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Catherine Duggan is director, academic department
of pharmacy, at Barts and the London NHS Trust and senior clinical
lecturer at the University of London School of Pharmacy
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Analysing and interpreting data is the subject
of this month’s Hospital Pharmacist special
feature (p39–51).
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Managing patient care in the NHS is an increasingly complex challenge. Health care professionals are faced with making decisions about a patient's care based on evidence from studies that may not directly relate to the individual situation, while simultaneously accounting for cost and safety.
Such decision making is further complicated when the patient has an uncommon
pathology for which little therapeutic evidence exists, or when the patient
has comorbidities which require intensive risk management.
The fundamental aim is to ensure patient care is maximized and that the
therapy is current and suited to individual requirements, yet is also
safe and cost-effective. It is no longer sufficient to manage one patient
in isolation; the NHS has to manage the entire patient population within
a restricted budget, therefore tough decisions must be made.
Decision making in medicines management is further challenged with the
continuous discovery and development of new drugs and emerging technologies,
for example, the use of stem cells and gene therapy.
To live up to the title of drug expert, pharmacists have to be able to
interpret clinical data that is presented in peer-reviewed papers and
publications, whether the evidence is equivocal or not.
To appraise evidence critically requires a professional to evaluate and
interpret the study in addition to being able to contextualise the data
within their own situation — not simply to follow a set of rules
on what constitutes a good paper. Understanding data and its implications
for practice means more than understanding statistical significance;
a pharmacist has to consider importance, relevance, feasibility and utility
of the findings in practice together with the complex issues of clinical
impact and cost-effectiveness.
This is made even more difficult in the case of rare diseases where there
are often not enough patients to test the effectiveness of a treatment
in a highly-powered, double blinded, randomised placebo controlled trial.
However, patients still require access to therapy and a decision has
to be made that is clear and transparent. Again, a professional requires
advanced skills to inform such decision making and not simply disregard
a study if its design is not a randomised controlled trial or does not
provide a definitive answer.
One example requiring advanced appraisal skills is the infamous “MMR
and autism” study.1 This study was widely publicised in the media
and suggested an association between measles-containing vaccines and
inflammatory bowel disease (that was not confirmed in subsequent studies).
Yet, probably because the paper was published in a highly esteemed journal
and despite the fact the authors called for more work to verify the proposed
association, the media attention the paper received had an adverse effect
on immunisation uptake. Many children are now at risk of measles, mumps
and rubella and the immediate possibility of measles eradication has
been delayed. Because of the media attention, many of us have a perspective
on the paper, yet few pharmacists (in my experience) have actually read
the original study, appraised the evidence or can usefully discuss the
limitations of extrapolating from regression lines or defend an association
as cause and effect.
Other examples of “not quite” evidence-based practice are
on the increase; where patient populations are small, disease states
are severe and non-treatment would almost certainly result in mortality.
One example is the use of antifungal agents following bone marrow transplantation.
In such situations, patient data has to be collated on a case-by-case
basis in order to underpin best practice, to inform the evidence base
and to reassure health care commissioners that such drugs are cost-effective.
Pharmacists are the key personnel for the evaluation of such data; appraising
the existing evidence and contributing to the evidence base with real
life examples. This it is neither easy nor clear cut.
Already, advanced level pharmacist practitioners have established themselves
in the health care team as the drug expert. They routinely find themselves
in key decision-making positions and are key figures on drugs and therapeutics
committees and the National Institute for Health and Clinical Excellence.
These roles require advanced critical appraisal skills. The demand for
these appraisal skills, and the resulting informed advisory roles, will
increase as we see consolidation of commissioning and tendering, with
resultant higher expectations of primary care trust pharmacists and community
pharmacists.
The ability to appraise evidence is a core skill required from undergraduate
level to consultant pharmacist. Using this skill to inform difficult
decisions underpins excellent and mastery levels of practice and establishes
the consultant pharmacist as a leader in the evaluation and development
of drugs for the benefit of patients.
Reference
1. Wakefield AJ, Murch SH, Anthony A, Linnell J, Casson DM, Malik M.
Ileal-lymphoid-nodular hyperplasia, non-specific colitis and pervasive
developmental disorder in children. The Lancet 1998;351:637–41. |