1. Building platform for implementation of GPP in the
Republic of Macedonia
A Report of the Project 2012
Pharmaceutical Chamber of Macedonia
2. 2
Authors
Professor Lidija Petrushevska-Tozi, PhD
Faculty of Pharmacy, University Ss Cyril and Methodius, Skopje, Macedonia
Pharmaceutical Chamber of Macedonia
Professor Kristina Mladenovska, PhD
Faculty of Pharmacy, University Ss Cyril and Methodius, Skopje, Macedonia
Pharmaceutical Chamber of Macedonia
Contributors
Jasminka Patceva, pharm.spec
Pharmaceutical Chamber of Macedonia
Dr Dick Thromb,
EuroPharm Forum, President
Kirsten Holme,
Professional secretary EuroPharm Forum ,
Project manager at Pharmakon WHO Collaborative Centar
Nina Sautenkova,
WHO Europe, programme manager at World Health Organization
Acknowledgements
The authors and PCoM gratefully acknowledge the EuroPharm Forum and WHO Europe for
financial and expert support for the project. We are particularly thankful to Kirsten Holme, Dick
Tromb and Nina Sautenkova for their commitment to help pharmacists in Macedonia to
implement GPP. We would like to thank the pharmacists in Macedonia (community and
hospital) for participating in this study by answering and commenting the questionnaires. All
outstanding errors are our own.
Suggested citation: Petrushevska-Tozi L, Mladenovska K. Building platform for implementation
of GPP in Macedonia. A Report from the project 2012, Pharmaceutical Chamber of Macedonia,
2012
3. 3
Content
Introduction 5
Methodology 18
Results 23
I Community pharmacy practice and services 23
I.1. Demographic characteristics and management of community pharmacies 23
I.2. Indicators and components included in the PP and PSs assessment
tool and scores from the community pharmacies in the RoM 30
II Hospital pharmacy practice and services 38
I.1. Demographic characteristics and management of hospital pharmacies 38
I.2. Indicators and components included in the PP and PSs assessment
tool and scores from the hospital pharmacies in the RoM 44
Discussion and recommendation for improvement of PP and services 54
Legal framework 54
Economic framework 60
Workforce framework 62
Standards for good pharmacy practice 67
Conclusion 78
References 88
Annex 1 93
Annex 2 112
4. 4
Glossary
RoM Republic of Macedonia
MoH Ministry of Health
HIF Health Insurance Fund
HPL Health Protection Law (Law on Health Protection)
DB Drug Bureau
PCoM Pharmaceutical Chamber of Macedonia
MCoM Medical Chamber of Macedonia
MAP Macedonian Association of Pharmacists
FF-UKIM Faculty of Pharmacy at the University “Ss Cyril and Methodius” Skopje
HIL Health Insurance Law (Law on Health Insurance)
LMMD Law on Medicines and Medical Devices
NDIC National Drug Information Centre
NCP National Centre for Pharmacovigilance
GPP Good Pharmacy Practice
DRG Diagnoses Related Groups
HEI High Educational Institutions
FIP Federation International Pharmacy
PSs Pharmacy Services
PP Pharmacy Practice
PC Pharmaceutical Care
CPD Continuing Professional Development
CE Continuous Education
CCE Center for Continuous Education
PoM Prescription only medicines
NPoM Non prescription only medicines
DPFM-UGD Department of Pharmacy at the Faculty of Medicine, University “Goce Delcev” Stip
DPUT Department of Pharmacy at the University Tetovo
PK Pharmaco Kinetics
PD Pharmaco Dinamics
TDM Therapeutic Drug Monitoring
MTM Medication therapy management
ADR Adverse drug reaction
CPOE Computer prescribing order entry system
GP General Practitioners
5. 5
Introduction
The Republic of Macedonia (RoM) is a landlocked country in the heart of the Balkan Peninsula (Fig. 1), in
Southeastern Europe, with about 2 100 000 inhabitants and 25.713 km2
. In autumn 1991, after 45 years
union with five other republics in the Socialist Federal Republic of Yugoslavia, the country gained
independence in a peaceful secession and established political system as a parliamentary democracy. As
foreign policy priorities, peaceful and stable relations with the all neighboring countries and accession to
the European Union and the collective security system of the North Atlantic Treaty Organization are
considered. Economic reforms have focused on fully establishing market economy structures, including
deregulation and introduction of the necessary privatization trends in the public sector, liberalization of
international trade, etc. Alongside facing a number of unforeseen obstacles owing to regional instability,
reform implementation has been faced with frequent political changes. Since independence, the RoM
has seen six prime ministers and 11 different compositions of government. During the same period, 14
ministers of health have been appointed, which indicates the stewardship challenges for continuous and
consistent health policy1,2,3
.
Fig. 1. Map of the Republic of Macedonia (Source: United Nations Cartographic Section).
The population density is 79.00 inhabitants/km2
, 60 % live in urban areas. The population growth rate is
0.257% (2010 est.). Life expectancy at birth for both sexes has increased slightly from 72.12 years in
1991 to 74.92 years in 2010. However, this figure is still much lower than in Western Europe and was
five years below the EU average of 78.49 years in 2004. Median age is 35.4 yrs (2010) with 11.6% of
population over 65 years. In the period 1999-2009, the percent of population up to 14 years decreased
from 22.8 to 17.1%, while for population older than 65 years, it increased from 22.8 to 11.6%. Thus, the
RoM shows a tendency towards an ageing population with similar problems of health care and social
care system as elsewhere in EU. Neonatal mortality rate, under 5 mortality rate, maternal mortality ratio
and adolescent fertility rate are lower than average in the region. Immunization coverage is high.
Cardiovascular diseases (57.9%) and malignancies (19.4%) are the main causes of mortality, followed by
endocrine, nutritive and metabolic diseases with 3.9%4
.
6. 6
With a gross national income per capita of around $4120 in 2008, the RoM is a lower middle-income
country. GDP per capita (PPP) is $10,500 (2011 est.) Official unemployment is high, 29.1%.
Macroeconomic stability is maintained and GDP growth is modest, but positive. According to WHO
estimates, total health expenditure as a percentage of GDP in the RoM amounted from 6.8% in 2002 to
6.9% in 2009. This represents a significantly lower figure than that of the most of the other ex-Yugoslav
countries and the EU. In the same year, the health care expenditure in US$ (with purchasing power
parity) per capita amounted to US$ 341, with 84.7% of health expenditure coming from public sources.
Expenditure for investment in the health sector (0.7%) continued to be insufficient5
.
Following independence, the RoM inherited the health care model from the former Yugoslavia. In line
with the highly decentralized health system structures that had been in place in the Socialist Federal
Republic of Macedonia, the beginning of the 1990s saw a health system that was organized in stand-
alone, self-managing communities, with only the projects requiring large-scale capital investments being
centrally coordinated6
. The decentralized system led to fragmentation of service delivery and significant
oversupply and duplication of both facilities and services. Moreover, a series of different units were
established that frequently contained elements of primary, secondary and tertiary care. From that
period until recently, the country has moved from highly decentralized to more centralize structures,
while at present, the political aim is to move back to a decentralized system. The RoM set up an
insurance-based health system with the Government and the Ministry of Health (MoH) providing the
legal framework for operation and stewardship and the Health Insurance Fund (HIF) being responsible
for the collection of contributions, allocation of funds and supervision and contracting of providers.
Today HIF is an independent institution monitored by the MoH, with a central office in Skopje and
branch offices at local level.
Numbers of other reform initiatives in the field of health care were undertaken with an aim of sustaining
access for the whole population to a comprehensive health system as well as to improve the quality of
health services and enhance financial sustainability. But still the system was facing a number of
challenges. The Ministry of Health’s core functions were focused on health policy formulation and
implementation, priority-settings and monitoring of the health system’s performance. The need for the
MoH to develop a stronger role in policy development, implementation, monitoring and analysis and to
establish its role as a leader of strategic development in the health sector, including human resources
policy, has long been recognized but has proven difficult to address7
. Against this background, the
development of a new law was initiated. The Health Protection Law (HPL)8
of August 1991 laid the
groundwork for the current health system and has served as the framework for health policy ever since.
Based on the HCL, Drug Bureau (DB) was established as a unit of the MoH to take care of
pharmaceuticals, registration and licensing procedures for medicines, remedial medicines and medical
devices and to participate in the preparation of the essential and positive drug lists. Also, based on the
HCL and later by means of a separate Health Insurance Law (HIL)9
, the system of compulsory health
insurance was established. Equity, solidarity and reciprocity as well as provision of universal coverage
for the population have been defined as its core values. However, the established structures have been
characterized by large-scale inefficiencies in performance, the absence of uniform performance
standards, inequalities in health care delivery and insufficient financial support from the central budget
for the health care system. In 1992, “medical”, “dentists” and “pharmacists” chambers were established,
being responsible for licensing/relicensing of health professionals and their continuous professional
development; and the responsibility for continuous education was given to the medical, dentists and
pharmacists associations.
7. 7
The Pharmaceutical Chamber of Macedonia (PCoM) was established as a professional association of all
registered pharmacists of Macedonia. It is responsible for protection and promotion of the pharmacists’
competences and strengthening the role of the pharmacists in all aspects of the heath care system10
.
PCoM regulates the ethical aspects of the pharmacy profession, but also protects its interests and/or the
interests of the pharmacists. As a professional organization, it assures the continuing education and
licensing and re-licensing processes in the manner of professional development. For all the activities,
good relations and cooperation with the governmental bodies (e.g. MoH, HIF, DB, Accreditation
Agency), non-governmental associations (Medical Chamber of Macedonia (MCoM), Macedonian
Association of Pharmacists (MAP), etc.) and academia (Faculties/Departments of Pharmacy) have been
established, which can be confirmed by the involvement of the PCoM in all key projects and legislation
procedures related to the pharmacy practice and education of pharmacists. PCoM has been involved in
drafting Law on medicines and medical devices, Law on health care, Law on recognition of professional
qualifications, Health strategy 2020, Contracts between the community pharmacies and HIF and related
rulebooks. Considering the education of pharmacists, the PCoM collaborated with the Faculty of
Pharmacy at the University “Ss Cyril and Methodius” (FF-UKIM) in Skopje in the project titled
“Restructuring of Pharmacy Education in the Republic of Macedonia”, financed by TEMPUS program (as
a joint project of the Faculties of Pharmacy in Skopje, Copenhagen and Stockholm and the PCoM). The
project activities resulted in a modern graduate study program for obtaining title Master in pharmacy
organized as a 1st
and 2nd
integrated cycle according to Bologna. Also, partnership with the MCoM was
established regarding continuous education and professional development i.e. re-licensing of
pharmacists.
