European Society of Clinical Pharmacy
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The 32nd European Symposium on Clinical Pharmacy took place in Valencia, Spain, from 29 October to 1 November. The theme was “Pharmacists in the health care team: standards of practice and systems of care”. Sonia
Sanghani reports
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Practice research should be used to inform policy decisions
Health
care professionals are required to have an evidence-based approach
to their practice, said Moira Kinnear, Lothian NHS Trust, Scotland. There
is a need to shift thinking towards evidence-based community pharmacy
practice and to use pharmacy practice research in the design and delivery
of pharmacy services. Although practice is usually determined by policy,
which takes into consideration legislation, resources, professional
ethics
and individual patient needs in different countries, there is nevertheless
a role for using practice research to inform policy decisions in order
to develop and implement standards of patient care and standards of
pharmacy practice.
Clinical practice guidelines
“We know that decision-making is not based only on evidence; it
is also based on patients, their circumstances, preferences, resources
and the
societal context,” stated Mrs Marta Aymerich, Catalan Agency for
Health Technology Assessment and Research, Barcelona, Spain. However,
evidence assists decision-making at both policy and clinical levels.
Evidence-based pharmacy can therefore be defined as “the process
of systematic search, assessment and use of results as the basis of clinical
pharmaceutical decision-making. It is the detailed, explicit and well
thought out use of the best available information when making a decision
about patient care in the pharmacy.”
Clinical practice guidelines are systematically developed statements
to assist these health care decisions. The process of developing clinical
practice guidelines can be time-consuming, taking anywhere in the region
of nine months to three years, depending on the complexity of the condition.
Topic selection depends on criteria such as prevalence in the population
and variability in clinical practice. Once the
topic has been defined and the scope of the guideline narrowed sufficiently,
the development process begins. This requires input from a multidisciplinary
team whose main task is to undertake a systematic review of scientific
evidence. Existing clinical practice guidelines are assessed for their
quality and applicability. These can be updated with the latest scientific
evidence and then contextualised. Mrs Aymerich recommended the use of
databases such as the National Guideline Clearing House, a United States
database containing quality guidelines from all over the world. Acceptance
into this database is heavily dependent on quality methodological criteria.
To compare existing guidelines, a European instrument, entitled AGREE,
has been developed. Issues such as target populations, interventions,
etc, can be compared with this instrument. AGREE explores domains such
as scope, purpose, stakeholder involvement, rigour of development, quality,
applicability and editorial independence.
In an effort to overcome publication bias, statistical methods can be
used to double check the quality of published data. The Cochrane Collaboration
is also proving to be a proactive player by setting up a database of
all approved clinical trials. If data from these trials remain unpublished,
this may indicate bias. Mrs Aymerich urged researchers to move away from
thinking that negative results are not relevant and therefore should
not be published. For clinical decision-making purposes, such results
have a bearing on the development of quality, evidence-based practice
guidelines that serve society’s interest.
Once the preliminary version of the guidelines has been developed and
peer-reviewed by an external review panel, a pilot study is undertaken
to test feasibility and design issues. The final version has to be in
a flexible, user-friendly format, for example, paper-based, electronic
versions and algorithm-based. Different recommendations are written in
many different ways. The most important point to bear in mind is that
all recommendations should be graded from “best evidence” to “not
enough evidence” to enable the user to assess the quality of information
that forms the basis of their own decision-making. This is an issue of
transparency and is vital to clinical practice guideline development.
For clinical practice guidelines to be regarded as successful, there
has to be development, dissemination, implementation and evaluation.
Although there are issues surrounding all of these processes, the main
areas of concern centre around the evaluation of the impact of guideline
implementation. Mortality and morbidity changes happen over a longer
time-frame than that during which the guideline is being evaluated. Other
environmental effects, such as co-morbidities, pharmaceutical company
marketing techniques and lifestyle choices, influence the impact of the
use of guidelines. National guidelines
For many different guideline groups, the idea of national or European
guidelines seems an attractive proposition. Cultural influences are
visible when it comes to interpretation of evidence at levels below
the “gold standard” randomised, controlled
trial. A practical solution would therefore seem to be that of developing
national guidelines for local and regional implementation. This would
provide guideline implementers with the flexibility to take into consideration
local needs, resources and available implementation strategies. There
was a call for all guideline developers to network more closely with
each other at local, regional, national and international levels to ensure
the highest standards of patient care are delivered within their countries.
