OBJECTIVE:To analyze the differences of drug instructions between hospital directory and OTC standard model in-structions,and to provide reference for enhancing instruction management and reducing the safety risk of clinical drug use. METH-ODS:1 324 drugs of hospital directory in a hospital in 2014 were compared with OTC directory from CFDA websites. The instruc-tion of drug types included in OTC directory were compared OTC model instruction. According to the degree of risks which the dif-ferences may bring,differences were divided into four levels for analysis as negligible,general,important and severe. RESULTS:244 drugs belonged to OTC,of which 32.38%were different from standard model instructions. The four risk levels rates of negligi-ble,general,important and severe accounted for 29.11%,34.18%,7.59% and 29.11%,respectively. Among important risk,the difference of“indication limit”occupied the highest proportion,being 50.00%. Among severe risk,the difference of“forbidden for special disease”and“forbidden for pregnant women”accounted for 43.48% and 39.13%. CONCLUSIONS:There are problems, such as the absence of important medication information,statement conflicts. The hospital and administration departments should en-hance the standard management of drug instruction to guarantee safe and rational drug use in the clinic.