Methods
Design
This was a prospective, open, controlled, four period comparative study,
with and without CDSS (EES support), performed in the spring of 2019 in
one community pharmacy in southern Sweden.
Patients, settings and pharmacists
All patients with at least five prescribed medications dispensed at the
Hjärtat Pharmacy in the city of Eslöv were offered an opportunity to
participate. The three pharmacists involved all had an MSc in Pharmacy
and 25, 15 and 0.5 years of experience.
Intervention and control activities
The study was performed during four weeks in February- March 2019. Study
week 1 and 3 were intervention periods, and 2 and 4 controls. In the
intervention periods, the pharmacist used the EES support to detect
potential DRPs after consent from the patient. All additional
prescription dispense support information could be used by the
pharmacist during both intervention and control periods to detect
potential DRPs. After dispensing a drug in the control group, the
patients were offered EES support in the next dispensing.
Documentation template
A separate documentation template was developed and evaluated by the
research group, tested in two patients, and was used for documentation
in both periods where an actual DRP was identified and documented to be
acted upon (appendix 1). The template included basic demographic
information, and focused on the type of identified actual DRPs,
suggested actions, results of presented/not presented (reason should be
given) suggested actions (to patient or prescriber), and also if the DRP
was solved or not. Note that only identified potential DRPs that needed
action according to the pharmacist were considered an actual patient DRP
and documented, as a DRP in the template. No information on patient
identity or responsible pharmacist was collected and each patient
template only had a reference number. The DRPs were classified as high
dose, C/D-interactions, drug duplications, medication inappropriate in
children or in the elderly and other. For details on use and evaluation
of the form see appendix 1.
Analyses and Statistics
All data were written in MS Excel 2016 (Microsoft Corp, USA). Chi-2
tests were used for all comparisons. We assumed the proportion of
patients with at least one DRP to be 50% in the control group and that
this would increase to 70% in the EES support group. With a
5%-significance level and power of 80%, we needed 190 patients in
total, so we included 100 in each group [16].
Ethical consideration.
This study required no specific ethical approval according to the Malmö
University guidelines since the patients were not exposed to any kind of
danger and no personal data were collected. The EES is normally used
voluntarily by the pharmacists and the patients not receiving the EES
support were informed on the possibility to be used, in the next
dispensing.