THE EDQM

PHARMACEUTICAL CARE
QUALITY INDICATORS
PROJECT

EDQM Final report

Edition 2017
 The EDQM Pharmaceutical Care
Quality Indicators Project

Final report

European Directorate for the Quality of Medicines & HealthCare (EDQM)

The EDQM Pharmaceutical Care Quality Indicators Project – Final report is published by the European
Directorate for the Quality of Medicines & HealthCare of the Council of Europe (EDQM).

Note: the views expressed in this report do not necessarily reflect the official views of the Council of
Europe and its Euro­pean Directorate for the Quality of Medicines & HealthCare (EDQM).

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Contents
Executive summary, page 5 Appendices. Steps to be followed for data collection
Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  5 and data collection forms, page 45
Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  5 TG1 Indicator – Data collection form for general prac-
Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  5 titioners . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  47
Findings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  5 TG1 Indicator – Data evaluation form for pharmacist .  47
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  6 TG2 pre-study questionnaire . . . . . . . . . . . . . . . . . . . . .  48
TG2 indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  53
General introduction, page 7 TG3 Indicator 1 – ‘My CheckList’ form at the start of a
Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  7 chronic treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  59
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  11 TG3 Indicator 1 – Consultation form for pharmacist .  60
TG3 Indicator 2 – ‘My CheckList’ form regarding the
Results of the EDQM Pharmaceutical Care Quality
chronic use of my medications . . . . . . . . . . . . . . . . .  64
Indicators Project, page 13
TG3 Indicator 2 – Consultation form for pharmacist .  66
General discussion and conclusion, page 41 TG3 Indicator 2 – Form for medication review . . . . . .  68
TG3 Questionnaire for pharmacists . . . . . . . . . . . . . . . .  71
Acknowledgements, page 43 TG4 Pharmacist’s self-assessment tool . . . . . . . . . . . . . .  77

3
Executive summary
Background
P harmaceutical care is understood as a quality
concept and working methods for the responsible
provision of medicine therapy for definite outcomes
in the interest of patients’ quality of life (definition
established by C.D. Hepler and L.M. Strand in 1990).
With a view to improving the efficient and
safe use of medicines, the European Directorate for
the Quality of Medicines & HealthCare (EDQM)
(Council of Europe) has been working since 2008 on
a project to design indicators to assess the quality of
pharmaceutical care in Europe (EDQM Pharmaceu-
tical Care Quality Indicators Project).
Purpose
T he main goal of the EDQM Pharmaceutical Care
Quality Indicators Project was to develop, test
and validate 4 sets of quality indicators focusing on
the following pharmaceutical care areas:
• Adherence to nationally agreed clinical prac-
tice guidelines (Topic Group 1);
• Monitoring of therapeutic plans and medica-
tion safety by pharmacists through data linking
and exchange of information about therapy
and patient’s medical condition in anticoagu-
lant and antibiotic therapy (Topic Group 2);
• Structured patient-pharmacist consultations
(chronic therapy; polypharmacy; polymor-
bidity) via ‘My CheckList’ (Topic Group 3);
• Pharmaceutical care: special needs in certain
regions (Topic Group 4).
5
The last step of the project took place in 2013-
2014 and consisted of a multinational validation
study which was aimed at evaluating whether the
above indicators are fit for purpose, and at drawing
conclusions on the conditions of use of the proposed
indicators.
The outcomes of the multinational validation
study and of the workshop held at the EDQM in
Novem­ber 2015 to conclude the project are presented
in this report.
Methods
F or each indicator set, pilot studies were carried out
in different countries in Europe (in and beyond
EU member states), under real-life conditions, and
in different healthcare settings (community, ambu-
latory and hospital settings). Each pilot study was
managed by a Topic Group leader and, in each par-
ticipating country, national co-ordinators were iden-
tified to organise and ensure the smooth running of
the research activities. In order to standardise the re-
search working methods and ensure proper interpre-
tation of the pharmaceutical care model across the
scientists involved in the research process, ‘Action
Oriented Study Protocols’ for each topic group were
prepared. Standardised data collection forms and
data evaluation procedures were developed as well.
Findings
A total of 19 collaborators from 12 countries in
Europe were involved in the last phase of the
The EDQM pharmaceutical care quality indicators project. Final report
EDQM Pharmaceutical Care Quality Indicators
Project (multinational validation study).
Overall, the results of the project indicated that
the development, testing and validation of quality
indicators across different countries in Europe are
complex, given the differences between healthcare
systems in Europe.
Nevertheless, the project also showed that the
indicators under evaluation could be considered to
provide a pragmatic approach to encourage the im-
plementation of the pharmaceutical care philosophy
and working methods, and could help assure the
quality of different key areas of the pharmaceutical
care process.
Finally, the project highlighted that certain
capa­bilities need to be in place in a healthcare system
(e.g. availability of electronic health records, advanced
6
education and training initiatives for healthcare pro-
fessionals, improved interprofessional collaboration)
in order to support the delivery of pharmaceutical
care and the use of the proposed indicators in daily
practice.
Conclusion
T he EDQM Pharmaceutical Care Quality Indica-
tors Project drew up and validated 4 basic sets of
quality indicators covering 4 key areas of the phar-
maceutical care process.
These indicators can be used by health authori-
ties and healthcare professionals to evaluate pharma-
ceutical care practices and policies, and to promote
the efficient and safe use of medicines, leading to the
best possible medication outcome for the patient.
General introduction

Background effectively and safely, is not easily assessed in an in-

P rescribing medication is probably the most fre-

quent clinical intervention in healthcare in
Europe. Pharmacists dispense to the population of
dependent and systematic way.

Indicators for the quality of healthcare

the 28 European Union member states of about 500
million people an estimated ten billion of packs of The World Health Organization (WHO) was
prescription-only medicines per year [1]. The number among the first to develop systematic measures of
of pharmaceutical preparations derived from these medicines use [3]. These measures were intended as
medicines is countless. For the geographical area of a tool for evaluating national drug policies and com-
47 countries covered by the Council of Europe, with paring these policies internationally. Australia was
approximately 825 million inhabitants, the figures probably the first country to publish a country-wide
are less accurately known, but can be assumed to be standardised indicator set for evaluating and moni-
even larger. toring medication use [4]. This set was followed by an
Quality and safety of medicines and their indicator set specifically for Drug and Therapeutics
supply has been regulated by communal rulings in Committees [5] and a more general indicator set for
north-western Europe since 1964. Over the years, a drug use in hospitals [6]. These indicators, inspired
number of countries in the European continent by the earlier WHO work, were all based on quality
adopted the European Pharmacopoeia [2], the princi- criteria reached by consensus meetings of groups of
ples of Good Manufacturing Practice, Good Clinical experts, stakeholder groups’ consultations and, if
Practice and Good Distribution Practice and incor- possible, supported by published scientific evidence.
porated them into national legislation. Currently, a Typical examples of these indicators are given in the
lot of common regulatory experience has been built following table.
up and has evolved into a complex system of assess-
ments and safeguards, which guarantees a widely ac- Table 1.  Examples of early Australian drug-related
cepted level of efficacy and safety of medicines for the indicators
specific medical conditions. That is, when medicines Type Indicator Data collection method
are applied and used according to their intended Process Are there established Questionnaire
purpose. mechanisms for con-
sumers to report ADRs?
In contrast to the proven security and public
Impact Percentage of pharma- Self-reporting of phar-
trust generated by the quality and safety of Europe’s cies reporting at least macist
medicinal products, their application and effects one ADR annually
in practice are less well monitored, assured or con- Outcome Number of annual ADR Patient record coding
trolled, and indeed less controllable. Once out in the associated hospitalisa- and aggregating results
tions per hospital, state
open of everyday healthcare practice, the extent to and country-wide
which medicines are used responsibly and sensibly,

7
The EDQM pharmaceutical care quality indicators project. Final report
In these early approaches methodological
challenges were huge, relating to, amongst others,
the correct use of definitions and restraints in avail-
able classification and coding systems. The collec-
tion of the indicator data was primarily hand- and
paperwork, which put practical boundaries to sam-
pling frequency and size, and limited the options for
routine monitoring.
Comparable indicators initiatives were subse-
quently taken up in other countries such as Canada,
the Netherlands, Spain, the Scandinavian countries,
the UK and the USA. A common denominator of
these indicator sets is that the data collected served
as direct input for healthcare professionals and the
healthcare organisations they work with, in order
to evaluate the current level of care and improve its
quality and safety in the immediate future.
The collection of health data on a more aggre-
gate level was already done by WHO, and in the mid-
1980s the Organisation for Economic Co-operation
and Development (OECD), considering a good health
status of the population an asset and precondition for
economic development, started collecting health in-
dicator data in its member states [7-8]. OECD Health
Statistics are still being published on its website [9].
The consistency in definitions and data formats used
enabled OECD to collect comparable datasets over
time and these provide the user with unique time-se-
ries information over the last 15 years. However, in-
formation about the appropriate use of medicines as
such is not available.
The EU-funded Simpatie project resulted in
a list of 42 patient safety indicators [10]. Of this list
only two medication related indicators were deemed
feasible for parts of Europe: ‘Surveillance of adverse
drug events (ADEs) by an electronic trigger tool’ and
‘Side-effects of anti-psychotic treatment’. In 2007 the
European Commission set out a strategic health ap-
proach 2008-2013, which inter alia aimed to provide
a set of clear objectives ‘to guide future work in part-
nership with Member States about European Com-
munity Health Indicators (ECHI), with common
mechanisms for the collection and comparable
health data at all levels’ [11]. The ECHI 88 indicators
shortlist, which is both similar and supplementary
to the WHO Health Statistics and the OECD Health
Data, also proposed a very limited number of medi-
cines related indicators, such as the ‘Influenza vacci-
nation rate in elderly’ (No. 57) and the ‘Medicine use
of selected anatomical therapeutic chemical groups
in defined daily dose per 1 000 population’ (No. 74).
Because of its goal to compare health data and health-
care performance among participating countries, the
8
ECHI project paid a lot of attention to data availa-
bility and comparability of national registries.
The international indicator initiatives demon-
strate that policy makers need data on determinants
of public health, on the performance of the health-
care process in their countries, and on the quality
and safety of healthcare. At the same time indicators
for the appropriate use of medicines were not taken
up in the above initiatives.
Medication safety
Almost parallel to the development of health-
care indicators, increasing evidence was published
in the scientific community, demonstrating that
safe and effective healthcare is not self-evident. The
Harvard Medical Practice Study demonstrated that
adverse events are relatively frequent during hospital
treatment and 19 % of them were drug-related [12]. The
Quality in Australian Health Care Study [13] reviewed
14 000 hospital admissions for adverse events. Of these
adverse events 10.8 % was drug-­related, of which 8 %
resulted in death. A wake-up call was without doubt
the report of the USA Institute of Medicine: To Err is
Human: Building a Safer Health System, which cal-
culated that between 48 000 and 98 000 people died
each year in US hospitals as a result of medical errors,
originating both in ambulatory and hospital care
settings [14]. A substantial proportion (10-20 %) of
these errors were ­medication-related, accounting for
an estimated 7 000 deaths per year. To Err is Human
was followed by other publications with similar mes-
sages, such as the report Safer NHS for Patients: Im-
proving Medication Safety in 2001 [15]. The Dutch
Hospital Admission Related to Medication study in
2005 focused on patient harm related to medicine use,
derived from hospital patient records, arguing from
extrapolations that about 16 000 hospitalisations per
annum were drug-related and potentially avoidable
[16]. A Dutch population-based retrospective cohort
study of primary care data determined that 5.1 % of
all hospitalisations were probably or certainly due to
adverse drug reactions [17]. A systematic review of
studies from around the world showed that a median
of 3.7 % of all hospital admissions were preventable,
medication related admissions [18]. Interestingly
these studies showed a consistent association of the
same major therapeutic groups with preventable
patient harm: cardiovascular medicines (angiotensin-­
converting-enzyme inhibitors, diuretics, inotropics,
­beta-blockers), anticoagulants and antithrombotics,
non-steroidal anti-inflammatory drugs (NSAIDs)
and opioid analgesics, hypoglycemic substances
and corticosteroids. Patient-related risk factors were

found to be: age, multi-morbidity/multiple drug use,
reduced cognitive skills, non-adherence and reduced
kidney function. Two other studies indicated that
release from hospital was a particular high-risk sit-
uation, in which patients sometimes restarted med-
icines, previously discontinued due to adverse drug
reactions [19-20].
The Council of Europe also recognised the im-
portance of the issue of medication safety. Its Expert
Group on Safe Medication Practices (2003-2006)
published an extensive review of existing medication
safety practices and issued a number of recommen-
dations, focussed on safety culture [21]. These recom-
mendations to European healthcare organisations
included different measures such as the early detec-
tion of adverse drug events, the setup of medication
error reporting systems, strengthening awareness
and learning of professionals, introducing electronic
prescribing, improving naming, labelling and pack-
aging, and improving medicine information for
patients.
Indicator types and terminology
Whereas in the beginning healthcare quality
indicators were usually called performance indicators,
referring to the (relative) performance of a specific
healthcare process, a recognisable methodological
difference between performance indicator and indi-
cator could not be found. A key performance indi-
cator is usually a target value to be achieved within a
defined work plan or agreed improvement process (e.g.
number of clinical medication reviews performed per
year). The classification proposed by Donabedian has
proven to be valuable in practice [22]. Indicators are
classified in structure indicators (the tools, resources,
and organisational components), process indicators
(activities and tasks in patient episodes of care) and
outcome indicators (results). Indicator sets are often
named according to the anticipated use: clinical in-
dicators, primary care indicators, prescribing quality
indicators, diabetes indicators, public health indica-
tors, patient safety indicators, etc. In managed care
settings and with pay-for-performance approaches,
which originated in the USA, the element of compa-
rability and performance rankings remains promi-
nent. While public health data are usually available
on the web, such transparency becomes less evident
when indicators relate to the performance of smaller
healthcare settings and individual carers. In many
professional settings, indicators are relative meas-
ures that support non-disclosure comparability data
between peers and time-series analyses to monitor
personal or institutional improvement.
9
General introduction
In this context, the European Committee
on Pharmaceuticals and Pharmaceutical Care
(CD‑P‑PH) [23], of which the secretariat is ensured by
the Council of Europe and its European Directorate
for the Quality of Medicines & HealthCare (EDQM)
[24], commissioned a study on pharmaceutical care
(PC) and quality indicators that led to the develop-
ment of the Pharmaceutical Care Quality Indicators
Project under the co-ordination of the EDQM.
Overview of the EDQM’s activities in pharmaceutical
care
The EDQM’s activities in the field of pharma-
ceutical care are carried out in line with the accept-
ance that pharmaceutical care means the responsible
provision of drug therapy for the purpose of achieving
definite outcomes that improve a patient’s quality of
life (definition established by Hepler and Strand in
1990 [25]). Pharmaceutical care is based on a rela-
tionship between the patient and healthcare profes-
sional who accepts responsibility for the patient. This
concept implies the active participation of the patient
in medicine therapy decisions, co-operation of health-
care providers across disciplines, and gives priority to
the direct benefit of the patient. Pharmaceutical care
plays an important role in ensuring the appropriate
use of medicines and helps achieve the best possible
medication outcome for the patient. Therefore, phar-
maceutical care can ultimately improve quality of life
and rational use of healthcare resources, and reduce
inequalities in healthcare [25].
Pharmaceutical care activities are overseen by
the CD-P-PH (Steering Body) and carried out with
the support of one of its subordinate bodies, the Com-
mittee of Experts on Quality and Safety Standards in
Pharmaceutical Practices and Care (CD-P-PH/PC)
[26].
The Committee of Experts CD-P-PH/PC is
entrusted with improving ‘pharmaceutical care and
pharmaceutical practices in Europe through public
health oriented policies and practical programmes,
putting first the needs of patients and society in
general, having in mind the social and ethical context
of healthcare’ [26]. In order to achieve this goal, the
Committee of Experts CD-P-PH/PC develops and
undertakes a programme of activities aimed at im-
proving public healthcare in Europe through pro-
moting knowledge, skills, attitudes and values in care
practices involving pharmaceuticals. Among others,
these activities may comprise the development and
implementation of a quality assessment in pharma-
ceutical practices and care through quality indicators
[26]. The activities related to the development and im-
The EDQM pharmaceutical care quality indicators project. Final report
plementation of pharmaceutical care quality indica-
tors were performed with the support of the Quality
of Pharmaceutical Care Indicators Working Party,
which was established in 2009 and consisted of sci-
entific collaborators coming from different academic
institutions in Europe.
The EDQM Pharmaceutical Care Quality Indicators
Project
In 2008 the Committee of Experts CD-P-PH/
PC commissioned a survey on the key concepts in
pharmaceutical care and the performance indica-
tors used to evaluate the quality of pharmaceutical
care and pharmaceutical services in the Council of
Europe member states [27]. The survey concluded,
inter alia, that a set of indicators had to be devel-
oped and tested in Europe. In particular, it was
pointed out that quality indicators had to be devel-
oped in clearly defined areas, be equally applicable
to a wide range of countries, and their development,
testing and validation had to involve the co-oper-
ation between countries with different histories of
pharmaceutical care, medical traditions and health-
care systems [27].
In 2009, areas in PC relevant to be evaluated by
indicators were defined in scoping studies and dis-
cussed with member states’ experts and stakeholder
associations at the expert workshop ‘Assessing the
quality of patient-centred pharmaceutical care in
Europe – where do we stand, where should we go?’,
held in Strasbourg in November 2009 [28].
In 2010 the scientific rationale of model in-
dicators was further explored on the basis of pub-
lished literature and the experiences of the scientific
collaborators involved, and discussed at the expert
workshop ‘Indicators of the quality of pharmaceu-
tical care’, which took place in Strasbourg in De-
cember 2010 [29].
Based on the above-mentioned scientific de-
velopments (2008-2010), in 2011-2012 the Com-
mittee of Experts CD-P-PH/PC, with the support
of the Quality of Pharmaceutical Care Indicators
Working Party, defined and pre-tested five sets of
indicators in 17 countries in Europe. The pre-tests
were summarised in the report ‘Pharmaceutical
care: Policies and practices for a safer, more re-
sponsible and cost-effective health system (2012)’
[30]. The aforementioned sets of indicators focused
on the following PC areas: Adherence to nationally
agreed clinical practice guidelines (Topic Group
(TG) 1); Monitoring of thera­peutic plans and med-
10
ication safety by pharmacists through data linking
and exchange of information about therapy and pa-
tient’s medical condition in anti­coagulant and anti-
biotic therapy (TG2); Structured patient-­pharmacist
consultations (chronic therapy; polypharmacy;
poly­morbidity) via ‘My CheckList’ (TG3); Pharma-
ceutical care: special needs in certain regions (TG4);
Communication and inter-­ disciplinary co-opera-
tion (TG5) [30].
Finally, in 2013-2014, the Committee of
Experts CD-P-PH/PC, co-ordinated by the EDQM
and with the support of the Quality of Pharmaceu-
tical Care Indicators Working Party, carried out a
multinational validation study aimed at validating 4
of the above 5 sets of indicators (i.e. TG1; TG2; TG3;
TG4) by performing pilot studies in different coun-
tries in Europe (in and beyond EU member states),
under real-life conditions, and in different health-
care settings (community, ambulatory and hospital
settings). The main goal of the validation study was
to demonstrate which indicators are fit for purpose
(i.e. measurement of quality aspects related to pa-
tients’ health outcomes and quality of life) and to
permit drawing of conclusions on the conditions of
use of the proposed indicators.
In order to standardise the validation study
working methods and ensure proper interpretation
of the PC model across the scientists involved in the
research process, ‘Action Oriented Study Protocols’
for each topic group were prepared. In addition, a
Standard Operating Procedure was set up (Indicator
Piloting SOP). This latter, among others, included
a list of properties that indicators should meet in
order to be considered valid (i.e. specific; robust;
applicable; acceptable; feasible; easy to use; reliable;
relevant; sensitive to change; predictive value).
The results of the multinational validation
study and of the workshop held at the EDQM in
­November 2015 to conclude the project are presented
in this report. These results are aimed at identifying
the best ways to implement the pharmaceutical
care approach in the daily practice of pharmacists
and the other healthcare professionals they have
to interact with. The report focuses on the quality
indicators, which should be seen as a means for
monitoring the implementation and educating the
users of the indicators at the same time. The discus-
sion and conclusion indicate possible next steps for
implementation beyond the remits of the completed
pilot study, i.e. at full-scale throughout Europe via
partnerships with other stakeholders.

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28. EDQM (Council of Europe). Expert Workshop (Pro-
ceedings): Assessing the quality of patient-centred
pharmaceutical care in Europe – Where do we stand,
The EDQM pharmaceutical care quality indicators project. Final report

where should we go? 19 November 2009, Strasbourg –
Link: go.edqm.eu/PC (last accessed: October 2015).
29. EDQM (Council of Europe). Expert Workshop (Pro-
ceedings): Indicators of the quality of pharmaceutical
care. 10 December 2010, Strasbourg – Link: go.edqm.
eu/PC (last accessed: October 2015).
30. EDQM (Council of Europe). Pharmaceutical Care.
Policies and practices for a safer, more responsible and
cost-effective health system (2012) – Link: go.edqm.
eu/PC (last accessed: October 2015).

12
Results of the EDQM Pharmaceutical Care Quality Indicators
Project

Topic Group 1. Adherence to nationally agreed clinical practice guidelines

Background
in daily practice. Multiple and varied strategies and
Irrational prescribing of antibiotics is a global interventions to disseminate and implement guide-
problem [1]. Numerous studies point out an inappro- lines should be used. One approach could be the im-
priate antibiotic use and an increased antimicrobial plementation of the pharmaceutical care philosophy
resistance of antibiotics [1-3]. About 85-90 % of all and working methods in daily practice. In particular,
antibiotics are prescribed in primary care and 50 % the improvement of i­nter-professional collaboration
of these are of questionable value for the patient [4]. and the consolidation of the pharmacist’s role as drug
In addition to the increased resistance of antibiotics, therapy expert could have a positive impact on the
inappropriate prescribing is a waste of money, and provision of optimal pharmacotherapy and the ap-
exposes people to unnecessary side-effects with addi- propriate and safe use of medications, including ra-
tional costs for the treatment of the side-effects. What tional use of antibiotics in line with clinical practice
does this mean for the future? Physicians have to stop guidelines [7-9].
prescribing antibiotics for the treatment of infectious
diseases, and, with the co-operation of other health- Aim
care professionals, the effectiveness of available anti-
biotics may be sustained and the threat of resistance The aim of this study was to validate 1 quality
may be minimised [5]. indicator focusing on the impact of inter-professional
The development of clinical practice guidelines collaboration on adherence to antimicrobial pre-
as a tool for improving quality of care and controlling scribing guidelines in ambulatory care settings.
costs is an international trend and is stimulated by
rising healthcare costs, large variations in prescribing Indicator
patterns and the assumption that at least some of these
variations can be qualified as inappropriate care. Nev- The indicator is calculated using the formula:
ertheless, it is proven that the development of clinical TG1 = (A-B)/B × 100
practice guidelines does not ensure their use in daily Where
practice. Systemic reviews of professional behaviour A = Patients prescribed in compliance with clinical
changes show that relatively passive methods of dis- practice guidelines after pharmacist’s intervention (%).
seminating guidelines, such as publication or mailing, B = Patients prescribed in compliance with clin-
rarely lead to changes of professional behaviour [6]. ical practice guidelines before pharmacist’s
There is no single way to ensure the use of guidelines intervention (%).

