(235) What Makes EU Regulators Want to Communicate About Drug Safety Signals: Results from An Online Survey Study

Sunday, August 28, 2022

8:00 AM – 1:45 PM CEST

Location: Hall C

Publication Number: 1280

Presenting Author(s)

Sonia Roldan
– University Medical Center Groningen, Groningen, Groningen, Netherlands

Co-Author(s)

Douwe Postmus
– Department of Epidemiology, University Medical Center Groningen, Groningen, The Netherlands, Netherlands
Sieta de Vries
– Department of Clinical Pharmacy and Pharmacology, University Medical Centre Groningen, Groningen, The Netherlands, Netherlands
Hans Hillege
– Department of Epidemiology, University Medical Center Groningen, Groningen, The Netherlands, Netherlands
Peter Mol, PharmD, PhD
– University Medical Center Groningen, Assen, Drenthe, Netherlands

Background: Regulators frequently communicate about new safety issues by updating the summary of product characteristics (SmPC) and by sending direct healthcare professional communications (DHPCs). While they assess the same scientific information when evaluating the safety issues, previous studies have shown differences in the communication of such issues across agencies.

Objectives: This study aimed to assess to what extent 1) the communication of safety issues related to sodium-glucose cotransporter-2 (SGLT-2) inhibitors is influenced by regulators’ concern about the safety issue, and 2) their concern is influenced by characteristics of the safety issue, personal and professional characteristics, and attitudes.

Methods: We conducted an online cross-sectional survey study with a rating-based conjoint analysis. European regulators were presented with 12 safety issues described by four characteristics: safety issue, source of information, causality, and frequency. Regulators’ were asked about their level of concern and their opinion on the need to communicate for each of the safety issues. For the first aim, the outcomes were updating the SmPC (Yes/No) and sending a DHPC (Yes/No) and the determinant was regulators’ level of concern (visual scale 0-100%). The outcome of the second aim was regulators’ concern, and the determinants were the characteristics of the safety issue, personal and professional characteristics (i.e., gender, age, country, and experience in pharmacovigilance or endocrinology), and attitudes (i.e. medicines beliefs, and risk perception).

Results: A total of 222 regulators completed the survey (64% women; mean age 46±10 years). Regulators’ level of concern influenced their opinion on the need of updating the SmPC and sending a DHPC (OR 13.0 95%CI 7.8–21.7 and OR 13.6 95%CI 9.5–9.2, respectively, for every 10% increase in the level of concern). All characteristics of the safety issue as well as regulators’ gender, age, country, medicines beliefs, and general risk perception had an influence on their concern.

Conclusions: Regulators’ concern for safety issues is influenced by scientific evidence as well as personal characteristics and attitudes. Diverse groups of experts regarding such factors would ensure that various perspectives are incorporated in risk communication decision-making.