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FARMACIA, 2019, Vol. 67, 3
https://doi.org/10.31925/farmacia.2019.3.25 ORIGINAL ARTICLE
STANDARDS FOR GOOD PHARMACY PRACTICE – A COMPARATIVE
ANALYSIS
ANDREEA CHERTES, OFELIA CRIŞAN *
Pharmaceutical Legislation and Management, Faculty of Pharmacy, “Iuliu Haţieganu” University of Medicine and
Pharmacy, 12 Ion Creangă Street, 400010, Cluj-Napoca, Romania
*corresponding author: ofelia.crisan@umfcluj.ro
Manuscript received: March 2017
Abstract
The purpose of this paper is to research the standards for quality of pharmacy services included in national and international
guidelines on good pharmacy practice. The documents were investigated using the comparative method and methods of legal
interpretation. The Joint FIP/WHO Guidelines recommend national standards for procurement, storage, preparation, dispensing,
medication therapy management and improving effectiveness of the health-care system and public health. The Romanian
regulations establish standards for procurement, storage, preparation, dispensing, patient information and the rational use of
medicines. However, they could be optimized by setting out standards for quality of the role of pharmacists in providing
medication therapy management as well as their contribution to improving the effectiveness of the national health-care system.
Rezumat
Scopul lucrării este cercetarea standardelor de calitate pentru activitatea farmaciei, incluse în regulile de bună practică
farmaceutică adoptate la nivel naţional şi internaţional. În acest scop s-au utilizat metoda comparativă şi metodele interpretării
juridice. Ghidul FIP/OMS recomandă elaborarea de standarde naţionale pentru aprovizionarea, conservarea, prepararea şi
eliberarea medicamentelor, furnizarea unui management eficient al terapiei medicamentoase, contribuţia la îmbunătăţirea
sănătăţii publice şi a eficienţei sistemului sanitar. Reglementările româneşti stabilesc standarde de calitate pentru aprovizionarea,
conservarea, prepararea şi eliberarea medicamentelor, informarea pacientului şi încurajarea utilizării raţionale a medicamentelor.
Ele ar putea fi optimizate prin elaborarea de standarde de calitate pentru activităţile care definesc rolul farmacistului în
managementul terapiei pacientului, respectiv contribuţia sa la creşterea eficienţei sistemului sanitar naţional.
Keywords: good pharmacy practice, standards for quality, procedures
Introduction By including pharmacists, especially those with
The quality of pharmacy services represents a major competencies in clinical pharmacy, in the medical
concern for the professional associations of pharmacists team, the quality of health services increases not only
as well as for health authorities and patients. Although, in the case of patients with mild diseases treated
in numerous countries pharmaceutical care has become with OTC products, but especially in complicated
an important component of professional practice in chronic cases [6, 11, 14, 15]. In order to assure the
pharmacy, it could be improved, especially by providing quality of all these services, appropriate standards and
education to pharmacists [8-11, 14, 17]. Some authors operating procedures must be set out according to the
believe that the efficient functioning of a pharmacy principles of good pharmacy practice. Good pharmacy
greatly depends on the management of the available practice includes rules that govern pharmacy services
space, staff training and automatization [10, 17]. in order to assure their quality and provide appropriate
Appropriate policies and procedures that match the patient services. The International Pharmaceutical
reality in different countries or regions are also Federation (FIP) and World Health Organization
required, especially as far as the supply of medicines, (WHO) created the most important international
the resources required for quality services, patient documents regarding good pharmacy practice, the
satisfaction and adherence are concerned [5, 11, 15, 18]. most recent being the Joint Guidelines adopted in
Important benefits could be gained by involving 2011 [19-21]. In Romania, good pharmacy practice
pharmacists in the political decision-making process rules were first introduced by Order of the Minister
in this field, since they generally have a good of Health no. 1552/2004 [12], which failed to be
understanding of their community of patients [16, 18]. implemented. This order was repealed by Order of
The role of pharmacists in pharmacy is no longer the Minister of Health no. 75/2010, which adopted
confined to dispensing medicines but has developed the good pharmacy practice rules currently in force
towards patient treatment management [6, 11, 15]. [13]. In order to implement these rules, the College of
Pharmacists of Romania organized training programs
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FARMACIA, 2019, Vol. 67, 3
for pharmacists and created procedure models for key premises and equipment. The standards regarding
pharmacy services, as well as procedures for the reception are included in the chapter on the preparation
