title: Reporting patterns of adverse drug reactions over recent years in China: analysis from publications.
abstract: OBJECTIVE
  The goal of this study was to clarify the reporting patterns of self-reported adverse drug reactions (ADRs) in China.
  
  
  METHODS
  A variety of sources were searched, including the official website of China FDA, the national center for ADR monitoring center, publications from PubMed, and so on. We retrieved the relevant information and made descriptive and comparative analysis from the year 2009 to 2013.
  
  
  RESULTS
  The ADR reporting numbers were 638,996, 692,904, 852,799, 1,200,000 and 1,317,000 from 2009 to 2013, respectively. Healthcare professionals contributed significantly, and their proportion always exceeded 80% before 2012. The average report per million inhabitants has increased from 479 to 983 from 2009 to 2013. However, the proportion of new or serious report was always below 25%. The reports mainly concern anti-infective agents and traditional Chinese medicine (TCM), especially TCM injection. The proportion of ADR reports in geriatric patients has increased for 4 consecutive years.
  
  
  CONCLUSIONS
  ADR report numbers and reporting rates in China are on the rise. However, the proportion of new or serious reports as well as the proportion of reports contributed by consumers and pharmaceutical companies are still quite low. More attention should be paid to the elderly, anti-infective agents and TCM, especially TCM injections.
authors.affiliation: Second Military Medical University, Department of Health Statistics , Shanghai, 200433 , China.
authors.forename: Xiao-jing
authors.initials: XJ
authors.lastname: Guo
authors.forename: Xiao-fei
authors.initials: XF
authors.lastname: Ye
authors.forename: Xing-xing
authors.initials: XX
authors.lastname: Wang
authors.forename: Jing
authors.initials: J
authors.lastname: Wang
authors.forename: Wen-tao
authors.initials: WT
authors.lastname: Shi
authors.forename: Qing-bin
authors.initials: QB
authors.lastname: Gao
authors.forename: Tian-yi
authors.initials: TY
authors.lastname: Zhang
authors.forename: Jin-fang
authors.initials: JF
authors.lastname: Xu
authors.forename: Tian-tian
authors.initials: TT
authors.lastname: Zhu
authors.forename: Jia
authors.initials: J
authors.lastname: He
mesh_terms: D017677:Age Distribution; D000890:Anti-Infective Agents / Q000009:adverse effects; D002681:China / Q000453:epidemiology; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D006801:Humans; D008516:Medicine, Chinese Traditional / Q000009:adverse effects; D010506:Periodicals as Topic / Q000639:trends*; D057566:Self Report
chemical_list: D000890:Anti-Infective Agents
keywords: China; pharmacovigilance; reporting pattern; self-reported adverse drug reaction