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HOSPITAL PHARMACY PRACTICE IN THE REPUBLIC OF MACEDONIA –

DESIGN OF AN ASSESSMENT TOOL FOR QUANTIFICATION OF THE ACTUAL
STATUS AND IDENTIFYING PRIORITY AREAS FOR IMPROVEMENT INTRO....

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Available online at www.pharmacie-globale.info ISSN 0976-8157

Research Article
PHARMACIE GLOBALE
INTERNATIONAL JOURNAL OF COMPREHENSIVE PHARMACY

HOSPITAL PHARMACY PRACTICE IN THE REPUBLIC OF MACEDONIA – DESIGN OF AN

ASSESSMENT TOOL FOR QUANTIFICATION OF THE ACTUAL STATUS AND
IDENTIFYING PRIORITY AREAS FOR IMPROVEMENT
Kristina Mladenovska*1, Lidija Petrushevska-Tozi2, Dick Tromb3, Kirsten Holme3, Nina Sautenkova4 and Jasminka Patceva5
1Faculty
of Pharmacy, Vodnjanska, Skopje, Republic of Macedonia.
2Facultyof Pharmacy, University “Ss Cyril and Methodius”, Vodnjanska, Skopje, Republic of Macedonia.
3EuroPharm Forum, WHO Collaborating Centre for Drug Policy and Pharmacy Practice Development,

Pharmakon A/S, Milnersvej, Hillerød, Denmark.

4World Health Organization, Regional Office for Europe, Scherfigsvej, DK-2100 Copenhagen Ø, Denmark.
5Pharmaceutical Chamber of Macedonia, 50-ta Divizija, Skopje, Republic of Macedonia.

Received: 9 March 2013; Revised: 13 March 2013; Accepted: 27 March 2013; Available online: 5 April 2013

ABSTRACT
The objective of the study was to evaluate the actual status of the hospital pharmacy practice and quality of
services in the Republic of Macedonia and to identify the gaps and barriers to implement the best pharmacy
practice and care. Cross-sectional descriptive survey was conducted for the hospital pharmacies/pharmacists
where pre-coded multiple choice closed questions were used with response format: activity fully applied,
partially applied, applicable or not applicable. Set of 191 indicators was developed covering five essential
components: patient safety (clinical pharmacy services); medicines and medical devices; manufacturing
practice; environment, workflow and staff availability and qualifications; and quality assurance and risk
management. To summarize the complete data, to all five areas equal weight was given, with up to 20 as a
maximum score. The actual score was 55.3 out of 100. Practice and clinical pharmacy services related to
providing patient safety (7.8 out of 20) were identified as an area of highest priority for improvement, followed
by the other areas, with scores between 11 and 12.5 (out of 20). Priorities for intervention by key stakeholders
(national authorities, academia and professional associations) and recommendations for introducing new and
improving the existing roles of the pharmacists were also defined. In addition, the assessment tool provided for
quantification of the pharmacy practice and quality of services can facilitate comparison of the results over time
within and between the hospital pharmacies.
Keywords: Hospital pharmacy; practice; services; standards; Macedonia (Republic).

INTRODUCTION
The Republic of Macedonia (RoM) is located in the central
Balkan Peninsula, with an area of 25.713 km2 and
population density of 79 inhabitants/km2, of which 60 %
live in urban areas. Showing tendency towards an ageing
population (11.6% of the population is over 65 years), it
has similar problems with the health and social care
system as other countries in the Europe. The main causes
of mortality are cardiovascular diseases (57.9%) and
malignancies (19.4%), followed by endocrine, nutritive
and metabolic diseases with 3.9 %.1,2 According to the
gross national income per capita, it is a lower middle-
income country, with high official unemployment (29.1%).
The total health expenditure as a percentage of the gross
domestic product in the RoM amounted to 6.9% in 2009.
In the same year, the health care expenditure per capita
amounted to US$ 341, with 84.7% of the health
expenditure coming from public sources. The expenditure
for investment in the health sector (0.7%) is evidently
*Corresponding Author:
Kristina Mladenovska
Faculty of Pharmacy, Vodnjanska 17, 1000 Skopje,
PO 36, Republic of Macedonia.
Contact no: +389-23126032; Email: krml@ff.ukim.edu.mk
insufficient for ensuring activities that should be
undertaken within the good pharmacy practice (GPP).3
The demographic data collected by the end of 20124,5
pointed that there were 44 hospital pharmacies located in
general and clinical hospitals in the secondary and tertiary
care with in-patients beds. Most of the hospitals are state-
owned (88.64%). Approximately 22.73% of the hospitals
belong to a group of hospitals with common ownership, of
which one is governed by a hospital group with
administration located in EU-member country (Bulgaria)
and one by a group with administration located in non-EU-
member country (Turkey). The rest of them are with
domestic governance. App. 86% of the pharmacies are
central hospital pharmacies, while the others are satellite
hospital pharmacies located at the university clinics. The
pharmacy practice (PP) is managed internally in 94.12%
of the hospital pharmacies and the pharmacy managers
respond to the hospital directors. In most of the hospital
pharmacies, the pharmacy manager is a qualified
pharmacist.
The hospital pharmacy budget for acquisition of medicines
per year is lower than 40% of the total hospital budget for

