Patients who report suspected adverse drug reactions (ADRs) help minimize drug safety risks and bolster the pharmacovigilance system. The aim of this study was to examine the contribution of patients to pharmacovigilance and compare the tools used to promote patient reporting in European countries that implemented this reporting type in 2012–2013. A web-based questionnaire was sent to the national competent authorities (NCAs) of the European countries. The received answers were systematized and compared using statistical analysis. The performed statistical analysis demonstrated that changes in the number of received ADR reports increased significantly in each country during the analyzed period. These changes were significantly different in Ireland and Finland from those in the other reviewed countries. The common source of information on direct patient reporting was the country’s NCA website. Other sources used were social media pages, leaflets, and posters. This is the first study on patient reporting schemes implemented after the significant reform of the European regulatory system for pharmacovigilance. However, some countries did not actively promote their patient reporting schemes. Our findings indicate that countries with minimal experience in pharmacovigilance systems that include direct patient reporting should organize comprehensive campaigns on ADR reporting.

Background: Despite the fact that for over ten years, Lithuanian consumers have been able to report adverse drug reactions (ADR) directly to the competent authority, reporting rates remain low. A comprehensive understanding of consumer perceptions and experiences regarding ADRs is needed to ascertain further factors impacting their engagement in ADR reporting. This study aimed to assess consumer knowledge of, attitude toward, and practice of reporting ADRs. Methods: A questionnaire-guided cross-sectional survey among 404 consumers between October 2021 and June 2022 was conducted. The semi-structured questionnaire comprised open-ended and closed-ended questions to explore the sociodemographic characteristics and general knowledge of ADRs and pharmacovigilance. Other question items evaluated attitudes toward ADR reporting and ADR reporting practice. The data were summarised using descriptive statistics, while the chi-square test was used to assess categorical variables at p < 0.05. The overall percent score in the knowledge and attitude domains was divided into groups of “poor”, “moderate”, and “good” knowledge, as well as “positive” and “negative” attitudes. Results: While having a generally poor understanding, this study demonstrates that Lithuanian consumers have a favourable attitude toward pharmacovigilance, particularly regarding issues involving the requirement for reporting. The data also revealed the justifications for reporting and not reporting ADRs. Conclusions: The current study provided the first understanding of consumer awareness and ADR reporting intentions, which can help to develop educational campaigns and interventions addressing pharmacovigilance and ADR reporting.

Direct patient reporting of adverse drug reactions (ADRs) is available in many countries, as patients are often knowledgeable about their health conditions and medicines. This study aimed to assess whether patients can recognize ADRs and whether they know how to proceed with ADR reporting. The study also assesses ADR information sources and the main barriers to reporting. Through the purposive and snowball sampling techniques, 42 consumers participated in focus group discussions. All discussions were audio recorded, transcribed verbatim, and analyzed for thematic content analysis. The thematic content analysis yielded four major themes: knowledge about medication safety, ADRs, and pharmacovigilance; information sources about medicines and ADRs; knowledge about ADR reporting; attitudes towards ADR reporting; benefits of ADR reporting; barriers to ADR reporting. Participants were able to identify ADRs and used different information sources about medicines and ADRs to confirm their beliefs. However, the poor communication between consumers, pharmacists, and physicians is the main barrier to ADR reporting. This study identified the challenges in relation to pharmacovigilance in Lithuania from patients’ perspectives. Our study indicated a lack of clearly set standards and communication guidelines between patients, physicians, and pharmacists. Active pharmacovigilance might help develop consumer habits regarding the reporting of ADRs in the presence of spontaneous pharmacovigilance.

