• 한국임상약학회지
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• 제23권2호
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• pp.123-128
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• 2013

Purpose: The aim of study was to investigate the racial or ethnic differences in FDA-approved medications. Methods: Data on racial-based differences of drugs in PDR (Physician's Desk Reference) were analyzed by searching with keywords, "ETHNIC" and "RACE". Results: There were descriptions related to "ETHNIC" in product directions of 53 cases and "RACE" in 266 cases in 2010 PDR. After excluding 30 cases of duplicates, 289 cases were shown of which 28 cases were verified to demonstrate racial or ethnic differences. Drug category showing the higher racial or ethnic differences was cardiovascular drugs (7), followed by alimentary tract and metabolism drugs (6), nervous system drugs (5), and antineoplastic and immunomodulating agents (3). Pharmacokinetic differences between race and ethnicity were observed most frequently; differences in AUC or Cmax showed in 15 drugs and clearance differences in 7 drugs. Conclusions: This study identified the racial differences in medication usage in PDR. Therefore, the results can contribute to safe use of medication in real clinical settings in regards to the racial or ethnic differences.

• 한국임상약학회지
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• 제21권1호
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• pp.22-29
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• 2011

Purpose: This study aims to investigate how gender-based differences are actually reflected on drug approval. Methods: Data on gender-based differences of drugs were analyzed by searching PDR (Physician's Desk Reference) with the keyword, "GENDER". Results: There were descriptions related to gender in product directions of 361 drugs in 2009 PDR, out of which 63 items actually showed gender-related differences. Drug categories showing comparatively high gender-based differences were nervous system, cardiovascular system, and alimentary tract and metabolism. Pharmacokinetic differences between genders were observed most frequently; compared to men, 32 drugs showed higher absorption while 18 drugs revealed lower clearance in women. There were 2 drugs which gender should be considered before prescribing, and 5 drugs which showed different severity of adverse effects according to gender. Conclusions: It is necessary to establish domestic policies for drug approval and use which reflects gender-based differences through sufficient researches.