LINLu 1,2 , ZENGYing-tong 1 , LIUXiao-qi 1 , LUNYu-ning 1 , LIYou-ping 3 , YANGMin 1,4 , LAOHai-yan 1
  • 1. Department of Pharmacy, Guangdong General Hospital(Guangdong Academy of Medical Sciences), Guangzhou 510080, China;
  • 2. School of Pharmaceutical Sciences, SUN YAT-SEN University, Guangzhou 510006, China;
  • 3. Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China;
  • 4. Guangdong Provincial Cardiovascular Research Institute, Guangzhou 510080, China;
LAOHai-yan, Email: laohaiyan1208@vip.sina.com
Alprostadil injection; Off-label drug use; Inpatient; Guangdong General Hospital; Cross-sectional survey
10.7507/1672-2531.20140171
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Objective Based on the off-label drug use (OLDU) record application of alprostadil injection (Lipo-PGE1) which was the only one rejected in the Guangdong General Hospital in 2013, we retrospectively investigated all the background information of inpatients' OLDU of Lipo-PGE1 in 2012, so as to provide references for intervention of OLDU and effect evaluation. Methods According to OLDU in dose record application of clinical departments, we summarized medical orders about inpatients' use of Lipo-PGE1 during hospitalization in 2012 and analyzed OLDU situation according to drug labels. Then, we summarized situation of drug use in all departments, analyzed OLDU incidence in dose, calculated prescribed daily dose (PDD) and drug use density (DUD) in each department to evaluate the degree of OLDU in dose. Results a) A total of 106 576 medical orders involving 8 620 case-times were analyzed. According to the data of cases, medical orders and drug use amount, the OLDU incidences were 34.43%, 25.16% and 41.37%, respectively. Lipo-PGE1 was used in every clinical department in this hospital and OLDU occurred in 69.44% departments (25/36). b) According to the number of medical orders, there were 6 departments with the OLDU incidence in dose > 50% and 5 departments with the OLDU incidence in dose during 50% to 20%. c) The average of PDD of the whole hospital was 12.77 μg. A total of 25 departments' PDDs were off-label, and 10 departments' PDDs were above the average level of the whole hospital. The ICU's PDD was the highest, with 2.35 times more than label dose. d) The PDD in each department was not directly proportional to DUD, which indicated the degree of OLDU in dose was not directly proportional to use intensity. This may be caused by different disease burdens in departments. Conclusion Lipo-PGE1 is widely used in the Guangdong General Hospital where OLDU in dose occurs commonly. Since PDD and DUD reflect different contents, the two indicators should be combined to monitor OLDU.

Citation： LINLu, ZENGYing-tong, LIUXiao-qi, LUNYu-ning, LIYou-ping, YANGMin, LAOHai-yan. Off-label Drug Use of Alprostadil Injection among Inpatients in Guangdong General Hospital in 2012: A Status-quo Survey. Chinese Journal of Evidence-Based Medicine, 2014, 14(9): 1038-1043. doi: 10.7507/1672-2531.20140171 Copy

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