13
The EDQM pharmaceutical care quality indicators project. Final report
Methods
Participating countries
Three countries participated in the study, i.e.
Georgia, Poland and Ukraine.
In each country a national co-ordinator was
identified in order to organise and ensure the smooth
running of the research activities.
Each national co-ordinator was in charge of
recruiting the community pharmacists and pro-
viding them with some basic training about the study
goals and methodology to be followed. In addition,
national co-ordinators were also requested to hand
out the following study materials, translated into
the local language, to the pharmacists: nationally
agreed clinical practice guidelines (antimicrobial
prescribing guidelines), invitation letter for general
practitioners (GPs), outline of pharmacist’s interven-
tion, data collection form for GPs, patient data eval-
uation form for pharmacists, pilot study evaluation
form. Finally, national co-ordinators were in charge
of collecting all the completed data collection forms,
translating them into English and sending the data
to the TG leader for the preparation of the final study
database for statistical analysis.
No ethics committee approval was needed in
the participating countries, except for Poland (where
the requested approval was obtained from the Ethics
Committee of the Poznań University of Medical
Sciences).
Indicator testing
Each pharmacist was requested to perform
the following research activities: recruit a total of
10 GPs; invite the GPs to complete a data collection
form with the requested data (i.e. patient’s date of GP
visit, gender and date of birth; diagnosis according to
ICD-10 or ICPC-2R diagnostic codes; prescribed anti-
biotics) covering the time-frame 01.04.2013-31.05.2013;
collect the completed data collection forms; meet the
GPs, hand out a copy of the antimicrobial prescribing
guidelines, briefly discuss the guidelines with the
GPs as well as the prescription data that were col-
lected, and ask the GPs to fill in a new data collection
Table 1.  Number of study participants in TG1 Phase 1 and Phase 2
Country Pharmacists
Phase 1 Phase 2
Georgia 10 10
Poland 4 4
Ukraine 7* 5 15
Total 19 19
* Only data from the 5 pharmacists who completed both study phases were included in the statistical analysis. However, for the pilot study
evaluation, the feedback received from all 7 pharmacists was taken into consideration.
14
form covering the time-frame 01.04.2014-31.05.2014;
collect the completed data collection forms; meet the
GPs again and discuss with them the prescription
data that they collected; complete the patient data
evaluation form for pharmacists, based on the dis-
cussions that he/she had with the GPs; complete the
pilot study evaluation form; send all the completed
study materials back to the national co-ordinator.
The following inclusion criteria were used:
patients aged between 18 and 75 years with acute
bronchitis (diagnostic codes: ICPC-2R: R78; ICD-10:
J20.0-J20.9; J21.0, J21.8, J21.9, J22, J40); female patients
older than 18 years with cystitis/other urinary tract
infection (diagnostic codes: ICPC-2R: U71; ICD-10:
N30.0-N30.9, N39.0); patients older than 18 years with
acute/chronic sinusitis (diagnostic codes: ICPC-2R:
R75; ICD-10: J01.0-J01.9, J32.0-J32.9).
The meeting that took place between the phar-
macist and GP to discuss antimicrobial prescribing
guidelines and the collected data was called ‘pharma-
cist’s intervention’.
As stated above, the data collection was divided
into 2 phases: Phase 1: collection of prescription data
before the pharmacist’s intervention; Phase 2: collec-
tion of prescription data after the pharmacist’s inter-
vention. In order to avoid seasonal variations in the
incidence and frequency of bacterial infections, the
same time period for data collection was used in
Phase 1 and Phase 2.
All data were collected anonymously and par-
ticipation in the research activities was voluntary.
Data analysis
Descriptive statistics was used to examine
treatment adherence to antimicrobial prescribing
guidelines.
Statistical significance between Phase 1 and
Phase 2 and the variable ‘treatment adherent to
guidelines’ was calculated by means of the Pearson
Chi-Square test. For all comparisons, a p-value < 0.05
was considered to be statistically significant.
All statistical analyses were performed with
IBM SPSS Statistics 22 [10].
GPs Patients
Phase 1 Phase 2 Phase 1 Phase 2
76 60 1391 900
4 4 41 54
15 184 172
95 79 1616 1126
 Results of the EDQM Pharmaceutical Care Quality Indicators Project

Table 2.  Phase 1 – Assessment of antibacterial treatment (adherence to guidelines)

Country Adherent Non-adherent
Frequency Percentage Frequency Percentage
Georgia 1256 90.3 135 9.7
Poland 11 26.8 30 73.2
Ukraine 110 59.8 74 40.2
Total 1377 – 239 –

Table 3.  Phase 2 – Assessment of antibacterial treatment (adherence to guidelines)

Country Adherent Non-adherent
Frequency Percentage Frequency Percentage
Georgia 887 95.2 43 4.8
Poland 18 33.3 36 66.7
Ukraine 130 75.6 42 24.4
Total 1035 – 121 –

Table 4.  Calculation of Indicator 1

Country Calculations
A (Phase 2) B (Phase 1) (A-B) (A-B)/B *100 P-value
Georgia 95.2 90.2 5.0 5.5 0.000*
Poland 33.3 26.8 6.5 24.3 0.495
Ukraine 75.6 59.8 15.8 26.4 0.001*
All countries together 68.0 58.9 9.1 15.4 0.002*
(average)
* P-value < 0.05 considered to be statistically significant.

Table 5.  Pilot study evaluation form – Community pharmacists’ feedback

Country Specificity Specificity Acceptability Feasibility

Indicator suitable for
measuring impact of
pharmacist intervention
relating to nationally
agreed guidelines for
treatment of the selected
acute diseases
Georgia No data
Poland Strongly agree: –
(Total number of phar- Agree: 4 (100 %)
macists: 4) Neutral: –
Disagree: –
Strongly disagree: –
Indicator suitable for
measuring impact of
pharmacist intervention
relating to nationally
agreed guidelines for
treatment of other
diseases
No data
Strongly agree: –
Agree: 3 (75 %)
Neutral: –
Disagree: 1 (25 %)
Strongly disagree: –
Data collection is
acceptable for both GPs
and pharmacists
No data
Strongly agree: –
Agree: 2 (50 %)
Neutral: 1 (25 %)
Disagree: 1 (25 %)
Strongly disagree: –
Indicator is feasible
because it relies on
existing data sources
No data
Strongly agree: 1 (25 %)
Agree: 3 (75 %)
Neutral: –
Disagree: –
Strongly disagree: –

Ukraine Strongly agree: 1 Strongly agree: 2 Strongly agree: – Strongly agree: 3

(Total number of phar-
macists: 7)
(14.3 %)
Agree: 5 (71.4 %)
Neutral: 1 (14.3 %)
Disagree: –
Strongly disagree: –
(28.6 %)
Agree: 3 (42.9 %)
Neutral: 2 (28.6 %)
Disagree: –
Strongly disagree: –
Agree: 3 (42.9 %) (42.9 %)
Neutral: 4 (57.1 %) Agree: 4 (57.1 %)
Disagree: – Neutral: –
Strongly disagree: – Disagree: –
Strongly disagree: –

Results Feedback was received from Poland and

An overview of the study outcomes is summa- Ukraine, but not from Georgia.
rised in Tables 1 to 4. With regard to the general comments, the fol-
lowing issues were pointed out:
Pilot study evaluation form 1. The indicator might not be suitable in case of
A summary of the pharmacists’ feedback on long-term treatment (this latter is usually pre-
TG1 study is reported in Table 5. scribed by specialists and not GPs);

15
The EDQM pharmaceutical care quality indicators project. Final report
2. The quality of guidelines could be an issue
when using TG1 indicator in Ukraine;
3. Data should be collected electronically, with
the support of a specific IT tool: this would be
less time-consuming and probably more ac-
ceptable for GPs (some of them were not very
open to data collection performed by pharma-
cists);
4. Diagnostic codes were not always present in
GPs’ records and drug brand names were used
(instead of generic names) > data collection
problematic and time-consuming;
5. Inter-professional collaboration is easier when
GPs and pharmacists have a well-established
professional relationship.
Discussion and conclusions
The present study was designed to evaluate the
properties of TG1 indicator in real-life pilot settings
in different countries in Europe and to permit a con-
clusion on its validity.
Given the limited number of healthcare pro-
fessionals involved in the research activities and the
relative rather small number of patients included
in Poland and Ukraine it is clear that the indicator
properties that are reported in the Indicator Piloting
SOP cannot be fully evaluated.
Nevertheless, the current study provides a
framework for the exploration of the use of TG1 indi-
cator in some countries in Europe.
The results of the indicator calculations suggest
that there was an increased adherence to clinical
practice guidelines after the discussion around the
antimicrobial prescribing guidelines that took place
between community pharmacists and general prac-
titioners (pharmacist’s intervention). The observed
increased adherence was higher in Poland and
Ukraine (24.3 % and 26.4 %, respectively) than in
Georgia (5.5 %) In addition, the association between
the increased adherence and Phase 1 and Phase 2 of
the study was found to be statistically significant in
Georgia and Ukraine, but not in Poland.
With reference to the pharmacists’ study as-
sessment, the outcomes showed that, in general, com-
munity pharmacists were rather positive about the
indicator under evaluation. However, pharmacists
also pointed out that there could be some barriers
to the use of TG1 indicator in daily practice (e.g. in
Ukraine the quality of national guidelines could be
questionable; IT tools would be needed to support
the data collection process; lack of diagnostic codes
in GPs’ records and use of drug brand names instead
of generic names could be problematic; inter-profes-
16
sional collaboration works better when good working
relationships between GPs and pharmacists are in
place).
Despite these promising results, the general-
isability of the study outcomes in the participating
countries is subject to certain limitations.
Firstly, our sample may not be a full represent-
ative of the target study population: only highly mo-
tivated study participants could have been recruited
and, therefore, the possibility of selection bias cannot
be completely ruled out.
Secondly, the long time period between the 1st
and 2nd round of data collection could also have af-
fected the reliability of the results obtained. During
this time-frame other activities, such as participation
in training or targeted campaigns, could have signif-
icantly affected GPs’ adherence to clinical practice
guidelines and, therefore, the observed increased ad-
herence might not be fully attributable to the phar-
macists’ interventions.
Thirdly, it is possible that some pharmacists
were used to working together with the GPs and
inter-professional collaboration was already well
­
established. Furthermore, some pharmacists could
have been more skilled and experienced than others
at communicating with physicians. As a consequence,
the above factors could have played an important role
in directing professional practice in the desired di-
rection and thus influenced our findings.
In addition, it cannot be excluded that the lack
of electronic records and difficulties encountered
during the data collection process (e.g. GPs’ reluc-
tance to having the pharmacists collecting prescrip-
tion data; the use of drug brand names instead of
generic names; incompleteness of patients’ medical
records) could have hampered the data collection and
resulted in low data quality.
Lastly, a small number of countries partici-
pated in TG1 study and all of the participating coun-
tries were located in eastern Europe. Therefore, since
not all European regions were included in this study,
the generalisability of the study outcomes at Euro-
pean level is limited and, as a consequence, it should
be further investigated.
In conclusion, despite the above limitations,
our findings suggest that community pharmacists
can play an active role in promoting general prac-
titioners’ adherence to antimicrobial prescribing
guidelines and that TG1 indicator can be used to
measure the effects of collaborative practice on the
reduction of off-guideline antibiotic use in certain
patient groups (i.e. acute bronchitis; cystitis/other
urinary tract infection; acute/chronic sinusitis). Ad-
ditionally, positive feedback was received from Polish
 Results of the EDQM Pharmaceutical Care Quality Indicators Project

and Ukrainian community pharmacists about the 3. Achong MR, Hauser BA, Krusky JL. Rational and
indicator specificity in measuring the impact of phar- irrational use of antibiotics in a Canadian teaching
macists’ intervention on adherence to the guideline, hospital. J Can Med Ass 1977; 116: 256-259.
and the acceptability and feasibility of the data collec- 4. Mitrzyk B. Treatment of extensively drug-resistant
tion process. On the other hand, some barriers to the tuberculosis and role of the pharmacist. Pharmaco-
use of the indicator were also reported (e.g. quality therapy 2008; 28 (10): 1243-1254.
of guidelines and patients’ medical records; GPs’ atti- 5. Hand K. Antibiotic pharmacists in the ascendancy.
tudes to pharmacists’ intervention). Addressing these J Antimicrob Chemother 2007; 60: 173-176.
barriers might help to implement TG1 indicator in 6. Grimshaw J, Eccles M, Tetroe J. Implementing clinical
ambulatory care settings and realise the full benefit guidelines: Current evidence and future implications.
of inter-professional co-operation between pharma- J Contin Educ Health Prof 2004; 24 (1): S31-37.
cists and physicians to support safe and appropriate 7. FIP Statement of Policy on Collaborative Pharmacy
use of medications and provision of optimal patient Practice (2010, Lisbon) – Link: goo.gl/k1Ki7k (last ac-
care. cessed: June 2017).
8. Kelly DV, Bishop L, Young S, Hawboldt J, Phillips L,
References Keough TM. Pharmacist and physician views on col-
laborative practice: Findings from the community
1. Hogerzeil H. Promoting rational prescribing: An in- pharmaceutical care project. CPJ 2013; 146 (4): 218-226.
ternational perspective. Br J Clin Pharmac 1995; 39: 1-6. 9. Rigby D. Collaboration between doctors and pharma-
2. Klem C, Dasta J. Efforts of pharmacy to reduce anti­ cists in the community. Aust Prescriber 2010; 33 (6):
biotic resistance. New Horiz 1996; 4 (3): 377-384. 191-193.
10. IBM Corp. Released 2013. IBM SPSS Statistics for
Windows, Version 22.0. Armonk, NY: IBM Corp.

Topic Group 2. Monitoring of therapeutic plans and medication safety by

pharmacists through data linking and exchange of information about
therapy and patient’s medical condition in anticoagulant and antibiotic
therapy

Background
Safe and effective pharmacotherapy can be
promoted by increasing the active involvement of
pharmacists in the development, implementation
and monitoring of patients’ therapeutic plans [1]. In
order to support proper decision-making in the med-
ication management process, accurate and compre-
hensive information about the patients’ health status
is needed. A wide variety of patient-related data is
currently collected in health systems. Unfortunately,
in several countries the exchange of patient health
data between different members of the health care
team is still limited [2]. Proper health data linkage
and information exchange could facilitate the timely
availability of patient-specific health information to
all members of the healthcare team [3]. Therefore,
through improving access to information, reducing
reliance on memory, increasing vigilance, and con-
tributing to standardisation of the care processes,
information technology (IT) systems could provide
important and fundamental contributions for the
improvement of the medication management process
and could thus improve patient safety [4-6].
Aim
The aim of the study was to validate 2 quality
indicators focused on the access to individual pa-
tient’s medical and prescription data (patient health
record) at hospital pharmacists’ level. Health data
availability would allow hospital pharmacists to
play an active role in the development, implementa-
tion and ­follow-up of the therapeutic plan (structure
indicators).
In addition, a pre-study questionnaire was pre-
pared to define the baseline conditions and existing
situations in health data sharing practices in the par-
ticipating countries.
Indicators
• Indicator 1: Number of patients who were pre-
scribed an anticoagulant and suffered from a
bleeding event where hospital pharmacists had
information about this latter/Number of pa-
tients who were prescribed an anticoagulant
and suffered from a bleeding event (%).

17
The EDQM pharmaceutical care quality indicators project. Final report

• Indicator 2: Number of patients with a culture • Representative of the chamber of physicians;

and sensitivity test (antibiogram) performed • Representative of the chamber of pharmacists.
and available to hospital pharmacists/Number In each participating country the pre-study
of patients with a culture and sensitivity test questionnaire was translated from English into the
(antibiogram) performed (%). national language and was sent either via mail or via
email to the above respondents. If deemed necessary,
Methods the pre-study questionnaire could also be completed
during a face-to-face meeting between the respondent
Participating countries and national co-ordinator, or over the phone.
Four countries participated in the study, i.e.
Georgia, Hungary, Ireland and Poland. In Ireland and Indicators study
Poland only Indicator 2 (antibiotics) was evaluated. Each national co-ordinator was in charge of
In each country a national co-ordinator was recruiting the hospital pharmacists and, if needed,
identified in order to organise and ensure the smooth providing them with some basic training. In addition,
running of the research activities. national co-ordinators were also requested to hand
out the following study materials, translated into
Pre-study questionnaire the local language, to the pharmacists: Instruction
The questionnaire was developed by the for pharmacists; TG2 anticoagulant data collection
TG leader, with the support of TG2 national co-­ form; TG2 antibiotic data collection form. Finally,
ordinators, and focused on data exchange between national co-ordinators were in charge of collecting
community and hospital pharmacies and other all the completed data collection forms, translating
health care establishments, e.g. physicians’ practices them into English and sending the collected data to
and hospital wards. the TG leader for the preparation of the final study
The questionnaire consisted of both closed and database for statistical analysis.
open questions covering the following main areas:
• existence of legal restrictions for sharing Indicator 1 – Anticoagulants
patient health data between physicians and Each pharmacist was requested to identify all
pharmacists; health records referring to patients who were hos-
• authority in charge of supervising the sharing pitalised between 1 January and 31 March 2013 and
practices; met the following criteria: major bleeding diagnosis
• sharing practices (type of data that healthcare (in line with ICD-10 codes affiliated with bleeding)
professionals are authorised to share); and use of anticoagulant medications (ATC codes:
• IT equipment and technologies used in phar- Vitamin K antagonists – B01AA; Heparin group –
macies and physicians’ practices; B01AB; Platelet aggregation inhibitors excl. heparin
• actual level of exchange of laboratory test – B01AC; Enzymes – B01AD; Direct thrombin inhib-
results (laboratory test remuneration and itors – B01AE; Direct factor Xa inhibitors – B01AF;
guidelines). Other antithrombotic agents – B01AX). In order to
These were the target respondents of the pre- limit the pharmacists’ workload, pharmacists were
study questionnaire: asked to randomly select 10 % of the identified health
• Representative of the Ministry of Health; records (minimum number of patients to be included:
• Medical licensing authority at the Ministry of 50). For all the selected patients, pharmacists were re-
Health; quested to check whether, in the hospital pharmacy
• Pharmacy licensing authority at the Ministry system, data on both bleeding event and prescribed
of Health; anticoagulant medications were available.

Table 1.  Pre-study questionnaire respondents

Respondents Georgia Hungary Ireland Poland
Ministry of Health 1 1 – 2
Medical licensing authority 1 1 – –
Pharmacy licensing authority 1 – – 2
Chamber of physicians 1 – – 1
Chamber of pharmacists 1 1 1 2
Total 5 3 1 7

18
 Results of the EDQM Pharmaceutical Care Quality Indicators Project
Indicator 2 – Antibiotics
The same methodology as Indicator 1 was fol-
lowed for Indicator 2. However, in this part of the
study, when an antibiotic was prescribed, hospital
pharmacists were requested to check whether a
culture and sensitivity test (antibiogram) was per-
formed. If this was the case, pharmacists were asked
to verify if the outcomes of the above test were made
available to them.
The following inclusion criteria were used: pa-
tients who were prescribed an active substance from
the ATC group J01 (Antibacterials for systemic use).
Patients were excluded if they were hospitalised at an
intensive care unit and/or if antibiotics were used for
prophylactic purposes.
In Ireland it was decided to change the data
collection from retrospective to prospective, because
retrospective data collection was not feasible. Nev-
ertheless, it is believed that the above change in the
study protocol did not adversely affect the final study
outcomes.
In both Indicator 1 and Indicator 2 all data
were collected anonymously.
Each participating pharmacist was also asked
to complete a short questionnaire aimed at collecting
some general details about the hospital and its phar-
macy (e.g. number of beds; number of physicians;
available IT equipment) as well as the pharmacist’s
views on the research project.
No ethics committee approval was needed in
the participating countries.
Data analysis
Descriptive statistical analyses were performed
with IBM SPSS Statistics 22 [7].
Results
Pre-study questionnaire
An overview of the respondents of the pre-
study questionnaire is reported in Table 1.
In general, some inconsistencies were noted
when comparing the replies from the representatives
of the Ministry of Health with those of the represent-
atives of the chamber of physicians/pharmacists at
national level.
In brief, about half of the respondents indicated
that certain (unspecified) legal restrictions applied to
the exchange of patient-related information between
pharmacists and physicians.
Ministries of Health and/or National Data Pro-
tection Authorities were reported to be in charge of
supervising data sharing practices between health-
care professionals.
19
Half of the respondents assumed that health-
care inspectorates were responsible for carrying out
regular inspections aimed at checking data exchange
practices in community and hospital pharmacy
settings.
Patient health records seemed to be often
shared in hospital settings, but not in ambulatory
care settings. Nevertheless, the level of data sharing
seemed to vary a lot from country to country (e.g.
70 % of data sharing in Ireland; 5 % of data sharing
in Georgia).
With respect to the availability of IT equip-
ment, telephones, desktop computers and printers
seemed to be available in both physicians’ surgeries
and pharmacies. Smartphones were mentioned more
frequently than tablets or laptop computers. Internet
access was reported to be good and only limited in
rural areas in Poland and Ireland. Nevertheless, the
pre-study respondents often reported that there was
a lack of good (affordable) software to support the
sharing of data.
Finally, according to the respondents, these
were the main barriers hampering health data
sharing in their countries: patient data protection,
lack of standardised electronic health records and
lack of clear data exchange procedures.
Indicator 1 – Anticoagulants
Two countries completed Indicator 1 study, i.e.
Georgia and Hungary. In both countries 3 hospitals
participated in the study. In total 223 patient records
were evaluated (128 records in Georgia and 95 records
in Hungary). Since 15 patients had a bleeding event
without using an anticoagulant, these records were
discarded and, therefore, 208 records were included
in the final data analysis.
An overview of the data collected is summa-
rised below (Table 2).
Table 2.  Data availability – Anticoagulants
Country Anticoagulant Information available
+ bleeding event to pharmacist
Georgia 128 0
Hungary 80 27
Total 208 27
Calculation of Indicator 1
Number of patients who were prescribed an
anticoagulant and suffered from a bleeding event
and hospital pharmacists had information about this
latter/Number of patients who were prescribed an
anti­coagulant and suffered from a bleeding event (%).
The EDQM pharmaceutical care quality indicators project. Final report

• Georgia: 0/128 = 0 → 0 % • All countries together: 158/366 = 0.43 → 43 %

• Hungary: 27/80 = 0.34 → 34 %
• All countries together: 27/208 = 0.13 → 13 % Table 3.  Data availability – Antibiotics
Country Antibiogram Information available
Indicator 2 – Antibiotics performed to pharmacist
Four countries completed Indicator 2 study, i.e. Georgia 146 0
Georgia (4 hospitals), Hungary (5 hospitals), Ireland Hungary 139 134
(1 hospital) and Poland (1 hospital). In total 569 patient Ireland 31 24
records were evaluated (Georgia: 181; Hungary: 288; Poland 50 0
Ireland: 50; Poland: 50). Since 62 records were not Total 366 158
complete, these records were discarded and, therefore,
507 records were selected for the final data analysis. Additional details about the participating hospitals
Based on the details reported in the selected records, Additional details concerning the hospitals
366 patients underwent a culture and sensitivity test. that participated in TG2 study are summarised in
An overview of the data collected is summa- Table 4 and Table 5.
rised in Table 3. It is clear that differences in the number of staff
members exist between Georgia and Hungary. In par-
Calculation of Indicator 2 ticular, it can be noted that the number of nurses per
Number of patients with a culture and sensitivity 100 beds is comparable, but the number of physicians
test (antibiogram) performed and available to hospital and the number of pharmacists per 100 beds differ sig-
pharmacists/Number of patients with a culture and nificantly between these two countries. Nevertheless,
sensitivity test (antibiogram) performed (%). since no data was collected about the size and number
• Georgia: 0/146 = 0 → 0 % of staff members in other hospitals in Georgia and
• Hungary: 134/139 = 0.96 → 96 % Poland, it is not possible to draw further conclusions
• Ireland: 24/31 = 0.77 → 77 % on the representativeness of the hospital sample.
• Poland: 0/50 = 0 → 0 %

Table 4.  Size of participating hospital and number of staff members per 100 hospital beds
Country Hospital Beds Physicians/100 beds Pharmacists/100 beds Nurses/100 beds
Georgia Hospital 1 26 61.5 15.4 84.6
Hospital 2 28 64.3 7.1 128.6
Hospital 3 44 65.9 9.0 72.7
Hospital 4 64 43.8 18.8 171.9
Hospital 5 60 43.3 3.3 46.7
Hospital 6 12 50.0 8.3 100.0
Hospital 7 12 50.0 8.3 83.3
Total/Average 246 52.4 10.5 101.6
Hungary Hospital 1 804 30.2 1.0 89.2
Hospital 2 504 21.4 0.8 118.1
Hospital 3 55 34.5 1.8 81.8
Hospital 4 2011 No data No data No data
Hospital 5 316 37.3 0.6 57.0
Hospital 6 36 22.2 2.8 44.4
Total/Average without Hospital 4 1715 28.9 0.9 90.6
Ireland Hospital 1 1040 44.2 3.7 No data
Poland Hospital 1 76 97.4 2.6 157.9

20
 Results of the EDQM Pharmaceutical Care Quality Indicators Project

Table 5.  Available IT tools in the hospital pharmacy

Country Number Telephone Fax Desktop PC Printer Internet
of hospitals
Georgia 7 100 % 14.3 % 100 % 100 % 100 %
Hungary 6 100 % 100 % 100 % 100 % 100 %
Ireland 1 Yes Yes Yes Yes Yes
Poland 1 Yes Yes Yes Yes Yes

Table 6.  Pharmacist’s views on TG2 research project

Country Indicator suitability in the selected patient populations
Georgia These indicators can be used only in case of availability of
electronic medical records
Hungary 1 hospital agreed on the indicator suitability in the selected • Lack of IT software in the pharmacy for data sharing
patient population
2 hospitals neither agreed or disagreed
2 hospitals disagreed – reasons: lack of suitable software,
and difficulties encountered in accessing medical records
Reasons for non-availability of data and general com-
ments
• Lack of electronic records
• Records not made available to pharmacists at the dispens-
ing point
• Quality of shared data is low and, therefore, it is difficult
for pharmacists to check the appropriateness of prescrip-
tions
• If requested, physicians were willing to share medical
records; however, this does not mean that medical records
were automatically made available to hospital pharma-
cists
• Patients’ records should be as complete as possible to
allow pharmacists to make the right decision on pre-
scribed medications. Good software is available for such
data check-up and, therefore, could be used to make an
in-depth assessment of patients’ health status and pre-
scribed medications
• Systems currently in use do not seem to be able to com-
municate with each other

In Ireland and Poland only one medical centre
joined the study; therefore, no calculations could
be performed about the average number of staff
members per 100 hospital beds and no comparisons
can be made with the rest of the countries that joined
TG2 study.
Overall, it seems that IT tools are widely avail-
able in hospital pharmacy settings in all participating
countries.
With reference to the pharmacist’s views on the
research project, Ireland and Poland did not provide
any feedback. The comments made by Georgian and
Hungarian hospital pharmacists are summarised in
Table 6.
Discussion and conclusions
The present study was designed to evaluate the
properties of TG2 indicators in real-life pilot settings
in different countries in Europe and to permit a con-
clusion on their validity.
Given the limited number of countries in-
volved in the validation of Indicator 1 (anticoagu-
lants) (Georgia and Hungary only), the small sample
size of the Irish and Polish data for Indicator 2 (anti-
biotics) and the limited feedback received from the
participating pharmacists concerning the indicators
under evaluation, it is clear that the indicator prop-
erties that are reported in the Indicator Piloting SOP
could not be evaluated and no final conclusions can
be made on the validity of TG2 indicators at Euro-
pean level.
Nevertheless, some general observations and
conclusions can be drawn from the study outcomes
in the participating countries.
The results of the pre-study questionnaire
showed that legal and traditional organisational
aspects of the health system in the participating coun-
tries are not fostering the exchange of patient health
data between pharmacists and physicians. Despite
the lack of a legal framework, the availability of IT
equipment in physicians’ offices and pharmacies has
increased and is expected to enable the exchange of
patient health data between these healthcare pro-
fessionals in the near future. However, in order to
ensure that data exchange is in place, the following
points should be improved: clear and harmonised
rules on patient data protection, availability of elec-
tronic health records, well-defined data exchange
procedures.
Data collected for the anticoagulant indicator
(Indicator 1) clearly showed that medical records
are either not available to hospitals pharmacists

