Effectiveness Evaluation of Additional Risk Minimization Measures for Adolescent Use of Aripiprazole in the European Union: Results from a Post-Authorization Safety Study

Wally Landsberg (), Imad Al-Dakkak, Antonia Coppin-Renz, Uli Geis, Timothy Peters-Strickland, Emiel Heumen and Mirza Rahman
Additional contact information
Wally Landsberg: Otsuka Europe Development and Commercialization Ltd.
Imad Al-Dakkak: Pope Woodhead & Associates Ltd.
Antonia Coppin-Renz: Otsuka Europe Development and Commercialization Ltd.
Uli Geis: Otsuka Europe Development and Commercialization Ltd.
Timothy Peters-Strickland: Otsuka Pharmaceutical Development and Commercialization Inc.
Emiel Heumen: Otsuka Europe Development and Commercialization Ltd.
Mirza Rahman: Otsuka Pharmaceutical Development and Commercialization Inc.

Drug Safety, 2018, vol. 41, issue 8, No 8, 797-806

Abstract: Abstract Introduction Two risk minimization (RM) tools—a healthcare professional frequently asked questions (HCP-FAQs) brochure and a patient/caregiver information brochure (PCIB)—were developed for HCPs and for adolescents (aged ≥ 13 years) receiving aripiprazole for bipolar I mania and their caregivers. Objectives This study evaluated the effectiveness of these RM tools in improving the awareness and education of HCPs and patients/caregivers. Method The RM tools were distributed to HCPs (identified in agreement with the marketing authorization holder [MAH] and local regulatory authorities), who in turn distributed the PCIBs to patients/caregivers. A web-based survey was then conducted targeting HCPs and patients/caregivers. Results The response rate was low: 118 of 23,282 invited HCPs and 16 patients/caregivers completed the survey. Overall, 42% (49/118) of HCP respondents were aware of aripiprazole RM tools; of these, 59% (29/49) of HCPs read them at least once and 66% (19/29) of these used the RM tools while discussing the benefit–risk profile of aripiprazole with patients/caregivers. In total, 30 of the 118 HCPs (25%) were aware of the PCIB, and 26 distributed it to their patients/caregivers, whereas seven HCPs advised them to read the brochure. Overall, 15 of the 16 patients/caregivers were aware of the PCIB, and 13 read/referred to it. Of these, 12 found the PCIB useful, and five monitored their weight while receiving aripiprazole and reported potential risks immediately to their HCP. Conclusion The response rate to the survey was low, and the tools displayed limited utility and effectiveness in improving awareness and education in a small number of responders. Therefore, the aripiprazole risk management plan was amended, and the tools were discontinued.

Date: 2018
References: View complete reference list from CitEc
Citations: View citations in EconPapers (2)

Downloads: (external link)
http://link.springer.com/10.1007/s40264-018-0662-2 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:41:y:2018:i:8:d:10.1007_s40264-018-0662-2

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

DOI: 10.1007/s40264-018-0662-2

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 ().