1. �Ĵ���ѧ�����ڶ�ҽԺ, a.ҩѧ��, b. ѭ֤ҩѧ����, c. ����ȱ������ظ��������������ص�ʵ����, d. ������,�ɶ� 610041; 2. �Ĵ���ѧ����ҩѧԺ,�ɶ� 610041
A Comparative Study of Risk Classification Systems for Drug Use During Pregnancy
ZHANG Chuan1a,1b,1c, ZHANG Ling-li1a,1b,1c*, WANG Xiao-dong1c,1d*, LIU Dan1a,1b,1c, LI Jia-lian1a,1b,1c,2, XIAO Dan2
1a. Department of Pharmacy, 1b. Evidence-Based Pharmacy Center, 1c. Key Laboratory of Birth Defects and Related Diseases of Women and Children Sichuan University, Ministry of Education, 1d. Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, Chengdu 610041, China; 2. West China School of Pharmacy, Sichuan University, Chengdu 610041, China
Abstract��OBJECTIVE To compare and analyze three risk classification systems for drug use during pregnancy, so as to provide evidence for drug safety used in pregnancy.METHODS The drugs included in the risk classification systems from the US Food and Drug Administration (FDA), the Australian Drug Evaluation Committee (ADEC) and the Swedish Catalogue of Approved Drugs (FASS) were searched, and descriptive analysis was performed in terms of definition of category, allocation of drugs and difference of categories. RESULTS FDA uses animal studies and human observations studies in pregnancy to define the risk of drugs in pregnancy. The classification systems of ADEC and FASS are similar, which use experience in human and animal research for defining the drug safety during pregnancy. The category assignments for 1 113 drugs in FDA system, 1 232 in ADEC system and 983 in FASS system were compared. Only 367 (11.6%) drugs among the total of 3 167 in the three systems were placed in the same risk level category, which accounted for 33.0%, 29.8% and 37.3% of FDA, ADEC and FASS systems, respectively. The main differences existed in drugs in X and C categories between FDA and ADEC/FASS systems. CONCLUSION Differences in category allocation for the same drug can be a source of great confusion among users of the classification systems, and may limit the usefulness and reliability of risk classification systems.
�Ŵ�, ������, ������, ����, �����, Ф��. ȫ����������ҩΣ���Էּ�ϵͳ�ıȽϷ���[J]. �й�ҩѧ��־, 2016, 51(3): 234-238.
ZHANG Chuan, ZHANG Ling-li, WANG Xiao-dong, LIU Dan, LI Jia-lian, XIAO Dan. A Comparative Study of Risk Classification Systems for Drug Use During Pregnancy. Chinese Pharmaceutical Journal, 2016, 51(3): 234-238.
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