Investigation And Analysis Of Off-label Drug Use In A Orthopedics Hospital

Objective:To investigate and analyse the Off-label Drug Use in prescriptions for chemical and biological in outpatient and emergency department,also in adverse drug reaction report in a orthopedics hospital,and to provide data reference and suggestions for the development of the medication management system.Methods:The outpatient and emergency prescriptions for chemical and biological in 2015 were extracted from the department of Emergency,Pediatric Orthopedics,Orthopedics,Internal Medicine,Surgery,Hand Surgical,Osteoarthrosis,Sports Medicine,Spine,Ankylosing Spondylitis,Traditional Chinese Manipulation,Soft Injury,Rehabilitation,Pain in Zhenggu Hospital of QuanZhou by a randomized stratification method,and the behavior of off-label drug use was determined according to the drug package insert which the drugs were used in the hospital.The prescriptions were implemented by a double review,if there has any divergence,it was resolved by discussion or by a third party.The off-label drug use proportion of the prescriptions,the off-label drug use proportion of medication records,the type of off-label drug use and the top ten drugs of each type,the off-label drug use drug classification,the off-label drug use proportion of each department were analyzed.Results:A total of 2213 prescriptions were collected,5375 medication records were analyzed,involving 193 kinds of drugs.The off-label drug use proportion of the prescriptions was 66.2%,the off-label drug use proportion of medication records was 43.8%,the off-label drug use proportion of durg varieties was 53.3%.The most common of off-label drug use types was off-label indications,accounting for 78.7%,followed by off-label frequency,accounting for 26.1%.The top three of off-label drug use drug calssification were digestive system drugs,endocrine system drugs and anti-rheumatic drugs,accounting for 38.6%,13.5% and 13.0%,respectively.Among them,the gastric acid secretion inhibitor was the most one,omeprazole enteric-coated capsules,omeprazole enteric-coated tablets,and famotidine tablets amount to accounted for 43.6% of the drug off-label indications use records,accounting for 34.3% of the total off-label drug use records.The top three off-label drug use proportion of the prescriptions were 90.4%,88.1% and 80.0% respectively for the department of Internal Medicine,Pain and Surgery,and the top three off-label drug use proportion of medication records were 56.0%,55.4% and 53.2% for the department of Ankylosing Spondylitis,Internal Medicine and Soft Injury.Conclusion:There are a large number of generic drugs in China,and the quality of standard for drug package insert is low,there is not very binding on drug manufacturer to revise the drug package insert,the legal risk of the off-label drug use is high.Off-label drug use was widespread in outpatient and emergency prescriptions which about chemical and biological in this hospital,it must as soon as possible to develop off-label drug use management system to maximum reduction and avoid legal risks.