This paper presents emerging Good Practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) Measures. The ISOQOL Translation and Cultural Adaptation Special Interest Group (TCA-SIG) undertook the review of several TA approaches, with the collaboration of organizations who are involved in conducting TA, and members of the TCA-SIG. The effort led to agreement by the writing group on Good Practices for 1) the terminology to be used in referring to translatability process, 2) the best definition of TA, 3) the methodology that is recommended at each step of the process, 4) the persons involved in TA, 5) the timing of assessment, 6) the review criteria for TA, and 7) the recommendations to be made at the end of the TA process. With input from the TCA-SIG membership and in consultation with experts in the field, these emerging good practices can guide the future use of TA in the development of PROs.

Background: Sarajevo has had the destiny of a place where different civilizations collided. This reflected on all aspects of life in Sarajevo. The development of pharmacy in Sarajevo began a long time ago. This article presents the development of private Sarajevo pharmacies in the 19th and 20th centuries. Objective: The article aims to introduce the reader to a chronological overview of the opening of pharmacies, their owners and the addresses where they were located. Results and Discussion: The article deals with prominent doctors who were also pharmacists, as well as attars and attar shops which are considered the forerunners of modern pharmacies. During the Austro-Hungarian period, pharmacies and pharmacy activities flourished. They introduce reforms and organize the pharmacy business as we know it today. Conclusion: At that time, the owners of the pharmacies were foreigners, mostly Czechs and Poles. During the old Yugoslavia, additional pharmacies were opened. After the Second World War, all private pharmacies in this area became state property.

Introduction: Diabetes is reaching epidemiological scales worldwide. Beside health implications diabetes bears significant financial impact on health systems. Different treatment options aiming to prevent diabetes complications are available. Dipeptidyl-peptidase-IV (DPP-4) inhibitors like linagliptin are usually add-on therapy to metformin in order to achieve glycemic control. Expenditure for oral antidiabetic medicines in Bosnia and Herzegovina (B&H) is low accounting for only 2.53% of the total drug market expenditure. Linagliptin is not reimbursed in B&H mainly due to it’s perception of high cost medication. Aim: To assess budget impact (BI) of introducing linagliptin into health insurance reimbursement list in B&H through development of the budget impact model (BIM). Material and methods: Budget impact model was developed using Microsoft Excel 2010 based on current legislation and practice in B&H. Local epidemiology data and data on drug consumption from government reports in 2014 were used. Two scenarios with three-year time horizon have been developed: 1) without and 2) with linagliptin reimbursed and compared. Results: Inclusion of linagliptin into reimbursement list in Canton Sarajevo and Canton Tuzla would have positive budget impact on national level of B&H resulting in total savings of 18,194€, 235,570€ and 699,472€, in 2016, 2017 and 2018, respectively. Conclusion: Introduction of linagliptin into reimbursement list would decrease total costs for DPP-4 inhibitors and is favorable for positive decision on reimbursement in B&H. Applying BIM in decision making would assure better allocation and planning of resources at any region or administrative level in B&H.

BackgroundManaged entry agreements (MEAs) are a set of instruments to facilitate access to new medicines. This study surveyed the implementation of MEAs in Central and Eastern Europe (CEE) where limited comparative information is currently available.MethodWe conducted a survey on the implementation of MEAs in CEE between January and March 2017.ResultsSixteen countries participated in this study. Across five countries with available data on the number of different MEA instruments implemented, the most common MEAs implemented were confidential discounts (n = 495, 73%), followed by paybacks (n = 92, 14%), price-volume agreements (n = 37, 5%), free doses (n = 25, 4%), bundle and other agreements (n = 19, 3%), and payment by result (n = 10, >1%). Across seven countries with data on MEAs by therapeutic group, the highest number of brand names associated with one or more MEA instruments belonged to the Anatomical Therapeutic Chemical (ATC)-L group, antineoplastic and immunomodulating agents (n = 201, 31%). The second most frequent therapeutic group for MEA implementation was ATC-A, alimentary tract and metabolism (n = 87, 13%), followed by medicines for neurological conditions (n = 83, 13%).ConclusionsExperience in implementing MEAs varied substantially across the region and there is considerable scope for greater transparency, sharing experiences and mutual learning. European citizens, authorities and industry should ask themselves whether, within publicly funded health systems, confidential discounts can still be tolerated, particularly when it is not clear which country and party they are really benefiting. Furthermore, if MEAs are to improve access, countries should establish clear objectives for their implementation and a monitoring framework to measure their performance, as well as the burden of implementation.

Aim To investigate the effects of carbocisteine treatment in the reduction of frequency of productive cough episodes, preventing disease progression and improving the quality of life as well as the tolerability of the administered treatment and patient compliance during the study. Methods This observational, non-interventional, multicenter, cohort study included 501 patients with chronic obstructive pulmonary disease (COPD) who were administrated carbocisteine capsules 375 mg and followed up during the next 15 days. The patients were observed at 3 points, baseline and two additional assessments. General clinical condition of patients, along with the spirometry testing at all three points were examined. Thr quality of life was assessed on the 1st and 3rd observation with Leicester Cough Questionnaire. Tolerability and patient compliance were measured throughout the study. Results There was a significant change of forced expiratory volume in 1 second (FEV1) status between the second and third observation (p=0.002). Examination of general symptoms showed a statistically significant reduction in cough by 74.9%, in sputum production by 48.5%, in dyspnea by 29% and in fatigue by 50%. After the administration of carbocisteine the median value of overall quality of life was 3.79 (3.63 - 3.89). Conclusion 375mg carbocisteine capsules were found to be effective and well-tolerated in the treatment of COPD, with a small percentage of reported mild adverse reactions and with a significant improvement of quality of life.

