Off-label Use of Aspirin in Outpatients of Sun Yat-sen Memorial Hospital in 2013: A Retrospective Survey_Chinese Journal of Evidence-Based Medicine

Authors：

 HEZhi-chao ¹ , LIYou-ping ² , WUJun-yan ¹ , LIJian-fang ¹ , ZHAOWen-xia ¹ , SUChen ¹ , ZHUJian-hong ¹ , DONGShi-yu ¹ , CHENZe-peng ¹ ,  QIUKai-feng ¹

1. Department of Pharmacy, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou 510120, China;
2. Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China;

Corresponding author：

QIUKai-feng, Email: feng.qk@163.com

Keywords：

Aspirin; Off-label use; Outpatient; Risk factors analysis; Drug safety

DOI：

10.7507/1672-2531.20150224

Video：

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Objective To understand the situation of off-label use of aspirin among outpatients in Sun Yatsen Memorial Hospital, so as to provide baseline data for developing off-label drug use policy. Methods A stratified random sampling method was used to collected prescription data of aspirin among outpatients in 2013. The incidence rates between different types of off-label use of aspirin were determined by chi-square test, and the influence factors of off-label drug use were analyzed by logistic regression model. Results A total of 5 023 prescriptions with aspirin were collected and analyzed, with incidence rate of off-label use up to 17.7%. The major category of off-label use was no indication (94.38%). The top 3 no indications were recurrent abortion, infertility and systemic lupus erythematosus. Drug specification, gender, age and prescribed department were the risk factors of off-label use. Conclusion Aspirin off-label use is common among outpatients in Sun Yat-sen Memorial Hospital in 2013, especially in obstetrics and gynecology department and assisted reproductive center. The results suggest that more clinical studies about aspirin for reproduction are needed to provide more evidence of drug use, so as to ensure the safety of drug use in special populations and avoid potential medical risk.

Citation： HEZhi-chao, LIYou-ping, WUJun-yan, LIJian-fang, ZHAOWen-xia, SUChen, ZHUJian-hong, DONGShi-yu, CHENZe-peng, QIUKai-feng. Off-label Use of Aspirin in Outpatients of Sun Yat-sen Memorial Hospital in 2013: A Retrospective Survey. Chinese Journal of Evidence-Based Medicine, 2015, 15(12): 1365-1371. doi: 10.7507/1672-2531.20150224 Copy

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2.	Thorat MA, Cuzick J. Role of aspirin in cancer prevention. Curr Oncol Rep, 2013, 15(6):533-540.
3.	Patrono C, Garcia Rodriguez LA, Landolfi R, et al. Low-dose aspirin for the prevention of atherothrombosis. N Engl J Med, 2005, 353(22): 2373-2383.
4.	Garcia Rodriguez LA, Hernandez-Diaz S. Risk of uncomplicated peptic ulcer among users of aspirin and non-aspirin non-steroidal anti-inflammatory drugs. Am J Epidemiol, 2004, 159(1):23-31.
5.	Cuzick J, Thorat MA, Bosetti C, et al. Estimates of benefits and harms of prophylactic use of aspirin in the general population. Ann Oncol, 2014, 26(1):47-57.
6.	方积乾. 生物医学研究的统计方法. 第1版. 北京:高等教育出版社, 2007:347-348.
7.	赵敏, 常才. 阿司匹林在妇产科的应用. 国外医学妇产科学分册, 2007, 34(6):391-394.
8.	Backos M, Rai R, Baxter N, et al. Pregnancy complications in women with recurrent miscarriage associated with antiphospholipid antibodies treated with low dose aspirin and heparin. BrJ Obstet Gynaecol, 1999, 106(2):102-107.
9.	Rubinstein M, Marazzi A, Polakde de Fried E. Low-dose aspirin treatment improves ovarian responsiveness, uterineand ovarian blood flow velocity, implantation, and pregnancy rates in patients undergoing in vitro fertilization:a prospective, randomized, double blind placebo controlled assay. Fertil Steril, 1999, 71(5):825-829.
10.	McCowan LM, Harding J, RobertsA, et al. Administration of lowdose aspirin to mothers with small for gestational age fetuses and abnormal umbilical Doppler studies to increase birth weight:a randomized double-blind controlled trial. Br J Obstet Gynaecol, 1999, 106(7):647-651.
11.	Sibai BM, Caritis SN, Thom E, et al. Prevention of preeclampsia with low-dose aspirin in healthy, nulliparous pregnant women. The National Institute of Child Health and Human Development Network of Maternal-Fetal Medicine Units. N Engl J Med, 1993, 329(17):1213-1218.
12.	Rogers MS, Fung HY, Hung CY. Calcium and low-dose aspirin prophylaxis in women at high risk of pregnancy-induced hypertension. Hypertens Pregnancy, 1999, 18(2):165-172.
13.	American Society of Hospital Pharmacists. ASHP statement on the use of medications for unlabeled uses. Am J Hosp Pharm, 1992, 49(8):2006-2008.

