Drug safety in Canada: 2 steps forward, 1 step back/Response from the manufacturer

Importantly, when we received concerns, we took measures to change the label. These included informing the Institute for Safe Medication Practices about the absence of the generic name on the Polyamp®, and working with our colleagues to make equipment modifications enabling the inclusion of the generic name. With regard to existing stock, we investigated the option of attaching pre-printed labels to the Polyamp®. This was considered unacceptable, as it could have compromised the safety of the product due to potential leaching of adhesive through the Polyamp® into the solution. In a recent commentary,1 it was stated that Health Canada uses the World Health Organization Good Clinical Practice (GCP) guideline. In 1997, Health Canada adopted the GCP guideline developed by the International Conference on Harmonization.2 In notifying us of the error, Jean Saint-Pierre, coordinator at the Good Clinical Practice Unit at Health Canada, stated that the Health Products and Food Branch Inspectorate has been conducting GCP inspections on clinical trials. These inspections assess the level of compliance with GCP of qualified investigators conducting trials. Two summary reports of findings made during these inspections are publicly available.3 Fig. 1: Cases of invasive pneumococcal infection per 100 000 among adults 65 years and older according to year and serotype group. Data from CASPER Surveillance, 1998-2004 (χ^sup 2^ or Fisher exact test for comparisons). When compared with the combined rate between 1998 and 2001, the rate in 2004 decreased by 62.7% to 8.5 (95% CI 3.7-16.7) for PCV7 serotypes (p = 0.007); the change of 23.9% to 28.6 (95% CI 18.9-41.7) for all serotypes was not significant (p = 0.24), nor was the change of 24.1% to 8.5 (95% CI 3.7-16.7) for PPV23 serotypes that are not in PCV7 (p = 0.59). The increase of 163.9% to 9.5 (95% CI 4.4-18.1) for nonPPV23 serotypes was significant (p = 0.03).