|
KMID : 1142220200150010065
|
|
Regulatory Research on Food, Drug & Cosmetic
2020 Volume.15 No. 1 p.65 ~ p.80
|
|
|
A Comparative Analysis of International Labeling Regulations Governing Package Inserts for Prescription Medicines
|
|
Yang Jin-Wook
Kwon Kyeng-Hee
|
|
|
Abstract
|
|
|
|
The package insert, a document that contains the information necessary for the safe and effective use of medicine, is enclosed in the product packaging and delivered to users such as health care professionals and patients. However, the current package insert has low readability and usability due to its difficult content and complex structure. Furthermore, some package inserts attached to the prescription medicines may not be delivered to patients due to domestic practices. As the usefulness of the package insert is still questionable, it is necessary to analyze whether the regulations related to package inserts in Korea are appropriate from an regulatory point of view. In this study, the regulations related to package inserts in Korea, USA, Europe, Australia and Canada were compared and analyzed based on legislation, target audience and content. As a result, all the investigated countries except Korea classified the target audience for package inserts for health care professionals and patients, and the content and format of the package insert varied. In addition, the package inserts were organized systematically to provide key information relevant for each target audience in an easy-to-find structure. In order to increase the utilization and convenience of package inserts for prescription drugs in Korea, package inserts should be designed to target health care professionals and patients separately. In particular, the regulatory framework should ensure readability of package inserts using evaluation tools such as user testing procedures. In addition, it is necessary to strengthen the specificity and standards for preparation of package inserts and to systematically compensate for any clinical limitations preventing access to them by some patients. A user-friendly labeling system can be implemented based on the supply of comprehensive regulations governing package inserts and participation of all stakeholders, such as regulators, pharmaceutical companies, health care professionals and consumers.
|
|
|
KEYWORD
|
|
|
prescription medicines, package insert, labeling, readability
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|
|