ArticleSaudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society2017
Comparison of the safety information on drug labels in three developed countries: The USA, UK and Canada.
Article in Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
9 citing papers in PubMed.
- Safety without the counter: transparency of online safety information for women's over-the-counter medicines across markets.Journal of pharmaceutical policy and practice · 2026Article
- The UK's Early Access to Medicines Scheme 10 years on: an evaluation using publicly available data.JRSM open · 2025Article
- A comparison of the labeling of antineoplastic and supportive medicines in China, Japan, and the US based on the WHO essential medicines list.Frontiers in medicine · 2025Article
- Are drug safety measures harmonized? A real-world evidence from three regulatory authorities.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2024Article
- A Comparison of Safety Information in Drug Labeling at the Initial Approval of New Drugs Approved Both in Japan and the United States.Therapeutic innovation & regulatory science · 2022Article
- Comprehensibility of Contraindications in German, UK and US Summaries of Product Characteristics/Prescribing Information-A Comparative Qualitative and Quantitative Analysis.Journal of clinical medicine · 2022Article
- Regulation of Drug Prescribing Information in Latin America and the Caribbean.Therapeutic innovation & regulatory science · 2022Review
- The Quality and Reliability of Information in the Summaries of Product Characteristics.International journal of environmental research and public health · 2022Review
- Discrepancies Between the Labels of Originator and Generic Pharmaceutical Products: Implications for Patient Safety.Drugs - real world outcomes · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.