Context
Direct-to-consumer (DTC) advertising of prescription drugs in the United States is both ubiquitous and controversial. Critics charge that DTC advertising leads to over-prescribing, while proponents counter that it helps avert under-use of effective treatments, especially for conditions such as depression that are poorly recognized or stigmatized.
Objective
To ascertain the effects of patients’ DTC-related requests on physicians’ initial treatment decisions (prescribing, referral, and follow-up) in patients with depressive symptoms.
Design
Randomized trial using Standardized Patients (SPs). Six SP roles (experimental cells) were created by crossing two conditions (major depression or adjustment disorder) with three request types (brand-specific, general, or none).
Setting
Offices of primary care physicians in Sacramento, CA; San Francisco, CA; and Rochester, NY.
Participants
152 family physicians and general internists recruited from solo and group practices and health maintenance organizations; cooperation rates ranged from 53% to 61%.
Interventions
SPs were randomly assigned to make 298 unannounced visits, with assignments constrained so physicians saw 1 SP with major depression and 1 with adjustment disorder (approximately 50 visits per experimental cell).
Main Outcome Measures
Data on prescribing, mental health referral, and primary care follow-up were obtained from SP written reports, visit audio-recordings, chart review, and analysis of written prescriptions and drug samples. The effects of request type on prescribing were evaluated using contingency tables and confirmed in generalized linear mixed models that accounted for clustering and adjusted for site, physician, and visit characteristics.
Results
SP role fidelity was excellent, and the detection rate was 12%. In major depression, rates of antidepressant prescribing were 53%, 76%, and 31% for SPs making brand-specific requests, general requests, and no requests, respectively (p<.0001). In adjustment disorder, antidepressant prescribing was 55%, 39%, and 10%, respectively (p<.0001). The results were confirmed in multivariate models. “Minimally acceptable initial care” (any combination of an antidepressant, mental health referral, or follow-up within two weeks) in the major depression role was offered to 98% of SPs making a general request, 90% of those making a brand-specific request, and 56% of those making no request (p<0.001).
Conclusions
Patients’ requests have a profound effect on physician prescribing in major depression and adjustment disorder. DTC advertising may have competing effects on quality, potentially both averting under-use and promoting over-use.