21
The EDQM pharmaceutical care quality indicators project. Final report
(Georgia: 0 % data availability) or only partially avail-
able (Hungary: 34 % data availability).
Data collected for the antibiotic indicator (In-
dicator 2) indicated that the outcomes of culture and
sensitivity tests are either not available (Georgia and
Poland: 0 % data availability), or available in the ma-
jority of the health records under evaluation (Ireland:
77 % data availability), or almost completely available
(Hungary: 96 % data availability).
Besides the limited number of countries in-
volved in the research and small sample size of the
data, some additional study limitations should be
taken into account.
Firstly, data collected from the participating
hospitals in Georgia and Hungary could potentially
reflect their national situations. However, this is
probably not the case for the data from Ireland and
Poland; therefore, further research should be carried
out to establish if the current results can be extrapo-
lated to other hospitals located in these 2 countries.
In addition, it would be interesting to explore if the
above outcomes could be representative for hospitals
situated in different areas of the same country (e.g.
urban and rural areas).
Secondly, a small number of countries par-
ticipated in TG2 study and, out of 4 participating
countries, 3 countries were located in eastern Europe.
Therefore, since not all European regions were in-
cluded in this study, the generalisability of the study
outcomes at European level is limited and, as a conse-
quence, it should be further investigated.
Lastly, it is assumed that, if patient health
records are available, pharmacists will be able to use
them and, as a result, the quality of pharmaceutical
care will improve. However, it is likely that the above
assumption can be checked only in a controlled trial
setup, where proper clinical endpoints are chosen.
Furthermore, given that TG2 indicators are structure
indicators, at this stage no conclusions can be made
concerning the positive impact of health data linkage
on patients’ health outcomes.
Despite the above limitations, the following
conclusions can be drawn about the 2 indicators
under evaluation:
a. Data access in the case of anticoagulants seems
to be limited. These findings indicate that hos-
pital pharmacists do not have yet a structural
role in monitoring and evaluating the bleeding
risk in relation to the medications used.
b. Pharmacists seem to have a better access to
health data in the case of antibiotics. This indi-
cates that a more extensive role for the hospital
pharmacist in evaluating the appropriateness
22
and dosage of the prescribed antibiotics is fea-
sible in current practice.
c. Comparison between hospitals and between
countries could not be fully performed. These
results provide further support for the hypoth-
esis that international indicator development
and validation is complex and it is difficult to
design and implement pharmaceutical care in-
dicators that are robust and insensitive to dif-
ferences in healthcare systems and yet easy to
use for data collection on a routine basis.
d. If electronic records are in place, it is likely that
the type of information requested in TG2 study
can be obtained in a simple manner. There-
fore, the data collection forms proposed in
the current study are probably not suitable for
large scale monitoring unless automated health
records become routinely available.
e. Both indicators could be used to monitor health
data availability in hospital pharmacies and
could play a role in promoting good and safe
use of medications. In particular, in the case
of high-risk medications, health information
exchange between healthcare professionals
could facilitate the availability of patient-­
specific health information which, in turn,
could be used to check the appropriateness of
the patient’s therapeutic plan and ensure safe
and effective use of medications. Nevertheless,
measures need to be put in place in order to
guarantee appropriate and secure health data
exchange in both inpatient and outpatient set-
tings (e.g. harmonised rules on patient data
protection, availability of electronic health
records, and availability of computer applica-
tions able to communicate with other applica-
tions). Finally, further work needs to be done
to evaluate the potential of improved patient
safety through enhanced health information
exchange.
References
1. Hepler CD, Strand LM. Opportunities and respon-
sibilities in pharmaceutical care. Am J Hosp Pharm
1990; 47 (3): 533-543.
2. Overview of the national laws on electronic health re-
cords in the EU Member States and their interaction
with the provision of cross-border eHealth services –
Link: goo.gl/IIcW9V (last accessed: October 2015).
3. Patient access to Electronic Health Records: Report
of the eHealth Stakeholder Group – Link: goo.gl/
m61NJm (last accessed: October 2015).
 Results of the EDQM Pharmaceutical Care Quality Indicators Project
4. Kaelber DC, Bates DW. Health information exchange
and patient safety. J Biomed Inform 2007; 40: S40-S45.
5. Mattison ML, Afonso KA, Ngo LH, Mukamal KJ. Pre-
venting potentially inappropriate medication use in
hospitalized older patients with a computerized pro-
vider order entry warning system. Arch Intern Med
2010; 170: 1331-1336.
Topic Group 3. Structured patient-pharmacist consultations (chronic
therapy; polypharmacy; polymorbidity) via ‘My CheckList’
Background
In the pharmaceutical care model, patient coun-
selling is a crucial component [1-2]. The conversation
with patients is essential to determine what they un-
derstand about drug therapy, what their expectations
are and what concerns they may have. For the phar-
macist this will eventually lead to a translation of pa-
tient-related needs into a problem-solving format [3].
Furthermore, a conversation with patients about the
prescribed medicines can increase the involvement
of the patients in decisions about their medication
use [4]. Lastly, a conversation with the patient will
probably give the patient more knowledge about the
medication, which means that he/she is better able
to consider the advantages and disadvantages of his/
her medicine, improve its use and ultimately achieve
better drug therapy outcomes [2; 4; 5].
Review of medicines is seen as an important
aspect of health care. A medicine review can be
defined as ‘a structured, critical examination of a
patient’s medicines with the objective of reaching
an agreement with the patient about treatment, op-
timising the impact of medicines, minimising the
number of medicine-related problems and reducing
waste’ [6]. A medication review can be performed in
the pharmacy and can be seen as a cornerstone of
medicines management, preventing unnecessary ill
health, avoiding waste and involving patients in de-
cisions about prescribed medicines and supporting
a patient’s adherence to therapy [7]. Medication
review is particularly relevant in elderly patients.
This specific patient group is often at increased risk
of suffering side-effects due to a number of factors
such as physiological changes, multiple diseases and
polypharmacy. As a consequence, in this group, the
pharmacist’s intervention can play a crucial role in
medicines management, optimisation of the impact
of treatment and improvement of health-related
quality of life [8-11].
23
6. Seger AC, Jha AK, Bates DW. Adverse drug event
detection in a community hospital utilising comput-
erised medication and laboratory data. Drug Saf 2007;
30: 817-824.
7. IBM Corp. Released 2013. IBM SPSS Statistics for
Windows, Version 22.0. Armonk, NY: IBM Corp.
Aim
The aim of this study was to validate 2 quality
indicators. The indicators under evaluation aim to
measure the level of patient involvement and, hence,
the quality of pharmaceutical care by evaluating the
following items:
1. documented counselling provided by a phar-
macist during a patient-pharmacist consulta-
tion based on the so-called ‘My CheckList’ at
the start of a new chronic treatment;
2. provision of documented medication reviews
following the needs that arose during the so-
called ‘My CheckList’ consultations, in the
case of elderly patients who are suffering from
­multi-morbidity and receiving polypharmacy.
Indicators
• Indicator 1: Documented counselling during
‘My CheckList’ consultation/Total number of
patients receiving ‘My CheckList’ (%).
• Indicator 2: Documented medication review
in patients having attended a ‘My CheckList’
consultation/Total number of patients who at-
tended a ‘My CheckList’ consultation (%).
Methods
Participating countries
Two countries participated in the study, i.e.
Poland and Serbia.
In each country a national co-ordinator was
identified in order to organise and ensure the smooth
running of the research activities. Each national
co-ordinator was in charge of recruiting and training
the community pharmacists who agreed to join the
study. In addition, national co-ordinators were also
requested to hand out the following study materials,
translated into the local language, to the pharmacists:
instructions for pharmacists; letter for patients; Indi-
cator 1: ‘My CheckList’ (i.e. a short checklist where
The EDQM pharmaceutical care quality indicators project. Final report
patients can write down their experience with the
use of their new medication and questions to be dis-
cussed with the pharmacists) and consultation form
for pharmacists; Indicator 2: ‘My CheckList’ (i.e. a
short checklist where patients can include the medi-
cations they are using, their experience with the use-
fulness of their chronic treatment and questions to be
discussed with the pharmacists), consultation form
for pharmacists and form for medication review;
evaluation questionnaire for pharmacists. Finally,
national co-ordinators were in charge of collecting
all the completed data collection forms, translating
them into English, entering the data in an Excel form
and sending it to the TG leader for the preparation of
the final study database for statistical analysis.
Ethics approval was obtained in both partici-
pating countries.
Methods Indicator 1
Each pharmacist was invited to recruit at least 10
patients, who met the following inclusion criteria: age:
18-65; start of a new chronic treatment (i.e. medication
not used in the previous 12 months and intended to
be used at least for the next 6 months); selected med-
ication groups: cardiovascular (ATC codes: C01-C10),
alimentary tract and metabolism (ATC codes: A01-
A16), musculoskeletal system (ATC codes: M01-M09),
respiratory system (ATC codes: R01-R07).
Patients who agreed to join the research, were
provided a ‘My CheckList’ form and asked to com-
plete the list at home. An appointment between the
pharmacist and patient was made within 2-4 weeks
after the start of the treatment and a consultation
took place, in the pharmacy (if feasible, in a separate
room), based on what the patient had reported in his/
her ‘My CheckList’. After the consultation, the phar-
macist completed a consultation form, aimed at sum-
marising what was discussed during the meeting with
the patient and the main outcomes of the consultation
(including a general evaluation of the consultation).
Methods Indicator 2
The same methodology as Indicator 1 was fol-
lowed for Indicator 2. However, for Indicator 2, pa-
tients had to meet the following inclusion criteria:
minimum age: 65 years; multi-morbidity; polyphar-
macy (i.e. use of at least 5 medications for chronic
conditions).
The procedure was similar to the one followed
in Indicator 1. However, in Indicator 2, when com-
pleting ‘My CheckList’, patients were requested to
focus on their chronic medications and their experi-
ences with their chronic treatments. In addition, after
the pharmacist-patient consultation, based on the
24
outcomes of this latter, patients were invited to have
a second appointment with the pharmacist during
which a medication review was carried out. The med-
ication review was performed in line with a specific
template that was proposed by the Topic Group leader
and involved the pharmacist and the patient only (no
involvement of the patient’s general practitioner and/
or other healthcare professionals was requested).
In both Indicator 1 and Indicator 2, the fol-
lowing exclusion criteria were used: no possibility
for personal contact with the patient; physically frail
elderly and patients receiving palliative care; patients
with cognitive impairment.
In both Indicator 1 and Indicator 2 all data
were collected anonymously and participation in the
research activities was voluntary and free of charge.
At the end of the process each participating
pharmacist was asked to complete a questionnaire
aimed at collecting some general details about the
pharmacy (e.g. size of patient population served;
number of staff members; availability of consulting
room; number of medication reviews performed in
the last 6 months) as well as the pharmacist’s views
on the research project.
Data analysis
Descriptive statistical analyses were performed
with IBM SPSS Statistics 22 [12].
Results
In Serbia 70 pharmacies agreed to participate
in the study and 64 of these pharmacies sent back the
completed data collection forms.
In Poland 22 pharmacies agreed to participate
in the study and 5 of these pharmacies sent back the
completed data collection forms.
Because of the difference in the number of
pharmacies involved in the project in Serbia and
Poland, statistical analyses were performed sepa-
rately for each country.
Note that, in the tables that follow, certain
questions could have more than one answer.
Indicator 1
In Serbia 826 ‘My CheckList’ forms were
handed out to patients and 542 patients were included
in Indicator 1 activities.
In Poland 34 ‘My CheckList’ forms were
handed out to patients and 10 patients were included
in Indicator 1 activities.
An overview of the data analyses outcomes is
provided in Tables 1-6.
 Results of the EDQM Pharmaceutical Care Quality Indicators Project

Table 1.  What patients wished to know about their therapy

Answer Serbia Poland
Number Percentage Number Percentage
Side-effects 177 27.8 5 33.3
Regimen–related issues 59 9.3 1 6.7
Mechanism of action 53 8.3 – –
General therapy information 63 9.9 4 26.7
Therapy duration 49 7.7 3 20.0
Indications 42 6.6 – –
Expected treatment outcome 33 5.2 1 6.7
Reasons for therapy change 26 4.1 – –
Use 18 2.8 – –
Interactions 17 2.7 – –
Alternatives to current treatment 9 1.4 – –
Price 7 1.1 – –
Additional therapy needed 5 0.8 1 6.7
Self–care 5 0.8 – –
Ineffectiveness 2 0.3 – –
Not applicable 49 7.7 – –
Not filled in 22 3.5 – –
Total 636 100 15 100

Table 2.  Patients’ expectations from their therapy

Answer Serbia Poland
Number Percentage Number Percentage
Control of medical condition 264 48.7 6 60.0
Quality of life improvement 125 23.1 2 20.0
Effectiveness 48 8.9 2 20.0
Permanent solution 35 6.5 – –
Absence of side-effects 17 3.1 – –
Better results than previous therapy 13 2.4 – –
Prevention of complications 9 1.7 – –
Do not know 8 1.5 – –
Other 4 0.7 – –
No expectations 1 0.2 – –
Not filled in 18 3.3 – –
Total 542 100 10 100

Table 3.  Experienced problems

Answer Serbia Poland
Number Percentage Number Percentage
No 306 56.5 8 80.0
Yes 190 35.1 2 20.0
Do not know 33 6.1 – –
Not filled in 13 2.4 – –
Total 542 100 10 100

25
The EDQM pharmaceutical care quality indicators project. Final report

Table 4.  Patients’ concerns

Answer Serbia Poland
Number Percentage Number Percentage
Side-effects 167 30 4 40.0
Chronic therapy issues 29 5.2 – –
Duration 26 4.7 – –
Therapy appropriateness 21 3.8 2 20.0
Therapy ineffectiveness 18 3.2 – –
Disturbance of daily routine 15 2.7 – –
Diagnosis and progress of condition 9 1.6 – –
Financial matters 7 1.3 – –
Pregnancy and chronic treatment 7 1.3 – –
Addiction 7 1.3 – –
Not well specified concerns 4 0.7 – –
None 219 39.3 4 40.0
Not filled in 28 5.0 – –
Total 557 100 10 100

Table 5.  Reasons to stop therapy

Answer Serbia Poland
Number Percentage Number Percentage
Side-effects 180 30.5 6 54.5
Ineffectiveness 122 20.7 2 18.2
Physician’s advice 94 15.9 – –
Achieved disease control 37 6.3 – –
Financial reasons 21 3.6 – –
Regimen problems 11 1.9 – –
Better therapeutic alternatives 10 1.7 – –
Already stopped / Changed therapy 7 1.2 – –
Progress of medical condition 7 1.2 – –
Pregnancy 6 1.0 – –
Disturbance of daily routine 6 1.0 – –
Do not know 4 0.7 – –
None 72 12.2 3 27.3
Not filled in 13 2.2 – –
Total 590 100 11 100

Additional comments and/or questions Calculation of Indicator 1

67 % of the patients in Serbia completed this Documented counselling during ‘My Check-
section of ‘My CheckList’. Their comments and ques- List’ consultation/Total number of patients receiving
tions were mainly related to the medication posology ‘My CheckList’ (%).
(e.g. frequency and administration instructions), • Serbia: 542/826 = 0.65 → 65 %
additional therapy details (e.g. possible drug-drug • Poland: 10/34 = 0.29 → 29 %
interactions, actual need for the medication, other In order to ensure that the pharmacist-patient
available treatment options), self-care matters and consultation was fruitful and of added value for the
request for further details on potential side-effects. patients, the following additional calculations were
80 % of the patients in Poland completed the performed for Indicator 1:
above section. Their comments and questions were Documented counselling during ‘My Check-
mainly related to self-care matters and duration of List’ consultation with at least one positive outcome
their treatment. (based on pharmacist’s assessment – answers 1 to 5)/
Total number of patients receiving ‘My CheckList’ (%).
• Serbia: 497/826 = 0.60 → 60 %
• Poland: 9/34 = 0.26 → 26 %

26
 Results of the EDQM Pharmaceutical Care Quality Indicators Project

Table 6.  Main outcomes of the consultation (pharmacist’s assessment)

Answer Serbia Poland
Number Percentage Number Percentage
Patient better understood use of pre- 432 51.1 8 38.1
scribed drugs
Identification of potential side-effects 141 16.7 5 23.8
Identification of non-adherence to 78 9.2 1 4.8
therapy
Patient referred to GP due to side-effects 41 4.9 – –
Patient referred to GP due to non-­ 18 2.1 1 4.8
adherence
Other (no specific details provided by 100 11.8 6 28.6
pharmacists)
No major outcome 2 0.2 – –
Do not know 4 0.5 – –
Not filled in 29 3.4 – –
Total 845 100 21 100

Documented counselling during ‘My Check-
List’ consultation with at least one positive outcome
(based on pharmacist’s assessment – answers 1 to 5)/
Total number of documented counselling (%).
• Serbia: 497/542 = 0.92 → 92 %
• Poland: 9/10 = 0.90 → 90 %
Indicator 2 – ‘My CheckList’
In Serbia 859 ‘My CheckList’ forms were handed
out to patients and 549 patients attended a consulta-
tion based on their completed ‘My CheckList’.
In Poland 95 ‘My CheckList’ forms were handed
out to patients and 19 patients attended a consultation
based on their completed ‘My CheckList’.
An overview of the data analyses outcomes is
provided in the tables below (Tables 7-14).
Patients’ mean age: the patients’ mean age in
Serbia was 72 years, whereas in Poland it was 75 years.

Table 7.  What patients wished to know about their therapy

Answer Serbia Poland
Number Percentage Number Percentage
Side-effects 93 15.6 2 9.5
Regimen–related issues 68 11.4 2 9.5
Drug combinations 34 5.7 2 9.5
Therapy duration 28 4.7
General therapy information 27 4.5 3 14.3
Indications 26 4.4 – –
Change of therapy 18 3.0 – –
Mechanism of action 15 2.5 1 4.8
Additional therapy needed 10 1.7 – –
Medication use 9 1.5 – –
Treatment outcomes 8 1.3 – –
Alternatives to current treatment 8 1.3 – –
Ineffectiveness 6 1.0 – –
Costs of therapy 6 1.0 1 4.8
Self–care / Life–style changes 5 0.8 – –
Addiction 4 0.7 – –
Other (no details reported) 2 0.3 – –
Informed 157 26.3 10 47.6
Not filled in 73 12.2 – –
Total 597 100 21 100

27
The EDQM pharmaceutical care quality indicators project. Final report

Table 8.  Patients’ expectations from their therapy

Answer Serbia Poland
Number Percentage Number Percentage
Control of medical condition 201 33.3 6 27.3
Quality of life improvement 191 31.6 12 54.5
Effectiveness 65 10.8 2 9.1
Maintain current health condition 36 6.0 1 4.5
Permanent solution 23 3.8 – –
Prevent complications 11 1.8 1 4.5
Other 11 1.8 – –
Life prolongation 9 1.5 – –
Satisfied with therapy 7 1.2 – –
Reduction of number of medicines 5 0.8 – –
None 5 0.8 – –
Not filled in 40 6.6 – –
Total 604 100 22 100

Table 9.  Patients’ expectations from their therapy

Answer Serbia Poland
Number Percentage Number Percentage
Yes 301 54.8 16 84.2
In part 128 23.3 2 10.5
No 76 13.8 1 5.3
Do not know 7 1.3 – –
Not filled in 37 6.7 – –
Total 549 100 19 100

Table 10.  Experienced problems

Answer Serbia Poland
Number Percentage Number Percentage
No 276 50.3 17 89.5
Yes 219 39.9 2 10.5
Do not know 46 8.4 – –
Not filled in 8 1.5 – –
Total 549 100 19 100

Table 11.  Patients’ concerns

Answer Serbia Poland
Number Percentage Number Percentage
Side-effects 104 17.9 3 15.0
Addiction 39 6.7 1 5.0
Polypharmacy issues 37 6.4 2 10.0
Therapy duration 30 5.2 – –
Ineffectiveness 28 4.8 – –
Financial issues 14 2.4 – –
Progress of medical condition 14 2.4 – –
Not well specified concerns 7 1.2 – –
Doubts about therapy appropriateness 6 1.0 – –
Self–care 3 0.5 – –
Do not know 2 0.3 – –
None 230 39.6 11 55.0
Not filled in 67 11.5 3 15.0
Total 581 100 20 100

28
 Results of the EDQM Pharmaceutical Care Quality Indicators Project

Table 12.  Patient considered stopping therapy

Answer Serbia Poland
Number Percentage Number Percentage
No 379 69.0 13 68.4
Yes 126 23.0 6 31.6
Do not know 33 6.0 – –
Not filled in 11 2.0 – –
Total 549 100 19 100

Table 13.  Reasons to stop therapy

Answer Serbia Poland
Number Percentage Number Percentage
Side-effects 38 6.7 1 5.0
Financial reasons 34 6.0 – –
Regimen problems 24 4.2 – –
Ineffectiveness 20 3.5 2 10.0
Physician’s advice 14 2.5 – –
Achieved disease control 10 1.8 2 10.0
Other reasons (not specified) 7 1.2 – –
Already stopped / Changed therapy 5 0.9 – –
Experiment 4 0.7 – –
Addiction 4 0.7 – –
Other health problems 4 0.7 – –
Drug shortages 3 0.5 – –
None 58 10.2 – –
Not filled in 344 60.5 15 75.0
Total 569 100 20 100

Table 14.  Main outcomes of the consultation (pharmacist’s assessment)

Answer Serbia Poland
Number Percentage Number Percentage
Patient better understood use of pre- 407 39.0 13 36.1
scribed drugs
Identification of potential side-effects 154 14.8 6 16.7
Identification of non-adherence to 116 11.1 2 5.6
therapy
Patient referred to GP due to side-effects 89 8.5 2 5.6
Patient referred to GP due to non-­ 55 5.3 1 2.8
adherence
Other (no specific details provided by 175 16.8 11 30.6
pharmacists)
No major outcome 19 1.8 1 2.8
Do not know 1 0.1 – –
Not filled in 27 2.6 – –
Total 1 043 100 36 100

Additional comments and/or questions
56 % of the patients in Serbia filled in the above
section. Their comments and questions were mainly
related to the medication posology, side-­effects and
drug safety issues, and need for further details on po-
tential side-effects.
22 % of the patients in Poland filled in the above
section. Their comments and questions were mainly
related to medical issues and concerns about the con-
comitant use of several medications.
Indicator 2 – Medication review
In Serbia 529 patients had their list of medica-
tions reviewed by the pharmacist.
In Poland 16 patients had their list of medica-
tions reviewed by the pharmacists.

29
The EDQM pharmaceutical care quality indicators project. Final report

An overview of the data analyses outcomes is

provided in Tables 15-18.

Table 15.  Identified issues

Issue Serbia Poland
Number Percentage Number Percentage
Drug interactions 172 14.9 3 16.7
Inappropriate drug choice 165 14.3 1 5.6
Adverse reactions 157 13.6 4 22.2
Regimen inappropriateness 155 13.5 2 11.1
Additional therapy needed 131 11.4 2 11.1
Poor therapy adherence 111 9.6 1 5.6
Poor therapeutic outcomes 107 9.3 – –
Lack of patient monitoring 51 4.4 – –
Financial issues 50 4.3 – –
Unhealthy lifestyle 34 3.0 – –
Other 11 1.0 2 11.1
None 6 0.5 – –
Not filled in 2 0.2 3 16.7
Total 1 152 100 18 100

Table 16.  Proposed actions

Action Serbia Poland
Number Percentage Number Percentage
Regimen adjustments 203 16.0 7 38.9
Drug change 175 13.8 2 11.1
Laboratory tests and monitoring 172 13.6 1 5.6
New medication added 168 13.3 1 5.6
Revision of therapy 165 13.0 – –
Suggestions to increase adherence 108 8.5 – –
Discontinuation of drug 95 7.5 2 11.1
Suggestions to improve lifestyle 88 6.9 1 5.6
Medical examination 41 3.2 2 11.1
Increased patient’s surveillance 22 1.7 – –
Other 4 0.3 2 11.1
None 3 0.2 – –
Not filled in 23 1.8 – –
Total 1 267 100 18 100

Table 17.  Persons in charge of taking the identified actions into consideration
Answer Serbia Poland
Number Percentage Number Percentage
GP 360 30.1 8 28.6
Patient 342 28.6 13 46.4
Other healthcare professional 234 19.6 1 3.6
Pharmacist 183 15.3 6 21.4
Other 41 3.4 – –
Not filled in 36 3.0 – –
Total 1 196 100 28 100

30
 Results of the EDQM Pharmaceutical Care Quality Indicators Project

Table 18.  Proposed actions authorised/refused

Answer Serbia Poland
Number Percentage Number Percentage
Yes 709 67.1 15 83.3
No 113 10.7 – –
Do not know 163 15.4 2 11.1
Not filled in 72 6.8 1 5.6
Total 1 057 100 28 100

Calculation of Indicator 2 • Poland: 16/19 = 0.84 → 84 %

Documented medication review in patients
having attended a ‘My CheckList’ consultation/Total
number of patients who attended a ‘My CheckList’
consultation (%).
• Serbia: 529/549 = 0.96 → 96 %
Questionnaire for pharmacists
In this section only the results that are of rele-
vance for the overall evaluation of TG3 indicators are
presented (Tables 19-23).

