title: Impact of amending the acetylcysteine marketing authorisation on treatment of paracetamol overdose.
abstract: In September 2012, the Medicines and Healthcare products Regulatory Agency (MHRA) substantially amended the Marketing Authorisation for acetylcysteine following an extensive review. The present study examined the impact of this license change on patterns of acetylcysteine use in patients presenting to hospital after paracetamol (acetaminophen) overdose. Between September 2011 and April 2013, 785 consecutive patients presented to York Hospital due to paracetamol overdose, and a before-after analysis was used to compare outcomes. There were 483 patients before and 302 patients after the license amendment, and age, gender, acute or staggered overdose pattern, and dose were similar in both groups. In the patients with paracetamol concentrations between the "100-line" and "200-line," a significantly higher proportion received acetylcysteine treatment (51% before versus 98% after, P = 0.0029), as expected. A modest increase was also observed in relation to late or staggered overdose or cases where the time of ingestion was uncertain (53% versus 74%, P = 0.0430). The median duration of hospital stay increased across the entire study population, from 15 to 24 hours (P = 0.0159) due to the increased proportion of patients requiring acetylcysteine treatment. The findings indicate that the MHRA amendment is a financially costly intervention, and further studies are needed to examine clinical outcomes so that its cost effectiveness might be addressed.
authors: Acute Medical Unit, York Teaching Hospital NHS Foundation Trust, Wigginton Road, York YO31 8HE, UK.
authors: G
authors: G
authors: Thompson
authors: S B
authors: SB
authors: Fatima
authors: N
authors: N
authors: Shah
authors: G
authors: G
authors: Kitching
authors: W S
authors: WS
authors: Waring
references: Br J Clin Pharmacol. 2001 Jan;51(1):87-91
references: 11167669
references: BMC Pharmacol Toxicol. 2013 Apr 04;14:20
references: 23556549
references: Open Access Emerg Med. 2011 Dec 23;3:87-96
references: 27147856
references: Hepatology. 2002 Apr;35(4):876-82
references: 11915034
references: Br J Clin Pharmacol. 2012 Dec;74(6):1066-7
references: 22835053
references: Basic Clin Pharmacol Toxicol. 2012 Nov;111(5):356-60
references: 22510218
references: Scand J Gastroenterol. 2012 Nov;47(11):1344-52
references: 22827594
references: Expert Rev Clin Pharmacol. 2012 May;5(3):311-8
references: 22697593
references: Gut. 2005 Apr;54(4):515-21
references: 15753537
references: Am J Ther. 2013 Jan;20(1):37-40
references: 23299230
references: QJM. 2007 Feb;100(2):93-6
references: 17237484
references: Eur J Clin Pharmacol. 2012 Nov;68(11):1541-7
references: 22527349
references: Pediatrics. 1975 Jun;55(6):871-6
references: 1134886
references: Open Access Emerg Med. 2011 Oct 13;3:69-76
references: 27147854
references: J Toxicol Sci. 2007 Feb;32(1):1-7
references: 17327689
references: Acad Emerg Med. 2008 Jan;15(1):54-8
references: 18211314
references: Clin Toxicol (Phila). 2011 Jul;49(6):452-6
references: 21824056
references: Clin Toxicol (Phila). 2008 Jul;46(6):496-500
references: 18584360
references: Curr Clin Pharmacol. 2013 May;8(2):164-8
references: 23062037
references: Lancet. 1977 Aug 27;2(8035):432-4
references: 70646
references: Clin Chem. 1983 Feb;29(2):358-61
references: 6821946
references: Clin Toxicol (Phila). 2013 Mar;51(3):130-3
references: 23473457
references: Br J Clin Pharmacol. 2013 Dec;76(6):946-50
references: 23488574