Research
ORIGINAL ARTICLE
Standardising pharmacist patient-profiling activities
in a rehabilitation hospital in Malta
Maria Mamo, Francesca Wirth, Lilian M Azzopardi, Anthony Serracino-Inglott
Department of Pharmacy,
University of Malta, Msida,
Malta
Correspondence to
Maria Mamo, Department of
Pharmacy, University of Malta,
Msida, Malta;
mmam0004@um.edu.mt
Received 12 June 2013
Revised 27 August 2013
Accepted 9 September 2013
ABSTRACT
Objectives To develop, validate, test for applicability
and practicality, implement and undertake a preliminary
evaluation of a standard operating procedure (SOP) for
pharmacist patient-profiling activities at Rehabilitation
Hospital Karin Grech (RHKG).
Methods Following direct observation of pharmacist
patient-profiling activities in the hospital, a draft SOP
was developed. The SOP was validated twice using a
self-administered validation questionnaire and was
amended according to suggestions proposed during
validation. The validated SOP was tested for applicability
and practicality through an observation study.
Pharmacists were trained to follow the SOP correctly and
the SOP was subsequently implemented. Preliminary
evaluation of the SOP was undertaken using a selfadministered evaluation questionnaire 1 and 4 months
post implementation.
Results A ‘patient-profiling’ SOP for pharmacists was
developed. Validation was beneficial since constructive
suggestions were proposed and improvements with
respect to SOP content, length, presentation, layout and
comprehensiveness were implemented to develop the
final version of the SOP. The SOP was found to be
practical and applicable for use at RHKG. Preliminary
evaluation showed that all pharmacists (nine) found the
SOP fit for purpose, easy to follow for training new
pharmacists, user friendly, easy to understand and
promotes consistency in patient-profiling activities.
Conclusions The ‘patient-profiling’ SOP provides a
comprehensive approach to standardisation of
pharmacist patient-profiling activities at RHKG to improve
the quality of patient care. The SOP will need to be
regularly reviewed and updated and can be transferred
to other hospital settings with minor amendments.
INTRODUCTION
To cite: Mamo M, Wirth F,
Azzopardi LM, et al. Eur J
Hosp Pharm Published
Online First: [ please include
Day Month Year]
doi:10.1136/ejhpharm2013-000351
Quality in healthcare is accomplished when patient
care conforms to current regulations, provides services consistent with current professional knowledge
and results in optimal patient outcomes, with the
fewest possible adverse effects and at reduced
costs.1 2 Hospitals worldwide are becoming increasingly aware of the importance of accountability and
transparency in healthcare, motivating the implementation of standard operating procedures (SOPs) for
healthcare processes.3 4 Documentation, standardisation and validation processes allow assessment of
hospital services and ensure that the service provided
is targeted towards the quality of patient care.5 The
importance of introducing quality and standardisation in healthcare has been recognised, however it is
occurring at a relatively slow pace in European
Mamo M, et al. Eur J Hosp Pharm 2013;0:1–5. doi:10.1136/ejhpharm-2013-000351
countries,6 particularly with respect to clinical pharmacy services. Examples of initiatives in Northern
Ireland and Sweden have been reported from the
Intregrated Medicines Management project,7 the
Lund Integrated Medicines Management project8
and Uppsala projects, respectively.9
Hudson et al10 emphasised that “there continues
to be a need to establish documented standards of
clinical pharmacy” to sustain such a service. Within a
clinical setting, written SOPs provide evidence that
the hospital is working within requirements of
clinical governance. Regularly updated, well written,
efficiently organised and well formatted SOPs
demonstrate commitment to high standards of performance and documentation.11 SOPs should be
implemented to assure safety and consistency of a
service, ensure good practice, clarify job descriptions,
facilitate audit review of clinical practice, provide an
opportunity to analyse existing working procedures
and implement improved procedures, and serve as a
tool for training new recruits.11 12 Additionally, SOPs
lead to development of standardised documentation
systems which ensure that patient medication records
are complete and accessible to pharmacists and other
members of the healthcare team.13 The main limitations of documented standards are that they may be
perceived as time consuming to follow and produce a
large amount of paperwork.11 14
Clinical pharmacists proactively participate in