Table 19.  Usefulness of ‘My CheckList’

Answer Serbia Poland
Number Percentage Number Percentage
Yes 56 87.5 5 100
No 7 10.9 – –
Yes and no 1 1.6 – –
Total 64 100 5 100

Table 20.  Groups of patients for which ‘My CheckList’ could be useful
Answer Serbia Poland
Number Percentage Number Percentage
Polypharmacy patients 17 20.2 5 71.4
Chronic therapy patients 11 13.1 1 14.3
Patients starting a new therapy 9 10.7 – –
Elderly patients 9 10.7 – –
Patients who trust their pharmacist 8 9.5 – –
Patients aged 18–65 5 6.0 – –
All patients 5 6.0 – –
Patients at risk of poor therapeutic 3 3.6 – –
outcome
Patients interested in having a consul- 2 2.4 – –
tation
Non–adherent patients 1 1.2 – –
Self–medicated patients 1 1.2 – –
Patients who have more than 1 physician 1 1.2 – –
Patients recently discharged from 1 1.2 – –
hospital
Patients with frequent hospital admis- 1 1.2 – –
sions
Patients experiencing side-effects 1 1.2 1 14.3
Other (not specified) 2 2.4 – –
None 6 7.1 – –
Not filled in 1 1.2 – –
Total 84 100 7 100

31
The EDQM pharmaceutical care quality indicators project. Final report

Table 21.  Presence of consulting room in the pharmacy

Answer Serbia Poland
Number Percentage Number Percentage
Yes 13 20.3 2 40.0
No 51 79.7 3 60.0
Total 64 100 5 100

Table 22.  Presence of data recording system for medication reviews

Answer Serbia Poland

Number Percentage Number Percentage
Not recorded 37 56.1 4 66.7
Paper record 16 24.2 2 33.3
Electronic record 10 15.2 – –
Not filled in 3 4.5 – –
Total 66 100 6 100

Table 23.  Additional comments

Answer Serbia Poland

Number Percentage
TG3 activities not part of daily practice 6 8.8
Lack of time 5 7.4
TG3 activities are of great importance for 3 4.4
patients
Workload does not allow extra activities 2 2.9
Poor co–operation from patients 2 2.9
Problems experienced with question- 2 2.9
naire
Patients have greater trust in physician 1 1.5
Taking questionnaire home not conven- 1 1.5
ient
Closed questions recommended 1 1.5
Lack of separate consulting room 1 1.5
Duplication of therapy 1 1.5
Drugs in use not registered 1 1.5
None 42 61.8
Not filled in – –
Total 68 100
Number Percentage
– –
1 12.5
– –
2 25.0
2 25.0
– –
– –
– –
– –
1 12.5
– –
– –
– –
2 25.0
8 100

Discussion and conclusions

The present study was designed to evaluate the
properties of TG3 indicators in real-life pilot settings
in different countries in Europe and to permit a con-
clusion on their validity.
Due to the limited number of countries in-
volved in the study, the indicators’ properties that
are reported in the Indicator Piloting SOP could not
be evaluated. In addition, due to the small sample
size of the Polish data, it is clear that aggregation
of the Polish and Serbian datasets and comparisons
between these 2 countries could not be achieved. As
a consequence, no final conclusions can be made on
the validity of TG3 indicators at European level.
Nevertheless, the present research can be
considered as a pragmatic trial to evaluate if TG3
indicators could be used in real world practice and,
consequently, some general observations and conclu-
sions can be drawn from the study outcomes in the
participating countries.
The results of Indicator 1 calculations suggest
that a rather high percentage of Serbian patients were
willing to have a conversation with their pharmacist
concerning their expectations and concerns in the
first weeks of their new chronic treatment. On the
contrary, only 26 % of Polish patients seemed to be
interested in engaging in a pharmacist-patient con-
sultation at the start of a new treatment.

32
 Results of the EDQM Pharmaceutical Care Quality Indicators Project
In addition, it is interesting to note that,
in both countries, approximately 90  % of the
­pharmacist-patient consultations were evaluated pos-
itively by the pharmacist who performed them.
The results of Indicator 2 calculations suggest
that 96 % of Serbian patients and 84 % of Polish pa-
tients participated in a medication review process
after having attended a ‘My CheckList’ consultation.
These high percentages suggest that elderly patients,
suffering from multi-morbidity and receiving poly-
pharmacy, are interested in discussing their ther-
apeutic plan and co-operate with their pharmacist
with a view to optimising their drug therapy and
improving the effective use of their medications. Fur-
thermore, the fact that general practitioners and pa-
tients accepted the majority of the proposed actions
provides further support for the hypothesis that, on
the one hand, GPs were rather supportive of the ex-
panded roles of the pharmacists and, on the other
hand, patients were actively involved in the med-
ication review process and had a positive attitude
towards the pharmacists’ suggestions.
Finally, the outcomes of the pharmacists’ study
evaluation showed that community pharmacists
found ‘My CheckList’ useful (Serbia: 87.5 % of the
pharmacists; Poland: 100 % of the pharmacists), es-
pecially in the case of polypharmacy patients. On the
other hand, in Serbia some pharmacists pointed out
that TG3 pharmaceutical care activities were not part
of their daily practice, whereas in Poland 25 % of the
pharmacists stated that their workload did not allow
extra pharmaceutical care activities and another 25 %
of the pharmacists pointed out that patients were not
very co-operative. These findings suggest that, on the
one hand, community pharmacists could be inter-
ested in implementing ‘My CheckList’ consultations
and medication reviews in their daily practice, but,
on the other hand, measures should be put in place
in order to ensure proper integration of TG3 activ-
ities into local primary care provision. In addition,
the fact that in both countries no consulting room
or data recording system for medication reviews is
available, suggests that it could be difficult for the
pharmacists to properly carry out TG3 pharmaceu-
tical care activities.
Besides the limited number of countries in-
volved in the research and small sample size of the
Polish data, some additional study limitations should
be taken into account.
Firstly, it could be argued that the sample of
pharmacists and patients was not a random sample
and, in particular, only highly motivated study par-
ticipants were actually recruited. Therefore, the pos-
sibility of selection bias cannot be ruled out and the
33
findings might not be representative of the general
population.
Secondly, both the outcomes of the question-
naires for pharmacists and national co-ordinators’
feedback indicated that TG3 activities are not part of
the community pharmacy daily practice in the par-
ticipating countries and that pharmacists often have
a heavy workload. Therefore, it could be speculated
that TG3 activities were not performed in a proper
manner and, as a result, their actual added value
could be questioned.
Thirdly, due to the novelty of the above activ-
ities, it is possible that patients were unaccustomed
to having a consultation with their pharmacists and
lacked awareness of what it could offer. As a conse-
quence, it could be argued that they did not entirely
engage in the pharmacist-patient discussion and did
not take full advantage of the opportunities offered
by TG3 pharmaceutical care activities. Furthermore,
since no data was gathered concerning the patients’
perspective on TG3 indicators, the patients’ view-
point cannot be assessed. Nevertheless, given that the
action points identified during the medication review
process were well accepted overall, it could conceiv-
ably be hypothesised that TG3 pharmaceutical care
activities were rather well received among Polish and
Serbian patients.
In addition to the above limitations, it is im-
portant to also point out that both ‘My CheckList’
and the form for medication review, mainly con-
sisted of open questions, and, as a result, patients and/
or pharmacists often had to provide information in
free text format. This approach was chosen due to its
potential to obtain more in-depth responses, expand
upon answers to closed questions, and allow the par-
ticipants to fully express themselves and potentially
identify new issues not captured in the closed ques-
tions. Nevertheless, open questions could have also
resulted in a lack of clarity of free text entries and,
therefore, in difficulties in the data coding process.
Consequently, it cannot be excluded that the re-
searcher in charge of data coding could have misin-
terpreted (and therefore misclassified) a response.
Furthermore, no patient follow-up was per-
formed after ‘My CheckList’ consultations and med-
ication reviews; therefore, it is unknown if the above
interventions actually improved patients’ knowledge,
understanding and use of medicines, and ultimately
contributed to delivering better therapy outcomes for
patients.
Lastly, it is important to note that communi-
cation and collaboration between healthcare profes-
sionals seem to play a valuable role in the safe and
effective delivery of healthcare, and are a central
The EDQM pharmaceutical care quality indicators project. Final report

tenet of pharmaceutical care [13-15]. In particular, 2. Hepler CD, Strand LM. Opportunities and respon-
previous research has shown that the roles of the sibilities in pharmaceutical care. Am J Hosp Pharm
pharmacist and the doctor are complementary in 1990; 47 (3): 533-543.
ensuring appropriate safety, effectiveness and ad- 3. Roughead EE, Semple SJ, Vitry AI. Pharmaceutical
herence to therapy, and medication reviews could be care services: A systematic review of published studies,
considered as a good opportunity for pharmacists 1990 to 2003, examining effectiveness in improving
and GPs to work together with patients to improve patient outcomes. Int J Pharm Pract 2005; 13: 53-70.
health outcomes [13; 16]. In this study, the medication 4. Cipolle RJ, Strand LM, Morley PC. Pharmaceutical
review process did not involve the patient’s treating care practice: The patient-centered approach to medi-
physician and, therefore, it could be argued that the cation management services, 3rd edition. McGraw-Hill,
benefits of the above process could have been limited 2012.
and the optimisation of therapeutic plans was only 5. Sabaté E. Adherence to long-term therapies: Evidence
partially achieved. for action. World Health Organization (WHO) –
In conclusion, whilst this study did not confirm Geneva, 2003.
the validity of the indicators under consideration, it 6. Task Force on Medicines Partnership and the Na-
did partially substantiate the hypothesis that TG3 tional Collaborative Medicines Management Services
indicators have the potential to play a considerable Programme. Room for review: A guide to medication
role for the involvement of certain patient groups review: The agenda for patients, practitioners and
in the pharmaceutical care process in community managers. Wallingford: Pharmaceutical Press, 2003.
pharmacies. 7. Clyne W, Blenkinsopp A, Seal R. A guide to medica-
These outcomes suggest that, on the one hand, tion review. Keele University. NPC Plus and Medicines
the proposed indicators could be implemented in Partnership 2008.
community pharmacy daily practice, but, on the 8. Zermansky AG, Petty DR, Raynor DK, Lowe CJ, Free-
other hand, improvements could be made in sup- mantle N, Vail A. Clinical medication review by a
porting community pharmacists in the delivery of pharmacist of patients on repeat prescriptions in gen-
TG3-related interventions. In particular, the study eral practice: A randomised controlled trial. Health
findings highlighted the need for policy makers and Technol Assess 2002; 6: 1-86.
professional bodies to consider the following points: 9. Krska J, Cromarty JA, Arris F, Jamieson D, Hansford
provision of education, mentoring and peer review of D, Duffus PRS, Downie G, Seymour DG. Pharmacist
consultations to help pharmacists improve their con- led medication review in patients over 65: A rand-
sultation and communication skills to engage more omized, controlled trial in primary care. Age Ageing
effectively with patients; availability of incentives 2001; 30: 205-211.
for pharmacists to perform the requested activities; 10. Lenander C, Elfsson B, Danielsson B, Midlöv P, Has-
reduction of pharmacists’ workload enabling more selström J. Effects of a pharmacist-led structured
time for the delivery of pharmaceutical care; expan- medication review in primary care on drug-related
sion of TG3-related activities into other defined target problems and hospital admission rates: A randomized
patient groups; access to the patient’s medical records controlled trial. Scand J Prim Health Care 2014; 32 (4):
in order to facilitate pharmacist advice giving during 180-186.
consultations and provide a more effective phar- 11. Bernsten C, Björkman I, Caramona M, Crealey G,
macist-patient discussion; better interprofessional Frøkjaer B, Grundberger E, Gustafsson T, Henman
collaboration between general practitioners and M, Herborg H, Hughes C, McElnay J, Magner M, van
pharmacists (and, when applicable, other healthcare Mil F, Schaeffer M, Silva S, Søndergaard B, Sturgess
professionals) to meet medication management and I, Tromp D, Vivero L, Winterstein A. Pharmaceutical
healthcare needs of their patients; presence of a con- care of the Elderly in Europe Research (PEER) Group.
sultation area in the pharmacy that allows patients Improving the well-being of elderly patients via com-
privacy to discuss their medicines and health. munity pharmacy-based provision of pharmaceutical
care: A multicentre study in seven European coun-
References tries. Drugs Aging 2001; 18 (1): 63-77.
12. IBM Corp. Released 2013. IBM SPSS Statistics for
1. Barnett CW, Nykamp D, Ellington AM. Patient-guided Windows, Version 22.0. Armonk, NY: IBM Corp.
counseling in the community pharmacy setting. J Am 13. Rigby D. Collaboration between doctors and pharma-
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191-193.

34
 Results of the EDQM Pharmaceutical Care Quality Indicators Project
14. Geurts MM, Talsma J, Brouwers JR, de Gier JJ. Med-
ication review and reconciliation with cooperation
between pharmacist and general practitioner and the
benefit for the patient: A systematic review. Br J Clin
Pharmacol 2012; 74 (1): 16-33.
15. FIP Working Group on Collaborative Practice. FIP
Reference Paper Collaborative Practice. 2009 – Link:
goo.gl/loy55P (last accessed: October 2015).
Topic Group 4. 2013-2014 feasibility study on Pharmacist’s self-assessment
tool (PharmSAT) for pharmaceutical care implementation (Armenia,
Denmark, Hungary, Italy, the Netherlands)
Background
The EDQM study on pharmaceutical care
quality indicators was completed by a study arm fo-
cussing on a tool aimed at evaluating, monitoring and
improving the use of the pharmaceutical care philos-
ophy and working methods in European countries.
For this purpose, in 2009-2010 TG4 ‘Pharmaceutical
Care: special needs in certain regions’ developed a
Pharmacist’s self-assessment tool (PharmSAT) to
determine the level of pharmaceutical care imple-
mentation in the community pharmacies of coun-
tries where the approach has not yet been promoted
(mainly eastern European countries).
Pharmaceutical care is a philosophical concept
that is hard to understand or implement in coun-
tries where community pharmacy practice is not ad-
vanced and mainly focussed on medicine sales. The
principle of the tool is that pharmacists assess their
own community pharmacies regarding, for instance,
the practices of: patient counselling and education;
documentation of interactions between healthcare
professionals and patients concerning decisions on
medication; follow-up of medication decisions (stop,
continue or modify medication); inter-professional
collaboration or patient involvement. At the same
time the tool has an educational function, because it
explains the components of the pharmaceutical care
process to community pharmacists and highlights
steps and quality measures that are needed to ensure
best pharmaceutical care practice. This way, gaps in
pharmaceutical care implementation can be identi-
fied and recommendations on best ways to narrow
these gaps may be made.
Figure 1 illustrates how the pharmaceutical
care approach should be implemented in pharmacy
practice.
In 2011-2012 a pilot study was performed in
several European countries (i.e. Albania, Georgia,
Latvia, Moldova and Ukraine) in order to validate
35
16. Tallon M, Barragry J, Allen A, Breslin N, Deasy E,
Moloney E, Delaney T, Wall C, O’Byrne J, Grimes T.
Impact of the Collaborative Pharmaceutical Care at
Tallaght Hospital (PACT) model on medication ap-
propriateness of older patients. Eur J Hosp Pharm
2016; 23: 16-21.
the tool. Based on the results of this pilot study, it
was concluded that the PharmSAT could be used
to monitor and improve community pharmacists’
knowledge of pharmaceutical care and the imple-
mentation of pharmaceutical care in community
pharmacy settings in Europe.
During the February 2013 meeting of the Phar-
maceutical Care Quality Indicators Working Party,
it was decided to include further countries in the
study on the proposed tool (i.e. Armenia, Denmark,
Hungary, Italy and the Netherlands) in order to
widen the assessment of the suitability of the Phar-
macist’s self-assessment tool by including some
countries more familiar with the pharmaceutical
care philosophy and working methods. For a pan-­
European project, it is important to use the same tool
in all countries in order to harmonise the implemen-
tation of the pharmaceutical care approach.
The 2013-2014 feasibility study was managed by a
Topic Group leader co-ordinating the work of national
collaborators (one for each country) in the develop-
ment and carrying out of TG4 research activities.
Methods
An action-oriented study protocol was devel-
oped by the TG leader in order to ensure that the
same methodology was followed in all of the partici-
pating countries.
A letter was also prepared to invite pharmacists
to participate in the feasibility study and to explain to
them the steps to be followed to complete the study.
The target number of community pharmacies
to be involved in the feasibility study was set between
five and ten.
Each national study collaborator had to trans-
late the English version of the Pharmacist’s self-­
assessment tool (version no. 4) and invitation letter
for pharmacists into local languages.
The EDQM pharmaceutical care quality indicators project. Final report

Figure 1.  Implementation of the pharmaceutical care approach in pharmacy practice

Pharmaceutical Pharmaceutical
services directly care
delivered to
patients, e.g. Patient counselling
• dispensing of and education
medicines
• blood
pressure
measurement
• self-care Patient
services involvement
Inter-professional (desired quality of life,
• etc.
collaboration needs and
expectations)

Follow-up to
Documentation of
medication decision
interaction
(stop, continue,
(medication
modify medication)
decision)

Figure 2.  Main milestones of the PharmSAT study

• Albania • Armenia
Pilot study
• Georgia • Denmark
(-)
• Moldova • Hungary
• Ukraine • Italy
• Albania
• Netherlands
• Georgia
PharmSAT elaboration • Latvia Feasibility study
• Moldova
(-) (-)
• Ukraine

In the Netherlands the English versions were
used, given the good command of English among
Dutch pharmacists.
No ethics committee approval was needed for
the national arms of the study.
The national study collaborators were in charge
of recruiting the 5 to 10 community pharmacists and
sending them the Pharmacist’s self-assessment tool.
Participating pharmacists had two weeks to complete
and return questionnaires to the national study col-
laborator, for him/her to check the delivered ques-
tionnaires, assess them and meet or speak over the
phone with participating pharmacists in order to
collect their feedback and suggestions regarding the
tool.
National study collaborators compiled the na-
tional feasibility study reports and sent them to the
TG leader. During teleconferences national collabo-
rators were invited to focus, in their reports, on a crit-
ical review of the tool in their country’s community
pharmacy practice. All remarks and recommenda-
tions (either received from community pharmacists
or made by national study collaborators) had to be
included in the national study reports.

36
 Results of the EDQM Pharmaceutical Care Quality Indicators Project
The TG leader and the EDQM performed the
overall assessment for the preparation of the present
study report.
Pharmacist’s self-assessment tool
As stated above, version no. 4 of the Pharma-
cist’s self-assessment tool was used in the 2013-2014
feasibility study. This version includes the revisions of
the tool that were made following the outcomes and
recommendations of the 2011-2012 pilot study.
In some countries additional open-ended ques-
tions were included in the questionnaire, giving better
guidance to pharmacists in their feedback about the
suitability of the tool, taking into account specific na-
tional practices.
Denmark:
• How does the questionnaire describe the daily
practice in your pharmacy?
• Which sections of the questionnaire describe
your daily practice in the pharmacy well?
• Which sections of the questionnaire describe a
realistic future for your pharmacy?
• Which sections of the questionnaire seem un-
realistic regarding the development in Danish
pharmacies?
• Each section is terminated by an evaluation
and list of recommendations, how does this
work?
• Is anything missing in the questionnaire? If yes,
please elaborate.
• What is pharmaceutical care to you in Danish
community pharmacy practice in 2014?
The Netherlands:
• Is this way of filling the questionnaire for
Dutch pharmacists realistic?
• How much time did it take?
• Is the system of summing marks helpful?
Coaching of pharmacies
Prior to completion of the questionnaire re-
spondents received, as needed, further guidance on
the background, the approach or the terminology.
In parallel or after completion of the ques-
tionnaire of the Pharmacist’s self-assessment tool,
meetings or phone calls took place between national
collaborators and pharmacists in order to collect
their feedback and suggestions for improvements.
Scoring
The self-assessment tool consists of a question-
naire in which questions should raise the awareness
of pharmacists about pharmaceutical care and also
37
lead to a score and an assessment of the issues to
address in order to implement, or better implement,
pharmaceutical care.
The parts of the questionnaire, with scoring,
are as below:
• Part 3: Continuous professional development:
up to 18 points;
• Part 4: Dispensing of medicines (Patient as-
sessment, Patient counselling and education,
Documentation, Follow-up, Inter-professional
collaboration): up to 163 points;
• Part 5: Self-care services (same subsections as
for Dispensing): up to 152 points;
• Part 6: Point-of-care testing (health screening)
services (same subsections as for Dispensing):
up to 65 points.
As the main objective of the study was to eval-
uate the suitability of the tool in the 5 participating
countries, scoring was not a mandatory condition.
In Armenia and Hungary, scoring was performed by
the pharmacists themselves whereas in Italy scoring
was performed by the national study collaborator. In
Denmark and in the Netherlands, scoring was not
performed.
Analysis and evaluation of completed questionnaires
It is important to point out that, at this stage of
the project, given the small number of participating
pharmacies and the various ways the assessment and
scoring was performed between the 5 countries, the
aim of the assessment of the questionnaires was not
to make any general conclusion on the level of formal
implementation of pharmaceutical care. When ana-
lysing the questionnaires, each national collaborator
focussed more on the suitability of the tool regarding
awareness-raising and future monitoring.
Results
Recruitment of community pharmacists
Various response rates from pharmacies were
observed in the different countries, as illustrated in
Table 1. This seems to be mainly dependent on the
awareness of pharmacists about the formal phar-
maceutical care approach and the channels taken to
invite them to participate, on an individual basis or
via associations. For example, in Denmark the ques-
tionnaire was sent to 10 community pharmacists
chosen amongst pharmacists assumed from their
background or experience to have a good under-
standing of both community pharmacy practice and
the methodology of the study.
The EDQM pharmaceutical care quality indicators project. Final report

Table 1.  Number of pharmacies invited and eventually recruited in the study
Armenia Denmark Hungary Italy Netherlands Total
Number of invited pharmacies 6 10 15 14 30 75
Number of respondents 6 6 12 6 6 36
Response rate 100 % 60 % 80 % 43 % 20 % 48 %

Outcomes of the feasibility study in the participating
countries
A brief overview of the main outcomes of the
suitability studies is reported below.
Armenia
Applicability
The use of the tool seems not to cause any prob-
lems in Armenia.
Relevance
In the Armenian context, the only problem is
the lack of control of dispensing of prescription-only
medicines (e.g. antibiotics or hormones). Therefore,
there are many occurrences of pharmacists dis-
pensing these medicines without prescription. It was
suggested that questions be added to the question-
naire to evaluate the extent of this bad practice.
Recommendations
As stated above, questions would need to be
introduced regarding the bad practice of dispensing
prescription-only medicines without a prescription.
Denmark
Applicability
The applicability of the tool was generally
good, with some remarks on the scoring (the parts
of the questionnaire on evaluation and recommenda-
tions were generally missed by respondents) and on
the quality assurance approach being insufficiently
addressed.
the work of the EDQM and the tool, including
the definition of pharmaceutical care.
• The ratio questions (4.3, 5.3, 6.9) are difficult to
answer. A rephrasing of the questions might be
considered, asking more directly and giving
less abstract response categories.
• As working systematically with quality-assured
workflows would help with implementing
pharmaceutical care, a section of the question-
naire could be developed regarding experience
with quality assurance in the pharmacy.
• The questionnaire is meant to be a tool for
self-evaluation of pharmaceutical care prac-
tice in community pharmacy practice. Maybe
open-ended questions could be included for
the respondents’ personal observations in
order to motivate respondents.
• A better guidance on the scoring methodology
could be given as an incentive to fill in this part
of the questionnaire.
• Some concepts or wordings could be modified
or rephrased:
– ‘patients per day’ → ‘handlings per day’;
– ‘customer loyalty’ → ‘customer satisfaction’;
– Question 4.5: it is unclear what ‘dispensing
label’ means/refers to;
– Question 4.6: ‘medication review’ was trans-
lated into ‘pharmacotherapeutic check’.
• In question 4.14, many other healthcare pro-
fessionals are mentioned, but in the summing
up of the section, they only count as one – this
may cause a bias in the scoring.
Hungary

Relevance Applicability
The questionnaire content was found relevant, The tool was found applicable to give an over-
with some modifications suggested. The question on view of the development of pharmaceutical care in
the ratio of time spent between dispensing and coun- Hungary. It was found that the Pharmacist’s self-­
selling was found rather difficult to answer because assessment tool addresses key components of phar-
some pharmacies were equipped with a time-saving maceutical care, but, since daily practice in this area
dispensing robot. evolves rapidly, its applicability could be limited in
time.
Recommendations
• The title of the target group should be changed Relevance
to include all respondents in Europe. A short The content of the questionnaire was found rel-
background (½ page) should be written about evant, except for two aspects:

