The first system indicators set out in the section I (Annex 2) 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 in-, out- and homecare patients by the hospital pharmacists). The histogram in Fig. 25 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. Similarly with the data analysis for the community pharmacies, the weight of the indicators responding to D is always 0. The results of the survey point to a very low actual score for this section (7.8 out of 20).
It was declared that pharmacists whether in central or satellite hospital pharmacy do not participate or partially participate (22%) in clinician / ward rounds or discuss with the physicians about the patient pharmacotherapy. No information regarding demographics, disease state, allergies, drug history and actual list of prescribed drugs and OTC drugs is available for the pharmacists or stored in electronic records (incl. CPOE) available for the pharmacists. In this respect, there is no activity such as verification by the pharmacist that any patient medication and allergy information is accurately evidenced in the patient record or routine review of medication orders prior to administration of first doses. App. 42% of the pharmacists declared that partially participate in verification of the patient medication record. The pharmacists are not engaged in patient chart and medication use review and/or reconciliation and accordingly they do not document their interventions related to PC activities. This is valid for all type and group of patients. In addition, there is no communication between the pharmacists at the transfer of care. Only 42% of the hospital pharmacists declared that communicate sporadically with the community pharmacists for the individual patient’s therapy when the patient discharged from hospital. The responses also point to restricted communication between the patients and the pharmacists.
provided by the pharmacists prior and during the therapy and no pharmacist is skilled to provide counseling and education to patients with special needs (deaf patients, blind patients, etc.). Written information on the drugs, incl. supplementary information important for the outcome of the therapy (nutrition, life-habits, etc.) is not provided in the patient primary language or it is partially provided in app. 19% of the pharmacies. When there is a contact with the patient, the pharmacists politely and clearly answer to all questions. However, as previously said, the contact with the patients is limited and therefore, they or their family members are not encouraged or they are partially encouraged to ask questions about the medications they use. Namely, only 6% and 29% of the interviewed pharmacists declared that apply or partially apply this activity. Although all these activities related to PC and rational pharmacotherapy not applied, almost all of the hospital pharmacies declared that these activities could be applied showing their willingness to increase their knowledge, adopt the PC roles and offer high quality PSs. However, more than half of the interviewed hospital pharmacists point that the structure of the pharmacy does not allow efficacious practice and high quality PSs. (For more detailed inspection into the survey results for the Section I see Annex 2).
20 7,8 0,72 1,53 5,75 0 20 Maximum possible score Actual score A B C
Fig. 25. Histogram depicting PP and PSs assessment scores for patient safety
The system indicators set out in the section II (Annex 2) intended to assess all the activities related to the use of medicines and medication devices such as the ordering communication (e.g. use and availability of prescribing recording system, degree of computerization, etc.) and practice of their purchase, storage, labeling, distribution and administration. In addition, availability and providing up-to- date and accurate information on medicines and medication devices to the patients and healthcare givers were also evaluated. The histogram in Fig. 26 depicting component scores as the actual score points to the value 11.54 out of 20.
Less than half of the hospital pharmacies in the RoM (39%) are connected with the NDIC and those which are connected obtain regularly up-to-date and accurate information on medicines and medication devices which are further delivered to the healthcare givers mostly at the hospital units. In only five of the interviewed hospital pharmacies, a designated pharmacist or specialist in drug information is engaged in providing information on medicines and medication devices and only one of the interviewed representatives declares that has easy access to user-friendly, up-to-date computerized information
literature, life science journals, online books or their printed editions is limited for most of the hospital pharmacies (more than 65%), while protocols or standardized dosing guidelines and/or checklists are not available or they are partly available in 22%. One can say that internationally developed drug information tools (e.g. pocket references, drug information cards, standard order sets, checklists, etc.) are not available in most of the hospital pharmacies (available in app. 10%). Pharmacists are (partly) informed about the information technology systems used to assure adequate drug and dosage regimens (in app. 77% of the pharmacies), however, they are not available in most of the hospital pharmacies (more than 90%). Pharmacists are partly involved in the development and implementation of evidence- based drug therapy protocols, hospital drug formularies, guidelines, etc (in app. 29% of the hospitals). However, in app. 65% of the hospitals, no internal risk assessment or ongoing-hospital wide surveillance is made before submitting drug monograph to the Pharmacy & Therapeutics Committee. Only 4 representatives of the hospital pharmacies declare that have a pharmacist responsible for providing up- to-date information on medical errors and ADRs and they evaluate his/her activity as partially applied.
