Informed consent for a prescription drug: Impact of disclosed information on patient understanding and medical outcomes

Based on the two legal standards of informed consent currently in use, the Medical Practice Standard and the Reasonable Person Standard, two disclosures containing information about the risks and benefits of the anticonvulsant, Carbamazepine, were empirically derived. One of these two disclosures was randomly given to a sample of 39 seizure patients and the parents of pediatric seizure patients prescribed this drug. Subjects were interviewed either immediately after disclosure and at followup, or at followup only. The results provide no evidence for the hypothesized negative effects — anxiety, treatment refusal, reduced compliance and increased side effects — of providing patients with extensive disclosures about prescription drugs.