Improving the Safety of Medicines via Digital Technology: An Assessment of the Scope and Quality of Risk Minimization Websites in the United States and United Kingdom

Meredith Y. Smith (), Sarah Frise, Jane Feron and Ryan Marshall
Additional contact information
Meredith Y. Smith: Alexion AstraZeneca Rare Disease
Sarah Frise: AstraZeneca
Jane Feron: AstraZeneca
Ryan Marshall: AstraZeneca

Drug Safety, 2022, vol. 45, issue 3, No 5, 259-274

Abstract: Abstract Introduction EHealth holds tremendous promise for enhancing drug safety initiatives known as risk minimization programs. Little is known, however, regarding the scope and quality of existing risk minimization websites. Methods Two publicly accessible repositories, REMS@FDA [1] and Electronic Medicines Compendium [2], were reviewed to identify all regulatorily approved risk minimization programs in the United States (US) and United Kingdom (UK) with websites. Website quality was evaluated using the Enlight Quality Assessment tool, a psychometrically validated instrument that addresses seven quality domains. Results Ninety-three websites were identified: 59 for healthcare professionals (7 UK/52 US), and 34 for patients (5 UK/29 US). The websites functioned chiefly as archives for electronic copies of educational materials; a subset (31/93) had additional features. Mean quality ratings for Usability (mean 4.70, SD 0.59), Visual Design (mean 4.03, SD 0.87) and Content (mean 4.31, SD 0.82) were good. General Subjective Evaluation was fair (mean 3.15, SD 1.21). Mean scores for Therapeutic Alliance and Therapeutic Persuasiveness were poor (mean 2.62, SD 1.47; and mean 2.50, SD 1.48, respectively); those for User Engagement were very poor (mean 2.25, SD 1.03). No differences were found by target audience but several were identified based on region. Conclusions Risk minimization websites are easy to navigate and well organized. Few, however, incorporate eHealth design elements that facilitate user engagement, build therapeutic alliance and exert therapeutic persuasiveness. Such elements can enhance program uptake and effectiveness. Results highlight opportunities for improving the quality of risk minimization websites and their ability to bridge pharmaceutical and healthcare systems.

Date: 2022
References: View complete reference list from CitEc
Citations:

Downloads: (external link)
http://link.springer.com/10.1007/s40264-022-01165-4 Abstract (text/html)
Access to the full text of the articles in this series is restricted.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:spr:drugsa:v:45:y:2022:i:3:d:10.1007_s40264-022-01165-4

Ordering information: This journal article can be ordered from
http://www.springer.com/adis/journal/40264

DOI: 10.1007/s40264-022-01165-4

Access Statistics for this article

Drug Safety is currently edited by Nitin Joshi

More articles in Drug Safety from Springer
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().