Pharmacy Practice and Education in Bulgaria

Pharmacies in Bulgaria have a monopoly on the dispensing of medicinal products that are authorized in the Republic of Bulgaria, as well as medical devices, food additives, cosmetics, and sanitary/hygienic articles. Aptekari (pharmacists) act as responsible pharmacists, pharmacy owners, and managers. They follow a five year Masters of Science in Pharmacy (M.Sc. Pharm.) degree course with a six month traineeship. Pomoshnik-farmacevti (assistant pharmacists) follow a three year degree with a six month traineeship. They can prepare medicines and dispense OTC medicines under the supervision of a pharmacist. The first and second year of the M.Sc. Pharm. degree are devoted to chemical sciences, mathematics, botany and medical sciences. Years three and four center on pharmaceutical technology, pharmacology, pharmacognosy, pharmaco-economics, and social pharmacy, while year five focuses on pharmaceutical care, patient counselling, pharmacotherapy, and medical sciences. A six month traineeship finishes the fifth year together with redaction of a master thesis, and the four state examinations with which university studies end. Industrial pharmacy and clinical (hospital) pharmacy practice are integrated disciplines in some Bulgarian higher education institutions such as the Faculty of Pharmacy of the Medical University of Sofia. Pharmacy practice and education in Bulgaria are organized in a fashion very similar to that in most member states of the European Union.


Introduction
Concerning general health in Bulgaria, the World Health Organization (WHO) estimated that a person born in Bulgaria in 2016 can expect to live 74.6 years on average: 78 years if female and 71.2 years if male (Table 1). WHO also estimated that life expectancy at birth for both sexes increased by 3 years over the period of 2000-2012; the WHO regional average increased by 4 years in the same period. In 2012, healthy life expectancy, in both sexes, was 9 years lower than the European average. This lost healthy life expectancy represents 9 equivalent years of full health lost through years lived with morbidity and disability. Table 1. Health statistics for Bulgaria [1].
Pharmacology and Toxicology 6.
Social Pharmacy Following graduation, students have the opportunity to specialize for a further 3 years. Whilst working in a hospital or industrial environment, they follow a study program with courses at the faculty of pharmacy two weeks per year. After the third year of such specialization they pass a state examination in a given specialty. This possibility is granted by the Ministry of Education to all pharmaceutical students and graduates.
Since 1989, there have been many changes in the curriculum to harmonize courses and diplomas with those of the other schools in the European Union (EU). Many new study areas have been introduced such as: bio-pharmacy, clinical laboratory testing and analysis, and biology. The Department of Social Pharmacy has introduced new study areas such as: history of pharmacy, pharmaco-epidemiology, pharmaco-economics, pharmaceutical law, pharmaceutical marketing, and pharmaceutical management.
In 2000, a new course in pharmaceutical care was introduced. The lectures and seminars on this subject are given during the first semester of the fifth year. The lectures synthesize the knowledge gained during the five-year pharmacy course and blend this with communication skills and the development of the logic of pharmaceutical care. University lecturers together with pharmacy practitioners, provide the training.

Design
Given the changes in pharmacy practice and education in Bulgaria outlined above, the PHARMINE (Pharmacy Education in Europe) European consortium surveyed the state of pharmacy education and practice in Bulgaria in 2012, with an update in 2017. The PHARMINE consortium was interested in general practice and education and in specialization in pharmacy education for hospital and industrial pharmacy practice. The survey also looked at the impact of the Bologna agreement on harmonization of the various European degree courses [3], and on the directive of the European Commission on education and training for the sectoral profession of pharmacy [4]. These two documents are somewhat contradictory in that the Bologna agreement proposes a bachelor plus master degree structure for all degrees including pharmacy, whereas as the European directive lays down a five-year "tunnel" degree structure for pharmacy, i.e., a degree course that has no possibility for intermediate entry or exit for example after a three-year bachelor period. The methodology used in the PHARMINE survey [5] and the principal results obtained in the EU [6] have already been published. Table 2 provides details of the numbers and activities of community pharmacists and pharmacies in Bulgaria. The following are entitled to carry out retail trade in medicinal products: A natural or legal person. One who is registered as a pharmacy trader under the Bulgarian legislation or under the legislation of an EU member state. One who has signed a labour contract or a contract for management of a pharmacy with a pharmacist (in possession of an M.Sc. Pharm. degree. Or one who, in the cases provided under the law (no pharmacist available and until the arrival of master of a pharmacist), has signed a contract with an assistant pharmacist (for dispensation of OTC drugs only) One person may open no more than 4 pharmacies in Bulgaria [7].