38
 Results of the EDQM Pharmaceutical Care Quality Indicators Project
• The educational Part 3 might be questionable
depending on whether or not pharmaceutical
care is considered as being already part of the
current curriculum provided by universities.
• Part 5 of the self-assessment tool focuses on
health screening, which is not available in
every pharmacy in Hungary.
Recommendations
Adapting the scoring methodology to take into
account curricula already addressing the pharma-
ceutical care approach.
Italy
Applicability
The applicability might be partial based on the
comments received from the respondents:
• According to some pharmacists, patients
already receive a lot of information both from
the prescriber and in the labelling instructions.
This might be an issue more related to educa-
tion of patients and pharmacists on the formal
pharmaceutical care approach than an issue
with the questionnaire itself. It was acknowl-
edged that some pharmaceutical care topics are
not regularly included in the Italian pharma-
cist curriculum.
• Regarding the general applicability of the ques-
tionnaire and the approach, comments were
made about the remuneration system of phar-
macy, which in Italy is mainly based on the
medicines dispensed to patients rather than
other services offered.
• Regarding the scoring performed by the na-
tional study collaborator, one pharmacist dis-
agreed with the outcome (i.e. ‘no qualification
or implementation of pharmaceutical care’)
challenging the marks given and/or the current
scoring approach (evaluation criteria).
Relevance
The content of the questionnaire was found rel-
evant, but not all questions could be answered – e.g.
no answers could be provided on services like point-
of-care testing (health screening) services, because
these activities were not performed due to a lack of
resources (education and manpower).
Recommendations
• Questions 2.3 and 3.4 could be modified to cover
more specifically the pharmacy staff other than
pharmacists and pharmacy technicians.
39
• The scoring methodology could be revised to
avoid the scores being wrongly interpreted as a
performance audit – while it is in fact an eval-
uation.
The Netherlands
Applicability
The applicability of the tool was considered
partial as Dutch pharmacies are quite advanced in
the implementation of pharmaceutical care while the
questionnaire aims to evaluate the implementation
of concepts that are already part of the pharmacy
routine in the Netherlands.
Examples of pharmaceutical care activities not
addressed in the current tool:
• In the Dutch pharmacy practice, Medication
Therapy Management (MTM) has existed since
the end of the 1980s and is part of pharmaceu-
tical care. In the questionnaire the activities of
pharmacists in MTM are not highlighted and
are definitely needed.
• Standards and guidelines have been developed
in pharmacy practice for handling patients
with chronic diseases such as diabetes, asthma
or rheumatism. The databases in the phar-
macy (Patient Medication Records or PMRs)
are essential for this purpose. Patient loyalty
schemes are needed as an incentive for feeding
PMRs by pharmacies and all the other health-
care providers, especially in the transfer to
and from hospitals. This fast-evolving aspect
of pharmacy practice is not captured in the
current questionnaire.
• Collaboration with physicians and with hospi-
tals (pharmacists, wards and physicians) is not
sufficiently addressed at the moment.
Relevance
The part on health screening services might not
be relevant as there is not much focus on this service
in Dutch community pharmacies.
Recommendations
• Medication Therapy Management services
need to be reflected in the questionnaire.
• Questions on collaboration between commu-
nity pharmacists and physicians, and com-
munity pharmacists and hospitals (hospital
pharmacists, wards and physicians) should be
included in the tool, too.
The EDQM pharmaceutical care quality indicators project. Final report
Discussion and conclusions
According to the national study reports, the
tool under evaluation seems to have a relevance to
community pharmacy practice in most of the partic-
ipating countries, but its applicability as it is designed
now is limited in countries with a longer history
of pharmaceutical care, such as Denmark and the
Netherlands.
Based on the main outcomes of the feasibility
study, a number of questions should be revised
and the scoring system should be adjusted, as well.
However, the difficulty seems to be in finding the
right balance between those countries advanced in
the implementation of pharmaceutical care and those
at an earlier stage of implementation. In this respect,
scoring could be perceived by some as a performance
audit or a benchmarking exercise, while it should be
viewed as an evaluation tool assessing the progress of
an individual pharmacy, a region or a country on the
path to full implementation.
Improving the tool by taking into account the
comments is one option, bearing in mind that any
further changes will continue to attract comments on
the suitability of the tool vis-à-vis the national back-
grounds in terms of pharmacists’ training or practice,
which vary from one country to another.
Because of the variety of approaches taken
in self-assessment (scoring) from one country to
another, there was no indicator designed for this arm
of the EDQM Pharmaceutical Care Quality Indica-
tors Project. It remains to be discussed whether or
not quality indicators based on the Pharmacist’s self-­
assessment tool could be developed to ensure that the
questionnaire brings an added value in monitoring,
for example, the level of adherence to the pharmaceu-
40
tical care approach taking into account the discrep-
ancies between the countries.
Beyond specific issues on the content of the
questionnaire, rapid changes in pharmacy practice
are taking place and promising opportunities are
offered, for example, by PMR systems able to deliver
much more than detecting potential drug interac-
tions between previously dispensed and newly pre-
scribed medication. Therefore, the tool could also be
seen as a basis for design of a list of data to be securely
captured in the PMR of pharmacies to encourage
the implementation of the pharmaceutical care ap-
proach and to regularly monitor its implementation
without bias coming from the self-assessment part.
For example, a drug-related problem suspected by
the pharmacist could trigger early on an entry in the
PMR that could lead to different options for follow-up
and investigation. The different possible actions (e.g.
pharmacovigilance notification, patient follow-up
inter­action, healthcare professional interaction)
could be captured and automatic reminders could be
configured in order to follow an approved procedure
before closing the local investigation. Along these
lines, an online version of the self-assessment tool
could be developed to replace the paper-based ques-
tionnaire and boost its use as a stand-alone electronic
tool or through integration within the PMR systems.
Finally, a more automated way to assess phar-
maceutical care implementation could also play a role
in addressing the issue of the lack of incentives for
the pharmacists to invest time and resources in the
formal implementation of pharmaceutical care and
in its monitoring, while maintaining the essential
service of dispensing medicines.
General discussion and conclusion
T he enormous volume of medicines used in
Europe, the associated risk for patients and the
financial investments from society require that the
safe and responsible use of medicines be measured,
monitored, evaluated and improved in a system-
atic, valid and standardised way. Authorities bear a
responsibility to manage and steer this process in a
timely and effective way.
Quality indicators are a valuable tool for
achieving safe, high-quality care, cost-effective
therapy and rational use of medicines. The design
and validation of quality indicators requires exten-
sive field testing and compliance with agreed, stand-
ardised methods.
The EDQM Pharmaceutical Care Quality In-
dicators Project has shown that the development,
testing and validation of quality indicators across
different countries are complex processes given the
differences between healthcare systems in Europe.
This provides a challenge for the design of robust and
generally applicable indicators that can be used for
data collection on a routine basis.
The project has also shown that the indicators
under evaluation could be considered to provide a
pragmatic approach to encourage the implemen-
tation of the pharmaceutical care philosophy and
working methods, and could help assure the quality
of different key areas of the pharmaceutical care
process.
Finally, the project has highlighted that certain
capabilities need to be in place in a healthcare system
(e.g. availability of electronic health records, con-
cordance between healthcare professionals and pa-
tients and joint decision-making) in order to support
the delivery of pharmaceutical care and the use of the
proposed indicators in daily practice.
41
Based on the project findings, and discussions
during the November 2015 workshop, the following
conclusions and recommendations can be drawn up:
1. Pharmaceutical care philosophy and working
methods: improving and ensuring the efficient
and safe use of medicines should be a priority
both nationally and internationally. The im-
plementation of pharmaceutical care in daily
practice could help deliver a high quality of
care, promote improved health outcomes, and
achieve better use of resources within health
systems.
The following elements have been identified at
this stage for the implementation of pharma-
ceutical care:
• Postgraduate and continuing education in
clinical pharmacy, medication therapy man-
agement services, communication skills and
structured interviewing techniques is essential
to ensure that the practice of pharmaceutical
care is delivered in a responsible and compe-
tent manner.
• Pharmaceutical care involves the process
through which a pharmacist co-operates with
a patient and other professionals in designing,
implementing, and monitoring a therapeutic
plan that will produce specific therapeutic out-
comes for the patient. Interprofessional col-
laboration and active involvement of patients
in their own care should be in place to ensure
high quality and safe patient care. In addi-
tion, standards for sharing electronic patient
records should be established and implemented
as part of collaborative working models.
• Routine use of quality indicators is only fea-
sible in practice if data collection can be done
with little effort during care activities. This re-
The EDQM pharmaceutical care quality indicators project. Final report
quires the availability and use of valid and re-
liable health information technology systems
at hospital and community pharmacy level.
• The development of quality indicators is a
complex and resource-consuming task. A com-
prehensive and sustainable long-term indicator
repository should be established as a means
of providing policy-makers, healthcare profes-
sionals and researchers with valid measures for
the assessment, monitoring, and evaluation of
the quality of pharmaceutical care at national
and regional levels.
2. Political context: provision of a legal basis for
the implementation of pharmaceutical care at
European and national level requires a polit-
ical willingness by policy-makers. This should
be based on the acknowledgement that the
pharmaceutical care philosophy and working
methods could enhance responsible use of
medicines, improve medication safety, better
meet the health needs of patients, and achieve 4. International collaboration: given the identified
cost-effectiveness. This cost-effectiveness
should pave the way for the establishment of
a policy framework supporting the implemen-
tation of the pharmaceutical care philosophy
and working methods in national healthcare
systems as well as the creation of incentives for
healthcare professionals to invest time and re-
sources in pharmaceutical care activities.
3. EDQM and its European Committee on Phar-
maceuticals and Pharmaceutical Care (CD-P-
PH): in line with its mission to provide policies
and model approaches for the safe use of med-
42
icines in Europe, the EDQM should make the
current indicators available to health author-
ities and other stakeholders for implementa-
tion. Since the healthcare environment evolves
rapidly, the question of the maintenance and
enlargement of the current list of indica-
tors is raised, especially for other key areas of
the pharmaceutical care process, e.g., inter­
professional co-operation; patient monitoring
and follow-up; medication-related health lit-
eracy. This question is strictly related to the
above points on working methods and tools
(postgraduate and continuing education of
healthcare professionals; interprofessional col-
laboration and active patient involvement; use
of health information technology systems, in-
dicator repository) and political willingness
needed for the actual implementation of the
pharmaceutical care philosophy and working
methods in daily practice.
challenge of the differences between national
healthcare systems, international collabora-
tion among national and pan-European organ-
isations working in the field of quality of care
plays an important role in the implementation
of pharmaceutical care in daily practice. There-
fore, resources and forces should be grouped
to develop synergies, avoid duplication of
efforts, and eventually meet the common ob-
jective of achieving better, patient-centred
healthcare in Europe.
Acknowledgements
S incere thanks are owed to the members of the
Quality of Pharmaceutical Care Indicators
Working Party for their great support and valuable
contributions throughout the carrying out of the
2013-2014 multinational validation study.
In particular, the authors would like to thank:
TG1 Leader
Prof Dr Michael Hartmann, Jena University Hos-
pital – Jena, Germany
TG1 National Co-ordinators
Ms Magdalena CERBIN-KOCZOROWSKA, Poznań Uni-
versity of Medical Sciences – Poznań, Poland
Dr Zaza CHAPICHADZE, State Regulation Agency for
Medical Activities – Tbilisi, Georgia
Dr Olga GRINTSOVA, Department for Clinical Phar-
macology and Pharmaceutical Care – Kharkiv,
Ukraine
TG2 Leader
Prof Dr Agnieszka SKOWRON, Jagiellonian University
Medical School – Kraków, Poland
TG2 National Co-ordinators
Ms Emily AHERN, St. James’s Hospital – Dublin,
Ireland
Dr Zaza CHAPICHADZE, State Regulation Agency for
Medical Activities – Tbilisi, Georgia
Dr Mariola DROZD, Medical University of Lublin –
Lublin, Poland
Prof Dr Gyöngyvér SOÓS and Dr Reka VIOLA, Uni-
versity of Szeged – Szeged, Hungary
TG3 Leader
Prof Dr Han de GIER, University of Groningen – Gro-
ningen, the Netherlands
43
TG3 National Co-ordinators
Ms Justyna DYMEK, Jagiellonian University Medical
School – Kraków, Poland
Prof Dr Branislava MILJKOVIĆ, University of Bel-
grade – Belgrade, Serbia
TG4 Leader
Dr Zinaida BEZVERHNI, State University of Medicine
and Pharmacy – Chișinău, Moldova
TG4 National Co-ordinators
Mr Marcello ChIAVONI, Italian Medicines Agency
(AIFA) – Rome, Italy
Dr Balász HANKO, National Institute of Pharmacy –
Budapest, Hungary
Dr Charlotte ROSSING, Pharmakon – Hillerød,
Denmark
Prof Dr Albert SAHAKYAN and Ms Lilit MARTI-
ROSYAN, Scientific Center of Drug and Medical Tech-
nology – Yerevan, Republic of Armenia
Dr Dick TROMP, Quality Institute for Pharmaceutical
Care – Kampen, the Netherlands
The authors would also like to thank the fol-
lowing people:
Prof Dr Frank EGGERT, Institute of Psychology, TU
Braunschweig – Braunschweig, Germany (statistical
analysis)
Mr Nico KIJLSTRA, Scientific Project Leader, Health
Care Inspectorate, Ministry for Health, Welfare and
Sport – Utrecht, Netherlands
Dr Sabine WALSER, European Directorate for the
Quality of Medicines & HealthCare (EDQM)
(Council of Europe) – Strasbourg, France (Adminis-
trative Officer)
The EDQM pharmaceutical care quality indicators project. Final report

Mr Michael WRAITH, European Directorate for the Last but not least, the authors would like to
Quality of Medicines & HealthCare (EDQM) (Council thank all medical doctors, pharmacists and patients
of Europe) – Strasbourg, France (proofreading) who made this research possible.

44
Appendices. Steps to be followed for data collection and
data collection forms

T his section contains a brief overview of the proce-

dures to be followed to collect data, the data col-
lection forms and TG4 Pharmacist’s self-­assessment
tool for pharmaceutical care implementation that
were developed and used in the 2013-2014 multina-
tional validation study.
Please note that the data collection forms ap-
pended hereafter have been slightly modified in order
to facilitate their use outside research settings.

45
Appendix 1. Topic Group 1 – Adherence to nationally agreed clinical
practice guidelines

Steps to be followed for data collection

6. Collect the completed data collection forms.
Pharmacist 7. Meet the GPs again and discuss with them the
1. Provide the GPs with a data collection form prescription data that were collected.
(paper or electronic format) and invite them 8. Complete the patient data evaluation form for
to complete it with the requested data covering pharmacists based on the discussions that you
the time frame dd.mm.yyyy – dd.mm.yyyy. had with the physicians.
2. Collect the completed data collection forms.
3. Set up a face-to-face meeting with GPs. GP
4. Meet the GPs, hand out a copy of the current 1. Complete the data collection form provided
antimicrobial prescribing guidelines, briefly and return it to pharmacist by the due date.
discuss the guidelines as well as the prescrip- 2. Meet with pharmacist to discuss antimicrobial
tion data that were collected. prescribing guidelines and prescription data.
5. Ask the GPs to fill in a new data collection form 3. Complete a new data collection form and send
covering the time frame dd.mm.yyyy – dd.mm. it back to pharmacist by the due date.
yyyy (NB: this time frame should cover a 4. Meet with pharmacist again to discuss pre-
period of time following the meeting with the scription data.
GPs).

46
 Appendices. Steps to be followed for data collection and data collection forms

TG1 Indicator – Data collection form for general practitioners

Study stage: 1 ☐ 2☐
Physician name and contact details (address, e-mail,
telephone): . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Pharmacist name and contact details (address,
e-mail, telephone): . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Visit date: . . . . . . . . . . . . . . . . . . . . . . . . .

Patient data collection form

Patient number* Date of GP visit Gender Date of birth Diagnosis Prescribed Notes
(patient) ­according antibiotic
to ICD-10 or
(trade name;
ICPC‑2R**
posology; phar-
maceutical form;
pack size)

* For privacy reasons, a unique identification number should be assigned to each patient who is included in this form. In this way, it will not be
possible to identify the patients outside the healthcare facility.
** ICD-10: International Statistical Classification of Diseases and Related Health Problems – http://goo.gl/bC1zE
ICPC-2R: International Classification of Primary Care, Second edition – http://goo.gl/5wrNBq

TG1 Indicator – Data evaluation form for pharmacist

To be used after the conversation with the GP (1 form for each GP).

Study stage: 1 ☐ 2☐

Physician name and contact details (address, e-mail,
telephone): . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Pharmacist name and contact details (address,
e-mail, telephone): . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .

Patient data evaluation form

Patient number*
Diagnosis accord- Prescribed
ing to ICD-10 or ­antibiotic
ICPC-2R
(ATC code + INN;
posology; pharma-
ceutical form; pack
size)**
Assessment of anti- In case of JNA treat- Additional
bacterial treatment ment, state the ­comments
main reason here
(A; NA; JNA)***
(if known)

* Patient number: this number is assigned to the patients by the GP. In this way, it will not be possible to identify the patients outside the GP’s
healthcare facility.
** ATC: Anatomical Therapeutic Chemical classification system (World Health Organization (WHO) Collaborating Centre for Drug Statistics
Methodology – www.whocc.no/atc_ddd_index/)
INN: International non-proprietary name (WHO – http://goo.gl/CIhnjj)
*** A = adherent
NA = non-adherent
JNA = justified non-adherent

47
Appendix 2. Topic Group 2 – Monitoring of therapeutic plans and
medication safety by pharmacists through data linking and exchange
of information about therapy and patient’s medical condition in
anticoagulant and antibiotic therapy

TG2 pre-study questionnaire

NB: This questionnaire can be used to evaluate the Community pharmacy settings
baseline conditions that may influence the applica-
bility of TG2 indicators at national/regional level (e.g. ☐ Yes
supervision of medical data sharing practices; actual
sharing of medical data; available technologies for ☐ No
managing and sharing medical data).
☐ I do not know
Date:  . . . . . . . . . . . . . . . . . . . . . . . . . .
Hospital pharmacy settings
Respondent
☐ Yes
☐ Representative of the Ministry of Health
☐ No
☐ Representative of the medical licensing
authority at the Ministry of Health ☐ I do not know

☐ Representative of the pharmacy licensing 2. If yes, please briefly describe the current legal
authority at the Ministry of Health restrictions (in both community pharmacy
and hospital pharmacy settings): . . . . . . . .
☐ Representative of the chamber of physicians . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
☐ Representative of the chamber of pharmacists . . . . . . . . . . . . . . . . . . . . . . . . . . .

National law concerning sharing of patient’s medical Supervision of the sharing practices of patient’s
and prescription data (patient health record) medical and prescription data (patient health record)

1. Are there any legal restrictions, in community
pharmacy and hospital pharmacy settings, for
sharing patient’s medical and prescription
data (patient health record) between
physicians and pharmacists?
3. Who is in charge of supervising the sharing
practices of patient’s medical and prescription
data (patient health record) between
physicians and pharmacists in community
pharmacy and in hospital pharmacy settings?

48
 Appendices. Steps to be followed for data collection and data collection forms

Community pharmacy settings ☐ Other, please specify . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . .
☐ The Ministry of Health
Hospital pharmacy settings
☐ The medical licensing authority (at the
physicians’ level) ☐ Regular inspections of physicians’ practices/
pharmacies (e.g. 1 inspection every 2 years)
☐ The pharmacy licensing authority (at the
pharmacists’ level) ☐ Regular checks of the data-sharing platforms
to evaluate who is sharing what (e.g. 1 check
☐ The chamber of physicians every 6 months)

☐ The chamber of pharmacists ☐ I do not know

☐ I do not know ☐ Other, please specify . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . .
☐ Other, please specify . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . Data sharing of patient’s medical and prescription
records
Hospital pharmacy settings
5. In community pharmacy and in hospital
☐ The Ministry of Health pharmacy settings, do physicians and
pharmacists share patient’s medical and
☐ The medical licensing authority (at the prescription data (patient health record)?
physicians’ level)
☐ Yes, in both community pharmacy and
☐ The pharmacy licensing authority (at the hospital pharmacy settings
pharmacists’ level)
☐ Yes, in community pharmacy settings only
☐ The chamber of physicians
☐ Yes, in hospital pharmacy settings only
☐ The chamber of pharmacists
☐ No
☐ I do not know
☐ I do not know
☐ Other, please specify . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . ☐ Other, please specify . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
4. How is the supervision of the sharing of
patient’s medical and prescription data 6. If yes, what type of patient’s data (patient
(patient health record) carried out in health record) is shared?
community pharmacy and in hospital
pharmacy settings? Community pharmacy settings

Community pharmacy settings ☐ Medical data (e.g. results of laboratory tests)

☐ Regular inspections of physicians’ practices/ ☐ Prescription data (i.e. patient’s medication

pharmacies (e.g. 1 inspection every 2 years) record)

☐ Regular checks of the data-sharing platforms ☐ I do not know

to evaluate who is sharing what (e.g. 1 check
every 6 months) ☐ Other, please specify . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
☐ I do not know

49
The EDQM pharmaceutical care quality indicators project. Final report

Hospital pharmacy settings ☐ Database of the Ministry of Health

☐ Medical data (e.g. results of laboratory tests) ☐ Database of the medical licensing authority

☐ Prescription data (i.e. patient’s medication ☐ Database of the pharmacy licensing authority
record)
☐ Database of the chamber of physicians
☐ I do not know
☐ Database of the chamber of pharmacists
☐ Other, please specify . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . ☐ Personal estimate

7. If yes, what is the percentage of physicians ☐ Other, please specify . . . . . . . . . . . . . . .

and pharmacists who share with each other . . . . . . . . . . . . . . . . . . . . . . . . . . .
patient’s medical and prescription data
(patient health record) in both community IT equipment
pharmacy and hospital pharmacy settings?
Please write it down here. 8. Which of the following information
technology (IT) equipment is available in
Community pharmacy settings: . . . . . . . . . . . . physicians’ practices? In addition, what is the
. . . . . . . . . . . . . . . . . . . . . . . . . . . percentage of physicians’ practices having the
. . . . . . . . . . . . . . . . . . . . . . . . . . . selected IT equipment?

Hospital pharmacy settings: . . . . . . . . . . . . . . ☐ Telephone

. . . . . . . . . . . . . . . . . . . . . . . . . . . Percentage of physicians’ practices having a
. . . . . . . . . . . . . . . . . . . . . . . . . . . telephone: . . . . . . . . . . . . . . . . . . . .

Community pharmacy settings ☐ Fax

Please mention the source on which the above per- Percentage of physicians’ practices having a
centage is based: fax: . . . . . . . . . . . . . . . . . . . . . . . . .

☐ National statistical database ☐ Desktop computer

Percentage of physicians’ practices having a
☐ Database of the Ministry of Health desktop computer: . . . . . . . . . . . . . . . .

☐ Database of the medical licensing authority ☐ Portable computer, smartphone or tablet

Percentage of physicians’ practices having a
☐ Database of the pharmacy licensing authority portable computer, smartphone or tablet: . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
☐ Database of the chamber of physicians
☐ Printer
☐ Database of the chamber of pharmacists Percentage of physicians’ practices having a
printer: . . . . . . . . . . . . . . . . . . . . . .
☐ Personal estimate
☐ Internet connection
☐ Other, please specify . . . . . . . . . . . . . . . Percentage of physicians’ practices having an
. . . . . . . . . . . . . . . . . . . . . . . . . . . Internet connection: . . . . . . . . . . . . . .

Hospital pharmacy settings ☐ I do not know

Please mention the source on which the above per-
centage is based: ☐ Other IT equipment, please specify . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
☐ National statistical database Please mention the source on which the above
answers are based:

50
 Appendices. Steps to be followed for data collection and data collection forms

☐ National statistical database Please mention the source on which the above
answers are based:
☐ Database of the Ministry of Health
☐ National statistical database
☐ Database of the medical licensing authority
☐ Database of the Ministry of Health
☐ Database of the pharmacy licensing authority
☐ Database of the medical licensing authority
☐ Database of the chamber of physicians
☐ Database of the pharmacy licensing authority
☐ Database of the chamber of pharmacists
☐ Database of the chamber of physicians
☐ Personal estimate
☐ Database of the chamber of pharmacists
☐ Other, please specify . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . ☐ Personal estimate

9. Which of the following it equipment is ☐ Other, please specify . . . . . . . . . . . . . . .

available in community pharmacy and in . . . . . . . . . . . . . . . . . . . . . . . . . . .
hospital pharmacy settings? In addition, what
is the percentage of community and hospital Hospital pharmacy settings
pharmacies having the selected IT equipment?
☐ Telephone
Community pharmacy settings Percentage of pharmacies having a telephone:
. . . . . . . . . . . . . . . . . . . . . . . . . . .
☐ Telephone
Percentage of pharmacies having a telephone: ☐ Fax
. . . . . . . . . . . . . . . . . . . . . . . . . . . Percentage of pharmacies having a fax: . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
☐ Fax
Percentage of pharmacies having a fax: . . . . ☐ Desktop computer
. . . . . . . . . . . . . . . . . . . . . . . . . . . Percentage of pharmacies having a desktop
computer: . . . . . . . . . . . . . . . . . . . . .
☐ Desktop computer
Percentage of pharmacies having a desktop ☐ Portable computer, smartphone or tablet
computer: . . . . . . . . . . . . . . . . . . . . . Percentage of pharmacies having a portable
computer, smartphone or tablet: . . . . . . . .
☐ Portable computer, smartphone or tablet . . . . . . . . . . . . . . . . . . . . . . . . . . .
Percentage of pharmacies having a portable
computer, smartphone or tablet: . . . . . . . . ☐ Printer
. . . . . . . . . . . . . . . . . . . . . . . . . . . Percentage of pharmacies having a printer: .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
☐ Printer
Percentage of pharmacies having a printer: . ☐ Internet connection
. . . . . . . . . . . . . . . . . . . . . . . . . . . Percentage of pharmacies having an Internet
connection: . . . . . . . . . . . . . . . . . . . .
☐ Internet connection
Percentage of pharmacies having an Internet ☐ I do not know
connection: . . . . . . . . . . . . . . . . . . . .
☐ Other IT equipment, please specify . . . . . .
☐ I do not know . . . . . . . . . . . . . . . . . . . . . . . . . . .
Please mention the source on which the above
☐ Other IT equipment, please specify . . . . . . answers are based:
. . . . . . . . . . . . . . . . . . . . . . . . . . .

51
The EDQM pharmaceutical care quality indicators project. Final report

☐ National statistical database of the laboratory tests are not paid by the
national social insurance any more)?
☐ Database of the Ministry of Health
☐ Yes
☐ Database of the medical licensing authority
☐ No
☐ Database of the pharmacy licensing authority
☐ I do not know
☐ Database of the chamber of physicians
If yes, please briefly explain . . . . . . . . . . .
☐ Database of the chamber of pharmacists . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
☐ Personal estimate . . . . . . . . . . . . . . . . . . . . . . . . . . .

☐ Other, please specify . . . . . . . . . . . . . . . Clinical practice guidelines concerning laboratory

. . . . . . . . . . . . . . . . . . . . . . . . . . . testing of biological specimens

10. Is the electronic prescribing service in use? 13. Are there clinical practice guidelines that
recommend laboratory testing of blood
☐ Yes, in both community pharmacy and specimens in case of patients who are
hospital pharmacy settings prescribed an anticoagulant (e.g. blood
clotting tests in order to assess bleeding
☐ Yes, in community pharmacy settings only problems and to monitor people who are
prescribed anticoagulant medicines)?
☐ Yes, in hospital pharmacy settings only
☐ Yes
☐ No
☐ No
☐ I do not know
☐ I do not know
Payment of the costs of laboratory tests
If yes, please mention the recommended
11. If a laboratory test is performed (e.g. laboratory tests . . . . . . . . . . . . . . . . .
International Normalized Ratio (INR) test or . . . . . . . . . . . . . . . . . . . . . . . . . . .
antibiogram) who has to pay for the costs of . . . . . . . . . . . . . . . . . . . . . . . . . . .
the test? . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
☐ National social health insurance
14. If yes, in the last 24 months, were there
☐ Private health insurance charges concerning the above guidelines?

