Dataset Information

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

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.

SUBMITTER: Alshammari TM

PROVIDER: S-EPMC6111122 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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

Alshammari Thamir M TM Devadasu Venkat Ratnam VR Rathnam Rajendra Prasad RP

Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society 20170711 8

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) ...[more]

PMID: 30166896

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Project description:Developing countries can generate effective solutions for today's global health challenges. This paper reviews relevant literature to construct the case for international cooperation, and in particular, developed-developing country partnerships. Standard database and web-based searches were conducted for publications in English between 1990 and 2010. Studies containing full or partial data relating to international cooperation between developed and developing countries were retained for further analysis. Of 227 articles retained through initial screening, 65 were included in the final analysis. The results were two-fold: some articles pointed to intangible benefits accrued by developed country partners, but the majority of information pointed to developing country innovations that can potentially inform health systems in developed countries. This information spanned all six WHO health system components. Ten key health areas where developed countries have the most to learn from the developing world were identified and include, rural health service delivery; skills substitution; decentralisation of management; creative problem-solving; education in communicable disease control; innovation in mobile phone use; low technology simulation training; local product manufacture; health financing; and social entrepreneurship. While there are no guarantees that innovations from developing country experiences can effectively transfer to developed countries, combined developed-developing country learning processes can potentially generate effective solutions for global health systems. However, the global pool of knowledge in this area is virgin and further work needs to be undertaken to advance understanding of health innovation diffusion. Even more urgently, a standardized method for reporting partnership benefits is needed--this is perhaps the single most immediate need in planning for, and realizing, the full potential of international cooperation between developed and developing countries.

Project description:ImportanceDespite major differences in their health care systems, medical crowdfunding is increasingly used to finance personal health care costs in Canada, the UK, and the US. However, little is known about the campaigns designed to raise monetary donations for medical expenses, the individuals who turn to crowdfunding, and their fundraising intent.ObjectiveTo examine the demographic characteristics of medical crowdfunding beneficiaries, campaign characteristics, and their association with funding success in Canada, the UK, and the US.Design, setting, and participantsThis cross-sectional study extracted and manually reviewed data from GoFundMe campaigns discoverable between February 2018 and March 2019. All available campaigns on each country domain's GoFundMe medical discovery webpage that benefitted a unique patient(s) were included from Canada, the UK, and the US. Data analysis was performed from March to December 2019.ExposuresCampaign and beneficiary characteristics.Main outcomes and measuresLog-transformed amount raised in US dollars.ResultsThis study examined 3396 campaigns including 1091 in Canada, 1082 in the UK, and 1223 in the US. Campaigns in the US (median [IQR], $38 204 [$31 200 to $52 123]) raised more funds than campaigns in Canada ($12 662 [$9377 to $19 251]) and the UK ($6285 [$4028 to $12 348]). In the overall cohort per campaign, Black individuals raised 11.5% less (95% CI, -19.0% to -3.2%; P = .006) than non-Black individuals, and male individuals raised 5.9% more (95% CI, 2.2% to 9.7%; P = .002) than female individuals. Female (39.4% of campaigns vs 50.8% of US population; difference, 11.3%; 95% CI, 8.6% to 14.1%; P < .001) and Black (5.3% of campaigns vs 13.4% of US population; difference, 8.1%; 95% CI, 6.8% to 9.3%; P < .001) beneficiaries were underrepresented among US campaigns. Campaigns primarily for routine treatment expenses were approximately 3 times more common in the US (77.9% [272 of 349 campaigns]) than in Canada (21.9% [55 of 251 campaigns]; difference, 56.0%; 95% CI, 49.3-62.7%; P < .001) or the UK (26.6% [127 of 478 campaigns]; difference, 51.4%; 95% CI, 45.5%-57.3%; P < .001). However, campaigns for routine care were less successful overall. Approved, inaccessible care and experimental care raised 35.7% (95% CI, 25.6% to 46.7%; P < .001) and 20.9% (95% CI, 13.3% to 29.1%; P < .001), respectively, more per campaign than routine care. Campaigns primarily for alternative treatment expenses (16.1% [174 of 1079 campaigns]) were nearly 4-fold more common for cancer (23.5% [144 of 614 campaigns]) vs noncancer (6.5% [30 of 465 campaigns]) diagnoses.Conclusions and relevanceImportant differences were observed in the reasons individuals turn to medical crowdfunding in the 3 countries examined that suggest racial and gender disparities in fundraising success. More work is needed to understand the underpinnings of these findings and their implications on health care provision in the countries examined.

Dataset Information

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

Publications

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

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