A Questionnaire for Rating Health-related Quality of Life.

BACKGROUND: Translations of instruments for measuring quality of life developed in certain, mostly more developed, parts of the world usually do not cover regionally specific aspects of health-related quality of life, even after transcultural validation. The aim of this study was to develop and validate a reliable questionnaire in Serbian, Croatian, Bosnian, and Montenegrin languages suitable for measuring health-related quality of life in adults. METHODS: The study was of a cross-sectional type, assessing the reliability and validity of a newly developed questionnaire for measuring health-related quality of life (HRQoL) in adults residing in western Balkan states (WB-HRQoL). It was conducted on a sample of 489 adults from Serbia, Croatia, Bosnia & Herzegovina, and Montenegro, with a mean age of 52.2±14.4 years and a male/female ratio of 195/294 (39.9%/60.1%). RESULT: The definitive version of the WB-HRQoL scale with 19 items showed very good reliability, with Cronbach's alpha 0.905. The scale was temporally stable, and satisfactory results were obtained for divergent and convergent validity tests. Exploratory factorial analysis brought to the surface four domains of health-related quality of life, namely the physical, psychical, social, and environmental. CONCLUSION: The WB-HRQoL scale is a reliable and valid generic instrument for measuring HRQoL that takes into account the cultural specifics of the western Balkan region.

Pharmaceutical care in a long-stay psychiatric hospital.

OBJECTIVES: The aim of this study was to evaluate implementation of services provided by a clinical pharmacist for long-term-hospitalised patients with schizophrenia in a pharmaceutical-care-naive developing country. METHOD: This was a prospective, healthcare-system, interventional, 'before-and-after' study. Long-term (≥6 months) inpatients with schizophrenia were included. A clinical pharmacist reviewed the full patient notes, identified drug-related problems (DRPs), and proposed interventions using a DRP Registration Form (PCNE classification V6.2). Acceptance rate and outcomes of interventions were assessed. RESULTS: For 49 patients, 71 DRPs were identified, ranging from one to four problems/patient (1.43±0.68), predominantly related to tolerability and treatment effectiveness. The DRPs were mostly caused (N=184) by inappropriate drug selection (64%) or dose (23.4%): too many drugs for indication (N=33); a non-cost-effective choice (N=29); inappropriate combination (N=27); an inappropriate drug (N=23); lack of therapeutic drug monitoring (N=14); subtherapeutic (N=13) or supratherapeutic (N=11) dosing. Excessive treatment duration was observed for 14 DRPs. The clinical pharmacist proposed 182 interventions (70% at the drug level): discontinuation of medication (N=58); dosage change (N=35); other interventions (monitoring) (N=35); a change of drug (N=18) or instructions for use (N=9); and/or introduction of a new drug (N=7). Physicians accepted 91 interventions and refused 36. Finally, 38 DRPs were solved (25 completely and 13 partially), for 25 a solution was either not needed or not possible, and, for eight, the outcome was not known. CONCLUSIONS: The study underlines the high potential for pharmaceutical care to improve prescribing practices in developing countries without shared pharmacist-physician decision-making.

Cost-Effectiveness Comparison of Fidaxomicin and Vancomycin for Treatment of Clostridium difficile Infection: A Markov Model Based on Data from a South West Balkan Country in Socioeconomic Transition.

BACKGROUND: Recent studies have shown that fidaxomicin, a novel antibiotic, can reduce the rate of complications and mortality in patients with colitis induced by Clostridium difficile. Introduction of fidaxomicin in clinical practice is limited by its high costs. OBJECTIVES: The purpose of this study was to estimate the cost effectiveness of using fidaxomicin versus vancomycin in patients with colitis induced by C. difficile who did not respond to oral metronidazole. METHODS: We constructed a Markov model that was than simulated by Monte-Carlo simulation using 1000 virtual patients with colitis induced by C. difficile. The perspective in our model was institutional. The time horizon was 3 months. Values of transition probabilities and therapy outcomes were estimated from the available literature, the prices of health services were obtained from the Republic Institute for Health Insurance Tariff Book, and the price of fidaxomicin was derived from data gained from the drug manufacturer. RESULTS: The total costs of treating one statistical patient for 3 months with fidaxomicin were higher (48,106.19 ± 118.07 Republic of Serbia dinars [RSD]; 95% confidence interval 47,988.12-48,224.27) than the total costs of treating with vancomycin (25,872.85 ± 41.44 RSD; 95% confidence interval 25,831.41-25,914.29). Our results showed that the treatment of infections induced by C. difficile with fidaxomicin correlated with a lower rate of mortality and with a smaller number of colectomies. The incremental cost-effectiveness ratio of fidaxomicin versus vancomycin for colitis induced by C. difficile per saved life was estimated at 2.97 million RSD and for one avoided colectomy at 10.07 million RSD. CONCLUSIONS: Results of our model indicate that fidaxomicin is a cost-effective therapy compared with vancomycin in patients with colitis induced by C. difficile if the outcome is life-year saved. However, if the outcome is the number of avoided colectomies, then fidaxomycin is not a cost-effective option compared with vancomycin.

The preclinical discovery and development of ezogabine for the treatment of epilepsy.

INTRODUCTION: The weak anticonvulsant activity of the analgesic flupirtine led to the creation of ezogabine; an analogue which demonstrated both stronger antiepileptic activity and weaker analgesic effects. It's use as an anticonvulsant has been particularly effective in treating patients who have therapy-resistant epilepsy. Ezogabine binds to the KCNQ potassium channel, thereby decreasing the membrane potential threshold for its activation and increasing the probability of its maximum opening. AREAS COVERED: This drug discovery case history provides an overview of the history of the anticonvulsant, ezogabine, and presents relevant information pertaining to its discovery and preclinical development. The article helps explain the methods of discovery through the explanation of ezogabine's mechanism of action. Further, the authors also highlight the drugs clinical development and its postlaunch developments. EXPERT OPINION: More intense investment in research on the molecular mechanism of action early in the preclinical development of a drug could allow for the more suitable planning of preclinical studies and for the early discovery of specific, but important drug toxicities. This investment would make transitioning from the preclinical to the clinical phase easier and could result in better planning for what will be more productive clinical studies.