Martin Anderson summarises the available guidance on joint working between the NHS and the pharmaceutical industry, and provides examples of successful case studies
  • In joint working, the NHS and the pharmaceutical industry work together for the benefits of patients
  • Mutual benefits to both organisations may arise from joint working, as long as patients are the prime beneficiaries of joint-working activities
  • Arrangements for joint working should be based on fundamental principles:
    • shared vision
    • equity
    • transparency
    • mutual benefit
    • respect
  • Trust, transparency, and accountability are key to getting joint-working projects off the ground
  • There are several documents and a toolkit available that provide guidance on the process of joint working
  • Joint working projects must comply with the Association of the British Pharmaceutical Industry Code of Practice
  • A joint-working project could include activities such as staff training, nurse services, support for guideline implementation, secondments, and audits
  • Joint-working discussions and agreements must take place at an appropriate organisational level within the NHS and the pharmaceutical company
  • Joint working has already proven successful in a number of case studies

In response to forthcoming pressures on public finances, the NHS has recognised that significant change is required to ensure high-quality patient care continues. The approach to dealing with this has been described as the Quality, Innovation, Productivity, and Prevention agenda (QIPP).

Much of the work that is currently being undertaken by pharmaceutical companies with local NHS organisations will help address the QIPP challenge (see case studies below). The challenge will be to increase the scope and scale of these activities.

The NHS and the Government increasingly want to work together with the pharmaceutical industry to improve patient care. For many years, pharmaceutical companies have shown their commitment to improvements in the NHS in a variety of ways. For example, they have provided medical and educational goods and services, and unrestricted educational grants. More recently, however, the NHS and the pharmaceutical industry have been seeking to extend the nature of these relationships in order to develop higher quality care and improve mutual understanding and trust through joint working.

Guidance for joint working

The Association of the British Pharmaceutical Industry (ABPI) has been working on behalf of its member companies to ensure that the pharmaceutical industry is seen as part of the solution to NHS-funding concerns rather than part of the problem.

Together with the Department of Health (DH), the ABPI has been promoting the ‘joint working’ concept for the past 2 years to show how it can improve patient care as well as provide mutual benefits to the organisations involved.
In England, the DH published its guidance on joint working in February 2008,1 thus confirming the Government’s wish to see a closer and more mature working relationship between the NHS and the pharmaceutical industry. The DH policy on joint working was further emphasised in the Darzi Report.2

The joint-working toolkit, Moving beyond sponsorship: Interactive toolkit for joint working between the NHS and the pharmaceutical industry, produced jointly by the DH and the ABPI in March 2008,3 provides guidance on establishing joint-working projects. It also contains a number of templates and files (e.g. action plan, joint-working agreement template) to ensure that the governance arrangements are robust. A number of examples of joint-working projects are also included in the toolkit.

What is joint working?

The underlying principle for joint working is that it must bring benefits to patients; transparency and openness are also key considerations. The DH guidance and toolkit define joint working as situations where, for the benefit of patients, NHS and industry organisations pool skills, experience and/or resources for the joint development and implementation of patient-centred projects and share a commitment to successful delivery.1,3 Joint working is thus distinctly different from sponsorship in which pharmaceutical companies simply provide funds for a specific event or work programme. In joint working, in the interest of patients, goals are agreed jointly by the NHS organisation and the company, and shared throughout the project. A joint-working agreement is drawn up and management arrangements conducted with participation from both parties in an open and transparent manner.3

For many pharmaceutical and NHS organisations, joint working will represent a new way of working. It requires not only a different mindset from sponsorship, but also a collaborative approach. Successful experiences have shown that it can be of major benefit to patients, the NHS, and pharmaceutical companies.3

Objectives of joint working

The NHS seeks to increase standards of healthcare through:3

  • improved patient experience
  • provision of effective packages of care
  • improved quality of care for patients
  • reductions in unnecessary consultations and hospital visits
  • effective self care, health promotion and disease prevention
  • optimising the cost effectiveness of services so that as many patients as possible can benefit.

The pharmaceutical industry seeks to increase shareholder value through:3

  • researching and developing innovative medicines that meet clinical needs
  • optimising the use of its medicines in appropriate patients
  • more proactive treatment and management of patients.

The common agenda of the NHS and the pharmaceutical industry is therefore to improve patient outcomes by ensuring that patients receive optimal care, including appropriate use of cost-effective and innovative medicines, with support to help individuals receive the full benefits from their treatment. This can be achieved through services that:

  • identify appropriate patients
  • appropriately use innovative medicines that are cost effective for the NHS
  • provide a positive patient experience
  • ensure good professional and patient understanding of medicines and how to use them best.