Besides reform achievements in pharmaceutical sector related to the strengthening of the capacities
(e.g. establishing of MoH, HIF, DB, PCoM), the establishment of a National Drug Information Centre
(NDIC) in 1998 as an institution responsible for collection, processing and dissemination of information
and data concerning drug control, registration and rational prescribing was one of the major
achievements. A National Centre for Pharmacovigilance (NCP) was also established in 1991. In 1997, it
was networked with the WHO Center for Drug Adverse Effects as accompany member, while full
membership was obtained in 2000. The main task of this Center is to collect data on adverse drug
reactions and give recommendations regarding any withdrawal of a drug from the market that may
ultimately be necessary11
.
Today, health care in the RoM is delivered through a system of health care institutions covering the
country’s territory relatively evenly. The health facilities range from health care stations and centers at
primary health care level and specialty-consultative and inpatient departments at secondary level to
university clinics and institutes at tertiary level, with the latter also carrying out research and
educational activities. Recent years have seen substantial growth of the private sector, especially in the
field of primary health care. The private practice is regulated by the Law on health care of 1991 with
amendments in 2004 and 2005. In 2005, the private sector employed roughly one third of all physicians
working in primary care, the privatization of dentists’ offices at primary care level has been completed
and the process of privatizing publicly-owned pharmacies by sale or leasing has been initiated in 2005
and completed in 2007.8
With the privatization process, pharmacists and pharmacy managers (not
obligatory having pharmaceutical education) became owners of the space and equipment only, with the
same level and scope of services (i.e. procurement, storage and dispensing of medicines) and lot of
professional problems typical for the countries in transition. The privatization system intended to spread
liberalization, however, led pharmacy to be increasingly seen as a part of the commercial sector rather
than a part of the professional system within health care.
8. 8
In order the process of privatization to be supported, the World Bank provided assistance through
several projects such as the project for “Quality Improvement of Health Services and Licensing” by which
the model for continuing education and licensing was established based on a modern best practice
processes for the health professionals (including pharmacists). In addition, under the “Health sector
management project”12
, also financed by the World Bank, the MoH of the RoM (Project Coordination
Unit) and the PCoM prepared and realized training seminars for "Developing pharmacy practice" for
community pharmacists conducted by the experts from the university and practice (2007/08). The main
goal of the training seminars was to improve the quality of pharmaceutical services in community
pharmacies and to increase patient satisfaction by establishing a basis of a modern best practice process
and Good Pharmacy Practice (GPP) for the pharmacy professionals in the reformed health care system in
Macedonia. The key objectives were focused on preparing appropriate training material on
pharmaceutical care and GPP, including pharmacovigilance. Fourteen workshops for about 500
participants from all around the country were carried out. The key outcome included recognition of the
new roles, skills and attitudes beyond the scope of the traditional pharmacy practice and within the
GPP, which pharmacists need to master in order to become members of multi-disciplinary health care
teams as well as added values which they can provide through their professional input and expansion of
existing roles. The enthusiasm among the community pharmacists for adopting new roles and
responsibilities was evident although aware that the implementation of GPP in community pharmacies
was a major problem due to the overall economic development and lot of problems that had to be
solved within the overall health system, among which the following with the highest priority: legislation
not supporting the best pharmacy practice and pharmaceutical care concept; low level of community
pharmacy practice and services; lack of knowledge sufficient for introducing and implementation of
pharmaceutical care services in community pharmacies; low level of cooperation (partnership) between
the health care providers (e.g. prescriptionists and pharmacists); lack of inter-professional training
programs, etc13
.
In 2009, FIP Foundation for education and research under FIP approved the PCoM application for the
project titled ”Implementation of GPP in Macedonia” under the call for projects Future Implementation
Plan for Good Pharmacy Practice (GPP)14
. Implementation of pharmaceutical care services in community
pharmacies, improving quality of the pharmacy practice and pharmaceutical care in community
pharmacy settings through implementation of GPP standards established on a basis of a modern best
practice process were the main objectives of the project. The following aims were also included in the
project proposal: (i) review on the current status of Macedonian community pharmacy in both practice
and research; (ii) identification of the perceived barriers to implementing best pharmacy practice and
pharmaceutical care in the community pharmacy settings; (iii) definition of the main priorities for
intervention to improve the quality of the pharmacy practice and pharmaceutical care services in line
with the National Drug Policy and WHO/FIP Guidelines on GPP; (iv) setting up a plan of action for
stepwise approach and managing pharmacy practice and pharmaceutical care changes; (v) providing
assistance in developing mechanisms and tools for monitoring of the implementation process and
dissemination of the results. Unfortunately, although approved, this project was never financed by FIP.
Today, there are 740 private-owned community pharmacies all around the state with unbalanced
distribution in some geographic regions (Table 1) and 44 hospital pharmacies located in general and
clinical hospitals in secondary and tertiary care with in-patients beds (Table 2). Five private
hospitals/hospital pharmacies have been established since 2005 covering the following specialties:
10. 10
Bosilovo 2 5 14.129
Vasilevo 3 4 12.572
Novo Selo 5 4 11.070
Polog 76 106 314.804
Gostivar 22 28 82.554
Vrapciste 2 9 26.798
Mariovo, Rostusa 1 3 8.843
Tetovo 40 30 89.730
Brvenica 1 5 16.432
Bogovinje 1 10 30.154
Zelino 1 9 26.697
Jegunovce 0 4 10.866
Tearce 5 8 22.730
East 67 67 200.522
Berovo 3 4 13.404
Pehcevo 1 2 5.188
Vinica 1 7 19.533
Delcevo 6 6 16.964
M. Kamenica 5 3 7.863
Kocani 22 13 38.187
Zrnovci 0 1 3.146
Cesinovo,Oblesevo 0 2 7.226
Probistip 6 5 15.665
Sv. Nikole 2 6 18.114
Lozovo 0 1 2.638
Stip 21 16 48.517
Karbinci 0 1 4.077
*actual number-the number of existing pharmacies
**maximum number-the number of maximum needed pharmacies
Source: Regulation for Network of Health Institutions (Official Gazette of RoM, No. 81/12)
general medicine, gynecology/obstetrics, (cardio)surgery and ophthalmology. A new Rulebook for
establishing pharmacies is expected to be issued by the end of the year. The MoH has drawn up a
“medical map” (carte sanitaire 2008) to provide regulatory basis for further expansion of the private
sector i.e. in future, licenses for opening private clinics or hospitals or community pharmacy will be
issued according to the need. In July 2012, the MoH has drafted a network of health institutions, incl.
network of community pharmacies, to ensure proper coverage with health institutions all over the
country15
. Health institutions included in the network have signed contracts with the HIF. Contracts with
the HIF can be signed only after obtaining license for work issued by the MoH. All state/private health
facilities are allowed to apply for contracts with the HIF. HIF, however, have the right to contract
selectively, according to the criteria set out in the Rulebook16
. The contracts with the HIF are modified
every year in order to best regulate the mutual relationships17,18
. As there is only one HIF in the RoM,
the provisions in the contracts are mostly in favor of the HIF.
11. 11
Table 2. Network of general and clinical hospitals (with central and satellite pharmacies) in secondary
and tertiary health care level with in-patients beds
Name / location of the hospital (hospital pharmacy) Ownership/Level of care
Clinical Hospital, Bitola Public / Secondary
General Hospital, Gostivar Public / Secondary
General Hospital, Gevgelija Public / Secondary
General Hospital, Veles Public / Secondary
General Hospital, Kavadarci Public / Secondary
General Hospital, Kicevo Public / Secondary
General Hospital, Kocani Public / Secondary
City General Hospital 8
th
September, Skopje Public / Secondary
University Clinic of Surgical Diseases Sveti Naum Ohridski, Skopje Public / Tertiary
Psychiatric Hospital, Skopje Public / Secondary
University Pediatric Clinic, Skopje Public / Tertiary
University Hospital Pharmacy, Skopje Public / Tertiary
University Clinic of Hematology, Skopje Public / Tertiary
University Clinic of Abdominal Surgery, Skopje Public / Tertiary
University Clinic of Gynecology and Obstetrics, Skopje Public / Tertiary
University Clinic of Radiotherapy and Oncology, Skopje Public / Tertiary
University Clinics of Urgency, Traumatology, Orthopedic, Anesthesiology and
Reanimation, Skopje
Public / Tertiary
Special Hospital for Gynecology and Obstetrics Cair, Skopje Public / Secondary
General Hospital, Kumanovo Public / Secondary
General Hospital, Ohrid Public / Secondary
General Hospital, Prilep Public / Secondary
Institute of Nephrology, Struga Public / Secondary
General Hospital, Struga Public / Secondary
General Hospital, Strumica Public / Secondary
Clinical Hospital, Tetovo Public / Secondary
Clinical Hospital, Stip Public / Secondary
Psychiatric Hospital, Demir Hisar Public / Secondary
Psychiatric Hospital, Negorci Public / Secondary
Special Hospital for Pulmonary Diseases, Lesok Public / Secondary
Institute for Prevention, Treatment and Rehabilitation of Chronic Respiratory,
Non-specific and Allergic Diseases, Otesevo, Resen
Public / Secondary
Special Hospital for Pulmonary Diseases and Tuberculosis, Jasenovo, Caska Public / Secondary
General hospital, Debar Public / Secondary
Special Hospital for Orthopedic and Traumatology Sveti Erazmo, Ohrid Public / Secondary
Re-Medika Hospital, General Hospital, Skopje Private / Secondary
Special Hospital for Surgical Diseases Filip Vtori, Skopje Private / Secondary
Acibadem Sistina Clinical Hospital, Skopje Private / Secondary
Specialized Obstetric Gynecology Hospital Sveti Lazar, Skopje Private / Secondary
Special Hospital for Ocular Diseases European Ophthalmology Hospital, Skopje Private / Secondary
Health Institute, Kriva Palanka Public / Secondary
Institute for Prevention, Treatment and Rehabilitation of Cardiovascular
Diseases, Ohrid
Public / Secondary
Institute of Pediatric Pulmonary Diseases Kozle, Skopje Public / Secondary
Institute of Pulmonary Diseases and Tuberculosis, Skopje Public / Secondary
Institute of Physical Medicine and Rehabilitation, Skopje Public / Secondary
Gerontology Institute 13 Noemvri, Skopje Public / Secondary
Sources: Macedonian Association of Hospital Pharmacists, PCoM; Regulation for Network of Health Institutions (Official Gazette
of RoM, No. 81/12)
12. 12
In the Strategic plan of the MoH for 2009-201119
, more improvements in the health care system were
planned according to the priorities of the Government. One of these priorities was drafting improved
legislation. New Law of health protection was issued in March 201220
. This Act clearly defines all
pharmaceutical activities as
“part of the health care activities, including purchasing of medicines and medical devices,
production of medicines, distribution and drug quality control, giving information on drugs to
patients and other health care providers, counseling and education on rational and effective use
of medicines and medical devices and therapeutic drug management”.
