Publishing Histories of Adverse Reactions to Medicaments Anecdotally
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I was interested to read the recent guidelines proposed by Kelly et al. for reporting cases of adverse events (i.e. suspected adverse drug reactions), published under the aegis of the International Society of Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) in Drug Safety and simultaneously in Pharmacoepidemiology and Drug Safety.
However, I was surprised and disappointed that the authors wrote that they had found “only one [other] set of usable guidelines,” since I published a usable and readily accessible set of guidelines, called PHARMA (Publishing Histories of Adverse Reactions to Medicaments Anecdotally) in 2003. The PHARMA guidelines were published as table 3 in the appendix to the editorial that Kelly et al. cited as reference 3 in their paper. The appendix to that editorial also included extensive discussion of the PHARMA guidelines.
I have compared PHARMA with the ISPE/ISoP guidelines, item by item. For the most part, they are...
KeywordsCocaine Adverse Drug Reaction Crack Cocaine Anecdotal Report Susceptibility Factor
The author has no conflicts of interest that are directly relevant to the content of this letter.
- 4.Aronson JK. PHARMA: Publishing Histories of Adverse Reactions to Medicaments Anecdotally online]. Available from URL: http://www.bmj.com/cgi/content/full/326/7403/1346/DC1?.maxtoshow=&HITS=10&hits=10&RESULTFORMAT=1&author1=aronson&andorexacttitle=and&andorexacttitleabs=and&fulltext=anecdotes&andorexactfulltext=and&searchid=1&FIRSTINDEX=0&sortspec=relevance&resourcetype=HWCIT Accessed 2007 Dec 4]
- 5.Derry S, Loke YK, Aronson JK. Incomplete evidence: the inadequacy of databases in tracing published adverse drug reactions in clinical trials online]. Available from URL: www.biomedcentral.com/1471-2288/1/7/ Accessed 2007 Dec 4]