Principles of joint working

Joint working is a process that requires energy and commitment. All arrangements for joint working should be founded on fundamental principles that hold them together (see Box 1). These principles should be agreed by all parties at the start and act as a touchstone when decisions have to be made or obstacles overcome.3

Naturally enough, trust, transparency, and accountability are key to getting joint-working projects off the ground. The joint-working guidance and toolkit offer further advice in these areas, with the latter also providing documents that will ensure governance arrangements are robust.

In order to provide further clarity for pharmaceutical companies entering into joint-working arrangements, the ABPI has also produced, ABPI guidance notes on joint working between pharmaceutical companies and the NHS and others for the benefit of patients: Taking into consideration the 2008 ABPI Code of Practice for the pharmaceutical industry.4 It may be a cumbersome title, but the document is important.

It is perhaps worth explaining that pharmaceutical companies that are members of the ABPI are required to comply with the ABPI Code of Practice,5 which regulates the promotion of prescription medicines and certain other non-promotional activities. The Code also applies to many non-member companies. It states that joint working with the NHS (health authorities, trusts, and the like) is permitted if carried out in a manner compatible with the Code.5

The ABPI guidance seeks to support appropriate joint working and to provide a framework and greater clarity for pharmaceutical companies.4 It extends beyond matters covered by the ABPI Code and copies of the guidance can
be viewed on the ABPI website (www.abpi.org.uk).

The guidance is not a standalone ‘how to’ guide and should be read in conjunction with the relevant national Government policy documents, for example:

  • England—NHS best practice guidance on joint working1
  • Scotland—A common understanding: guidance on joint working between NHS Scotland and the pharmaceutical industry 20036
  • Wales—Guidance for partnership working between NHS organisations, primary care contractors, the pharmaceutical industry and the allied commercial sector in Wales 2004.7

The ABPI recommendations are, for the most part, written as though joint-working arrangements will be made between a single pharmaceutical company and an NHS organisation. However, they are also intended to cover initiatives between several pharmaceutical companies and/or several NHS organisations, and joint working conducted through third-party service providers and/or with suppliers of private healthcare.4

It is important to note that only informal guidance about compliance with the ABPI Code can be obtained from the Prescription Medicines Code of Practice Authority (PMCPA), which operates the Code on behalf of the ABPI. The decision as to whether any individual arrangements comply with the Code will be determined by the PMCPA if a complaint is made and each case will considered on its own merits.4

Box 1: Principles of joint working3

Shared vision

  • Each party must have mutually shared aims and outcomes that underpin all aspects of working together; for example, reduced morbidity and mortality, a better patient experience, or fewer unnecessary consultations

Equity

  • Recognition, backed by behaviour, that each party has a right to be at the table and their contributions valued (beyond terms of cash or public profile)
  • Acknowledgement of the interdependent nature of the relationship between both groups

Transparency

  • Openness and honesty (a precondition to trust); access to and sharing information
  • Benefits to patients, NHS, and industry identified and shared

Mutual benefit

  • Each party should be entitled to benefit from the arrangement—ideally working to specific benefits for each party (e.g. meeting NHS targets, better identification of patients, optimal numbers of appropriate patients receiving treatment) as well as the common benefits to all

Respect

  • Respect for the other parties and for their ability to add value

Scope?

A joint-working project may comprise a number of activities including, but not limited to:4

  • staff training
  • staff and/or patient education
  • economic analysis
  • nurse services
  • facilitation of pathway redesign
  • support for guideline implementation
  • funding of project staff requirements (e.g. provision of staff resources)
  • secondments
  • audit.

It is likely that most projects will be of a significant size and duration because of the considerable governance and administrative requirements involved in organising proper arrangements for joint working: as a guide, generally involving resources (e.g. manpower, materials, funding) costing in the region of £15,000 to £20,000, and lasting 6 months or more.4

There are a number of non-promotional and/or commercial practices that involve interaction with the NHS and healthcare professionals that are not subject to the joint-working guidance. These include clinical trials, package deals, and medical and educational goods and services; all are subject to applicable laws, regulations, guidance, and codes of practice, including the ABPI Code.4

Governance

To ensure that joint working between the pharmaceutical industry and the NHS is conducted in an open and transparent manner, it is necessary to enter into appropriate joint-working agreements, establish steering groups, and consult relevant stakeholders about each particular project.4

