Investigation And Analysis Of Off-label Use Of Omeprazole In Third-grade Class A Hospital

ObjectiveTo investigate the omeprazole off-label use in outpatient and inpatient department in third-grade class A hospital from June 2015 to May 2016.Then,based on the results of the investigation,the causes and risks of omeprazole over-the-counter medications were analyzed,so as to promote the rational use of omeprazole in hospital.MethodsIn retrospective survey,1042 omeprazole prescriptions were selected from outpatient department and 989 omeprazole hospitalized cases were selected from inpatient department during Jun 2015 to May 2016 by random number table.According to the omeprazole drug product specification,to determine whether to use the drug beyond the specification,then compare the analysis of outpatient and inpatient Off-label use;Off-label use was analyzed by reviewing domestic and foreign guidelines,literatures and Micromedex Health Care Series database.ResultsOutpatient prescriptions: Among 1042 prescriptions,there were 989 prescriptions of off-label drug use,the incidences of off-label drug use were94.91%,involving 20 items and 3 types of off-label drug use.Main type of off-label drug use was over-indication medication and the constituent ratio was 96.39%.There was no statistical significance in the incidence of off-label drug use between digestive department and non-digestive department or among physicians at different levels(P>0.05).Among 20 items of off-label drug use,8 items were supported by evidence-based medicine evidence of domestic and foreign guideline,expert consensus/suggestion or literature reports,etc.;among which 1 item of off-label drug use were included in Micromedex grading system and other 12 items had no evidence-based medicine evidence.Hospitalized cases: Among 989 hospitalized cases,there were 764 hospitalized cases of off-label drug use,the incidences of off-label drug use were77.25%,involving 14 items and 3 types of off-label drug use.Main type of off-label drug use was over-indication medication and the composition ratio was 92.58%.There was a statistically significant difference in the incidence of drug abuse between the digestive and non-specialist guidelines and the incidence of over-specific drug use among physicians at different levels(P<0.05).Among 14 items of off-label drug use,10 items were supported by evidence-based medicine evidence of domestic and foreign guideline,expert consensus/suggestion or literature reports,etc.;among which 1 item of off-label drug use were included in Micromedex grading system and other 4 items had no evidence-based medicine evidence.Outpatient and inpatient comparisons:The incidence of out-of-spec medication in outpatients is greater than that in over-inpatient admissions.There was a significant difference in the incidence of out-of-label medications between outpatients and inpatients(P<0.01).There was a significant difference between outpatient and inpatient hospitals for different over-specific medication types(P<0.01).Omeprazole was used in outpatient and in-patient gastroenterology departments.There was no statistically significant difference between the incidence rates(P>0.05).There was a significant difference in the incidence of omeprazole use between the outpatients and the non-specialized hospitals(P<0.01).The outpatient chief physician and the chief physician were super.The incidence of prescription drug use was not statistically significant(P>0.05).There was a statistically significant difference in the incidence of over-specific drug use between the outpatient deputy chief physician and the in-patient deputy chief physician,outpatient attending physician and in-patient attending physician,outpatient resident physician and inpatient resident physician(P<0.05).Conclusion1.The phenomenon of omeprazole off-label use is widespread in outpatient department and inpatient department of the hospital,and some off-label drug use are supported by evidences.There are differences in the quality of those evidences.2.In clinical practice,it is reasonable and necessary for the existence of off-label drug use.3.Off-label drug use is intricate.There is legal risk in off-label drug use.Clinicians should standardize off-label drug use,in the interests of the patients,weighing the pros and cons of off-label drug use,perfect the off-label drug use for the record,and reduce the legal risk and ensure patient medication safety.