3)Tick

here

Do members have an explicit description of their role within the committee? Are members

aware of the functions that they personally are required to fulfil? ]Do all committee members make an ‘active’ contribution to the committee? How can inactive

members be encouraged to participate? ]

Do any members of the committee have training needs? How are these going to be met? ]

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Structure (section 3.2) continued

Key links (section 3.2.4)Tick

here

Has the APC done a stakeholder analysis to identify all the organisations / groups that the APC

needs to have key links with? ]For each of these organisations / groups are the communication links well defined? How are

they working? ]

Are there any areas of confusion or potential conflict? How are they being resolved? ]

Resources (section 3.2.6)Tick

here

Does the APC have any dedicated resources to support delivery of its functions? Are these

resources being effectively managed? ]What dedicated resources does the APC need to support delivery of its functions? How can

these be obtained? ]

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Processes (section 3.3)

Setting the agenda (section 3.3.1) Tick here

Does the APC have an explicit process in place to decide what items it should consider? Is this

working effectively? If no process exists can one be developed? ]Does the APC forward plan and set a work programme for the year? How effective is this

process? If not, how could this be improved? ]

Does the APC horizon scan? How effective is this process? If not, how could this be improved? ]How does the APC react to unexpected issues? How effective is this process? If not, how

could this be improved? ]

Decision-making (section 3.3.2)Tick

here

Does the APC have a robust, systematic process for reviewing evidence? ]How is APC decision-making / guidance production supported? Check the list of standardised

documentation in section 3.3.2, does your APC have these standardised processes? If not, can

they be developed?]

Does the APC utilize the full range of information sources available to inform decision-making?

Are any of the information resources in Appendix 3 of use to the APC? ]

Communication (section 3.3.3)Tick

here

Are APC decisions communicated in a timely way? Review a selection of decisions made in

the last year, was communication timely? If not, how could things be improved? ]Does APC communication reach the right people? Review communication channels to key

groups, how can these channels be made more effective? ]Do clinicians ‘on the ground’ have easy access to the APC? Is there a clear process? When

was this route of communication last used, was it successful? ]

Implementation and monitoring (section 3.3.4)Tick

here

How are APC decisions implemented? Review the implementation of APC decisions over the

last year, was implementation effective? If not, how could things be improved? ]Are APC decisions monitored? If not, how could they be? Review the list of suggestions in

section 3.3.4., can any of these be used? ]

Are multi-sector audit results reviewed and recommendations for further action made? ]

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It is important that APCs are aware of the information and support that is available nationally to help them

understand and manage high quality, safe and cost-effective prescribing in the overall commissioning

process.

This appendix contains a summary of a range of information resources available to APCs to assist them in

their advisory and decision-making capacities.

Appendix 3 — Useful information sources for APCs

1 ePACT data Page 67

2 Better Care, Better Value Indicators Page 68

3 Practice-based commissioning toolkit Page 69

4 National activity on drug pricing reimbursement Page 70

5 Information on prescribing in secondary care Page 71

6 The Information Centre for Health and Social Care Page 72

7 DH good practice guidance Page 73

8 National Institute for Health and Clinical Excellence Page 77

9 National Patient Safety Agency Page 78

10 Healthcare Commission Page 79

11 Primary care contracting (PCC) Page 80

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1 ePACT data

The website www.epact.ppa.nhs.uk/ contains information about the Prescription Pricing Division (PPD) of

the NHS Business Services Authority (NHSBSA). Selected prescribing data is available through two main

electronic systems:

1.1 Electronic Prescribing Analysis and Cost (ePACT.net)

PCTs can use the system and standard analytical tools to quantify their achievements in areas of high

prescribing volume and cost, and benchmark their performance against other PCTs. Prescribing advisers

can demonstrate how the systems are used to monitor and improve performance.

This tool allows authorised users, including pharmaceutical and prescribing advisers, to view and analyse

prescribing data and prescribing costs from the PPD of the NHSBSA. It allows real time on-line analysis of

the previous 60 months’ prescribing data. Information is available at prescriber, practice and PCT level for

PCT users. Using the British National Formulary classification data are available down to presentation level,

for example simvastatin tab 40mg.