To prevent prescribers from being inappropriately influenced, joint-working discussions and agreements must take place at an appropriate organisational level within the NHS (e.g. authorised negotiators or signatories of an NHS trust, health board, primary care trust [PCT], and/or NHS commissioning group) and the pharmaceutical company (e.g. at senior manager or director level). However, it is likely that individual GP practices, hospital departments, and healthcare professionals will be closely involved in the planning and implementation of joint-working projects.4

Although pharmaceutical companies and individual GP practices or hospital departments may wish, and will continue, to work together, such projects are unlikely to be recognised as joint-working projects unless an NHS body (e.g. a PCT or health board) is involved. These are likely to fall under the remit of provision of medical and/or educational goods and/or services.4

A few examples of joint-working projects that have been successfully implemented or are underway, which demonstrate the range of potential activities, are described below. It is important to note that none of these projects have been conducted under clinical-trial conditions, and as a result, benefits cannot be directly associated to specific interventions.

Case studies

A partnership approach to improving COPD care

Chronic obstructive pulmonary disease (COPD) is a clinical priority for Salford PCT, which has a recorded prevalence of 2% (4640 diagnosed patients) and an estimated actual prevalence of up to 4.7% (10,904 patients). GlaxoSmithKline (GSK) has partnered with the PCT to improve primary care management capabilities and capacity. The objectives of the project were to reduce inappropriate hospital admissions and referrals of COPD, and to reduce inequalities across the PCT. This was achieved by upskilling clinical staff, moving COPD management to NICE standards, and by standardising care across the eight practice-based commissioning clusters (59 practices).

Variations in care were identified via a health–needs analysis, and an integrated strategic approach to address these issues was then implemented. Existing services were redesigned to support this approach. This was done in an integrated manner bringing together expertise from primary and secondary care and the industry.

Improvement of capability was addressed through development and implementation of a best-practice management guideline for COPD. This included guidance on referral to specialist interventions (consultant-led community clinics, pulmonary rehabilitation, and home oxygen). Self-management action plans and a bespoke healthcare professional educational programme were developed jointly by the specialist respiratory nurses, secondary care consultants, and GSK’s Respiratory Care Associates following the completion of a health–needs assessment.

An automated patient audit tool (POINTS) system, developed by GSK, was deployed in a large number of practices, enabling healthcare professionals to identify and optimise the treatment of at-risk and undiagnosed patients with COPD. It also allowed the PCT to benchmark its current treatment and management strategies, and track progress towards the achievement of NICE standards. The evolution capacity was increased through deployment of an additional nurse resource by the PCT and third-party contract nurses by GSK. They worked together in a collaborative manner to deliver local policies and guidelines.

Over 1300 at-risk patients were identified for diagnosis and review. The PCT was able to develop and implement best-practice guidelines and improve consistency of care. For GSK, the enhanced services increased the market for appropriate prescribing of medicines for COPD. Evaluation of the project is ongoing and analysis of the POINTS database is being undertaken.

A number of other pharmaceutical companies (Pfizer, AstraZeneca, Boehringer Ingelheim, and Novartis among them) are also working with local NHS organisations on different aspects of the COPD care pathway. Many other pharmaceutical companies would welcome the opportunity to engage with key stakeholders on diagnosing the issues around the management of patients with COPD.

North Lancashire Teaching Primary Care Trust Clostridium difficile project

A key NHS target is a reduction in the incidence of C. difficile. The aim of this joint-working project was to reduce the incidence of C. difficile infection by addressing the issues that lead to its spread. In tackling this, it is important that the care pathway—particularly for elderly patients—is fully considered, with all stages being addressed. The project involved seven pharmaceutical companies: Bristol-Myers Squibb, GSK, Merck Sharp & Dohme, Pfizer, Sanofi-Aventis, Servier Laboratories, and Wyeth. The group was jointly chaired by Dr Jim Gardner, the PCT Medical Director, and a member of the pharmaceutical industry. Input and expertise from Lancaster University and University Hospitals of Morecambe Bay were also invaluable in taking the project forward. Bringing the skills of a number of pharmaceutical companies alongside those of the NHS helped the PCT reduce the spread of C. difficile.

Dr Jim Gardner said: ‘This partnership was quite a departure for us at first and admittedly there were some reservations about how the process would work but in actual fact it has had significant results in terms of treating and preventing C. difficile and we are now looking forward to many more joint-working projects.

