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

Authors：

 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;

Corresponding?author：

LAOHai-yan, Email: laohaiyan1208@vip.sina.com

Keywords：

Alprostadil injection; Off-label drug use; Inpatient; Guangdong General Hospital; Cross-sectional survey

DOI：

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

1.	余翠琴.凱時的制劑特點.中國醫院藥學雜志, 2002, 22(11):691-692.
2.	許統儉, 陳劍群.前列腺素E1脂微球載體制劑治療肝硬化腹水臨床療效評價.中華現代內科學雜志, 2005, 2(4):347-349.
3.	謝玉桃, 蔣孝華, 譚德明, 等. Lipo PGE₁治療肝腎綜合征的臨床研究.中日友好醫院學報, 2003, 17(1):29-31.
4.	呂芳芳, 陳雪鳳, 徐小微, 等.不同劑量脂質體前列腺素E1治療早期慢性重型肝炎臨床療效觀察.浙江醫學, 2002, 24(9):566-567.
5.	周華堅, 李韶光, 楊小云, 等.前列腺素E1脂微球載體制劑治療病毒性肝炎高膽紅素血癥的療效和安全性.中國新藥雜志, 2005, 14(7):909-911.
6.	鄧洪波, 李友元, 劉丹. Lipo PGE₁注射液對老年人頸動脈斑塊及血小板聚集的影響.實用醫藥雜志, 2005, 22(8):685-686.
7.	韓朝, 林國經.前列地爾治療突發性聾的效果觀察.臨床耳鼻咽喉科雜志, 2004, 18(4):245.
8.	昝立新.前列地爾治療47例短暫性腦缺血發作的臨床療效觀察.中國實用醫藥, 2011, 6(6):150-151.
9.	何文貞, 歐利民, 鄭俊忠.前列地爾改善腦梗死后眩暈癥狀的效應.中國臨床康復, 2013, 7(3):424-426.
10.	鐘偉強, 劉冠賢, 楊永銘, 等.前列腺素E1脂微球載體制劑治療慢性腎小球腎炎的臨床研究.中國危重病急救醫學, 2004, 16(5):292-294.
11.	李鐵嶺, 趙秀梅, 蔡力力, 等.脂微球化前列腺素E1干預老年動脈硬化閉塞癥患者的下肢功能:不同量化標準的評估.中國臨床康復, 2005, 9(15):40-41.
12.	孫勇, 李強, 王建安.前列腺素E1對急性冠脈綜合征介入治療圍術期纖溶系統的影響.中華急診醫學雜志, 2003, 12(10):699-700.
13.	孫勇, 王建安.前列腺素E1對急性冠脈綜合征早期部分炎癥因子的影響.中華急診醫學雜志, 2003, 12(10):405-407.
14.	馮玉欣, 逄力男, 張奕.脂化前列腺素E1治療糖尿病足療效觀察.中華糖尿病雜志, 2004, 12(5):317-320.
15.	邱有波, 楊拯, 咼金海, 等.凱時注射液治療糖尿病腎病的系統評價.中國循證醫學雜志, 2010, 10(7):832-837.
16.	張伶俐, 李幼平, 曾力楠, 等. 15國超說明書用藥政策的循證評價.中國循證醫學雜志, 2012, 12(4):426-435.
17.	張伶俐, 李幼平, 胡蝶, 等.四川大學華西第二醫院2010年兒科住院患兒超說明書用藥情況調查.中國循證醫學雜志, 2012, 12(2):161-167.
18.	張伶俐, 李幼平, 梁毅.全球住院兒童超說明書用藥現狀的系統評價.中國循證醫學雜志, 2012, 12(2):176-187.
19.	Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med, 2006, 166(9):1021-1026.
20.	李延敏, 楊悅. "藥品說明書之外的用法"相關問題研究.中國藥房, 2010, 21(37):3469-3471.

1. 余翠琴.凱時的制劑特點.中國醫院藥學雜志, 2002, 22(11):691-692.
2. 許統儉, 陳劍群.前列腺素E1脂微球載體制劑治療肝硬化腹水臨床療效評價.中華現代內科學雜志, 2005, 2(4):347-349.
3. 謝玉桃, 蔣孝華, 譚德明, 等. Lipo PGE₁治療肝腎綜合征的臨床研究.中日友好醫院學報, 2003, 17(1):29-31.
4. 呂芳芳, 陳雪鳳, 徐小微, 等.不同劑量脂質體前列腺素E1治療早期慢性重型肝炎臨床療效觀察.浙江醫學, 2002, 24(9):566-567.
5. 周華堅, 李韶光, 楊小云, 等.前列腺素E1脂微球載體制劑治療病毒性肝炎高膽紅素血癥的療效和安全性.中國新藥雜志, 2005, 14(7):909-911.
6. 鄧洪波, 李友元, 劉丹. Lipo PGE₁注射液對老年人頸動脈斑塊及血小板聚集的影響.實用醫藥雜志, 2005, 22(8):685-686.
7. 韓朝, 林國經.前列地爾治療突發性聾的效果觀察.臨床耳鼻咽喉科雜志, 2004, 18(4):245.
8. 昝立新.前列地爾治療47例短暫性腦缺血發作的臨床療效觀察.中國實用醫藥, 2011, 6(6):150-151.
9. 何文貞, 歐利民, 鄭俊忠.前列地爾改善腦梗死后眩暈癥狀的效應.中國臨床康復, 2013, 7(3):424-426.
10. 鐘偉強, 劉冠賢, 楊永銘, 等.前列腺素E1脂微球載體制劑治療慢性腎小球腎炎的臨床研究.中國危重病急救醫學, 2004, 16(5):292-294.
11. 李鐵嶺, 趙秀梅, 蔡力力, 等.脂微球化前列腺素E1干預老年動脈硬化閉塞癥患者的下肢功能:不同量化標準的評估.中國臨床康復, 2005, 9(15):40-41.
12. 孫勇, 李強, 王建安.前列腺素E1對急性冠脈綜合征介入治療圍術期纖溶系統的影響.中華急診醫學雜志, 2003, 12(10):699-700.
13. 孫勇, 王建安.前列腺素E1對急性冠脈綜合征早期部分炎癥因子的影響.中華急診醫學雜志, 2003, 12(10):405-407.
14. 馮玉欣, 逄力男, 張奕.脂化前列腺素E1治療糖尿病足療效觀察.中華糖尿病雜志, 2004, 12(5):317-320.
15. 邱有波, 楊拯, 咼金海, 等.凱時注射液治療糖尿病腎病的系統評價.中國循證醫學雜志, 2010, 10(7):832-837.
16. 張伶俐, 李幼平, 曾力楠, 等. 15國超說明書用藥政策的循證評價.中國循證醫學雜志, 2012, 12(4):426-435.
17. 張伶俐, 李幼平, 胡蝶, 等.四川大學華西第二醫院2010年兒科住院患兒超說明書用藥情況調查.中國循證醫學雜志, 2012, 12(2):161-167.
18. 張伶俐, 李幼平, 梁毅.全球住院兒童超說明書用藥現狀的系統評價.中國循證醫學雜志, 2012, 12(2):176-187.
19. Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med, 2006, 166(9):1021-1026.
20. 李延敏, 楊悅. "藥品說明書之外的用法"相關問題研究.中國藥房, 2010, 21(37):3469-3471.

Chinese Journal of Evidence-Based Medicine

Off-label Drug Use of Alprostadil Injection among Inpatients in Guangdong General Hospital in 2012: A Status-quo Survey

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