Active pharmacovigilance and healthcare utilization

Abstract

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.