Organisation of the Activities of Pharmacists, Professional Bodies
Rules on geographical distribution of pharmacies?

No
There are no governmental restrictions on the geographical distribution of community pharmacies as a function of population density for instance.
Are drugs and healthcare products available to the general public by channels other than pharmacies?

No
Medicinal products, medical devices authorised in the Republic of Bulgaria, with or without medical prescription, as well as food additives, cosmetic, and sanitary-hygienic articles, are sold only in pharmacies. There are no mail-order pharmacies in Bulgaria. Any attempt to sell drug products at a lower price than originally planned is prohibited. Medicinal products not subject to a medical prescription may be sold on the internet only by a pharmacy or drugstore that has been granted authorisation under the terms and conditions of Medicinal Products in the Bulgarian Human Medicine Act [7].
The data in Table 2 shows that compared to the EU linear regression estimation (for definition and calculation see reference 5) the ratio of the actual number of community pharmacists in Bulgaria (/population) compared to the linear regression estimation for Bulgaria = 1.16. Thus number of pharmacists per population is very close to the EU norm. The same comparison for community pharmacies produces a ratio of 1.99. Thus the number of community pharmacies in Bulgaria is double the EU average.
The activities and occupations of pharmacists in Bulgaria are similar to those of community pharmacists in other member states [5]. The organization of community pharmacists regarding ownership, etc. is similar to that elsewhere in the EU; it should be noted that there are no government-imposed rules on the geographical distribution of community pharmacies in Bulgaria. The sale of medicinal products on the internet is limited to authorized pharmacies. Table 3 provides details of the numbers and activities of assistant pharmacists in Bulgaria.

Yes
In addition to pharmacists, assistant pharmacists are also considered to be professional pharmacy staff. Article 220/3 of the "Medicinal Products in Human Medicine Act" states that "An assistant pharmacist may carry out all operations under the control of a Master of Pharmacy, with the exception of: dispensation of a medicinal product under medical prescription, control, and consultations connected with medicinal products..." [7]. The assistant pharmacist´s code 5.7 states: "The students graduated from that speciality can work at the clinical pharmacy, at herbal stores, sanitary and drug stores, pharmacy stores, pharmacy laboratories, science institutes, and pharmaceutical factories." [8].

Their titles and number(s)
There is no official data. There is no upper limit on the number; some pharmacies work without assistant pharmacists.
There is a register of the pharmacists on the site of the Bulgarian Pharmaceutical Union The studies of assistant pharmacists cannot be compared to bachelor studies at a university. There is no bachelor degree of "pharmaceutical education" in Bulgaria. There are uniform requirements for achievement of higher education as assistant pharmacist.

Conditions of entry
The entrance examination is in biology (that for pharmacy is in biology and chemistry).
In some colleges there is also an interview.

Subject areas
Basic pharmaceutical sciences such as pharmaceutical chemistry, pharmaceutical technology, drug legislation, etc. The course lasts a minimum of 1200 h.

Competences and roles
Assist a pharmacist in the dispensation of OTC medicines only while under the supervision of a pharmacist.
Bulgarian legislation recognizes that assistant pharmacists are health care professionals and defines their role in the health care system. Five pharmaceutical colleges provide education and training for assistant pharmacists. Although this is in the form of a three-year course, it cannot be compared to a "B. Pharm." as defined by the Bologna declaration (see above). Table 4 provides details of the numbers and activities of hospital pharmacists in Bulgaria. Bulgarian legislation recognizes the existence of a hospital pharmacy, although the number of hospital pharmacists is low compared to the EU average. The ratio of the actual number of hospital pharmacists in Bulgaria (/population) compared to the linear regression estimation for Bulgaria = 0.29, (for definition and calculation see reference 5). The estimated number of hospital pharmacies is higher than that of hospital pharmacists. It appears therefore that the function of "hospital pharmacist" in Bulgaria is defined by competences and roles and/or by place of work. In the latter case, health care personnel other than pharmacists are involved.   The number is estimated from the number of students graduating with the industrial pharmacy degree option; students taking the industrial pharmacy option account for <10% of the class size. EFPIA has estimated that the total number of people employed in the pharmaceutical industry equals 9900 [14].
Competences and roles Drug manufacturing, control, analysis, registration, etc.

Pharmacists Working in Other Sectors
Sectors in which pharmacists are employed Industrial pharmacists in Bulgaria have similar practices and duties to those in other EU countries [5]. As numbers of industrial pharmacists were not available for most European countries a comparison with the EU average is not possible. Table 6 provides information on professional associations for pharmacists in Bulgaria.

