Clinical relevance of information in the Summaries of Product Characteristics for dose adjustment in renal impairment



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).


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.


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.


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.

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We would like to thank Fundaçao para a Ciencia e a Tecnologia, Ministry of Education and Science, Portugal, for supporting this work (Doctoral Grant reference number SFRH/BD/43999/2008).

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Correspondence to Fernando Fernandez-Llimos.

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Online Appendix 1

Formulary structure used to extract data from SmPCs (DOC 41 kb)


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Salgado, T.M., Arguello, B., Martinez-Martinez, F. et al. Clinical relevance of information in the Summaries of Product Characteristics for dose adjustment in renal impairment. Eur J Clin Pharmacol 69, 1973–1979 (2013) doi:10.1007/s00228-013-1560-2

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  • Clinical decision support systems
  • Dose adjustment
  • Drug labelling
  • Physician order entry systems
  • Renal impairment