☐ Patient ☐ Yes

☐ I do not know ☐ No

☐ Other, please specify . . . . . . . . . . . . . . . ☐ I do not know

. . . . . . . . . . . . . . . . . . . . . . . . . . .
If yes, please briefly explain . . . . . . . . . . .
12. In the last 24 months, were there changes . . . . . . . . . . . . . . . . . . . . . . . . . . .
concerning the payment of the costs of . . . . . . . . . . . . . . . . . . . . . . . . . . .
laboratory tests (e.g. International Normalized . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ratio (INR) test or antibiogram) (e.g. the costs
Thank you!

52
 Appendices. Steps to be followed for data collection and data collection forms

TG2 indicators
Steps to be followed for data collection

A. Indicator 1 – Anticoagulant data collection

Pharmacist the final patient selection (minimum number

1. In the hospital database identify all health of records to be included: 50).
records of patients hospitalised between 3. For each patient retrieve, in the hospital data­
dd.mm.yyyy and dd.mm.yyyy which meet the base, the ICD-10 code used to identify the
inclusion criteria for the anticoagulant data bleeding event (see table ‘ICD-10 codes affili-
collection (inclusion criteria: patients with ated with bleeding’) and the prescribed/deliv-
major bleeding diagnosis (ICD-10 codes), who ered anticoagulant medication.
previously used anticoagulant medications 4. Check, in the hospital pharmacy database,
(ATC codes: B01AA; B01AB; B01AC; B01AD; whether anticoagulant treatment data and pa-
B01AE; B01AF; B01AX)). tients’ medical data relating to the bleeding
2. Randomly choose 10 % of all data that meet the event were available to you.
inclusion criteria. The randomisation may be 5. Complete the ‘Anticoagulant data collection
done by including every 10th patient record in form’ with the requested details.

Anticoagulant data collection form

1. Date: . . . . . . . . . . . . . . . . . . . . . . . . ☐ Telephone

2. Hospital identification (name and address): . ☐ Fax

. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . ☐ Desktop computer
. . . . . . . . . . . . . . . . . . . . . . . . . . .
☐ Portable computer, smartphone or tablet
Hospital characteristics (if applicable)
☐ Printer
3. Number of beds: . . . . . . . . . . . . . . . . .
☐ Internet connection
4. Specialisation (e.g. oncology, geriatric,
paediatric, orthopaedic; if none – write N.A.): ☐ Other, please specify . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
6. Time frame of data collection (dd.mm.yyyy –
5. Information technology (IT) equipment dd.mm.yyyy): . . . . . . . . . . . . . . . . . . .
available in the pharmacy (multiple answers . . . . . . . . . . . . . . . . . . . . . . . . . . .
possible)

Patient data collection form

Patient Gender Date of Hospitalisation ICD-10 code Anticoagulant Patient’s medical Comments
­number (m/f) birth dates (start and of bleeding prescribed in the data relating to
end) (dd.mm.yyyy past (ATC code + bleeding event
– dd.mm.yyyy) INN*) available to phar-
macist (yes/no)

* ATC: Anatomical Therapeutic Chemical classification system (World Health Organization (WHO) Collaborating Centre for Drug Statistics
Methodology – www.whocc.no/atc_ddd_index/)
INN: International non-proprietary name (WHO – http://goo.gl/CIhnjj)

53
The EDQM pharmaceutical care quality indicators project. Final report

7. If patient’s medical data relating to his/her
bleeding event (e.g. outcome of INR test) were
not available to you, what was the main reason
for the non-availability of the above data?
☐ Lack of technical equipment (e.g. computer;
telephone) for sharing of patient’s medical
data
☐ Lack of IT system (i.e. pharmacy software) for
sharing of patient’s medical data
☐ The costs of data sharing are high
☐ The quality of shared data is low
☐ The data sharing process is not secure
☐ I do not know
☐ Other, please specify . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .

☐ Legal restrictions (i.e. not allowed to receive/ 8. General comments/remarks: . . . . . . . . . .

share patient confidential data) . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
☐ Lack of personnel/time to implement and . . . . . . . . . . . . . . . . . . . . . . . . . . .
maintain patient’s data sharing procedures . . . . . . . . . . . . . . . . . . . . . . . . . . .

ICD-10 codes affiliated with bleeding – Link: goo.gl/bC1zE

Block Title
D68.3 Haemorrhagic disorder due to circulating anticoagulants
Haemorrhage during long-term use of anticoagulants
Hyperheparinaemia
Increase in:
• antithrombin
• anti-VIIIa
• anti-IXa
• anti-Xa
• anti-Xia
Use additional external cause code (Chapter XX), if desired, to identify any administered anticoagulant.
Excludes: long-term use of anticoagulants without haemorrhage (Z92.1)
D69.9 Haemorrhagic condition, unspecified
I60 Subarachnoid haemorrhage
I61 Intracerebral haemorrhage
I62 Other non-traumatic intracranial haemorrhage
I64 Stroke, not specified as haemorrhage or infarction
I71.1 Thoracic aortic aneurysm, ruptured
I71.3 Abdominal aortic aneurysm, ruptured
I71.5 Thoracoabdominal aortic aneurysm, ruptured
I71.8 Aortic aneurysm of unspecified site, ruptured
I77.2 Rupture of artery
I84.1 Internal haemorrhoids with other complications (bleeding)
I84.4 External haemorrhoids with other complications (bleeding)
I84.8 Unspecified haemorrhoids with other complications
I85 Oesophageal varices with bleeding
K22.3 Rupture of oesophagus
K.25.0 Gastric ulcer, acute with haemorrhage
K.25.1 Gastric ulcer, acute with perforation
K.25.2 Gastric ulcer, acute with both haemorrhage and perforation
K.25.4 Gastric ulcer, chronic or unspecified with haemorrhage
K.25.5 Gastric ulcer, chronic or unspecified with perforation
K.25.6 Gastric ulcer, chronic or unspecified with both haemorrhage and perforation
K.26.0 Duodenal ulcer, acute with haemorrhage
K.26.1 Duodenal ulcer, acute with perforation
K.26.2 Duodenal ulcer, acute with both haemorrhage and perforation

54
 Appendices. Steps to be followed for data collection and data collection forms

Block Title
K.26.4 Duodenal ulcer, chronic or unspecified with haemorrhage
K.26.5 Duodenal ulcer, chronic or unspecified with perforation
K.26.6 Duodenal ulcer, chronic or unspecified with both haemorrhage and perforation
K.27.0 Peptic ulcer, site unspecified, acute with haemorrhage
K.27.1 Peptic ulcer, site unspecified, acute with perforation
K.27.2 Peptic ulcer, site unspecified, acute with both haemorrhage and perforation
K.27.4 Peptic ulcer, site unspecified, chronic or unspecified with haemorrhage
K.27.5 Peptic ulcer, site unspecified, chronic or unspecified with perforation
K.27.6 Peptic ulcer, site unspecified, chronic or unspecified with both haemorrhage and perforation
K.28.0 Gastrojejunal ulcer, acute with haemorrhage
K.28.1 Gastrojejunal ulcer, site unspecified, acute with perforation
K.28.2 Gastrojejunal ulcer, site unspecified, acute with both haemorrhage and perforation
K.28.4 Gastrojejunal ulcer, site unspecified, chronic or unspecified with haemorrhage
K.28.5 Gastrojejunal ulcer, site unspecified, chronic or unspecified with perforation
K.28.6 Gastrojejunal ulcer, site unspecified, chronic or unspecified with both haemorrhage and perforation
K.62.5 Haemorrhage of anus and rectum
K92.0 Other diseases of digestive system, Haematemesis
K92.1 Other diseases of digestive system, Melaena
K92.2 Other diseases of digestive system, Gastrointestinal haemorrhage, unspecified
R04 Haemorrhage from respiratory passages
R19.5 Occult blood in faeces
R23.3 Spontaneous ecchymoses, Petechiae
R31 Unspecified haematuria
T45.5 Poisoning by primarily systemic and haematological agents, not elsewhere classified, Anticoagulants
T45.7 Poisoning by primarily systemic and haematological agents, not elsewhere classified, Anticoagulant antagonists, vitamin
K and other coagulants
Y44.2 Complications of medical and surgical care, anticoagulants
Y44.3 Complications of medical and surgical care, Anticoagulant antagonists, vitamin K and other coagulants
Z88 Personal history of allergy to drugs, medicaments and biological substances
Z91.1 Personal history of noncompliance with medical treatment and regimen
Z.92.1 Personal history of long-term (current) use of anticoagulants

B. Indicator 2 – Antibiotic data collection

Pharmacist
1. In your hospital pharmacy records identify all 3. Complete the ‘Antibiotic therapy data collec-
health records of patients hospitalised between tion form’ using the patient’s health records,
dd.mm.yyyy and dd.mm.yyyy, which meet which are available to you (NB: collect the fol-
the inclusion criteria for the antibiotic indi- lowing information separately for each patient:
cator study (inclusion criteria: patients, who brand and international name of antibiotic;
were prescribed/dispensed during his/her hos- dose; schedule time of all antibiotic; informa-
pitalisation an active substance from J01 ATC tion about patient’s culture and sensitivity tests
group (all subclasses). Exclusion criteria: a. pa- (antibiogram)).
tients hospitalised at the intensive care unit; b. 4. Check with the diagnostic/laboratory depart-
patients with prophylactic use of antibiotic (e.g. ment in your hospital every record where there
after surgery)). is a lack of information about the patient’s an-
2. Randomly choose 10 % of all data, which meet tibiogram in order to confirm whether the an-
the inclusion criteria. The randomisation may tibiogram was done or not, and complete the
be done by including every 10th patient record ‘Antibiotic therapy data collection form’ ac-
in the final patient selection (minimum number cordingly.
of records to be included: 50).

55
The EDQM pharmaceutical care quality indicators project. Final report

TG2 Indicator 2 – Antibiotic therapy data collection form

1. Date: . . . . . . . . . . . . . . . . . . . . . . . . ☐ Telephone

2. Hospital identification (name and address): . ☐ Fax

. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . ☐ Desktop computer
. . . . . . . . . . . . . . . . . . . . . . . . . . .
☐ Portable computer, smartphone or tablet
Hospital characteristics (if applicable)
☐ Printer
3. Number of beds: . . . . . . . . . . . . . . . . .
☐ Internet connection
4. Specialisation (e.g. oncology, geriatric,
paediatric, orthopaedic; if none – write N.A.): ☐ Other, please specify . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
6. Time frame of data collection (dd.mm.yyyy –
5. Information technology (IT) equipment dd.mm.yyyy): . . . . . . . . . . . . . . . . . . .
available in the pharmacy (multiple answers . . . . . . . . . . . . . . . . . . . . . . . . . . .
possible)

Patient data collection form

performed but not available

Antibiotic therapy

Sensitivity and culture test

Results of sensitivity and
culture test available for

for pharmacist (yes, no)

(dd.mm.yyyy – dd.mm.

(dd.mm.yyyy – dd.mm.

pharmacist (yes, no)

INN* of a­ ntibiotic 1

INN* of antibiotic 2
Start and end date

Start and end date

Patient number

Daily dose (mg)

Daily dose (mg)

Admin. route**

Admin. route**
Gender (m/f)

Date of birth

Comments
yyyy)

yyyy)

* INN: International non-proprietary name (WHO – http://goo.gl/bC1zE)

** IMPL: implant; INHAL: inhalation; INSTILL: instillation; N: nasal; O: oral; P: parenteral; R: rectal; SL: sublingual; TD: transdermal; V: vaginal; OTH:
other

7. If patient’s medical data (i.e. results of ☐ Lack of personnel/time to implement and

sensitivity and cultural test) were not available maintain patient’s data sharing procedures
to you, what was the main reason for the non-
availability of the above data? ☐ The costs of data sharing are high

☐ Lack of technical equipment (e.g. computer; ☐ The quality of shared data is low
telephone) for sharing of patient’s medical
data ☐ The data sharing process is not secure

☐ Lack of IT system (i.e. pharmacy software) for ☐ I do not know

sharing of patient’s medical data
☐ Other, please specify . . . . . . . . . . . . . . .
☐ Legal restrictions (i.e. not allowed to receive/
share patient confidential data) 8. General comments/remarks: . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .

56
Appendix 3. Topic Group 3 – Structured patient-pharmacist consultations
(chronic therapy; polypharmacy; polymorbidity) via ‘My CheckList’
Steps to be followed for data collection
A. Indicator 1
Pharmacist ‒ Patient inclusion
1. When a patient delivers you a prescription for
one (or more than one) of the medications of
interest (i.e. cardiovascular (ATC codes: C01-
C10); alimentary tract and metabolism (ATC
codes: A01-A16); musculoskeletal system (ATC
codes: M01-M09); respiratory system (ATC
codes: R01-R07)) check the patient’s age.
2. If the patient’s age is between 18 and 65 years,
check if this is the 1st prescription that the
patient has received for the prescribed medica-
tion (i.e. the patient should not have received
this medication in the last 12 months). If you
make use of a pharmacy computer system, you
may check the patient’s prescription records to
see whether he/she is receiving the prescribed
medication for the 1st time. If you do not make
use of a pharmacy computer system, you may
ask the patient if he/she is receiving the pre-
scribed medication for the 1st time.
3. If the patient is receiving the prescribed medi-
cation for the 1st time, check whether the patient
meets one or more exclusion criteria (exclusion
criteria: a. No possibility for personal contact
with the patient (e.g. patients who cannot leave
their home); b. Physically frail elderly and
­patients receiving palliative care; c. Patients
with cognitive impairment). If not, the patient
can be included in the patient selection.
4. Inform the patient about the pharmaceutical
care activity he/she could be involved in. In par-
ticular, inform the patient that the goal of the
activity is to evaluate the level of patients’ in-
volvement in decisions about their medication
use and, hence, to promote and improve the ra-
57
tional use of medications. Inform the patient
that, if he/she agrees to join the process, he/she
will be asked to complete a short questionnaire
focused on his/her expectations and concerns
in the first weeks of the new treatment and to
attend a patient-pharmacist consultation fo-
cusing on the answers that he/she provided in
the questionnaire. The patient-pharmacist con-
sultation will last no more than 20 minutes,
will be voluntary and free.
5. After providing the above details, ask the
patient if he/she has any questions and if he/she
wants to be included in the above pharmaceu-
tical care activity.
6. If yes, take one empty ‘My CheckList’ form,
make an appointment for the patient-­
pharmacist consultation within 2-4 weeks
(if the patient agrees, this can be done at the
second dispensing of the medication) and write
date and time of the appointment on the form.
Hand the form over to the patient and inform
him/her that the form has to be completed at
home and brought back to the pharmacy at the
time of the patient-pharmacist consultation.
Pharmacist ‒ Patient-pharmacist consultation
1. Because personal information may be dis-
cussed, it is recommended to have the consul-
tation in a separate room/at a separate desk in
the pharmacy.
2. Ask the patient for the (filled in) ‘My Check-
List’ form.
3. Have a consultation with the patient based on
the answers given by the patient to the ques-
tions of ‘My CheckList’ form. It is recom-
mended to start the consultation by asking
the patient what subject he/she considers the
most important subject to discuss. The con-
The EDQM pharmaceutical care quality indicators project. Final report
sultation should be started by discussing this
subject. By doing so, the item that is the most
important for the patient will be discussed ad-
equately. Moreover, it is important to focus on
the answers given by the patient. If possible, try
to answer any questions that the patient may
have and discuss possible concerns. If possible,
try to think of solutions to problems that the
patient has experienced with the use of the
medication. In general, communicate posi-
tively and effectively throughout the consulta-
tion session, using language that is appropriate
and respectful to the patient, and adapt your
communication/consultation skills to meet the
needs of different patients.
4. Some consultations may lead to further action
points. If needed, another appointment can be
made with the patient for follow-up, either by
telephone or in a new face-to-face consultation.
5. Before concluding the consultation, determine
whether ‘My CheckList’ form has been thor-
58
oughly discussed and whether the patient re-
quires further explanation/information.
6. After the consultation, record the main out-
comes of the consultation by filling in the ‘Con-
sultation form for pharmacist’. Lastly, provide
an overall evaluation of the patient-pharma-
cist consultation; in particular, try to evaluate
whether the consultation was a constructive
consultation (in other words, it resulted in an
outcome aimed at improving the patient’s ra-
tional use of medications) or not (e.g. due to
the fact that the patient did not complete ‘My
CheckList’ form in a suitable way for the con-
sultations).
NB: it is important to keep track of the number
of ‘My CheckList’ forms that you handed out to your
patients and the number of completed ‘My CheckList’
forms that patients gave back to you.
 Appendices. Steps to be followed for data collection and data collection forms
TG3 Indicator 1 – ‘My CheckList’ form at the start of a chronic treatment
Pharmacy details (to be filled in by pharmacist): . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Patient details: . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Appointment:
Date: . . . . . . . . . . . . . . . . . . . . . . . .
Time: . . . . . . . . . . . . . . . . . . . . . . .
Please take a few minutes to answer the questions
reported in this form. The questions deal with
your expectations and concerns in the first weeks
of your new treatment.
Please answer the questions reported below at
home and bring this form with you for the consulta-
tion with your pharmacist. Your pharmacist will be 4b. If yes, please list unwanted effects that you
pleased to answer your questions during the consul-
tation, which will take approximately 15-20 minutes.
Questions that you, the patient, may have when
starting a new medication
1. What medication were you prescribed for the
1st time? Please write down the name of the
medication (or medications).
Medication 1: . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Medication 2: . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Medication 3: . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
2. What would you like to know about this
medication (or medications)? . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
3. What are your expectations of the effects of
this medication (or medications)? . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Please bring ‘My CheckList’ to your appointment with the pharmacist
59
4. Have you experienced problems using this
medication during the first weeks of treatment
(i.e. practical problems and/or unwanted
effects)?
☐ Yes
☐ No
☐ I do not know
4a. If yes, please list practical problems that
you experienced (e.g. problems in taking
the medication at the time indicated by the
prescriber). If you did not experience any
practical problems, please write ‘None’.
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
experienced. If you did not experience any
unwanted effects, please write, ‘None’.
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
5. Do you have concerns about taking this
treatment for long term (e.g. afraid of
experiencing side-effects; afraid that the
medication will affect my normal daily
routine; etc.)? If yes, please write your
concerns down. . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
6. What would be a reason for you to stop using
this medication? . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
7. Please note here any questions or issues that
you think will be important to discuss with
your pharmacist as you continue to receive the
treatment . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
The EDQM pharmaceutical care quality indicators project. Final report
TG3 Indicator 1 – Consultation form for pharmacist
Pharmacy details (to be filled in by pharmacist): . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Patient details: . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Appointment:
Date: . . . . . . . . . . . . . . . . . . . . . . . .
Time: . . . . . . . . . . . . . . . . . . . . . . .
1. Medication prescribed for 1st time (please, for
each medication, write down ATC code; INN;
pharmaceutical form and strength; posology;
pack size).
Medication 1
ATC: . . . . . . . . . . . . . . . . . . . . . . . .
INN: . . . . . . . . . . . . . . . . . . . . . . . .
Pharmaceutical form and strength: . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Posology: . . . . . . . . . . . . . . . . . . . . .
Pack size: . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Medication 2
ATC: . . . . . . . . . . . . . . . . . . . . . . . .
INN: . . . . . . . . . . . . . . . . . . . . . . . .
Pharmaceutical form and strength: . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Posology: . . . . . . . . . . . . . . . . . . . . .
Pack size: . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Medication 3
ATC: . . . . . . . . . . . . . . . . . . . . . . . .
INN: . . . . . . . . . . . . . . . . . . . . . . . .
Pharmaceutical form and strength: . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Posology: . . . . . . . . . . . . . . . . . . . . .
Pack size: . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
60
2. Patient-pharmacist consultation (please
provide a brief summary of main reactions
to the patient’s answers reported in the
completed ‘My CheckList’ form).
• What the patient would like to know about
his/her recently prescribed medication: . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
• Expectations of the medication effects: . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
• Problems experienced in first weeks of
treatment: . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
• Concerns: . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
• Reasons to stop treatment: . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
• Patient’s general comments: . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
3. Main outcome of the consultation (please
specify).
☐ Patient agreed that he/she understood better
the use of his/her medication
☐ Identification of possible side-effects
☐ Identification of patient’s non-adherence to
therapy
☐ Patient referred to the doctor due to side-
effects of prescribed medication
☐ Patient referred to the doctor due to patient’s
non-adherence to therapy
 Appendices. Steps to be followed for data collection and data collection forms
☐ No major outcome to be reported due to the
fact that the ‘My CheckList’ form was not
completed meaningfully (i.e. the patient’s
answers were not appropriate for this type of
consultation)
☐ I do not know
☐ Other, please specify
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
B. Indicator 2
Pharmacist ‒ Patient inclusion
1. When a patient delivers you a prescription for
one (or more than one) of the medications of
interest (i.e. cardiovascular (ATC codes: C01-
C10); alimentary tract and metabolism (ATC
codes: A01-A16); musculoskeletal system (ATC
codes: M01-M09); respiratory system (ATC
codes: R01-R07)) check the patient’s age.
2. If the patient is ≥ 65 years, check if the patient
is a polypharmacy patient (i.e. he/she uses ≥ 5
medications for chronic conditions, belonging
to the medication categories reported above). If
you make use of a pharmacy computer system,
you may check the patient’s prescription
records to see whether he/she receives ≥ 5 med-
ications belonging to the above medication cat-
egories. If you do not make use of a pharmacy
computer system, you may ask the patient if he/
she is a polypharmacy patient.
3. If the patient is a polypharmacy patient, check
whether the patient meets the exclusion cri-
teria (exclusion criteria: a. No possibility for
personal contact with the patient (e.g. patients
who cannot leave their home); b. Physically
frail elderly and patients receiving palliative
care; c. Patients with cognitive impairment). If
not, the patient can be included in the patient
selection.
4. Inform the patient about the pharmaceutical
care activity he/she could be involved in. In
particular, inform the patient that the goal of
the activity is to evaluate the level of patients’
involvement in decisions about their medica-
tion use and, hence, to promote and improve
the rational use of medications. Inform the
patient that, if he/she agrees to join the process,
he/she will be asked to complete a short ques-
tionnaire focused on his/her expectations
and concerns around the medications he/she
is currently taking and to attend a patient-­
61
pharmacist consultation based on the answers
that he/she provided in the questionnaire. The
patient-pharmacist consultation will last no
more than 20 minutes. Inform the patient that,
after attending the patient-pharmacist consul-
tation, if needed and wished, he/she may be
invited to participate in a second meeting with
the pharmacist (medication review) which will
be a discussion of his/her complete set of med-
ications with the aim of optimising medicines
use and improving therapy outcomes. Lastly,
inform the patient that participation in the ac-
tivity is voluntary and free.
5. After providing the above details, ask the
patient if he/she has any questions and if he/she
wants to be included in the activity.
6. If yes, take one empty ‘My CheckList’ form,
make an appointment for the patient-­
pharmacist consultation (at a convenient time
for the patient) and write date and time of the
appointment on the form. Hand the form over
to the patient and tell him/her that the form
has to be completed at home and brought back
to the pharmacy at the time of the patient-­
pharmacist consultation.
Pharmacist – Patient-pharmacist consultation
Please see Indicator 1 ‘Patient-pharmacist
consultation.’
Pharmacist ‒ Involvement of patients in medica-
tion review
1. After performing the patient-pharmacist con-
sultation, ask the patient if he/she would like to
take part in a medication review. Explain to the
patient that a medication review is a meeting
to discuss in detail his/her medicines with you.
The meeting is free and is an opportunity to
check that his/her medicines are the best ones
for him/her. It is also an opportunity for him/
her to ask questions and find out more about
his/her medicines. Its purpose is to check that
he/she is getting the best from his/her medi-
cines. Point out that the meeting is confiden-
tial (whoever the patient talks to, the details
will be kept private). He/she can speak openly
about any worries he/she may have about his/
her medicines and the person conducting the
medication review will listen to him/her. No
medicines will be altered without agreement
with him/her and the doctor.
2. After providing the above details, ask the
patient if he/she has any questions and if he/she
wants to have his/her medications reviewed.
The EDQM pharmaceutical care quality indicators project. Final report