1.2 Prescribing Toolkit

The Prescribing Toolkit contains prescribing indicators and a range of prescribing comparators and data

sets, designed to assist in financial monitoring and allocation. Data is updated on a quarterly basis and is

available for the previous 36 months. The Toolkit allows comparison between prescribing organisations — to

help identify areas for improvement.

The Toolkit is useful for an overview and comparison of prescribing, but ePACT.net should be used for

further analysis, particularly at practice level. Both systems require a valid user identifier and password, and

a connection to the NHSnet.

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2 Better Care, Better Value Indicators

The Better Care, Better Value Indicators (formerly called the Productivity Metrics) are designed to help local

NHS organisations make the most effective use of public money, to deliver quality healthcare. These

indicators can be used locally to:

• Help inform planning

• Inform views on the scale of potential efficiency savings in different aspects of care and

• Generate ideas on how to achieve these savings.

The indicators were published for the first time in October 2006 and will be updated every quarter. The

indicators are supported by a web-based tool, NHS Indicator Explorer, developed in partnership with the

NHS Institute for Innovation and Improvement, the DH, and Dr Foster Intelligence.

The indicator set will be expanded during 2007–2008, following consultation with the NHS and other key

stakeholders. Further information is available at www.productivity.nhs.uk/.

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3 Practice-based commissioning toolkit

The PBC initiative is the next step in moving healthcare resources and accountability nearer the patient.

The NHS-wide Secondary Uses Service is being developed as a partnership between the Information

Centre and NHS Connecting for Health, supported by the DH. A key component of the Secondary Uses

Service in 2007 will be the provision of access to practice level comparators and indicators, covering

practices’ utilisation of healthcare resources to support PBC.

This component will provide access to information on:

• The utilisation of secondary care (admissions, outpatients, A&E)

• Information on the prevalence and management of patients with certain conditions — derived from the

QOF indicators and

• Information on prescribing costs and activity and comparators.

These data sources will be linked together to give added value.

The initial comparators package will be released in April 2007, but development will be ongoing and

requirements will be developed in response to feedback. These data will be directly accessible by practices

as well as PCTs, so practices will be able to review their own activity and resource use and compare

themselves on a range of comparators with peers. This access will only be through the National Programme

for IT Spine portal.

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4 National activity on drug pricing reimbursement

4.1 Pharmaceutical Price Regulation Scheme (PPRS)

The PPRS indirectly controls the prices of branded prescription medicines to the NHS by regulating the

profits which companies can make on these sales. The latest scheme started in January 2005. It is a

package of measures, which rewards innovation and research but also keeps public expenditure under

control. It includes a price reduction of 7% in the prices of branded prescription medicines supplied to the

NHS. The price cut delivered £370 million in primary care in England in 2005. It is estimated to deliver

expenditure savings of £1.8 billion for the NHS in England over the five year agreement. Further information

is available at www.dh.gov.uk/PolicyAndGuidance/MedicinesPharmacyAndIndustry/Pharmaceutical

PriceRegulationScheme/ThePPRSScheme/fs/en.

4.2 Reimbursement prices of Generic Medicines (Scheme M)

In April 2005, the DH introduced a new category (Category M) into the Drug Tariff — for the calculation of

generic reimbursement prices. The basic prices of Category M medicines reflect the average manufacturers’

market prices after discount. Reimbursement prices now more accurately track market changes. Further

information is available at www.dh.gov.uk/PolicyAndGuidance/MedicinesPharmacyAndIndustry/

GenericMedicines/fs/en.

4.3 Dispensing doctors

From April 2006, the DH introduced new remuneration arrangements for dispensing doctors. In the past,

there was some evidence that the way dispensing doctors were paid (as a percentage of drug cost) was an

incentive to prescribe more expensive drugs. The new system involves the payment of a fixed fee per item,

regardless of the drug cost. DH is monitoring the impact of this change on prescribing patterns.

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5 Information on prescribing in secondary care

Hospital prescribing has less direct impact on the total cost of prescribing than that of primary care

prescribing. However, drug choices made in secondary care have a significant effect on what is prescribed,

and paid for, in primary care. In 2005, medicines issued in hospital represented around 23.1% of the £10.3

billion total cost of medicines.