20 11,54 4,75 2,68 4,11 0 20 Maximum possible score Actual score A B C
Fig. 26. Histogram depicting PP and PSs assessment scores for use of medicines and medication devices As previously said, ordering communication practice was also subject to evaluation. According to the survey, most of the activities in this section are applicable but not applied in more than half of the hospital pharmacies. Only 3 of the hospital pharmacies/pharmacists declared that use CPOE system for order entry and in only 5 hospitals, the medicines/medication devices are ordered from the wards by pharmacists. Verbal or telephone orders are always accepted for oral or parenteral chemotherapeutic agents, incl. chemotherapeutic agents used for non-oncologic indications and they are immediately transcribed and verified in app. 61% of the hospital pharmacies. Also, in most of the hospital pharmacies (app. 77%), the medications are removed from patient unit stock before a pharmacist review the specific patient order because mainly she/he has no access to the medication administration records. Pharmacy interventions regarding potentially harmful medication orders are immediately communicated to the nurses/prescribers in most of the hospital pharmacies (app. 80%). However, pharmacists have no role in off-label drug orders or orders for drugs in atypical doses. The pharmacists’ involvement in prescribing therapeutic substitution is minor as well as in prescribing of any authorized non-controlled medicine. Only 35% of the pharmacists declared that they are partially authorized to prescribe therapeutic substitution, while authorization for prescribing any licensed medicine, with exception of controlled
drugs, is partially given to a pharmacist in 16% of the hospital pharmacies. Time for order verification is (partially) consistent and adequate to urgency in 68% of the hospital pharmacies.
Pharmacists are actively involved in all medications and medication devices purchasing in all hospital pharmacies and this activity is performed via public tendering procedure. Pharmacy and Therapeutic Committees consisted of one pharmacist at least decide for acquisition of drugs and medication devices in app. 74% of the interviewed hospitals, however, an initial risk assessment to identify the possible difficulties in utilization of medication devices is fully or partially performed in low number of hospitals (app. 20%). In app. 74% of the hospitals, the pharmacists participate in planning of annual budget for acquisition of drugs and medication devices and there they are informed on the budget allocated and the dynamic of expenditure.
All drugs in all interviewed pharmacies are stored in a designated area within the hospital pharmacy, however, in only 32% of the hospital pharmacies, the areas are sufficient to ensure proper sanitation, temperature, light, ventilation, moisture control and segregation. App. 80% of the hospital pharmacies declared that the areas for storing alcohol and flammables do not comply fully with the code requirements for storage of volatiles, while 16% declared that they have no separate storage areas for volatiles. In addition, solutions, drugs, supplies and equipment used to prepare or administer sterile products are stored fully in accordance with the manufacturer or Pharmacopoeia requirements in only 48% of the pharmacies. Temperatures in refrigerators and freezers used to store ingredients and finished sterile preparations are fully or partially monitored and documented daily in all of the pharmacies that prepare these pharmaceuticals, however, electronic systems that document temperature ranges and provide immediate problem notification are not used for refrigerators that store critical, temperature-sensitive medications. In addition, SOP for how to handle any breach has not been developed in most of the hospital pharmacies (app. 90%). Also, for more than 90% of the pharmacies, no automatic storage or distribution devices are available. Pharmacy and/or ward stocks are reviewed at least annually to determine low usage in almost all of the hospital pharmacies (in 35% they are reviewed rarely) and similarly, the drugs stocked in wards are carefully selected by considering the needs of each patient care ward. Unit stock is reviewed every day in 58% of the hospital pharmacies, while in 42% of them, this activity is applied rarely. Drugs stocked in wards are available or partially available in the least number of doses, concentrations and forms that meet essential patient needs between replenishment (not exceeding 72 h) in more than 90% of the hospital pharmacies.
