一般用医薬品の外箱への表示および添付文書への記載内容における理解しやすさ・行動しやすさの評価に関する研究

抄録

This study aimed to evaluate the understandability and actionability of information in the outer package labeling and package inserts of over-the-counter (OTC) medications. Thirty products were assessed, including five products each from cold medicines, antipyretic analgesics, analgesic antipruritics, gastrointestinal medicines, and ophthalmic medicines. A partially modified version of the Patient Education Materials Assessment Tool for Printed Materials (PEMAT-P) was used. Two evaluators assessed 18 understandability-related and seven actionability-related items, assigning one point for “agree,” and calculated percentage scores. Scores of ≥70% were considered “understandable” or “actionable.” Inter-rater reliability was evaluated using Cohen’s κ coefficient. All outer package labels scored <70%, indicating limited understandability and actionability. Contrastingly, 14 package inserts (46.7%) were judged understandable and three (10.0%) were judged actionable. The main factor contributing to the difference in understandability between package inserts and outer package labeling was “structure,” likely reflecting regulatory differences. For actionability, a significant difference was observed in the item “clearly explained in step-by-step procedures,” with 13 package inserts (43.3%) rated as “agree,” compared to 0 outer package labels (0%). Therefore, outer package labels were insufficient for understandability and actionability, and package inserts required improvements. Future measures should focus on enhancing the visibility of risk information, regulating space allocation on outer package labels, and including clear statements of purpose and concrete support tools in package inserts.