PATIENT PERCEPTIONS OF PRESCRIPTION DRUG RISK IMPORTANCE: SURVEY AND EXPERIMENTAL EVIDENCE

Purpose: The FDA recently recommended that prescription drug labeling and advertising inform patients only of a drug’s “most important” risks, to avoid burying essential risk information within exhaustive lists of possible adverse effects.  But which risks are “most important?” This study explores patients’ perspectives on which risks are most important: both what patients say they want to be told about drug risks, and which risk information actually influences their decisions to use a prescription drug.

   Method: A sample of 508 US adults ages 40-75 was recruited from a national online survey panel.  The sample was roughly representative of the US population on gender (52% male), ethnicity (28% non-White) and education (33% high school diploma or less).  Respondents were asked their preferences for the presentation of prescription drug risk information.  In addition, an experiment examined which risk information actually influenced patients’ intentions to use a prescription drug.  Respondents were randomly assigned to different versions of a prescription drug description, which varied on side-effect severity, side-effect likelihood, and seriousness of the disease being treated.  Afterwards they reported their intentions to use or recommend the drug.

   Result: Most respondents stated they wanted to be told about all possible side effects.  However, experimental findings indicated that the decision impact of risk information varied considerably depending on the risk’s severity and likelihood, and the seriousness of the disease being treated.  The possibility of a mild side effect (mild headache) had no impact on drug-use intentions, regardless of likelihood (1 in 10,000 patients vs. 1011 in 10,000 patients) or the severity of the disease being treated (eczema vs. Alzheimer’s).  However, the decision impact of a potential severe side effect (internal bleeding) was more complex.  For a drug treating a relatively mild disease (eczema), the mere possibility of a severe side effect sharply reduced drug-usage intention, even if this side effect was extremely unlikely.  However, in treating a debilitating disease (Alzheimer’s), patients were willing to tolerate a potentially severe side effect if it was extremely unlikely (1 in 10,000).  

   Conclusion: The recommendation that drug risk disclosures focus on the “most important” risks seems reasonable in theory, but may be challenging to implement, since patient perceptions of risk importance involve complex interactions of perceived severity, perceived likelihood, and the disease being treated.