Lithuania is the leader in pharmacovigilance among the three Baltic countries. However, comparisons with other European countries are difficult because the reported number of adverse drug reactions (ADRs) in Lithuania is too low to rely on in terms of the annual use of medicines by the population over the year. The aim of this study was to explore challenges related to the understanding and practices of general practitioners and community pharmacists in reporting ADRs in Lithuania. The qualitative study approach of face-to-face interviews was used. All interviews were recorded, transcribed verbatim, and thematically analyzed. Twelve interviews with general practitioners and community pharmacists were conducted from March 2020 through December 2020. All participants had a basic knowledge of pharmacovigilance, but only four participants reported ADRs to the interviewer. Six main barriers regarding ADR reporting were identified, and appropriate interventions were suggested. The importance of collaboration between physicians and pharmacists was highlighted, and the need for guidelines supporting collaboration was expressed. Medications are becoming more complex, and comprehensive medication management is key for the optimization of patient outcomes. Our results reveal the need to improve and innovate the current pharmacovigilance system at all levels, starting from education for pharmacy and healthcare students and continuing through the development of ADR procedures.

Background Spontaneous reporting of suspected adverse drug reactions (ADRs) by a patient is an important method in minimizing safety risks related to medicine use. Patients as reporters of suspected ADRs are valuable participants of pharmacovigilance system. The aim of this study to examine the contribution of the patients to pharmacovigilance in European countries that started patient reporting schemes in 2012-2013 and to compare different tools used by their authorities to promote patients’ reporting. Methods A web-based questionnaire was sent to the NCAs of the Europe countries. The received answers were systematized and compared with each other through meta-analysis. Pooled standardized mean difference (SMD) with 95% confidence interval (CI) was calculated in a random or fixed-effects model. Heterogeneity was determined using the Cochrane Q-Test. Results The performed meta-analysis demonstrates that the changes in the number of received ADR report over the analyzed period increased significantly in each country. The reported statistic from Ireland and Finland significantly differ from other reviewed countries. Personalized feedback is a part of the pharmacovigilance system in 5 (41,6%) countries. Only Finland and Ireland (16,6%) do not offer specific reporting forms to patients. The common source of information on direct patient reporting is the websites of NCAs. Other tools in use are information on social media pages, leaflets, posters, etc. Conclusions This is the first insight into patients reporting schemes implemented after the significant reform of the European regulatory system for pharmacovigilance. The statistical data received from the interviewed countries indicate that it is essential for countries with minimal experience in pharmacovigilance systems with direct patient reporting schemes to organize comprehensive campaigns on ADR reporting. However, some countries do not promote the patient’s reporting schemes actively, which implies that the patient reporting is considered as mandatory and not as a supporting tool for safer medicines to consumers.

Background Spontaneous reporting of suspected adverse drug reactions (ADRs) by a patient is an important method in minimizing safety risks related to medicine use. Patients as reporters of suspected ADRs are valuable participants of pharmacovigilance system. The aim of this study to examine the contribution of the patients to pharmacovigilance in European countries that started patient reporting schemes in 2012-2013 and to compare different tools used by their authorities to promote patients’ reporting.Methods A web-based questionnaire was sent to the NCAs of the Europe countries. The received answers were systematized and compared with each other through meta-analysis. Pooled standardized mean difference (SMD) with 95% confidence interval (CI) was calculated in a random or fixed-effects model. Heterogeneity was determined using the Cochrane Q-Test.Results The performed meta-analysis demonstrates that the changes in the number of received ADR report over the analyzed period increased significantly in each country. The reported statistic from Ireland and Finland significantly differ from other reviewed countries. Personalized feedback is a part of the pharmacovigilance system in 5 (41,6%) countries. Only Finland and Ireland (16,6%) do not offer specific reporting forms to patients. The common source of information on direct patient reporting is the websites of NCAs. Other tools in use are information on social media pages, leaflets, posters, etc.Conclusions This is the first insight into patients reporting schemes implemented after the significant reform of the European regulatory system for pharmacovigilance. The statistical data received from the interviewed countries indicate that it is essential for countries with minimal experience in pharmacovigilance systems with direct patient reporting schemes to organize comprehensive campaigns on ADR reporting. However, some countries do not promote the patient’s reporting schemes actively, which implies that the patient reporting is considered as mandatory and not as a supporting tool for safer medicines to consumers.