evaluation of compliance with good pharmacy practice of medicines, although they only refer to pharmaceutical
rules [1-3]. substances and not to all medicines and other health
The aim of this paper is to research the standards for products, as they should in order to assure the quality
quality of pharmacy services included in national and of the products entered into the pharmacy stock and
international guidelines on good pharmacy practice. their traceability. There are no standards for quality of
The objectives are to analyse the standards for quality medicine storage according to traditional criteria (route
included in the Joint FIP/WHO Guidelines on good of administration, pharmaceutical form, alphabetical
pharmacy practice and the Romanian regulations in order, validity date), the return of medicines, their
force, to compare the two in order to identify any recall from the market, the identification of falsified
differences and to draw proposals for better national products, the storage and disposal of expired, degraded
regulations in the field. or returned medicines. There are no standards for
quality regarding the provision of other services
Materials and Methods such as the assessment of biological parameters, the
The following materials were used in this research: administration of medicines or other health products
Joint FIP/WHO Guidelines on good pharmacy practice: including vaccines, or the dispensing of medicines
standards for quality of pharmacy services, adopted for veterinary use. There are no standards for quality
in 2011 [21]; Order of the Minister of Health no. of the relation between community pharmacies and
75/2010 for approving the regulations for good hospitals or other inpatient healthcare facilities, in
pharmacy practice [13]; procedure models for the case these do not have their own pharmacy. Also,
application of regulations for good pharmacy practice there are no standards for quality of specific services
in community and hospital pharmacies, created under provided by hospital pharmacies such as the distribution
the aegis of the College of Pharmacists of Romania of medicines and other health products to hospital
[1, 2]; Decision no. 1/2011 of the College of departments or the activity of clinical pharmacists.
Pharmacists of Romania regarding the approval of Some of these shortcomings were remedied by the
procedures for the evaluation of compliance with College of Pharmacists, which, in order to help
the Regulations for good pharmacy practice [3]. pharmacists conform to the standards for quality
These documents were studied using the comparative established by good pharmacy practice rules, created
method and methods of legal interpretation [4, 7]. models of standard operating procedures for the
Comparison determined the structure of the paper, most important services offered by community and
which comprises the analytical presentation of each hospital pharmacies: the management of pharmacy
compared element, including an individual analysis of premises and equipment, staff management, the
both national regulations and international guidelines, procurement, reception, storage, return, recall, preparation
together with a comparative synthesis focusing on and dispensing of medicines and other health products,
similarities and differences between the compared the disposal of expired pharmaceutical products, the
terms [4]. The main criteria for analysis and comparison assurance of hygienic conditions, the provision of
were the standards for quality of pharmacy premises other pharmacy services, the solving of complaints
and equipment, pharmacy staff and services. and the assurance of traceability [1, 2].
As far as the standards for quality of pharmacy
Results and Discussion premises and equipment are concerned, we believe
that the following contribute greatly to the creation
National regulations of the health space that pharmacies should embody:
The Order of the Minister of Health no. 75/2010 creating the pharmacy must be the responsibility of
includes rules of good practice applicable to some the future chief pharmacist, who takes part in all
pharmacy services. Thus, this order establishes standards stages of the authorization process, even if, according
for quality of pharmacy premises, equipment and staff, to the Romanian legislation, pharmacy owners need
as well as of the most important services offered by a not necessarily to be pharmacists; the location of the
pharmacy: preparation and dispensing of medicines, pharmacy must be accessible to all potential patients,
patient information and encouraging the rational use including elderly and/or disabled persons, and the
of medicines [13]. Standards for quality of other pharmacy displays must promote health programs;
pharmacy services are either not mentioned, or they a screened area is recommended in order to ensure
are included among those referring to other services. patient confidentiality; besides specific equipment,
Thus, some standards for quality regarding the supply the pharmacy must have the complete legal and
of medicines are included in the chapter on the professional documentation for proper functioning.
