Advertisement

Canadian Journal of Public Health

, Volume 106, Issue 8, pp e477–e482 | Cite as

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

  • Julie Degroot
  • Laura N. Anderson
  • Yang Chen
  • Catherine S. Birken
  • Patricia C. Parkin
  • Sarah Carsley
  • Marina Khovratovich
  • Muhammad Mamdani
  • Jonathon L. Maguire
  • TARGet Kids! collaboration
Quantitative Research

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 

Résumé

OBJECTIFS : En raison d’effets secondaires rares mais graves, Santé Canada a exigé en octobre 2009 que les fabricants refassent les étiquettes des médicaments en vente libre contre la toux et le rhume (MEVLCTR) pour indiquer que ces produits ne doivent pas être administrés aux enfants de <6 ans. Le principal objectif de notre étude était de déterminer si cette norme d’étiquetage a réduit l’administration des MEVLCTR aux jeunes enfants ayant récemment eu une toux, un rhume ou une grippe.

MÉTHODE : Nous avons mené une étude des séries chronologiques interrompues à l’aide des données de TARGet Kids!, un réseau de recherche fondée sur la pratique. Entre 2008 et 2011, nous avons recruté 3 515 enfants sains âgés de 1 à 5 ans; de ce nombre, 1 072 avaient eu une toux, un rhume ou une grippe au cours du mois précédent. Les parents ont rempli un instrument de sondage standardisé. Pour l’analyse primaire, nous avons comparé l’administration des MEVLCTR avant et après le 1er octobre 2009 à l’aide d’analyses des séries chronologiques. Pour l’analyse secondaire, nous avons utilisé la régression logistique multivariée pour repérer les variables prédictives de l’utilisation récente de MEVLCTR.

RÉSULTATS : L’utilisation de MEVLCTR a été déclarée pour 222 des 1 072 (20,7%) enfants ayant eu une toux, un rhume ou une grippe au cours du mois précédent. L’utilisation des MEVLCTR a baissé, passant de 22,2% à 17,8%, après l’imposition de la norme d’étiquetage par Santé Canada en octobre 2009 (p= 0,014). L’âge maternel <35 ans (RC 1,49; IC de 95%: 1,05–2,13) et la présence de frères et sœurs plus âgés (RC 1,65; IC de 95%: 1,16–2,35) étaient indépendamment associés à l’utilisation des MEVLCTR.

CONCLUSION : La loi sur l’étiquetage des MEVLCTR pour en empêcher l’administration aux enfants <6 ans a entraîné une légère diminution de l’utilisation de ces produits. Des mesures plus strictes pourraient être nécessaires pour limiter l’utilisation des MEVLCTR, particulièrement par les jeunes parents et dans les familles de plusieurs enfants.

Mots Clés

médicaments en vente libre enfant d’âge préscolaire législation pharmaceutique analyse des séries chronologiques 

