Effectiveness Evaluation of Additional Risk Minimization Measures for Adolescent Use of Aripiprazole in the European Union: Results from a Post-Authorization Safety Study
| Autor: | Timothy Peters-Strickland, Antonia Coppin-Renz, Uli Geis, Mirza Rahman, Wally Landsberg, Imad Al-Dakkak, Emiel van Heumen |
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| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Male
medicine.medical_specialty Risk management plan Bipolar Disorder Adolescent Health Personnel education Aripiprazole MARKETING AUTHORIZATION HOLDER Toxicology 030226 pharmacology & pharmacy Risk Assessment 03 medical and health sciences 0302 clinical medicine medicine Product Surveillance Postmarketing media_common.cataloged_instance Humans Pharmacology (medical) 030212 general & internal medicine Original Research Article European Union European union media_common Pharmacology Response rate (survey) business.industry Frequently asked questions Authorization Cross-Sectional Studies Family medicine Female medicine.symptom business Mania medicine.drug Antipsychotic Agents |
| Zdroj: | Drug Safety |
| ISSN: | 1179-1942 0114-5916 |
| Popis: | 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. Electronic supplementary material The online version of this article (10.1007/s40264-018-0662-2) contains supplementary material, which is available to authorized users. |
| Databáze: | OpenAIRE |
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