Quality of medicines in Canada: a retrospective review of risk communication documents (2005–2013)

OBJECTIVE: To explore the quality and safety of medicines in Canada. DESIGN: A retrospective review of drug recalls and risk communication documents conveying issues relating to defective (ie, substandard and falsified) medicines. SETTING: The Health Canada website search for drug recalls and risk communication documents issued between 2005 and 2013. ELIGIBILITY CRITERIA: Drug recalls and risk communication documents related to quality defect in medicinal products. MAIN OUTCOME MEASURE: Relevant data about defective medicines reported in drug recalls and risk communication documents, including description of the defect, type of formulation, year of the recall and category of the recall or the document. RESULTS: There were 653 defective medicines of which 649 were substandard. The number of defective medicines reported by Health Canada increased from 42 in 2005 to 143 in 2013. The two most frequently reported types of defects were stability (205 incidents) and contamination issues (139 incidents). Some of these defects were found to be more prominent and repetitive over other types within some manufacturers. Tablet formulation (251 incidents) was the formulation most frequently compromised. No significant differences were observed between the manufacturers and distributors in the number of substandard medicines reported under each defect type. There were only four falsified medicines reported over the 9-year period. CONCLUSIONS: Substandard medicines are a problem in Canada and have resulted in an increasing number of recalled medicines. Most of the failures were related to stability issues, raising the need to investigate the root causes and for stringent preventative measures to be implemented by manufacturers.