This definition gives real opportunity for the pharmacists to perform wide range of pharmaceutical
activities and services. The reimbursement of the drugs is on the basis of referent prices21
. At present,
the HIF reimbursement practices for pharmaceuticals on the positive list of drugs take insufficient
account of the pharmacists’ overhead costs22,23
. For the community pharmacies, the HIF is paying for the
medicaments plus fix margin according to the scale based on referent price of the medicine, lower fee
for lower referent price, higher fee for higher referent price (lower is 0,2 euro, higher is 3,33 euro). For
the hospital pharmacies, the expenses are calculated according to the DRG system. The reference
pricing system was established for the drugs in the primary care. Data collection on drug expenditure in
the country is difficult as drug consumption is not monitored closely. In 2007, Law on medicines and
medical devices was issued11
. The Law is generally harmonized with the EU legislation, following all the
EU provisions concerning pharmaceuticals. Under this Law, the pricing of medicines is regulated, which
is not in line with the EU legislation. There is a single act titled “Methodology for establishing medication
prices”24
, adopted by the Government in October, 2011, which strictly defines the establishment of drug
prices, on the basis of comparative study conducted in 12 countries (in the region, EU, including Russia
and Turkey).
The pharmaceutical sector currently operates on the basis of a positive list of drugs (by generic names)
that defines which drugs are eligible for reimbursement by the compulsory health insurance. The sector
is supervised by the DB. The DB (MoH) and the PCoM issued National Drug Formulary25
in 2006 The
National Drug Registry26
, first time issued in 2006, is updated every year.
In the RoM, unlike most of the EU27
and most world countries, there is no Pharmacy law as a single
legislative act to regulate the pharmacy practice and scope of pharmaceutical activities and services.
Instead, in the Law on medicines and medical devices from 200711
there are 2 articles that outline the
activities related to the medicinal retailing within pharmacies. This Act considers pharmacies to be legal
entities where purchasing, storage and dispensing of medicines are undertaken. It is very encouraging
that this Law creates new opportunity for pharmacies by endorsing the need to introduce quality
systems and to organize work process according to the principles of GPP28
. This document is a very short
one with only 4 articles, but it provides directions for the evolution of the pharmaceutical activities into
the pharmaceutical care concept. The GPP guideline explicitly quotes the need for development of
national GPP standards to guarantee professional roles of the pharmacists and to ensure essential
conditions are in place for implementation of GPP. Unfortunately, to date neither national standards
have been developed, nor the wider professional debate has been initiated by the DB (MoH) to promote
the concept of pharmaceutical care on a national basis.
In 2007 the Government, MoH and the DB have also clearly recognized the need for improvement in the
health policy, decision making process at all level of health protection and the quality and efficiency of
health services and health professionals. The activities necessary for overcoming the problems and
13. 13
achieving the goals were set out in the “Health strategy of the Republic of Macedonia (2020) for safe,
efficient and just health system”29
. The main objective of the Strategy at the level of primary care is to
ensure the population to have a better access to the family- and community-oriented health care
services supported by a flexible and responsive health system. The pharmacy practice problems and
priorities for improvement are described in a separate chapter (titled Pharmaceutical services) where
the weaknesses in the pharmacy practice are identified, such as irrational prescribing of drugs, lack of
drugs in the pharmacies, submission of claims for drug cost reimbursement in front of the HIF, lack of
data for the overall drug consumption in the country, training of health professionals, etc. Also, it is
recognized that a system of compulsory and accredited continuing education required for relicensing
has not been established yet. The financing of continuing educational activities was and it is still a
problem in a view of the low income of health care professionals, incl. pharmacists. As another major
bottleneck, lack of access to internet sources of information was detected. The Strategy also recognizes
the steps for improvement of the pharmacy practice and services, including
(i) revision of the national drug policy from 2001;
(ii) renewal of the positive list of essential drugs (based on clinical protocols and guidelines)
that will be fully reimbursed by the HIF;
(iii) establishment of referent prices for drugs, with generic names;
(iv) strengthening and enlarging the functions of the DB with its transformation into an
autonomous Drug Agency authorized to control all phases of drug registration, import and
distribution of pharmaceuticals and implementation of GPP in pharmacies.
The Strategy also points that the concept of pharmaceutical care is not a dominant form of practice for
most of the pharmacists in the RoM. The transformation from commodity-based mercantile operations
into a clinical profession is evaluated as very slow. It is emphasized that encouragement and setting
appropriate GPP guidelines containing national standards are needed, which would meet professional-
determined needs for pharmaceutical care. The necessity of developing standards for the pharmacy
services which ensure proper co-ordination and communication between the health- and
pharmaceutical care providers and consumers is also emphasized. It is recommended the number of the
pharmacists (especially in the hospitals) to be increased, partnership between physicians, nurses and
pharmacists to be strengthen, the role of the pharmacists in reporting adverse effects to be increased,
participation of the pharmacists in clinical studies and ethics committees to be recognized, the
communication and co-ordination between the pharmacies and/or pharmacists in the hospitals and
community pharmacists to be improved and employment of specialists in clinical pharmacy and
pharmacoinformatics in the hospital pharmacies to become obligated.
Another similar document, “Green Book - Improvement of the Health System in RoM” was also issued in
2009/2010 by the Committee for improvement of the health system in the RoM30
. The Committee was
established by the MoH with an aim to help the Government to finish the reforms in the health system.
Valuable recommendations were gathered by the health experts in five areas: (i) management of the
health system; (ii) health care practice; (iii) financing; (iv) pharmacy; and (v) patients rights. PCoM
(pharmacy experts) has actively participated in drafting the recommendations. Main recommendations
were focused on the need of issuing Law on pharmacy practice as a single legislative act, defining the
structure and role of the community/hospital pharmacies/pharmacists, defining the mechanisms for
transfer of patients through the levels of health care, defining the roles of the pharmacists in
prescribing, strengthening the communication between the health care providers (pharmacists and
physicians) and between them and the patients, defining the levels of education and training for the
14. 14
pharmacists (depending on their professional needs), establishing standards for the pharmacy structure,
developing programs for therapeutic management, stimulating use of clinical guidelines and specialized
formularies, increasing the budget for medicines and medical devices, etc.
Considering education of pharmacists, accredited high educational institutions (HEIs) in the RoM are
the FF-UKIM in Skopje, Department of Pharmacy at the Faculty of Medicine, University “Goce Delcev” in
Stip and the Department of Pharmacy at the State University Tetovo in Tetovo. They are all public HEIs
and accredited by the National Accreditation Committee, which is under jurisdiction of the Ministry of
education and science of the RoM. Criteria for enrollment in the 1st
and 2nd
level integrated pharmacy
study programs include 4-year secondary education (gymnasium or secondary medical school) and
state exam, excluding entrance exam. At these HEIs, the students are enrolled as regular full-time
students and their education is financed or co-financed by the State. The pharmacy study programs at all
HEIs last 10 semesters (1st
and 2nd
cycle integrated, 300 ECTS-credits according to Bologna). In the last
(10th
) semester, professional practice is provided and after graduation, the students obtain a title
Master in pharmacy. Professional practice is conducted in community and hospital pharmacy. In the
practical teaching and training, professionals from the university clinical centers, and hospital,
community and industrial pharmacists are included. In 2009/2010, the Faculty of Pharmacy at UKIM in
Skopje in collaboration with the PCoM introduced new pharmacy study program according to Bologna,
harmonized with the study programs of several Faculties of Pharmacy in Europe (see above) and with
the Directive 2005/36 on recognition of professional qualifications. In the period 2010-2012, new study
programs related to pharmacy practice at 2nd
level were also introduced and the existing ones
modernized, such as the academic specialist and master study programs in health management &
pharmacoeconomy, phytotherapy. At the Departments of Pharmacy/ Faculties of Medicine in Stip and
Tetovo, only study programs in pharmacy at 1st
and 2nd
integrated level (300 ECTS-credits according to
Bologna) are conducted.
After graduation and obtaining diploma Master in pharmacy, additional 6-month professional practice in
community and hospital pharmacy and in national/regional drug information centers is required for
the pharmacists to obtain license for independent work. The training program is in accordance with the
rulebooks31-37
issued by the PCoM, which is in compliance with the LHP8
. The internship period of 6
months embraces five pharmacy fields: (i) community pharmacy, (ii) hospital pharmacy, (iii) clinical
pharmacy, (iv) pharmacoinformatics and (vi) pharmacy legislation. After 6-month training, the residents
have to pass the state exam in order to become licensed pharmacists i.e. eligible for independent work,
registered in the PCoM register. The training program is under supervision of certified mentors and
conducted by trained and certified (by the MoH) educators. The training program, state exam and
licensing are under jurisdiction of the PCoM and in accordance with the Law on health protection.
The state exam is conducted in accordance with the “Rulebook on state exam for masters in
pharmacy” and the Examination committee is consisted of accredited examiners. Under the same LHC,
the PCoM is authorized for recognition of the training, state exam and license conducted/obtained
abroad for domestic and foreign citizens. During the exam, knowledge and skills in the area of
pharmacy practice in hospital and community pharmacy are assessed. Under the Health sector
management project38
, the examination process was positively evaluated by external evaluators39
. The
comments of the external evaluators were as follows: “The assessments are criterion-referenced and
are very well designed, reliable and valid. There are mark sheets and supporting documents available for
the examiners and the students well prepared. Criteria are clear. The combination of the three forms of
assessment gives a good profile of the student’s readiness to practice safely and competently. Students
receive feedback on their performance and thus the assessments are formative as well as summative.
