Factors associated with hematological adverse reactions of drugs authorized via the centralized procedure.

Serious hematological adverse drug reactions (HADRs) may lead to or prolong hospitalization and even cause death. The aim of this study was to determine the regulatory factors associated with HADRs caused by drugs that were authorized up to July 2023 by the European Medicines Agency (EMA) and to evaluate the frequency of HADRs. Using a cross-sectional approach, the type and frequency of HADRs were collected from the Summaries of Product Characteristics of Drugs Authorized by the EMA and analyzed within proprietary, nonproprietary, and biosimilar/biological frameworks. Multivariate statistical analysis was used to investigate the associations of generic status, biosimilar status, conditional approval, exceptional circumstances, accelerated assessment, orphan drug status, years on the market, administration route, and inclusion on the Essential Medicines List (EML) with HADRs. In total, 54.78% of proprietary drugs were associated with HADRs at any frequency, while anemia, leucopenia, and thrombocytopenia were observed in approximately 36% of the patients. The predictors of any HADR, anemia, and thrombocytopenia of any frequency are generic status, biosimilar status, and inclusion on the EML, while the only protective factor is the administration route. Biosimilars and their originator biologicals have similar frequencies of HADRs; the only exception is somatropin. Knowledge of the regulatory factors associated with HADRs could help clinicians address monitoring issues when new drugs are introduced for the treatment of patients.

Undiagnosed Hyperglycaemia and Hypertension as Indicators of the Various Risk Factors of Future Cardiovascular Disease Among Population of Serbian Students.

BACKGROUND: A number of risk behaviours, such as smoking, overweight, excessive alcohol intake, insufficient physical activity, excessive and frequent intake of salt, reduced fruit and vegetable intake, increased fat intake, which constitute living habits of an individual can influence the occurrence of hypertension and hyperglycaemia. The changing of these lifestyles can reduce the risk of developing prehypertension and prediabetes. METHODS: The survey was conducted at student's campuses. The respondents were subjected to the height, weight, blood glucose and blood pressure. Respondents filled in previously created questionnaire that was approved by the Ethics Committee for Biomedical Research Faculty of Pharmacy, University of Belgrade. RESULTS: The percentage of respondents with a glucose value above the reference value was 14.6% (n=19), 2.4% (n=3) had values greater than 7 mmol/L without being diagnosed with diabetes, and accordingly, 2.4% (n=3) had elevated HbA1c values (above 42 mmol/mol or 6.0%). The percentage of respondents with elevated systolic and diastolic blood pressure was 14.9% and 7.4% respectively. Regarding calculated risk scores, they showed parallel increase with increas-ing of BMI (HPS), systolic and diastolic pressure (OHS), and glucose concentration (OPS). CONCLUSIONS: When analysing all the factors that could cause the later development of diabetes, which is associated with hypertension as well, it is observed that the student population is very much exposed to those factors. The results of this study cannot be representative for the general population of students, but they can provide recommendations for further research.

Seventy Years of Biochemical Subjects' Development in Pharmacy Curricula: Experience from Serbia.

INTRODUCTION: The pharmacists played an important role in the development of biochemistry as applied chemistry in Serbia. What is more, the first seven state chemists in Serbia were pharmacists. State chemists performed the chemical-toxicological analysis as well as some medical and biochemical ones. When it comes to the education of medical biochemists as health workers, the period after the beginning of the second half of the twentieth century should be taken into account because that is when the training of pharmaceutical staff of the Faculty of Pharmacy, University of Belgrade, begins on the territory of Serbia. This paper presents the development of medical biochemistry through the development of curriculum, personnel and literature since the foundation of the Faculty of Pharmacy in Serbia until today. OBJECTIVE: The aim of this paper is to present the historical development of biochemistry at the Faculty of Pharmacy, University of Belgrade, through analysis of three indicators: undergraduate and postgraduate education of medical biochemists, teaching literature and professional associations and trade associations. METHOD: The method of direct data was applied in this paper. Also, desktop analysis was used for analyzing of secondary data, regulations, curricula, documents and bibliographic material. Desktop research was conducted and based on the following sources: Archives of the University of Belgrade-Faculty of Pharmacy, Museum of the History of Pharmacy at the University of Belgrade-Faculty of Pharmacy, the Society of Medical Biochemists of Serbia and the Serbian Chamber of Biochemists. RESULTS AND CONCLUSION: The curricula, the Bologna process of improving education, the expansion of the range of subjects, the number of students, professional literature for teaching biochemistry, as well as professional associations and trade associations are presented through the results.

[Analysis of regulatory-ethical framework of clinical trials].

INTRODUCTION: Every clinical trial has to meet all ethical criteria in addition to the scientific ones. The basic ethical principles in the clinical trials are the following: nonmaleficence, beneficence, respect for autonomy and the principle of justice. OBJECTIVE: The aim of the study was to analyse clinical cases with the outcomes leading to the changes in regulatory-ethical framework related to the clinical trials, as well as the outcomes of key clinical trials that influenced the introduction of the ethical principles into clinical trials. METHODS: This was a descriptive research (methods of analysis and documentation; desk analysis of the secondary data). RESULTS: By analysing the cases from the secondary sources as well as clinical and ethical outcomes, it may be noticed that the codes, declarations and regulations have been often preceded by certain events that caused their adoption. Moral concern and public awareness of the ethical issues have initiated not only the development of numerous guidelines, codes, and declarations, but also their incorporation into the legislative acts. CONCLUSION: It is desirable that ethical instruments become legally binding documents, because only in this way will be possible to control all phases of the clinical trials and prevent abuse of the respondents.