Guidelines for submitting adverse event reports for publication

Drug Safety

Volumn 30, Issue 5, 2007, Pages 367-373

  Kelly, William N ^a   Arellano, Felix M ^b,c   Barnes, Joanne ^d   Bergman, Ulf ^e   Edwards, Ralph I ^f   Fernandez, Alina M ^g   Freedman, Stephen B ^h   Goldsmith, David I ⁱ   Huang, Kui A ^j   Jones, Judith K ^k   McLeay, Rachel ^l   Moore, Nicholas ^m   Stather, Rosie H ^l   Trenque, Thierry ⁿ   Troutman, William G ^o   Van Puijenbroek, Eugene ^p   Williams, Frank ^q   Wise, Robert P ^r  

^a William N Kelly Consulting Inc   (United States)

^b Risk Management Resources   (United States)

^c Risk Management Resources   (Spain)

^d UNIVERSITY OF AUCKLAND   (New Zealand)

^e KAROLINSKA INSTITUTE   (Sweden)

^f UPPSALA MONITORING CENTRE   (Sweden)

^g TAP PHARMACEUTICAL PRODUCTS INC   (United States)

^h HOSPITAL FOR SICK CHILDREN   (Canada)

ⁱ Goldsmith Pharmacovigilance and Systems   (United States)

^j PFIZER INC   (United States)

^k The Degge Group Ltd   (United States)

^l Wolters Kluwer Health   (New Zealand)

^m UNIVERSITÉ DE BORDEAUX   (France)

ⁿ REIMS UNIVERSITY HOSPITAL   (France)

^o UNIVERSITY OF NEW MEXICO   (United States)

^p Netherlands Pharmacovigilance Centre   (Netherlands)

^q Nav Med Educ and Training Command   (United States)

^r CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

HERBACEOUS AGENT; VACCINE;

ALTERNATIVE MEDICINE; DRUG INDUCED DISEASE; DRUG SURVEILLANCE PROGRAM; MEDICAL INFORMATION SYSTEM; MEDICAL SOCIETY; PRACTICE GUIDELINE; PRIORITY JOURNAL; PUBLICATION; REVIEW;

EID: 34248383514     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200730050-00001     Document Type: Review

References (21)

1. Venulet J. Informativity of adverse reactions data in medical publications. Drug Inf J 1985; 19: 357-65
2. Cohen LG, Rovers JP. Addendum to guidelines for reporting adverse drug reactions. Br Med J (Clin Res Ed) 1988; 296: 1800
3. Aronson JK. Anecdotes as evidence. BMJ 2003; 326: 1346
4. Abanades S, Farre M. Guidelines for anecdotes might include more information. BMJ 2003; 327: 290
5. BMJ paper styles. Drug points [online]. Available from URL: http://bmj.bmjjournals.com/advice/sections.shtml [Accessed 2005 Sep 9]
6. Ferguson JA, Mockbee C, Erbele A, et al. Evaluation of published case reports' standards and notification. Drug Inf J 2002; 36: 303-7
7. DeBakey L, DeBakey S. The case report. I. Guidelines for preparation. Int J Cardiol 1983; 4: 357-64
8. Abrutyn E. Better reporting of adverse drug reactions. Ann Intern Med 1985; 102: 264-5
9. Berneker GC, Ciucci AG, Joyce J. Standards for reporting adverse drug reactions. Br Med J (Clin Res Ed) 1983; 287: 1720
10. Haramburu F, Begaud B, Pere JC, et al. Role of medical journals in adverse drug reaction alerts. Lancet 1985; II: 550-1
11. Venulet J, Blattner R, von Bulow J, et al. How good are articles on adverse drug reactions? Br Med J (Clin Res Ed) 1982; 284: 252-4
12. Kelly WN. The quality of published adverse drug event reports. Ann Pharmacother 2003; 37: 1774-8
13. Loke YK, Price D, Derry S, et al. Case reports of suspected adverse drug reactions: systematic literature survey of follow-up. BMJ 2006; 332: 335-9
14. Auriche M, Bertrand P, Blay N, et al. Les bonnes pratiques de publication de cas cliniques de pharmacovigilance: commentaires. Groupe de Travail sur les Bonnes Pratiques de Publication de Cliniques en pharmacovigilance: commentaires. Thérapie 1997; 52: 123-7
15. Monteagudo JL. Data exchange in the European pharmacovigilance. Stud Health Technol Inform 1996; 28: 69-77
16. International Conference on Harmonisation; guidance on data elements for transmission of individual case safety reports; availability. Notice. Food and Drug Administration, HHS. Fed Regist 1998; 63: 2396-404
17. Hill AB. The environment and disease: association or causation? Proc R Soc Med 1965; 58: 295-300
18. Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30: 239-45
19. Edwards IR, Lindquist M, Wiholm BE, et al. Quality criteria for early signals of possible adverse drug reactions. Lancet 1990; 336: 156-8
20. Benichou C. Criteria of drug-induced liver disorders. Report of an international consensus meeting. J Hepatol 1990; 11: 272-6
21. Danan G, Benichou C. Causality assessment of adverse reactions to drugs: I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries. J Clin Epidemiol 1993; 46: 1323-30