Exposure of Pharmacists and Pharmacy Technicians to Violence in Community Pharmacies in Southeast Europe: Frequency and Ethical Considerations.

Pharmacists and pharmacy technicians working in community pharmacies are exposed to the risk of violence in their workplaces. Studies have shown that workplace violence is affecting their job satisfaction, productivity, and mental health. This study aims to identify the frequency of different types of violence, as well as the common perpetrators that community pharmacy staff in SEE (Southeast Europe) are dealing with. A cross-sectional study was conducted using an online questionnaire created for this purpose. Selected community pharmacies in Croatia, Serbia, Bosnia and Herzegovina, and Montenegro participated in this study. In total, 732 responses were collected from 24 pharmacy chains or independent pharmacies including all community pharmacy staff. More than 80% of pharmacists and pharmacy technicians reported having been exposed to verbal violence at the workplace, while more than 20% of them reported physical and sexual violence in the preceding 12 months. There were no statistically significant differences between pharmacists and pharmacy technicians, gender, age groups, or countries in relation to exposure to physical, verbal, and sexual violence. The most common perpetrators were identified as patients/clients. More than 90% of pharmacy staff reported they did not receive any kind of support from their employer nor any other help after experiencing a robbery. There is a need for a structured approach to addressing violence in pharmacies including organized support for pharmacy staff. Achieving quality patient care, despite dealing with violent individuals or situations daily, is one of the greatest ethical challenges for healthcare providers in community pharmacies to be empowered.

Individualized education and competency development of Croatian community pharmacists using the general level framework.

OBJECTIVES: To measure Croatian community pharmacists' progress in competency development using the General Level Framework (GLF) as an educational tool in a longitudinal study. METHODS: Patient care competencies of 100 community pharmacists were evaluated twice, in 2009 and in 2010 in a prospective cohort study. During this 12-month period, tailored educational programs based on the GLF were organized and conducted, new services and standard operating procedures were implemented, and documentation of contributions to patient care in the pharmacist's portfolio became mandatory. RESULTS: Pharmacists' development of all GLF patient care competencies was significant with the greatest improvements seen in the following competencies: patient consultation, monitoring drug therapy, medicine information and patient education, and evaluation of outcomes. CONCLUSIONS: This study, which retested the effectiveness of an evidence-based competency framework, confirmed that GLF is a valid educational tool for pharmacist development.

A practical validation approach for virus titer testing of avian infectious bursal disease live vaccine according to current regulatory guidelines.

The method for virus titer determination of avian infectious bursal disease (IBD) live vaccine, developed long before regulatory validation guidelines is a cell culture based biological assay intended for use in vaccine release testing. The aim of our study was to perform a validation, based on fit-for-purpose principle, of an old 50% tissue culture infectious dose (TCID(50)) method according to Guidelines of the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This paper addresses challenges and discusses some key aspects that should be considered when validating biological methods. A different statistical approach and non-parametric statistics was introduced in validation protocol in order to derive useful information from experimental data. This approach is applicable for a wide range of methods. In conclusion, the previous virus titration method had showed to be precise, accurate, linear, robust and in accordance with current regulatory standards, which indicates that there is no need for additional re-development or upgrades of the method for its suitability for intended use.

Social and medical care of preschool children with epilepsy in Croatia: population-based survey.

BACKGROUND: Early detection of mental retardation and other epilepsy-associated impairments is essential for successful medical and social care of children with epilepsy; the corresponding information for children in Croatia has not yet been known. AIMS OF THE STUDY: To obtain the basic information of epilepsy-associated disability in preschool children, and fundamentals of their medical and social care. METHODS: Data about mental retardation and other associated impairments (motor, speech, seeing, hearing), antiepileptic drug therapy and diurnal residence were collected by means of questionnaires completed by physicians working in primary health care (PHPs). Only children (0-7 years) with active epilepsy confirmed previously by neuropaediatricians were included. RESULTS: A total of 37 PHPs provided the required data for 116 children. One or more impairments were found in 56% children; most frequent were motor impairments (47%), speech impairments (42%) and mental retardation (40%). The regular kindergarten attendance rate of children without impairment (33%) was not different from the children without epilepsy, but high proportion (76%) of children with impairment stayed with their families during weekdays. In this subgroup monotherapy was more rarely used (64% vs. 90% in children without impairment (p<0.01)). Valproate was predominantly used (56%) in children with and without impairment; lamotrigine was more frequently used in the former subgroup (p<0.01). CONCLUSIONS: Existence of associated impairments has significant impact on medical and social care in preschool children with epilepsy. These children need an early diagnosis and consecutive multidisciplinary care of their intellectual and body impairments, as well as problems in social development.

