환자 안전 측면에서 살펴본 분할 불가 정제 의약품의 분할선 사용 현황

Abstract

Scoring is marked by a groove on the tablet surface to facilitate easy division or splitting into two or moreequal pieces. It allows easy swallowing in different populations and to maintain weight and dose uniformity amongfractions. In Korea, however, an undividable tablet is scored, which confuses consumers about the splitting efficacy. Thisstudy aims to clarify the scoring status of an undividable tablet and propose a policy for improvement. Public dataobtained from the Ministry of Food and Drug Safety (MFDS) were utilized for the frequency analysis according to thephysical and pharmaceutical characteristics of the product. The results showed that 33 products, i.e., 2.5% of all 1,300undividable medicines, were scored. It was estimated that either the general practice to engrave scoring to facilitate doseadjustment or to distinguish appearance leads to confusion, and interferes with the function of the scoring and dosage form. In Korea, due to ambiguous scoring standards and poor consensus regarding the function of scoring, the regulatoryframework for tablet scoring is incomplete. In contrast, foreign regulatory bodies such as FDA and EMA prohibit scoringof undividable tablets and provide a legal basis to ensure the quality of the split portion of medicines. Efforts by doctors,pharmacists and consumers as well as pharmaceutical companies are needed for appropriate scoring. We expect a promptregulatory mechanism to promote drug safety.