Analysis Of Off-label Drug Use In Children From 4 Maternal And Child Health Hospitals In Shanxi Province

Objective:Investigating the extent of off-label drug use in pediatric outpatient and ward of 4Maternal and Child health Hospitals located in different parts of Shanxi Province in 2013.To provide baseline data and the foundation of making policy, supervise laws and policies set up though analyzing causes, risk factors, and giving suggestions, so as to promote clinical rational drug use.Methods:The simple random sampling was conducted in 4 Maternal and Child health Hospitals located in different areas of Shanxi Province to select outpatient prescriptions and hospitalized cases of children from January to December in 2013, and collect the information with the specifically designed form. To collect the corresponding instructions according to advices, to judge whether there existed off-label using from indication, usage and dosage, method, contraindication and compatibility. We used Excel 2003, χ2 test and logistic regression in SPSS17.0 to analyze the statistics.Results:Outpatient prescriptions:(1) Maternal and Child health hospital of Shanxi Province, Maternal and Child health hospital of Taiyuan, Maternal and Child health hospital of Changzhi, Maternal and Child health hospital of Linfen, the rate of off-label drug use was 82.75%, 65.46%, 37.17%,83.75% respectively according to prescriptions; 64.48%, 49.64%, 30.43%, 74.86%according to medical advices.(2) Dosage and frequency, age, indication(or no information with children) were the main categories of off-label drug use.(3) Off-label drug use exists in each age group. And only the rates among age groups in Maternal and Child health hospital of Taiyuan were different(P<0.001), the others’ were no difference.(4) The top 4 drugs used in all hospitals were Chinese patent medicine, alimentary tract and metabolism, anti-infectious for systemic use and respiratory. The rate of off-label use was not only related to the frequency usage of a drug, but also the drug species.Hospitalized cases:(1) Maternal and Child health hospital of Shanxi Province, Maternal and Child health hospital of Taiyuan, Maternal and Child health hospital of Changzhi, Maternal and Child health hospital of Linfen, the rate of off-label drug use was 98.36%, 95.66%, 98.67%,96.20% respectively according to prescriptions; 66.54%, 65.55%, 63.78%, 69.16%according to medical advices.(2) Dosage and frequency, age, indication(or no information with children) were the main categories of off-label drug use.(3) Each age group exists off-label drug use. Except the rates were statistically different(P=0.009) among age groups in Maternal and Child health hospital of Shanxi Province, the others’ were no difference.(4) The primary drugs used in hospitalized children were respiratory, anti-infectious for systemic use and Chinese patent medicine in Maternal and Child health hospital of Taiyuan. The other 3 hospitals used 4 kinds of medicine commonly, they were alimentary tract and metabolism, anti-infectious for systemic use and respiratory, only differ in the fourth drug. The rate of off-label use was not only related to the frequency usage of a drug,but also the drug species.Conclusion:(1) The off-label drug use is widespread in Shanxi Province. There are differencesamong regions, and the rate of off-label drug use in ward is higher than outpatient.(2) Off-label drug use is intricate, it should be treated dialectically between rational drug use and abuse.(3) To clarify the legal status and process etc. of off-label drug use is the most important affairs. With off-label drug use legitimizing and standardizing, rational drug use in children and the doctors’ profession rights will be protected.(4) Under the condition of preferential policies and coercive power to enterprises, it’s the fundamental to solve the problem of off-label drug use that carrying out more pediatric clinical trials.