Adverse drug reactions: Can consumers provide early warning?

Andrew S. Mitchell, David A. Henry, Deborah Hennrikus, Dianne L. O'Connell

Research output: Contribution to journalArticlepeer-review

20 Scopus citations


In order to investigate the potential value of a drug monitoring system based on consumer reports we asked community pharmacists to distribute previously validated event report forms to users of two popular non‐steroidal anti‐inflammatory drugs (NSAIDs), piroxicam and diclofenac, in the Hunter Region of New South Wales, Australia. Although response rates were low, comparisons of replies from NSAID users and drug‐free subjects in the community identified a range of established symptomatic reactions from NSAIDs affecting the gastrointestinal tract, central nervous system and lower urinary tract. In comparison, analysis of adverse reaction reports from health professionals revealed a tendency to report more severe but rarer reactions affecting the upper gastrointestinal tract, liver, skin and haematological system. It is likely that a system based on consumer reports could augment current sources of information on adverse drug effects by revealing reactions which are important to consumers and yet often evade detection during pre‐marketing clinical trials. Such a system might also have a capacity to generate very early signals of previously unsuspected symptomatic reactions with new drugs.

Original languageEnglish (US)
Pages (from-to)257-264
Number of pages8
JournalPharmacoepidemiology and Drug Safety
Issue number5
StatePublished - 1994
Externally publishedYes


  • Adverse drug reaction
  • consumer report
  • hypothesis generation


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