No student has failed the assessment although a couple has been borderline (this is because students
15. 15
would not reach this stage without their deficiencies being recognized and addressed by the faculty and
the educators and mentors). The assessments, dealing with relatively small numbers, are very well run
and organized and are a model of postgraduate assessment)”. In addition, it was emphasized that a
Fig. 2. Education and training of the pharmacists in the RoM
Graduate degree course
Five years covering
- Basic biomedical sciences (incl. physiology, anatomy,
biochemistry, microbiology, pathophysiology, pathology)
- Pharmaceutical chemistry
- Pharmaceutical technology
- Drug quality control
- Phytochemistry and phytotherapy
- Food and nutritition
- Pharmacotherapy
- Pharmacy practice
Postgraduate pre-registration
Six month-training
- Pharmacy practice
- Regulatory affairs
Professional examination
- Licensing (entry into the professional register)
CE and CPD
- All registered pharmacists are subject to
relicensing after 7 yrs
- Collect credits by attending various types of CPD
activities
Post-graduate education and training
- Many pharmacists voluntarily pursue further post-
graduate academic and health professional degrees
in fields as clinical pharmacy, drug information,
phytotherapy, clinical biochemistry, pharmacy
practice, etc.
- Gain certificate as (health) specialists in specific
fields
16. 16
good system of communication is in place to identify struggling students and also to improve the
assessment and overall learning process. The assessors were evaluated as very competent and well
briefed, supportive and encouraging of the students whilst remaining rigorous in their expectations.
Starting from 2006, 941 pharmacy residents have passed the internship program and 886 successfully
passed the state exam.
The masters in pharmacy may/must renew their license after 7 years by fulfilling the following
conditions: at least 60% of working time in the profession during this period and participation in
continuing education courses and professional development programs. By the same LHP, the temporal
and permanent confiscation of license is regulated. According to the “Rulebook for types of continuing
education activities and professional development programs, criteria and credits allocation for
continuing education and professional development”40
, the Expert Committee at the PCoM
approves accreditation of the educational activities upon submission of the application and allocates
credits depending on the type of the continuing education activities and professional development
program. For the past 6 years, 205 workshops, seminars, symposiums and other forms of continuous
education have been accredited.
Continuing education and professional development as well as application of modern scientific and
expert achievements in practice are the main objectives and tasks of the Macedonian association
of pharmacists, which is actively involved in organizing educational and scientific events, conventions
and congresses which are rated in the CME system. Other institutions are also involved in organizing
various types of educational activities, such as the Center for continuing education (CCE) and the
NDIC located at and under jurisdiction of the FF-UKIM in Skopje.
Pharmacists may also obtain health specialist title in adequate field of health practice according to the
LHP8
and the Rulebook for health specialist and subspecialist studies of health practitioners41
. The
Faculty of Pharmacy at UKIM in Skopje is the only designated HEI for organizing health specialist
studies for the pharmacists in the RoM. Health specialist study programs were recently (2011)
modernized and there are training programs in clinical pharmacy, pharmacoinformatics, medical
biochemistry, drug quality control and testing, pharmaceutical technology, sanitary chemistry,
toxicological chemistry, herbal drugs (pharmacognosy), medicinal laboratory genetics and pharmacy
practice. Health specialist studies are fully regulated by the Law on health protection, by which a
system of mentorship and educators was introduced and the responsibilities of the health institutions
where training is conducted, in respect to quality, agreement protocols and planning are regulated.42
Adoption of standards for pharmacy services (PSs) in 1993 by the International Pharmaceutical
Federation under the heading “Good pharmacy practice in community and hospital pharmacy settings”
developed as a reference to be used by national pharmaceutical organizations, governments and
international pharmaceutical organizations to set up nationally accepted standards of Good Pharmacy
Practice (GPP), their subsequent adoption in a wide number of developing countries43,44
and significant
changes in practice, applied science and technology and pharmaceutical policy that have occurred
worldwide in community and hospital settings45-49
were the main provocation for the PCoM to propose
the project titled “Building platform for implementation of GPP in the Republic of Macedonia” for
financial and expert support by the EuroPharm and WHO.
The main goal of the project is to set up a platform for improving the quality of the PP and PSs in
community/hospital pharmacy settings through implementation of the GPP standards established on
a basis of a modern best practice process (joint WHO/FIP document 2011). For this goal to be
17. 17
achieved, a survey for the standards of PP and for the quality of PSs in the RoM was conducted with the
aims given below:
to define the standards for PP and quality of PSs in the community and hospital pharmacies in the
RoM in respect to the standards set in the Joint FIP/WHO guideline on Good Pharmacy Practice (GPP):
standards for quality of pharmacy services;
to define the regulatory system and political, legal and economic framework supporting the PP and
services in the RoM;
to identify the gaps and perceived barriers to implementing the best PP and pharmaceutical care (PC)
in the community and hospital pharmacy settings in the RoM;
to assess the level of education, knowledge and skills of both the community and hospital pharmacists
and their attitude towards PP, PC and continuing professional development (CPD);
to identify the main priorities for intervention to improve the quality of the PP and PC in line with the
National Drug Policy and WHO/FIP Guidelines on GPP based on consideration of the realities, policies,
strategies and new roles;
to create a document with set of recommendations for improving the PP and set up a plan of action
for stepwise approach and managing the PP and PC changes;
to provide assessment tool for quantification of PP status and quality of PSs that can facilitate
comparison of results over time.
18. 18
Methodology
For these aims to be achieved, a descriptive indicator study has been used. Structured and standardized
questionnaires, separately for the community and hospital pharmacies were designed and as
stakeholders, 740 in total (individual and chain-) community pharmacies and 44 (central and satellite)
hospital pharmacies were adequately targeted. Simple random sample design was used for both,
community and hospital pharmacists, so the questionnaires were delivered to all community and
hospital pharmacies by e-mail or mail using data base (e-mail addresses) for the pharmacies of the
PCoM. For completion of the questionnaire by the community pharmacists, instructions and
explanations were given to the responsible pharmacists of the regional offices (8 regional offices). For
completion of the questionnaire by the hospital pharmacists, a workshop was organized during which
the questionnaire was discussed and explanations for the complex issues were given.
In addition, as stakeholders, the DB within the MoH of the RoM, HIF, PCoM and FF-UKIM were also
considered in order to define the legal, economic and educational framework for the PP and PC in the
RoM. The information from these stakeholders was collected by meetings and from available
documentation and legislation.
The information from the questionnaire for the community pharmacies was collected partly by e-mail or
mail (using the Dillman Method)50
and partly by face-to-face in the pharmacy where the respondent
works. The time elapsed before receiving the completed questionnaires was not longer than 5 weeks
(May-June, 2012). For the hospital pharmacies, having in regard the relatively low number of hospital
pharmacies and participation of the hospital pharmacists at the workshop, the information was
completely obtained by in-person. Of 740 total number of community pharmacies, 123 responses were
obtained from the chain pharmacies and additional 122 responses from the individual pharmacies.
Considering the hospital pharmacies, 31 responses out of 44 were obtained. It is worth to emphasize
that 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 drugs and for the PC (if any) mostly medical
technicians are engaged. Improving the standards of PP and quality of services and recognition of
existing and adoption of new pharmacists’ roles was a motivation for the pharmacists to show
enthusiasm and interest to participate in the survey.
Improving legislation and creating better climate for PP and PC services was the point of interest for the
DA and MoH of the RoM, HIF and PCoM, while for the FF-UKIM, the interest was focused on creating
new academic and/or specialist study programs and types of CPD activities (within the CCE established
at the FF-UKIM) to increase pharmacists knowledge and skills for performing the best PP.
Populations of interest were all the pharmacists and pharmacy technicians employed at the community
and hospital pharmacies on the territory of the RoM. According to the data from the Register of the
PCoM, there are app. 1140 community pharmacists, 1225 pharmacy technicians (app. 74 working in the
hospital pharmacies) and 56 hospital pharmacists. The number of community pharmacists varies
significantly from year to year due to the great variations in the number of pharmacies (app. 30
community pharmacies are opened and 15 are closed per year). Most of the community pharmacists are
female, 80% vs. 20% male pharmacists. Average number of pharmacist per community pharmacy is 1.4,
while the average number of employees per pharmacy is 2.86. The average age is 30±5 yrs. For the
hospital pharmacists, the proportion of female pharmacists is significantly higher, 95% vs. 5% male
pharmacists, with an average age of 35±5 yrs. Average number of pharmacist per hospital pharmacy is
less variable and at the first half of 2012 it is 1.27 pharmacists per pharmacy, while the average number
19. 19
of employees per pharmacy is 3.79 (incl. cleaning personnel and administration). The number of
prescriptions/per year for reimbursed medicines (by HIF) in 2010 was 15.228 (increasing app. 2000 per
year), while average value per prescription is 1.9 euro.
The resources (financial and expert) for designing the questionnaires and conducting the survey were
provided dominantly by the EuroPharm Forum, WHO and the PCoM. In creating questionnaires,
conducting the survey/interviews and analysis of data collected, 2 professors with a background
understanding of GPP from the FF-UKIM (members of the PCoM), Lidija Petrusevska Tozi (president of
the PCoM for app. 10 yrs, professor at the FF-UKIM) and Kristina Mladenovska (specialist in clinical
pharmacy, 10 yrs working experience in hospital pharmacy, professor at the FF-UKIM) and 1
administrative officer Jasminka Patceva (specialist in pharmaceutical regulatory affairs, 10 yrs working
experience in community pharmacy, employed at the PCoM) were involved. The questionnaires were
revised by Dr Dick Thromb, president of EuroPharm Forum, and Kirsten Holme, professional secretary
EPF, Pharmakon-WHO Collaborative Centar, and Nina Sautenkova, NIS programme manager at World
Health Organization, who also participated in creating the overall project proposal. The meetings were
organized with the representatives from the stakeholders, the DB (MoH), HIF and FF-UKIM and the data
were also collected by inspection in available documentation, laws and rulebooks. With the survey, the
issues given below were explored.
