A cross‐sectional survey to evaluate prescribers' knowledge and understanding of safety messages following Dengvaxia® product information update. Issue 7 (13th May 2022)

• Record Type: Journal Article
• Authors: Almas, Mariana F.; Toussi, Massoud; Valero, Elisa; Moureau, Annick; Marcelon, Lydie
• Is Part Of: Pharmacoepidemiology and drug safety. Volume 31:Issue 7(2022)
• Page Start: 758
• Page End: 768
• Publication Date: 2022-05-13
• Subjects: dengue -- Dengvaxia -- post‐authorisation safety study -- prescribing behaviour -- risk minimisation measures -- vaccine; Pharmacoepidemiology -- Periodicals; Chemotherapy -- Periodicals; Epidemiology -- Periodicals; 615.705
• DOI: 10.1002/pds.5447
• Languages: English
• ISSNs: 1053-8569

Abstract

Abstract: Purpose: We evaluated the effectiveness of additional risk minimisation measures (aRMMs; i.e., educational materials) distributed to prescribers to ensure that only individuals with evidence of prior dengue infection (PDI, i.e., dengue seropositive) would be vaccinated with the tetravalent dengue vaccine (CYD‐TDV; Dengvaxia®). Methods: A survey was conducted in 2020 among 300 CYD‐TDV prescribers in Brazil and Thailand to ascertain three success criteria: prescribers' awareness of the materials (receiving and reading them); knowledge of the key messages; and whether their self‐reported behaviour regarding practice‐related scenarios was aligned with the updated guidance. Results: The aRMMs were not generally effective as <80% of prescribers in both countries met two of the three predefined success criteria. In Brazil, 98.7% were aware of the aRMMs whereas in Thailand this criterion was fulfilled by 74.0%. Almost all prescribers knew that CYD‐TDV was recommended only in individuals with PDI (98.7% and 96.7% in Brazil and Thailand, respectively). In Brazil, where vaccination was restricted to those with a documented history of PDI, 11.3% considered that confirmation should be done through a blood test. More than 75% in both countries considered additional signs of dengue, as early warning signs, and not only those regarded as such by the 2009 WHO guidelines. Conclusions: These results do not support that the aRMMs were effective as the predefined success criteria were not met. The use of reliable rapid diagnosis tests together with the revised prescribing information and educational materials will facilitate the implementation and compliance with pre‐vaccination screening for CYD‐TDV eligibility.