3. If yes, make an appointment for the medica- perienced in ordering, obtaining, taking, using
tion review. Moreover, ask the patient to bring and storing the medicines; drug interactions;
along a list of all medicines that are prescribed medicine costs; lifestyle issues (e.g. smoking
for him/her and any medicines that he/she status; weight management; etc.).
buys from the pharmacy, health shop or super- 3. Action proposed: discuss the issue with the
market (e.g. painkillers, vitamins, herbal prod- patient and, whenever possible, propose an
ucts). Lastly, tell the patient that, if he/she has action. If the patient agrees, write down the
any questions/concerns/suggestions about his/ proposed action. Actions may include: need to
her medicines, he/she can write them down change the medication form (e.g. from tablets
and bring this aide-mémoire with him/her for to liquids) to facilitate effective medication
the medication review. usage; addition of a non-prescription product
to improve overall health; need to change the
Pharmacist ‒ Medication review process medication (due, for instance, to side-effects);
commencement of a smoking cessation pro-
Patient details gramme.
1. If applicable, write down any known allergies/ 4. For consideration: tick who is to consider the
sensitivities/contraindications. action proposed.
2. If applicable, write down any tests that the 5. Implementation authorised/refused: if possible,
patient is currently undergoing. write down whether the proposed action was
authorised or refused (e.g. after contacting the
Medicine list patient’s GP and asking for a change the med-
1. Avoid abbreviations/symbols which may cause ication form, record if the GP accepted your
confusion (e.g. use ‘microgram’ rather than proposal).
‘µg’).
2. Duration of therapy: provide an approximate Review date
length of time the patient has been treated with 1. The patient should be urged to follow up on the
this medicine. agreed implementations.
3. Indication or reason for use: provide the in- 2. Provide a goal date when the agreed implemen-
dication (based on your pharmacy records – tations will be reviewed.
if applicable – or on the patient’s statement)/
reason for use. If possible, use simple language. General considerations for medication review
4. Prescribed by whom: record whether the medi- 1. Check that:
cation was prescribed by the GP or a specialist; • The medication prescribed is appropriate for
when possible, record the prescriber’s name the patient’s needs
and contact details (this will allow you to get in • The medication is effective for the patient
touch with the prescriber, in case of need). • The medication is appropriate for the patient
5. Special instructions: list any instructions that • The medication is a cost-effective choice
the patient needs to follow when taking a • Any required monitoring has been done or ar-
certain medicine. rangements are in place (e.g. blood monitoring
6. Please note that the medication review should tests specific to a medication or to monitoring
cover all medications (prescription and a disease)
non-prescription medicines), and should be as • The patient’s concerns, needs and expectations
in-depth as possible. are addressed appropriately
2. Consider:
Action plan • Drug interactions
1. Medicine number: if applicable, write down • Contraindications to the drug (e.g. impaired
the medicine number (in line with the medi- kidney function)
cine number reported in the Medicine list) in • Side-effects
order to be able to record, for each medicine, • Therapy adherence
the identified issues and action taken. • Non-prescription and complementary medi-
2. Issue: if applicable, record any identified issue cines
linked to the use of a certain medicine. Issues • Lifestyle and non-medicinal interventions
may include: medication adherence issue; • Unmet need (e.g. identification of untreated/
adverse effects from medicine; difficulties ex- new conditions)

62
 Appendices. Steps to be followed for data collection and data collection forms
3. Record:
• Information pertinent to any decisions made
• Recommendations
• Acceptance/refusal of proposed recommenda-
tions
• Follow-up
Possible questions to be asked to patients while per-
forming a medication review
1. Please explain what your medicines are for.
2. Please explain when you have to take your
medicines.
3. Please let me know whether you find it easy
to take your medicines as prescribed/recom-
mended by your physician/pharmacist.
4. Please let me know whether you always re-
member to take your medicines.
5. Please let me know whether the medicines cur-
rently prescribed by your GP/specialists are the
only medicines you take.
6. Please explain whether you feel comfortable
with your current medications.
7. Please let me know whether you are facing
some problems/obstacles in ordering all your
medicines at the same time.
NB:
1. It is important to keep track of the number of
‘My CheckList’ forms that you handed out to
your patients and the number of completed ‘My
CheckList’ forms that patients gave back to you.
2. It is important to keep in mind that ‘My Check-
List form’ (Indicator 2) should only be filled in
with chronic medications belonging to the se-
lected ATC groups (i.e. cardiovascular (ATC 4. Pharmaceutical Care Network Europe (PCNE) – Link:
codes: C01-C10); alimentary tract and metab-
olism (ATC codes: A01-A16); musculoskeletal 5. Pharmaceutical Society of Australia (PSA). Guide-
system (ATC codes: M01-M09); respiratory
system (ATC codes: R01-R07)) and, as far as
possible, the patient-pharmacist consulta-
tion should only focus on these medications.
On the contrary, the ‘Form for medication
63
review’ can be filled in with all medications
that the patient uses and the medication review
should cover all medications (prescription and
non-prescription medicines, too), which might
represent a problem for the patient.
3. If easier/doable for both pharmacist and patient,
it is possible to perform the medication review
right after performing the patient-pharmacist
consultation (i.e. the consultation based on the
completed ‘My CheckList form’). If this is not
the case, the medication review can be per-
formed during a separate appointment.
References (used for: definitions; medication
review process; form for medication review)
1. NHS Cumbria Medicines Management Team. Clin-
ical medication review – A practice guide. 2013 – Link:
http://w w w.cumbria.nhs.uk /Professional​ Z one/
MedicinesManagement/Guidelines/Medication
Review-PracticeGuide2011.pdf (last accessed: August
2016).
2. Northern Health and Social Services Board. A guide
to patient medication review. 2003 – Link: http://goo.
gl/Dbp5cc (last accessed: August 2016).
3. Nunes V, Neilson J, O’Flynn N, Calvert N, Kuntze S,
Smithson H, Benson J, Blair J, Bowser A, Clyne
W, Crome P, Haddad P, Hemingway S, Horne R,
Johnson S, Kelly S, Packham B, Patel M, Steel J. 2009
Clinical Guidelines and Evidence Review for Medi-
cines Adherence: Involving patients in decisions about
prescribed medicines and supporting adherence.
London: National Collaborating Centre for Primary
Care and Royal College of General Practitioners.
http://www.pcne.org (last accessed: August 2016).
lines for pharmacists providing medicines use review
(MedsCheck) and diabetes medication management
(Diabetes MedsCheck) services. 2012 -Link: http://goo.
gl/5EpUxk (last accessed: August 2016).
The EDQM pharmaceutical care quality indicators project. Final report
TG3 Indicator 2 – ‘My CheckList’ form regarding the chronic use of my
medications
Pharmacy details (to be filled in by pharmacist): . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Patient details: . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Appointment:
Date: . . . . . . . . . . . . . . . . . . . . . . . .
Time: . . . . . . . . . . . . . . . . . . . . . . .
Please take a few minutes to answer the questions
reported in this form. The questions deal with
your expectations and concerns regarding the
medications that you are currently taking.
Please answer the questions reported below at
home and bring this form with you for the consulta-
tion with your pharmacist. Your pharmacist will be
pleased to answer your questions during the consul-
tation, which will take approximately 15-20 minutes.
Questions that you, the patient, may have
concerning the medications that you are
currently taking
1. What medications are you currently taking?
Please write down the names of your
medications.
Medication 1: . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Medication 2: . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Medication 3: . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Medication 4: . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Medication 5: . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Medication 6: . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Medication 7: . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Medication 8: . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
64
Medication 9: . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Medication X: . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
2. Is there anything that you would like to know
about these medications? If yes, please write it
down. . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
3. What are your expectations of the effects of
the medications that you are currently taking?
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
3a. Are your expectations actually met?
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
4. Are you experiencing any problems related
to the use of these medications (i.e. practical
problems and/or unwanted effects)?
☐ Yes
☐ No
☐ I do not know
4a. If yes, please list practical problems that you
are currently experiencing (e.g. problems in
taking the medication at the time indicated by
the prescriber). If you do not experience any
practical problems, please write ‘None’.
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
 Appendices. Steps to be followed for data collection and data collection forms
4b. If yes, please list unwanted effects that you
are currently experiencing. If you do not
experience any unwanted effects, please write
‘None’.
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
5. Do you have concerns about the fact that you
have been taking these medications for a long
time (e.g. afraid of experiencing more side-
effects; afraid of becoming dependent on your
medications; etc.)? If yes, please write your
concerns down. . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Please bring ‘My CheckList’ to your appointment with the pharmacist
65
6. Have you ever thought to stop taking your
medications?
☐ Yes
☐ No
☐ I do not know
6a. If yes, what was the main reason (or reasons)
that led you to such a consideration?
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
7. Please note here any questions or issues that
you think will be important to discuss with
your pharmacist about the chronic use of your
medications . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
The EDQM pharmaceutical care quality indicators project. Final report
TG3 Indicator 2 – Consultation form for pharmacist
Pharmacy details (to be filled in by pharmacist): . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Patient details: . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Appointment:
Date: . . . . . . . . . . . . . . . . . . . . . . . .
Time: . . . . . . . . . . . . . . . . . . . . . . .
1. Medications that your patient is currently
taking (please, for each medication, write
down ATC code; INN; pharmaceutical form
and strength; posology; pack size).
Medication 1
ATC: . . . . . . . . . . . . . . . . . . . . . . . .
INN: . . . . . . . . . . . . . . . . . . . . . . . .
Pharmaceutical form and strength: . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Posology: . . . . . . . . . . . . . . . . . . . . .
Pack size: . . . . . . . . . . . . . . . . . . . . .
Medication 2
ATC: . . . . . . . . . . . . . . . . . . . . . . . .
INN: . . . . . . . . . . . . . . . . . . . . . . . .
Pharmaceutical form and strength: . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Posology: . . . . . . . . . . . . . . . . . . . . .
Pack size: . . . . . . . . . . . . . . . . . . . . .
Medication 3
ATC: . . . . . . . . . . . . . . . . . . . . . . . .
INN: . . . . . . . . . . . . . . . . . . . . . . . .
Pharmaceutical form and strength: . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Posology: . . . . . . . . . . . . . . . . . . . . .
Pack size: . . . . . . . . . . . . . . . . . . . . .
Medication X
ATC: . . . . . . . . . . . . . . . . . . . . . . . .
INN: . . . . . . . . . . . . . . . . . . . . . . . .
Pharmaceutical form and strength: . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Posology: . . . . . . . . . . . . . . . . . . . . .
Pack size: . . . . . . . . . . . . . . . . . . . . .
66
2. Patient-pharmacist consultation (please
provide a brief summary of main reactions
to the patient’s answers reported in the
completed ‘My CheckList’ form).
• What the patient would like to know about
his/her chronic medications: . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
• Expectations of the medication effects: . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
• Problems that the patient is currently
experiencing: . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
• Concerns about the patient’s chronic
treatment: . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
• Reasons to stop treatment: . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
• Patient’s general comments: . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
3. Main outcome of the consultation (please
specify).
☐ Patient agreed that he/she understood better
the use of his/her medication
☐ Identification of possible side-effects
☐ Identification of patient’s non-adherence to
therapy
☐ Patient referred to the doctor due to side-
effects of prescribed medication
☐ Patient referred to the doctor due to patient’s
non-adherence to therapy
 Appendices. Steps to be followed for data collection and data collection forms

☐ No major outcome to be reported due to the ☐ I do not know

fact that the ‘My CheckList’ form was not
completed meaningfully (i.e. the patient’s
answers were not appropriate for this type of
consultation)
☐ Other, please specify
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .

67
The EDQM pharmaceutical care quality indicators project. Final report

TG3 Indicator 2 – Form for medication review

Definition of medication review

Pharmacy details (if applicable)
A medication review is an evaluation of a patient’s
medicines with the aim of optimising the outcomes
of medicine therapy. This entails identifying the pa- Pharmacy name: . . . . . . . . . . . . . . . . . . . . .
tient’s needs, concerns and expectations, (potential) . . . . . . . . . . . . . . . . . . . . . . . . . . .
risks, detecting medication-related problems and
suggesting solutions (source: based on a definition by Address: . . . . . . . . . . . . . . . . . . . . . . . . .
the Pharmaceutical Care Network Europe (PCNE) – . . . . . . . . . . . . . . . . . . . . . . . . . . .
Link: http://www.pcne.org/index.php). . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Patient details
Telephone: . . . . . . . . . . . . . . . . . . . . . . . .
Surname: . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . E-mail: . . . . . . . . . . . . . . . . . . . . . . . . . .

First name: . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . GP details

Date of birth: . . . . . . . . . . . . . . . . . . . . . . . Name : . . . . . . . . . . . . . . . . . . . . . . . . . . .

Address: . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Address: . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .

Telephone: . . . . . . . . . . . . . . . . . . . . . . . . Telephone: . . . . . . . . . . . . . . . . . . . . . . . .

E-mail: . . . . . . . . . . . . . . . . . . . . . . . . . . E-mail: . . . . . . . . . . . . . . . . . . . . . . . . . .

Known allergies/sensitivities/contraindications:
. . . . . . . . . . . . . . . . . . . . . . . . . . . Date of medication review (dd.mm.yyyy)
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .

Patient’s monitoring
(e.g. blood pressure; liver function tests; blood
clotting tests): . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .

68
 Appendices. Steps to be followed for data collection and data collection forms

Medicine list

Include details of all current, regular (taken on an on-going basis) and ‘p.r.n.’ (taken when necessary)
medicines, including prescription, non-prescription and complementary medicines.
ATC + INN Pharmaceutical Posology Duration of Indication or Prescribed by Special
form and therapy reason for use whom instructions
strength
Med. 1

Med. 2

Med. 3

Med. 4

Med. 5

Med. 6

Med. 7

Med. 8

Med. 9

Med. 10

Med. X

Action plan

Med. No. Issue Action proposed For consideration (tick to indi- Implementation authorised/
cate responsibility) refused
☐  Patient
☐  Pharmacist
☐  GP
☐  Other healthcare professional
☐  Other. . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
☐  Patient
☐  Pharmacist
☐  GP
☐  Other healthcare professional
☐  Other. . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

69
The EDQM pharmaceutical care quality indicators project. Final report

Med. No. Issue Action proposed For consideration (tick to indi- Implementation authorised/
cate responsibility) refused
☐  Patient
☐  Pharmacist
☐  GP
☐  Other healthcare professional
☐  Other. . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
☐  Patient
☐  Pharmacist
☐  GP
☐  Other healthcare professional
☐  Other. . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
☐  Patient
☐  Pharmacist
☐  GP
☐  Other healthcare professional
☐  Other. . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
☐  Patient
☐  Pharmacist
☐  GP
☐  Other healthcare professional
☐  Other. . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
☐  Patient
☐  Pharmacist
☐  GP
☐  Other healthcare professional
☐  Other. . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
☐  Patient
☐  Pharmacist
☐  GP
☐  Other healthcare professional
☐  Other. . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
☐  Patient
☐  Pharmacist
☐  GP
☐  Other healthcare professional
☐  Other. . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Review date (dd.mm.yyyy)

. . . . . . . . . . . . . . . . . . . . . . . . . . .

70
 Appendices. Steps to be followed for data collection and data collection forms

TG3 Questionnaire for pharmacists

NB: This questionnaire can be used to obtain an 6. Is there a separate consulting room present in
overview of the practice by which medication reviews the pharmacy?
are undertaken in community pharmacies located in
a given country/region/etc. ☐ Yes

1. Date (dd.mm.yyyy): . . . . . . . . . . . . . . . ☐ No

2. Pharmacy details: 7. Could you write down the estimated numbers

. . . . . . . . . . . . . . . . . . . . . . . . . . . of chronic polypharmacy patients, aged 65
. . . . . . . . . . . . . . . . . . . . . . . . . . . years or older (see footnote, page 72) of
. . . . . . . . . . . . . . . . . . . . . . . . . . . your pharmacy?
. . . . . . . . . . . . . . . . . . . . . . . . . . .
☐ Less than 100
3. What is the number of inhabitants of the
town/city where your pharmacy is located? ☐ > 100 but < 200

☐ Less than 10 000 inhabitants ☐ > 200 but < 300

☐ 10 000-50 000 inhabitants ☐ > 300 but < 400

☐ 50 000-150 000 inhabitants ☐ > 400 but < 500

☐ 150 000-1 000 000 inhabitants ☐ > 500 but < 600

☐ More than 1 000 000 inhabitants ☐ > 600 but < 700

4. What is the size of the patient population ☐ > 700 but < 800
served by your pharmacy?
☐ > 800 but < 900
Actual size (if known): . . . . . . . . . . . . . . . . .
☐ > 900 but < 1 000
Or estimated size:
☐ > 1 000
☐ < 3 000
8. Please estimate how many medication reviews
☐ 3 000-5 000 for chronic polypharmacy patients, aged
65 years or older, were undertaken in your
☐ 5 000-7 000 pharmacy in the past 6 months.

☐ 9 000-12 000 ☐ None

☐ 12 000-15 000 ☐ Less than 5

☐ > 15 000 ☐ > 5 but < 10

5. How many staff members in the dispensary/ ☐ > 10 but < 30

at the counter are operative in your pharmacy
(including all pharmacists and pharmacists’ ☐ > 30 but < 50
assistants)?
. . . . . . . . . . . . . . . . . . . . . . . . . . . ☐ > 50
full time-equivalents (FTEs)

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The EDQM pharmaceutical care quality indicators project. Final report

9a. How many medication reviews for chronic 9b. How are data from medication reviews
polypharmacy patients,* aged 65 years or recorded in your pharmacy?
older, were recorded in the past 6 months?
☐ Not recorded
☐ None
☐ A paper record
☐ Less than 5
☐ An electronic record
☐ > 5 but < 10
10. Please add any additional comments here
☐ > 10 but < 30 . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
☐ > 30 but < 50 . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
☐ > 50 . . . . . . . . . . . . . . . . . . . . . . . . . . .

* Definition of chronic polypharmacy patients: patients

who take 5 or more medicines for at least 6 months.

72
Appendix 4. Topic Group 4 – Pharmacist’s self-assessment tool (PharmSAT)
for pharmaceutical care implementation V.4

Background
sional collaboration, patient involvement, desired
The Committee of Experts on Quality and quality of life, needs and expectations. The diagram
Safety Standards in Pharmaceutical Practices and on page 74 (Figure 1) illustrates how the pharma-
Care (CD-P-PH/PC) (go.edqm.eu/PC), co-­ordinated ceutical care philosophy should be implemented in
by the European Directorate for the Quality of pharmacy practice.
Medicines & HealthCare (EDQM) (www.edqm.eu)
(Council of Europe), set up a work programme to Glossary of terms
assess the quality of pharmaceutical care and med-
ication use in Europe and its impact on patients’ Adverse drug reaction (ADR)
quality of life in order to provide support for health Response to a medicinal product which is noxious
policy-makers and to improve professional standards and unintended and which occurs at doses normally
for all professionals involved in the medication chain. used in man for the prophylaxis, diagnosis or therapy
Quality indicators help raise awareness and of disease or for the restoration, correction or mod-
provide practical guidance for healthcare profes- ification of physiological function. [Source: Council
sionals with the aim of improving the quality of of Europe Expert Group on Safe Medication Practices.
pharmaceutical practice and care throughout Europe, Creation of a Better Medication Safety Culture in
and giving policy-makers the data and rationale they Europe: Building Up Safe Medication Practices. 2006
require to prepare policies and harmonised provi- Strasbourg: Council of Europe]
sions and practices in the field of pharmaceuticals.
Indicators must have the following Documentation
characteristics: The detailed description of a patient-provider or
• ‘[…] applicable to all healthcare systems in ­provider-provider interaction. Documentation serves
Europe’ as a record for stating relevant participants, evidence,
• ‘[…] easiness to use and implement by health- assumptions, rationale, and analytical methods used
care professionals in different systems and cul- in evaluating patient progress and quality of care or
tures and languages’ outcomes for individuals. It also functions as a means
• ‘[…] no need for expert equipment or specific of communication among providers and analysis for
expertise to use the indicator and to interpret billing purposes. [Source: McGivney MS, Meyer SM,
the data’ Duncan-Hewitt W, Hall DL, Goode JV, Smith RB.
Medication Therapy Management: Its relationship to
This instrument is designed to help commu- patient counseling, disease management and pharma-
nity pharmacists implement pharmaceutical care ceutical care. J Am Pharm Assoc 2007; 47 (5): 620-628]
principles as a means of improving the quality of
care delivered. These principles include patient coun- Customer loyalty
selling and education, documentation of interactions An intended behaviour related to the product or
between healthcare professionals and patients (med- service. This includes the likelihood of future pur-
ication decision), follow-up of medication decisions chases or renewal of service contracts or, conversely,
(stop, continue or modify medication), inter-profes-

73
The EDQM pharmaceutical care quality indicators project. Final report

how likely it is that the customer will switch to Non-prescription medicines

another brand or service provider. Medicines which may be dispensed without a pre-
scription and which, in some countries, are available
Follow-up via self-service in pharmacies and/or other retail
Maintenance of contact with or re-­ examination outlets (e.g. drug stores). Selected non-prescription
of a person (as a patient) at usually prescribed products may be reimbursed for certain indications
intervals following diagnosis or treatment. in some countries. [Source: Pharmaceutical Health
[Source: ­Merriam-Webster’s Medical Dictionary. information System – Link: phis.goeg.at]
­Merriam-Webster Inc. – Link: www.merriam-webster.
com] Patient information leaflet (PIL)
A leaflet containing information for the user which
Medication review accompanies the medicinal product. [Source: Direc-
An evaluation of the patient’s medicines with the aim tive 92/27/EC of the European Council of 31 March
of optimising the outcome of medicine therapy by 1993 on the labelling of medicinal products for human
detecting, solving and preventing drug-related prob- use and on package leaflets. Official Journal L-113,
lems. [Source: Pharmaceutical Care Network Europe 30/04/1992]
– Link: www.pcne.org]
Patient
Interprofessional collaboration An individual awaiting or under medical care and
Working together with one or more healthcare pro- treatment; the recipient of any of various personal
fessionals who each make a unique contribution to services. [Source: Merriam-Webster’s Medical Dic-
obtain optimal patient medication outcomes, taking tionary. Merriam-Webster Inc. – Link: www.­merriam-
into account patient needs, expectations, and quality webster.com]
of life. [Source: adapted from College of Nurses of
Ontario – Link: www.hprac.org]

Figure 1.  Concept of pharmaceutical care

Pharmaceutical Pharmaceutical
services directly care
delivered to
patients, e.g. Patient counselling
• dispensing of and education
medicines
• blood
pressure
measurement
• self-care Patient
services involvement
Inter-professional (desired quality of life,
• etc.
collaboration needs and
expectations)

Follow-up to
Documentation of
medication decision
interaction
(stop, continue,
(medication
modify medication)
decision)

74
 Appendices. Steps to be followed for data collection and data collection forms

Patient medication profile The fundamental relationship in pharmaceutical care

A comprehensive summary of all regular medicines is a mutually beneficial exchange in which the patient
taken by the patient. [Source: The Pharmacy Guild grants authority to the provider and the provider
of Australia, Professional Pharmacy Services – Link: offers competence and commitment (accepts respon-
www.guild.org.au] sibility) to the patient. These fundamental goals, pro-
cesses, and relationships of pharmaceutical care exist
Patient counselling regardless of practice setting and professional back-
Providing product-specific advice to a patient re- ground. [Source: Hepler CD, Strand LM. Opportuni-
garding medications, health-related devices, con- ties and responsibilities in pharmaceutical care. Am J
cerns or disease states. [Source: McGivney MS, Meyer Hosp Pharm 1990; 47 (3): 533-543]
SM, Duncan-Hewitt W, Hall DL, Goode JV, Smith RB.
Medication Therapy Management: Its relationship to Pharmaceutical services
patient counseling, disease management and pharma- All services provided by a qualified pharmacist. These
ceutical care. J Am Pharm Assoc 2007; 47 (5): 620-628] include essential services provided by all pharma-
cists, such as dispensing of medicines, repeat med-
Patient education icines dispensing, self-care services, waste disposal,
The process of teaching a patient and/or caregiver signposting to key resources, etc., and enhanced
information about a related medication, product, (advanced) services provided by the pharmacist
device, or healthcare topic, taking account of patient that meet certain defined criteria, including a large
involvement, desired quality of life, needs and expec- spectrum of more comprehensive services such as
tations. Education is differentiated from counselling point-of-care or health screening services (e.g. blood
by inclusion of an evaluative component to assess the pressure measurement, blood glucose and cholesterol
patient’s level of understanding. [Source: McGivney testing, etc.), quitting smoking, weight management,
MS, Meyer SM, Duncan-Hewitt W, Hall DL, Goode JV, minor ailment service, and emergency hormonal
Smith RB. Medication Therapy Management: Its rela- contraception, etc. [Source: National Health Service,
tionship to patient counseling, disease management UK – Link: www.nhs.uk]
and pharmaceutical care. J Am Pharm Assoc 2007;
47 (5): 620-628] Professional assessment of prescription
Assessment of whether the prescription includes
Pharmaceutical care an appropriate dosage form and appropriate route
The responsible provision of drug therapy for the of administration; appropriateness with regard to
purpose of achieving definite outcomes that improve the patient’s condition; dosage within therapeutic
a patient’s quality of life. range; duration of treatment; appropriateness with
These outcomes are: regard to the patient’s parameters (age, weight, etc.)
• cure of a disease; and previous medication; compatibility with other
• elimination or reduction of a patients’ symp- medication; consistency with formularies, clin-
toms and signs; ical guidelines and protocols; possible side-effects;
• arresting or slowing a disease process; or risk of adverse drug reactions; potential for non-­
• preventing a disease or symptoms and signs. concordance, in­appropriate use and misuse by the
Pharmaceutical care involves the process by which a patient; and contra­indications [Source: Royal Phar-
pharmacist co-operates with the patient and health- maceutical Society of Great Britain. Developing and
care professionals in designing, implementing, and implementing standard operating procedures for dis-
monitoring a therapeutic plan that will produce spe- pensing – Link: goo.gl/lz6tA]
cific therapeutic outcomes for the patient. This in
turn involves three major functions: Instructions for conducting the self-assessment
• identifying potential and actual drug-related
problems; The aim of this self-assessment tool is to help
• resolving actual drug-related problems; pharmacists evaluate their progress in pharmaceu-
• preventing drug-related problems. tical care implementation. If there is more than one
Pharmaceutical care is a necessary part of healthcare, practising individual in your pharmacy, it is useful
and should be integrated with other elements. Phar- to appoint a team made up of the owners/managers,
maceutical care is, however, provided for the direct staff pharmacists and pharmacy technicians to assess
benefit of the patient, and the pharmacist is respon- your pharmacy’s system after thoroughly investi-
sible directly to the patient for the quality of that care. gating the level of implementation for each character-

75
The EDQM pharmaceutical care quality indicators project. Final report
istic covered. The person responsible for performing
the self-assessment should be allowed sufficient time
to complete the self-assessment and be asked to eval-
uate, accurately and honestly, the current status of
practices in the pharmacy.
Before completing the questionnaire, please
read the introduction and glossary of terms carefully.
The self-assessment tool is made up of 7 sections:
1. Information about the respondent
2. Pharmacy situation in context
3. Continuous professional development
4. Dispensing of medicines
5. Self-care services
6. Point-of-care testing (health screening) ser-
vices
7. Evaluation of self-assessment
Section 1 ‘Information about the respondent’
collates data about the respondent: name, function
and pharmacy name.
Section 2 ‘Pharmacy situation in context’ de-
scribes the main characteristics of the pharmacy,
such as its location, the number of visitors, staff
numbers, etc.
Section 3 ‘Continuous professional develop-
ment’ deals with staff qualification in the domain of
Pharmaceutical Care.
Sections 4, 5 and 6 are the main parts of this
self-assessment tool and describe the current ap-
proach to dispensing medicines, to customers re-
quiring non-prescription medicines either for
themselves or somebody else, and the provision of
health screening tests in your pharmacy. Each of
these sections is divided into 5 subsections, according
to the concept described in Figure 1, as shown below:
76
• Patient assessment
• Patient counselling and education
• Documentation
• Follow-up
• Inter-professional collaboration
Every subsection contains one or more ques-
tions designed to collect specific information about
the characteristics of pharmacy practice. Each ques-
tion states whether one or more answers are to be
given. For some questions, the answer will be a con-
crete number or percentage. Each question scores a
certain number of points. The total score is to be cal-
culated at the end of every section, and the MAXIMUM
POSSIBLE POINTS is also shown. The calculated mark
for each section is obtained by dividing your score by
the MAXIMUM POSSIBLE POINTS and multiplying the
result by 10.
At the end of sections 3, 4, 5 and 6 there is an
evaluation grid depending on the score obtained,
which can be used to determine your implementa-
tion category. Recommendations for improvement
are given for each category.
Section 7 ‘Evaluation of self-assessment’ pro-
vides a final scale which gives you a general overview
of the level of pharmaceutical care implementation in
your pharmacy. Your place on this scale is obtained
by combining the scores you obtained for sections
3, 4, 5 and 6 after multiplying them by the following
factors:
• Mark for section 3 – by 0.2
• Mark for section 4 – by 0.3
• Mark for section 5 – by 0.3
• Mark for section 6 – by 0.2.
 Appendices. Steps to be followed for data collection and data collection forms

TG4 Pharmacist’s self-assessment tool

1. Information about the respondent

1.1. Your name and surname: . . . . . . . . . . . . 1.3. Name of pharmacy: . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1.2. Your function in the pharmacy: . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .

2. Pharmacy situation in context

2.1. Is your pharmacy situated in a community a. Pharmacists: . . . . . . . . . . . . . . . . . . .

having:
b. Pharmacy technicians: . . . . . . . . . . . . . .
☐ Less than 10 000 inhabitants
c. Other, please specify . . . . . . . . . . . . . . .
☐ 10 000-50 000 inhabitants . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
☐ 50 000-150 000 inhabitants . . . . . . . . . . . . . . . . . . . . . . . . . . .

☐ 150 000-1 000 000 inhabitants 2.4. Is customer retention measured in your
pharmacy?
☐ More than 1 000 000 inhabitants
☐ Yes
2.2. How many patients/visitors does your
pharmacy supply/counsel per day? Please ☐ No
specify . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . 2.5. If yes, what percentage of your total clientele
per year consists of regular (loyal) customers?
2.3. How many staff work in your pharmacy? . . . . . . . . . . . . . . . . . . . . . . . . . . .

3. Continuous professional development

3.1. Share of pharmacists who completed 3.2. Share of pharmacists who completed
university education in Pharmaceutical Care. continuous education in Pharmaceutical Care.
Tick one. Tick one.

☐ 0-10 % (0 points) ☐ 0-10 % (0 points)

☐ 10-25 % (1 point) ☐ 10-25 % (1 point)

☐ 25-50 % (2 points) ☐ 25-50 % (2 points)

☐ 50-75 % (3 points) ☐ 50-75 % (3 points)

☐ 75-100 % (4 points) ☐ 75-100 % (4 points)

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The EDQM pharmaceutical care quality indicators project. Final report

3.3. How often do your pharmacists take ☐ No continuous education (0 points)

continuous education courses in
Pharmaceutical Care? Tick one. ☐ University (3 points)

☐ Never (0 points) ☐ Professional organisations (2 points)

☐ Once in 5 years or less (1 point) ☐ Pharmaceutical companies (1 point)

☐ Once in 3-5 years (2 points) Your points for section 3: . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . .
☐ Once in 1-3 years (3 points)
Maximum possible points: 18
☐ More than once a year (4 points)
Your calculated score for section 3: . . . . . .
3.4. Who provides continuous education courses . . . . . . . . . . . . . . . . . . . . . . . . . . .
in Pharmaceutical Care for your pharmacists?
Tick where applicable.

Evaluation of Section 3, ‘Continuous professional development’

Your total score Level of staff qualification in Pharmaceutical Care
≤ 9 No qualification in Pharmaceutical Care
10-12 Low level of qualification in Pharmaceutical Care
13-15 Medium level of qualification in Pharmaceutical Care
16-18 High level of qualification in Pharmaceutical Care

Recommendations for improvement, Section 3, • The proportion of pharmacists with contin-

‘Continuous professional development’ uous education in Pharmaceutical Care must
be increased.
A. No qualification in Pharmaceutical Care • The frequency of continuous education courses
• Not less than 50 % of pharmacists should have must be increased.
completed university education in Pharmaceu-
tical Care. C. Medium level of qualification in Pharmaceu-
• Not less than 50 % of pharmacists should have tical Care
completed continuous education in Pharma- • The frequency of continuous education courses
ceutical Care. needs to be increased.
• Frequency of continuous education should be
not less than once every 5 years. D. High level of qualification in Pharmaceutical
Care
B. Low level of qualification in Pharmaceutical • The current high level of staff qualification
Care must be maintained.

Areas for improvement:

• The proportion of pharmacists with univer-
sity-level education in Pharmaceutical Care
must be increased.

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 Appendices. Steps to be followed for data collection and data collection forms

4. Dispensing of medicines ☐ Every prescription (3 points)

In this section, please describe the current approach to
the dispensing of medicines in your pharmacy. How to identify adverse reactions and report them to
the pharmacist/doctor
A. Patient assessment
☐ Not offered (0 points)
4.1. In your pharmacy, are prescriptions
professionally assessed before the medicines ☐ If requested by patient (1 point)
are dispensed? Tick one.
☐ If considered necessary (2 points)
☐ No professional assessment of prescription,
prescription dispensed as it is (0 points) ☐ Every prescription (3 points)

☐ Professional assessment performed Techniques for self-monitoring

occasionally (5 points)
☐ Not offered (0 points)
☐ Always, using a pre-defined assessment
procedure (10 points) ☐ If requested by patient (1 point)

B. Patient counselling and education ☐ If considered necessary (2 points)

4.2. When dispensing medicines according to ☐ Every prescription (3 points)

prescriptions, what kind of information is
offered in your pharmacy and how often? Tick Proper storage
where applicable.
☐ Not offered (0 points)
Medication name, description and/or purpose
☐ If requested by patient (1 point)
☐ Not offered (0 points)
☐ If considered necessary (2 points)
☐ If requested by patient (1 point)
☐ Every prescription (3 points)
☐ If considered necessary (2 points)
Potential drug/drug or drug/food interactions
☐ Every prescription (3 points)
☐ Not offered (0 points)
Route, dosage, dosage form, and administration
schedule ☐ If requested by patient (1 point)

☐ Not offered (0 points) ☐ If considered necessary (2 points)

☐ If requested by patient (1 point) ☐ Every prescription (3 points)

☐ If considered necessary (2 points) Prescription refill information

☐ Every prescription (3 points) ☐ Not offered (0 points)

Precautions to be observed ☐ If requested by patient (1 point)

☐ Not offered (0 points) ☐ If considered necessary (2 points)

☐ If requested by patient (1 point) ☐ Every prescription (3 points)

☐ If considered necessary (2 points)

79
The EDQM pharmaceutical care quality indicators project. Final report

What to do in the event of a missed dose ☐ If available (2 points)

☐ Not offered (0 points) ☐ Every prescription (3 points)

☐ If requested by patient (1 point) Dispensing label based upon patient profile

☐ If considered necessary (2 points) ☐ Not offered (0 points)

☐ Every prescription (3 points) ☐ If requested by patient (1 point)

4.3. On average, how much time (%) is spent per ☐ If available (2 points)
patient visit on dispensing/counselling? Tick
one. ☐ Every prescription (3 points)

☐ 10/90 (10 points) 4.6. Is medication review (MR) (see Glossary

of terms, page 73) conducted in your
☐ 20/80 (9 points) pharmacy? Tick one.

☐ 30/70 (8 points) ☐ Yes (5 points)

☐ 40/60 (7 points) ☐ No (0 points)

☐ 50/50 (6 points) 4.7. If yes, medication review is performed: Tick

one.
☐ 60/40 (5 points)
☐ Occasionally, when indicated by professional
☐ 70/30 (4 points) experience/knowledge (2 points)

☐ 80/20 (3 points) ☐ Always, using a predefined MR procedure (5

points)
☐ 90/10 (2 points)
4.8. Is there a separate counselling room assigned
4.4. When counselling during medicines for Pharmaceutical Care in your pharmacy?
dispensing, is the treatment regimen Tick one.
discussed taking into consideration the
patient’s lifestyle and desired quality of life, ☐ Yes (3 points)
needs and expectations? Tick one.
☐ No (0 points)
☐ Not discussed (0 points)
C. Documentation
☐ Occasionally discussed (5 points)
4.9. Do you have access to a computer in your
☐ Always discussed (10 points) pharmacy? Tick one.

4.5. Are patients/visitors in your pharmacy given ☐ Yes (1 point)

written information regarding the medicines
dispensed? Tick where applicable. ☐ No (0 points)

Patient information leaflet (package leaflet)
☐ Not offered (0 points)
☐ If requested by patient (1 point)
4.10. If yes, what is it used for? Tick where
applicable.
☐ Accounting (0 points)
☐ Keeping patient profiles (5 points)

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 Appendices. Steps to be followed for data collection and data collection forms

☐ Detecting drug-drug interactions (5 points) E. Interprofessional collaboration

☐ Medication review (5 points) 4.14. How many health-related interactions (calls,

visits, etc.) with other healthcare professionals
☐ Registering adverse drug reactions (ADRs) (5 do you have per month? Tick where applicable.
points)
Communication with doctors
☐ Other, please specify . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . ☐ None (0 points)
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . Ad hoc
. . . . . . . . . . . . . . . . . . . . . . . . . . .
☐ ≤ 5 (3 points)
4.11. Have any adverse drug reactions (ADRs)
been documented in your pharmacy in the ☐ 6-15 (4 points)
last three months (see Glossary of terms, page
73)? Tick one. ☐ > 15 (5 points)

☐ Yes – Specify how many . . . . . . . . . . . . . Regular meetings

. . . . . . . . . . . . . . . . . . . . . (5 points)
☐ ≤ 5 (5 points)
☐ No (0 points)
☐ 6-15 (8 points)
4.12. Are the ADRs passed on to: Tick where
applicable. ☐ > 15 (10 points)

☐ Pharmacovigilance centre (5 points) Communication with other healthcare professionals

☐ Prescribing doctors (5 points) ☐ None (0 points)

☐ Relevant pharmaceutical company (3 points) Ad hoc

☐ Other, please specify . . . . . . . . . . . . . . . ☐ ≤ 5 (2 points)

. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . ☐ 6-15 (3 points)

D. Follow-up ☐ > 15 (4 points)

4.13. In your pharmacy, do you follow up patients Regular meetings

after an intervention or corrective action for
an ADR (by phone or in the pharmacy)? Tick ☐ ≤ 5 (4 points)
where applicable.
☐ 6-15 (5 points)
☐ Patient follow-up never carried out after an
intervention for a drug-related problem (DRP) ☐ > 15 (6 points)
(0 points)
Communication with pharmaceutical companies
☐ Patient follow-up occasionally carried out after (representatives)
a DRP related intervention (5 points)
☐ None (0 points)
☐ Patient follow-up always carried out after a
DRP related intervention (10 points) Ad hoc

☐ ≤ 5 (0 points)

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The EDQM pharmaceutical care quality indicators project. Final report

☐ 6-15 (1 point) Healthcare professionals

☐ > 15 (2 points) ☐ Questions relating to technical information on

patient conditions or drugs (2 points)
Regular meetings
☐ Referrals or recommendations to consult other
☐ ≤ 5 (2 points) healthcare professionals (including doctors) (2
points)
☐ 6-15 (3 points)
☐ Information on ADRs or other drug-related
☐ > 15 (4 points) information (2 points)

4.15. What type of communication is this? Tick Pharmaceutical companies

where applicable.
☐ Questions relating to technical information on
Doctors patient conditions or drugs (1 point)

☐ Questions relating to technical information on ☐ Referrals or recommendations to consult other

patient conditions or drugs (3 points)
☐ Referrals or recommendations to consult other
healthcare professionals (including doctors) (3
points)
healthcare professionals (including doctors) (1
point)
☐ Information on ADRs or other drug-related
information (1 point)

☐ Information on ADRs or other drug-related Your points for section 4: . . . . . . . . . . . . . .

information (3 points) . . . . . . . . . . . . . . . . . . . . . . . . . . .

Maximum possible points: 163

Your calculated score for section 4: . . . . . .

Evaluation of Section 4, ‘Dispensing of medicines’

Your total score Level of Pharmaceutical Care implementation in dispensing of medicines process
≤ 81 No implementation of Pharmaceutical Care in dispensing of medicines
82-114 Low level of implementation of Pharmaceutical Care in dispensing of medicines
115-138 Medium level of implementation of Pharmaceutical Care in dispensing of medicines
139-163 High level of implementation of Pharmaceutical Care in dispensing of medicines

Recommendations for improvement, Section 4,
‘Dispensing of medicines’
A. No implementation of Pharmaceutical Care in
dispensing of medicines
• Major improvement needed in the following
aspects:
– during dispensing, provision of medication-­
related information such as medication name,
description and/or purpose;
– route, dosage, dosage form, and administration
schedule;
– precautions to be observed;
– how to identify and report adverse reactions to
pharmacist/doctor;
– techniques for self-monitoring;
– proper storage, potential drug/drug and drug/
food interactions;
– prescription refill information;
– what to do in the event of a missed dose.
• When dispensing a prescription, at least 50 %
of the time should be devoted to consultation.
• When dispensing a prescription, the instruc-
tions for use of the medication should take into
consideration the patient’s lifestyle and desired
quality of life, needs and expectations.

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 Appendices. Steps to be followed for data collection and data collection forms
• When dispensing a prescription, the patient in-
formation leaflet must be provided.
B. Low level of implementation of Pharmaceutical
Care in dispensing of medicines
• Some improvement needed in:
– During dispensing, provision of medication-­
related information such as medication name,
description and/or purpose;
– route, dosage, dosage form, and administration
schedule;
– precautions to be observed;
– how to identify and report adverse reactions to
pharmacist/doctor;
– techniques for self-monitoring;
– proper storage, potential drug/drug and drug/ tical Care in dispensing of medicines
food interactions;
– prescription refill information;
– what to do in the event of a missed dose.
• Medication review should be conducted for
special categories of patients, for example, the
elderly, chronically ill patients, etc.
• The pharmacy should set aside a separate coun-
selling room for private consultations.
5. Self-care services
In this section, please describe your phar-
macy’s current approach to customers requiring
non-­prescription medicines either for themselves or
somebody else in your pharmacy.
A. Patient assessment
5.1. Is the appropriateness of the non-prescription
medicine for the actual patient assessed before
deciding whether or not to dispense the
medicine? Tick one.
☐ Never assessed before dispensing (0 points)
☐ Occasionally assessed before dispensing
(2 points)
☐ Always assessed before dispensing (5 points)
5.2. Are symptoms/signs which require the
intervention of a doctor checked before a non-
prescription medication is supplied? Tick one.
☐ Never checked (0 points)
☐ Occasionally checked (2 points)
C. Medium level of implementation of Pharmaceu-
tical Care in dispensing of medicines
• Electronic patient medication profiles should
be present for some categories of patients.
• Electronic drug-drug interactions’ databases
should be accessible in the pharmacy.
• ADRs should be documented and forwarded to
relevant organisations.
• Patients should be followed-up after interven-
tions or ADR correction.
• A sufficient number of health-related interac-
tions with doctors/healthcare professionals
should take place.
D. High level of implementation of Pharmaceu-
• The high score should be maintained by
strengthening inter-professional relationships
with doctors and other healthcare professionals.
• A multidisciplinary approach should be taken
to the treatment of patients.
☐ Always checked (5 points)
B. Interprofessional collaboration
5.3. What percentage of patients who are found to
present with dangerous symptoms is referred
to the doctor? Tick one.
☐ 1-10 % (1 point)
☐ 10-25 % (3 points)
☐ 25-50 % (5 points)
☐ 50-75 % (8 points)
☐ 75-100 % (10 points)
C. Documentation
5.4. Do you have a system for documenting these
referrals? Tick one.
☐ No (0 points)
☐ Yes, occasionally documented (3 points)
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The EDQM pharmaceutical care quality indicators project. Final report

☐ Yes, always documented (5 points) ☐ Occasionally monitored (5 points)

D. Patient counselling and education ☐ Always monitored (10 points)

5.5. Is advice on treatment of symptoms and 5.7. If monitored, are the instances of
appropriate use of non-prescription medicines inappropriate use reported to any person or
provided when supplying medication? Tick organisation? Tick one.
one.
☐ Yes (2 points)
☐ Advice never provided (0 points)
☐ No (0 points)
☐ Verbal advice occasionally provided (1 point)
5.8. If reported, who receives the reports? Tick
☐ Verbal advice always provided (3 points) where applicable.

☐ Verbal advice always provided verbal and ☐ Governmental organisations (Medicines

written advice occasionally provided (5 points) agency, Ministry of Health, etc.) (2 points)

☐ Verbal and written advice always provided (10 ☐ Professional organisations (2 points)
points)
☐ Pharmaceutical companies (1 point)
E. Follow-up
Your points for section 5: . . . . . . . . . . . . . .
5.6. Is inappropriate use of non-prescription . . . . . . . . . . . . . . . . . . . . . . . . . . .
medicines by the patient monitored? Tick one.
Maximum possible points: 152
☐ Never monitored (0 points)
Your calculated score for section 5: . . . . . .

Evaluation of Section 5, ‘Self-care services’

Your total score Level of Pharmaceutical Care implementation in self-care process
≤ 26 No implementation of Pharmaceutical Care in self-care process
27-36 Low level of implementation of Pharmaceutical Care in self-care process
37-44 Medium level of implementation of Pharmaceutical Care in self-care process
45-52 High level of implementation of Pharmaceutical Care in self-care process

Recommendations for improvement, Section 5, B. Low level of implementation of Pharmaceutical

‘Self-care services’
A. No implementation of Pharmaceutical Care in
self-care process
• Major improvement needed in:
– Assessment of appropriateness of non-­
prescription medicine for patient before
dispensing;
– Detection of dangerous symptoms/signs re-
quiring doctor’s intervention and referral of
these patients to doctor.
• Verbal advice must always be provided when
dispensing a non-prescription medication.
Care in self-care process
• Some improvement needed in:
– Assessment of appropriateness of non-­
prescription medicine for patient before
dispensing;
– Detection of dangerous symptoms/signs re-
quiring a doctor’s intervention and referral of
these patients to a doctor.
• Verbal and written advice should be provided
when dispensing a non-prescription medica-
tion.

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 Appendices. Steps to be followed for data collection and data collection forms
C. Medium level of implementation of Pharmaceu-
tical Care in self-care process
• Inappropriate use of non-prescription medica-
tion should be monitored and reported to rele-
vant organisations.
• Co-operation between doctors and other
health professionals regarding rational use of
non-prescription medication should be estab-
lished.
6. Point-of-care testing (health screening) services
In this section please describe the current ap-
proach to health screening services that may be offered
in your pharmacy.
6.1. What kinds of services are available and how
often do you offer them? Tick one.
Measurement of blood pressure
☐ Not offered (0 points)
☐ Not more than once a week (2 points)
☐ 3-5 times a week (3 points)
☐ Daily (4 points)
Weight control/BMI
☐ Not offered (0 points)
☐ Once a week or less (2 points)
☐ 3-5 times per week (3 points)
☐ Daily (4 points)
Blood glucose testing
☐ Not offered (0 points)
☐ Once a week or less (2 points)
☐ 3-5 times per week (3 points)
☐ Daily (4 points)
Cholesterol testing
☐ Not offered (0 points)
☐ Once a week or less (2 points)
85
D. High level of implementation of Pharmaceu-
tical Care in self-care process
• The high score should be maintained by
strengthening interprofessional relationships
with doctors and other healthcare professionals.
• A multidisciplinary approach should be taken
to the treatment of patients.
☐ 3-5 times per week (3 points)
☐ Daily (4 points)
Respiratory tests
☐ Not offered (0 points)
☐ Once a week or less (2 points)
☐ 3-5 times per week (3 points)
☐ Daily (4 points)
Other screening tests, please specify: . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
☐ Not offered (0 points)
☐ Once a week or less (2 points)
☐ 3-5 times per week (3 points)
☐ Daily (4 points)
A. Patient assessment
6.2. The services mentioned in question 6.1 are
usually offered: Tick one.
☐ At the patient’s request, as a measurement
without risk factor assessment (0 points)
☐ At the instigation of the pharmacist, as a
measurement without risk factor assessment (1
point)
The EDQM pharmaceutical care quality indicators project. Final report
☐ At the patient’s request, as part of the
health risk factor assessment service (e.g.
cardiovascular disease, diabetes, etc.) (3
points)
☐ At the instigation of the pharmacist, as part
of the health risk factor assessment service
(e.g. cardiovascular disease, diabetes, etc.) (5
points)
6.3. Are the results discussed in the context of the
patient’s overall health and lifestyle? Tick one.
☐ Not discussed (0 points)
☐ Occasionally discussed (3 points)
☐ Always discussed (5 points)
6.4. Is the need for a referral to a doctor explained
to the patient, when necessary? Tick one.
☐ Not explained (0 points)
☐ Occasionally explained (3 points)
☐ Always explained (5 points)
B. Patient counselling and education
6.5. Is the patient provided with a report giving
the results of the screening tests and offering
recommendations on the basis of these results?
Tick one.
☐ Not provided (0 points)
☐ Occasionally provided (2 points)
☐ Always provided (5 points)
C. Documentation
6.6. Are the key features of the explanation and
recommended follow-up actions, including
any referrals to the doctor, documented on the
service record form? Tick one.
☐ Not documented (0 points)
☐ Occasionally documented (2 points)
86
☐ Always documented (5 points)
D. Follow-up
6.7. Do you follow up your patients after they have
undergone screening tests in your pharmacy
(by phone or in the pharmacy)? Tick one.
☐ Patient follow-up is never performed after a
screening test (0 points)
☐ Patient follow-up is occasionally performed (3
points)
☐ Patient follow-up is always performed (5
points)
E. Interprofessional collaboration
6.8. Are there any arrangements between your
pharmacy and other healthcare professionals
and primary care organisations to which
patients can be referred when needed? Tick
one.
☐ Yes (1 point)
☐ No (0 points)
6.9. What percentage of the patients who received
health screening and were found to have
dangerous symptoms were referred to the
doctor? Tick one.
☐ 1-10 % (1 point)
☐ 10-25 % (3 points)
☐ 25-50 % (5 points)
☐ 50-75 % (8 points)
☐ 75-100 % (10 points)
Your points for section 6: . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Maximum possible points: 65
Your calculated score for section 6: . . . . . .
 Appendices. Steps to be followed for data collection and data collection forms

Evaluation of Section 6, ‘Point-of-care testing (health screening) services’

Your total score Level of Pharmaceutical Care in point-of-care testing
≤ 33 No implementation of Pharmaceutical Care in point-of-care testing
34-45 Low level of implementation of Pharmaceutical Care in point-of-care testing
46-55 Medium level of implementation of Pharmaceutical Care in point-of-care testing
56-65 High level of implementation of Pharmaceutical Care in point-of-care testing

Recommendations for improvement, Section 6, C. Medium level of implementation of Pharmaceu-

‘Point-of-care testing (health screening) services’
A. No implementation of Pharmaceutical Care in
point-of-care testing
• Major improvement needed in the range of
point-of-care testing offered (health screening).
• Results of point-of-care testing (health
screening) should be discussed in the context
of the patient’s overall health and lifestyle.
• The need to see a doctor should be explained
to patients with abnormal point-of-care testing
(health screening) results.
B. Low level of implementation of Pharmaceutical
Care in point-of-care testing
• Point-of-care testing (health screening) should
be offered on patient’s/pharmacist’s initiative
as part of health risk factors assessment.
• Patients should be given a report showing the
results of their screening tests and providing
recommendations on the basis of these results.
tical Care in point-of-care testing
• Point-of-care testing (health screening) should
be documented on a service record form.
• Follow-up should be provided after screening
tests (by phone or in the pharmacy).
• A system for referring patients after point-of-
care testing (health screening) should be set up
between the pharmacy and other healthcare
professionals (health screening).
D. High level of implementation of Pharmaceu-
tical Care in point-of-care testing
• The high score should be maintained by
strengthening inter-professional relationships
with doctors and other healthcare professionals.
• A multidisciplinary approach should be taken
to the treatment of patients.

7. Overall evaluation of self-assessment questionnaire

Total Score Level of Pharmaceutical Care implementation
≤5 No implementation of Pharmaceutical Care
5.1-7.0 Low level implementation of Pharmaceutical Care
7.1-8.5 Medium level of implementation of Pharmaceutical Care
8.6-10.0 High level of implementation of Pharmaceutical Care

87
 ENG
The Council of Europe is the continent’s leading human rights
organisation. It comprises 47 member states, 28 of which are members
of the European Union. The European Directorate for the Quality of
www.edqm.eu Medicines & HealthCare (EDQM) is a directorate of the Council of Europe.
Its mission is to contribute to the basic human right of access to good
quality medicines and healthcare and to promote and protect public
health.