1 Pharmacie Globale© (IJCP), Vol. 04, Issue 04

 Mladenovska K et al. / Pharmacie Globale (IJCP) 2013, 04 (02)
half of the hospital pharmacies. For only 5% of the hospital
pharmacies, over 60% of the total hospital budget is
available4. There is no group purchasing of medicines and
medical devices; the wholesalers are the main source for
their acquisition, followed by an industry. Only 20.45% of
the hospital pharmacies produce medicines and only
8.82% of them purchase medicines from other (hospital)
pharmacies. Part of the overall hospital pharmacy budget
is not regularly allocated for improvement of the
pharmacy structure, thus affecting the quality of PP and
services.
Considering the category of patients currently served by
the hospital pharmacies, 32.35% of the pharmacies
distribute medicines only for in-patients with full
hospitalization. Medicines, to outpatients only, are
dispensed in 5.88% of the pharmacies, while 61.76% of
the hospital pharmacies supply, store and
distribute/dispense medicines for both, in- and out-
patients.
Primarily, the pharmacies are focused on acquisition,
storage and distribution/dispensing of medicines and
medical devices. Drug information services are offered in
32% of the hospital pharmacies, while clinical pharmacy
services in 21%. In only 2 hospital pharmacies, I.V.
admixtures are prepared and services in this respect
offered, while the percent of the hospital pharmacies
involved in education is very low (5.9%), mostly the
pharmacies located in the large clinical and general
hospitals in the capital of the state. The pharmacists
participate in the hospital committees in 67.86% of the
hospitals and they are also involved in creation of drug
formularies in hospitals in which they are used for
therapeutic drug management (app. 16%). However, no
hospital pharmacy/pharmacist is involved in research or
clinical studies.
Most of the hospital pharmacists are female (95%), with
an average age of 35±5 yrs. There are 1.27 pharmacists
per pharmacy employed, of which 25 are
specialists/residents in different health specialist fields
(e.g. clinical pharmacy, pharmacoinformatics,
pharmaceutical technology, etc.). There are no
pharmacists with specific specialist competences, such as
the competence in oncology, (par) enteral nutrition,
therapeutic drug monitoring (TDM), etc. Giving
information on medicines and medical devices and their
acquisition, storage and distribution are the main tasks
assigned to the hospital pharmacists. Considering
pharmacy technicians (1.68 per pharmacy), they are
mostly involved in medicine preparation and their quality
control.4
There is no single legislation act that regulates the PP in
the RoM. Instead, it is regulated by several laws and
bylaws.6-9 It is required the pharmacies to have
appropriate premises, equipment and staff with high and
secondary education in the area of pharmacy. The Law on
medicines and medical devices6,9 regulates that “the
pharmacy should keep appropriate records of the
medicines consumption, introduce a system of quality and
organized work flow in accordance with the principles of
GPP and fulfill the obligations as a public service”. In the
hospital pharmacies, the integrity of supply chain and the
quality of medicines are ensured and the basic services
covered by the Health Insurance Fund (HIF) include
medicines from the List of medicines for hospital health
care.8,9 The HIF is a purchaser of the health services on
2 Pharmacie Globale© (IJCP), Vol. 04, Issue 04
behalf of the insured persons and currently it pays to the
hospitals/pharmacies only for the essential services of
supplying and dispensing/distribution of medicines.
Although, precise instructions on how these services
should be offered to meet the requirements are given in
the legislation, the minimum standards for establishing
GPP in the hospital pharmacies are not defined and there
is no strategic plan for introducing new and developing
the existing services. In addition, not all the roles that
pharmacists can play are recognized by the patients and
the society.
Considering the recommendations of FIP/WHO for
establishing minimum national standards for each activity
that supports the function and the role of the hospital
pharmacists10, the aim of this research was to identify the
gaps and perceived barriers to implement the best PP and
pharmaceutical care (PC) in the hospital pharmacy
settings in the RoM and to assess the level of education
and skills of the hospital pharmacists and their attitude
towards PP, pharmaceutical care (PC) and continuing
professional development (CPD). The assessment tool for
quantification of the PP status and quality of services was
designed in this study to provide identification of the main
priorities for intervention to improve the quality of PP and
PC and to facilitate the comparison of the results over time
within and between the hospital pharmacies. In addition,
the assessment tool here designed could be easily
modified to be used for assessing hospital PP and services
in the developing countries.
METHODOLOGY
Study design and data collection
For the aims to be achieved, a descriptive indicator study
has been conducted. Structured and standardized
questionnaire was designed and 44 (central and satellite)
hospital pharmacies were targeted for the study.4
Populations of interest were all the pharmacists and
pharmacy technicians employed at the hospital
pharmacies on the territory of the RoM. In 17 out of these
44 general or clinical hospitals or institutes with in-patient
beds, no pharmacists are employed and for the purchasing
and dispensing of medicines and for the PC (if any), mostly
pharmacy technicians are engaged.
Simple random sample design was used, so the
questionnaire was delivered to all hospital pharmacies by
e-mail or mail using database for the pharmacies from the
Pharmaceutical Chamber of Macedonia (PCoM). The
responses were completely obtained in-person from 31
(68%) hospital pharmacies within 5 weeks. Improving the
standards of PP and quality of services and recognition of
the existing and adoption of new pharmacists’ functions
and roles were a motivation for the pharmacists to show
great enthusiasm to participate in the survey. In addition,
the surveyors were also pharmacists with long-term
experience in hospital and clinical pharmacy.
Development of the assessment tool
In the design of the assessment tool, various publications
of survey questions, guidelines and already published
indicators for assessing specific topics around the PP and
services were consulted.11-17 No questionnaire adequate
for evaluation of the hospital PP in the RoM has been
designed so far. Set of 191 structural process and outcome
indicators were identified covering five essential
components of GPP: I Patient safety (Clinical pharmacy
services) (39 indicators); II Medicines and medical devices
(81 indicators); III Manufacturing practice (13 indicators);
 Mladenovska K et al. / Pharmacie Globale (IJCP) 2013, 04 (02)