There is no NHS collation of information on medicines prescribed and issued in NHS hospitals that is similar

to primary care. IMS Health collects and collates this data on a commercial basis. The IMS Health Hospital

Pharmacy Audit Index (HPAI) database is based on issues of medicines recorded on hospital pharmacy

systems. The information is sent to IMS Health each month electronically by hospital pharmacy

departments. Issues refer to all medicines supplied from hospital pharmacies: to wards, departments,

clinics, theatres, satellite sites and to patients in out-patient clinics and on discharge. Costs are calculated

by IMS Health using the Drug Tariff and other standard price lists. Many hospitals receive discounts from

suppliers, particularly for high volume drugs. These discounts are commercially confidential.

Access to the HPAI data is regulated by a contract between IMS Health and the Information Centre. The

provisions of the Freedom of Information Act permit limited disclosure subject to contract. Data extracts will

not normally be permitted under the contract.

Hospital comparators

The Information Centre, in collaboration with the Healthcare Commission, is developing a set of

comparators from the IMS data at Trust level. These will be designed to give PCTs and Trusts information to

assist medicines management across the whole health economy — together with comparative data from

other Trusts.

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6 The Information Centre for Health and Social Care

The Information Centre’s Prescribing Support Unit (PSU) (www.ic.nhs.uk/psu) produces reports and

publications to help you see where you fit into the national picture:

• Hospital prescribing, England, annual report

• Prescriptions dispensed

• Prescription cost analysis

• National prescribing costs and items monthly section level reports

• PSU national prescribing reports quarterly

• PSU prescribing monitoring documents quarterly

• National QOF achievement data derived from the Quality Management Analysis System (QMAS), a

national system that uses data from general practices to calculate individual practices' QOF

achievement. Further information is available at www.ic.nhs.uk/psu/services/QOF.

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7 DH good practice guidance

The DH resource, Good practice guidance on managing the introduction of new healthcare interventionsand links to NICE technology appraisal guidance (www.dh.gov.uk/en/Publicationsandstatistics/

Publications/PublicationsPolicyAndGuidance/DH_064983), lists the following sources of evidence

available to the NHS which can help APCs make decisions about the use of new interventions where NICE

guidance is not available.

7.1 Centre for Evidence-based Purchasing (CEP)

The role of CEP is to underpin NHS purchasing decisions by providing objective evidence to support the

uptake of useful, safe, innovative products and related procedures in health and social care. The CEP

provides a range of publications that are available on the NHS Purchasing and Supply Agency (PASA)

website. There is also a facility for individuals to make proposals of technologies, product(s) or related

procedures that they would like the centre to consider as part of its work programme. The website also

maintains details of any forthcoming presentations or meetings that the centre will be running. Further

information is available at www.pasa.nhs.uk.

7.2 The London Cancer New Drugs Group

The London Cancer New Drugs Group is a sub-committee of the London Cancer Networks Steering Group.

Members are nominated by, and represent, the five cancer networks in London. The group has delegated

responsibility to develop recommendations for the managed entry of new treatments in cancer across

London. The decisions of the New Drugs Group can be found on the National Electronic Library for

Medicines website at www.druginfozone.nhs.uk/search/product.aspx?id=98. The guidance is to help

PCTs reach decisions on the use of new cancer drugs until such time as NICE guidance becomes available.

7.3 London New Drugs Group (LNDG)

The LNDG aims to assist healthcare professionals in managing the entry of new drugs in a cost-effective

and equitable manner, by providing advice based on independent, evaluated information, in a timely

manner. The area covered by the LNDG now includes the London Region, Bedfordshire, East Anglia, Essex

and Hertfordshire. The LNDG consists of a range of healthcare professionals who volunteer their services.

In April 2002, the NHS was re-organised into larger regions, consisting of PCTs. The membership has

recently undergone a review to include representatives of PCTs, as well as Public Health and NHS Trusts.

The LNDG’s website is aimed at healthcare professionals who require a detailed summary of the clinical

trial information and discussion points or recommendations for use as well as the cost implications of new

drugs. LNDG documents are produced for use within the NHS and must not be reproduced for commercial

purposes. Any technology appraisal produced by NICE automatically supersedes a LNDG review written on

that subject. Further information is available at www.londonpharmacy.nhs.uk/lndg.

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7.4 National Horizon Scanning Centre (NHSC)

The NHSC aims to provide advance notice to the DH in England and national policy-making bodies in the

NHS of selected key new and emerging health technologies (including changing applications and uses of

existing technologies) that might require urgent evaluation, consideration of clinical and cost impact or

modification of clinical guidance.