The packages and labels of new drugs are examined before use and compared to other products to identify any potential for confusion in most of the hospital pharmacies (app. 80%), although auxiliary warning or specific labels are not extensively used to minimize the confusion (if identified). They are partially used in app. 42% of the pharmacies. Bulk chemicals, large-volume bags and bottles of irrigation solutions, organ storage solutions and sterile water are adequately stored and labeled in average 70% of the pharmacies. However, medication containers taken to the bedside are not adequately labeled in most of the hospitals. Only 22% declared adequate labeling.
Unit oral doses remain in the original packaging up to the point of actual drug administration at the bedside for checking for compliance with the MAR in half of the hospital pharmacies. Only one pharmacy declared dispensing oral liquid medications in ready-to-use patient specific doses, especially for pediatric patients, while 16% declared the same for parenteral medications. Similarly, doses that require less than a full dosage unit are not repacked by the pharmacy into unit-dose package in more than 77% of the hospital pharmacies and there is no central hospital pharmacy that has a unit-dose or
robotic packaging/distribution system. Vials of concentrated electrolytes are distributed to authorized patient care units in only 48% of the hospital pharmacies.
Barcode readers are not used before drug administration in all of the hospitals and error-reduction strategies, incl. calculation of dosage regimens based on TDM data and double check, have not been established for high-alert and NTI drugs in more than half of the hospitals. For example, more than 70% of the hospital pharmacies do not regularly calculate dosage regimens of NTI drugs, administration rates when using i.v. administration devices are (partially) calculated in less than 68% of the pharmacies, while double check when calculations are necessary is a standard practice in less than 20% of the hospital pharmacies. One can say that there is no practice to validate mathematical skills of the pharmacists responsible for calculations. Considering administration devices, specially designed oral syringes for administering oral/enteral liquid medicines are not available in more than 74% of the hospital pharmacies. In addition, electronic infusion control devices and smart pumps are almost not utilized in drug administration. Enteral feeding catheters that cannot connect with i.v. or other parenteral lines are used in app. 74% of the hospital pharmacies. Self-administration of drugs by patients is permitted only when specifically authorized by the treating or ordering physician in 68% of the pharmacies, while in app. 45% of the pharmacies, the patients are routinely provided with all necessary medications when discharged from hospital. (For more detailed inspection into the survey results for the Section II see Annex 2).
The system indicators set out in the section III (Annex 2) assess manufacturing practice, incl. production of both sterile and non-sterile medicines and their quality control. The histogram in Fig. 27 depicts component scores as the actual score which is 12.23 vs. maximum possible score of 20.
It must be emphasized that the actual score in this section is based on the responses obtained from 9 hospital pharmacies in which the production of pharmaceuticals (both sterile and non-sterile) was declared and where for production of sterile pharmaceuticals, glass bottle production lines are used. Only 3 of the hospital pharmacies declared production of sterile and non-sterile pharmaceuticals for an individual patient. Pharmaceuticals are mostly produced for use in the hospitals and only one of the hospital pharmacies (pharmacists) declared production for sell to other hospitals. The production of pharmaceuticals complies with the national policy in most of the hospital pharmacies and only 2 of them declared compliance with the EU/FDA GMP. Hazardous medicines (e.g. cytotoxic anticancer drugs) and unit-dose medicines for parenteral administration are prepared in biological safety cabinets in app. 43% of the hospitals, but the chemotherapy doses are not prepared under supervision of pharmacist or in a pharmacy department. It is worth to mention that during the survey, a pharmacist was employed for the first time at the University Clinic of Radiotherapy and Oncology in Skopje for performing PP and providing PSs.
Up-to-date policies and procedures for compounding sterile products are established and available to the personnel in app. 70% of the interviewed hospital pharmacies producing sterile pharmaceuticals and there, generally, master work and preparation sheets are developed for a batch of each discrete identity and concentration of sterile product and verified by a responsible pharmacist.