IV Environment, workflow and staff availability and closed questions were used, with a type of response
qualifications (30 indicators); and V Quality assurance and format: A - Activity fully applied; B - Activity partially
risk management (28 indicators). Cross-sectional applied; C - Activity not applied (applicable); D - Activity
descriptive survey was conducted where multiple choice not applicable (Table 1).
Table 1. Assessment tool for quantification of the status of the hospital PP and services*
Indicator A B C D
I PATIENT SAFETY
A. PATIENT INFORMATION (CLINICAL PHARMACY SERVICES)
1. (Clinical) pharmacists participate in clinician/ward rounds and discuss with the physician(s) about the patients’
pharmacotherapy
27.The pharmacists document their interventions and outcomes of the in-patients’ pharmacotherapy in electronic
records
………………
B. PATIENT COUNSELING AND EDUCATION
29. Counseling and education with an aim, efficacy and safety of the recommended pharmacotherapy, prescribed dose,
use of medical device(s), etc. are routinely provided by the pharmacists prior to and during the therapy to all in-
and/or out-patients and/or their family members
37. Patients are educated by the (clinical) pharmacist about the importance of regular TDM, where and how frequently
they should check the efficacy and safety parameters of the pharmacotherapy
………………
II MEDICINES AND MEDICAL DEVICES
A. MEDICINES/MEDICAL DEVICES INFORMATION
40. The hospital pharmacy is connected with the National/regional drug information center(s) and/or another hospital to
obtain up-to-date and accurate information on medicines and medical devices used in the therapeutic drug
management
43. Specialist in drug information is engaged in providing information services on medicines/medical devices, answering
complex clinical questions and educating prescribers about the use of medicines/medical devices
………………
B. ORDERING COMMUNICATION
57. Medicines/medical devices are ordered from the wards by entering orders into computerized physician order entry
(CPOE) system, which includes decision support and standardized order sets
59. Medicines/medical devices are ordered from the wards by pharmacists
………………

C. SUPPLY, STORAGE, LABELING, DISTRIBUTION AND ADMINISTRATION

76. At a minimum, pharmacists are actively involved in purchasing of all medicines

86. Medicines stocked in the wards are carefully selected by considering the needs of each patient and unit stock is
reviewed every day
93. Auxiliary warnings or specific labels are used on packages and storage bins of medicines with similar names,
packages and labels
100. The central pharmacy has a unit-dose distribution system

110. When using narrow therapeutic index (NTI) drugs, dosage regimens are regularly calculated taking into account the
individual pharmacokinetic (PK) parameters and TDM data
………………
III MANUFACTURING PRACTICE
A. PRODUCTION

121. The pharmacy prepares dosage forms for an individual patient, both sterile and non-sterile

123. The production of pharmaceuticals complies with the EU/FDA GMP

………………
B. QUALITY CONTROL
130. Analytical procedures are regularly performed to control the quality of the raw materials and pharmaceutical
products

133. Complete documentation for the sterile products is prepared

………………

IV ENVIRONENT, WORKFLOW, STAFF AVAILABILITY AND QUALIFICATIONS

A. ENVIRONMENT AND WORKFLOW
134. Existing areas, where medication orders are reviewed, and medicines stored and dispensed, have adequate space
and they are clean, adequately illuminated, without clutter, distractions, interruptions and noise
136. Employed pharmacists and pharmacy technicians are sufficient to perform every-day tasks 24 hours
………………

