Safety information in drug labeling: a comparison of the USA, the UK, and Japan

Shimazawa, Rumiko; Ikeda, Masayuki

doi:10.1002/pds.3408

Cited by 20 publications

(31 citation statements)

References 22 publications

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“…). Shimazawa and Ikeda () and Kesselheim et al. () indicated that there were variances in the information provided in different countries.…”

Section: Discussionmentioning

confidence: 99%

“…In addition, biologicals and small molecule drugs are governed by different legislation (Nieminen et al 2005). Shimazawa and Ikeda (2013) and Kesselheim et al (2013) indicated that there were variances in the information provided in different countries.…”

Section: Discussionmentioning

confidence: 99%

“…The authors reported that 14 of 32 PIs had the same degree of detail, 15 were less detailed, and three more detailed in the EU. Shimazawa and Ikeda (2013) compared safety information in PIs from the USA, the United Kingdom, and Japan by comparing the number of words in sections concerning safety, and they concluded that substantial differences in safety information existed. Kesselheim et al (2013) applied a similar method.…”

Section: Introductionmentioning

confidence: 99%

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Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA

Eriksson

Aagaard

Jensen

et al. 2014

Pharmacology Res & Perspec

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Pharmaceutical product information (PI) supplied by the regulatory authorities serves as a source of information on safe and effective use of drugs. The objectives of this study were to qualitatively and quantitatively compare PIs for selected drugs marketed in both Denmark and the USA with respect to consistency and discrepancy of listed adverse drug reaction (ADR) information. We compared individual ADRs listed in PIs from Denmark and the USA with respect to type and frequency. Consistency was defined as match of ADRs and of ADR frequency or match could not be ruled out. Discrepancies were defined as ADRs listed only in one country or listed with different frequencies. We analyzed PIs for 40 separate drugs from ten therapeutic groups and assigned the 4003 identified ADRs to System Organ Classes (Medical Dictionary for Regulatory Activities [MedDRA] terminology). Less than half of listed ADRs (n = 1874; 47%) showed consistency. Discrepancies (n = 2129; 53%) were split into ADRs listed only in the USA (n = 1558; 39%), ADRs listed only in Denmark (n = 325; 8%) and ADRs listed with different frequencies (n = 246; 6%). The majority of listed ADRs were of the type “gastrointestinal disorders” and “nervous system disorders”. Our results show great differences in PIs for drugs approved in both Denmark and the USA illuminating concerns about the credibility of the publicly available PIs. The results also represent an argument for further harmonization across borders to improve consistency between authority-supplied information.

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“…). Shimazawa and Ikeda () and Kesselheim et al. () indicated that there were variances in the information provided in different countries.…”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA

Eriksson

Aagaard

Jensen

et al. 2014

Pharmacology Res & Perspec

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“…Recent work has highlighted various types of inconsistencies in the reporting of drug safety information, including discrepancies among the reports for bio-equivalent drugs, or reports used in different countries [28-30]. However, systematic comparisons of the major safety data sets used in system pharmacological models and assessment of the impact of data-set choice on prediction performance are lacking.…”

Section: Introductionmentioning

confidence: 99%

Concordance and predictive value of two adverse drug event data sets

Cami

Reis

2014

BMC Med Inform Decis Mak

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BackgroundAccurate prediction of adverse drug events (ADEs) is an important means of controlling and reducing drug-related morbidity and mortality. Since no single “gold standard” ADE data set exists, a range of different drug safety data sets are currently used for developing ADE prediction models. There is a critical need to assess the degree of concordance between these various ADE data sets and to validate ADE prediction models against multiple reference standards.MethodsWe systematically evaluated the concordance of two widely used ADE data sets – Lexi-comp from 2010 and SIDER from 2012. The strength of the association between ADE (drug) counts in Lexi-comp and SIDER was assessed using Spearman rank correlation, while the differences between the two data sets were characterized in terms of drug categories, ADE categories and ADE frequencies. We also performed a comparative validation of the Predictive Pharmacosafety Networks (PPN) model using both ADE data sets. The predictive power of PPN using each of the two validation sets was assessed using the area under Receiver Operating Characteristic curve (AUROC).ResultsThe correlations between the counts of ADEs and drugs in the two data sets were 0.84 (95% CI: 0.82-0.86) and 0.92 (95% CI: 0.91-0.93), respectively. Relative to an earlier snapshot of Lexi-comp from 2005, Lexi-comp 2010 and SIDER 2012 introduced a mean of 1,973 and 4,810 new drug-ADE associations per year, respectively. The difference between these two data sets was most pronounced for Nervous System and Anti-infective drugs, Gastrointestinal and Nervous System ADEs, and postmarketing ADEs. A minor difference of 1.1% was found in the AUROC of PPN when SIDER 2012 was used for validation instead of Lexi-comp 2010.ConclusionsIn conclusion, the ADE and drug counts in Lexi-comp and SIDER data sets were highly correlated and the choice of validation set did not greatly affect the overall prediction performance of PPN. Our results also suggest that it is important to be aware of the differences that exist among ADE data sets, especially in modeling applications focused on specific drug and ADE categories.

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“…Denileukin diftitox and tositumomab which were approved for lymphoma by the FDA in 1999 and 2003, respectively, remain unavailable in both the EU and Japan, probably because better treatment modalities are available. can affect regulatory decisions [5]. A previous study revealed substantial differences in the pharmacogenomic information included on labels from the USA, the UK and Japan [3].…”

mentioning

confidence: 98%

International differences in companion diagnostic approvals: how are we able to manage the differences?

Shimazawa

Ikeda

2014

Expert Review of Molecular Diagnostics

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One would expect regulations for drugs and diagnostics not to differ significantly between countries, given that regulatory authorities evaluate the same scientific data generated in an increasingly globally harmonized context. However, studies of our own and others have provided compelling evidence of differences in regulations for drugs and in vitro companion diagnostics in personalized medicine. Differing regulatory processes create hurdles for both pharmaceutical and companion diagnostics companies with different platforms that employ different technologies. The rising cost of healthcare caused by improvements in technology is another issue that faces all advanced countries. To address these issues and to facilitate access to personalized medicine, regulatory authorities, academia and the pharmaceutical industry should increase dialogue on the differences on an international platform.

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Safety information in drug labeling: a comparison of the USA, the UK, and Japan

Abstract: Substantial differences in safety information exist depending upon outcome measures and therapeutic areas among the US, the UK, and the Japanese labels. This underscores the need for further analyses to determine causes of these differences to optimize drug safety regulations.

Cited by 20 publications

References 22 publications

Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA

Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA

Concordance and predictive value of two adverse drug event data sets

International differences in companion diagnostic approvals: how are we able to manage the differences?

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