Pharmacy Practice and Education in Bulgaria
Abstract
:1. Introduction
- Pharmaceutical Technology and Bio-Pharmacy
- Pharmacognosy and Pharmaceutical Botany
- Pharmaceutical Chemistry
- Chemistry
- Pharmacology and Toxicology
- Social Pharmacy
2. Design
3. Evaluation and Assessment
3.1. Organisation of the Activities of Pharmacists, Professional Bodies
3.2. Pharmacy Faculties, Students, and Courses
3.3. Teaching and Learning Methods
3.4. Subject Areas.
3.5. Impact of the Bologna Principles [3]
- ○
- Belgium, University of Antwerp and Vrije Universiteit Brussels
- ○
- France, Université de Lorraine, Nancy and Université de Limoges
- ○
- Germany, Ruprecht-Karls-Universität Heidelberg, Anhalt University of Applied Sciences Kothen and Freie Universität Berlin
- ○
- Czech Republic—University of Veterinary and Pharmaceutical Sciences, Brno
- ○
- Italy—Universita’ degli studi di Siena and Sapienza, University of Rome
- ○
- Spain—University of Navarra and Universitat autonoma de Barcelona
3.6. Impact of EU Directive 2013/55/EC
4. Discussion and Conclusions
Acknowledgments
Author Contributions
Conflicts of Interest
References
- The WHO Statistical Profile of Bulgaria. Available online: http://www.who.int/gho/countries/bgr.pdf?ua=1 (accessed on 10 February 2017).
- Bulgarian Law on Drugs and Pharmacies in Human Medicine. Available online: http://www.zdrave.net/document/institute/e-library/BG_Health_Acts/Drugs_Act.htm (accessed on 10 February 2017).
- Bologna Agreement of Harmonisation of European University Degree Courses. Available online: http://www.ehea.info/ (accessed on 10 February 2017).
- The European Commission Directive on Education and Training for Sectoral Practice Such as That of Pharmacy. Available online: http://eur-lex.europa.eu/legal-content/FR/TXT/?uri=celex:32013L0055 (accessed on 10 February 2017).
- Atkinson, J. The PHARMINE Survey Methodology. Submitted.
- Atkinson, J.; Rombaut, B. The 2011 PHARMINE report on pharmacy and pharmacy education in the European Union. Pharm. Pract. 2011, 9, 169–187. [Google Scholar] [CrossRef]
- Bulgarian Drug Agency. Available online: http://bda.bg/bg/?lang=enimages/stories/documents/legal_acts/ZLPHM_en.pdf (accessed on 10 February 2017).
- Bulgarian Assistant Pharmacists’ Code. Available online: http://old.mu-sofia.bg/index.php?p=166&l=1 (accessed on 10 February 2017).
- Register of the Pharmacists of the Bulgarian Pharmaceutical Union. Available online: https://bphu.bg/19_Register.htm (accessed on 10 February 2017).
- Bulgarian Branch of the European Association of Hospital Pharmacists (EAHP). Available online: http://www.eahp.eu/about-us/members/bulgaria (accessed on 10 February 2017).
- Bulgarian Association of Hospital Pharmacists. Available online: http://www.ohpb.org/styled/page5/index.php (accessed on 10 February 2017).
- European Federation of Pharmaceutical Industries and Associations (EFPIA) Bulgaria. Available online: http://www.arpharm.org/en (accessed on 10 February 2017).
- Association of the Research-Based Pharmaceutical Manufacturers in Bulgaria (ARPharM). Available online: www.arpharm.org/en (accessed on 10 February 2017).
- European Federation of Pharmaceutical Industries and Associations (EFPIA): The Pharmaceutical Industry in Figures 2016. Available online: http://www.efpia.eu/publications/data-center/ (accessed on 10 February 2017).
- The Bulgarian Pharmaceutical Union Certification. Available online: http://bphu.eu/about_us.php?id_page=1 (accessed on 10 February 2017).
- Quality Commission of the Bulgarian Pharmaceutical Union. Available online: https://bphu.bg/bg.htm (accessed on 10 February 2017).
- Student Numbers in Bulgarian pharmacy HEIs. Available online: http://www.medfaculty. EC Directive on Sectoral Professions org/forum/index.php?action=printpage;topic=6177.0 (accessed on 10 February 2017).
