20 Therefore, the possibility

that the increase in substandard medicines was a result of poor manufacturing practices cannot be excluded. Manufacturing errors and investigation of the root cause It is the responsibility of the manufacturers and marketing authorisation holders to recall their substandard products selleck after consultation with Health Canada. The majority of these recalls were issued by the manufacturers or marketing authorisation holders using the Health Product Recall type I, II and III, which accounted for 95% of the total substandard medicines reported. Stability issues were mainly identified by the manufacturers during ongoing stability testing. However, it is unknown whether these defects were identified by internal auditing systems of the manufacturers, by intervention of the Health Canada inspection team or by reports from healthcare professionals. Analysing pharmaceutical product recalls can be of great importance to identify the root causes of recalled medicines. The prompting of a drug recall can be regarded as a disastrous failure of the manufacturer’s quality plan. Even with stringent quality measures, errors can occur.21 22 Thus, it is very important to identify

the root cause of the defects to avoid similar episodes in the future. The root cause for a defect is required to be submitted to Health Canada, as soon as it is identified, along with other information relating to the quantity and depth of the distribution of the affected medicine. It is the responsibility

of Health Canada to monitor the overall procedure and assess the root cause for this problem and, if required, to conduct an inspection to verify that a corrective action is implemented.23 24 It has been highlighted in this review that stability failure and contamination issues were the defect types being reported most frequently. These issues affected several manufacturers on more than one occasion (see online supplementary table S4). This highlights the need for root cause investigations and appropriate Brefeldin_A measures to be implemented by manufacturers as well as effective monitoring by Health Canada. Falsified medicines Only four incidents of falsified medicines were reported by Health Canada. The detection is extremely low compared with substandard medicine. Health Canada has robust GMP inspections that cover all drug establishments including manufacturers, distributors and wholesalers. The reporting system of Health Canada is concerned with falsified medicines detected within the scope of GMP inspections.18 Some falsified medicines may be intercepted and seized by enforcement bodies on their way to target destinations, but not necessarily intended for the Canadian market. This may explain the low detection rate by Health Canada.