Informed consent and the prescription of nonsteroidal antiinflammatory drugs

OBJECTIVE: To examine disclosure of side effects of nonsteroidal antiinflammatory drugs (NSAIDs) and to identify patient- and physician-specific factors associated with greater disclosure. METHODS: Forty-six encounters between rheumatologists and new adult outpatients who were prescribed an NSAID they had not been taking prior to the visit were audiotaped. Reviewers coded the NSAID prescribed, specific side effects mentioned, demographic features of patients and physicians, and patient clinical characteristics. Neither patients nor physicians were aware that side effect disclosure was being studied. RESULTS: A mean of 1.7 side effects was mentioned per encounter. Epigastric discomfort was mentioned in 72% of encounters, while other side effects, including hepatic, renal, hematologic, or central nervous system effects, were mentioned in < or = 15% of encounters. Three factors were identified as independent predictors of less disclosure of side effects: senior clinician (versus less experienced), patient not taking another NSAID immediately prior to the visit, and patient age < 40. Increased disclosure by less experienced clinicians occurred exclusively with patients who were taking another NSAID prior to the visit. CONCLUSION: Disclosure of side effects other than epigastric discomfort to patients who are prescribed a new NSAID is limited. Patients not taking NSAIDs previously, who presumably have the most to gain from such discussions, are told the least. These results have implications with regard to doctor-patient decision-making and malpractice litigation in the outpatient setting.