| ABSTRACT Objective:To understand the off labeled use of medication, through analysis and discussion to seek a reasonable scientific way to solve the off labeled use problem and provide the baseline data for improving the rationality drug use in clinical practice. Methods:The outpatient prescriptions were randomly selected in our hospital from June 2011 to May 2012, and the off labeled use was analyzed according to the package inserts in the following aspects and classification of statistics.Results:3 890 of the total 10 000 prescriptions, (38.90%) were involved in the off label use. All the sample prescriptions contained 34 876 records, and 5 676 (16.27%) had their off label use. According to the prescription rate calculation, 1 486(59.08%) of the total 2 515 pediatric prescriptions had their off label use. According to the calculation of pediatric medication orders record, 2 484(24.54%) of the total 10 124 records had their off label use. The off labeled use types mainly included 2 763 records of indications for drug use accounting for48.68%, 1 885 records of changes in the route of administration accounting for 33.21%, and 1 028 records of super dosage accounting for 18.11%. The higher off labeled drug uses were pediatric Lactobacillus capsules with 642 records, azithromycin capsules with 388 records, obstetrics and gynecology salbutamol with 204 records, 67 times of bromhexine hydrochloride, and 221 times of cimetidine . Conclusion:The off labeled use was a common prevalence in main sections of pediatrics and obstetrics in the aspects of the indications and change in the route of administration for most clinical drug usage. Complied with evidence based medicine basically, the off labeled use was also put in its risk. Physicians and pharmacists must pay more attention to adverse drug reaction, contraindications and precautions to reduce medical disputes and ensure clinical safety and effectiveness of drugs by using drug registration usage and learning from foreign experience to seek legislation. |
