Random and systematic medication errors in routine clinical practice: a multicentre study of infusions, using acetylcysteine as an example

• Published in: British journal of clinical pharmacology 2001-11, Vol.52 (5), p.573-577
• Main Authors: Ferner, R. E., Langford, N. J., Anton, C., Hutchings, A., Bateman, D. N., Routledge, P. A.
• Format: Article
• Language: English
• Subjects: acetaminophen (paracetamol); Acetaminophen - poisoning; acetylcysteine; Acetylcysteine - analysis; Acetylcysteine - therapeutic use; Analgesics, Non-Narcotic - poisoning; Biological and medical sciences; Dose-Response Relationship, Drug; Free Radical Scavengers - analysis; Free Radical Scavengers - therapeutic use; General pharmacology; Humans; infusions; Infusions, Intravenous; intravenous; Medical sciences; medication errors; Medication Errors - statistics & numerical data; Miscellaneous; Pharmacology. Drug treatments; Pharmacovigilance; Poisoning - drug therapy; quality control
• ISSN: 0306-5251; 1365-2125
• DOI: 10.1046/j.0306-5251.2001.01490.x

Aims  The nature and incidence of errors in prescribing and giving medicines have previously been estimated by trained observers, or by retrospective analysis of incidents in which patients have come to harm. We have examined prospectively in routine clinical practice the concentrations of intravenous infusions of a drug (acetylcysteine) which is given according to a complicated dosing schedule. Methods  We prospectively collected samples before and, where possible, after the infusion of acetylcysteine in 66 anonymous patients requiring treatment for acetaminophen (paracetamol) overdose in four centres in the United Kingdom. We measured the concentration in each infusion bag, and deduced from the weight of the patient the percentage of the anticipated dose that had actually been given. Results  The experimentally determined dose was within 10% of the anticipated dose in 68 of 184 individual bags (37%), and within 20% of the anticipated dose in 112 bags (61%). Doses in 17 bags were more than 50% from the anticipated doses. In three patients, values in all three bags appeared to be systematically wrong by 50% or more; in a further seven cases, individual bags differed by 50% or more from the anticipated value. The median difference between pre‐ and post‐infusion samples was 0% [interquartile range −5.2% to +14.6%], but 9% showed a disparity of greater than ± 50%. Conclusions  Our data suggest that there is large random variation in administered dosage of intravenous infusions. Systematic calculation errors occur in about 5% [95% confidence interval 2, 8%] of cases, and major errors in drawing up in a further 3% [1, 7%], with inadequate mixing in 9% [4, 14%]. While we have no evidence that patients were adversely affected, and while the regime of administration of the drug studied (acetylcysteine) is complicated, these data suggest that the delivered dose often deviates from the intended dose, and that methods of quality control are needed.