Impact of Risk Communication on the Number of Pharmacovigilance ICSRs in Brazil

• Published in: Drug safety Vol. 45; no. 10; pp. 1220 - 1221
• Main Authors: Capucho, H, Rodrigues, J S, Silva, A S D N, Cardoso, A C S, Araujo, A C F D O G D, Cruz, F M, Gasparotto, F S, Siqueira, H N, Vidal, J S, Fleck, K, Silva, L A M, Ribeiro, L B, Araujo, N G A, Andrade, P A D A, Jube, T A
• Format: Journal Article
• Language: English
• Published: Auckland Springer Nature B.V 01.10.2022
• Subjects: Adverse events; Communication; Internet; Mass media; Medical personnel; Pharmacology; Pharmacovigilance; Risk communication; Websites; Brazil
• ISSN: 0114-5916; 1179-1942

Introduction: Since December 2018 the Brazilian Health Regulatory Agency (Anvisa) adopted the system VigiMed (Brazilian name given to VigiFlow), to receive the Individual Cases Safety Reposts (ICSRs). Since March 2021, it has intensified the implementation of risk communication strategies like the publication of alerts and notices, the promotion of online events open to the general public. Objective: Check whether the greater interest in pharmacovigilance topics on the internet and Anvisa's risk communication had an impact on the increase in ICSRs. Methods: This study where were compared the interest on the internet for searching the terms like "VigiMed", "report of adverse event", "how to report" and "adverse reaction" (terms in Portuguese) and the impact on the number ICSRs forwarded to the Agency, collected through Google Trends (terms), VigiMed (notifications) and Anvisa's website (risk communication actions). The study period was from 1st March to 15 June 2021. It was considered as an impact the increase of ICSRs above the average after up to 72 hours of the risk communication actions or interest in the terms related above. Results: After the 19 risk communication actions in the period evaluated, there were an increase in ICSRs in 15 (79%). In 13 actions, categorized as alerts and communications, an increase in reports from health professionals and pharmaceutical companies was identified. In the other two actions, consumers were the main reporters and seem to have been impacted by online open events and in interviews with mass media-the two actions that had the greatest impact. Looking at terms, 11 of the 12 peaks of interest for "VigiMed" coincided with 6 communication actions and resulted in an increase in notifications in 5 moments. Interest in the term "report of adverse event", improved after the publication of 3 alerts, but it did not affect the number of reports received. The term "how to report" was the most interesting in the period evaluated, with 25 peaks, which coincided with 18 risk communication actions and with 11 peaks of increased ICSRs. Conclusion: Despite being a preliminary study and with the possibility of bias from other actions such as the dissemination of objects related by the media, there is a coincidence between the interest of internet users in topics related to pharmacovigilance and the increase in ICSRs sent to the Anvisa. Another importance of the study is knowing the terms of interest can support the language to be used in risk communication.