The scope of the NHSC’s activity includes health technologies in the broadest sense and includes

pharmaceuticals, devices, diagnostic tests and procedures, surgical and other interventions, rehabilitation,

and public health activities.

The NHSC writes briefings about potentially significant developments up to two years before their launch on

the NHS. The NHSC maintains copies of all the technology briefings it has produced to date (from January

2000) on its website. Further information is available at www.pcpoh.bham.ac.uk/publichealth/horizon.

7.5 National Prescribing Centre (NPC)

The NPC is a Health Service organisation, formed in 1996 by the DH. Its aim is to promote and supporthigh quality, cost-effective prescribing and medicines management across the NHS, to help improve patientcare and service delivery.

The NPC is developing its work programme to support the specific needs of commissioners, providers and

individuals with an involvement in prescribing, therapeutics and medicines management. In particular the

NPC is aiming to maximise the impact and reach of its outputs by utilising delivery systems which exploit

the opportunities provided by electronic learning environments, thus improving the flexibility, accessibility

and timeliness of its outputs. A dynamic and engaging educational web-based resource, NPCi, will be

launched in September 2007. Additional functionality to the NPC portfolio includes the production of

implementation tools and templates for local use to facilitate uptake of effective, efficient and safe

prescribing and medicines management into practice. Information resources provided by NPC include:

• New Medicines Scheme. A range of evaluated information, both pre-and post- market launch, on new

medicines

• On the Horizon and Planning Ahead for New Medicines. Provide senior decision-makers in the NHS

with advance information. Alert the NHS to significant new medicines, and facilitate local planning,

commissioning, and a more effective managed introduction. On the Horizon information is published

approximately six months pre-launch for medicines either not currently covered in the NICE programme

or, where covered, the NICE appraisal is not expected for at least four to six months post launch. This

information is produced in collaboration with Wessex Regional Medicines Information Centre. NPC

information is updated at product launch, where significant additional information has emerged since the

first publication and if no NICE guidance is planned near that time

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• MeReC Publication portfolio. Provides concise, evidence-based information on marketed medicines

and prescribing-related issues. These publications are distributed to healthcare professionals working in

primary care organisations and hospital Trusts providing prescribing support and medicines management

services. However, managers and those working in other sectors of the NHS will also find them a useful

resource. MeReC publications are funded by NICE

• Medicines Management. The NPC has produced a number of practical guides, resources and

implementation programmes to promote and facilitate optimal medicines management systems and

innovation within organisations and across health communities.

All the above publications are accessible via the NPC’s websites at www.npc.co.uk and www.npc.nhs.uk.

Users can register for an e-mail alert to notify them when new information is published. The New Medicines

Scheme pre-launch information is available on NHSnet only.

7.6 Scottish Medicines Consortium (SMC)

The SMC provides advice to NHS Boards and their Area Drug and Therapeutics Committees (ADTCs)

across Scotland about the status of all newly licensed medicines, all new formulations of existing medicines

and new indications for established products (licensed from January 2002). This advice is made available

as soon as practical after the launch of the product involved. The remit of SMC excludes the assessment of

vaccines, branded generics, non-prescription-only medicines (POMs), blood products, plasma substitutes

and diagnostic drugs. The review of device-containing medicines will be confined to those licensed as

medicines by the MHRA / EMEA. While the guidance contained within the SMC’s advice is aimed at NHS

Scotland, the analysis of the evidence considered by the Consortium is a useful source of information to all

local NHS managers when making decisions on the introduction of new medicines. The SMC’s advice is

available on its website and the site also has a list of forthcoming assessments. The website offers a

subscription service to inform individuals when new guidance is published. Note that NICE Multiple

Technology Appraisal guidance always supersedes SMC advice. Further information is available at

www.scottishmedicines.org.uk.

7.7 UK Medicines Information (UKMi)

The UKMi is an NHS pharmacy based service. Its aim is to support the safe, effective and efficient use of

medicines by the provision of evidence-based information and advice on the therapeutic use of medicines.

The UKMi service is provided by a network of:

• 260 local medicines information centres based in the pharmacy departments of most hospital Trusts

• 16 regional centres

• National centres (Northern Ireland and Wales).