- Details of Courses in Sofia. Available online: http://www.pharmfac.net/course.htm (accessed on 10 February 2017).
- Atkinson, J.; De Paepe, K.; Sánchez Pozo, A.; Rekkas, D.; Volmer, D.; Hirvonen, J.; Bozic, B.; Skowron, A.; Mircioiu, C.; Marcincal, A.; et al. Does the Subject Content of the Pharmacy Degree Course Influence the Community Pharmacist’s Views on Competencies for Practice? Pharmacy 2015, 3, 137–153. [Google Scholar] [CrossRef]
Total Population | 7,067,024 |
---|---|
Life expectancy at birth m/f (years) | 71.2/78 (2016) |
Healthy life expectancy at birth m/f (years) | 63/67 (2015) |
Total expenditure on health per capita | 1399$ (2014) |
Total expenditure on health as % of GDP | 8.4 (2014) |
Item | Numbers | Comments |
---|---|---|
Pharmacists | 5500–6000 | 1284 Inhabitants/Pharmacist |
Pharmacies | 4208 | 1.2–1.3 pharmacists per pharmacy 1679 inhabitants/pharmacy |
Competences and roles of community pharmacists | After graduation from university, pharmacists can work in a pharmacy and can perform drug preparation, dispensing of drugs and consulting of patients on the proper drug treatment and prepare a pharmaceutical care plan (identifying drug-related problems, making a plan for proper drug treatment, monitoring of the treatment, etc.) | |
Is ownership of a community pharmacy limited to pharmacists? | No | 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]. |
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]. |
Are persons other than pharmacists involved in community practice? | 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 [9]—but not of the assistant pharmacists. | |
Organizations providing and validating education and training of assistant pharmacists | Five pharmaceutical colleges provide education for assistant pharmacists: Medical College-Sofia: http://mu-sofia.bg/node/32 Medical College-Varna: http://www.mu-varna.bg/muVarna/index.php?option=com_content&task=view&id=193&Itemid=122 Medical College-Plovdiv: http://www.medcollege-plovdiv.org/ Medical College-Bourgas: http://www.btu.bg/bg/homebg.htm Pleven: http://www.mu-pleven.bg/index.php?lang=en&Itemid=254: | |
Duration of studies (years) | 3 | 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. |
Does such a function exist? | Yes | The Bulgarian branch of the European Association of Hospital Pharmacists is the professional organization of the Bulgarian hospital pharmacies [10]. |
Number of hospital pharmacists | 197 | This is the number of pharmacists registered with the Bulgarian Association of Hospital Pharmacists [11] |
Number of hospital pharmacies | There are 344 (2011) hospitals in Bulgaria—most have a hospital pharmacy. | |
Competences and roles of hospital pharmacists | Preparation and dispensing of drugs on hospital wards and also: Part of multidisciplinary patient-care team. Purchasing of drugs and medical material. Monitoring of drug use. Production of patient-specific medicines. Participation in clinical studies. |
Industrial Pharmacy and Pharmacists | ||
Number of pharmaceutical companies with production, R&D and distribution | 22 | The European Federation of Pharmaceutical Industries and Associations (EFPIA) has 22 members in Bulgaria [12]. The Bulgarian representative is the Association of the Research-based Pharmaceutical Manufacturers in Bulgaria [13]. |
Number of companies producing generic drugs only | 9 | Examples: Actavis http://www.actavis.bg/bg/default.htm Sopharma http://www.sopharma.bg/ |
Number of pharmacists working in industry | About 1000 | 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 | Academia (faculties of pharmacy) Wholesale Medical and pharmaceutical information Bulgarian Drug Agency Ministry of health Representative offices of Bulgarian and foreign drug companies Drug manufacturing in the Bulgarian drug companies. | |
Competences and roles in other sectors | Teaching, tutoring, drug accounting, communication, advertising, etc. The exact number of pharmacists working in other sectors in Bulgaria is impossible to determine. |
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/ |
Item | Number | Comments | |||
---|---|---|---|---|---|
