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Abstract
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Respiratory tract infections are common in children. Evidence for the efficacy of over-the-counter cough and cold medications in young children is limited,1, 2 but they can lead to severe adverse events, including death.3 In Australia, the Therapeutic Goods Administration (TGA) introduced compulsory labelling changes for non-prescription cough and cold products in 2012 (but not herbal products),4 with further changes in 2020 for first generation (sedating) antihistamine-containing products.
We evaluated whether these labelling changes were followed by reductions in reported poisoning exposures. We reviewed calls to the New South Wales Poisons Information Centre (NSWPIC) during 1 January 2010 - 31 December 2021 about children under six years of age exposed to over-the-counter cough and cold medications. NSWPIC receives about 50% of the approximately 220 000 calls to Australian poisons information centres each year. We estimated annual percentage changes (APCs) in annual report rate with the regression program, Joinpoint 4.8.0.1, using permutation test model selection. The study was approved by the Sydney Children's Hospitals Network Human Research Ethics Committee (2021/ETH00165).
A total of 8327 exposures of children under six years of age to non-prescription cough and cold products were reported during 2010-2021 (Box). Almost all were accidental exposures (4264, 51.2%) or therapeutic errors (3953, 47.5%) (Supporting Information, table 2). The mean annual number of reported exposures declined significantly, from 1067 before to 587 after the 2012 changes (APC, -6.3%; 95% confidence interval [CI], -10.3% to -2.0%), primarily because of the decline during 2010-2014 (APC, -17.3%; 95% CI, -26.5% to -6.9%). For products subject to the 2012 labelling change (ie, non-herbal preparations only), the declines were more marked (2010-2021: APC, -11.1%; 95% CI, -14.5% to -7.5%; 2010-2014: -21.4%; 95% CI, -29.2% to -12.7%). The largest decline was for exposures to combinations of sedating antihistamines and decongestants (APC, -15.8%; 95% CI, -26.2% to -3.8%). Exposures to formulations of sedating antihistamines without decongestants did not decline significantly across the entire study period, nor after the 2020 labelling changes, although a reduction during 2010-2018 was evident (APC, -6.8%; 95% CI, -9.8% to -3.8%). Reported exposures to herbal preparations increased during 2010-2021 (APC, 25.1%; 95% CI, 16.0-34.9%)...
Language: en |