Practice research mirrors drug development stages
The framework for research into complex health services could be paralleled
with the stages of drug development research (pre-study phase to post-marketing
surveillance), according to Mrs Hannah Herborg, Pharmakon, Denmark.
Service developers need to undertake pre-delivery work, modelling,
definitive control trials and long-term implementation. Research, pilot
studies
and instrument testing are used during the service development process
in order to learn as much as possible about service delivery, design
and feasability in practice.
Once services have been developed and tested, implementation provides
valuable opportunities to observe activities in a “live setting”.
Although RCTs are important for implementation purposes, Mrs Herborg
believed that they are essentially over-valued. She recommended the use
of mixed research methodologies as RCTs are designed for technical, controllable
situations and practice research
into service development is more of a “moving target” — a
social construction that exhibits many variables and is highly context
dependent.
Project management skills and tools are essential components in understanding
the research of new service design and implementation. Testing and modelling
the service, designing appropriate tools to support implementation such
as decision algorithms, training manuals, guidelines, practice standards
and documentation methods, form an invaluable part in shaping the service
and creating the evidence base to support the pharmacist’s role
in delivering high quality pharmaceutical care. Barriers to implementation
Barriers to implementation are not just related to time, workflow, skills,
attitudes and values. There is a more fundamental issue which needs resolving;
that of improving the clinical judgement competency of community pharmacists
if these services are to be implemented successfully and sustainably.
From Danish research, internal pharmacy training programmes have proven
more effective in improving performance in this area than complex, externally
developed courses.
Quality audits and the use of “mystery shoppers” also support
sustainable implementation.
In Mrs Herborg’s experience, all support mechanisms, documentation
processes and service designs are only implemented successfully if they
are kept as simple as possible with easy to follow procedures.
Integrating pharmacists into the health care team: what is the key to
success?
Professor Steve Hudson, University of Strathclyde, Scotland, emphasised
that improving health gains in a population requires all agencies involved
in health care delivery to undertake more collaborative working.
New ways of practising health care require pharmacists to learn about
teamworking and also require closer links between research and practice.
With hospital services in mind, he recommended the horizontal integration
of pharmacists into the health care team to supervise the patient’s
journey through the secondary care system better. This enables pharmacists
to verify treatment decisions and monitor and evaluate patient outcomes,
resulting in a pharmacy service based on individual patient assessment
and separation of clinical and dispensing tasks, with pharmacists and
technicians mutually supporting each other’s roles. Building such
services into the hospital setting would streamline systems of discharge
of patients into the community setting.
Professor Hudson highlighted two projects designed to streamline hospital
integrated care processes in cancer care and outpatients care, alongside
a third project based in community pharmacies in the area of rheumatoid
arthritis and medicines management of patients on methotrexate. Documentation
plays an important role in the pharmaceutical care plan and the data
from these projects is being systematically collected and developed into
a database for evaluation purposes. Pharmacists are wary of writing down
their activities and this may be due to lack of self-confidence in their
decision-making abilities and fear of taking responsibility.
Professor Hudson reminded participants that the opposite of “integration” is “disintegration” and
urged pharmacists to join health care colleagues in striving to reduce
the impacts of disintegration within health care and society in general. A US perspective
Dr Brian Isetts, University of Minnesota, US, warned that “national
economies would not be prepared to bear the burden of paying pharmacists
the equivalent of $100,000 to count out tablets in fives”. He provided
participants with his “recipe” for the successful integration
and implementation of pharmacists and pharmaceutical care services into
health care team settings. The two major components (ingredients) are the
ability of the pharmacist to assume full responsibility for all the patient’s
drug-related needs and the separation of the care and consultation process
from the dispensing process. Over-specialisation and unrealistic expectations,
as well as ineffective communication and lack of relationship building and
trust between health care professionals and patients, are recipes for ineffective
integration. Feedback mechanisms are important since they ensure the services
provided by pharmacists within the “pharmaceutical care” framework
are continuously improved. Patient and employer satisfaction are big
driving forces to moving pharmaceutical care from a supply-oriented to a
demand-oriented
service.
Dr Isetts encouraged pharmacists to take responsibility for implementing
pharmaceutical care more widely. Linking with patient and consumer lobby
groups will provide the momentum to become more demand-oriented. Undergraduate
and postgraduate programmes have much to do to ensure that pharmacists are
equipped with the appropriate caring attitudes, the ability to take responsibility
for their decisions and the self-confidence and self-esteem to work in these
new, challenging, demanding, yet professionally rewarding ways. |