3 Pharmacie Globale© (IJCP), Vol. 04, Issue 04

 Mladenovska K et al. / Pharmacie Globale (IJCP) 2013, 04 (02)
B. COMPETENCY, CONTINUING EDUCATION AND PROFESSIONAL DEVELOPMENT
142. A dedicated pharmacist offers clinical pharmacy services (specialist in clinical pharmacy)

158. Pharmacists prepare annual portfolio for their own continuing education (CE) and CPD

159. Pharmacists are obliged to collect credits and they are subject to relicensing

………………
V QUALITY ASSURANCE & RISK MANAGEMENT

165. Up-to-date policies and standard operative procedures (SOPs) are established and considered in every-day practice

178. Medication errors and adverse drug reactions (ADRs) are reported to the National Pharmacovigilance Center
183. Pharmacist are regularly educated on participating in medication error reduction process and understand the
importance of reporting medication errors
………………
*Complete assessment tool is accessible at https://fk.mk/, from March 1, 20134
When calculating the score, the maximum score of 100 (20 section was obtained when the initial and three weeks
per section) and minimum zero were given if the after responds to the questionnaire were compared.
responses from all hospital pharmacies for all indicators The manual data collection sheet ensured independent
had been A and D, respectively. The weight of each data collection on site of all data required. The data were
indicator in the section depended on the number of the saved by Excel software and analyzed by excel-based
indicators in the section and the type of the response assessment tool.
format. For example, the number of indicators per section
I was 40 and the weight of each indicator responding to A RESULTS AND DISCUSSION
was 0.500 [= 20 (maximum score per section) / 40 The first system indicators intended to assess the PP and
(number of indicators)]. The weight of each indicator clinical pharmacy services offered to ensure the patient
responding to C in the same section was calculated as a safety. Very low actual score for this section was obtained
half of the weight of the indicator responding to A (in the (7.8; Figure 1-I).
given example, 0,500 / 2 = 0.250), while the weight of each Figure 1. Histogram depicting assessment scores for:
indicator responding to B was calculated by dividing the (I) patient safety (clinical pharmacy services); (II)
sum of the weights of the indicators responding to A and C medicines and medical devices; (III) manufacturing
by 2 [i.e. (0.500 + 0.250) / 2 = 0.375]. The actual score per practice; (IV) environment, workflow and staff
section was a sum of the scores of A, B and C, while the availability and qualifications; (V) quality assurance
individual scores of A, B and C depended on the number of and risk management; (VI) all five components.
pharmacies that for a given indicator responded under A,
B or C, respectively. For example, if for a given indicator in
the section I, 10 of the hospital pharmacies responded
under A, 8 under B, 9 under C and 4 under D, then the
value for that indicator would be 0.160 under A [= 10
(number of pharmacies that declared A) x 0.5 (weight of
the indicator under A) / 31 (total number of pharmacies)],
under B, it would be 0.096 [= 8 x 0.375 / 31], and under C,
it would be 0.072 [= 9 x 0.25 / 31]. Thus, the individual
scores of A, B and C in the corresponding section would be
calculated as a sum of the values of each indicator under A,
B and C, respectively. Hypothetically, if all hospital
pharmacies for all indicators in one section responded
under B, the total score per section would be 15, such as
the individual score for B. Similarly, the total score per
section as well as the individual score for C would be 10 if
the responses from all hospital pharmacies to all
indicators in one section were under C.
The questionnaire was previously tested by involving a
target group of 10 responders (from different hospital
pharmacies) in the design to evaluate the specific
questions, format, questions sequences and instructions,
by which the apparent (logical) validity of the
questionnaire was evaluated. For the same reason, a
workshop for all hospital pharmacists was organized
during which the questionnaire was discussed and
explanations for the complex issues were given. For
content and construct validation, the questionnaire was
reviewed by 2 experts in pharmacy practice. In addition, a
pilot study was designed in which the targeted group of 10
responders was asked to respond to the questionnaire at
the beginning and after three weeks. High correlation (>
0.997) between the actual and individual scores in each
4 Pharmacie Globale© (IJCP), Vol. 04, Issue 04
 Mladenovska K et al. / Pharmacie Globale (IJCP) 2013, 04 (02)
It was declared that the pharmacists, whether in central or
satellite pharmacy, did not participate or partially
participated (22%) in ward rounds or discussed with the
physicians about the patients’ pharmacotherapy. No
information regarding demographics, disease state,
allergies, drug history and actual list of medicines is
available for the pharmacists or stored in electronic
records. The pharmacists are not engaged in the patient
chart and medication use review and reconciliation. This is
true for all types and groups of patients. In addition, there
is no communication between the pharmacists at the
transfer of care.
Patient counseling and education for the recommended
pharmacotherapy is not routinely provided by the
pharmacists prior to and during the therapy and no
pharmacist is skilled to provide counseling to patients
with special needs. Written information on the medicines
to the patients is partially provided in only 19% of the
pharmacies. When there is a contact with the patient, the
pharmacists politely answer to all questions, however, the
contacts with the patients are limited. Almost all hospital
pharmacists declared that they were skilled to provide
patient education and counseling and pointed to
inadequate structure of the pharmacies for efficacious
practice and high quality services.
The system indicators in the section II intended to assess
all the activities related to the use of medicines and
medical devices, including availability and providing up-
to-date and accurate information. The histogram in Figure
1-II points to the actual score for this section, which is
11.54. Less than half of the pharmacies (39%) are
connected with the National Drug Information Center
5 Pharmacie Globale© (IJCP), Vol. 04, Issue 04
(NDIC) and they regularly obtain up-to-date and accurate
information on medicines and medical devices, which are
further delivered to the healthcare givers. In only 5 of the
interviewed hospital pharmacies, a designated pharmacist
(specialist in drug information) is engaged in providing
information on medicines and medical devices and only
one of the interviewed hospital pharmacists declared that
had easy access to user-friendly, up-to-date computerized
information system from his/her working location. Access
to important databases on biomedical literature, life
science journals, online books or their printed editions is
limited for most of the hospital pharmacies/pharmacists
(more than 65%), while protocols or standardized dosing
guidelines and/or checklists are not available or they are
partly available in 22%. One can say that internationally
developed drug information tools are not available in most
of the hospital pharmacies (available in app. 10%).
Pharmacists are (partly) informed on the information
technology systems used to assure adequate drug and
dosage regimens (app. 77%); however, they are not
available in most of the hospital pharmacies. Pharmacists
are partly involved in development and implementation of
evidence-based drug therapy protocols, hospital drug
formularies, guidelines, etc. (only 29%). No internal risk
assessment or surveillance is made before submitting drug
monograph to the Pharmacy&Therapeutics (P&T)
committees in more than half of the hospital pharmacies.
Only 4 representatives of the hospital pharmacies
declared that they had a pharmacist responsible for
providing up-to-date information on medical errors and
ADRs.
According to the survey, most of the activities related to
the ordering communication practice are applicable, but
not applied in more than half of the hospital pharmacies.
Only 3 of the hospital pharmacies/pharmacists declared
that they used CPOE system. In only 5 hospitals, the
medicines/medical devices are ordered from the wards by
pharmacists, while in most of the hospital pharmacies