Registration of pharmacists Yes
The Bulgarian Pharmaceutical Union [15] provides a certificate of entry onto the register of the corresponding Regional College of the Bulgarian Pharmaceutical Union, to every Master of Pharmacy who is at the head of a pharmacy.
In order to be registered as a professional pharmacist one has to submit to the Bulgarian Pharmaceutical Union: Diploma of a higher educational pharmaceutical department. Diploma(s) for specialization (hospital, industrial) or Ph.D./DSc/Associate professor/Professor. Certificate from the working place attesting that he/she is working as a pharmacist. A certificate showing no previous criminal conviction. After approval, the pharmacist becomes a member of the Bulgarian Pharmaceutical Union and gains his/her unique identification number as a pharmacist.
Creation of pharmacies and control of territorial distribution

Yes
The Bulgarian Drug Agency issues an authorisation for retail trade in medicinal products in a pharmacy and controls the implementation of requirements for the retail trade of medicines.
Ethical and other aspects of professional conduct Yes The Bulgarian Pharmaceutical Union has an ethical code for pharmacy practice.
Quality assurance and validation of university courses

Yes
University courses are controlled by the quality commission of the Bulgarian Pharmaceutical Union [16]. http://bphu.eu/ The Bulgarian pharmaceutical union, which is the representative organisation of pharmacists in the country, oversees pharmacy education and training (PET), pharmacy practice, and ethics in a fashion similar to that in other member states of the EU [5]. Table 7 provides details of pharmacy higher education institutions (HEIs), staff and students in Bulgaria. Table 7. Pharmacy higher education institutions (HEIs), staff, and students in Bulgaria.

Item Number Comments
Teaching staff

Staff (nationals) 250
Professionals from outside the HEIs 20 They are from the pharmacies (supervision of student traineeships), pharmaceutical companies, wholesalers, etc.

Students
Graduates that become registered pharmacists.

More than 400 per year
The number of graduates during the past five years was increased due to the increase in the number of the faculties and the introduction of a pharmacy course in English in most of the faculties-especially Sofia and Plovdiv.

Entry requirements following secondary school
Specific national entrance examination for pharmacy Yes National entrance examination in biology and chemistry.

Fees per year
For home students 375€

For EU MS students 375€
For non EU students 7000€ The ratios of the actual number of HEIs, staff, and students in Bulgaria (/population) compared to the linear regression estimations for Bulgaria are 1.07, 1.01, and 0.76, respectively (for definition and calculation see reference [5]). Thus, figures for Bulgarian PET reflect those of the EU average for the country with a population the size of that of Bulgaria. Student numbers show a substantial international intake. It should be noted that the Erasmus Programme (European Region Action Scheme for the Mobility of University Students) is an EU student exchange program. Table 8 provides details of specialization electives in pharmacy HEIs.
Both pre-and post-graduate specialization are possible in Bulgaria. The last wave of pharmacists in post-graduate specialization in the medical university of Sofia was composed as follows-social pharmacy: 25; pharmacognosy: one; pharmaceutical analysis: one; pharmaceutical technology: one; industrial pharmacy: three. In this context, social pharmacy can be considered to consist of all the social factors that influence medicine use. Table 9 provides details of past and present changes in education and training in Bulgarian pharmacy HEIs.

Do HEIs Provide Specialized Courses? Yes Comments
In which years? third, fourth and fifth; also post-graduate In which specialisation (industry, hospital . . . )? Industry and clinical pharmacy after the third year.
What are the student numbers in each specialization?

(industry) and 12 (clinical pharmacy)/year
for pre-graduate Following graduation there is a possibility to start post-graduate specialization (three year course) in one of five different areas: industrial pharmacy; social pharmacy; pharmacognosy; pharmaceutical analysis; and pharmaceutical technology. Table 9. Past and present changes in education and training in Bulgarian pharmacy HEIs.
Have there been any major changes since 1999?

Yes
The main changes were towards harmonising with the EU requirements-more practical than theoretical subjects. Teaching of "new" subjects such as, pharmaceutical care, pharmaco-economics, bromatology/food science, history of pharmacy, etc. Changes were made in the state exam in order to harmonize the final examinations to those of EU HEIs.
Are any major changes envisaged before 2019? Yes Changes in the relative number of hours of some subject areas. Chemical subjects will decrease while the special subjects like pharmaceutical technology will increase their number of hours. Table 10 provides details of student hours [18] by learning method. The data from Sofia is taken as an example in this table and Table 11. Table 10. Student hours by learning method.

