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- Title
Survey of Hospital Pharmacist's Opinions Regarding Information Provision on Regenerative Medicine Products.
- Authors
Keisuke Saso; Chiyomi Okamoto; Naoki Yoshikawa; Yuichiro Kurone; Naoto Hirata; Sadahiko Shimoeda
- Abstract
Regenerative medicine products share important characteristics with pharmaceuticals and medical devices. We hypothesized that information should be provided to reflect the characteristics of regenerative medicine products. As they are a new style of product, there are few medical provider-focused surveys on regenerative medicine products. We conducted an efficacy survey, evaluating whether the regenerative medicine package insert meets the informational needs of those in the clinical field. Hospital pharmacists were the target survey group. The survey asked about the importance of each item of information in the package insert, the importance of the specific information included in the package insert, and the degree to which desirable information is not included in the package insert. The format of the survey was based on a five-point scale of importance. In a survey of the specific information contained in Kymriah's package insert, more than 50% of respondents rated all the information covered in the survey as important. However, some information currently not included in the package insert also had a high importance rating. The results of the survey indicated that the current information provided in the regenerative medicine product package inserts is important. However, respondents indicated additional information was required. Information provided during the approval review process is not adequately provided to clinical practice. As the package insert already contains a large amount of important information, it is proposed that package insert creation is improved by developing Optimal Clinical Use Guidelines, to systematically incorporate approval review process information and supplement the package insert information.
- Subjects
HOSPITAL surveys; REGENERATIVE medicine; PHARMACISTS; MEDICAL equipment
- Publication
Pharmacometrics / Ōyō Yakuri (0300-8533), 2023, Vol 105, Issue 3/4, p69
- ISSN
0300-8533
- Publication type
Article