(more than 77%); the medicines are removed from the
patient unit stock before a pharmacist reviews the specific
patient order. The pharmacy interventions regarding
potentially harmful medication orders are immediately
communicated to the nurses/prescribers in most of the
hospital pharmacies (app. 80%). However, the
pharmacists have no role in off-label medicines orders or
orders for medicines in atypical doses. The pharmacists’
involvement in prescribing therapeutic substitution is
minor (35%) as well as in prescribing of any authorized
non-controlled medicine (16%).
Considering the medicines and medical devices supplying
practice in the hospital pharmacy settings, the
pharmacists are all actively involved and this activity is
performed via public tendering procedure. In app. 74% of
the hospitals, the pharmacists participate in planning of
annual budget for acquisition and there they are informed
on the budget allocated and the dynamic of expenditure. P
&T committees consisted of one pharmacist at least decide
for acquisition of medicines and medical devices in app.
74% of the interviewed hospitals.
All medicines are stored in designated areas within the
hospital pharmacies, however, in less than half of the
hospital pharmacies these areas are sufficient to ensure
proper sanitation and environmental conditions, which
comply fully with the code requirements. Temperatures in
refrigerators and freezers used to store ingredients and
 Mladenovska K et al. / Pharmacie Globale (IJCP) 2013, 04 (02)
finished sterile preparations are fully or partially
monitored and documented daily in all of the pharmacies
that prepare these pharmaceuticals, however, electronic
systems that document temperature ranges and provide
immediate problem notification are not used. In addition,
SOPs for how to handle any breach have not been
developed in most of the hospital pharmacies. Also, for
more than 90% of the pharmacies, no automatic storage or
distribution devices are available.
The packages and labels of new medicines are examined
before use and compared with the other products to
identify any potential for confusion in most of the hospital
pharmacies, although auxiliary warning or specific labels
are not extensively used. Bulk chemicals, large-volume
bags and bottles of solutions are adequately stored and
labeled in average 70% of the pharmacies, however,
medication containers taken to the bedside are not
adequately labeled in most of the hospitals. Unit oral doses
remain in the original packaging up to the point of
medicine administration in half of the hospital
pharmacies. Only one pharmacy declared dispensing oral
liquid medicines in ready-to-use patient specific doses,
while 16% declared the same for the parenteral
medicines. Similarly, doses that require less than a full
dosage unit are not repacked by the pharmacy into unit-
dose package in more than 77% of the hospital
pharmacies and there is no central hospital pharmacy that
has a unit-dose or robotic packaging/distribution system.
Barcode readers are not used before medicine
administration in all of the hospitals and error-reduction
strategies during administration have not been
established even for high-alert and NTI drugs in more than
half of the hospitals. In addition, in most of the hospital
pharmacies, no specially designed administration devices
are available.
The system indicators in the section III are used to assess
manufacturing practice, including production of both
sterile and non-sterile medicines and their quality control.
The histogram in Figure I-III shows that the actual score is
12.23. It must be emphasized that the actual score in this
section is based on the responses obtained from 9 hospital
pharmacies in which the production of pharmaceuticals
(both sterile and non-sterile) was declared. Only 3 of the
hospital pharmacies declared production of
pharmaceuticals for an individual patient. Pharmaceuticals
are mostly produced for use in the hospitals and only one
of the hospital pharmacists declared production for sell to
other hospitals. The production of pharmaceuticals
complies with the national policy in most of the hospital
pharmacies and only 2 of them declared compliance with
the EU/FDA GMP. Hazardous medicines and unit-dose
medicines for parenteral administration are prepared in
biological safety cabinets in app. 43% of the hospitals, but
the chemotherapy doses are not prepared under
supervision of pharmacist or in a pharmacy department.
Up-to-date policies and procedures for compounding
(non-)sterile products are established and available to the
personnel in app. 70% of the hospital pharmacies
producing pharmaceuticals and there, generally, master
work and preparation sheets are developed for a batch of
each discrete identity and concentration of the product
and verified by a responsible pharmacist. Analytical
procedures to control the quality of the raw materials and
pharmaceutical products are regularly performed in 5 of
the hospital pharmacies producing pharmaceuticals. For
6 Pharmacie Globale© (IJCP), Vol. 04, Issue 04
the rest of them, the quality of pharmaceuticals is
controlled in accredited laboratories outside the
pharmacy. The final sterile products are inspected when
prepared in all of the hospital pharmacies, however, in
only one; the final sterile products are inspected when
dispensed.
In the section IV, system indicators were used to assess
workflow and staff availability and qualifications. At the
histogram in Figure 1-IV, actual score (12.53) is
presented. Adequate, clean and illuminated areas for
reviewing medication orders and storing and dispensing
of medicines are present in only 39% of the hospital
pharmacies. App. 54% of the hospital pharmacists are
partly satisfied with the room for performing these
activities. In only 3% of the pharmacies, the pharmacists
and pharmacy technicians employed are sufficient to
perform every-day tasks 24 hours. Moreover, the rest of
the hospital pharmacists declared that there were no
essential preconditions for employing more staff. The
personnel work 8 hours/day with 30-min break in almost
all of the hospital pharmacies, however, an effective back-
up plan for days when staffing is short is established in
only 22% of the hospital pharmacies. Pharmacy
students/residents are partially trained (less than 8
h/day) in app. 38% of the pharmacies, but their role in
every-day activities is insignificant and therefore, they
cannot be included in the back-up plan.
Pharmacists control all medicine-related logistics in 48%
of the hospital pharmacies. Considering their
competencies, a dedicated pharmacist offers drug
information services in 35% of the hospital pharmacies,
clinical pharmacy services in 16% of the hospital
pharmacies, and in 26% of the hospital pharmacies,
information on the evidence and pharmacoeconomic
issues for each drug is provided. Specialists in
pharmaceutical technology are employed in all, while
specialists in quality control in approximately half of the
hospital pharmacies manufacturing (non-)sterile
pharmaceuticals. Pharmacists are encouraged to extent
their knowledge in the field of pharmacy management in
only 22% of the hospital pharmacies and they are not
stimulated or motivated at all to complete postgraduate
studies in specific clinical areas, such as the oncology,
pediatrics, etc. or in prescribing medicines. Pharmacists
participate in hospital multi-disciplinary committees as
full voting members in app. 22% of the hospital
pharmacies. However, they do not participate in ethical
and review committees for clinical studies.
All newly-employed pharmacists spend a defined time
before working independently and the training period is
based on an ongoing assessment in only 30% of the
hospital pharmacies. During this training period,
pharmacists spend time in patient care areas in only 22%
of the hospital pharmacies. Pharmacists are trainers of
pharmacy students and residents in app. 80% of the
pharmacies, they are reimbursed for this activity by the
PCoM and academia, but their workload is generally not
reduced in account for these activities. All pharmacists
working in the hospital pharmacies are licensed by the
PCoM and subject to relicensing. They collect credits by
attending various types of educational activities related to
their practice. However, for these activities they are not
financially supported by the hospital management.
With the indicators in the section V, standards of quality
assurance and risk management were assessed. The
 Mladenovska K et al. / Pharmacie Globale (IJCP) 2013, 04 (02)

