Investigation on Adhesion Control Standards and Skin Adverse Effects of Skin Attached Formulations

파스제의 점착력 관리기준 및 피부 부작용 조사연구

  • Kim, Ji Yeon (Department of Food and Drug, Chosun University Graduate School) ;
  • Kim, Kwang Joon (College of Pharmacy, Chosun University) ;
  • Park, Sang-Wook (Department of Food and Drug, Chosun University Graduate School) ;
  • Bang, Joon Seok (Graduate School of Clinical Pharmacy, Sookmyung Women's University) ;
  • Lee, Wonjae (Department of Food and Drug, Chosun University Graduate School)
  • 김지연 (조선대학교 대학원 식품의약학과) ;
  • 김광준 (조선대학교 약학대학 약학과) ;
  • 박상욱 (조선대학교 대학원 식품의약학과) ;
  • 방준석 (숙명여자대학교 임상약학대학원) ;
  • 이원재 (조선대학교 대학원 식품의약학과)
  • Received : 2014.07.02
  • Accepted : 2014.08.21
  • Published : 2014.09.30

Abstract

Objectives: This paper was aimed to investigate the adhesion control standards of pain relieving patch (PRP) drugs and to survey it's adverse effects on the skin of patients for safe use of PRP drugs. Methods: In this study, the related documents of PRP drugs of Korea pharmacopoeia (KP), United States pharmacopoeia (USP), Japanese Pharmacopoeia (JP), European pharmacopoeia (EP), and information web sites of the Ministry of Food and Drug Safety (MFDS) were surveyed. Also, the past and current labeling of PRP drugs marketed in the pharmacy was investigated and compared. Results: In KP and JP, the lower limit standard for PRP's adhesion control is established, but the upper limit standard is not designated. In USP and EP, neither the lower nor upper limit standard is established. The main reasons of skin adverse effects are considered as inherent adverse reactions of the applied drugs for PRP. Another reason is involved in patient's medication mistakes related to PRP's adhesion control, respiratory depression of skin according to physical skin closure, and microbial growth, etc. Conclusion: For safe use of PRP drugs, we proposed ensured guidelines like additional instructions of pharmacist's prescription and detailed labeling systems for usage of PRP drugs applied on skin.

Keywords

References

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