1. Mandatory labeling requirements and over-the-counter cough and cold medication use in early childhood
- Author
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Degroot, Julie, Anderson, Laura N., Chen, Yang, Birken, Catherine S., Parkin, Patricia C., Carsley, Sarah, Khovratovich, Marina, Mamdani, Muhammad, and Maguire, Jonathon L.
- Subjects
Children -- Diseases ,Nonprescription drugs -- Labeling -- Research ,Public health -- Research ,Pharmaceutical research -- Research ,Government ,Health ,Health care industry - 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 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 CONCLUSION: Labeling legislation against OTC CCM use for children KEY WORDS: Nonprescription drugs; child; preschool; drug legislation; time series analysis Can J Public Health 2015;106(8):e477-e482 doi: 10.17269/CJPH.106.5148 OBJECTIFS: En raison d'effets secondaires rares mais graves, Sante Canada a exige en octobre 2009 que les fabricants refassent les etiquettes des medicaments en vente libre contre la toux et le rhume (MEVLCTR) pour indiquer que ces produits ne doivent pas etre administres aux enfants de METHODE: Nous avons mene une etude des series chronologiques interrompues a l'aide des donnees de TARGet Kids!, un reseau de recherche fondee sur la pratique. Entre 2008 et 2011, nous avons recrute 3 515 enfants sains ages de 1 a 5 ans; de ce nombre, 1 072 avaient eu une toux, un rhume ou une grippe au cours du mois precedent. Les parents ont rempli un instrument de sondage standardise. Pour l'analyse primaire, nous avons compare l'administration des MEVLCTR avant et apres le 1er octobre 2009 a l'aide d'analyses des series chronologiques. Pour l'analyse secondaire, nous avons utilise la regression logistique multivariee pour reperer les variables predictives de l'utilisation recente de MEVLCTR. RESULTATS: L'utilisation de MEVLCTR a ete declaree pour 222 des 1 072 (20,7 %) enfants ayant eu une toux, un rhume ou une grippe au cours du mois precedent. L'utilisation des MEVLCTR a baisse, passant de 22,2 % a 17,8 %, apres l'imposition de la norme d'etiquetage par Sante Canada en octobre 2009 (p = 0,014). L'age maternel CONCLUSION: La loi sur l'etiquetage des MEVLCTR pour en empecher l'administration aux enfants MOTS CLES: medicaments en vente libre; enfant d'age prescolaire; legislation pharmaceutique; analyse des series chronologiques, There has been much debate about the appropriateness of over-the-counter (OTC) cough and cold medication (CCM) use in young children, such use being a frequent topic of conversation between parents [...]
- Published
- 2015
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