title: Mandatory labeling requirements and over-the-counter cough and cold medication use in early childhood.
abstract: OBJECTIVE
  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 &lt;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 &lt;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.
  
  
  CONCLUSIONS
  Labeling legislation against OTC CCM use for children &lt;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.
authors.affiliation: The Applied Health Research Centre of the Li Ka Shing Knowledge Institute, St. Michael's Hospital. juliedegroot@gmail.com.
authors.forename: Julie
authors.initials: J
authors.lastname: DeGroot
authors.forename: Laura N
authors.initials: LN
authors.lastname: Anderson
authors.forename: Yang
authors.initials: Y
authors.lastname: Chen
authors.forename: Catherine S
authors.initials: CS
authors.lastname: Birken
authors.forename: Patricia C
authors.initials: PC
authors.lastname: Parkin
authors.forename: Sarah
authors.initials: S
authors.lastname: Carsley
authors.forename: Marina
authors.initials: M
authors.lastname: Khovratovich
authors.forename: Muhammad
authors.initials: M
authors.lastname: Mamdani
authors.forename: Jonathon L
authors.initials: JL
authors.lastname: Maguire
mesh_terms: D000367:Age Factors; D002170:Canada; D002675:Child, Preschool; D015331:Cohort Studies; D003139:Common Cold / Q000188:drug therapy*; D003371:Cough / Q000188:drug therapy*; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D005191:Family Characteristics; D005260:Female; D006801:Humans; D007223:Infant; D007251:Influenza, Human / Q000188:drug therapy*; D065186:Interrupted Time Series Analysis; D008297:Male; D037141:Mandatory Programs; D009035:Mothers / Q000706:statistics & numerical data; D004366:Nonprescription Drugs / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D014505:Urban Population / Q000706:statistics & numerical data
chemical_list: D004366:Nonprescription Drugs