6 7 It is a large category that comprises two main types of compromised drugs, substandard and falsified medicines. A substandard medicine is a medicine that does not meet the regulator standards selleck products due to an unintentional or negligent error.8 A falsified medicine, however, is one where deliberate and criminal intent is involved.8 In high-income countries (HIC), there have been no studies with good methodological quality examining the overall prevalence of substandard or falsified medicines.3 The surveillance system in HIC in Europe and North America, however, is a well-established system that has identified and withdrawn several medicines from the

market with serious safety concerns.9 10 These surveillance systems have reported numerous incidents of substandard and falsified medicines, and highlighted the problem of such drugs in these countries. Examples of these are the falsified cancer drug, avastin, and substandard spinal steroid injections reported in the USA.11 12 In our previous study on the UK, we studied the problem of defective

medicines in the UK by reviewing the drug alerts issued by the drug regulator over an 11-year period. The study showed that substandard medicines are a problem that appears to be increasing.7 We wished to explore another HIC and chose Canada, as the problem of defective medicines has never been explored in this setting and because of the level of data available in the public domain. In Canada, health products are regulated by Health Canada, which is the federal department responsible for the monitoring and regulating of medicines.13 It issues a number of risk communication documents to the public and healthcare professionals. These involve identification of the possible risk, assessment of its severity and clarification of the nature of the problem. This communication is also initiated to disseminate information regarding new safety issues of medicines

or existing health risks to allow healthcare professionals and their patients to make well-informed decisions about their health.14 The aim of this study was to explore the quality and safety of medicines in Canada by analysing the AV-951 risk communication documents conveying issues relating to defective medicines. Methods Health Canada uses 13 risk communication documents, which can be issued for the public, healthcare professionals and hospitals.14 A preliminary search for these risk communication documents found that only five documents can be used by Health Canada to convey any defective health product issue in the Canadian official supply chain. These can be described as follows: Public Warning (PW): issued by Health Canada if the use of the drug can cause a severe adverse health consequence that may lead to death.