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These centres work closely together to provide a 'virtual' national service. The centres are staffed by

pharmacists with clinical expertise, and particular skills in locating, assessing and interpreting information

about medicines. Details of the individual centres are available in the UKMi address book

www.ukmi.nhs.uk.

The Prescribing Outlook Series is also published on the UKMi website. This series is intended to assist

NHS budget holders and those involved in prescribing planning, assess the potential impact of new drugs

and national guidance on the local health economy. It is available in three parts:

Prescribing Outlook A includes information on drugs with launches planned over the next 12 to 18 months

and on marketed drugs with new major indications. It contains brief clinical and therapeutic data plus

information on predicted launch date, potential target population and estimated impact on service delivery

and cost. Prescribing Outlook A is produced in collaboration with the NPC and the NHSC.

Prescribing Outlook B contains information on existing and forthcoming NICE guidance, NSFs, the GMS

contract and other national targets that may have budgetary implications over the next 12 to 18 months. It is

intended to facilitate the implementation of national targets and guidelines and to calculate the cost of such

implementation.

Prescribing Outlook C is an excel spreadsheet based on the content of Prescribing Outlook A and B. It

allows crude calculations of potential costs of prescribing changes for a local population.

7.8 The National Electronic Library for Medicines (NELM)

The NELM website www.nelm.nhs.uk provides a gateway to many sources of information produced by

medicines information services.

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8 National Institute for Health and Clinical Excellence

The guide How to put NICE guidance into practice (www.nice.org.uk/usingGuidance) is the cornerstone of

NICE’s implementation support programme. It provides an implementation model to help NHS organisations

comply with the DH’s ‘Standards for better health’ and meet the expectations of the Healthcare Commission.

There are a range of tools available on the NICE website that may be of use to APCs:

• Two types of costing tool (for all technology appraisals, public health guidance and clinical guidelines). A

national costing report estimating the overall resource impact associated with implementation, based on

assumptions about current practice and predictions of how it might change following implementation. A local

costing template, based on a simple spreadsheet template, enabling local users to estimate the costs whilst

taking into account local variation from the national estimates (see www.nice.org.uk/

page.aspx?o=costingtools)

• Implementation advice (for all public health guidance, clinical guidelines and selected technology

appraisals). Targeted at those responsible for planning and implementing guidance, this not only considers

implementation issues specific to a particular piece of NICE guidance, but also provides links with other

national initiatives relating to that topic area (see www.nice.org.uk/page.aspx?o= implementationadvice)

• Audit criteria (for all public health guidance, clinical guidelines and technology appraisals). Criteria are

published to facilitate audit at a local level, thus supporting the process of monitoring and feedback (see

www.nice.org.uk/page.aspx?o=auditcriteria)

• Slide sets (for all public health guidance, clinical guidelines and technology appraisals). Covering key

messages in the guidance, these aim to provide a framework for discussion at a local level for a variety of

audiences such as commissioners or clinicians (see www.nice.org.uk/page.aspx?o=slidesets)

• Forward planner (for all public health guidance, clinical guidelines and technology appraisals). Helps people

plan for and implement NICE guidance by summarising published guidance organisations may still be

implementing, and listing forthcoming guidance to help NHS bodies plan ahead (see

www.nice.org.uk/page.aspx?o=ForwardPlanner)

• Commissioning guides, to support NHS commissioners in England to effectively commission evidence-

based care for patients. The guides offer detailed practical information on specific clinical topics, including

local needs assessment and opportunities for clinical service redesign. They signpost to other relevant

sources of information, including commissioning guidance, and set benchmarks to help commissioners

determine the level of service needed (see www.nice.org.uk/page.aspx?o= commissioningGuides)

• Shared learning database, which contains examples of local implementation projects and aims to share

learning across the NHS and organisations with responsibility for delivering public health programmes (see

www.nice.org.uk/sharedlearning)

• ERNIE (evaluation and review of NICE implementation evidence) database, which provides a bank of

guidance-specific implementation uptake reports produced by NICE and references to external studies

looking at how NICE guidance is being implemented (see www.nice.org.uk/page.aspx?o=ernie)

• Implementation Consultants who are out in the field who meet regularly with NHS organisations and can

provide advice and engage with organisations and networks to encourage, inform and facilitate their own

implementation activities, gather feedback to underpin all aspects of NICE’s work (see www.nice.org.uk/

page.aspx?o=350123).

