Comparison of the safety information on drug labels in three developed countries: The USA, UK and Canada

• Main Authors: Thamir M. Alshammari, Venkat Ratnam Devadasu, Rajendra Prasad Rathnam
• Format: Article
• Language: English
• Published: Elsevier 2017-12-01
• Series: Saudi Pharmaceutical Journal
• Online Access: http://www.sciencedirect.com/science/article/pii/S1319016417301433

The safety information on drug labels of a company marketing the same drugs in different countries is sometimes different. The aim of the present study is to understand the differences in the volume and content of safety information on the drug labels from the same manufacturers in three developed countries: the United States of America (USA), the United Kingdom (UK) and Canada. This study involved the calculation of the proportion of total safety information (PSI) and of contraindications (PCI) in comparison to all information on the label and the percentage of boxed warnings (PBW) among the 100 labels studied from each country. The PSI on the labels of different countries is different with USA labels bearing lesser value PSI and UK labels bearing higher value PSI. The qualitative information provided on these drug labels from each country in ‘contraindications’ sections, ‘boxed/serious warnings’ and ‘overdosage’ sections presented differences in the information provided on most of the labels. We have found distinct differences between the safety information available on drug labels in terms of volume and content. We conclude that the safety information for the same products should be standardised across all countries. Keywords: Drug labelling, Drug safety, Boxed warnings, Contraindications