Physician Response to Patient Reports of Adverse Drug Effects

Implications For Patient-Targeted Adverse Effect Surveillance

Physician response to patient reports of potential adverse drug reaction (ADR) was the focus of this study. Patient reports of ADR were conceptualized as a form of postmarketing surveillance for rates of ADR that may be underreported in clinical trials. Study participants were 650 patients taking HMG-CoA reductase inhibitors or statins. Participants completed a general survey and if they reported muscle, cognitive and neuropathy symptoms they also completed follow-up surveys in these areas. Overall, 207, 113 and 85 patients completed surveys in muscle, cognitive and neuropathy areas, respectively.

Key Findings:

  • In all, 87 percent of participants reported communicating with their physicians about potential ADRs related to their use of statins.
  • Participants described beginning discussions of ADRs with physicians 98 percent, 96 percent and 86 percent of the time in regard to cognition, neuropathy and muscle symptoms, respectively.
  • Participant accounts of physicians not considering their reports of ADR varied by area with neuropathy patients reporting the phenomenon most often (51%).
  • Physicians initiated discussion of ADRs more frequently for muscle adverse effects as compared to cognitive or neuropathy symptoms.