title: Inconsistencies among European Union pharmaceutical regulator safety communications: a cross-country comparison.
abstract: BACKGROUND
  The European Medicines Agency (EMA) and national regulators share the responsibility to communicate to healthcare providers postmarketing safety events but little is known about the consistency of this process. We aimed to compare public availability of safety-related communications and drug withdrawals from the EMA and European Union member countries for novel medicines.
  
  
  RESULTS
  We performed a cross-sectional analysis using public Dear Healthcare Professional Communications (DHPCs) for all novel medicines authorized between 2001 and 2010 by the EMA and available for use in France, Netherlands, Spain, and the United Kingdom. Between 2001 and 2010, the EMA approved 185 novel medicines. DHPCs could not be ascertained for the EMA. Among the 4 national regulators, as of April 30, 2013, at least one safety DHPC or withdrawal occurred for 53 (28.6%) medicines, totaling 90 DHPCs and 5 withdrawals. Among these 53 medicines, all 4 national agencies issued at least one communication for 17 (32.1%), three of the four for 25 (47.2%), two of the four for 6 (11.3%), and one of the four for 5 (9.4%). Five drugs were reported to be withdrawn, three by all four countries, one by three and one by two. Among the 95 DHPCs and withdrawals, 20 (21.1%) were issued by all 4 national regulators, 37 (38.9%) by 3 of the 4, 22 (23.2%) by 2 of the 4, and 16 (16.8%) by one. Consistency of making publicly available all identified safety DHPC or withdrawal across regulator pairs varied from 33% to 73% agreement.
  
  
  CONCLUSIONS
  Safety communications were not made publicly available by the EMA. Among the 4 European member countries with national regulators that make DHPCs publicly available since at least 2001, there were substantial inconsistencies in safety communications for novel medicines. The impact of those inconsistencies in terms of public health remains to be determined.
authors.affiliation: Sciences Po, Paris, France; Department of Gastroenterology and Nutrition, Saint-Antoine Hospital, APHP, Paris, France; Department of Proctology, Deaconesses Hospital, Paris, France.
authors.forename: Jean-David
authors.initials: JD
authors.lastname: Zeitoun
authors.affiliation: Department of Digestive and General Surgery, Saint-Antoine Hospital, APHP, Paris, France; University Paris VI, Paris, France.
authors.forename: Jérémie H
authors.initials: JH
authors.lastname: Lefèvre
authors.affiliation: Yale University School of Medicine, New Haven, Connecticut, United States of America.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Downing
authors.affiliation: Sciences Po, Paris, France; Senior Research Fellow at the National Centre for Scientific Research (CNRS), Paris, France.
authors.forename: Henri
authors.initials: H
authors.lastname: Bergeron
authors.affiliation: Section of General Internal Medicine and the Robert Wood Johnson Clinical Scholars Program, Department of Internal Medicine, Yale University School of Medicine, and the Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut, United States of America.
authors.forename: Joseph S
authors.initials: JS
authors.lastname: Ross
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards; D003430:Cross-Sectional Studies; D005062:European Union; D006801:Humans; D007390:International Agencies / Q000458:organization & administration*; D007880:Legislation, Drug / Q000592:standards*; D004364:Pharmaceutical Preparations / Q000592:standards*; D056737:Safety-Based Drug Withdrawals
chemical_list: D004364:Pharmaceutical Preparations