How good are articles on adverse drug reactions?

Vénulet, J; Blattner, Russell J.; Bülow, Jacob; Berneker, G C

doi:10.1136/bmj.284.6311.252

Cited by 60 publications

(14 citation statements)

References 5 publications

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“…[2][3][4][5][6][7][8][9][10][11][12][13] The review revealed only one usable set of guidelines published in 1985. 1 Another set of guidelines published in 1997 was not readily accessible.…”

Section: Resultsmentioning

confidence: 99%

“…[1][2][3][4][5][6][7][8][9][10][11][12][13] In 1985, an international conference attended by professionals interested in adverse drug events and by editors of several major medical journals proposed guidelines that editors should adopt when reviewing adverse event reports submitted for publication. 1 Another working group commissioned by the French authorities also published recommendations in 1997.…”

Section: The Need For Guidelinesmentioning

confidence: 99%

“…However, the completeness of published reports has been shown to vary considerably. [1][2][3][4][5][6][7][8][9][10][11][12][13] Their value is limited, and they can even be misleading, when they lack relevant information about the patient, the event, all potentially relevant exposures, the clinical decision making processes, and most importantly, the possible alternative etiologies. Even when they contain all the essential information, it is often not possible to arrive at a definitive diagnosis for the event.…”

Section: Introductionmentioning

confidence: 99%

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Guidelines for submitting adverse event reports for publication

Kelly

Arellano²,

Barnes

et al. 2007

Pharmacoepidemiology and Drug

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Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines, and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide sufficient details for either (i) a differential diagnosis or provisional assessment of cause‐effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports, and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic, and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' web sites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events. Copyright © 2007 Kelly et al. Reproduced with permission by John Wiley & Sons, Ltd.

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“…[2][3][4][5][6][7][8][9][10][11][12][13] The review revealed only one usable set of guidelines published in 1985. 1 Another set of guidelines published in 1997 was not readily accessible.…”

Section: Resultsmentioning

confidence: 99%

Section: The Need For Guidelinesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Guidelines for submitting adverse event reports for publication

Kelly

Arellano²,

Barnes

et al. 2007

Pharmacoepidemiology and Drug

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“…In 1979, Laganiere and Biron [60] surveyed 23 papers on adverse drug reactions and discussed their shortcomings; Venulet et al [61] did likewise with a series of 5737 articles from 80 countries published between 1972 and 1979. Others pointed to problems with the reporting of harms in clinical trials [60,62,63] and the need for systematic reviews.…”

Section: Individual Cases and Case Seriesmentioning

confidence: 98%

Toward standardized reporting of drug interactions: the READI checklist for anecdotal reports

Aronson

2015

Expert Review of Clinical Pharmacology

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Anecdotal reports contribute 30% of the literature on adverse drug reactions and interactions. However, the quality of such reports has not been uniformly high. Standardized reporting of clinical studies is of increasing interest, including the CARE guidelines on reporting anecdotal cases in general. Although there are guidelines on evaluating and managing drug-drug interactions, there are none recommending methods for reporting suspected drug interactions. Here, based on published guidelines for reporting suspected adverse drug reactions, I propose a checklist for reporting details of suspected drug interactions, the REporting Anecdotal Drug Interactions (READI) checklist, hoping to stimulate discussion and improve reporting of suspected drug interactions. The checklist includes items relating, among others, to the patient affected, the drugs involved, and the outcome.

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“…Laganiere and Biron (1979) surveyed 23 papers on ADRs and discussed their shortcomings. Venulet et al (1982) did likewise with a series of 5737 articles from 80 countries published between 1972 and 1979. Others have pointed to problems with the reporting of harms in clinical trials (Bradford, 1950;Hemminki, 1980;Hibberd and Meadows, 1980) and the need for systematic reviews.…”

Section: Journals That Publish Case Reports Of Suspected Adverse Drugmentioning

confidence: 99%

Case Reports as Evidence in Pharmacovigilance

Aronson

2014

Mann's Pharmacovigilance

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How good are articles on adverse drug reactions?

Cited by 60 publications

References 5 publications

Guidelines for submitting adverse event reports for publication

Guidelines for submitting adverse event reports for publication

Toward standardized reporting of drug interactions: the READI checklist for anecdotal reports

Case Reports as Evidence in Pharmacovigilance

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