July 15, 2020

Cough and cold products containing opioids

Query 19-06: Cough and cold products containing opioids: prescribing and patient utilization patterns in the pediatric population.

This research is funded by the Drug Safety and Effectiveness Network (DSEN) and conducted by the following investigators: Anick Berard, Sasha Bernatsky, Cristiano Moura, Sherif Eltonsy, Dan Chateau, Brandy Windquist, Padma Kaul.


  • Opioid-related harms constitute a significant public health concern in Canada, currently ranked as second in per capita prescription opioid use, after the United States. Approximately 29 cough and cold prescription products containing codeine, hydrocodone or normethadone are available in Canada. Although these products, like opioids, may be misused and abused, no current data are available to quantify the prevalence/incidence of abuse, misuse, addiction, overdose and dependence in children associated with opioids in different formulations.
  • A Health Canada signal assessment (SA) revealed a knowledge gap in available evidence regarding a potential association between cough and cold opioid-containing medicines (CCOMs) and abuse, misuse and opioid use disorder (OUD) in the Canadian pediatric population. Based on the SA, Health Canada advised against Canadian children and adolescents (under 18 years of age) using cough and cold products containing codeine, hydrocodone and normethadone.
  • Canadian prescribers’ and patients’ decision-making will benefit from studies addressing the potential role of CCOMs in the opioid-related risks among the pediatric population. Studies can also help contextualize the individual contribution of CCOMs to the national opioid crisis.

Study aim:

  • To identify physician’s prescribing patterns and patients’ use patterns of prescribed cough and cold opioid-containing medicines (CCOMs) in pediatrics

Study description:

  • We propose to bring together data from the Canadian Mother-Child Cohort Active Surveillance Initiative funded by DSEN/HC, which includes data from five provinces – Quebec, Ontario, Manitoba, Saskatchewan, and Alberta to answer this query. The five provincial birth cohorts that we intend to align will be developed by linking to provincial health care administrative databases.
  • A birth cohort will include all births in the province between 1998-2018. Follow-up will occur from DOB until i) the child is 18 years of age, ii) end of medication coverage or iii) December 31, 2018, whichever comes first.
  • CCOMs considered will be fentanyl, codeine, hydrocodone, normethadone, dextromethorphan alone or in combination forms (i.e. acetaminophen and codeine, etc.) dispensed as pills, syrups, oral formulations or elixirs.

Current status:

  • The query was obtained at the end of December 2019. The protocol was presented to the team at the CAMCCO symposium on February 20th, 2020 (CHR KT funding). Collaboration contracts and fund transfer agreements are underway in four provinces, including the University of Saskatchewan, Ottawa Hospital Research Institute, University of Alberta, University of Manitoba.
  • We plan to start the study soon as our research center re-opens after COVID-19 and the contracts finalized.

For more information, contact: Autumn Neville, Research Coordinator. [email protected]