환자 안전 측면에서 살펴본 분할 불가 정제 의약품의 분할선 사용 현황

• 영문명: The Status of Scored Line on an Undividable Tablet based on Patient Safety
• 발행기관: 대한약학회
• 저자명: 양진욱(Jinwook Yang) 권경희(Kyenghee Kwon)
• 간행물 정보: 『약학회지』제64권 제4호(2020년), 319~326쪽, 전체 8쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2020.08.30

영문 초록

Scoring is marked by a groove on the tablet surface to facilitate easy division or splitting into two or more equal pieces. It allows easy swallowing in different populations and to maintain weight and dose uniformity among fractions. In Korea, however, an undividable tablet is scored, which confuses consumers about the splitting efficacy. This study aims to clarify the scoring status of an undividable tablet and propose a policy for improvement. Public data obtained from the Ministry of Food and Drug Safety (MFDS) were utilized for the frequency analysis according to the physical and pharmaceutical characteristics of the product. The results showed that 33 products, i.e., 2.5% of all 1,300 undividable medicines, were scored. It was estimated that either the general practice to engrave scoring to facilitate dose adjustment 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 regulatory framework for tablet scoring is incomplete. In contrast, foreign regulatory bodies such as FDA and EMA prohibit scoring of 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 prompt regulatory mechanism to promote drug safety.

목차

서 론(Introduction)

연구 방법(Research Methods)

결 과(Results)

고 찰(Discussion)

결 론(Conclusion)

Conflict of Interest

References

키워드

medicine scoring splitting extended release