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.
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.
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.
%
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 2ndintegrated 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. 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.
The pharmacy staff participates in hospital committees (e.g. Pharmacy & Therapeutic Drug Committee, etc.) in 67.86% of the hospitals. Hospital drug formulary is created and used for therapeutic drug management in only 15.91% of the hospital pharmacies, while the other hospital pharmacies use only national list of essential drugs. Hospital drug formulary is updated every year in most of them (85.71%). The hospital formularies are created and implemented with a participation of the hospital pharmacists in app. 43% of the hospitals. Hospital drug formularies usually contain price information (57.14%), information on dosage regimens (42.86%), prescribing information (14.29%), hospital drug use policy (14.29%) and antibiotic prescribing protocols (14.29%). Number of pharmaceuticals in the hospital drug formularies is fewer than 300 in app. 67% of the hospital formularies and in 16,67% it is over 1000. Number of chemical entities is lower than 300 in 80% of the formularies. In addition, for therapeutic drug management, own protocols/guidelines based on evidence are used in app. 28% of the hospital pharmacies, app. 43% use national protocols/guidelines, while in the rest of the hospital pharmacies, no protocols or guidelines are used. This response might be related to no participation of the pharmacists in therapeutic drug management.
According to the information gathered during the survey, the pharmacists in the hospital pharmacies are in a phase of preparation of SOPs. Up-to-date policies and SOPs established so far and the proportion of hospital pharmacies incorporating these standards are given below (Table 5).
Table 5. Up-to-date policies and SOPs established in the hospital pharmacies in the RoM
SOPs Hospital
pharmacies (%)
Compounding sterile products
Personnel education, training and competency evaluation Product acquisition, storage and handling
Supplies, storage and delivery of final products Use and maintenance of facilities and equipment
Appropriate garb and conduct for personnel working in the controlled area Process validation
Preparation technique Labeling
Documentation Drug quality control
Personnel access into and near the controlled area Movement of materials into and near the controlled area Monitoring environmental conditions in the controlled area
Safe use of sterile products once they are distributed out of pharmacy Giving drug information
41.67 20.83 66.67 45.83 25 16.67 37.5 29.17 33.33 54.17 25 12.5 29.17 25 4.17 4.17
Considering the capacity for production of pharmaceuticals and their quality control in the hospital pharmacies, representatives of 9 from 31 interviewed hospital pharmacies declared that prepare both sterile and non-sterile pharmaceuticals for use in the hospital. Only 1 of 9 hospital pharmacies sells pharmaceuticals to other hospitals, while no hospital pharmacy prepare pharmaceuticals for intensive care units. All of the hospital pharmacies with capacity for manufacturing practice produce pharmaceuticals for inpatients, 43.75% for outpatients and none of them for homecare patients. Drug quality control and analytical procedures are performed in 44.44% of the pharmacies that prepare
laboratories outside the pharmacy. In all hospital pharmacies, final pharmaceutical products are analyzed and sterility is tested, chemical content and non-pyrogenicity is tested in 86% of the pharmacies, purity, raw materials and packaging materials are analyzed in 71%, while stability studies are conducted in 57.14% of the hospital pharmacies. More information on the manufacturing practice in the hospital pharmacies can be found in the Annex 2 (Section III).
All interviewed hospital pharmacies in the RoM have installed a computer system. However, in 64.52% it is not integrated and/or interfaced with the computer system of the hospital ward. Interfacing with the computer system in the hospital ward was declared in only 3.23% of the hospital pharmacies.
In app. 76% of the hospital pharmacies, a pharmacy training program that has been approved by the university/faculty council for training of master of pharmacy students and health specialist residents is provided. The same is the percent of hospital pharmacies that provide residency-training for graduated pharmacists during their licensing period. The training program and final exam are approved and under jurisdiction of the PCoM (see Introduction). Around 67% of the hospital pharmacists provide also training program approved by the secondary school council and Ministry of health for pharmacy technicians. In nearly half of the hospital pharmacies, the number of residents usually does not exceed five per year.
II.2 Indicators and components included in the PP and PSs assessment tool and scores from the