Safety Warnings on the Same Harmful Effects of Medicines: A Comparison of Four National Regulators.

IF 3.1 Q2 PHARMACOLOGY & PHARMACY

Pharmaceutical Medicine Pub Date : 2025-06-25 DOI:10.1007/s40290-025-00573-y

Lucy T Perry, Alice Bhasale, Ashleigh Hooimeyer, Eliza J McEwin, Annim Mohammad, Barbara Mintzes

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引用次数: 0

Abstract

Background: Safety advisories provide critical information to clinicians and patients on the harms of medicines. Previous research has shown that national regulators vary in their decisions to issue safety warnings. However, it is not known whether clinicians receive similar information when regulators communicate about the same medicines' harms.

Aim: Our aim was to assess whether content provided to clinicians in safety advisories on risk, fatal outcomes, evidence and clinician advice was comparable.

Methods: This retrospective content analysis examines safety advisories issued by the Australian Therapeutic Goods Administration, Health Canada, the United Kingdom Medicines and Healthcare products Regulatory Agency, and the US Food and Drug Administration between 2007 and 2016. Content was extracted from advisories issued on the same medicine and harm (n = 40), including evidence, risk quantification, fatal outcomes and clinician advice. A case study on pioglitazone and bladder cancer illustrates differences in regulatory communications.

Results: Variation was seen in the detail and presentation of information on evidence, deaths, risk quantification and advice to clinicians. Specific advice to clinicians was provided in 70% (96/155) of advisories with no significant differences between regulators (p = 0.19). Evidence of harm was presented in 81% (130/160) of advisories and risk quantification in 61% (98/160). The type of evidence presented and directness of information differed however. In the pioglitazone case study, for example, regulators differed in how bladder cancer risks were characterised and advice provided.

Conclusions: Our analysis of safety advisories on the same harms of medicines indicates that while regulators provide similar content elements in safety advisories, risk messages to clinicians vary. This may lead to differences in knowledge and awareness between countries and potentially impact public health outcomes. Further transparency around regulatory decisions on safety advisories is needed.

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对药物同样有害影响的安全警告：四个国家监管机构的比较。

背景：安全咨询为临床医生和患者提供了关于药物危害的重要信息。此前的研究表明，各国监管机构发布安全警告的决定各不相同。然而，尚不清楚当监管机构就相同药物的危害进行沟通时，临床医生是否收到了类似的信息。目的：我们的目的是评估向临床医生提供的关于风险、致命结局、证据和临床医生建议的安全咨询内容是否具有可比性。方法：本回顾性内容分析检查了2007年至2016年间澳大利亚治疗用品管理局、加拿大卫生部、英国药品和保健产品监管局以及美国食品和药物管理局发布的安全建议。内容摘自同一药物和危害发布的咨询（n = 40），包括证据、风险量化、致命结果和临床医生建议。吡格列酮和膀胱癌的案例研究说明了监管沟通的差异。结果：在证据、死亡、风险量化和临床医生建议等信息的细节和呈现方面存在差异。70%（96/155）的咨询报告向临床医生提供了具体建议，监管机构之间无显著差异（p = 0.19）。81%（130/160）的咨询报告提出了危害的证据，61%（98/160）的咨询报告提出了风险量化。然而，提出的证据类型和信息的直接性有所不同。例如，在吡格列酮案例研究中，监管机构在如何描述膀胱癌风险和提供建议方面存在分歧。结论：我们对相同危害药物的安全警告的分析表明，尽管监管机构在安全警告中提供了类似的内容元素，但给临床医生的风险信息不同。这可能导致各国之间的知识和认识存在差异，并可能影响公共卫生结果。有关安全咨询的监管决定需要进一步透明。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmaceutical Medicine PHARMACOLOGY & PHARMACY-

CiteScore

5.10

自引率

4.00%

发文量

期刊介绍： Pharmaceutical Medicine is a specialist discipline concerned with medical aspects of the discovery, development, evaluation, registration, regulation, monitoring, marketing, distribution and pricing of medicines, drug-device and drug-diagnostic combinations. The Journal disseminates information to support the community of professionals working in these highly inter-related functions. Key areas include translational medicine, clinical trial design, pharmacovigilance, clinical toxicology, drug regulation, clinical pharmacology, biostatistics and pharmacoeconomics. The Journal includes:Overviews of contentious or emerging issues.Comprehensive narrative reviews that provide an authoritative source of information on topical issues.Systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by PRISMA statement.Original research articles reporting the results of well-designed studies with a strong link to wider areas of clinical research.Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pharmaceutical Medicine may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.All manuscripts are subject to peer review by international experts. Letters to the Editor are welcomed and will be considered for publication.