20 12,23 8,61 0,04 3,58 0 20 Maximum possible score Actual score A B C
Fig. 27. Histogram depicting PP and PSs assessment scores for manufacturing practice
The responsible pharmacist verifies that the product was compounded accurately with the correct ingredients, quantity of each ingredient, containers and reservoirs in all of the hospital pharmacies producing both sterile and non-sterile pharmaceuticals. Analytical procedures to control the quality of the raw materials and pharmaceutical products are regularly performed in 5 of the hospital pharmacies producing pharmaceuticals. For the rest of them, the quality of pharmaceuticals is controlled in accredited laboratories outside the pharmacy (contract service). Quality control includes stability studies of the formulation (chemical, physical), sterility tests, non-pyrogenicity testing, analysis of chemical content, purity analysis of raw materials and analysis of the final pharmaceutical product. The final sterile products are inspected when prepared in all of the hospital pharmacies. However, in only one of them the final sterile products are inspected when dispensed. Complete documentation for sterile products consisted of master work sheet, preparation and sterilization records, quarantine records, end- product evaluation and testing results, training and competency evaluation, refrigerator and freezer temperatures, certification of laminar-airflow workbenches is prepared in app. 67% of the corresponding hospital pharmacies.
The pharmacists do not participate in clinical studies and therefore they do not prepare medicines for clinical studies. (For more detailed inspection into the survey results for the Section II see Annex 2). The section IV uses system indicators to assess workflow and staff availability and qualifications (Annex 2). The histogram in Fig. 28 presents component scores as the actual score which is 12.53 out of 20 (maximum possible score).
Indicators assessing environment for PP and PSs point to adequate, clean and illuminated space for reviewing medication orders and storing and dispensing of medicines, free of clutter, distractions, interruptions and noise, which enables efficacious performance of these pharmacy activities in app. 39% of the hospital pharmacies. App. 54% of the hospital pharmacists are partly satisfied with the room for performing these activities. In conjunction with the previous finding, only small percent of hospital pharmacies (less than 10%) have adequate space for manufacturing practice. It is very important to emphasize that in only 3% of the pharmacies, the pharmacists and pharmacy technicians employed are sufficient to perform every-day tasks 24 hours. Moreover, the rest of the hospital pharmacists declare
pharmacies are state-owned and in 39% of the hospitals with in-patient beds there is no hospital pharmacist employed. The personnel work 8 hours/day with 30-min break in almost all of the hospital pharmacies, however, an effective back-up plan for days when staffing is short is established in only 22% of the hospital pharmacies. App. 26% of the pharmacists declared that the pharmacy’s back-up plan is partially effective. Pharmacy students/residents are partially trained (less than 8 h/day) in app. 38% of the pharmacies, but their role in every-day activities in the pharmacy is insignificant and in addition, they cannot be included in the back-up plan.
20 12,53 6,65 2,29 3,59 0 20 Maximum possible score Actual score A B C
Fig. 28. Histogram depicting PP and PSs assessment scores for environment, workflow and staff availability and qualifications
Pharmacists control all drug-related logistics in 48% of the hospital pharmacies. Considering their competencies, a dedicated pharmacist offers drug information services in 35% of the hospital pharmacies, clinical pharmacy services in 16% of the hospital pharmacies, in 26% of the hospital pharmacies, information on the evidence and pharmacoeconomic issues for each drug is provided, specialists in pharmaceutical technology are employed in all, while specialist in drug quality control are employed in approximately half of the hospital pharmacies manufacturing sterile and/or non-sterile pharmaceuticals. Pharmacists are encouraged to extent their knowledge in the field of pharmacy management in only 22% of the hospital pharmacies and they are not stimulated or motivated at all to complete postgraduate studies in specific clinical areas, such as the oncology, pediatrics, etc. or in prescribing medications. Pharmacists participate in hospital multi-disciplinary committees as full voting members in app. 22% of the hospital pharmacies. However, they do not participate in ethical and review committees for clinical studies.
All 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 in app. 30% of the hospital pharmacies. In average 35% of the pharmacies, this activity is partially applied. During this training period, pharmacists spend full-time in patient care areas in only 13% of the hospital pharmacies, while in