patient care through interaction with other members
of the healthcare team to support safe and effective
medication use.15 Pharmacists make recommendations to physicians in various hospital settings with
respect to dosing and administration of medications,
current evidence-based treatment guidelines, adverse
drug reactions (ADRs), drug interactions, intravenous
drug compatibility and drug therapy monitoring.16
Documentation of interventions is important to
enable pharmacist accountability and continuity of
care, and to demonstrate the value of clinical pharmacy service provision to high-quality care and
improvement of patient outcomes.17–19
‘Patient profiling’ was selected as an activity for
standardisation because, from a time and motion
study undertaken at Rehabilitation Hospital Karin
Grech (RHKG), 15% of the pharmacists’ time dedicated to clinical pharmacy activities was for patient
profiling. During this study a lack of consistency
between pharmacists with regards to documentation
of pharmaceutical care issues was identified.20
‘Patient profiling’ is an activity undertaken by pharmacists which involves filling in a new ‘pharmacy
patient profile’ for each patient admitted to RHKG
and updating it during the patient’s stay in hospital.
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A pharmacy patient profile is a paper-based patient record used by
pharmacists as a medication-review tool by documentation of
patient information, medications, laboratory investigations and
pharmaceutical care issues (table 1). This record is filled in using
consulting patient notes, treatment charts, laboratory investigations and also during patient/carer interviews. Emphasis on documentation of pharmaceutical care issues is made to prepare for
interventions in collaboration with physicians during ward rounds.
The aim of this study was to develop, validate, test for applicability and practicality, implement and undertake preliminary
evaluation of a SOP for pharmacist patient-profiling activities in
a rehabilitation hospital.
METHOD
Setting
The study was undertaken at RHKG, a 155-bed hospital consisting of four geriatric rehabilitation wards and one adult rehabilitation ward. The pharmacy department consists of 12 members:
nine pharmacists (Head of Pharmacy Services, Clinical
Pharmacy Coordinator and five full-time and two part-time
pharmacists), two pharmacy technicians and a pharmacy clerk.
All pharmacists have clinical pharmacy duties and these cover
around 60% of their time.20 Patient care at RHKG is provided
through an interdisciplinary team approach, including physicians, nurses, pharmacists, physiotherapists, occupational therapists, speech language pathologists and social workers.
Development of SOP
Approval to carry out the study was obtained from the RHKG
Research Committee and the Head of Pharmacy Services.
The investigator carried out direct observation of 11 patientprofiling sessions (each session involving one patient), observing
(three) different pharmacists over an 18-day period to develop the
SOP content. A detailed list of steps carried out by the pharmacists
during patient profiling was documented. Following this observation, inconsistencies among pharmacists and weaknesses in the
current patient-profiling process that needed to be strengthened
were identified. Points for improvement in consistency, particularly
with regards to documentation of pharmaceutical care issues, were
discussed with the pharmacists for inclusion in the SOP. The SOP
was divided into a ‘title page’ and nine sections: ‘Scope’,
Table 1 Information collected during ‘patient profiling’
Patient information
Patient medication
records
Active medication
problems
Pharmaceutical care
issues
Laboratory
investigations
Therapeutic drug
monitoring
First and last name, address, identification card
number, age, consultant responsible for patient, date
of admission, place from where patient was admitted,
reason for referral, carer/s name and telephone number
Past medical history, drug history, ADRs/sensitivities,
current medications—noting start and stop date (if
applicable), presence/absence of catheter, presence/
absence of enteral tube
Date of onset, problems identified, comments, date
resolved
Date when pharmaceutical care issue arose, care issue,
date when action is taken, action taken, date of
outcome, outcome
Weight, height, laboratory investigations within range
are ticked, serum creatinine, estimated glomerular
filtration rate, potassium, urea, calcium, albumin+any
abnormal results are always recorded
Medication, reference range, result, date and time of
last dose administered, date and time of last sample
taken, comments
ADR, adverse drug reaction.
