Translating NHS reform into healthy profits
pharmafile | October 21, 2003 | Feature | Sales and Marketing |Â Â NHS, healthcare, reformÂ
The UK's public health system is the subject of increasing scrutiny from the media, the public and indeed the profession itself. As a result of this focus, clinical governance and other important steps to modernisation have been introduced to the NHS, requiring all of its organisations to have in place a comprehensive programme for clinical improvement. This fresh need for continuous quality assessment and advance, alongside new opportunities for supplementary prescribing by nurses and pharmacists and the changes the proposed new GP contract would bring about, offers pharmaceutical companies unparalleled opportunities to become more involved and more influential in patient care – and ultimately to improve the health of their bottom line.
Clinical governance a cultural shift
The UK was shocked when the 'Bristol babies' scandal hit the headlines. The resulting inquiry, published in January 2002, found that from 1991 to 1995, between 30 and 35 babies died needlessly when undergoing heart surgery at the Bristol Royal Infirmary. The woeful lack of regard for clinical safety and accountability highlighted by the investigation added to a general dissatisfaction with a system that had allowed Harold Shipman to murder at least 15 patients, and disgraced gynaecologists Rodney Ledward and Richard Neale to continue working unchecked for years. Further debacles over organ retention and inadequate storage and use of embryos ensued.
Against this backdrop it was clear that changes needed to be made in the public health system. As well as introducing new agencies such as the National Clinical Assessment Authority and the Commission for Health Improvement (CHI), the 1999 NHS Act placed a duty of quality on NHS organisations for corporate accountability for clinical quality and performance. The concept of clinical governance was now embodied within the system. The inquiry into the Bristol case further became a blueprint for wide reform of the NHS, spawning fresh health legislation in the form of the 2002 NHS Reform and Healthcare Professions Act. Hugh Griffiths, Director of Policy at the national Clinical Governance Support Team (NCGST), identifies that this era effectively "drove quality up the agenda." Times, and practices, were changing.
Audit – the heart of clinical governance
Reportedly, the first ever audit was carried out by Florence Nightingale during the Crimean War, but from 1850 to 1998 very little changed and audit was not of primary concern. However, following the 1989 Working for Patients' White Paper, the 1990s saw the use of audit move into the mainstream. In todays NHS, clinical governance, officially defined by The National Institute for Clinical Excellence (NICE) as "the organisational approach for quality", serves to place the process of clinical audit at the very heart of the system. Audit, which seeks to improve patient care and outcomes through systematic review, dictates that outcomes must be measured against explicit criteria and used to implement changes that ensure best practice across the health system.
Full participation in clinical audit by hospital doctors became an explicit component of clinical governance by the Department of Health (DoH) and the Welsh Office in 1998. The DoH's NHS Plan 2000 took that policy further proposing mandatory participation by all doctors in clinical audit and support for the involvement of other NHS staff such as nurses. The General Medical Council also now advises all doctors that they must take part in systematic and regular clinical audits.
Organisations such as NICE and CHI and, indeed, the Government are all keen to promote clinical audit as a mainstream activity and to increase its profile. Under the provisions of the NHS Reform and Healthcare Professions Act 2002, CHI itself is now responsible for managing the national clinical audit programme, which currently includes stroke, myocardial infarction national audit project, venous ulcers and violence in mental health settings. The group works with royal colleges to maintain audits and outline future plans and together with NICE has launched the 'Principles for Best Practice in Clinical Audit' handbook to help NHS staff.
To implement best practice, however, healthcare personnel must have access to the necessary time, facilities, advice and expertise. But this is not always the reality, as CHI and NICE themselves accept that the past has thrown up audit failures and poor recording of clinical data, resulting in a lack of enthusiasm for audit in some camps. Next year, the Commission for Healthcare Audit and Inspection (CHAI) should come in to being, tasked with further organisational change in favour of evidence-based care and prescribing. However, a key issue involved in clinical audit remains one of resources.
Pharma industry involvement
When it comes to the management of the chronically ill, audits represent an effective way to review treatment that may not have kept pace with drug development. For many primary care organisations (PCOs) the supply of sponsored nurse advisors to facilitate such assessments is vital, and is commonplace within the industry. Patients suffering from a chronic illness can also benefit from a fresh look at their prescriptions it is estimated that up to 90% of patients would otherwise receive repeat prescriptions automatically, when there may well be a new treatment that would work better for them. This increasing contact with a PCO creates a favourable selling environment for the pharma company, increases the patient pool and facilitates brand switching.
Patient groups involved in audit also represent a highly valuable asset within the process. Not only do they provide the 'raw data', but also insights into patient concerns, beliefs and actual practice. For a pharmaceutical company this is an ultimate opportunity to liaise and learn from the very patients that use its products, and to identify any barriers that may affect the way in which a drug is promoted, understood and used, or – perhaps more importantly – under-promoted, misunderstood and subsequently misused.
