| Abstract [eng] |
Master‘s thesis of Ugnė Lingytė, supervisor assistant dr. Tomas Janušonis, Vilnius University, Faculty of Medicine, Institute of Biomedical Sciences, Center of Pharmacy and Pharmacology. Title of the thesis: Analysis of Paracetamol Safety Information Aim: to assess the differences in safety information in the summaries of product characteristics of different paracetamol medicinal products registered in Lithuania, and to assess the knowledge of pharmacy specialists and pharmacy students about the safety of paracetamol and compare it with the summaries of product characteristics data. Objectives: 1. To assess the differences in safety data of the summaries of product characteristics of paracetamol products registered in Lithuania. 2. To assess the knowledge of pharmacy specialists and pharmacy students about the safety of paracetamol. Methods: During the study, a quantitative survey was conducted (145 respondents), and summaries of product characteristics of paracetamol were taken from the Lithuanian State Medicines Control Agency and analyzed. The survey questions were based on summaries of product characteristics. The questionnaire was shared with the pharmacy specialists and students via work e-mail, social media, and private messages. Data collection took place from December 10th, 2025, to February 16th, 2026. Statistical analysis was performed using R Commander software. Results: In the first part of the study, the summaries of product characteristics of 9 paracetamol medicinal products were analyzed and compared. The information provided in the summaries of product characteristics was not identical, the most significant differences in information were observed in contraindications, special warnings and precautions, and interactions with other medicinal products. In the second part of the study, the knowledge of pharmacists and pharmacy students about paracetamol safety information was analyzed. The answers differed the most when respondents were asked about the use of paracetamol in liver failure, 63,8 % (n= 67) of pharmacy specialists answered positively, while only 12,5 % (n=5) of pharmacy students answered the same, but only one of the analyzed summaries of product characteristics (Paracetamol LIVSANE) did not indicate liver failure as a contraindication. The maximum permissible daily dose of paracetamol was 4 grams, noted by 95,2 % (n= 100) of pharmacy specialists and 85 % (n= 34) of pharmacy students, but only four out of nine summaries of product characteristics mentioned such a dose (4 grams). Conclusions: 1. After evaluating the summaries of product characteristics of paracetamol preparations registered in Lithuania, it can be stated that there are many differences between the information provided, including important information for safety, such as dosage, contraindications, special warnings and precautions, interactions with other medicinal products, use during pregnancy and lactation, and adverse reactions. Such differences may negatively affect the pharmaceutical services provided by pharmacy specialists and influence treatment effectiveness and patient safety. 2. After assessing the knowledge of pharmacy specialists and pharmacy students of paracetamol safety, the results showed that pharmacy specialists have more knowledge about paracetamol safety information than students. After comparing the summaries of product characteristics of paracetamol with the knowledge of pharmacy specialists and pharmacy students, it was found that the knowledge of respondents about paracetamol safety information only partially aligns with the information provided in the summaries of product characteristics. |
