Background : Providing proper drug information so that the patient takes medication as prescribed is essential for patient safety. Labels for prescription medicines include core information and are effective tools for achieving this end. The aim of this study was to propose a Korean labeling guideline for outpatient prescription medications. Methods : We compared and analyzed the current status and guidelines for prescription drug labeling in Korea, Australia, the UK, and the US. We performed a focus group interview and a two-round Delphi survey with hospital pharmacists in order to improve and evaluate an initially proposed guideline. We evaluated the reliability and validity of the Delphi survey and constructed a final draft of the guideline. Results : In Australia, the UK, and the US, labeling guidelines for prescription medicines were provided to prevent drug misuse. The UK released the most structured and practical guide. The items in the amended draft of our guideline were divided into five groups based on the results of the Delphi survey on necessity, urgency, and feasibility. For the items with high necessity, urgency and feasibility which has already been implemented in hospitals, an urgent need for standardization of labelling across hospitals was found. For items that were assessed high in necessity and urgency but low in feasibility, a need to give priority in resource distribution was found. For items ranking low in all aspects, society needs to seek fundamental changes in perception and culture from each stakeholder’s view. Conclusions : Through international comparison and qualitative research, a final draft of the Korean labeling guideline for prescription medications was proposed. To put the proposed guideline into practice, further investigation and ongoing society-wide efforts are required.


Labeling, Prescribing medicine, Guideline, Hospital pharmacy, Delphi method