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Introduction: According to current understanding of the role of excipient in medicines, they could not be considered as completely pharmacologically inert substances. Although excipients do not have the potential to cause adverse drug reactions (ADRs) in most patients, some of their negative effects have been established. Special caution regarding excipients intake is advised, especially in vulnerable populations such as pediatric one. Aim: The aim of this paper was to investigate the exposure of children on antibiotic therapy to excipients with known effects (EKE). Methods: During a one-month period antibiotic prescriptions data were taken from community pharmacies in Novi Sad, Serbia. Age, diagnosis and prescribed therapy were observed. Data about qualitative content of prescribed medicines were taken from Summaries of Product Characteristics (SmPC) available at the official website of Medicines and medical devices agency of Serbia (ALIMS). Excipients were considered to be potentially harmful if they were listed in European Medicines Agency (EMA) guidelines. Results: The most commonly observed diagnosis was a respiratory infection, which affected more than 88% of children prescribed with an antibiotic. Only 5 out of 33 prescribed antibiotic formulations did not contain at least one EKE. Prescribed medicines mostly contained sodium compounds (77.78%), sucrose (34.07%) and sodium benzoate (31.11%). In addition, the following EKE were detected: propylene glycol, aspartame, sorbitol, lactose, potassium, mannitol, benzalkonium chloride, azorubine, parabens, sodium metabisulfite and sunset yellow. Around 75% of prescribed antibiotic formulations contained inappropriately labeled EKE (sodium and potassium compounds, sodium benzoate and propylene glycol). Additionally, inappropriately labeled information leaflets did not include possible adverse effects caused by the EKE. Conclusions: This paper indicates high exposure of patients to EKE, where almost all children treated with antibiotics (96.3%) were simultaneously administered at least one EKE. We confirmed that approved medicines cannot meet the treatment needs of all patients, and that inappropriately labeled medicines carry a risk of ADRs, especially in newborns. Personalized treatment is especially important in children, as the appropriate dosage forms and diversity in formulation ingredients is lacking. Knowing the type and roles of each ingredient of the medicines it is possible to formulate a preparation that will meet all the individual children's needs.

Introduction: Hypertension is a condition which represents one of the main risk factors for the development of cardiovascular diseases. High sodium intake contributes to occurrence of hypertension, increasing the volume of extracellular fluid. Therefore, World Health Organization (WHO) and other associations involved with hypertension research advise to decrease intake of sodium. Effervescent dosage forms usually contain high levels of sodium which could lead to above mentioned health issues. Aim: The aim of this study was to evaluate the levels of sodium in the effervescent dosage forms available in the Serbian drug market. Methods: Data about sodium levels, and excipients was obtained from Summary of Product Characteristics from website of Medicines and Medical Devices Agency of Serbia (ALIMS). Maximum daily doses recommended by the manufacturer and approved by ALIMS were observed. Exposure to sodium through consumption of maximum daily doses was calculated as percentages of the adequate daily intake given by Food and Nutrition Board (Institute of Medicine, National Academies, Washington D.C., USA), and also as percentage of recommended daily intake of sodium given by WHO. Results: There are five formulations with exposure to sodium through consumption of maximum daily doses higher than 100% of the adequate daily intake (2 g), all of which are effervescent tablet formulations. The highest exposure to sodium was found in effervescent tablets containing acetylsalycic acid (500 mg) as active pharmaceutical ingredient: 250.62 % for people aged 51 to 70 years; 271.50 % for people aged 70 and older. Conclusion: In effervescent dosage forms available on Serbian market, level of sodium can be very high, even up to 271.50% of adequate daily intake when maximum daily doses are consumed. Major cause for concern is for vascular patients who use effervescents for chronic therapy. This data should be considered during prescribing and dispensing this category of medicines as well as during analyzing pharmacovigilance.

Introduction: Antibiotic resistance is a growing problem. Adherence to national guidelines is one of the key factors necessary for the rational use of antibiotics. Aim: The aim of the study was to examine characteristics of antibiotic prescribing practice in primary health care in Novi Sad. Method: The analysis was designed as a descriptive, cross-sectional study based on the data obtained from the health institution Cvejić Pharmacy. The guidelines available to physicians at the time of prescribing were used to assess the compliance of the prescribed antibiotics with the guidelines. Additionally, the most frequently dispensed antibiotics for all diagnoses were recorded and results were expressed as a percentage of frequency of analyzed antibiotic prescriptions. Results: The study has shown that antibiotic prescriptions make 5.48% of all prescriptions (719 out of 13115), 513 (71.35%) of which were established by national guidelines, and 206 (28.65%) for less frequent diagnoses which was not included in national guidelines. In the study sample, 297 (65.42%) terapeutical regimes had adequate terapeutical dosage. The most commonly prescribed antibiotic groups were: macrolides (35.18%), penicillins (28.68%) and cephalosporins (14.60%). Conclusions: Irrational prescribing and dispensing of antibiotics is both national and global problem. It is necessary to pay close attention to antibiotics prescribing and dispensing. The focus should be on national guidelines and their extension.

Introduction: In addition to the active pharmaceutical ingredient (API), excipients and the pharmaceutical dosage form can also affect the overall effect of pharmacotherapy. Knowledge about these effects is not important only from the aspect of drug efficacy, but also from the aspect of pharmacovigilance. Materials and Methods: This paper presents secondary academic study results. Data on the dosage form and content of excipients were taken from SmPC documents on the official website of Medicines and Medical Devices Agency of Serbia. The presence of excipients with known effect (EKE) and their labeling was considered in accordance with the national and European regulations regarding this area. Results: We analyzed a total of 50 medicines for topical administration that are registered in Serbia. These all contained corticosteroids as API. Thirty-five (70 %) of them had one or more EKE. Creams had the highest number of different EKE per drug (3.25). Five out of seven identified EKE have the preservative function in formulations, which could be avoided by extemporaneous drug production. The labeling of these compounds was in accordance with the regulations in most drugs. Conclusions: The cause of an adverse drug reaction should be considered in a wider context and all the drug ingredients should be taken into account. In case of topical corticosteroids, over two third of drugs have the potential to cause adverse drug reactions that are non-API-related.