Variability in the quality of overdose advice in Summary of Product Characteristics (SPC) documents: gut decontamination recommendations for CNS drugs
Version of Record online: 15 OCT 2008
© 2008 The Authors. Journal compilation © 2008 The British Pharmacological Society
British Journal of Clinical Pharmacology
Volume 67, Issue 1, pages 83–87, January 2009
How to Cite
Wall, A. J. B., Bateman, D. N. and Waring, W. S. (2009), Variability in the quality of overdose advice in Summary of Product Characteristics (SPC) documents: gut decontamination recommendations for CNS drugs. British Journal of Clinical Pharmacology, 67: 83–87. doi: 10.1111/j.1365-2125.2008.03322.x
- Issue online: 22 DEC 2008
- Version of Record online: 15 OCT 2008
- Received 21 August 2008Accepted2 October 2008
- gastric lavage;
- gut decontamination;
- poisoning management;
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT
• The Summary of Product Characteristics (SPC) is a legal document that gives healthcare providers information concerning each specific drug, including advice on the management of overdose.
• Clinical outcomes after drug overdose may be influenced by the appropriate use of gut decontamination procedures.
• The extent to which poisoning management advice in the SPC agrees with Poisons Centres recommendations is uncertain.
WHAT THIS STUDY ADDS
• Significant discrepancies exist between poisoning management advice contained in SPC documents and TOXBASE recommendations.
• SPC documents may include inappropriate recommendations for induced emesis and gastric lavage, or omission of oral activated charcoal as a potentially effective therapy.
• The SPC document cannot be relied on as a primary reference source for advice concerning drug overdose.
Deliberate self-poisoning is a major cause of morbidity and mortality. The Summary of Product Characteristics (SPC) document is a legal requirement for all drugs, and Section 4.9 addresses the features of toxicity and clinical advice on management of overdose. The quality and appropriateness of this advice have received comparatively little attention.
Section 4.9 of the SPC was examined for all drugs in the central nervous system (CNS) category of the British National Formulary. Advice concerning gut decontamination was examined with respect to specific interventions: induced vomiting, oral activated charcoal, gastric lavage, and other interventions. Data were compared with standard reference sources for clinical management advice in poisoning. These were graded ‘A’ if no important differences existed, ‘B’ if differences were noted but not thought clinically important, and ‘C’ if differences were thought to be clinically significant.
SPC documents were examined for 258 medications from 67 manufacturers. The overall agreement was ‘A’ in 23 (8.9%), ‘B’ in 28 (10.9%) and ‘C’ in 207 (80.2%). Discrepancies were due to inappropriate recommendation of induced emesis in 21.7% (95% confidence interval 17.1, 27.1), gastric lavage in 38.4% (32.7, 44.4), other gut decontamination in 5.8% (3.6, 9.4) and failure to recommend oral activated charcoal in 57.4% (51.1, 63.4).
Gut decontamination advice in SPC documents with respect to CNS drugs was inadequate. Possible reasons for the observed discrepancies and ways of improving the consistency of advice are proposed.