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Canadian Journal of Public Health = Revue Canadienne de Santé Publique logoLink to Canadian Journal of Public Health = Revue Canadienne de Santé Publique
. 2015 Nov 1;106(8):e477–e482. doi: 10.17269/CJPH.106.5148

Mandatory labeling requirements and over-the-counter cough and cold medication use in early childhood

Julie Degroot 17, Laura N Anderson 27, Yang Chen 37, Catherine S Birken 27,37,47, Patricia C Parkin 27,37,47, Sarah Carsley 27,37, Marina Khovratovich 27, Muhammad Mamdani 17,37, Jonathon L Maguire 17,27,37,47,✉; TARGet Kids! collaboration
PMCID: PMC6972244  PMID: 26986907

Abstract

OBJECTIVES: Due to rare but severe adverse events, Health Canada in October 2009 required manufacturers to relabel over-the-counter (OTC) cough and cold medication (CCM) to state that the products should not be used in children <6 years of age. The main objective of this study was to determine whether this labeling standard decreased OTC CCM use among young children with a recent cough, cold or flu.

METHODS: An interrupted time series study was conducted using data from the TARGet Kids! practice-based research network. A total of 3,515 healthy children 1–5 years of age were recruited from 2008–2011; of these, 1,072 had a cough, cold or flu in the previous month. Parents completed a standardized survey instrument. For the primary analysis, use of OTC CCMs prior to and after October 1, 2009 was compared using time series analyses. For the secondary analysis, multivariable logistic regression was used to identify predictors of recent OTC CCM use.

RESULTS: OTC CCM use was reported in 222 of 1,072 (20.7%) children with a cough, cold or flu within the previous month. OTC CCM use declined from 22.2% to 17.8% following the October 2009 Health Canada labeling standard (p = 0.014). Maternal age <35 years (OR 1.49; 95% CI: 1.05–2.13) and having older siblings (OR 1.65; 95% CI: 1.16–2.35) were independently associated with OTC CCM use.

CONCLUSION: Labeling legislation against OTC CCM use for children <6 years resulted in a small decrease in OTC CCM use. Stronger measures may be needed to curtail OTC CCM use, particularly for younger parents and those with multiple children.

Keywords: Nonprescription drugs, child, preschool, drug legislation, time series analysis

Footnotes

Members of the TARGet Kids collaboration are defined in the acknowledgements section.

Acknowledgements: Overall support for the TARGet Kids! program was provided by the CIHR Institutes of Human Development, Child and Youth Health and of Nutrition, Metabolism and Diabetes, as well as the St. Michael’s Hospital Foundation. The Paediatric Outcomes Research Team is supported by a grant from The Hospital for Sick Children Foundation.

TARGet Kids! Collaboration - Scientific Committee: Kawsari Abdullah, Laura N. Anderson, Catherine S. Birken, Cornelia M. Borkhoff, Sarah Carsley, Yang Chen, Mikael Katz-Lavigne, Kanthi Kavikondala, Christine Koroshegyi, Grace Jieun Lee, Jonathon L. Maguire, Dalah Mason, Jessica Omand, Patricia C. Parkin, Navindra Persaud, Meta van den Heuvel, Weeda Zabih; Site Investigators: Jillian Baker, Tony Barozzino, Joey Bonifacio, Douglas Campbell, Sohail Cheema, Brian Chisamore, Karoon Danayan, Paul Das, Mary Beth Derocher, Anh Do, Michael Dorey, Sloane Freeman, Keewai Fung, Charlie Guiang, Curtis Handford, Hailey Hatch, Sheila Jacobson, Tara Kiran, Holly Knowles, Bruce Kwok, Sheila Lakhoo, Margarita Lam-Antoniades, Eddy Lau, Fok-Han Leung, Jennifer Loo, Sarah Mahmoud, Rosemary Moodie, Julia Morinis, Sharon Naymark, Patricia Neelands, James Owen, Michael Peer, Marty Perlmutar, Navindra Persaud, Andrew Pinto, Michelle Porepa, Nasreen Ramji, Noor Ramji, Alana Rosenthal, Janet Saunderson, Rahul Saxena, Michael Sgro, Susan Shepherd, Barbara Smiltnieks, Carolyn Taylor, Thea Weisdors, Sheila Wijayasinghe, Peter Wong, Ethel Ying, Elizabeth Young.

We thank Matthew D’Ascanio, Sharmilaa Kandasamy, Azar Azad, Tonya D’Amour, Kanthi Kavikondala, Tarandeep Malhi, Magda Melo, Subitha Rajakumaran, Juela Sejdo, and Laurie Thompson for administrative and technical support for the TARGetKids! Program.

Conflict of Interest: Dr. Mamdani is a consultant to Astra Zeneca, Bristol-Myers Squibb, Glaxo Smith Kline, Hoffman LaRoche, Novartis and Pfizer, which may produce cough and cold medications. All other authors declare no conflicts of interest.

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Articles from Canadian Journal of Public Health = Revue Canadienne de Santé Publique are provided here courtesy of Springer

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