Med Decis Making - Risk perception of prescription drugs: results of a survey among experts in the European regulatory network.

Tópicos

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Resumo

CKGROUND: 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.OBJECTIVE: 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.DESIGN: 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.RESULTS: 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.CONCLUSION: 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.

Resumo Limpo

ckground expert perceiv verid focus object data evalu risk research studi attempt character subject risk evalu among expertsobject hypothesi studi expert evalu pharmaceut drug can part explain dimens describ drug individu characteristicsdesign seventyf medic assessor eu countri evalu list pharmaceut drug use scale risk benefit serious harm patient knowledg risk also given mock clinic dossier ask rate dimens risk benefit worri magnitud exposur scientif knowledg risk familiar risk ethic concern risk acceptabilityresult femal assessor perceiv signific higher benefit men larg number drug princip compon analysi rate clinic dossier reveal under compon serious harm scientif evid regress model predict risk percept drug show variabl serious harm benefit worri magnitud exposur ethic concern risk accept year regulatori experi gender type drug explain variabl among assessorsconclus assessor view risk associ pharmaceut drug influenc worri patient safeti magnitud patient exposur ethic concern dimens may influenc percept benefit risk accept senior assessor risk avers junior assessor femal assessor seem sensit promis benefit medicin consequ may less risk avers male assessor

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