Abstract:
OBJECTIVE To supply basises and references for the formulation of the policy by analyzing the applications of off-label prescriptions in the reproductive center of Ningbo Women and Children's Hospital in 2015 retrospectively.
METHODS By a retrospective survey method, all prescriptions were selected from fertility clinics center of the hospital in 2015. Firstly, all prescriptions were judged whether off-label or not according to drug instructions and were classified to which type it belonged to and were analyzed to study how many kinds of drugs they involved. Then, to compare constituent ratio of off-label prescriptions with different grades evidence support in the total prescriptions. At last, compared of off label drugs uses in different age group using Chi-square test to detect if there was significant difference.
RESULTE A total of 46 621 prescriptions were extracted from the outpatient reproductive center, and they contained 90 951 medication orders. The incidences of the off-label drug uses stood at 58.76% or 35.70% of them. The types of off-label drug uses mainly included two kinds, which were super adaptation (56.25%) and super dosage (39.55%) and they sumed up to 95% of all off-label drug uses. Steroid hormone drugs (45.11%) and growth hormone (31.26%) were in the top two of the super adaptation. The difference was significant in each two groups of the three groups of the age group 30-39 and below age 29 and elder age 40 (
P<0.01). Comparisons of the three kinds of different medical evidence of off label uses, the off-label prescriptions with higher authority evidence support were of higher proportion in the total prescriptions.
CONCLUSION It was generally of off-label drugs in the reproductive center of Ningbo Women and Children's Hospital in 2015. Through reasonable evaluation of prescriptions, the study provides the basis for the rational use of drugs in the clinics. Corresponding laws and regulations should be introduced by the relevant national institutions to protect reasonable off-label use behavisis in clinical practice.