Abstract
Background: Case reports of suspected adverse drug reactions (ADRs) are common in the biomedical literature. Standards for authors and editors for writing, submitting and publishing ADR case reports have been empirically established since the 1980s; however, these recommendations have not been widely disseminated or incorporated into practice. Comprehensive and standardized guidelines on good publication practice have recently been proposed. No study has been performed so far to assess the adherence of published ADR case reports to these guidelines.
Objective: To describe the current situation with regards to the reliability and completeness of published ADR case reports.
Methods: A random sample of 100 single ADR case reports published between 2005 and 2008 (25 for each year) was retrieved from Pfizer’s pharmacovigilance database. Reliability and completeness were assessed by comparing the relevant information contained in the retrieved ADR case reports against the recommendations prescribed by the guidelines. Descriptive statistics and correlation analysis using the Statistical Package for Social Science (SPSS) were undertaken.
Results: The patient’s medical history relevant to the ADR was reported in 92% of the case reports. Concerning the suspected drug, 11% of the reports included the proprietary name; duration, dosage, route and formulation were reported in 87%, 85%, 37% and 21% of the reports, respectively. Information on concomitant therapies was included in 71% of the reports. The description of the ADR contained details on management (99%), time-course (97%) and diagnostic tests (95%), while final outcome and seriousness were reported in 73% and 52% of the reports, respectively. A discussion on the possible mechanism for the ADR was present in 70% of the case reports. The possible implications for clinical practice of the reported drug-event association were described in 75% of the cases. Causality assessment was reported in 81%, and rating scales to support the causal link were used in 20% of the reports. The major predictive factor for the presence of an objective causality assessment was found to be publication in specialized pharmacoepidemiology or clinical pharmacology journals: 47% specialized versus 11% non-specialized (odds ratio = 6.93; 95% CI 2.37, 20.26).
Conclusions: The findings of this study show that published ADR case reports, especially those coming from non-specialized journals, still lack important information necessary for comprehensive evaluation. As published ADR case reports are expected to be reported to regulatory authorities using the same approach as for spontaneous cases, it is paramount for their effective integration in the pharmacovigilance system that pharmaceutical companies and learned societies actively promote a culture of good publication practices.
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References
van Puijenbroek EP. Case reports and drug safety. Drug Saf 2006; 29(8): 643–5
Haramburu E, Begaud B, Pere JC. Comparison of 500 spontaneous and 500 published reports of adverse drug reactions. Eur J Clin Pharmacol 1990; 3: 287–8
Aronson JK, Derry S, Loke YK. Adverse drug reactions: keeping up to date. Fundam Clin Pharmacol 2002; 16(1): 49–56
Vandenbroucke JP. In defence of case reports and case series. Ann Intern Med 2001; 134(4): 330–4
Russmann S. Case reports of suspected adverse drug reactions: case reports generate signals efficiently [letter]. BMJ 2006; 332(7539): 488
Berneker GC, Ciucci AG, Joyce J. Standards for reporting adverse drug reactions [letter]. Br Med J (Clin Res Ed) 1983; 287(6406): 1720
Venulet J. Informativity of adverse reactions data in medical publications. Drug Inf J 1985; 19(2): 357–5
Venulet J. Improving reports on adverse drug reactions [letter]. BMJ 1984; 289(6449): 898
Aronson JK. Anecdotes as evidence: we need guidelines for reporting anecdotes of suspected adverse drug reactions. BMJ 2003; 326(7403): 1346
Kelly WN, Arellano FM, Barnes J, et al. Guidelines for submitting adverse event reports for publication. Drug Saf 2007; 30(5): 367–73
Aronson JK. Publishing histories of adverse reactions to medicaments anecdotally: the PHARMA guidelines for reporting suspected adverse drug reactions. Drug Saf 2008; 31(4): 355–6
Hauben M, Aronson JK. Gold standard in pharmacovigilance: the use of definitive anecdotal reports of adverse drug reactions as pure gold and high-grade ore. Drug Saf 2007; 30(8): 645–55
Ferguson J, Mockbee C, Erbele S, et al. Evaluation of published case reports: standards and recognition. Drug Inf J 2002; 36(2): 303–7
Kelly WN. The quality of published adverse drug event reports. Ann Pharmacother 2003; 37(12): 1774–8
Karch SB. Peer review and the process of publishing of adverse drug event reports’. J Forensic Leg Med 2007; 14(2): 79–84
Haramburu F, Miremont G, Chaslerie A, et al. Efficiency of medical journals for pharmacovigilance. Lancet 1993; 341: 1030–1
Golder S, Loke Y. Search strategies to identify information on adverse effects: a systematic review. J Med Libr Assoc 2009; 97(2): 84–92
Harmark L, van Grootheest AC. Pharmacovigilance: methods, recent developments and future perspectives. Eur J Clin Pharmacol 2008; 64(8): 743–52
Fontaine AL. Current requirements and emerging trends for labelling as a tool for communicating pharmacovigilance findings. Drug Saf 2004; 27(8): 579–89
Loke YK, Price D, Derry S, et al. Case reports of suspected adverse drug reactions: systematic literature survey of follow-up. BMJ 2006; 332(7537): 335–9
Edwards RI. The future of pharmacovigilance: a personal view. Eur J Clin Pharmacol 2008; 64(2): 173–81
Hirst C, Cook S, Dai W, et al. A call for international harmonization in therapeutic risk management. Pharmacoepidemiol Drug Saf 2006; 15(12): 539–49
Acknowledgements
Both authors are employees of Pfizer Inc., otherwise no sources of funding were used to assist in the conduct of this study. The authors have no conflicts of interest to declare that might potentially bias this study.
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Impicciatore, P., Mucci, M. Completeness of Published Case Reports on Suspected Adverse Drug Reactions. Drug-Safety 33, 765–773 (2010). https://doi.org/10.2165/11537500-000000000-00000
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DOI: https://doi.org/10.2165/11537500-000000000-00000