Active pharmacovigilance and healthcare utilization.

OBJECTIVES While active surveillance for adverse drug events using electronic medical records (EMRs) and claims data is expanding, these data do not fully capture patient experiences with medication-related symptoms. Our objective was to describe adherence and outcomes associated with an automated pharmacovigilance call. STUDY DESIGN/METHODS Prospective cohort of patients receiving a prescription for a target medication at a participating primary care clinic were eligible for an automated phone pharmacovigilance call. Outcomes, compared for participants who completed (n = 1184) versus did not complete the call (n = 407), included EMR documentation during the 6 months following the call that the patient had: stopped the medication, used acute care services or died, or received a specialty or primary care visit. RESULTS Compared with those who agreed to participate but did not complete the pharmacovigilance call, subjects who completed the call had greater rates of EMR-documented medication cessation (3.9% vs 1.0%, adjusted P value = .007), and use of primary or specialty care (32.8% vs 18.7%, P value <.0001), but similar use of acute care services or death (12.2% vs 9.8%, P = .38). Of participants, 50.2% reported >1 symptom; of these, 22.0% thought the symptom was medication-related. In contrast to the low rates of EMR-documented medication cessation, 21.2% of participants said that they were no longer taking the medication; 69% said that their doctor did not know that they had stopped. CONCLUSIONS Automated phone pharmacovigilance provides important information about adherence, and was associated with greater EMR-documented medication cessation and planned service use.