What Factors Make EU Regulators Want to Communicate Drug Safety Issues Related to SGLT2 Inhibitors? An Online Survey Study

Sonia Roldan Munoz, Douwe Postmus, Sieta T. Vries, Liana Gross-Martirosyan, Priya Bahri, Hans Hillege and Peter G. M. Mol ()
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Sonia Roldan Munoz: University of Groningen, University Medical Center Groningen
Douwe Postmus: University of Groningen, University Medical Center Groningen
Sieta T. Vries: University of Groningen, University Medical Center Groningen
Liana Gross-Martirosyan: Dutch Medicines Evaluation Board
Priya Bahri: European Medicines Agency
Hans Hillege: University of Groningen, University Medical Center Groningen
Peter G. M. Mol: University of Groningen, University Medical Center Groningen

Drug Safety, 2023, vol. 46, issue 3, No 2, 243-255

Abstract: Abstract Introduction Previous studies have found differences in the communication of safety issues among medicines regulatory agencies. Objectives To explore (1) to what extent regulators’ opinions regarding the need to communicate safety issues related to sodium-glucose cotransporter-2 (SGLT2) inhibitors might be influenced by their concern about the safety issue, and (2) whether regulators’ concerns might be influenced by certain characteristics of the safety issue or by the demographic and professional characteristics and attitudes of the regulators. Methods An online cross-sectional survey study with a rating-based conjoint analysis among clinical and pharmacovigilance assessors from the EU regulatory network was performed between April and June 2021. Regulators were invited by email, and participants were asked about their level of concern and their opinion regarding the need to communicate about 12 scenarios defined by four characteristics: adverse drug reaction, source of information, causality, and frequency. The outcomes for the first objective were to update the summary of product characteristics (SmPC; yes/no) and to send direct healthcare professional communications (DHPC; yes/no). The determinant was regulators’ level of concern (range 0–100%). The outcome of the second objective was regulators’ level of concern, and the determinants were the characteristics of the safety issue, demographic and professional characteristics, and attitudes of the regulators (beliefs about medicines and risk perception). Results A total of 222 regulators completed the survey (64% women; mean age 46 ± 10 years). Depending on the scenario, 54–94% and 25–74% of the participants would update the SmPC or send a DHPC, respectively. The participants’ level of concern influenced their opinions regarding the need to update the SmPC and send a DHPC (odds ratio (OR) 13.0; 95% confidence interval (CI) 7.8–21.7 and OR 13.6; 95% CI 9.5–19.2, respectively, for every 10% increase in the level of concern). All characteristics of the safety issue influenced the level of concern. Younger participants, women, and those working for Eastern European agencies had a higher level of concern than older participants, men, and those working in other regions. Beliefs about medicines and general risk perception also influenced their concern. Conclusions The opinion regarding the need to communicate safety issues was influenced by the concern of regulators. Regulators’ concern was influenced by the characteristics of the safety issue, demographic characteristics, and attitudes. Diverse groups of experts regarding such factors would ensure that various views are incorporated in risk communication decisions.

Date: 2023
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DOI: 10.1007/s40264-022-01270-4

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