histogram with component scores presented separately an open, non-punitive manner. There is no reward for
and as the actual score (11.29) is presented in Figure 1-V. individuals who report medication errors and ADRs and
Quality assurance policy is fully or partially established, when an event involves human error, an investigation is
implemented and evaluated in accordance with the state not undertaken to detect the reasons. Protocols or practice
provisions for accreditation in app 42% of the hospital guidelines for the use of particular medication classes
pharmacies, while in app. 77% of the hospital pharmacies, have not been implemented in most of the
SOPs are established and considered in every-day practice. pharmacies/hospitals. In addition, (computer) markers or
Policies and procedures that ensure adequate selection, triggers for selected drug orders are generally not used to
training and supervision of the staff have been fully or enhance detection of potential adverse drug events
partially developed in only 23% of the hospital (ADEs).
pharmacies, while in less than 50% of them there are To summarize the complete data from the hospital
policies and procedures that ensure reasonable workload pharmacy questionnaire, the spidograph in the Figure 1-VI
and working hours. Sufficient staff to perform tasks was designed where to all five areas equal weight with up
adequately 8 h/day is available or partly available in app. to 20 as maximum score was given, independently on the
80% of the hospital pharmacies. Safety plans have been number of questions contributing to the assessment. The
established in around 77% of the hospital pharmacies, spidograph provides a simplistic visual overview of PP
while multidisciplinary teams for risk management or (shaded area), visualizing the strengths and weaknesses of
quality assurance in not more than 40%. In addition, 32% the PP in interviewed hospital pharmacies, thus pointing
of the pharmacists declared that they were partly to the priorities for intervention. It is obvious that the
educated about the advantages of technology and/or practice and services related to providing patient safety is
evidence-based practices to improve medication safety. an area with the highest priority for intervention to
One can say that there is no a designated pharmacist improve the quality of PP and PC in line with the National
responsible for detection and analysis of medication Drug Policy and WHO/FIP Guidelines on GPP.10 The final
errors and developing of effective error-reduction plan. PP assessment score was based on the score of all
Multidisciplinary teams for formulating medication safety indicators as a fraction of the actual score relative to the
polices have been fully established in only 26% of maximal possible score and for the PP and quality of
hospitals. App 80% of the hospital pharmacists declared services in the hospital pharmacy it was 55.27 out of 100.
that medication errors were not monitored, tracked and Considering the results obtained with this survey, it is
evaluated. Pharmacists are instructed to report the obvious that the implementation of GPP and qualitative
medication errors and ADRs occurring in their hospitals to services through GPP standards in hospital (pharmacy)
the NDIC, but they are not regularly educated on settings is of essential importance. National authorities,
participating in medication error reduction processes. academia and professional associations have to put more
Medication error reporting system has been completely or efforts in this respect and the list of priorities is presented
partially established in around 30% of the hospital in Table 2.
pharmacies and in the same number of pharmacies, the In addition, new pharmacists’ roles have to be introduced
pharmacists thoroughly evaluate the medication errors in and the existing ones improved.10 (Table 3)
Table 2. Priorities for intervention by the key stakeholders
Stakeholder Priorities
Drug Buro / Ministry of Health / HIF  Establishing Law on Pharmacy Practice
/ Government  Revising criteria for establishing hospital pharmacies
 Introducing minimum standards for GPP
 Recognizing the economic and health benefits of PC services
 Establishing reimbursement policy for essential, advanced and enhanced PC services
 Establishing medication-error-reporting system
 Increasing the investment in the hospital pharmacy sector
Academia / Professional associations  Modernizing education in PP using information and health assessment technologies
 Introducing inter-professional training and training of trainers for PP
 Increasing awareness of the necessity of basic and specialist competences
 Offering more educational, training and innovative programs and multiple CPD activities
 Promoting pharmacists’ roles in the health care system

