Formulation of the Consensus of Experts on Pregnancy Drug use in China
DU Bo-ran1, LI Yi-fan1, SHI Xiang-jun2, FENG Xin1*, YIN Cheng-hong1*
1. Beijing Obstetrics and Gynecology Hospital, Capital Medical University/Beijing Maternal and Child Health Care Hospital, Beijing 100026,China; 2. School of Medicine, Tsinghua University, Beijing 100084, China
Abstract：OBJECTIVE To build up the consensus of experts on pregnancy drug registry in China based on Delphi method, and to provide a methodological basis for further studies. METHODS Based on studies of pregnancy drug registry, the manuscript of the consensus of experts on pregnancy drug registry in China was made, the questionnaire was designed. Twenty-six experts from different provinces of China were selected to conduct two rounds of expert consultation with Delphi method, and the content of experts on pregnancy drug registry in China was revised. RESULTS The recovery rates of the two rounds of questionnaire were 100%. The expert authority coefficient(CR) was(0.86±0.1), and the CV of expert opinion was( 0.13±0.06) in the first round,(0.12±0.02) in the second round. The coordination coefficient of expert opinion(Kendall-W) was 0.235 in the first round and 0.605 in the second round. The chi square test was statistically significant (P<0.001). Finally, the expert consensus on pregnancy drug registry in China was determined. CONCLUSION Building up the consensus of experts on pregnancy drug registry in China based on Delphi method, a methodological basis for studies of pregnancy drug registry in China could be provided.
杜博冉, 李轶凡, 史湘君, 冯欣, 阴赪宏. 基于德尔菲法构建中国妊娠用药登记专家共识的研究[J]. 中国药学杂志, 2022, 57(12): 961-965.
DU Bo-ran, LI Yi-fan, SHI Xiang-jun, FENG Xin, YIN Cheng-hong. Formulation of the Consensus of Experts on Pregnancy Drug use in China. Chinese Pharmaceutical Journal, 2022, 57(12): 961-965.
NÖRBY U, KÄLLéN K, EIERMANN B, et al. Drugs and birth defects: a knowledge database providing risk assessments based on national health registers[J].Eur J Clin Pharmacol, 2013, 69(4): 889-899.
[2]
ZHENG Z Z. Attention on vulnerable groups and improvement on health level of the whole population[J].Popul Health(人口与健康), 2021,(3): 16.
[3]
LI X L, FENG X. Analysis of pregnant and lactating women medication in 490 drug instructions[J]. Chin Pharm J(中国药学杂志), 2013,48(21): 1886-1888.
[4]
DU B R, FENG X, SHI X J, et al. Discussion on necessity of therapeutic drug monitoring for advanced maternal aged multiparous women after the “universal two-child policy”[J]. Chin Pharm J(中国药学杂志), 2019, 54(19):1631-1636.
[5]
JONKER C J, VAN DEN BERG H M, KWA M S G, et al. Registries supporting new drug applications[J].Pharmacoepidemiol Drug Saf, 2017, 26(12): 1451-1457.
[6]
ZHANG Y, LIU X, YANG L, et al. Current researches, rationale, plausibility, and evidence gaps on metformin for the management of hypertensive disorders of pregnancy[J].Front Pharmacol, 2020, 11: 596145. Doi:10.3389/fphar.2020.596145
[7]
DUAN N, ZHANG S G. Discussion on rationality and safety of drug use in pregnant and lactating women—Summary of expert meeting on rational drug use in obstetrics and gynecology system[J].Eval Anal Drug Use Hosp China(中国医院用药评价与分析), 2010, 10(8): 673-675.
[8]
BOHREN M A, HOFMEYR G J, SAKALA C, et al. Continuous support for women during childbirth[J].Cochrane Database Syst Rev, 2017, 7: d3766. Doi:10.1002/14651858.CD003766.pub6
[9]
TRAVERS K, SALLUM R H, BURNS M D, et al. Characteristics and temporal trends in patient registries: focus on the life sciences industry, 1981-2012[J].Pharmacoepidemiol Drug Saf, 2015, 24(4): 389.
[10]
SCAFFIDI J, MOL B W, KEELAN J A.The pregnant women as a drug orphan: a global survey of registered clinical trials of pharmacological interventions in pregnancy[J].BJOG, 2017, 124(1): 132.
[11]
REN Y, LI DD, PAN C, et al. Application status of delphi method in clinical pharmacy[J].Eval Anal Drug Use Hosp China(中国医院用药评价与分析), 2019, 19(12): 1525-1527.
[12]
GAI D, YUAN S S, LI Y F, et al. Selection of high-alert medications list for specialized hospital of maternity and child:based on the Delphi method[J].Clin Med J(临床药物治疗杂志), 2020, 18(11): 54-58.
[13]
ZHOU Q, WANG Q, YU Y, et al. Consensus methods in the development of clinical practice guidelines[J].Drug Eval(药品评价), 2016, 13(16): 13-17.
[14]
GELPERIN K, HAMMAD H, LEISHEAR K, et al. A systematic review of pregnancy exposure registries: examination of protocol-specified pregnancy outcomes, target sample size, and comparator selection[J].Pharmacoepidemiol Drug Saf, 2017, 26(2): 208-214.
[15]
MEHTA U, CLERK C, ALLEN E, et al. Protocol for a drugs exposure pregnancy registry for implementation in resource-limited settings[J].BMC Pregnancy Childbirth, 2012, 12: 89. Doi:10.1186/1471-2393-12-89
[16]
JING Y H, GUO J F, LI X.Pregnancy exposure registries: US FDA guidance and case studies[J].Chin J Pharmacovigil(中国药物警戒),2006,3(2): 72-75, 80.
[17]
SHEN L, LI X L, HE Y.Guidelines of data collection in pregnant women of CHMP[J].Chin J Pharmacoepidemiol(药物流行病学杂志), 2010, 19(4): 226-231.
[18]
WILMER E, CHAI S, KROUMPOUZOS G.Drug safety: Pregnancy rating classifications and controversies[J].Clin Dermatol, 2016, 34(3): 401-409.
2022, Vol. 57 