2
‘Objective’, ‘Definitions’, ‘Responsibility’, ‘Competences’,
‘Procedure’, ‘References’, ‘Revision history’ and ‘Appendices’.
Details of the process were described in the ‘Procedure’. This
section was structured in a ‘hierarchical steps’ format with a flowchart because it was long, detailed and required many decisions.
Steps were written as short, direct sentences in the imperative
form with emphasis on accuracy, comprehensiveness and user
friendliness.
Validation of SOP
Validation was undertaken to confirm the robustness, comprehensiveness, presentation and consistency of the SOP. Communication
with the pharmacists was sought during the entire validation
process to ensure user satisfaction, which results in an improved
sense of responsibility to follow the SOP. The draft SOP was validated twice by a validation panel consisting of the nine pharmacists. Each member was given a consent form and contact details
of the investigator, SOP draft, validation sheet (divided according
to the SOP sections with instructions to tick appropriately if they
agree or disagree with the selected statements, with the possibility
to include other remarks) and self-administered validation questionnaire (divided into five sections to rate presentation, comprehensiveness, topic specificity, statement validity with the possibility
to include other comments). Font clarity and size, readability of
layout, line spacing, SOP length and order of sections were validated with regards to presentation. The pharmacists were given
1 month to complete the first validation and 2 weeks to complete
the second validation. Amendments suggested were considered
and a third draft of the SOP was developed. The questionnaires of
both validations were scored out of a total score of 12. Descriptive
comparative analysis using the one-way analysis of variance test
was undertaken.
Applicability and practicality testing of SOP
Applicability and practicality testing was undertaken to ensure
relevance of the SOP to be used in practice at RHKG. An observation study using a checklist was undertaken over 5 days on the
five wards. The SOP was tested by observing four pharmacists
complete 12 patient profiles (three each) and comparing their
actions with the steps included in the third draft of the SOP.
This step compared the normal routine patient-profiling activity
with that documented in the SOP. Discrepancies were clarified
and discussed with the pharmacy staff and a final SOP draft was
developed and subsequently implemented.
Implementation of SOP and training
The final version of the SOP was authorised for implementation following applicability and practicality testing. Implementation
involved training pharmacists to familiarise themselves with the SOP
and follow it correctly, and distribution of authorised copies in specific distribution points. Reading copies of the original, in hard and
soft copy format, were issued, marked as such and used for pharmacist training. An electronic reading copy was placed on the main
computer system in the pharmacy to allow access to the SOP by all
pharmacists. Authorised copies of the original were subsequently
issued, marked as such, and placed in seven distribution points: the
pharmacy, the office of the hospital clinical director and the five
wards. The pharmacists were given 1 week to read and understand
the SOP, clarify any ambiguous areas of the SOP with the Head of
Pharmacy Services and sign a ‘Read and Understood Form’.
Preliminary evaluation of SOP
The implemented SOP was evaluated twice: a preliminary evaluation 1 and 4 months post implementation. A group discussion
Mamo M, et al. Eur J Hosp Pharm 2013;0:1–5. doi:10.1136/ejhpharm-2013-000351
Research
session between the pharmacists and the investigators (MM,
FW) was held to evaluate the SOP during both evaluations.
A self-administered evaluation questionnaire was distributed.
The questionnaire consisted of 11 ‘Yes/No’ and 2 open-ended
questions relating to the SOP sections, SOP characteristics (user
friendliness, detail, length), experience from implementation,
SOP value to service provision and frequency of referral to the
SOP. The results obtained from both evaluations were
compared.
