LINLu 1 , LAOHai-yan 1 , LUNYu-ning 1 , LIYou-ping 2 , YANGMin 1,3
  • 1. Department of Pharmacy, Guangdong General Hospital(Guangdong Academy of Medical Sciences), Guangzhou 510080, China;
  • 2. Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China;
  • 3. Guangdong Cardiovascular Institute, Guangzhou 510080, China;
YANGMin, Email: mnmyang@aliyun.com
Alprostadil injection; Off-label drug use; Interventional effect; Guangdong General Hospital
10.7507/1672-2531.20160134
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Objective Based on the off-label drug use (OLDU) record application of Alprostadil injection (LipoPGE1) which was the only one rejected in the Guangdong General Hospital in 2013, the interventional measures were carried out to reduce unreasonable off-label drug use of Lipo-PGE1. Methods Medical orders about OLDU in dosage of Lipo-PGE1 were intervened in through education, communication and monitoring. The situation of drug use was summarized in all departments after intervention through exporting all the medical orders about inpatients' use of LipoPGE1 during hospitalization in August, 2013 to July, 2014 and OLDU incidence in dosage, prescribed daily dose (PDD) and drug use density (DUD) in each department were calculated. The interventional effect was analyzed by comparing with the baseline data. Results a) A total of 78 044 medical orders involving 6 426 case-times were analyzed. According to the data of cases, medical orders and drug use amount, the OLDU incidences were 8.68%, 5.87% and 10.53%, respectively, compared with 34.43%, 25.16% and 41.37% before intervention had declined significantly (P < 0.05). OLDU occurred in 69.44% departments (25/36) before intervention and declined to 55.56% (20/36) after intervention. b) OLDU incidences of 22 departments were declined after intervention. There were 2 departments with the OLDU incidence in dose > 20%: ICU (39.68%) and cardiac surgery (32.78%). c) After the intervention, the PDD of the whole hospital fell to 10.52μg from 12.77μg and DUD fell to 8.87 from 15.12. There were 20 departments whose PDDs were off-label and 3 departments whose PDDs were above the average level of the whole hospital after the intervention. The three departments were ICU (13.61μg), cardiac surgery (12.68μg) and rheumatology (11.26μg). Conclusion Extensive publicity and education, targeted communication and regular monitoring and feedback are effective measures to intervene in unreasonable OLDU. After intervention, the phenomenon of off-label drug use of Lipo-PGE1 is improved significantly. This study provides a workable avenue to manage off-label drug use in hospital.

Citation： LINLu, LAOHai-yan, LUNYu-ning, LIYou-ping, YANGMin. Interventional Effect of Off-label Drug Use of Alprostadil Injection among Inpatients in Guangdong General Hospital: A Before-after Study. Chinese Journal of Evidence-Based Medicine, 2016, 16(8): 869-875. doi: 10.7507/1672-2531.20160134 Copy