title: Risk perception of prescription drugs: results of a survey among experts in the European regulatory network.
abstract: Experts are perceived to be veridical and to focus only on objective data when evaluating risk. Only a few research studies have attempted to characterize the subjectivity in risk evaluation among experts.
  
  
  
  The hypothesis of this study is that expert evaluation of a pharmaceutical drug can be partly explained by dimensions that describe the drug and by individual characteristics.
  
  
  
  Seventy-five medical assessors in 9 EU countries evaluated a list of 28 pharmaceutical drugs using 4 scales: risk, benefit, seriousness of harm, and patients' knowledge of the risk. They were also given a mock "clinical dossier" and asked to rate it on 8 dimensions: risk, benefit, worry, magnitude of the exposure, scientific knowledge of the risk, familiarity of the risk, ethical concerns, and risk acceptability.
  
  
  
  Female assessors perceived significantly higher benefits than men for a large number of the 28 drugs. Principal component analysis of the ratings for the clinical dossiers revealed 2 underlying components: seriousness of harm and scientific evidence. A regression model predicting the risk perception of the drug showed that the variables seriousness of harm (benefit, worry, magnitude of exposure, ethical concerns, and risk acceptability), years of regulatory experience, gender, and type of drug explained 54% of the variability among assessors.
  
  
  
  Assessors' view of the risks associated with pharmaceutical drugs is influenced by worry for patient safety, magnitude of patient exposure, and ethical concerns. These dimensions may influence their perceptions of benefit and risk acceptability. Senior assessors are more risk averse than junior assessors, and female assessors seem to be sensitive to the promise of benefit from medicines and consequently may be less risk averse than male assessors.
authors.affiliation: University Medical Center of Groningen (ARMB, PADG, HLH)|London School of Economics and Political Science (ARMB, BF, LDP)|European Medicines Agency (ARMB, BF, LDP)
authors.forename: Andrea R
authors.initials: AR
authors.lastname: Beyer
authors.affiliation: London School of Economics and Political Science (ARMB, BF, LDP)|European Medicines Agency (ARMB, BF, LDP)
authors.forename: Barbara
authors.initials: B
authors.lastname: Fasolo
authors.affiliation: London School of Economics and Political Science (ARMB, BF, LDP)|European Medicines Agency (ARMB, BF, LDP)
authors.forename: Lawrence D
authors.initials: LD
authors.lastname: Phillips
authors.affiliation: University Medical Center of Groningen (ARMB, PADG, HLH)
authors.forename: Pieter A
authors.initials: PA
authors.lastname: de Graeff
authors.affiliation: University Medical Center of Groningen (ARMB, PADG, HLH)
authors.forename: Hans L
authors.initials: HL
authors.lastname: Hillege
mesh_terms: D000328:Adult; D003625:Data Collection; D064420:Drug-Related Side Effects and Adverse Reactions; D005062:European Union; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D055553:Prescription Drugs; D018570:Risk Assessment; D055815:Young Adult
chemical_list: D055553:Prescription Drugs
keywords: gender differences; individual characteristics; risk; risk management; risk perception