RESULTS
Rationale of ‘patient-profiling’ SOP
The ‘patient-profiling’ SOP developed describes in detail the
procedure to be followed by pharmacists when filling in a pharmacy patient profile to ensure that it is complete and accurate to
be used as a medication review tool during the patient’s stay in
hospital. The procedure section was divided into three main sections: completing the pharmacy patient profile; documentation
of pharmaceutical care issues; and a flowchart which summarises
the entire procedure. In the first section, the pharmacist is
guided to fill in the patient profile with information including
patient and carer details, reason for referral, past medical
history, medication history, current medications, ADRs and sensitivities, mental score, presence/absence of a catheter, presence/
absence and type of enteral tube, active problems, weight,
height, ideal body weight, laboratory investigations and therapeutic drug monitoring (TDM). In the second section, the
pharmacist is guided to classify and document pharmaceutical
care issues identified during patient-profiling activities.
Improvements in patient profiling activities implemented
A new version of the paper-based pharmacy patient profile, with
an improved layout, was designed and implemented. The layout of
the patient profile was modified to allow more space to document
pharmaceutical care issues, active problems, laboratory investigations and TDM. A classification system for pharmaceutical care
issues, adapted from the one developed at the University of
Strathclyde in Scotland,10 was implemented at RHKG to improve
identification, implementation, classification and documentation
of pharmaceutical care issues by pharmacists during patient profiling. The pharmaceutical care issues identified were classified into
five main categories based on ‘Indication’, ‘Effectiveness’, ‘Safety’,
‘Compliance’ and ‘Administration’ of medications. Such a system is
important to provide a standardised and consistent classification
and documentation of pharmaceutical care issues identified by
pharmacists at RHKG, and across institutions, if the process were
to be adapted in other institutions, allowing for comparability.
A paper-based ‘pharmaceutical care issues daily log sheet’ was
developed to document the pharmaceutical care issues identified
by each pharmacist per day (figure 1). This document enables
the pharmacists to capture trends in pharmaceutical care issues
to be discussed with other healthcare professionals. The sheet is
divided into the established pharmaceutical care issue categories
and the pharmacist classifies and documents each identified care
issue into the respective category, together with the outcome
(accepted, modified, not accepted) using tally marks. Drugs
involved are also documented. An electronic system for documentation of these pharmaceutical care issues was developed
using Microsoft Excel. This system was uploaded on each computer in the pharmacy, allowing access by each pharmacist. A
separate Excel file divided into 12 sheets ( January–December)
was created for each ward. Each sheet is divided into the established pharmaceutical care issue categories and lists the days of
each month. Each file is linked to a master file uploaded on the
Mamo M, et al. Eur J Hosp Pharm 2013;0:1–5. doi:10.1136/ejhpharm-2013-000351
Figure 1
Pharmaceutical care issues daily log sheet.
computer of the Head of Pharmacy Services which collects data
inputted from all the wards. At the end of the day, each pharmacist is required to input the data which was documented on the
paper documentation sheet into the file of their respective ward,
calculating the total number of care issues identified. These data
can be accessed immediately by the Head of Pharmacy Services
from the master file.
Validity, applicability and practicality of SOP
The validity, applicability and practicality of the SOP were confirmed. Face and content validation resulted in the improvement
of various criteria relating to SOP presentation and content.
Major improvements following validation of the SOP draft were
the inclusion, modification and/or elimination of information,
arrangement of the sequential order of sections in the procedure, and improvement in SOP presentation and comprehensiveness. The scoring system for validation ranged from 0 to 12,
with a higher score indicating higher validity. The mean validation score for validation 1 and 2, out of a total score of 12,
was 10.444 (range 9.0–11.50) and 11.500 (range 10.50–12.0),
respectively, meaning that there was a stastistically significant
improvement in mean validation score between validaton 1 and
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2 ( p=0.005). The SOP was found to be applicable and practical
for use at RHKG since all the steps required to carry out patient
profiling were included in the procedure section of the SOP and
the pharmacists found the SOP comprehensive and easy to
follow and understand.
