Trust in local media and information they share during the Covid-19 pandemic: Belgrade example

The analysis of the relevant literature, especially earlier empirical research of serious pandemics (not including the forces of nature and the processes they create), refers to the assumption that man is (directly or indirectly) guilty of them. Given that the media transmits information related to the intensity of the spread of the pandemic, the death rate of the sick, etc., a survey of citizens' trust in the local media and the information they convey was conducted in order to find out how much the media contribute to the intensity of the spread of the negative effects of the Covid 19 pandemic. Four assumptions were defined as questions to which respondents' answers were requested: frequency of information through different types of media;assessment of the extent to which different types of media offer the possibility of objective information;the existence of free, independent and impartial media in Serbia, and finding the truth in the media. The research is of a quantitative type, conducted on a sample of 600 respondents in the city of Belgrade. For the collection and processing of data used the desk method, using interviews and via electronic questionnaires, in which the questions in the first part related to the socio-demographic variables of the respondents, while in the second part the group of dependent variables was operationalized through the statements, which were evaluated on a Likert scale. More sub-questions are offered within the four main questions. Descriptive statistical analysis (percentages, arithmetic mean), T-test, One-factor analysis of variance, Standard deviation, Multiple regression analysis and Pearson's correlation coefficient were used for data analysis. The level of statistical significance was set at p<0.05, and all obtained data were processed in the SPSS program, version 23. © 2022 University of Craiova, Faculty of Social Sciences, Department of Geography. All rights reserved.

First Patient Reports in Montenegro

Introduction: In August 2020, the new Law on Medicines was adopted in Montenegro, which for the first time allows patients to report suspected adverse drug reactions (ADRs) directly to the Institute for Medicines and Medical Devices (CInMED) [1]. According to the experience of many countries, patient reports are an important source of information on the safety of medicines [2, 3, 4]. Objective(s): Analyze reports submitted to CInMED by patients Methods: A retrospective analysis of reports submitted by patients from August 2020 to May 2022 was performed. Reported ADRs were coded using the appropriate Lowest Level Term (LLT) of the Med- DRA. Results were analised at MedDRA Preferred Term (PT) level. Important Medical Events (IME) list was used in assessing seriousness of cases. Descriptive statistics were used. Result(s): All reports submitted by patients were valid. In the mentioned period, patients submitted 45 reports, which contained 200 reactions (4.4 reactions per report). Of these, 40 reports (88.9%) were related to adverse events following immunization (AEFIs) with COVID-19 vaccines. This represents 9.1% of the total number of reported AEFIs for COVID-19 vaccines in Montenegro. The majority of patient reports (32;71.1%) were submitted via the eReporting module for VigiFlow [5]. Women submitted 28 (62.2%) reports, and men 17 (37.8%). Reports were mostly submitted by adult patients, 18-64 years old (34;75.5%). A total of 8 (17.8%) reports described serious adverse reactions. In 14 (31.1%) cases, a follow-up request was made and patients provided additional information. Although the majority of reported adverse reactions were expected, 72 of 176 (40.9%) reactions to COVID-19 vaccines reported by patients were unexpected-not listed in the relevant Summary of Product Characteristics at the time of reporting (e.g. chest pain, chest discomfort, arrhythmia, face oedema, hypoaesthesia, musculoskeletal stiffness, pain in extremity). Conclusion(s): Patient reports are of good quality. Patients prefer the electronic way of reporting and are willing to answer follow-up inquiries. Patient reports are valuable source of new information on the safety of medicines and can be precious for signal detection, especially when it comes to new medicines. Further promotion of patient reporting and cooperation with patient associations are needed to increase the number of patient reports.

First Patient Reports in Montenegro: An International Journal of Medical Toxicology and Drug Experience

Introduction: In August 2020, the new Law on Medicines was adopted in Montenegro, which for the first time allows patients to report suspected adverse drug reactions (ADRs) directly to the Institute for Medicines and Medical Devices (CInMED) [1]. According to the experience of many countries, patient reports are an important source of information on the safety of medicines [2, 3, 4]. Objective: Analyze reports submitted to CInMED by patients Methods: A retrospective analysis of reports submitted by patients from August 2020 to May 2022 was performed. Reported ADRs were coded using the appropriate Lowest Level Term (LLT) of the MedDRA. Results were analised at MedDRA Preferred Term (PT) level. Important Medical Events (IME) list was used in assessing seriousness of cases. Descriptive statistics were used. Results: All reports submitted by patients were valid. In the mentioned period, patients submitted 45 reports, which contained 200 reactions (4.4 reactions per report). Of these, 40 reports (88.9%) were related to adverse events following immunization (AEFIs) with COVID-19 vaccines. This represents 9.1% of the total number of reported AEFIs for COVID-19 vaccines in Montenegro. The majority of patient reports (32;71.1%) were submitted via the eReporting module for VigiFlow [5]. Women submitted 28 (62.2%) reports, and men 17 (37.8%). Reports were mostly submitted by adult patients, 18-64 years old (34;75.5%). A total of 8 (17.8%) reports described serious adverse reactions. In 14 (31.1%) cases, a follow-up request was made and patients provided additional information. Although the majority of reported adverse reactions were expected, 72 of 176 (40.9%) reactions to COVID-19 vaccines reported by patients were unexpected-not listed in the relevant Summary of Product Characteristics at the time of reporting (e.g. chest pain, chest discomfort, arrhythmia, face oedema, hypoaesthesia, musculoskeletal stiffness, pain in extremity). Conclusion: Patient reports are of good quality. Patients prefer the electronic way of reporting and are willing to answer follow-up inquiries. Patient reports are valuable source of new information on the safety of medicines and can be precious for signal detection, especially when it comes to new medicines. Further promotion of patient reporting and cooperation with patient associations are needed to increase the number of patient reports.

