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Ed England is a pharmacist at Mid Hampshire Primary
care Trust
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The Court of Appeal judgment in favour of Ann Marie Rogers in her case against Swindon Primary Care Trust, which had refused to fund Herceptin treatment, challenges the role many pharmacists play in developing policies about the local availability of medicines. As reported in The Financial
Times for 13 April, the judges said that policies should be capable of
being rationally explained and that trusts will still be able to choose
between patients as long as they make cost a factor in their decision.
The Department of Health said that PCTs should not rule out treatments
on principle but should consider individual circumstances when reaching
decisions and should not refuse to fund Herceptin solely on the grounds
of the cost of the drug.
Policies and regulations designed to protect the public can give the
impression of doing the opposite. A marketing authorisation aims to ensure
a product has a favourable risk-benefit balance and a guaranteed quality.
However, the granting of a marketing authorisation appears to be slow
and cumbersome resulting in the perception that, rather than protecting
individuals, the mechanism is putting patients at risk (as many believe
in the case of Herceptin). The National Institute for Health and Clinical
Excellence appraisal process is in a similar situation.
Evidence-based health care aims to improve outcomes which have meaning
to patients, and perhaps this paradigm should be extended to organisational
decision-making. Evidence-based health care involves balancing the evidence
from research with the patient’s perspective and beliefs, and the
clinician’s professional judgement and expertise. In the absence
of national advice local organisations are expected to provide guidance
on when it is appropriate to treat or not to treat patients with licensed
and unlicensed medicines. These decisions impact on patients’ lives
and therefore organisational guidelines should also balance evidence,
clinicians’ experience and the public perspective.
The involvement of patients and the public in decision making is in line
with the health reform agenda. In “Patient and public involvement:
the evidence for policy implementation”, the Department of Health
says that “effective patient and public involvement is fundamental
to an NHS based on choice, responsiveness and equity. … The involvement
of patients and the public in health decision-making is now a central
theme of national and local policy in the NHS.” The aim is to deliver
a health service that is responsive to individual and community needs.
The Herceptin case suggests this is not the current situation.
Prescribing and clinical priority committees should involve the public
in the decision making process. Often the “medical professions” have
taken a paternalistic rather than a patient-centred view, though this
is changing as committees may now include patient representatives. It
has been argued that all committee members have a patient perspective,
although I suggest trust employees would be expected to represent their
employers’ views and not their own. Independent contractors (for
example, GPs and community pharmacists) may not be constrained by organisational
priorities; however they are likely to be influenced by their own personal
experiences, cultural beliefs and values. Individuals on prescribing
committees (whether employees, independent contractors or patient representatives)
are unlikely to be representative of the local community.
Harnessing the support of local voluntary and community groups in decisions
about the appropriate use of medicines is one method of involving the
public. There is no consensus on what public involvement is, however
the creation of partnerships with local voluntary and community groups
is essential to successful public involvement and is likely to lead to
health developments which meet local needs. Many stakeholders will believe
that partnership with the voluntary sector does not represent public
involvement because these groups do not represent “ordinary” people.
However, the development of partnerships has the potential for these
groups to work with the NHS to help improve communication with the public,
to help explain the risks and benefits of medicines and help support
individual patients.
Local voluntary and community groups should be consulted and actively
involved in appraisals of medicines. On an individual patient level,
progress is being made on moving from paternalistic compliance towards
patient-centred concordance, ie, empowering and involving patients in
decisions about their medicines. The same should now be happening at
the local level, where primary care organisations are responsible for
improving the health of local people and ensuring equity of access to
high quality health care.
Pharmacists have a key role to play in empowering patients and in enabling
the public to become involved in making local decisions about medicines.
Media reports of the Herceptin case have often taken a viewpoint that
has differed from those held by many health professionals. As pharmacists
we understand that taking medicines is a balance of risks and of benefits.This
perspective and understanding does not always appear to be shared by
the public or by politicians.
At the one-to-one patient consultation we are able to interpret and put
the evidence into the context of an individual, and discuss the risks
and benefits. However, at the organisational level we appraise the literature
and make recommendations that are often inaccessible to the public, written
in jargon and describing outcomes using statistical terms. We do need
to do this. However we also need to interpret the risks and benefits
of taking a medicine in terms that have meaning to the public, and which
the public and patients can use to make informed decisions.
As pharmacists we should embrace the culture shift towards a patient-led
health service. The aim — set out in the Department of Health’s “Health
reform in England: update and next steps” — is for a health
service where politicians set targets and undertake performance management
and where continuous improvement is driven by patients’ needs and
expectations. Active public involvement in the work of prescribing and
clinical priority committees is likely to delay decision making. However,
the development of partnerships with community groups will improve communication
between the public and health professionals, and will, it is hoped, result
in health decisions that reflect community needs.
We have learnt from the Herceptin case that in the publicly funded health
system explicit criteria should be in place on which to base funding
decisions. The days of paternalism in the health service are over, and
the public must be involved in local decisions about the use of medicines.
I suggest pharmacists are ideally placed to empower individual patients
and the general public by ensuring that information about the risks and
benefits of medicines is available in an accessible form, so that meaningful
health decisions can be made. |
The
Pharmaceutical Journal