For the community pharmacies (Annex 1), set of 155 structural process and outcome indicators were
identified covering five essential components given below. The indicators describe the highest standards
of PP and quality of PPs. Data for the demographic characteristics and management of the community
pharmacies were also collected.
I Pharmacy structure and practices (60 indicators)
- Pharmacy structure (premises, equipment, etc.)
- Supplying, storage and stock
- Dispensing
- Access to drug information
II Patient – access to patient data, communication, counseling and education (25 indicators)
III Manufacturing practice and drug quality control (13 indicators)
IV Staff – workflow, competency and professional development (25 indicators)
- Workflow
- Competency, continuing education and professional development
V Quality assurance, risk and data management (32 indicators)
- Quality assurance
- Data management within the pharmacy
20. 20
For the hospital pharmacies (Annex 2), set of 191 structural process and outcome indicators were
identified covering five essential components, given below. Data for the demographic characteristics
and management of the community pharmacies were also collected.
I Patient safety (39 indicators)
- Patient information
- Patient counseling and education
II Drugs and medication devices (81 indicators)
- Drug & medication device information
- Ordering communication
- Purchasing, storage, labeling, distribution and administration
III Manufacturing practice (13 indicators)
- Production
- Drug quality control
IV Environment, workflow and staff availability and qualifications (30 indicators)
- Environment and workflow
- Competency, continuing education and professional development
V Quality assurance and risk management (28 indicators)
For the DB and MoH, the following issues were covered:
I Regulations/restrictions on location and number of pharmacies (geographic and demographic criteria)
II Regulations/restrictions on ownership (limitation of ownership to pharmacists, limits to the ownership
of multiple pharmacies i.e. pharmacy chains)
III Criteria for establishing pharmacy (room, equipment, staff)
IV Distribution of pharmaceutical products outside a pharmacy
V Opening hours
As source of information, the Law on health protection, Law on medicines and medical devices,
rulebooks relevant for establishing pharmacies and performing pharmacy practice and Regulation for
network of health Institutions were considered.
21. 21
For the HIF, the following issues were covered:
I Pricing regulation
II Contracting
III Remunerations and incentives mechanisms
As source of information, the Law on health insurance, Law on medicines and medical devices,
rulebooks relevant for contracting pharmacies and performing/reimbursement of pharmacy practice
were considered.
For the PCoM, the following issues were covered:
I Registration
II Licensing and relicensing
III Accreditation of CPD activities
III Relations with governmental institutions, academia and professional associations
As source of information, the Law on health protection, Law on medicines and medical devices,
rulebooks relevant for licensing/relicensing, accreditation of CE activities were considered.
For the FF-UKIM, the following issues were covered:
I Graduate study program in pharmacy, with particular emphasis on PP and PC (harmonization with
Directive 2005/36/EC on the recognition of professional qualifications)
II Postgraduate professional (academic and specialist) study programs covering PP and PC
(harmonization with Directive 2005/36/EC on the recognition of professional qualifications)
III Involvement of the NDIC at the FF-UKIM in PP of the community and hospital pharmacies
IV Involvement of the CCE at the FF-UKIM in continuing education and CPD of the community and
hospital pharmacists
As source of information, the study programs accredited by the Ministry of education and science at the
FF-UKIM, relevant rulebooks and the Statutes of the Faculty and University were considered51,52
.
In writing the questionnaires, various publications of survey questions and guidelines and already
established (published) indicators for assessing specific topics around PP were consulted53-64
. The chosen
PP indicators assess standard requirements for PP which are in line with the official licensing
requirements in the RoM.
For the community and hospital pharmacists, cross-sectional descriptive surveys were conducted where
combined pre-coded open ended and multiple choice closed questions were used with type of response
format: A - Activity fully applied; B - Activity partially applied; C - Activity not applied (applicable); D -
Activity not applicable (Annex 1 and Annex 2). Multiple choice closed questions were used to create
22. 22
assessment tool for quantification of PP status and quality of PSs that can facilitate comparison of
results over time within and between the community and hospital pharmacies. When calculating the
GPP and PSs score, the maximum score of 100 (20 per section) and minimum zero for both community
and hospital pharmacies were given for all the indicators (155 for community and 191 for hospital
pharmacies, respectively) if all indicators were responded to A and D, respectively. The weight of each
indicator in the section depended on the number of the indicators in the section and if all responded to
A, it was calculated by dividing 20 with the number of indicators. For example, if the total sum of
indicators per section I is 40 and each indicator responds to A, the weight of each indicator would be
0.500 (= 20/40). The weight of the indicators responded to C was calculated as a half of the weight of
the indicator responded to A (in the given example, it would be 0,500/2 = 0.250), while the weight of
each indicator responded to B was calculated by dividing the sum of the weights of the indicators
responded to A and C by 2 (i.e. (0.500 + 0.250)/2 = 0.375). Thus, in the given example if all the indicators
were responded to B, the total score would be 15 per section and 10 per section if the answers to all
questions were C.
The questionnaires were previously tested by involving the target groups/stakeholders (actual
respondents) in the design to evaluate the specific questions, format, questions sequences and
instructions. During the pilot study, the measurability of the questions, interpretation of the questions
by all respondents, whether close-ended questions have a response which applies to all respondents,
clarity and understandability of the questions, length of the questions, time for completing and
responses from the different response categories, etc., were evaluated. Considering that for almost all
indicators a professional background was required to undertake the necessary assessment, both the
surveyors and respondents were pharmacists.
The manual data collection sheet ensured independent data collection on site of all data required. The
sheet contained data collection space for all indicators in the form of structured information. The data
were saved by Excel software. Excel-based assessment tool depicts the findings in the form of a
histogram and a spidograph of all components calculated for each pharmacy settings.
23. 23
Results
I Community pharmacy practice and services
I.1. Demographic characteristics and management of community pharmacies
According to the data obtained with the survey, only 8.43% of the community pharmacists are state or
local governance, while independent (owned by the pharmacist itself) and owned by two or more
pharmacists (partnership of pharmacists) are 24.1% and 15.61%, respectively. Most of the respondents
belong to corporate body owning more than 1 pharmacy (part of pharmacy chain), 53.3%. There is not a
single community pharmacy with an international ownership or ownership of non-profit making
institution (Fig. 3).
2,41
6,02
24,1
15,61
53,3
0
0 60
state governence
local governence
indipendant
partnership
coorporate body
international ownership
Fig. 3. Ownership/institutions responsible for establishing community pharmacy
3,05
7,83
72,3
1,2
16,3
0 80
rural
suburban
city
out of town
health centre
Fig. 4. Location of the community pharmacies
24. 24
Most of the pharmacies (72.3%) are located in the cities, especially in the centers of the cities. Only
7.83% of the community pharmacies are located in suburban areas, while very few (3.05%) are placed in
rural areas. Within or near the health centers, there are 16.3% (Fig. 4) of community pharmacists, which
indicates inadequate distribution of the community pharmacies for providing PSs for the patients.
The categories that best describe the number of citizens currently served and the number of patients
served by the community pharmacy is presented in Fig. 5.
3,01
6,63
12,7
10,8
31,3
27,1
24,7
16,3
14
21,7
13,3
17,5
0 35
up to 500
500-1000
1000-3000
3000-5000
5000-10 000
over 10 000
citizens served
patients served
Fig. 5. The number of citizens and patients served in/by the community pharmacy
21,2
38,6
24,1
15,1
0 40
up to 2000
2000-3000
3000-5000
over 5000
Fig. 6. The number of prescriptions dispensed per month in the community pharmacy
Considering the category of patients currently served by the community pharmacies, 31.3% of them
dispense medicines for 1000-3000 patients and 24.7% serve 3000-5000 patients. Approximately similar
percentage (12.7%, 14.0% and 13.3%) of the pharmacies dispense medicines to 500 - 1000; 5000 - 10
000 and <10 000 patients, respectively. Only 3.01% of the respondents serve less than 500 patients per
25. 25
month. Comparing the number of citizens and patients served in the community pharmacies, it is
obvious that the number of citizens and number of patients go along for the pharmacies that have 1000-
3000 citizens/patients. It is interested to note that the community pharmacies serving higher number of
citizens, serve lower number of patients.
Considering the number of prescriptions dispensed by the community pharmacy per month (reimbursed
or not by the HIF), most of the pharmacies (38.6) dispense up to 3000 prescriptions. Similar number of
pharmacies dispenses medicines for up to 3000 or 5000 prescriptions (21.2% and 24.1%, respectively).
Only 15.1% of the community pharmacies dispense over 5000 prescriptions and only 1.2% dispenses
more than 6000 prescription (Fig. 6).
One of the parameters for evaluating the structure of the community pharmacy was the total size of the
pharmacy floor. In only 3.01% of the community pharmacies, the total size of the floor is less than 25m2
,
while the community pharmacies with total floor size over 100m2
are 7.23%. Most of the community
pharmacies (45.2%) are with floor size from 25-45m2
and 26.5% have the size of 45-65m2
(Fig. 7). Almost
all of the community pharmacies (95.8%) are open 12 h/day, six days per week, and approximately 70%
of the pharmacies are open for providing services on Sunday and holidays (67.5% and 76.5%,
respectively). Only 10.8% of the community pharmacies provide on call services during the whole week.
All the community pharmacies have installed a computer system. However, in 39.2% of them it is used
as connection to other pharmacies (usually in chain pharmacies) and only 14.5% of the pharmacies use
the computer system for gathering information from the NDIC.
3,01
45,2
26,5
17,5
7,23
0 10 20 30 40 50
up to 25m2
25-45m2
45-65m2
65-100m2
over 100m2
Fig. 7. Total size of the pharmacy floor
Considering the staff employed in the community pharmacies, the point of interest was the number of
full-time or part-time employed with the degree graduated pharmacist or master in pharmacy, but also
stuff with a health specialization (2nd
cycle according to Bologna, see the Introduction). Almost all
community pharmacies are equipped with 1-2 technicians and 1-2 pharmacists as full-time employed,
with 1 responsible (licensed) pharmacist. There are no pharmacists with specialist competences such as
competence in community pharmacy (due to lack of specialized education in this area), clinical
pharmacy, pharmacoinformatics, regulatory affairs, nutrition, etc. Full-time employed cleaning personal
is 0.38/pharmacy and administrative stuff 0.03/pharmacy (accounting personal). There are no part-time
employed pharmacists, pharmacy technicians or administrative staff in the community pharmacies in
the RoM, as they are not recognized by the HIF for contracting with the pharmacy. Only 1% of the
26. 26
community pharmacies have specialists in certain field of medicine and pharmacy, mostly the specialists
in pharmaceutical technology.