Preliminary evaluation of SOP
Both preliminary evaluations showed that all nine pharmacists
agreed that the SOP was fit for purpose, easy to follow for training
of new pharmacists, user friendly for reference during daily activities and supported development of consistent patient-profiling
activities. Moreover, all nine pharmacists agreed that the ‘Scope’
and ‘Objective’ were clearly outlined, the ‘Procedure’ was easy to
understand, no steps were ambiguous or omitted, the SOP was not
too detailed or too long, it did not need to be further split into
other SOPs and no other datasheets were required in the
‘Appendices’ section. The numbers of pharmacists who referred to
the SOP during the first months of implementation are given in
table 2. Within a quality system, SOPs are meant for use as a training tool for pharmacists to perform a procedure in a standardised
way; SOPs are available for referral by the user as required.
DISCUSSION
The ‘patient-profiling’ SOP was developed with the rationale of
achieving standardisation and consistency in the way pharmacists at RHKG carry out patient-profiling activities. Accurately
and consistently completing pharmacy patient profiles facilitates
pharmaceutical care planning and pharmacist participation
during ward rounds and improves continuity of care between
pharmacists.21 An important benefit of the developed SOP is
that it can be used as an audit tool to ensure that patientprofiling activities are being performed accurately and consistently, to identify risk areas and provide a basis for continuous
improvement of patient-profiling activities.
During development and validation of the SOP there was no
gold standard implemented locally or internationally to refer to
for comparison. The SOP developed is robust and comprehensive and following further studies to demonstrate its impact it
may be proposed as a gold standard. The validation process was
important in SOP development since there was a statistically significant improvement in the mean validation score between validation 1 and 2. This improvement can be explained by the fact
that many new improvements to the activity were implemented
and that the activity is relatively complex.
Applicability and practicality testing showed that the SOP was
relevant and practical for use at RHKG. However, the vision for
developing this SOP was set on an international dimension and
was not limited to RHKG. International evidence-based literature was consulted during SOP development to apply the
concept of cross-cultural adaptability. The SOP was based on
experiences from the pharmaceutical industry and by consulting
guides on the development and implementation of SOPs.22–24
The SOP is detailed to be used in practice at RHKG. However,
Table 2
Pharmacist referral to the SOP post implementation
Time postimplementation
Number of pharmacists who
referred to SOP (N=9)
1 month
4 months
7
7
SOP, standard operating procedure.
4
Frequency of referral
Once Twice >Twice
5
2
2
4
0
1
it is adaptable since the basic processes within the activity are
comparable to those in various hospitals. Nevertheless, some
details included in this SOP are dependent on the hospital
policy and the geriatric-rehabilitation speciality for which it was
developed. Consequently, minor adjustments are required to
apply the SOP to other hospital settings and specialities. A positive evaluation of the SOP was obtained by the pharmacists.
There was no resistance from the pharmacists to implement the
SOP since they were constantly consulted during the development and validation process.
Although the design of the pharmacy patient profile was modified, it still remained paper based. Creating more space on the
paper pharmacy patient profile, for example to document all
medication checks, was not possible. Electronic pharmacy patient
profiles are required to suit this purpose. Discussion on the computerisation of patient profiles in this hospital was attempted in a
previous study25 in which the feasibility of a computerised programme for patient profiles was considered. Although all the
pharmacists agreed that computerisation of patient profiles was
the way forward, they were reluctant to implement the program
suggested by hospital management at the time, since they perceived it to be very basic with many shortcomings, especially
with regards to user interface. The program proposed was viable
for calculating the cost of patient treatment; however, the pharmacists felt that it would not improve the quality and safety of
patient care since it lacked basic important clinical features.
