|
KMID : 0869619980150020203
|
|
Journal of Korean Society of Hospital Pharmacists
1998 Volume.15 No. 2 p.203 ~ p.207
|
|
|
Usefulness of Drug Package Inserts of Cardiovascular Drugs in Korea
|
|
정하식/Jung, Ha Sik
조보선/손기호/최경업/Cho, Bo Sun/Sohn, Kie Ho/Choi, Kyung Eob
|
|
|
Abstract
|
|
|
An observational study was conducted to evaluate the adequacy of required elemets and the usefulness of drug package inserts as a drug information source. Out of 461 cardiovascular prescription drugs enlisted in the 1996 KSHP Drug Identification Database, 344 package inserts of 419 drugs were collected from 104 pharmaceutical companies from October 1st to 31st of 1997. The information of pack age inserts was divided into 4 categories and 21 subcategories which have been developed based on regulatory requirements, AHFS Drug Information, Micromedex^(®) CCIS drug evaluation monographs and frequent drug information requests.
The results revealed that the basic required information including generic names, brand names, active ingredients, dosages, precautions and manufacturers´ information were well documented, being, consistent with regulatory requirements. However, the lack of documentation on pharmacological descriptions, clinical pharmacological information such as pharmacokinetic parameters, symptoms and managements of intoxication, and their corresponding references has been observed, suggesting that package inserts should be further improved to serve as reliable and easily accessible source of drug information for healthcare professionals.
|
|
|
KEYWORD
|
|
|
|
|
|
FullTexts / Linksout information
|
|
|
|
|
Listed journal information
|
|
|
|