주사제 첨부문서의 규격화 필요성 검토(Ⅱ)

Abstract

It is necessary that the essential scientific information is conveyed to the healthcare professional for safe and effective drug use. Especially, parenteral drugs need more different information than oral drugs. However, there are no specific regulations about the format and content of parenteral drug package insert. So, many differences are discovered between pharmaceutical companies in contents and format of package inserts. In this review, an attempt should propose concrete guideline about the format and contents of package inserts for parenteral drugs. Parenteral drug package insert required a specific section, compared with oral drugs, entitled 'method of admixture', 'stability or sterility after reconstitution and dilution', 'precaution of handling', 'recommendation for the safe handing' and so on. Also, an effort should make the information regulated from a package insert to another. Collaboration between pharmaceutical companies and regulatory agencies will lead good drug development programmes that provide more informative package inserts.