The pharmacists are involved in all activities in the community pharmacy, administrative and traditional
activities (drug supply and dispensing) as well as activities related to pharmaceutical care services
(patient counseling and education, giving information on medicines and medical devices, etc.)
Considering the pharmacy technicians, they are mostly involved in drug dispensing (89.2%), patients
counseling (81.9%) and giving drug information (78.9%). Around 42.2% of the employed pharmacy
technicians are involved in drug supply and 23.5% are involved drug and medical devices acquisition,
storage and distribution. Only 8.43% are engaged in drug preparation. These data are logical
consequence of the actual situation regarding employment in the community pharmacies where usually
1 pharmacist and 1 pharmacy technician are employed (Fig. 8).
0
20
40
60
80
100
drug dispensing
Patient counseling
Drug information
Drug preparation and quality control
Acquisition, storage and distribution
drug supply
Fig. 8. Tasks assigned to pharmacy technicians in the community pharmacy
Considering purchasing of medicines and medical devices, the survey showed that wholesalers are the
main source for acquisition of drugs followed by industry (Fig. 9). Only 3.61% of the community
pharmacies have their own production and only 4.22% purchase drugs from other community
pharmacies. Most of the community pharmacies purchase medications daily (77.1%), 17.5% twice a
week and only 1.2% purchase medications weekly. There is no community pharmacy that supplies
medicines monthly.
27. 27
6,02
98,2
3,61
4,22
3,01
0 100
industry
wholesalers
own production
other pharmacies
group purcharing
Fig. 9. Sources for purchasing of medicines and medical devices by the community pharmacy
The types of pharmaceutical (care) services provided on an around-the-clock basis in the community
pharmacies are presented in Table 3. In only half of the community pharmacies (53.61%), medicines use
is reviewed. In addition, blood pressure is measured in 22.29% of the community pharmacies;
hypertension is managed in 19.28%, while diabetes and asthma management is offered in 16.27% of the
community pharmacies. Other services are offered in very low number of community pharmacies, there
are pharmacies where no additional services other than (repeat) dispensing prescriptions are offered
and some of them declared that the structure of the pharmacy does not provide minimum conditions
for offering pharmaceutical care services.
Table 3. The pharmacy services provided in the community pharmacy
The services provided in and by the community pharmacy %
Dispensing prescription 93.98
Repeat dispensing 88.55
Medicines use review 53.61
Disposal of medicines’ waste 40.36
Blood pressure measurement 22.29
Hypertension management 19.28
Glucose measurement 17.47
Diabetes management 16.27
Asthma management 16.27
Pregnancy test 11.45
Weight measurement 5.42
Smoking cessation 3.01
Cholesterol measurement 1.20
Home care services 1.20
Night services 1.20
Vaccination 0
28. 28
According to the data from the survey, the patients obtain information on the services provided in the
pharmacy in 72.89% of the community pharmacies. These services are offered regularly in 63.86% of the
pharmacies, for all patient groups in 42.17%, but in only 24.70% of the community pharmacies, the
pharmacists document the pharmaceutical services they provide. In addition, only dispensing of
prescription is reimbursed by the HIF, so 31.33% of the respondents claimed that services are
reimbursed (Fig. 10).
31,33
24,7
42,17
43,37
0 45
reimbursed
documented
all patients
offered on the advice
of the pharmacist
Fig. 10. Information on the services provided in/by the community pharmacy
Considering the data obtained for the reimbursement of medicines, one can see that the most of the
community pharmacies (95.18%) have a contract with the HIF and almost all of them (96.78%) have
fulfilled all the provisions from the contracts with the HIF. The reimbursement is sufficient to satisfy the
patient needs for medicines in only 63.05% of the community pharmacies, although the reimbursed
medicines are available in the pharmacy each and every day in 83.73% of the community pharmacies.
The evidence for reimbursed medicines is kept separately from the evidence for other medicinal
products, readily available for inspection in almost all of the community pharmacies (93.98%). The
received prescriptions are printed on paper in standardized form in 93.37% of the community
pharmacies, in app. 1.21% they are e-prescriptions and in 5.42% they are handwritten in standardized
form. The medicines without co-payment are first offered to the patients in 81.33% of the community
pharmacies (Fig. 11)
The survey also gives data for the management characteristics of the community pharmacies in the
RoM. The pharmacies are managed both (internally and externally) in 53.0% of the community
pharmacies, but dominantly internally (in 43.4%), while the pharmacy managers respond to the
pharmacy owners in app. 64.5% of the community pharmacies. In app. 92% of the community
pharmacies, the pharmacy manager is qualified pharmacist. In 73% of the pharmacies, the responsible
pharmacist is not the owner of the pharmacy and he/she responds to the pharmacy manager.
According to the information gathered during the survey, the pharmacists in the community pharmacies
are in a phase of preparation of written SOPs. Up-to-date policies and SOPs established so far and the
proportion of community pharmacies incorporating these standards are given below (Table 4).
29. 29
7,23
93,98
81,33
83,73
62,05
0 100
e-prescription
separate evidence
medicines without
co-payment
availability
sufficient budget
Fig. 11. Budgeting and reimbursement of medicines
Table 4. Up-to-date policies and SOPs established in the community pharmacies in the RoM
SOPs Community pharmacies (%)
Supplies, storage and delivery of products
Product acquisition, storage and handling
Fire safety
Management of disposal of expired stock
Pest control
Complain handling
Cash management
Hygiene procedures
Medicines recall
Documentation
Personnel education and training and competency evaluation
Reporting adverse drug reactions
Key holding
Personnel access
Incident management
Use and maintenance of facilities and equipment
Contingency in the event no pharmacy is present
Monitoring environmental conditions
Products requiring specialized handling
Labelling
Movement of materials
Compounding medicines
Quality control
Process validation
Preparation technique
66.3
64.5
62.6
61.4
57.2
56.6
56.6
56.0
53.1
47.6
45.2
45.0
44.5
43.9
38.5
35.5
33.7
26.5
24.1
16.9
10.8
9.64
8.4
7.83
5.42
%
30. 30
App. 33.1% of the community pharmacies provide residency-training for graduated pharmacists during
their licensing period. The training program and final exam are accredited by and under jurisdiction of
the PCoM (see Introduction). Approximately 47.2% of the community pharmacists also provide training
program approved by the secondary school council and Ministry of health for pharmacy technicians. In
nearly half of the pharmacies, the number of residents usually does not exceed five per year.
I.2 Indicators and components included in the PP and PSs assessment tool and scores from the
community pharmacies in the RoM
The first system indicators set out in the section I (Annex 1) intended to assess pharmacy structure (e.g.
premises, equipment, etc) and all the activities related to the medicines and medical devices such as
ordering communication, supply, storage, dispensing as well as access to drug information. The
histogram in Fig. 12 depicts component scores as the actual score compared to the possible maximum
score and comparison is also made between the indicators responding to A, B and C, accordingly (Note:
the weight of the indicators responding to D is always 0). The results depicting component scores from
the actual score point to the value 16.38 out of 20.
Considering indicators assessing the structure of the community pharmacies in the RoM, app. 97% of
the pharmacies are clearly identifiable as health care facilities with access for disabled patients. The
service areas in the pharmacies are clean, adequately illuminated and free of clutter, distractions,
interruptions and noise. Suitable waiting areas, areas for confidential conversation with the patients,
separate areas for OTC drugs and dietary supplements, herbal, homeopathic and alternative medicines
are fully or partially available in less than 83% of the pharmacies. It is interesting to note that only 39%
of the community pharmacies have areas for health promotion as it is a common practice to use the
dispensary area for health promotion. In very low number of community pharmacies (only 28 out of
245) there are separate manufacturing areas constructed according to the safety policies.
The dispensing area is suitable in size for the prescription volume and provides uninterrupted and safe
workflow in app. 84% of the community pharmacies. All pharmacies are equipped with refrigerator, but
in only 72% it is used for medicinal products (mainly storage) according to the safety requirements. Each
pharmacy is equipped with computerized system, which in app. 95% is used for dispensing medicines,
recording prescriptions, financial and stock management, while in 87% of the pharmacies it is fully or
partially used for obtaining information on medicines and treatments. However, for the important
activity FEFO (first expired first out) it is rarely used (in only 35%), while patient medication records are
generated in 17% of the pharmacies. Also, in only 14% of the pharmacies, the computerized system is
designed to alert for e.g. over/sub dosing, serious drug interactions, (cross) allergies, contraindications,
problematic/similar drug names, packaging and labels, etc. Dispensing system with printer for producing
legible and durable labels when dispense medicines re-packed from the bulk is fully or partially used in
only 14% of the pharmacies. Barcode scanners for reading of medicinal products and prescriptions are
used in every community pharmacy. No pharmacy uses automatic devices for storage, distribution and
dispensing of medicinal products.
31. 31
20
16,38
12,1
2,82
1,46
0
20
Maximum
possible
score
Actual
score
A B C
Fig. 12. Histogram depicting PP and PSs assessment scores for pharmacy structure and practice in
community pharmacies
According to the survey, half of the community pharmacies have written policies and procedures for
ordering, recipe and immediate supply of medicinal products, while in 22% they are in the phase of
preparation. Policies and procedures for reception, handling and dispensing of controlled i.e. narcotic
drugs are fully or partially established in 40% of the pharmacies and the rest of them do not
supply/dispense these drugs. Telephone ordering from reputable distributer/manufacturer is the most
exploited way for purchasing medicinal products.
Medicines are stored and shelved in designated areas to ensure proper sanitation, temperature, light,
ventilation, moisture control, segregation and security in almost all of the community pharmacies (95%).
The same percentage of the pharmacies segregate products with similar names and packaging ensuring
that they are not stored alphabetically and the place where the products are relocated is clearly marked.
