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

Salgado, Teresa M.; Arguello, Blanca; Martínez-Mart́inez, Fernando; Benrimoj, Shalom I.; Fernández-Llimós, Fernando

doi:10.1007/s00228-013-1560-2

Cited by 16 publications

(17 citation statements)

References 40 publications

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“…Despite being considered a leading source of information for safety data and evidence-based prescribing decisions [15], SmPCs have been criticized for containing important clinical pharmacology information deficits [16], for being suboptimal sources of information for drug−drug interactions [17], food−drug interactions [18], therapeutic drug monitoring [19], or dose adjustment in renal impairment [20]. In addition, SmPCs have also been criticized for being too verbose, lacking standardization and being heterogeneous [21].…”

Section: Introductionmentioning

confidence: 99%

Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation

Arguello

Salgado

Fernández-Llimós

2015

Brit J Clinical Pharma

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AIMSTo assess the completeness and applicability of information for the use of medicines in pregnancy and lactation contained in European Summaries of Product Characteristics (SmPCs). METHODSSmPCs available on the EMA website in April 2011 were retrieved, and information on the use of medicines during pregnancy and lactation was analyzed. A form was designed to extract information regarding drug concentrations crossing the placenta, excretion of the drug in milk, the existence of pre-clinical and clinical studies and clinical experience describing the use of the medicine in pregnancy and lactation, medicine effects on human fertility, medicines use in women of child-bearing potential and specific recommendations for use during pregnancy and breastfeeding. SmPCs were classified as containing 'conclusive' or 'ambiguous' information depending on whether (or not) they provided clear instructions regarding medicine use in pregnancy and lactation. RESULTSOf the 534 SmPCs, 89.3% did not mention whether the drug crossed the placenta, 67.6% indicated that there was no clinical experience during pregnancy and in 61.4% it was unknown whether the medicine was excreted in human milk. Recommendations for medicine use during pregnancy and breastfeeding were ambiguous in 57.0% and 16.5% of the SmPCs, respectively, and medicine use was restricted in over 90% SmPCs for both pregnancy and breastfeeding, despite no information supporting these restrictions being reported. The time elapsed since a SmPCs first approval was not associated with an increase in information quality. CONCLUSIONSImportant information deficits on the use of medicines during pregnancy and breastfeeding were found in European SmPCs. WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• Reliable information regarding the use of many medicines during pregnancy is critical for researchers and healthcare professionals who work in antenatal care, but this information has been found to differ across different sources.• The Summary of Product Characteristics (SmPCs) is the European official medicines information source for professionals and contains a specific section to include information on medicines use during pregnancy and lactation to guide decision making.• Future electronic versions of SmPCs to be included in clinical decision support systems will require intelligible and logical electronic information. WHAT THIS STUDY ADDS• Important information deficits on the use of medicines during pregnancy and lactation were found in European SmPCs, and the time elapsed since a SmPC's marketing authorization was not associated with an increase in information quality.• Post-authorization data on the exposure to medicinal products during pregnancy and lactation should be actively collected and included in official information sources to keep them updated and to assist decision making.

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Section: Introductionmentioning

confidence: 99%

Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation

Arguello

Salgado

Fernández-Llimós

2015

Brit J Clinical Pharma

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“…3 It might be relevant to recall that a similar issue as the one bs_bs_banner Letters to the Editor described by the authors was found in the official labelling in the European Union, the so-called Summaries of Product Characteristics (SmPC). 4 It might also be important to point out that discrepancies in renal drug dosing recommendations do have a primary origin that is related to the lack of uniformity in the definition of stages of renal impairment. Although the European Union regulation 3 and other international guidelines 5 clearly describe intervals to define each stage of renal impairment, these recommendations are not always followed.…”

Section: Lack Of Harmonisation In the Classification Of Renal Impairmmentioning

confidence: 99%

“…3 The same exclusion criteria applied in a previous study were considered for this analysis. 4 Out of the 309 (53.1%) SmPC that referred to a mild, moderate or severe stage of renal impairment, 200 (64.7%) presented explicit creatinine clearance limits to define these stages. Instead of complying with the European Union regulation, SmPC presented 11 different creatinine clearance ranges for mild renal impairment; 10 different ranges for mild to moderate renal impairment; 14 different ranges for moderate renal impairment; 3 different ranges for moderate to severe renal impairment; and 18 different creatinine clearance ranges for severe renal impairment.…”

Section: Lack Of Harmonisation In the Classification Of Renal Impairmmentioning

confidence: 99%

Lack of harmonisation in the classification of renal impairment in European Summaries of Product Characteristics

Salgado

Arguello

Martínez-Martínez

et al. 2015

Internal Medicine Journal

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“…However, Salgado et al [7] analyzed and assessed the clinical relevance of the method of dose adjustment in patients with renal insufficiency for the medications that were approved by the European Medicines Agency (EMA) with the Summaries of Product Characteristics (SmPCs) in Europe, and they concluded that only 48.8% of them provided information that was both explicit and relevant [7].…”

Section: Introductionmentioning

confidence: 99%

Evaluation of Concordance Among Different Drug Information Sources Regarding the Recommendations for Dosage Adjustment in Renal Impairment

Choi¹,

Ah²,

Sun³

et al. 2016

Int J Clin Pharmacol Pharmacother

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Background: It is very important to prescribe appropriate drugs and adjust medication and dosage for optimal disease management not only to maximize patient outcomes, but also to minimize adverse events. So, the accuracy of drug information and consistency among different resources would have a significant effect on drug therapy. Objectives: We aimed to evaluate the concordance among five drug information sources regarding the recommendations for dosage adjustment in renal impairment. Methods:The five drug information resources were selected the Korean National Formulary Drug (KNF), the British national formula 2013 (BNF 65), Daily Med in USA, Lexicomp-online, and Drug Prescribing in Renal Failure (DPRF, 5th ed.). After having classified the degrees of renal function and defined the terms used for the dosing methods, we analyzed the concordance in dosing recommendations in renal deficiency among the information sources by calculating Fleiss Kappa. Results: In the dosing adjustments of patients with renal insufficiency, there were some cases of contraindicated drugs that were not matched in each reference. Statistical analysis of the concordance of four references, except DPRF, and evaluation of 168 of the drugs that were mentioned in all four sources showed the Fleiss Kappa coefficientto be 0.243. This indicatesfair agreement among the data. Conclusion: Fair agreement was observed among 4 sources. This may be owing to discrepancies in the frequency of updating drug information sources. We suggest that the quantitative standard be used to classify renal function and to maintain consistency in definition of renal impairment.

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

Cited by 16 publications

References 40 publications

Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation

Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation

Lack of harmonisation in the classification of renal impairment in European Summaries of Product Characteristics

Evaluation of Concordance Among Different Drug Information Sources Regarding the Recommendations for Dosage Adjustment in Renal Impairment

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