Investigation of Off-label Drug Use of Pregnant and Parturient Women in Obstetrics Ward / 医药导报

ABSTRACT

Objective To investigate the off-label use status in obstetrics ward so as to provide references for carrying out obstetrics pharmaceutical care and promoting safe medication use in pregnant and parturient women. Methods The prescriptions for pregnant and parturient women from January to June, 2015 in obstetrics ward were investigated. According to drug instructions, the off-label drug use of prescriptions of all selected patients was analyzed in the following aspectsthe category of off-label drug use, and drugs use information. In addition, a logistic regression was conducted that modeled the odds of receiving an off-label prescription as a function of the following possible risk factorspregnant, parturient women and the rank of doctors. The clinical results including the unreasonable drug application, abortion rate and birth defect were compared between the off-label drug use and on-label drug use groups. Results Total of 384 patients were selected, and 5330 prescriptions involving 50 drugs were analyzed. The rate of off-label drug use was 68. 5%, 27. 7% and 24. 0% in patients, prescriptions and drug categories, respectively. The main categories of off-label drug use were super solvent use ( 76. 6%) and indication (14. 3%). The top 3 drugs of off-label use were those for urinary and reproductive (56. 2%), alimentary tract (46. 9%) and traditional Chinese medicine (43. 4%). In addition, there was no significant correlation between the risk of off-label drug use and maternal status and the level of doctors. And no significant difference between the two groups in the unreasonable drug application, abortion rate and birth defect was detected. Conclusion The off-label drug use in obstetrics ward is common in this hospital and most of them are supported by clinical evidence. Due to the lack of more authoritative evidence-based medication, the doctors are suggested to use the drug according to provisions of the drug instructions. When off-label drug use is really needed, it should be based on the surpport of evidence basde medicine,so as to ensure the drug safety for pregnant and parturient women and avoid professional risks.