Method
Year 1 Lecture  210  315  330  435  210  1500  Practical  540  525  585  825  345  2820  Hospital/community traineeship  800  800  Electives  90  120  Total  750  840  915  1260  1355  5120 Regarding the validation of traineeship, the pharmacist responsible for the trainee fills in a monthly and a final report at the end of the six months and these are validated (or not) by the HEI. It is to be noted that "practical" work is carried out by students at the university in the form of personnel projects, etc., whereas "traineeship" refers to work in a pharmacy setting.

Subject Areas.
Table 11 provides details of student hours by subject area. Table 11. Student hours by subject area (for definition of subject areas see [4]). The numbers are calculated according to the schema of the Uniform State Requirements of Bulgaria [14].

Subject Area
Year  [19] of the nature of the M. Pharm. degree course (ratio = 975/1,275 = 0.8) it appears that the Bulgarian course is more a "chemical science" course similar to that in Germany (ratio = 0.7), but different from "medicinal science" course given in Ireland (ratio = 2.6) [18].

Impact of the Bologna Principles [3]
Table 12 provides details the various ways in which the Bologna declaration impacts on Bulgarian pharmacy HEIs. "Two main cycles (B and M) with entry and exit at B level" No There is a five-year "tunnel" degree structure.
"European Credit Transfer System (ECTS) system of credits with links to life-long learning (LLL)" Yes The ECTS system of credits is applied during the fiv year period of learning and after graduation in the different courses of LLL.
"Addressing obstacles to mobility" Partial As the English language is not used extensively in Bulgaria there are language barriers for the proper application of mobility. Financial problems also exist. There is also an exchange program with Turkey-Mersin University.
3.6. Impact of EU Directive 2013/55/EC   Bulgarian PET mainly conforms to the different aspects of the EC directive with notably a five-year tunnel degree. Aspects of the Bologna agreement such as European Credit Transfer System (ECTS) and the Diploma Supplement are included. Figure 1 shows the scheme of PET in Bulgaria. There is also an exchange program with Turkey-Mersin University.  "Evidence of formal qualifications as a pharmacist shall attest to training of at least five years' duration,…"

Impact of EU Directive 2013/55/EC
The training of pharmacists M.Sc. in Bulgaria is five years induration. The curriculum covers the EU requirements. "…four years of full-time theoretical and practical training at a university or at a higher institute of a level recognised as equivalent, or under the supervision of a university;" Bulgaria complies.
"…six-month traineeship in a pharmacy which is open to the public or in a hospital, under the supervision of that hospitalʹs pharmaceutical department." Bulgaria complies.
Bulgarian PET mainly conforms to the different aspects of the EC directive with notably a five-year tunnel degree. Aspects of the Bologna agreement such as European Credit Transfer System (ECTS) and the Diploma Supplement are included. Figure 1 shows the scheme of PET in Bulgaria.
Year 5 Integrated course in pharmacy Year 3 Year 4 Year 4 Year 3 Year 5 Professional registered pharmacist Industry

Discussion and Conclusions
Pharmacies in Bulgaria have a monopoly on the dispensing of medicinal products in Bulgaria. Pharmacists follow a five-year (M.Sc. Pharm.) degree course with a six months traineeship. The first and second year of the M.Sc. Pharm. degree are devoted to chemical sciences, mathematics, botany,

Discussion and Conclusions
Pharmacies in Bulgaria have a monopoly on the dispensing of medicinal products in Bulgaria. Pharmacists follow a five-year (M.Sc. Pharm.) degree course with a six months traineeship. The first and second year of the M.Sc. Pharm. degree are devoted to chemical sciences, mathematics, botany, and medical sciences. Years three and four center on pharmaceutical technology, pharmacology, pharmacognosy, pharmaco-economics, and social pharmacy, and year five on pharmaceutical care, patient counselling, pharmacotherapy, and medical sciences. A six month traineeship finishes the fifth year together with redaction of a master thesis, and the four state examinations with which university studies end. Industrial pharmacy and clinical (hospital) pharmacy practice are integrated disciplines in some Bulgarian HEIs, such as the Faculty of Pharmacy of the Medical University of Sofia.
Following the changes in Bulgaria in 1989, pharmacy practice and education are organized in a fashion very similar to that in (most member states of) the European Union. Whilst new developments in pharmaceutical care with elements such as immunization, advice on tobacco use cessation, management of medication adherence, and provision of health screening to detect hypertension do not at the present time receive financial backing from the government, the fact that these elements are supported at the academic level, should reinforce the future role of the pharmacist in the promotion of patient well-being in Bulgaria.