title: Clinical relevance of information in the Summaries of Product Characteristics for dose adjustment in renal impairment.
abstract: OBJECTIVE
  Information about dosing adjustments in patients with chronic kidney disease is important to avoid toxicity for several medicines. The aim of our study was to assess the clinical relevance of the instructions for dose adjustment in patients with renal impairment provided in the Summaries of Product Characteristics (SmPCs) approved by the European Medicines Agency (EMA).
  
  
  METHODS
  SmPCs available on the EMA website on April 2011 were retrieved, and information on the elimination route and instructions for use in renal impairment was analysed independently by two of the authors. SmPCs were classified as containing 'explicit' or 'poor' information based on whether they presented (or not) instructions for use of the medicine in renal impairment. Information was considered 'relevant' if SmPCs provided clear instructions for dose adjustment.
  
  
  RESULTS
  Of the 356 SmPCs analysed, 13.8 and 37.4 % were classified as providing poor information and explicit but not relevant information, respectively. Only 48.8 % SmPCs provided both explicit and relevant information on medicine use in renal impairment. No difference was found in the average time since last update among SmPCs classified as containing explicit or poor information, as well as those classified as containing relevant or not relevant information. Also, no association was found between the clinical relevance of the information and whether or not the medication was an orphan drug, and 80 % SmPCs did not provide information on the use of the medicine in patients undergoing haemodialysis.
  
  
  CONCLUSIONS
  Based on our analysis, current versions of SmPCs are characterised by several information deficits and by containing recommendations that are not relevant to clinical practice in terms of dose adjustment in renal impairment. These shortcomings might limit their usefulness for healthcare professionals and integration into clinical decision-making support systems.
authors.affiliation: Research Institute for Medicines and Pharmaceutical Sciences (iMed.UL), Faculty of Pharmacy, University of Lisbon, Av. Prof. Gama Pinto, 1649-003, Lisbon, Portugal.
authors.forename: Teresa M
authors.initials: TM
authors.lastname: Salgado
authors.forename: Blanca
authors.initials: B
authors.lastname: Arguello
authors.forename: Fernando
authors.initials: F
authors.lastname: Martinez-Martinez
authors.forename: Shalom I
authors.initials: SI
authors.lastname: Benrimoj
authors.forename: Fernando
authors.initials: F
authors.lastname: Fernandez-Llimos
mesh_terms: D020000:Decision Support Systems, Clinical; D004346:Drug Information Services; D004348:Drug Labeling; D005060:Europe; D035082:Federal Government; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D051436:Renal Insufficiency, Chronic / Q000188:drug therapy*
chemical_list: D004364:Pharmaceutical Preparations