Audit alternatives
But audits are not a catch-all solution for the industry. Product Manager Eugene Osei-Bonsu explains how Shire Pharmaceuticals' COMBAT (Comparison of Mesalazine and Balsalazide Therapy to prevent relapse in Ulcerative Colitis) programme, although originally conceived as an audit, became an open labelled clinical study involving 20 centres in the UK, following a series of meetings with key gastroenterologists. He explains how the study will help not just improve the health of patients, but also to keep Shire fighting fit: "COMBAT will enable us to demonstrate the benefits of Colazide [balsalazide] in helping patients achieve remission quicker and stay in remission for longer." He adds: "COMBAT provides an opportunity for prescribers to proactively review patients' therapy when they relapse. It will offer us greater interaction with gastroenterologists with whom Shire have a strategic focus."
While the study is still in its infancy, Shire will determine its success by the extent of penetration of the 5-ASA market and gastroenterologist willingness to adopt balsalazide as a product of choice for ulcerative colitis patients as well as the stronger relationships it develops with gastroenterologists.
Eugene adds: "Lessons from COMBAT will provide Shire with a roadmap for future initiatives assisting us to overcome hurdles sooner and accelerate the implementation of future programmes. It will also help us to determine how well audits can facilitate patient reviews."
AstraZeneca is also keen to collaborate with PCOs in the UK, and has begun its AZ Academy in an effort to better understand PCOs. Neil Jessop, PCO Marketing and Partnership Leader, explains: "The Academy will provide opportunities for groups of PCO executives, including chief executives, to meet and receive expert advice on media training, evidence-based policy training, partnership with commercial sectors, presentational and IT skills."
He adds: "This programme is provided in a non-branded manner and will utilise UK known and acclaimed experts in their field to facilitate, develop and discuss these issues and opportunities."
Alongside the Academy, however, AstraZeneca continues to provide nurse advisors to its UK NHS customer base. Neil points out: "Given the pressure on primary care services we believe that most PCOs, etc welcome these additional expert clinical resources and we would wish to continue to review and provide this service."
Change allows pharma collaboration
Hugh Griffiths at the NCGST does indeed see massive change within the system, which he believes is now more strategic and multi-disciplinary. In the modern NHS, effective teamwork is the key to ensuring safe, accountable, high-quality care in a system with increasingly complex care pathways. With regards to the involvement of pharmaceutical companies within the NHS, Hugh believes that the new relationships on offer can be more productive, particularly in the arenas of new treatments, the pathways to those products and in medicines management. He recommends a "shift of emphasis from sales to supportive relationships between organisations" as the way forward.
Eugene Osei-Bonsu is keen to see best practice working within the NHS. He would like to see "joint initiatives where the NHS is open and willing to work with the industry for mutual benefits," adding: "Shire has worked closely with the NHS modernisation agency on projects with primary care trusts (PCTs) looking at patients in residential homes and falls/fracture prevention as required in the older persons NSF."
For him, changes and reform in the NHS mean that PCTs are increasingly accountable and that primary and secondary care needs to ensure the management of patients flows seamlessly from one to the other "with clear pathways and protocols." Shire, in turn, he explains, "seeks to align marketing programmes for the mutual benefit of patients, PCTs and the organisations, facilitating the interaction between primary and secondary care."
Changes such as supplementary prescribing, initially suggested by the 1999 Review of Prescribing, also offer potential to the industry. Defined by the DoH as "the voluntary prescribing partnership between an independent prescriber and a supplementary prescriber, to implement an agreed patient-specific clinical management plan with the patient's agreement", the changes to NHS regulations allow for supplementary prescribing by nurses and pharmacists, and were laid before Parliament last month. AstraZenecas Neil Jessop believes the change should be welcomed by UK-based pharma companies "not only as a new source of prescribers over and above that of GPs and other qualified clinicians but also as an additional key resource to improve access and services to patients, thus releasing more time for the GP to dedicate to new referrals and consultations."
On the horizon
Neil is also hopeful for other upcoming initiatives. "The expected roll out in 2003/4 of the CHAI-based PCO NHS Performance Indicators are linked to a variety of key targets, including several around access to primary care services, disease management and effective prescribing linked to key NSF," he says. These areas, he argues, provide pharma companies with "opportunities to work with and further support PCOs to achieve maximum efficiencies and optimal provision of care for their patients."
Likewise, he believes if the new GP contract is approved, the significant change in the way GPs are paid (linked directly to the quality of services provided rather than simply the number of patients treated) means that "pharma companies should understand the critical importance of patient registers and review systems, the weighting placed on certain disease groups over others." Critically, he also believes "the new GP contract introduces and reinforces the need for better disease management of registered patients, not only in the use or choice of drugs but also across the entire disease pathway. An understanding of this approach to treating disease in primary care by pharma companies will provide opportunities for collaboration."
Pharma market changed
Perhaps unsurprisingly then, the last decade has seen tremendous and far-reaching changes in the NHS at all levels. Reform has brought greater transparency and accountability to public health, placed an increased emphasis on patient care and feedback and has taken evidence-based medicine into the system through clinical audits. Through traditional and more imaginative collaborative efforts to align themselves itself this strategic outlook, the pharmaceutical industry has much to gain. Increased patient access and opportunities to positively influence both existing and an expanding group of prescribers has meant that pharmas selling environment has changed – for the better.
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