Information deficits in the summary of product characteristics preclude an optimal management of drug interactions: a comparison with evidence from the literature

Bergk, Verena; Haefeli, Walter E.; Gasse, Christiane; Brenner, Hermann; Martin‐Facklam, Meret

doi:10.1007/s00228-005-0943-4

Cited by 67 publications

(43 citation statements)

References 18 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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“…Important information can be the most common adverse effects, significant contraindications, significant drug interactions, and advice during special conditions, contraindications during pregnancy and lactation, driving and machine safety. 15 These important information must be printed in such a way that patient and often practitioners must be able to note it, the moment they go through the literature. In our study, we evaluated the ease of finding such important information in drug inserts and we found that our drug companies have to work a long way in making such patient friendly inserts.…”

Section: Discussionmentioning

confidence: 99%

Drug package inserts: how accessible is the information?

Sudha

Viveka

Remya

et al. 2015

Int J Basic Clin Pharmacol

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“…For example information about drug-drug interactions can be found in the SPC for drug A from provider 1 but is missing in the SPC for the same product from provider 2. Alternatively, the drug-drug interaction between drug A and B can be found in the SPC text for drug A but not for drug B (Bergk et al, 2005). Another example for inconsistencies is the classification for drug and pregnancy alerts for pharmaceutical products.…”

Section: Development Of Knowledge Databasesmentioning

confidence: 99%

Knowledge Bases for Clinical Decision Support in Drug Prescribing – Development, Quality Assurance, Management, Integration, Implementation and Evaluation of Clinical Value

Eiermann¹,

Rahmner²,

Korkmaz³

et al. 2010

Decision Support Systems

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Information deficits in the summary of product characteristics preclude an optimal management of drug interactions: a comparison with evidence from the literature

Cited by 67 publications

References 18 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

Drug package inserts: how accessible is the information?

Knowledge Bases for Clinical Decision Support in Drug Prescribing – Development, Quality Assurance, Management, Integration, Implementation and Evaluation of Clinical Value

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