Also, in almost all of the pharmacies (90%), hazardous and flammable substances are stored separately
in compliance with the legislation. Use of auxiliary warnings or specific labels on packages and storage
bins of drugs with similar names, packages and labels is fully applied in only 55% of the community
pharmacies. Pharmacy stocks are reviewed at least annually to determine low usage medications and
expired or returned products are clearly segregated from the rest of the stock in almost all of the
community pharmacies (app. 97%). In every pharmacy, expired or returned products awaiting disposal
are clearly and securely segregated from the rest of the stock. The storage areas for medicinal products
are under control of the pharmacists in only 38% of the pharmacies, while in the rest of them they are
under control of both pharmacist and pharmacy technician. It is interesting to note that in less than 70%
of the pharmacies, the structured system for stock management is established and followed and the
same percentage of the pharmacies follows policies for maintaining cold chain.
As previously said, dispensing practice in community pharmacy was also evaluated. According to the
survey, written dispensing procedures are fully established in only 52% of the pharmacies, while in 11%
they are in the phase of preparation. The received prescriptions are printed on paper standardized form
and routinely checked for legibility, validity and authenticity in all pharmacies. Almost all community
pharmacists (97%) regularly obtain relevant patient information before dispensing and evaluate the
prescriptions for possible problems prior to dispensing. However, not always the prescriber is contacted
32. 32
in cases when potential problem with the prescribed medicines is identified (53%), and even if the
pharmacists contact the prescriber they rarely record/document this pharmacy intervention (23%). All
of the community pharmacists routinely check expired dates during each dispensing process and the
medicinal products in original packages are additionally labeled by the pharmacists (handwriting)
providing information on dosage regimen, date and place of dispensing, etc. Limited number of
community pharmacies (15%) repacks medicines into unit-dose package when medication doses require
less than a full dosage unit. Low number of the community pharmacies (28 out of 245 interviewed
pharmacies) that produce pharmaceuticals adequately label the prepared products during dispensing.
In all community pharmacies, national medicines formulary and drug catalogues (registers) are available
and often used for therapeutic drug management. Pharmacists in the community pharmacy have easy
access to user-friendly, up-to-date computerized information systems which include drug information,
information on OTC drugs, herbal and alternative medicines and medication devices while working in
their respective location. Almost half of the community pharmacies in the RoM are connected with the
NDIC and/or another pharmacy, and those which are connected obtain regularly up-to-date and
accurate information on medicines and medication devices which are further used in therapeutic drug
management. However, access to important databases on biomedical literature, life science journals,
online books or their printed editions is limited for most of the community pharmacies in RoM. It is
interested to note that app. 43% of the community pharmacies declared that this activity is not
applicable due to lack of finances.
20
15,98
12,54
2,48
0,96
0
20
Maximum
possible
score
Actual
score
A B C
Fig. 13. Histogram depicting PP and PSs assessment scores for patient safety in community pharmacy
The system indicators set out in the section II (Annex 1) are intended to assess PP and quality of PSs
offered to ensure patient safety (e.g. scope of data and mechanisms for obtaining information on the
patients, level and quality of pharmaceutical care provided as well as counseling and education provided
to all patients by the community pharmacists). The results of the survey point to a very high actual score
(15.98 out of 20) (Fig. 13)
In app. 80% of the pharmacies, patient demographic data and information on drug history, co-morbid
and/or chronic conditions, allergies and patient social and personal habits are obtained and used when
dispensing medicines. In dispensing process, the pharmacists ascertain the clinical purpose of each
prescription, consider the need for dose adjustments upon available clinical data and take steps to
33. 33
understand the cultural issues and overcome language, visual or hearing barriers when communicate
with the patients in all community pharmacies. In addition, all pharmacists attempt to identify any drug
related problems patients may experiencing and use enough time for patient counseling and education
for medicines, therapy and dosage regimens, ADRs and importance of regular therapeutic drug
monitoring.
In all community pharmacies in the RoM, the patients are encouraged to ask questions about
medications they are receiving and pharmacists always answer politely and clearly. During discussions,
the patients are informed about the potential errors with medicines known to be problematic (e.g. look
– alike names, interactions, etc). However, written information on the drugs in the patient primary
language (including supplementary information, nutrition, life-habits, etc.) is provided in 52% of the
community pharmacies. Adequate information resources to the patients to facilitate proper recognition
and use of service for making informed choices are fully or partially available in 75% of the pharmacies.
In app. 50% of the pharmacies, a procedure for informing the pharmacy staff when to refer patient
exclusively to the pharmacist is established. Patients are referred to other health care providers when
necessary in 54% of the pharmacies. Policy to assist individuals who may be abuse/misuse non-
prescribed medicines is fully established in 29% of the community pharmacies. Similarly, regular audit
carried out by the pharmacist to ensure that abuse/misuse of non-prescription medicines is minimized is
carried out in only 12% of the pharmacies. Considering that in most of the pharmacies, only one
pharmacist is full-time employed, there are no staff members who are specially trained to provide
advice on the use of non-prescription medicines and therefore, they are not visible or approachable. In
limited number of community pharmacies (10%), educational programs for all or specific patient groups
are developed and organized with the aim to improve the use of medicines.
The system indicators set out in the section III (Annex 1) assess manufacturing practice and drug quality
control. The histogram in Fig. 14 depicts component scores as very low actual score which is 2.83 vs.
maximum possible score of 20.
The results from the survey point out that only 28 out of 245 interviewed community pharmacies
produce pharmaceuticals for individual patients, while 11 of them for all patients, also. App 75% of the
responders declared that this pharmacy activity is not applicable in their respective locations due to the
specific structure and low space requirements for establishing a pharmacy, while app. 15% of them
replied that there are preconditions for producing pharmaceuticals, but this activity is not applied. Up-to
date policies and procedures for manufacturing of the products are fully or partially established and the
pharmacy staff is competent for each step of the manufacture process in only 3 of the community
pharmacies. Appropriate range of containers for packaging of extemporaneously compounded products
is available in only 3 of the community pharmacies, where the responsible pharmacist verifies that the
product was compounded accurately with the correct ingredients and quantity of each ingredient. The
production of pharmaceuticals complies mostly with the national legislation.
34. 34
20
2,83
1,32
0,08
1,43
0
20
Maximum
possible
score
Actual
score
A B C
Fig. 14. Histogram depicting PP and PSs assessment scores for manufacturing practice in community
pharmacies
Analytical procedures for drug quality control of the raw materials and pharmaceutical products are
regularly performed in all 28 community pharmacies. In 20 of them, the procedures are performed in
the pharmacy, while for rest of them in accredited laboratories outside the pharmacy (contract service).
Records for compounded products are easily retrievable and stored in an appropriate manner for at
least five years from date of compounding in 2 pharmacies out of 28 that produce pharmaceuticals. (For
more detailed inspection into the survey results for the Section III see Annex 1).
The section IV uses system indicators to assess workflow and staff availability and qualifications (Annex
1). The histogram in Fig. 15 presents component scores as the actual score which is 15.52 out of 20
(maximum possible score).
The results from the survey point out that adequate, sufficient and trained staff is employed to ensure
that patients are timely served in app. 95% of the community pharmacies, working 7 hour/day with 30
min break. It must be emphasized that the staff is sufficient for traditional pharmaceutical services, not
considering PCs services for which the staff is sufficient in 10% of the pharmacies. However, an effective
back-up plan for days when staffing is short is established in most of the community pharmacies,
referring that one pharmacist can work more than 8 hours/day (double shift). All professional activities
are carried out under the supervision of the pharmacist in any time in app. 60% of the community
pharmacies. Pharmacy students/residents are trained and they work no more than 8 hours/day in app.
60% of the pharmacies.
All employed pharmacists are registered at the PCoM, meaning that they possess license for
independent work. They are aware of their professional role and the associated boundaries and
accountabilities and are regularly educated about new drugs added to the pharmacy inventory and any
35. 35
20
15,52
13,15
1,45 0,92
0
20
Maximum
possible
score
Actual
score
A B C
Fig. 15. Histogram depicting PP and PSs assessment scores for workflow, staff availability and
qualifications in community pharmacies
associated guidelines, restrictions, etc. It was declared that all pharmacists have competences for
gathering, analyzing and providing drug information, patient counseling and education, while only 31%
of the pharmacies declared that employ pharmacist competent for therapeutic drug monitoring and
evaluation of the outcome. Considering management competences, app. 57% declared that have
pharmacist with knowledge and skills in management. The pharmacists have professional relations with
pharmacists in their pharmacy or from other pharmacies and with other health workers. The
pharmacists are actively involved in the selection of the most appropriate medication for the patients.
However, in only 61% of the pharmacies, they are allowed to make generic substitution for prescribed
medicines.
Considering CPD activities, the pharmacist accept the concept of CPD and collect credits by attending
educational activities related to their professional practice. For these activities they are supported by
the pharmacy manager, however, financial support by the manager is fully or partially provided in only
60% of the pharmacies. App. 42% of the pharmacies declared that their pharmacists prepare annual
portfolio for their own continuing education and professional development.
App. 88% of the pharmacies declared that newly-employed pharmacists spend a defined time before
working independently and the training period is individualized and based on an ongoing assessment of
their needs. Pharmacists are trainers of pharmacy students and residents in app. 60% of the pharmacies
and they are reimbursed for this activity by the PCoM and faculties, but in only 17% of the pharmacies
they have reduced workload on account of the training activities. The pharmacy managers provide
formal teamwork training to the staff that incorporates elements of information sharing, conflict
management, communication and clarification of team roles and tasks in app. 70% of the community
pharmacies. (For more detailed inspection into the survey results for the Section IV see Annex 1).
The section V uses system indicators to assess standards of quality assurance, risk and data
management (Annex 1). The histogram with component scores presented separately and as the actual
score is presented in Fig. 16. The actual score is 13.45.
36. 36
20
13,45
10,51
1,7 1,24
0
20
Maximum
possible
score
Actual
score
A B C
Fig. 16. Histogram depicting PP and PSs assessment scores for quality assurance, risk and data
management in community pharmacies
All of the community pharmacies are well supplied with medicines according to the patient needs.
However, quality assurance policy is established, implemented and evaluated in accordance with the
state provisions for accreditation in only 50% of the community pharmacies, while in app. 65% of the
pharmacies, up-to date policies and SOPs to ensure adequate personnel selection, training, supervision,
evaluation and reasonable workload levels are established and considered in every day practice.
Sufficient personnel to perform tasks adequately 7 h/day are available or partly available in app. 80% of
the community pharmacies and the lines of authority and areas of responsibility are clearly defined in all
pharmacies.