Further information can be found on the NICE website at www.nice.org.uk.

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9 National Patient Safety Agency (NPSA)

The NPSA is a Special Health Authority, created in 2001 to coordinate efforts to identify, and learn from,

patient safety incidents. Its functions include:

• Collecting and analysing information on adverse events

• Assimilating other safety-related information

• Learning lessons and ensuring that they are fed back into practice

• Where risks are recognised, identifying solutions to prevent harm.

The NPSA promotes patient safety by helping to develop a more open and fair culture in which risk is

proactively assessed and patient safety is a high priority for everyone. In the past it has issued reports,

alerts and notices which concentrate on high risk areas for the NHS, including work around medicines.

Medication alerts already issued by the NPSA, and requiring action by the NHS, cover the following areas:

• Potassium chloride

• Methotrexate

• Diamorphine and morphine

• Repavax and Revaxis

• Anticoagulant medicines

• Liquid medicines administered via oral and other enteral routes

• Injectable medicines

• Epidural injections and infusions

• Paediatric intravenous infusions.

From 1st April 2005 the NPSA expanded, giving it greater scope to improve patient safety in the NHS. The

NPSA’s work now includes specific safety aspects of hospital design, cleanliness and food. The NPSA is

also ensuring research is carried out safely, through its responsibility for the National Research Ethics

Service (NRES) formerly the Central Office for Research Ethics Committees; and is supporting local

organisations in addressing their concerns about the performance of individual doctors and dentists, through

its responsibility for the National Clinical Assessment Service (NCAS).

Full details of this work and associated resources can be found on the NPSA website at www.npsa.nhs.uk.

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10 Healthcare Commission

The Healthcare Commission, which was set up in 2004, exists to inspect the quality and value for money of

healthcare and public health, to equip patients and the public with the best possible information about the

provision of healthcare and to promote improvements in healthcare and public health.

The Commission’s main statutory duties in England are:

• To assess the management, provision and quality of NHS healthcare and public health services

• To review the performance of each NHS Trust and award an annual performance rating

• To regulate the independent healthcare sector through registration, annual inspection, monitoring

complaints and enforcement

• To publish information about the state of healthcare

• To consider complaints about NHS organisations that the organisations themselves have not resolved

• To promote the coordination of reviews and assessments carried out by the Commission and others to

carry out investigations of serious failures in the provision of healthcare.

The annual health check (AHC). The Commission’s principal means of assessing the NHS in England is

by the AHC. The AHC, though directed to the DH’s Standards for Better Health, scores NHS Trusts on many

aspects of their performance, including the quality of the services they provide to patients and the public

and how well they manage their finances and other resources, such as their staff and property.

These scores are based on a range of information gathered throughout the year. This includes information

collected through various service reviews and inspections, as well as the data collected by other

organisations, such as the Commission for Social Care Inspection, the Mental Health Act Commission, the

Audit Commission and Monitor (the regulator for NHS Foundation Trust). Some data, such as those of the

Audit Commission and Monitor relating to the use of resources, form direct ‘feeds’ into the Commission’s

systems of asessment; others contribute to the systems of surveillance which, among other things, help to

verify the declarations that bodies make as part of the AHC.

The Commission does not give ratings to individual hospitals or to primary care practices. However, the

rating awarded to NHS Trusts covers all of the organisations they manage as well as the many services

they commission or provide in local communities. This could include hospitals, general practices or services

to improve the health of the public, such as those for smoking cessation.

Further information can be found at www.healthcarecommission.org.uk.

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11 Primary care contracting (PCC)

The NHS PCC website brings together information and resources to help users understand and implement

the new primary care contracting arrangements.

PCC supports the development of primary care across all PCTs in England. A team of advisors work with

PCTs and SHAs to provide detailed and expert information to help maximise the benefits offered by the new

contracts. Advisers also support local and national networks, communicating and facilitating change and

good practice, in particular the identification of change drivers in primary care.

Further information can be found at www.primarycarecontracting.nhs.uk.

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National Prescribing Centre

The Infimary

70 Pembroke Place

Liverpool

L69 3GF

Tel: 0151 794 8134

Fax: 0151 794 8139

websites: www.npc.co.uk (Internet) and

www.npc.nhs.uk (NHSnet)