Survey on Off-label Drug Use in Some Medical Institutions of Sichuan Province / 中国药房

ABSTRACT

OBJECTIVE:To provide reference for formulating related provisions,guidelines and regulations for off-label drug use,standardizing medical behavior in medical health institutions. METHODS:According to the connotation of off-label drug use,Questionnaire for off-label drug use was developed for medical institutions,in which drug name,treatment disease,the type and use evidence ofoff-label drug usewere included. The questionnaires were delivered to pharmacists who participatedClinical phar-macist practice skills training in Sichuan province to collect the related information of off-label drug use for statistical analysis, and suggestions were put forward. RESULTS:Totally 150 questionnaires were sent out,124 were effectively received with effec-tively recovery of 82.7%;the surveyed pharmacists came from 22 medical institutions,including 18 tertiary hospitals and 4 second-ary hospitals;there were 128 information about off-label drug use,including 14 (10.9%) with incomplete reporting information. The another 114 information were major in“super indication”(61) and“super administration”(43),accounting for 53.5% and 37.7%,respectively,and there are 8 other drug overdose(7.0%),2 super object(1.8%). The relevant off-label drug use mainly included anti-infection drugs (34 information,29.8%),anti-tumor drugs (16 information,14.0%),TCM injections (8 informa-tion,7.0%),and etc.;the relative concentration of varieties were metronidazole,dexamethasone,gentamicin,methotrexate, azithromycin,irinotecan,vancomycin,nystatin,etc.. Some medical institutions were absence of effective regulatory measures. CONCLUSIONS:Off-label drug use is quite common in medical institutions of Sichuan province,some of them exist obvious med-ication risk. It is suggested that the state should be as soon as possible to develop related provisions,guidelines and regulations for off-label drug use,endowing legal force for off-label drug use;medical staff should avoid no evidence-based drug use,unreason-able or even unnecessary off-label drug use;pharmaceutical production enterprises should strengthen communication with medical institutions and pay attention to collect information related to the clinical medication,timely update the drug instructions to ensure the legitimate rights for patients and the interests for medical staff.