1. 广东省药学会. 药品未注册用法专家共识. 2010年3月18日.
2. Thorat MA, Cuzick J. Role of aspirin in cancer prevention. Curr Oncol Rep, 2013, 15(6):533-540.
3. Patrono C, Garcia Rodriguez LA, Landolfi R, et al. Low-dose aspirin for the prevention of atherothrombosis. N Engl J Med, 2005, 353(22): 2373-2383.
4. Garcia Rodriguez LA, Hernandez-Diaz S. Risk of uncomplicated peptic ulcer among users of aspirin and non-aspirin non-steroidal anti-inflammatory drugs. Am J Epidemiol, 2004, 159(1):23-31.
5. Cuzick J, Thorat MA, Bosetti C, et al. Estimates of benefits and harms of prophylactic use of aspirin in the general population. Ann Oncol, 2014, 26(1):47-57.
6. 方积乾. 生物医学研究的统计方法. 第1版. 北京:高等教育出版社, 2007:347-348.
7. 赵敏, 常才. 阿司匹林在妇产科的应用. 国外医学妇产科学分册, 2007, 34(6):391-394.
8. Backos M, Rai R, Baxter N, et al. Pregnancy complications in women with recurrent miscarriage associated with antiphospholipid antibodies treated with low dose aspirin and heparin. BrJ Obstet Gynaecol, 1999, 106(2):102-107.
9. Rubinstein M, Marazzi A, Polakde de Fried E. Low-dose aspirin treatment improves ovarian responsiveness, uterineand ovarian blood flow velocity, implantation, and pregnancy rates in patients undergoing in vitro fertilization:a prospective, randomized, double blind placebo controlled assay. Fertil Steril, 1999, 71(5):825-829.
10. McCowan LM, Harding J, RobertsA, et al. Administration of lowdose aspirin to mothers with small for gestational age fetuses and abnormal umbilical Doppler studies to increase birth weight:a randomized double-blind controlled trial. Br J Obstet Gynaecol, 1999, 106(7):647-651.
11. Sibai BM, Caritis SN, Thom E, et al. Prevention of preeclampsia with low-dose aspirin in healthy, nulliparous pregnant women. The National Institute of Child Health and Human Development Network of Maternal-Fetal Medicine Units. N Engl J Med, 1993, 329(17):1213-1218.
12. Rogers MS, Fung HY, Hung CY. Calcium and low-dose aspirin prophylaxis in women at high risk of pregnancy-induced hypertension. Hypertens Pregnancy, 1999, 18(2):165-172.
13. American Society of Hospital Pharmacists. ASHP statement on the use of medications for unlabeled uses. Am J Hosp Pharm, 1992, 49(8):2006-2008.

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Off-label Use of Aspirin in Outpatients of Sun Yat-sen Memorial Hospital in 2013: A Retrospective Survey

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