Assessment of Readability and Appropriate Usability Based on the Product Labelling of Over-The-Counter Drugs in Korea

일반의약품 설명서의 이해도와 적정 사용가능성 평가

  • Received : 2012.03.07
  • Accepted : 2012.09.10
  • Published : 2012.10.31

Abstract

A product labelling is one of key tools in ensuring that a patient uses drugs safely and effectively in self-care without professional support. This study aimed to explore the readability and comprehensibility of the information contained on two package inserts of medicines. Two package inserts were tested with first year college students. Fifty-one potential consumers underlined words they could not understand and answered 10 scenario questions. Any differences among groups with different characteristics were statistically tested. Secondly, the readability of two package inserts was assessed with comparison to the level of the 6th grade Korean textbooks. As results, more than 80% of participants properly replied to straightforward questions concerning indication, dosage, duplication, use in pregnancy and contraindication, and 73% about formulation. Less than half answered correctly in multiple choice questions about pediatric use (41%) and side effects (35%). Little discrepancy was observed in the comprehensibility between participants' characteristics. Drug inserts contained about 20% more professional-level words than 6th grade textbooks. In conclusion, Korean consumers may face challenges to understand drug information due to professional terminology and outdated expressions in the current package inserts. To secure safe and effective use of over-the-counter agents, greater efforts should be made to develop more consumer friendly labels. In the other hand, educational supports are required to prepare consumers in a proper level of knowledge for the safe use of drugs.

Keywords

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