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KMID : 0941820060160020096
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Korean Journal of Clinical Pharmacy
2006 Volume.16 No. 2 p.96 ~ p.100
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The Effect of Biological Equivalence Examination on Prescribing Practice of Doctors
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Jang Mal-Sook
Choi Byung-Chul
Yong Chul-Soon
Choi Han-Gon
Rhee Jong-Dal
Yoo Bong-Kyu
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Abstract
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Korea Food and Drug Administration (KFDA) has been expediting the Biological Equivalence Examination (BEE) project to encourage generic substitution without expense of inappropriate therapeutic outcome. However, little is known about which considerations are most important in making the decision to prescribe a drug among many generic drugs. The purpose of this survey was to identify how strongly the KFDA certification of BEE influenced doctors when they make a choice between brand and generics of glimepiride preparations. Telephone survey was performed towords doctor working at local clinics by using a questionnaire. Most influential factor to doctors’ decision was drug cost followed by pharmaceutical representatives, therapeutic efficacy, and review guideline for reimbursement. Advertisement of the drug was the least influential followed by KFDA certification of BEE. The meaning of BEE was best understood by relatively young doctors with specialty in surgical parts. This survey result further indicated that the doctors considered the therapeutic equivalence examination a preffered measure to expedite generic substitution.
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KEYWORD
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biological equivalence examination, Glimepiride, Therapeutic equivalence examination, Generic substitution
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