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Drug Safety

, Volume 31, Issue 4, pp 355–356 | Cite as

Publishing Histories of Adverse Reactions to Medicaments Anecdotally

The PHARMA guidelines for Reporting Suspected Adverse Drug Reactions
  • Jeffrey K. Aronson
Correspondence

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[1] and simultaneously in Pharmacoepidemiology and Drug Safety.[2]

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.[3] The appendix to that editorial also included extensive discussion of the PHARMA guidelines.[4]

I have compared PHARMA with the ISPE/ISoP guidelines, item by item. For the most part, they are...

Keywords

Cocaine Adverse Drug Reaction Crack Cocaine Anecdotal Report Susceptibility Factor 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgements

The author has no conflicts of interest that are directly relevant to the content of this letter.

References

  1. 1.
    Kelly WN, Arellano FM, Barnes J, et al. International Society for Pharmacoepidemiology; International Society of Pharmacovigilance. Guidelines for submitting adverse event reports for publication. Drug Saf 2007; 30(5): 367–73PubMedCrossRefGoogle Scholar
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    Kelly WN, Arellano FM, Barnes J, et al. International Society of Pharmacoepidemiology; International Society of Pharmacovigilance. Guidelines for submitting adverse event reports for publication. Pharmacoepidemiol Drug Saf 2007; 16(5): 581–7PubMedCrossRefGoogle Scholar
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    Aronson JK. Anecdotes as evidence. BMJ 2003 Jun 21; 326(7403): 1346PubMedCrossRefGoogle Scholar
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    Loke YK, Price D, Derry S, et al. Case reports of suspected adverse drug reactions: systematic literature survey of followup. BMJ 2006; 332(7537): 335–9PubMedCrossRefGoogle Scholar
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    Aronson JK, Derry S, Loke YK. Adverse drug reactions: keeping up to date. Fundam Clin Pharmacol 2002; 16(1): 49–56PubMedCrossRefGoogle Scholar
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    Aronson JK, Hauben M. Anecdotes that provide definitive evidence. BMJ 2006; 333(7581): 1267–9PubMedCrossRefGoogle Scholar
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    Hauben M, Aronson JK. Gold standards in pharmacovigilance: the use of definitive anecdotal reports of adverse drug reactions as pure gold and high-grade ore. Drug Saf 2007; 30(8): 645–55PubMedCrossRefGoogle Scholar

Copyright information

© Adis Data Information BV 2008

Authors and Affiliations

  • Jeffrey K. Aronson
    • 1
  1. 1.University Department of Primary Health CareHeadingtonUK

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