In all of the community pharmacies similarly packed products are stored and positioned in a manner
that minimizes the possibility for mix-up, but the products with the narrow therapeutic index are
highlighted in only half of the community pharmacies.
All community pharmacists make interventions to avoid the errors that may occur during prescribing
and dispensing. Also, all pharmacists are instructed to report the medication errors and ADRs occurring
in their pharmacy to the NPC, but only 60% of the pharmacies declared that their pharmacists are
regularly educated on participating in medication error reduction process. In addition, a non-punitive
anonymous medication error reporting system has been fully or partially established in app. 63% of the
community pharmacies and there pharmacists involved in serious errors that cause patient harm have
professional help and are emotionally supported by their colleagues and manager. When an event
involves human error, in 50% of the pharmacies a thorough investigation is undertaken to detect
uncover and preexisting factors. Similarly, when/if medication errors reach the patient they are honestly
disclosed to patients/relatives in a timely manner. Patients are informed on the complain procedure in
only half of the community pharmacies, while the patients satisfaction is fully or partially monitored,
evaluated and documented in 56% of the community pharmacies.
Engaging “outside” agency to assist with the quality assurance documentation or to review the quality
assurance program is common practice in app. 27% of the community pharmacies.
37. 37
The results from the survey about data management within the community pharmacies point out that
app. 95% of the community pharmacies in the RoM protect the data obtained from/about the
patients/prescriptions in compliance with the provisions of the legislation which arise from the contracts
with the HIF. Pharmacists correctly endorse the prescriptions at each dispensing, but in only 69% of the
community pharmacists that information is registered in the prescription book and all entries in a
chronological order are documented using a system that allow prompt retrieval of each and every
prescription dispensed. One can notice that all pharmacies that supply and dispense narcotic drugs (app.
40%) evident these drugs in the controlled drugs register. App. 27% of the community pharmacies
evident, fully or partially, dispensed medicines in the patients’ record and only 2% of the pharmacies
obtain written consent from the patients for maintaining their records. In these pharmacies, the
patients have access to their records. (For more detailed inspection into the survey results for the
Section V see Annex 1).
0
5
10
15
20
Patient safety
Pharmacy structure and
practice
Manufacturing practice
Staff availability and
qualifications
Quality assurance and risk
management
Fig. 17. Spidograph depicting PP and PSs assessment scores of the five components
The spidograph in Fig. 17 is designed such all five areas are given equal weight with up to 20 as
maximum score, independent on the number of questions contributing to the assessment. As previously
explained, the questions within each of 5 assessment areas have different weight. The spidograph
visualizes the strength and weakness of pharmacy practice of interviewed community pharmacies
depicted in one (mean) spidograph thus providing a simplistic visual overview of PP (shaded area),
allows for prioritization of interventions and facilitate comparison of results over time. It is obvious that
practice and services related to manufacture practice and quality assurance, risk and data management
are the areas with priority for intervention to improve the quality of the PP and PC in line with the
National Drug Policy and WHO/FIP Guidelines on GPP.
A final PP and PSs assessment score was also calculated. This score was based on the score of all
indicators as a percentage of the actual score relative to the maximal possible score and for the PP and
quality of PSs in the community pharmacy area in the RoM it is 64.16 out of 100.
38. 38
II. Hospital pharmacy practice and services
II.1. Demographic characteristics and management of hospital pharmacies
According to the data obtained with the survey, the most of the hospitals where hospital pharmacies are
located are state-owned (88.64%) and the rest of them (11.36%) are investor-owned (profit making
institution). There is no hospital (pharmacy) in the RoM which is owned by non-profit making institution
or military governed. Approximately 22.73% of the hospital(s) (pharmacies) belong to a group of
hospitals with common ownership and/or governance of which 1 hospital (pharmacy) is
owned/governed by the hospital group with administration located in the EU-member country
(Bulgaria) and 1 by a group with administration located in non EU-member country (Turkey). In addition,
one of the hospitals has signed affiliation agreement with a Turkish healthcare group. The rest of the
hospital(s) (pharmacies), 70%, are with domestic ownership/governance. Approximately 77.27% of the
hospital(s) (pharmacies) are self-governed.
Figure 18.Type of the hospital in respect to services offered to inpatients
The categories that best describe the type of the hospital in respect to services offered to inpatients are
presented in Figure 18. App. 86% of the pharmacies are central hospital pharmacies located at the
clinical and general hospitals. The rest of them are satellite hospital pharmacies located at the university
clinics of gynecology and obstetrics, oncology, hematology, pediatrics, abdominal surgery, orthopedics
and acute and long-term intensive care.
The category that best describes the number of citizens currently served by the hospital (hospital
pharmacy) is presented in Fig. 19.
%
39. 39
2,94
5,88
35,29
28,53
11,76
20,59
0 10 20 30 40
<10 000
10 000 - 50 000
50 000 - 100 000
100 000 - 500 000
500 000 - 1 000 000
>1 000 000
Figure 19. Number of citizens served by the hospital (hospital pharmacy)
Considering the category of patients currently served by the hospital pharmacies, 32.35% of them
distribute medicines for in-patients with full hospitalization, only 5.88% dispense medications to
outpatients and 61.76% supply, store and distribute/dispense medications for in- and outpatients.
Approximately 18.52% of the hospital pharmacies are located in hospital settings with number of in-
patient beds up to 100, 22.22% of the hospital pharmacies serve hospitals with 100-300 in-patient beds,
most of them (29.63%) are located in hospitals with 300-400 in-patient beds, while slightly low number
(25.93%) serve hospitals with 500-1000 beds. Only 3.70% are located in large hospitals/university clinical
centers serving hospitals with more than 1 000 beds. The average duration of stay for in-patient per year
is fewer than 15 days in 72.73% of the hospitals, in 13.64% it is 15-30 days and in the same percent of
hospitals, the average duration of stay for inpatient per year is from 30 to 60 days. Considering the
number of outpatients served by the hospital pharmacies, 52.38% serve fewer than 1 000 patients,
4.76% from 1 000 to 5 000, 19.05% from 5 000 to 10 000, 10 000 to 20 000 outpatients are served in and
by 14.29% of the hospital pharmacies and only 9.52 serve more than 20 000 outpatients per year.
The types of pharmacy services provided on an around-the-clock basis are presented in Fig 20, while
availability for providing those services in Fig. 20. One can notice that primarily the pharmacies are
focused on acquisition, storage and distribution/dispensing of drugs and medical devices. In 32% of the
hospital pharmacies, drug information services are offered followed by 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 hospital pharmacies involved in education and research is even lower (5.9%),
mostly in hospital pharmacies located in large clinical and general hospitals in the capital of the state. It
is interesting to notice that most of the hospital pharmacies (app. 80%) are opened and available only 8
hours per day with no availability during the weekend (Fig. 21). In addition, only 41.18% of the hospital
pharmacies provide 24 hours on call service during the whole week.
40. 40
Fig.20. Types of pharmacy services provided on an around-the-clock basis in hospital pharmacies
2,94
2,94
2,94
5,88
79,41
5,88
0 20 40 60 80
24h every day exept weekends
24h every day incl. weekends
12h/day exept weekends
12h/day incl weekends
8h/day exept weekends
8h/day incl. weekends
Fig. 21. Availability of the hospital pharmacies for providing services
Hospital pharmacy budget for acquisition of drugs per year is lower than 40% of total hospital budget for
55% of the hospital pharmacies. Furthermore, for 25% of the hospital pharmacies it is lower than 30% of
the total hospital budget. For only 5% of the hospital pharmacies, over 60% of the budget is available. In
addition, overall hospital pharmacy budget of total hospital budget per year is lower than 50% for app.
73% of the hospital pharmacies. For the rest of the hospital pharmacies, it is between 50 and 70%. All
%
%
41. 41
the responders declared that part of the overall hospital pharmacy budget was not regularly allocated
for improvement of pharmacy structure and in this respect for PP and PC services.
Considering the staff employed in the hospital pharmacies, the point of interest was the number of full-
time or part-time employed with health specialization (2nd level of study program according to Bologna,
see Introduction). The data point that there are 9 in total specialists or residents in clinical pharmacy and
6 specialists or residents in pharmacoinformatics (0.34/pharmacy), 9 specialists in pharmaceutical
technology and 1 specialist in drug quality control. There are no pharmacists with specific specialist
competences such as the competence in oncology, (par)enteral nutrition, TDM, etc. Full-time employed
personnel in the hospital pharmacies include pharmacy technicians 1.68/pharmacy, pharmacists (master
in pharmacy degree, 1st and 2nd
integrated level of study according to Bologna) 0.68 /pharmacy, master
in pharmacy + health specialist 1.25/pharmacy and cleaning personnel and administrative staff
0.84/pharmacy.
Giving information on the drugs and medical devices and their acquisition, storage and distribution are
the main tasks assigned to the hospital pharmacists in 55.88% and 82.35% of the hospital pharmacies,
respectively. Other tasks include drug preparation and quality control, education and research and
administrative work as well (Fig. 22). Considering pharmacy technicians, they are mostly involved in drug
preparation and quality control (app. 23.81%) and drug and medical devices acquisition, storage and
distribution (76.19%) (Fig. 23). In some hospital pharmacies, they are involved in drug information and
administrative work as well.
Fig. 22. Tasks assigned to pharmacists
42. 42
Fig. 23. Tasks assigned to pharmacy technicians
Considering purchasing of medications and medical devices, the survey showed that there is no group
purchasing among the hospital pharmacies in the RoM. In fact, wholesalers are the main source for
acquisition of drugs followed by industry (Fig. 24). Only 20.45% of the hospital pharmacies have their
own production and only 8.82% of them purchase medicines from other (hospital) pharmacies.
61,76
94,12
20,45
8,82
0
0 100
industry
wholesalers
own production
other pharmacies
group purcharing
Fig. 24. Sources for acquisition of drugs and medical devices
The survey also pointed to the management characteristics of the hospital pharmacies in the RoM. The
PSs are managed internally in 94.12% of the hospital pharmacies and the pharmacy managers respond
to the hospital directors or directors of the clinical centers in app. 94% of the hospital pharmacies. In
app. 97% of the hospital pharmacies, the pharmacy manager is qualified pharmacist.
