ArticleEuropean journal of clinical pharmacology2013
Clinical relevance of information in the Summaries of Product Characteristics for dose adjustment in renal impairment.
Article in European journal of clinical pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Who cites it
11 citing papers in PubMed, 16 citations in OpenAlex.
- Article
- Renal Dose Adjustment in European Primary Care: Clinical Nuances and Practical Challenges.Journal of clinical medicine · 2026Article
- Investigating Variations in Medicine Approvals for Attention-Deficit/Hyperactivity Disorder: A Cross-Country Document Analysis Comparing Drug Labeling.Journal of attention disorders · 2024Article
- Discrepancies among equations to estimate the glomerular filtration rate for drug dosing decision making in aged patients: a cross sectional study.International journal of clinical pharmacy · 2024Article
- Comprehensibility of Contraindications in German, UK and US Summaries of Product Characteristics/Prescribing Information-A Comparative Qualitative and Quantitative Analysis.Journal of clinical medicine · 2022Article
- An inventory of medicinal products causing skin rash: Clinical and regulatory lessons.Experimental and therapeutic medicine · 2019Article
- Evaluation of Information in Summaries of Product Characteristics (SmPCs) on the Use of a Medicine in Patients With Hepatic Impairment.Frontiers in pharmacology · 2019Article
- Comparing cytochrome P450 pharmacogenetic information available on United States drug labels and European Union Summaries of Product Characteristics.The pharmacogenomics journal · 2017Article
- Drug-Induced Nephrotoxicity and Dose Adjustment Recommendations: Agreement Among Four Drug Information Sources.International journal of environmental research and public health · 2015Article
- Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation.British journal of clinical pharmacology · 2015Article
- Understanding physicians' behavior toward alerts about nephrotoxic medications in outpatients: a cross-sectional analysis.BMC nephrology · 2014Observational
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Authors and funding
5 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeInformation 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).
methodsSmPCs 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.
resultsOf 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.
conclusionsBased 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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