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

• Type: Article in International Scientific Journal
• Date: 2013

Authors

Salgado, TM (Author) Other; Arguello, B (Author) Other; Martinez Martinez, F (Author) Other; Benrimoj, SI (Author) Other; Fernandez Llimos, F (Author) Other

Journal

Title: European Journal of Clinical Pharmacology

Vol. 69

Pages: 1973-1979

ISSN: 0031-6970

Publisher: Springer Nature

Indexing

ISI Web of Knowledge - 13 Citations

Scopus - 12 Citations

Other information

Authenticus ID: P-006-6C9

DOI: 10.1007/s00228-013-1560-2

Abstract (EN): 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.

Language: English

Type (Professor's evaluation): Scientific

No. of pages: 7