FIP Congress 2005
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At a session organised by the Administrative Pharmacy Section on 6 September entitled “Evaluation studies as a basis for decision making”, Claire
Anderson was one of the speakers. She reports the session here
|
 The World
Congress of Pharmacy and Pharmaceutical Sciences was
organised by the International
Pharmaceutical Federation in association with the Syndicate
of Pharmacists of the Arab Republic of Egypt.
It took place in
Cairo from September 2 to 8, 2005 |
Usefulness of qualitative research
Claire Anderson, professor of social pharmacy, University of Nottingham,
talked about complex interventions in pharmacy. She began by explaining
that the randomised controlled trial is taken as the gold standard of
evidence. However, it may not always be possible to use an RCT and even
when it is it may be important to use other methods like qualitative
research alongside it to explain the results.
“The interventions that we often want to make in health services
such as pharmacy,” she said, “are often complex and, unlike
in an RCT, the ‘active ingredient’ is difficult to define.” She
explained that if, for example, we wanted to evaluate pharmaceutical
care compared with traditional advice about medicines, we would need
to examine relationships with doctors and other health care professionals
and relationships with patients as well as clinical outcomes.
Professor Anderson went on to explain that complex interventions are
made up of a number of parts, including behaviours, parameters of behaviours
(eg, frequency, timing) and methods of organising and delivering those
behaviours (eg, type of pharmacist, setting, location). She told the
audience about the UK Medicines Research Council’s framework
for complex interventions. First,
she said, the
theoretical basis of the intervention needs to be established. This may
be done by using a literature review and by exploring relevant theory.
Secondly, or phase I, the different components of the intervention should
be identified and the effects each might have on the final outcomes and
on each other established. Different methodologies, such as economic
modelling, computer simulations, case studies, observational studies,
in depth interviews and focus groups, may be used.
The third step in the MRC framework, the exploratory trial (phase II),
Professor Anderson said, is crucial to the whole study and it may be
appropriate to test alternative forms of the intervention at this stage.
It is also the time when outcome measures can be defined and suitable
control groups identified. Finally phase III, or the main trial, can
take place when the fully defined intervention can be compared with an
appropriate alternative using a theoretically appropriate protocol. The
final step, she explained, is to establish the long-term effect of the
intervention, that is, to broaden its application outside a research
context — a bit like post-marketing surveillance.
An important question to ask is whether others reliably replicate my
intervention and results in uncontrolled settings over the long-term.
Observational studies could be carried out here as could audits, audio
or videotaping of consultations, mystery shopping, mentoring and feedback.
Professor Anderson talked about the importance of using qualitative methods
alongside quantitative ones especially when we want to explain unexpected
negative outcomes.
Qualitative research, she told the audience, is used to understand events,
actions, values and meanings from the individual’s perspective
rather than the researcher’s. Qualitative researchers are interested
in the process as well as the outcomes.
She concluded by talking about the Community Pharmacy Medicines Management
Project. The trial, she explained, had quantified the effects of pharmacist
interventions with coronary heart disease patients. Qualitative research
was carried out with patients, doctor and pharmacists and this had led
the research team to understand some of the difficulties the pharmacists
had in providing the intervention, for example accessing patients’ notes.
They had then been able to make recommendations for future services.
Assessing remuneration for pharmacy services in Portugal
Suzete Costa, pharmacy-based disease management department manager at
the Portuguese National Association of Pharmacies, spoke about remuneration
of pharmacy services in Portugal. She said that evaluation studies are,
sometimes, a basis for decision-making but that they are just one of
the components of the decision-making process. A clear political vision
for pharmacy practice and a strategy focused both on the professional
and economic sustainability of pharmacy services are also crucial elements.
In 1998, an Agreement on Diabetes Care was signed between the National
Association of Pharmacies (ANF), the Portuguese Pharmaceutical Society,
wholesalers, the industry and the Ministry of Health through the National
Health Service in Portugal. Community pharmacies accepted a no-profit
deal on diabetes products in return for being allowed to dispense these
exclusively.
The National Association of Pharmacies, she explained, had started to
develop pharmacy-based disease management programmes for asthma/chronic
obstructive airways disease, hypertension and diabetes in 1999. Their
mission, she explained, was to develop methods and tools for community
pharmacists, to support community pharmacists in providing this type
of care and to assess the impact of care provided.
The service now provided is a combination of disease state management
principles and a pharmaceutical care approach.
Pharmacists analyse possible patient complaints, measure blood glucose,
blood pressure, cholesterol, etc, against target values and review drug
therapy looking for drug-related problems for each patient at scheduled
appointments, in between visits to a doctor.
Ms Costa told the audience that before expanding the programme, a pilot
was run in several pharmacies in 2001–02. In September 2003 a new
agreement was signed for diabetes. The scope of pharmacist’s interventions,
she explained, was expanded to an essential service performed in almost
every pharmacy and the diabetes management programme. A monthly fee was
set per patient on an experimental basis, 75 per cent co-paid by the
Ministry of Health and 25 per cent by the patient.
Ms Costa said that only a certified pharmacist may be the responsible
person in the pharmacy and that certification is provided by the pharmaceutical
association after completing an accredited training programme. By August
2005, 20 per cent of Portuguese pharmacies had at least one accredited
pharmacist providing the diabetes service to nearly 1,700 patients. The
pharmacists, she explained, have to keep records documenting their interventions
and these are forwarded to the NHS for payment.
Ms Costa went on to say that most drug-related problems identified while
providing the service are because drug therapeutic regimens seem to be
not working because they are probably not the most suitable or because
of too low dosage or poor compliance. Only 5 per cent of problems are
related to safety problems, whether it is because of too high dosages,
bad regimens or adverse effects. The remuneration, she explained, will
be on trial until 31 December and an external evaluation will be commissioned
by the NHS.
At the same time, the association plan to perform a definitive evaluation
of the programme involving a mix of retrospective data analysis and a
prospective intervention with a control group.
The process of implementation was also challenging, even when remuneration
is already in place. Most new pharmacy services, she explained, are designed
for innovators and early adopters because these are the first people
to try them. Things often seem to be going smoothly at the beginning
until they are implemented on a much larger scale, and that is when problems
begin.
She concluded by saying that it is important to perceive the political
and social environment around us and to prepare the ground for the implementation
of future services and possible remuneration schemes. |
The
Pharmaceutical Journal