Introduction: The purpose of this study was to validate Bosnian translation of disease specific quality of life measure MSQoL-54 which is widely used in practice. Material and Methods: Previously translated and culturally adopted MSQoL-54 questionnaire used in this study has been provided and licensed by Optum Inc. The questionnaire was validated in 62 MS patients seen at Neurology clinic at University Clinical Center Sarajevo, during April 2016 until May 2016. Internal reliabilities of Bosnian version MSQoL-54 were assessed for multiple item scales by using Cronbach’s alpha coefficient. Clinical validity was assessed comparing means of the two summary MSQoL-54 scores by the EDSS score. Pearson’s (r) correlation coefficient was used to investigate the relationship between the composite scores and the main clinical and demographic variables. Results: Patients’ participation was satisfactory and all scales fulfilled the usual psychometric standards. Highly significant inverse relationship was found between both composite scores and clinical characteristics of the disease and the EDSS. The lowest internal consistency reliability is found on social function scale (0.743), overall quality of life (0.782) and pain (0.833). The highest internal consistency reliability is found on role limitations due to physical problems (0.959), physical health (0.962) and role limitations due to emotional problems (0.966). The mean value of MSQoL-54 PHC (Physical Health Composite) and MHC (Mental Health Composite) were 49.82±18.90 (36.05-61.38) 51.84±22.22 (34.93-70.20) respectively. Our study has shown that the Bosnian version of MSQoL-54 is easy to administer and well accepted by patients and may be useful as clinical outcome measures in patients with MS.

Aim To investigate and assess knowledge and attitudes of pharmacists and physicians towards generic drugs prescription in order to evaluate current trends, obstacles to prescribe/dispense generics and suggest possible improvements of rational and economic prescribing having in mind scarce public budgets for drugs. Methods A cross-sectional survey among 450 primary care physicians (prescribers) and pharmacists in four major cities in Bosnia and Herzegovina (Sarajevo, Banja Luka, Tuzla and Mostar) during the period between January and March 2016 was conducted. The survey (questionnaire) was developed and physicians' and pharmacists' perception was examined using the 5-point Likert scale. Descriptive statistics was used to examine respondents' characteristics and their responses to survey questions. The respondents perception based on different characteristics was assessed using ordinal logistic regression. Results Generally, positive attitudes towards generic drugs were found. Majority of respondents, 392 (87.0%) considered generic drugs the same as originators and they could be mutually substituted. Physicians were more likely to prescribe branded drugs, 297 (66.6%), even 391 (86.8%) were aware of generic alternatives. Respondents believed that patients considered generic drugs less effective, 204 (45.4%), and 221 (49.0%) disapproved generic substitution. Conclusion Our findings suggest that further education and more information about benefits of generic drugs should be provided to key stakeholders including patients. Also, clearer generic drugs policies should be introduced in order to improve generic prescribing and potentially improve access and optimize pharmaceutical public expenditures.

Background: Nifuroxazide is well known and often used anti-diarrhoeal medicine which has been pushed back from routine practice in recent years and often replaced with probiotics. Even probiotics are accepted and placed in some therapeutic guidelines for diarrhoea treatment, there are no enough evidence for its effectiveness and no comparative efficacy data with nifuroxazide in treatment of acute diarrhea. Patients and Methods: In open, prospective observational study, the efficacy and safety of nifuroxazide were compared with a probiotic containing lactic acid bacteria in the treatment of acute diarrhoea. A total number of 169 adult patients were included in this study, who administered nifuroxazide in the dose of 200 mg/4 times a day, while they took preparation containing lactic acid bacteria (1,2 x 107 live lyophilised lactic-acid bacteria) three times a day for three days. Results: Mean time to last unformed stool (TLUS) in a group which was treated with nifuroxazide was two days, while it took five days for the stool normalisation in the group using probiotic (p=0.0001). Conclusions: Orally administered nifuroxazide has demonstrated better efficiency as compared to probiotic in treating acute diarrhoea, and both medicines have shown the same safety and tolerance in this study.

Introduction: Tonsillopharyngitis (sore throat) is a common disease mainly related to the seasonal common cold. To relieve unpleasant symptoms and discomfort of acute tonsillopharyngitis associated with common cold, patients usually take some non-prescription drugs. The aim: The primary aim of this study was to assess subjective determinations of the efficacy and the safety/tolerability of an oral spray comprising a combination of lysozyme chloride and cetylpyridinium chloride in those patients. Material and methods: The study involved 1727 patients with tonsillopharyngitis associated with common cold and treated with the studied drug, in the period from December 2014 through March 2015. Results: In total, 95% of patients rated the studied drug to be well, very well and excellently effective. In 32% of patients, the symptoms were relieved 10 minutes after the application of the spray. Significant correlations were found between the two subjective assessments of the drug efficiency with the total of 74.11% (95% CI: 73.41, 77.47%) of patients who said that the feeling of pain in the throat completely disappeared after the drug administration, evaluated the impact/effect of the drug was very good or good (Pearson Chi Square=391.401, p<0.001). The effectiveness was significantly better in patients with up to two episodes of common cold a year (Pearson Chi Square=6.101; p=0.014). The studied drug was rated to be well, very well and excellently tolerated by 97% of patients. Conclusion: According to patients’ subjective assessment, the combination of lysozyme chloride and cetylpyridinium chloride in a formulation of spray can quickly, efficiently and safely resolve the symptoms of acute tonsillopharyngitis associated with common cold.