Consumption of antihistamines in Serbia in the period 2011–2015 and the correlation with adverse drug reaction reports

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Consumption of antihistamines in Serbia in the period 2011-2015 and the correlation with adverse drug reaction reports

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FACTORS ASSOCIATED WITH ESTIMATE OF HIGH TERATOGENIC RISK IN FEMALES EXPOSED TO ANTI-INFECTIVE AND ANTI-INFLAMMATORY DRUGS DURING PREGNANCY

ABSTRACT Introduction. Considering that small number of drugs are completely safe for use during pregnancy, right choice and adequate risk assessment is extremely important. Objective. The aim of this study was to analyze factors associated with estimate of high teratogenic risk (as judged by clinical pharmacologist) in pregnant females who were prescribed anti-infective drugs or mild analgesics. Methods. A cross-sectional study included 284 pregnant women who came for an advice about teratogenic risk to clinical pharmacologist in Clinical Centre Kragujevac, Serbia during the period from 1997 to 2012. All of included pregnant women were prescribed mild analgesics and/or anti-infective drugs during the first 3 months of pregnancy. The data were collected from patient files and by phone interviews. Results. Clinical pharmacologists estimated the risk of teratogenicity as “high” in pregnant females who were using tetracyclines or propionic acid derivatives. Disorders of development reported by mothers during phone interviews were associated with cephalosporin use during first 3 months of pregnancy, while miscarriages or abortions happened more often in women who used a tetracycline. Conclusions. Estimate of risk from congenital anomalies after use of drugs during pregnancy, which make clinical pharmacologists as part of their routine healthcare services, depends on amount of published data about previous experiences with specific drugs during the first 3 months of pregnancy. Key Words: pregnancy; drugs; risk of teratogenicity; risk estimat

Translation to Serbian, cultural adaptation, reliability testing and validation of the questionnaire estimating the fear of injections

Background/Aim. The two-part questionnaire called Injection Phobia Scale (IPS)-Anxiety and IPS-Avoidance represents one of the most commonly used questionnaires for assessing the fear of injections. The aim of the present study was to translate and culturally adapt this questionnaire from English into Serbian as well as to assess reliability and validity of the translation. Methods. The translation and cultural adaptation of the IPS–Anxiety and IPS–Avoidance was performed in accordance with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines. Reliability testing, factor analysis and validation of Serbian translation of IPS-Anxiety and IPS-Avoidance were carried out on a sample of 485 students of pharmacy, or medicine at the University of Kragujevac, Serbia. Results. Serbian translation of IPS-Anxiety and IPSAvoidance demonstrated high internal consistency with Cronbach’s alpha of 0.934 for IPS-Anxiety and 0.911 for IPS-Avoidance. Factor analysis of IPS-Anxiety showed that there are two domains, which we have called as Direct Experience (9 items) and Indirect Experience (9 items); factor analysis of IPS-Avoidance also pointed out on two domains referring to direct and indirect fear of injections. Female students scored higher on the scale showing more extensive injection phobia than male students. It is also interesting that students of pharmacy have higher level of injection phobia than students of medicine, and those students of the fifth year of study feel more fear of injections than students from the first four years. Conclusion. Serbian translation of IPS-Anxiety and IPS-Avoidance showed good psychometric properties on population consisted of students medicine and pharmacy. [Project of the Serbian Ministry of Education, Science and Technological Development, Grant no. 175007