dispensing of medicines and some standards for As far as the standards for quality of pharmacy staff
quality regarding the preservation and storage of are concerned, we believe that the following can be
medicines are included in the chapter on pharmacy regarded as the most significant for the lifelong
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FARMACIA, 2019, Vol. 67, 3
professional development of pharmacists: the obligation out according to an assessment grid approved by the
of all staff members to know and respect the rights Decision no. 1/2011. The grid contains indicators
of the patients who seek pharmacy services, the referring to the pharmacy license, outdoor signs and
obligation to plan and assess the continuing education opening hours, premises and equipment, staff,
of pharmacy staff according to specific needs, the preparation and dispensing of medicines and other
analysis of the practical applicability of the knowledge health products. It also includes potential measures to
and competences acquired through continuing education be taken in case minimum standards are not met and
programs. sets deadlines for solving these issues [3]. However,
The standards for quality of pharmacy services were although the procedures established under the aegis
greatly developed by the College of Pharmacists, in of the College of Pharmacists contain standards for
comparison with those established by the Order no. quality of the most important pharmacy services/
75/2010. We believe that the most important standards activities, not all these standards were included in
for improving the quality of pharmacy services in the assessment grid. The following fall under this
Romania are as follows: procurement in order to category: assuring pharmacy access for disabled persons;
provide patients with authorized, quality and accessible the cleanliness of the pharmacy at the time of
products that allow treatment continuation and encourage evaluation; pharmacists initiating and/or participating
the rational use of resources; correct product reception in public health programs; pharmacists participating in
as far as qualitative, quantitative and value standards continuing professional education; the evaluation and
are concerned, including rules for resolving non- self-evaluation of professional development, including
conformities and for assuring the traceability of all training in the field of good pharmacy practice; some
the products and services offered by the pharmacy; pharmacy services: procurement, reception, assuring
checking the validity dates of products, temperature the traceability of medicines, preparation in pharmacy
and humidity conditions, separate storage of expired and other services, such as the assessment of biological
or returned products and initiation of the procedure parameters; knowing and respecting the patients’
for disposal according to category of waste; the rights regarding pharmacy services.
return and recall from the market of products, Therefore, we believe that the assessment grid should
including interaction with the competent authorities contain indicators for all the aspects related to the
in such situations; preparing medicines according to quality of services offered by both community and
special rules and categories for magistral, officinal, hospital pharmacies.
traditional and homeopathic formulas, although Joint FIP/WHO Guidelines
preparation has become optional in Romanian The Joint FIP/WHO Guidelines set out the definition,
pharmacies; respecting appropriate communication requirements and need to create standards for good
rules and the specific rules of pharmaceutical care pharmacy practice. The guidelines also recommend
when dispensing medicines, even in emergency that based on this document, national professional
situations; dispensing other health products according organizations establish minimum national standards
to specific rules for medical devices, hygiene and for services promoting the role and functions of
cosmetic products, food supplements, other herbal pharmacists according to local needs and the goals
products and products for children; supplying other of the profession [21].
services and respecting specific rules for the The guidelines do not refer to the standards for
measurement of arterial tension and blood sugar quality of pharmacy premises, except for stipulating
levels; resolving complaints regarding the products the need for a suitable space that ensures patient
and services offered by the pharmacy; this falls confidentiality. The pharmacy equipment is also not
under the responsibility of the chief pharmacist and covered by the guidelines, which only include some
must be carried out in accordance with patients’ recommendations for appropriate standards for quality
rights. of preparation equipment, as well as of suitable
Although the procedure models established under the storage conditions of all the products in the pharmacy
aegis of the College of Pharmacists were very useful or in the health establishment that the pharmacy
for pharmacies at the beginning of the campaign for belongs to. As far as the standards for quality of
the implementation of good pharmacy practice rules, pharmacy staff are concerned, we regard the
they only contain general specifications for every recommendations for the professional development
activity mentioned. This is why each pharmacy needs of pharmacists in complementary and alternative
to create their own standard operating procedures for therapies, as well as in the new technologies and
the services offered and to update these according automatization to be a very modern approach in line
to developments in the field, the current legislation with the development pace of the present-day society.
and their own services. The Joint FIP/WHO Guidelines recommend standards
The degree of implementation of good practice rules for quality of traditional pharmacy services (procurement,
is assessed yearly by evaluators appointed by the storage, preservation, preparation, distribution, dispensing
College of Pharmacists. This evaluation is carried and disposal of medicinal products), plus standards
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FARMACIA, 2019, Vol. 67, 3
for quality of modern pharmacy services such as in the patient’s best interest; sources of information
the administration of medicines, patient medication and lifelong professional development.
