Chinese Journal of Pharmacovigilance ›› 2011, Vol. 8 ›› Issue (1): 50-51.

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The Quality Evaluation of State Contraceptives Adverse Reaction Reports in 2009

CHEN Ying, ZHU Xiang-jun, LI Ying   

  1. State Contraceptives Adverse Reaction Surveillance Center, Jiangsu Institute of Planned Parenthood Research, Jiangsu Nanjing 210036, China
  • Received:2010-07-23 Online:2011-01-10 Published:2015-08-24

Abstract: Objective To evaluate the quality of the adverse drug reaction reports of the State Contraceptives Adverse Reaction Surveillance Center(SCARS). Methods 325 contraceptives adverse reaction(CAR) cases collected by SCARS in 2009 have been scored and analyzed from authenticity, normalization and integrality. Results There are 58.46% reports score above 90. Mistakes that happened concentrate on the following items: adverse drug reaction(ADR) process description was incomplete, item vacancies, ADR analysis and evaluation opinion were incompatible, and haven't receive any relative medical reports. Conclusion Totally the quality of CAR reports are fine, but there are still a few quality problems in common. According to the above results, SCARS can elevate the quality of CAR reports by more training.

Key words: contraceptive drugs, adverse drug reaction(ADR), quality evaluation

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