References

  1. 1.
    Vernacchio L, Kelly JP, Kaufman DW, Mitchell AA. Medication use among children <12 years of age in the United States: Results from the Slone Survey. Pediatrics 2009;124(2):446–54. PMID: 19651573. doi: 10.1542/ peds.2008-2869.CrossRefGoogle Scholar
  2. 2.
    Smith MB, Feldman W. Over-the-counter cold medications. A critical review of clinical trials between 1950 and 1991. JAMA 1993;269(17):2258–63. PMID: 8097268.CrossRefGoogle Scholar
  3. 3.
    Smith SM, Schroeder K, Fahey T. Over-the-counter (OTC) medications for acute cough in children and adults in ambulatory settings. Cochrane Database Syst Rev 2012;8:CD001831.Google Scholar
  4. 4.
    De Sutter IMA, van Driel ML, Kumar AA, Lesslar O, Skrt A. Oral antihistamine-decongestant-analgesic combinations for the common cold. Cochrane Database Syst Rev 2012;2:CD00497.Google Scholar
  5. 5.
    Dart RC, Paul IM, Bond GR, Winston DC, Manoguerra AS, Palmer RB. Pediatric fatalities associated with over the counter (nonprescription) cough and cold medications. Ann Emerg Med 2009;53(4):411–17. PMID: 19101060. doi: 10.1016/j.annemergmed.2008.09.015.CrossRefGoogle Scholar
  6. 6.
    Rimsza ME, Newberry S. Unexpected infant deaths associated with use of cough and cold medications. Pediatrics 2008;122(2):e318–22. PMID: 18676517. doi: 10.1542/peds.2007-3813.CrossRefGoogle Scholar
  7. 7.
    Centers for Disease Control and Prevention Infant deaths associated with cough and cold medications-two states 2005. MMWR Morb Mortal Wkly Rep 2007;56(1):1–4.Google Scholar
  8. 8.
    Shehab N, Schaefer MK, Kegler SR, Budnitz DS. Adverse events from cough and cold medications after a market withdrawal of products labeled for infants. Pediatrics 2010;126(6):1100–7. doi: 10.1542/peds.2010-1839.CrossRefGoogle Scholar
  9. 9.
    Klein-Schwartz W, Sorkin JD, Doyon S. Impact of the voluntary withdrawal of over-the-counter cough and cold medications on pediatric ingestions reported to poison centers. Pharmacoepidemiol Drug Saf 2010;19(8):819–24. PMID: 20533537. doi: 10.1002/pds.1971.CrossRefGoogle Scholar
  10. 10.
    Schillie SF, Shehab N, Thomas KE, Budnitz DS. Medication overdoses leading to emergency department visits among children. Am J Prev Med 2009;37(3):181–87. PMID: 19666156. doi: 10.1016/j.amepre.2009.05.018.CrossRefGoogle Scholar
  11. 11.
    Schaefer MK, Shehab N, Cohen AL, Budnitz DS. Adverse events from cough and cold medications in children. Pediatrics 2008;121(4):783–87.CrossRefGoogle Scholar
  12. 12.
    Consumer Health Products Association (CHPA). Makers of OTC Cough and Cold Medicines Announce Voluntary Withdrawal of Oral Infant Medicines 2007. Available at: http://www.chpa.org/10_11_07_InfantCC.aspx (Accessed August 15, 2015).
  13. 13.
    U.S. Food and Drug Administration. Public Health Advisory: Nonprescription Cough and Cold Medicine Use in Children - August 15, 2007. Available at: http://www.fda.gov/forconsumers/consumerupdates/ucm048682.htm (Accessed August 15, 2015).Google Scholar
  14. 14.
    Health Canada. Recommendations for the Appropriate Use of Cough and Cold Products in Children. 2007. Available at: http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2007/13171a-eng.php (Accessed August 15, 2015).Google Scholar
  15. 15.
    U.S. Food and Drug Administration. Using Over-the-Counter Cough and Cold Products in Children. 2008; Available at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048515.htm (Accessed August 15, 2015).Google Scholar
  16. 16.
    Health Canada. Health Canada’s Decision on Cough and Cold Medicines. 2008. Available at: http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2008/13267a-eng.php#a1 (Accessed August 15, 2015).Google Scholar
  17. 17.
    Penfold RB, Zhang F. Use of interrupted time series analysis in evaluating health care quality improvements. Acad Pediatr 2013;13:(6 Suppl):S38–44. PMID: 24268083. doi: 10.1016/j.acap.2013.08.002.CrossRefGoogle Scholar
  18. 18.
    Carsley S, Borkhoff CM, Maguire JL, Birken CS, Khovratovich M, McCrindle B, et al. Cohort profile: The Applied Research Group for Kids (TARGet Kids!). Int J Epidemiol 2015;44(3):776–88.CrossRefGoogle Scholar
  19. 19.
    Statistics Canada. Canadian Community Health Survey. 2004; Available at: http://www.www23.statcan.gc.ca/imdb/p2SV.pl?Function=getSur-vey&SDDS=3226 (Accessed August 15, 2015).Google Scholar
  20. 20.
    Postal Code Conversion File (PCCF), Statistics Canada. 2011 [updated 2011-07-202013-02-05]; Available at: http://www.statcan.gc.ca/pub/92-153-g/2011002/ overview-apercu-eng.htm (Accessed August 15, 2015).Google Scholar
  21. 21.
    Box G, Jenkins G, Reinsel G. Time Series Analysis: Forecasting and Control. New York NY: Wiley, 2011.Google Scholar
  22. 22.
    Shadish W, Cook T, Campbell D, Experimental and Quasi-Experimental Designs for Generalized Causal Inference. Boston, MA: Wadsworth Publishing 2002.Google Scholar
  23. 23.
    Kogan MD, Pappas G, Yu SM, Kotelchuck M. Over-the-counter medication use among US preschool-age children. JAMA 1994;272(13):1025–30. PMID: 8089884.CrossRefGoogle Scholar
  24. 24.
    Headley J, Northstone K. Medication administered to children from 0 to 7.5 years in the Avon Longitudinal Study of Parents and Children (ALSPAC). Eur J Clin Pharmacol 2007;63(2):189–95. PMID: 17200835. doi: 10.1007/s00228-006-0231-y.CrossRefGoogle Scholar
  25. 25.
    Vernacchio L, Kelly JP, Kaufman DQ, Mitchell AA. Cough and cold medication use by US children 1999–2006: Results from the Slone Survey. Pediatrics 2008;122(2):e323–29. PMID: 18676518. doi: 10.1542/peds.2008-0498.CrossRefGoogle Scholar
  26. 26.
    O’Donnell K, Mansbach JM, LoVecchio F, Cheng J, Piedra PA, Clark S, et al. Use of cough and cold medications in severe bronchiolitis before and after a health advisory warning against their use. J Pediatr 2015;167(1):196–98.e2. PMID: 25888349. doi: 10.1016/j.jpeds.2015.03.037.CrossRefGoogle Scholar
  27. 27.
    Mazer-Amirshahi M, Rasooly I, Brooks G, Pines J, May L. van den Anker J. The impact of pediatric labeling changes on prescribing patterns of cough and cold medications. J Pediatr 2014;165(5):1024–28. PMID: 25195159. doi: 10.1016/j.jpeds.2014.07.047.CrossRefGoogle Scholar

Copyright information

© The Canadian Public Health Association 2015

Authors and Affiliations

  • Julie Degroot
    • 1
  • Laura N. Anderson
    • 2
  • Yang Chen
    • 3
  • Catherine S. Birken
    • 2
    • 3
    • 4
  • Patricia C. Parkin
    • 2
    • 3
    • 4
  • Sarah Carsley
    • 2
    • 3
  • Marina Khovratovich
    • 2
  • Muhammad Mamdani
    • 1
    • 3
  • Jonathon L. Maguire
    • 1
    • 2
    • 3
    • 4
  • TARGet Kids! collaboration
  1. 1.The Applied Health Research Centre of the Li Ka Shing Knowledge Institute, St. Michael’s HospitalUniversity of TorontoTorontoCanada
  2. 2.Pediatric Outcomes Research Team (PORT), Division of Pediatric Medicine, Department of Pediatrics, University of TorontoThe Hospital for Sick ChildrenTorontoCanada
  3. 3.Institute for Health Policy, Management and EvaluationUniversity of TorontoTorontoCanada
  4. 4.Department of Pediatrics, St. Michael’s HospitalTorontoCanada

Personalised recommendations