Media coverage of drug regulatory agencies' safety advisories: A case study of citalopram and denosumab

Fabbri, Alice; O’Keeffe, Mary; Moynihan, Ray; Møllebæk, Mathias; Mohammad, Annim; Bhasale, Alice L; Puil, Lorri; Mintzes, Barbara

doi:10.1111/bcp.14255

Cited by 5 publications

(3 citation statements)

References 23 publications

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“…Due to the volume of unsolicited information received, primary care physicians seemed to rely on repetition of messages and medical and mainstream media to find out about new safety information. However, as regulatory warnings may receive little media coverage, 29,30 more concerted dissemination strategies may be needed using multiple channels, trusted clinical sources and professional networks. Commonly used and trusted information sources could include this information to reduce reliance on one‐off disseminations such as letters and emails.…”

Section: Discussionmentioning

confidence: 99%

Regulatory authority and clinical acceptability: Physicians' responses to regulatory drug safety warnings

Bhasale

Sarpatwari

Lipworth

et al. 2021

Brit J Clinical Pharma

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Aims: Medicines regulators issue post-market safety warnings to advise of newly uncovered risks, but with mixed impacts. We aimed to identify factors influencing the use of regulatory warnings by primary care and specialist physicians in the US and Australia.Methods: Semi-structured qualitative interviews were carried out with 40 primary care physicians, endocrinologists and other generalist specialists in Boston (USA) and Australia. Coding and analysis were performed inductively and iteratively to identify and examine key factors. Analysis centred around four areas: physicians' awareness of drug safety information, preferred information sources, opinion-forming and sharing of information with patients.Results: Uncertainty, trust and clinical authority emerged as factors influencing use of advisories. Although regulators were trusted as authoritative institutions, they appeared to lack clinical authority, and physicians validated regulatory information against other trusted sources including evidence, expert opinion and experience.Specialists became aware of drug safety issues through specialised literature, using evidence and clinical consensus to form opinions. Primary care physicians, fielding high volumes of information, relied on convenient, accessible information sources including the media and the "clinical grapevine" for awareness, and on clinical colleagues, specialists and experience for interpretation. Communicating risk to patients was complicated by uncertainty; physicians tailored information to patients' health literacy and information needs. US physicians were more aware of their national regulator's post-market safety role than Australian physicians of theirs.Conclusion: Drug safety warnings may not be optimally received or used. Regulators should consider strategies that increase trust, clinical relevance and accessibility, and address physicians' needs in communicating risk to patients.

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Section: Discussionmentioning

confidence: 99%

Regulatory authority and clinical acceptability: Physicians' responses to regulatory drug safety warnings

Bhasale

Sarpatwari

Lipworth

et al. 2021

Brit J Clinical Pharma

Self Cite

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“…Media research has shown that a favorable media portrayal of pharmacological agents leads to increased use among the population (e.g. Cassels et al, 2003; Fabbri et al, 2020), whereas an unfavorable representation contributes to reduced use (Wang et al, 2016). The prescription of AD/HD agents in Sweden has increased by the number of 1025% between 2006 and 2021 for children and adults (The National Board of Health and Welfare, 2021).…”

Section: Resultsmentioning

confidence: 99%

“…Similarly, Matthew-Simmons and Ritter (2014) display that the media in general reports positive effects of medication for AD/HD. In some studies, the media representations of AD/HD are contrasted with research evidence of pharmaceutical efficacy and effectiveness (Ponnou et al, 2020; Matthew-Simmons and Ritter, 2014; see also Fabbri et al, 2020).…”

Section: Introductionmentioning

confidence: 99%

Media portrayals of psychotropic agents in AD/HD treatment: A social constructionist approach

Qaderi

Lindblom

2023

Health (London)

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In recent decades there has been a significant increase in diagnosing children and adults with Attention-Deficit/Hyperactivity Disorder (AD/HD), and in the use of pharmacological treatment with Ritalin, Concerta and Strattera for AD/HD. This development has given rise to scientific criticism, claiming that the pharmaceuticals prescribed by doctors are, to a large extent, ineffective or harmful. This study discusses media’s portrayal of treatment of AD/HD. The aim of the article is to develop a social constructionist perspective, highlighting how scientific critique of pharmaceuticals for AD/HD is handled in the mass media. The authors introduce the concept of “psychopharmacological extensibility,” which demonstrates the importance of collective definitional processes in society. Psychopharmacological extensibility reflects the fact that the perception of AD/HD agents as beneficial medicines or harmful drugs is open to interpretation and dependent on social factors related to context, power, rhetoric, and marketization. The empirical data are based on 211 articles from eight of the largest newspapers in Sweden, published between 2002 and 2021. The result shows that Swedish mass media, in numerous ways, neglects or undermines the scientific criticism made, thereby facilitating an increased use of the diagnosis and of psychotropic agents in society.

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The emerging story of Sodium Valproate in British newspapers- A qualitative analysis of newspaper reporting.

Siriwardena

McAllister

Islam

et al. 2022

Seizure: European Journal of Epilepsy

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Media coverage of drug regulatory agencies' safety advisories: A case study of citalopram and denosumab

Abstract: This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process which may lead to differences between this version and the Version of Record. Please cite this article as

Cited by 5 publications

References 23 publications

Regulatory authority and clinical acceptability: Physicians' responses to regulatory drug safety warnings

Regulatory authority and clinical acceptability: Physicians' responses to regulatory drug safety warnings

Media portrayals of psychotropic agents in AD/HD treatment: A social constructionist approach

The emerging story of Sodium Valproate in British newspapers- A qualitative analysis of newspaper reporting.

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