title: Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports.
abstract: BACKGROUND
  The process of generating 'signals' of possible unrecognized hazards from spontaneous adverse drug reaction reporting data has been likened to looking for a needle in a haystack. However, statistical approaches to the data have been under-utilised.
  
  
  METHODS
  Using the UK Yellow Card database, we have developed and evaluated a statistical aid to signal generation called a Proportional Reporting Ratio (PRR). The proportion of all reactions to a drug which are for a particular medical condition of interest is compared to the same proportion for all drugs in the database, in a 2 x 2 table. We investigated a group of newly-marketed drugs using as minimum criteria for a signal, 3 or more cases, PRR at least 2, chi-squared of at least 4.
  
  
  RESULTS
  The database was used to examine retrospectively 15 drugs newly-marketed in the UK, with the highest levels of ADR reporting. The method identified 481 signals meeting the minimum criteria during the period 1996-8. Further evaluation of these showed that 70% were known adverse reactions, 13% were events which were likely to be related to the underlying disease and 17% were signals requiring further evaluation.
  
  
  CONCLUSIONS
  Proportional reporting ratios are a valuable aid to signal generation from spontaneous reporting data which are easy to calculate and interpret, and various refinements are possible.
authors.affiliation: Post-Licensing Division, Medicines Control Agency, Market Towers, 1, Nine Elms Lane, London SW8 5NQ.
authors.forename: S J
authors.initials: SJ
authors.lastname: Evans
authors.forename: P C
authors.initials: PC
authors.lastname: Waller
authors.forename: S
authors.initials: S
authors.lastname: Davis
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D003627:Data Interpretation, Statistical; D016208:Databases, Factual; D012984:Software