Table 3. Recommendations for introducing new and improving the existing roles and functions of the hospital
pharmacists
Role and function Recommendations (priorities for intervention)
1. Prepare, obtain, store, secure, distribute, administer, dispense and dispose of medicinal products
 Establishing regulatory difference between compounding and manufacturing
 Establishing written policies and procedures for preparation of medicine preparations and medical
products
A: Preparation of extemporaneous  Developing guidelines and protocols for preparation of medicine preparations and medical products
medicine preparations and medical  Establishing standards for compounding sterile products
products  Preparing drug formulations, dosage forms, strength and packaging for individual patients
 Increasing basic and specialist competences in formulation, development and production
 Increasing knowledge (in e.g. PK/PD, biopharmacy, biotechnology, genomics, nanotechnology, etc.)
 Investing in pharmacy structure (e.g. production lines, bar-coding technology, laminar airflow hoods, etc.)
 Strengthening national legislation for ensuring quality of supply
 Establishing policies and procedures for managing medicines acquisition (that will address formulary
B: Obtain, store and secure medicine development, competitive bidding, group purchasing, medicine shortages, etc.)
preparations and medical products  Establishing written policies for manufacturers’ representatives or vendors of drug products and related
supplies and devices
 Investing in pharmacy structure (e.g. automated storage devices, etc.)