Possible association between COVID-19-caused stress and periodontal health – a pilot study

Introduction/Objective Stress is proposed as one of the risk factors linked to periodontal disease. The COVID-19 pandemic has a significant negative impact in population on mental and somatic health. This study aimed to examine the possible association between COVID-19 resultant stress and periodontal health. Methods An observational pilot study was conducted from March 2020 to October 2021 and included 202 participants. Participants graded their stress level using the Perceived Stress Scale (PSS). Periodontal Disease Index and Clinical Attachment Level were determined. Participants were categorized into following groups: Ia (low stress), IIa (moderate stress), IIIa (high stress) and Ib (healthy parodontium), IIb (mild periodontal disease), IIIb (severe periodontal disease). The cause/effect relationship between stress and health was measured. Results The results indicated a statistically significant difference between the groups classified accord-ing to the stress level concerning values of all the measured parameters. The Poisson regression analysis showed that in both models, crude and adjusted, periodontal health-related covariables were higher in subjects perceiving greater stress (Periodontal Disease Index – Pradjusted = 1.042, 95% CI [1.030–1.055] and Clinical Attachment Level – PRadjusted = 1.108, 95% CI [1.094–1.122]). Conslusion During COVID-19 pandemic increased stress has a negative impact on mental health and may result in the deterioration of the entire oral cavity’s health, including the periodontium. © 2022, Serbia Medical Society. All rights reserved.

Spontaneously Reported Adverse Events Following Immunisation with Sputnik V Vaccine in Montenegro: An International Journal of Medical Toxicology and Drug Experience

Background/Introduction: Sputnik V (Gam-Covid-Vac, Gamaleya Research Institute of Epidemiology and Microbiology) was the first vaccine against Covid-19 available in Montenegro [1]. The vaccine was not registered in Montenegro, but it was imported in line with the Government's decision on medicines supply during the pandemic. In February and March 2021, 7000 doses of the Gam-Covid-Vac Component I and 7000 doses of the Gam-Covid-Vac Component II were imported. Objective/Aim: To assess safety profile of the vaccine. Methods: All Adverse Events Following Immunisation (AEFIs) related to Sputnik V received by CInMED until 15 June 2021 were coded using appropriate Lowest Level Term of the MedDRA (version 24.0) and analysed. Results are presented at MedDRA Preferred Term (PT) level. Follow-up information was requested as needed for the sake of clarification and obtaining data on the outcome. Descriptive statistics were used. Results: In total, 218 reports describing 746 adverse reactions were received. Majority were reported by physicians (215;98.6%). One case (0.5%) was reported by a pharmacist, and two by patients (0.9%). Only 7 (3.2%) reports were related to older patients (C 65 years), while in one case (0.5%) age was not reported. Four cases were assessed as Important Medical Events;no other serious cases were recorded. Out of the 218 reports, 188 described 636 reactions related to Gam- Covid-Vac Component I (27 reports per 1000 imported doses) and 30 described 110 reactions related to GamCovid-Vac Component II (4 reports per 1000 imported doses). Majority of reports concerning both Component I (147;78.2%) and Component II (23;76.7%) related to female patients. Most of the 188 reports received for Component I described reactions related to General disorders and administration site conditions (178;94.7%);Musculoskeletal and connective tissue disorders (84;44.7%), and Nervous system disorders (68;36.2%). The most frequently reported reactions for Component I are presented in Table. Similar distribution was noted for Component II. The number of linked cases describing AEFIs reported for the same patient after Component I and Component II was 18. Conclusion: No signal detected. No safety concerns raised based on spontaneously reported AEFIs. The most frequently reported AEFIs were in line with the available information on the safety profile of the Sputnik V vaccine [2, 3] and similar to those identified with other anti Covid-19 vaccines [4, 5]. Due to small number of doses only frequent AEFIs could be detected.