Number of pharmacy HEIs in Bulgaria | 5 | Pharmacy HEIs: Medical University of Sofia : www.pharmfac.net University of Plovdiv: http://meduniversity-plovdiv.bg/index.php?lang_id=2&prm=fac&subprm=farf University of Varna: http://www.mu-varna.bg/ (started accepting students in 2009) Sofia University: http://www.uni-sofia.bg/index.php/eng/faculties/faculty_of_chemistry_and_pharmacy Medical University of Pleven: http://www.mu-pleven.bg/index.php/structure/faculty-of-pharmacy?lang=en | |||
Public pharmacy HEIs | 5 | There are no private pharmacy HEIs in Bulgaria. | |||
Faculty attachment | The faculties of pharmacy in Sofia (Medical University of Sofia), Plovdiv, Pleven and Varna are faculties of the corresponding medical universities. The faculty of Chemistry and Pharmacy (number 4 above) is part of Sofia University. | ||||
Do HEIs offer B and M degrees? | No | Only an M.Sc. Pharm. Degree is offered; there is no Bulgarian B. Pharm degree (see later). | |||
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. | |||
Number of places on entry following secondary school | 260+ per year | For 2012 [
17]: Medical university of Sofia: 120 Plovdiv: 60 Varna: 30 Sofia University: 50 Pleven: not available | |||
Number of applicants for each entry place | Medical University of Sofia: 3.4
Plovdiv: 1.8 Figures from reference 18. | ||||
Number of non EU international students | ≥ 50 per year | Mainly from Macedonia, Turkey, Morocco, Tunisia and Serbia. | |||
Entry requirements following secondary school | |||||
Specific national entrance examination for pharmacy | Yes | National entrance examination in biology and chemistry. | |||
Is there a national numerus clausus? | No | ||||
Fees per year | |||||
For home students | 375€ | ||||
For EU MS students | 375€ | ||||
For non EU students | 7000€ |
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? | 15 (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. |
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. |
Method | Year 1 | Year 2 | Year 3 | Year 4 | Year 5 | Total |
---|---|---|---|---|---|---|
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 |
Subject Area | Year 1 | Year 2 | Year 3 | Year 4 | Year 5 | Total |
---|---|---|---|---|---|---|
CHEMSCI | 165 | 510 | 225 | 225 | 150 | 1275 |
PHYSMATH | 300 | 300 | ||||
BIOLSCI | 60 | 165 | 75 | 150 | 450 | |
PHARMTECH | 210 | 315 | 525 | |||
MEDISCI | 45 | 120 | 690 | 120 | 975 | |
LAWSOC | 30 | 90 | 45 | 120 | 285 | |
GENERIC | 300 | 300 | ||||
GENERIC + TRAINEESHIP | 300 | 800 | 800 | |||
Total | 900 | 795 | 600 | 1425 | 1190 | 4910 |
“Comparable degrees with diploma supplement” | Yes | The comparability of degrees is achieved through calculation of the hours and comparison with other EU countries. The Diploma Supplement provided is in English. The Diploma Supplement describes the nature, level, context, content, and status of the studies that were pursued. With the texts of the Law on Higher Education adopted by the Bulgarian Parliament on 4 June 2004 both the system for collection and transfer of credits and the Diploma Supplement were legally introduced. |
“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. |
“Application of European QA” | Partial | PET is regulated at a national level by the ministry of education, but it is harmonized to EU requirements |
ERASMUS staff exchange to Sofia from elsewhere | Staff months: zero | |
ERASMUS staff exchange from Sofia to other HEIs | Staff months: one | |
ERASMUS student exchange to Sofia from elsewhere | Student months: 28 | |
ERASMUS student exchange from Sofia to other HEIs | Student months: 72 |
“Evidence of formal qualifications as a pharmacist shall attest to training of at least five years‘ duration,…” | 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 hospital's pharmaceutical department.” | Bulgaria complies. |
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Petkova, V.; Atkinson, J. Pharmacy Practice and Education in Bulgaria. Pharmacy 2017, 5, 35. https://doi.org/10.3390/pharmacy5030035
Petkova V, Atkinson J. Pharmacy Practice and Education in Bulgaria. Pharmacy. 2017; 5(3):35. https://doi.org/10.3390/pharmacy5030035
Chicago/Turabian StylePetkova, Valentina, and Jeffrey Atkinson. 2017. "Pharmacy Practice and Education in Bulgaria" Pharmacy 5, no. 3: 35. https://doi.org/10.3390/pharmacy5030035
APA StylePetkova, V., & Atkinson, J. (2017). Pharmacy Practice and Education in Bulgaria. Pharmacy, 5(3), 35. https://doi.org/10.3390/pharmacy5030035