7 Pharmacie Globale© (IJCP), Vol. 04, Issue 04

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 Establishing policies and procedures (e.g. for effective storage and distribution system, prompt and
effective recall of medicines, etc.)
C: Distribute medicine preparations
 Establishing policies and procedures for pharmacist order review
and medical products
 Investing in pharmacy structure (e.g. automated distribution devices/robotics, unit dose/bar-code
distribution systems, etc.)
 Education in administration technologies
D: Administration of medicines,
 Training for pharmacy based i.v. admixture services
vaccines and other injectable
 Establishing protocols and guidelines (e.g. for patient identification, chemotherapy error-prevention, etc.)
medicines
 Investing in pharmacy structure (e.g. smart-pump infusion devices, etc.)
 Establishing policies and procedures for dispensing medical products to out-patients and homecare
E: Dispensing of medical products patients
 Investing in pharmacy structure (e.g. bar-code assisted dispensing system, CPOE system, etc.)
F: Dispose of medicine preparations  Informing the public on the benefit of returning expired or unused/unwanted medicines
and medical products
2. Provide effective medication therapy management
 Establishing policies and procedures for effective communication with the patients
A: Assess patient health status and  Recognizing different types of assessment services
needs  Developing specialist competences in clinical pharmacy
 Developing communication skills
 Improving collaboration between pharmacists and health-care practitioners
 Providing access to patient data
 Providing access to evidence databases
B: Manage patient medication
 Establishing effective communication with the NDIC
therapy
 Developing medication therapy management (MTM) service programs
 Developing specialist competences in clinical pharmacy
 Providing specialist pharmacists in high-risk areas (oncology, pediatrics, intensive care, etc.)
 Establishing policies and procedures for proactive assessment of patient problems
 Developing specialist competences in clinical pharmacy
C: Monitor patient progress and
 Establishing medication-error-reporting system
outcomes
 Introducing trigger tool methods
 Establishing structure, process and outcome indicators for measurement of medication practice
 Establishing guidelines for formulary system management and operation of P&T committees
D: Provide information about  Developing specialist competences in drug information
medicines and health-related issues  Providing access to evidence data bases
 Establishing effective communication with the NDIC
3. Maintain and improve professional performance
 Credit allocation only for the CPD activities related to PP
 Demonstrating CE and CPD in every-day practice
 Developing pharmacists’ skills in different fields of PP (e.g. business and management, information
technology, safety and risk management, laws and regulations)
4. Contribute to improve effectiveness of the health-care system and public health
A: Disseminate evaluated information
 Preparing and disseminating appropriate publications, presentations
about medicines and various aspects
 Establishing in-service training, educational programs and activities
of self-care

B. Engage in preventive care activities  Participating in programs or campaigns for health management, health promotion and disease prevention
and services  Providing evidence base for public health activities

C: Comply with national professional

 Establishing mechanisms for complying and improving legislation
obligations, guidelines and legislation
D: Advocate and support national
policies that promote improved  Taking proactive and demanding role individually and/or through professional associations
health outcomes

CONCLUSION needs to be enlarged and they should be documented and

The present study quantifies the status of PP and services
in the hospital pharmacies in the RoM and identifies the
gaps and rooms for improvement in the regulatory
framework, pharmacies' structure and process of PC and
education and skills of the hospital pharmacists. With
respect to the legal status of the PP and services, the
existing legislation should be updated or modern Law on
PP created that will incorporate the minimum
requirements contained in the Joint WHO/FIP Guidelines
on GPP10 and the national needs of the health system and
the population.
Investments in the pharmacy structure are essential. Also,
the budget for the medicinal products needs to be
increased, while the contractual framework between the
HIF and the hospital pharmacies needs to be revised in
respect to recognizing the different types of pharmacy
services. The scope of services for providing effective MTM
8 Pharmacie Globale© (IJCP), Vol. 04, Issue 04
reimbursed. In this respect, the level of education,
knowledge and skills of the hospital pharmacists needs to
be increased by introducing inter-professional education
and training for PP at graduate as well as at postgraduate
level. As legislation and other health care providers do not
recognize pharmacists as important part of the health care
team, pharmacists must strengthen their partnership with
the other health professionals and national authorities for
improving the effectiveness of the health-care system and
public health.
ACKNOWLEDGEMENT
The authors and the PCoM gratefully acknowledge the
EuroPharm Forum and WHO Europe for financial and
expert support for the project. Authors would like to thank
the hospital pharmacists in the RoM for participating in
this study by answering and commenting the
questionnaire.
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