ABSTRACT
OBJECTIVE:To analyze the situation of off-indication drug use of drugs for high altitude pulmonary edema (HAPE),and to provide reference for promoting rational drug use in medical institutions of plateau area and establishing relevant management process. METHODS:By taking"HAPE""treatment""Altitude illness""Treatment"as keywords,retrieving from CNKI,PubMed,Embase database during build up to Sept. 2017,drugs for HAPE were screened and extracted after reading the literatures. Drug package inserts of listed preparations were compared,summarized and analyzed. RESULTS:Drugs for HAPE in literatures were screened,and 16 kinds of drugs were summarized finally as nifedipine,sildenafil,tadalafil,aminophylline,etc. Indication of HAPE was not found in drug package inserts of those listed preparations. CONCLUSIONS:At present,there is a universal phenomenon of off-indication drug use of drugs for HAPE,and it is imminent to regulate the management of off-label drug use in the hospital. It is suggested to improve the off-label drug use management flow of drugs for HAPE so as to promote rational drug use.
ABSTRACT
OBJECTIVE:To investigate off-indication use of oral chemical drugs medical orders by the standards of CFDA and FDA,and to compare the differences between the two standards,analyze reasons and rationality of drug use,so as to pro-vide reference for establishing off-indications use management system. METHODS:The oral chemical drugs medical orders of inpatients were analyzed statistically during Jan.-Jun. 2016. Off-label uses was judged according to the standards of CFDA and FDA. RESULTS:Totally 507 oral chemical drugs medical orders were collected,the percentage of off-indications use were in high level,being 58.58% and 55.82% respectively by the standards of CFDA and FDA. The incidence of off-indication use of quetiapine and aripiprazole by the CFDA standards were significantly higher than the results of FDA standards,with statistical significance(P<0.05). Magnesium valproate(54.03%),escitalopram oxalate(10.45%)and quetiapine(10.15%)occupied the top 3 places in the list of constituent ratio. Among off-indication medical orders,7 orders had no evidence-based medicine,ac-counting for 2.36% of total. CONCLUSIONS:Most off-indication medical orders of our hospital could provide the basis and lit-erature support,while there are still a few off-indication use with insufficient evidence. The corresponding management system of the hospital should be formulated to guarantee the medication safety of the patients and legitimate rights and interests of the doctors.