Further collaboration among the pharmacists, hospital management and software companies is required to develop a suitable
electronic patient profile for RHKG.
It has been reported that while manual documentation using
paper forms is the most extensively used method of documentation, this type of documentation may be incomplete and inconsistent, and subsequent manual transfer of interventions from
paper form to the electronic system is inefficient, time consuming and may lead to errors.18 26 27 Having a computerised
system to document interventions immediately at the point of
care, such as handheld computers, is more effective and efficient
and facilitates data collection, compilation and analysis.27 28
The successful application of handheld computers, such as
personal digital assistants (PDAs) and tablet computers, to document pharmacists’ clinical interventions and activities in hospital
has been described in recent years, predominantly in the USA.
The PDA-based method of documentation has been reported to
be convenient, efficient, sustainable and feasible to monitor
care, easy to use with appropriate training, and makes data
entry and manipulation faster and easier to perform compared
with the paper-based method. In addition, data inputted are
standardised and data transfer to the main computer system is
not complicated.18 27 29 30 Reported limitations of PDAs
include a small screen size, which may limit the length of the
form if all data fields need to fit on one screen without scrolling,
confidentiality concerns and the cost of the system.18 29 30
Electronic patient profiles and documentation tools for pharmaceutical care issues should be considered as a possible improvement in this hospital.
LIMITATIONS
The aim of this study was to develop and implement the SOP
with a preliminary evaluation. The long-term impact of the SOP
on pharmacist activities and on patient care is still being evaluated. It is recommended that after 1 year of implementation, the
SOP is re-evaluated by carrying out a time and motion study
and assessing key performance indicators for medication safety
and rational use. During the study period no new pharmacists
Mamo M, et al. Eur J Hosp Pharm 2013;0:1–5. doi:10.1136/ejhpharm-2013-000351
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were employed at RHKG to use the SOP as a training tool.
Validation and evaluation required the pharmacists to fill out a
questionnaire; therefore, accuracy relies on the respondents’
enthusiasm and truthfulness.
5
6
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CONCLUSION
The implemented ‘patient-profiling’ SOP is robust, comprehensive, user friendly, applicable and practical for use within a hospital practice for the provision of standardised clinical pharmacy
services. The implemented SOP is dynamic and needs to be
regularly reviewed and updated.
8
9
10
11
Key messages
12
What is already known on this subject
▸ Development of tools to ensure standardisation in delivery of
clinical pharmacy services contribute to ensuring safe and
effective patient care.
▸ Documented standards, particularly for clinical pharmacy
services, are lacking, especially for the European scenario.
▸ Documentation of clinical pharmacist interventions in
patient-profiling activities during a patient’s stay in hospital
enables pharmacist accountability and improves patient
outcomes.
What this study adds
▸ Implementation of a dynamic, robust and comprehensive
standard operating procedure (SOP) to improve consistency
in patient-profiling activities by pharmacists.
▸ A proposed system for standardised documentation of
pharmaceutical care issues during patient profiling.
▸ The developed SOP is adaptable to other hospital settings.
13
14
15
16
17
18
19
Acknowledgements The authors are greatly indebted to Professor Steve Hudson
from the University of Strathclyde in Glasgow who sadly passed away before this
study was completed. We truly appreciate discussions we had with him on aspects
of quality in clinical pharmacy practice which have helped us to widen our
perspective on the practice. The authors acknowledge the assistance of Mr Aaron
Camilleri, Head of Pharmacy Services and all the pharmacy staff at RHKG,
pharmacist Mr Simon Serge and all the healthcare professionals for their
participation in the SOP development process, and Dr Liberato Camilleri from the
Department of Statistics and Operations Research within the Faculty of Science at
the University of Malta for his expert guidance in the statistical analysis.
23
Contributors I declare that all the authors have contributed to the development of
this article.
24
Competing interests None.
25
20
21
22
Provenance and peer review Not commissioned; externally peer reviewed.
26
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