management and the pharmacist’s contribution to Besides standards for quality of preventive actions
the effectiveness of the health-care system and (education, screening) and public health promotion
public health [21]. (support, participation in various program), the Joint
In the context of the international development of the FIP/WHO Guidelines recommend the creation of
legislation against the falsification of medicines, we standards for quality of activities through which
believe that the most important standards for quality pharmacists in pharmacies could contribute to the
regarding the procurement and distribution of medicines effectiveness of the health-care system [21]. Within
are those that ensure the protection of patients: the current context of commercial and information
transparent, professional and ethical procurement of pressure, we believe that the most important activities
medicines; preventing the use of falsified medicines, in this respect refer to patient education for the
including patient education regarding online sources correct evaluation of the available information, and
of information; quick and effective recall of falsified compliance with the ethical standards for pharmacy
products from the market under the responsibility services.
of a specially designated person, such as one of the Comparative synthesis
pharmacists in the pharmacy; involving pharmacists in As far as the pharmacy premises and equipment are
public policies regarding the access of the population concerned, the most important similarities between
to quality essential medicines, including in case of the Joint FIP/WHO Guidelines and the Romanian
disasters or pandemics. regulations refer to the need for a screened area that
The Joint FIP/WHO Guidelines suggest the creation ensures patient confidentiality/privacy, as well as the
of standards for quality of the administration of existence of appropriate conditions and equipment
medicines in pharmacy, including results monitoring, for the correct preservation and preparation of quality
as well as involvement in vaccination programs for products in pharmacy. As far as the continuing
better coverage of the population and safe vaccination professional development of pharmacy staff is
[21]. The development of pharmacy services to include concerned, both documents set out the need to plan and
the administration of injectable medicines, especially implement appropriate strategies in order to improve
vaccines, requires not only adequate staff training knowledge, skills and professional performance.
(vaccines, procedures), but also a redesign of the Most standards for quality of procurement, storage,
pharmacy premises in order to assure patient privacy. preservation, preparation and dispensing of medicinal
This development of pharmacy services also results in products as well as those regarding patient information
the production of more complex waste (medicines, and counselling can also be found in both documents.
medical devices, including devices contaminated with The most important differences between the Joint
biological fluids, etc.). Therefore, special, updated FIP/WHO Guidelines and the Romanian regulations
rules are required in order to manage safe disposal. refer to the standards for quality of administration of
In this respect, we would like to commend the medicines in pharmacy, participation of pharmacists
recommendation that patients and the general public in vaccination programs, role of pharmacists within
return any unwanted or expired medical products to medication therapy management and their contribution
the pharmacy in order to be safely disposed of [21]. to the effectiveness of the national health-care system.
Environmental protection and patient information Neither the Order of the Minister of Health no.
are thus becoming key objectives for pharmacists in 75/2010, nor the regulations of the College of
pharmacies. Pharmacists included good practice rules or established
As far as the management of the medicinal treatment standards for quality and operating procedures for
of patients is concerned, we believe that the creation these activities.
and implementation of standards for quality for the In our opinion, in order to improve good pharmacy
following aspects may have an essential role in practice rules in Romania, both categories of national
improving its effectiveness through the services regulations must be updated. Moreover, principles of
offered by pharmacists in pharmacies: the training good practice and standards for quality must be set
of pharmacists in order to be able to fully evaluate a out for the following: procurement and reception of
patient’s health condition and needs, by taking into medicines, especially for avoiding the selling of
consideration the patient’s level of education, falsified medicines; administration of medicines in
cultural beliefs, physical and psychological status; pharmacy and participation in vaccination programs;
collaboration with the patient in order to establish a informing pharmacists, assuring the quality of the
treatment plan, achieve adherence, encourage patient information sources, professional development in
responsibility, monitor results and support the patient the field of alternative therapies and the use of new
throughout the treatment; active collaboration with technologies in medicine; collaborating with prescribing
prescribing physicians and other healthcare professionals physicians and other healthcare professionals based
on protocols agreed on by professional associations;
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