Active pharmacovigilance and healthcare utilization

Area of Science:

• Pharmacovigilance
• Patient Adherence
• Medication Safety

Background:

• Electronic medical records (EMRs) and claims data are expanding for adverse drug event surveillance.
• These data sources do not fully capture patient experiences with medication-related symptoms.
• Automated pharmacovigilance calls offer a novel approach to gather patient-reported outcomes.

Purpose of the Study:

• To describe adherence and outcomes associated with an automated pharmacovigilance call.
• To compare outcomes between patients who completed and did not complete the call.
• To assess the utility of automated calls in capturing medication cessation and healthcare utilization.

Main Methods:

• A prospective cohort study of patients prescribed a target medication at a primary care clinic.
• Patients were offered an automated phone pharmacovigilance call.
• Outcomes included EMR-documented medication cessation, acute care use, death, and primary/specialty care visits.

Main Results:

• Patients completing the call showed higher rates of EMR-documented medication cessation (3.9% vs 1.0%) and primary/specialty care use (32.8% vs 18.7%).
• No significant difference in acute care services use or death was observed between groups (12.2% vs 9.8%).
• A significant portion of participants (21.2%) reported stopping medication, with 69% indicating their doctor was unaware.

Conclusions:

• Automated phone pharmacovigilance provides crucial information on patient adherence.
• This method is associated with increased EMR-documented medication cessation and planned healthcare service utilization.
• Automated calls enhance pharmacovigilance by capturing patient-reported adherence and symptoms often missed by EMRs.