Age-related pattern of the antiepileptic drug utilization in active epilepsy: a population-based survey.

The aim of this study was to investigate the relationship between antiepileptic drug (AED) utilization and patient age in a population of patients treated by primary health care physicians. Data were collected by using questionnaires completed by family physicians and paediatricians working in primary health care. Only patients with active epilepsy confirmed previously by neurologists or neuropaediatricans were included. One hundred and twenty-three physicians provided the requested data for 966 patients (range 1-92 years). Most frequently prescribed AEDs were barbiturates (BARB) (37%) and carbamazepine (CBZ) (37%). Valproic acid derivates (VPA) were prescribed in 28%, but the rate was higher (51%) in children. By calculating the correlation between age and the prescription of single AEDs across the whole sample, linear correlations were found for BARB (r = 0.94; p < 0.01), VPA (r = -0.93; p < 0.01) and for topiramate (TPM) (r = -0.90; p < 0.01). Since our results showed significant correlations between age and the use of the majority of AEDs, we concluded that the age may be considered a methodological bias in the presentation of data. Therefore we calculated AED utilization as the age-adjusted prevalence rates (per/1000 inhabitants). For the most commonly prescribed AEDs they were: BARB 1.8 (95% CI 1.6-2.0), CBZ 1.9 (95% CI 1.7-2.1), VPA 1.3 (95% CI 1.1-1.5), lamotrigine (LTG) 0.7 (CI 95% 0.6-0.8), TPM 0.6 (CI 95% 0.5-0.7). In conclusion, the age of patients has a significant impact on the prescription patterns not only between children and adults, but at every age. Therefore we suggest that reporting of AED utilization pattern should also include age-standardized prevalence rates of individual AED utilization.

Immunohistochemical expression of tumor antigens MAGE-A1, MAGE-A3/4, and NY-ESO-1 in cancerous and benign prostatic tissue.

OBJECTIVE: To investigate immunohistochemical expression of MAGE-A and NY-ESO-1/LAGE-1, cancer testis antigens in prostate tissues showing evidence of malignant transformation or benign hyperplasia. METHODS: 112 prostate samples from patients undergoing surgery at the Urology Clinic at the Zagreb Clinical Hospital Center from 1995 to 2003 were investigated in this study. Of these, 92 carcinoma samples were obtained by radical prostatectomy, and 20 benign prostatic hyperplasia samples by transvesical prostatectomy. Three monoclonal antibodies were used for immunohistochemical staining: 77B for MAGE-A1, 57B for multi-MAGE-A and D8.38 for NY-ESO-1 expression. RESULTS: Expression of MAGE-A1 was observed in 10.8% of carcinoma samples, whereas multi-MAGE-A and NY-ESO-1/LAGE-1 stained 85.9% and 84.8% of samples. Immunohistochemical staining was only detectable in the cytoplasm. A significant heterogeneity could be observed within a same tissue sample where areas with strong positivities coexisted with cancer testis antigens negative areas. Interestingly, a majority of 57B positive cases were also found to be D8.38 positive (correlation coefficient r=0.727 (P<0.01)). Cancer testis antigens expression was neither significantly correlated with PSA values nor with Gleason score. In benign prostatic hyperplasia tissues MAGE-A1 expression was detected in 5%, while 57B and D8.38 staining was observed in 15% samples, and in all cases percentages of positive cells were always <10%. CONCLUSION: Our data underline the peculiar relevance of cancer testis antigens expression in prostate cancers, with potential implications regarding both diagnosis and therapy.