‘Although the combined financial contribution from the companies was very welcome, much more valuable for us was the time spent sharing knowledge and expertise. We certainly feel that the products of this collaboration have been of a much higher standard as a result and we have also been able to take advantage of industry capabilities and expertise in targeting and distributing materials to local healthcare professionals.

‘The efforts of all the members have been rewarded and I think everyone has been able to achieve their various objectives through the project. Not least, this has meant a significant drop in the incidence of C. difficile in North Lancashire, which was far more marked than initial forecasts.

Combating substance misuse through a partnership approach

Wakefield Integrated Substance Misuse Service (WISMS), a partnership organisation that helps people in West Yorkshire who misuse alcohol and drugs, worked with Schering-Plough and Healthskills to find new approaches to combat substance abuse. With the success of WISMS measured largely within the confines of 12-week treatment programme, Dr Linda Harris, Clinical Director at WISMS, wanted a range of measures to assess the real-life impact of the organisation’s work beyond this arbitrary time period. Recognising the expertise of Schering-Plough and Healthskills, Dr Harris asked both to partner with WISMS to develop new measures:

  • Schering-Plough joined the steering committee—working alongside social services, police and other healthcare providers—and provided operational and research support
  • Healthskills acted as coordinator, consultant, and organisational facilitator.

Wakefield Integrated Substance Misuse Service applied for and won DH funding from the integrated care pilot scheme. One of only 16 successful projects from over 150 applications, it will receive ongoing support and funding over 2 years to further develop the model of integrated care.

Trafford education and training partnership

A project was set up to address the training needs of the multidisciplinary staff within Trafford PCT. A training–needs analysis day took place at the start of the project and healthcare development managers from various pharmaceutical companies have facilitated the events. This format has continued and has successfully delivered a number of training events.

South West Medicines safety partnership

Three project work streams looked at how to improve different aspects of patient safety through joint working between NHS South West (the Strategic Health Authority) and the pharmaceutical industry. The projects looked at:

  • drug shortages—minimising risk associated with drug shortages and improving how information is disseminated by standardising practice and improving communication systems
  • medicines reconciliation—development of a bespoke training package that will enable staff to carry out medicines reconciliation (in accordance with NICE guidelines) in settings in which there is limited access to pharmacists
  • allergy—designing a campaign, ‘Medicines allergy matters,’ aimed at improving the reporting and recording of drug allergies.

All three projects were successfully completed and showcased at a conference in Taunton in 2009. The outputs of the projects are being shared across the South West and with the DH and the National Patient Safety Agency.

Conclusion

The NHS is under pressure and changing rapidly. Now that the need for the NHS to engage more fully with the pharmaceutical industry has been recognised, DH policy documents, the ABPI/DH ‘Moving beyond sponsorship’ toolkit, and the ABPI guidance notes on joint working will provide the basis for appropriate associations leading to better patient care.

References

  1. Department of Health, Medicines, Pharmacy and Industry Group. Best practice guidance for joint working between the NHS and the pharmaceutical industry and other relevant commercial organisations. London: DH, 2008. Available at: www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_082370
  2. Department of Health. High quality care for all—NHS next stage review final report. London: DH, 2008. Available at: www.dh.gov.uk/en/publicationsandstatistics/publications/publicationspolicyandguidance/DH_085825
  3. Department of Health, ABPI. Moving beyond sponsorship: Interactive toolkit for joint working between the NHS and the pharmaceutical industry. London: DH, 2008. Available at: www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_082840
  4. Association of the British Pharmaceutical Industry. ABPI guidance on joint working between pharmaceutical companies and the NHS for the benefit of patients: Taking into consideration the 2008 ABPI Code of Practice for the pharmaceutical Industry. London: ABPI, 2009.
  5. Prescription Medicines Code of Practice Authority. ABPI Code of Practice for the pharmaceutical industry 2008. London: PMCPA, 2008. Available at: www.pmcpa.org.uk/?=codeofpractice
  6. NHS Scotland. A common understanding: Guidance on joint working between NHS Scotland and the pharmaceutical industry. Edinburgh: Scottish Executive, 2003. Available at: www.scotland.gov.uk/Resource/Doc/47043/0013545.pdf
  7. NHS Industry Forum. Guidance for partnership working between NHS organisations, primary care contractors, the pharmaceutical industry and the allied commercial sector in Wales. NHSIF, 2004. Available at: www.wales.nhs.uk/sites3/Documents/371/WHC%20%282005%29%2016%20%2D%20Partnership%20document.pdf G