Drug and patient safety studies: methods and implementation

Abstract

Background: The majority of healthcare is delivered in ambulatory care settings, where fragmented care, and high medication use prevalence may compromise patient safety. In particular, hypoglycemic diabetic agents lead to adverse drug events (ADE) among patients treated in outpatient settings. • Objective: The goals of this project are to: 1. identify sources of confounding and bias in safety studies; and 2. design a study for implementation and evaluation of pharmacy-based strategies to improve safety in ambulatory care settings. • Method: To achieve the first goal, I have planned a workshop in collaboration with the FDA. This workshop explores creative methods to address confounding and bias in pharmacoepidemiology safety studies. With respect to the second goal of this project, I will plan to assess the joint impact of a pharmacist-lead intervention to patients and physicians, aimed at identifying and resolving drug therapy problems in high risk elderly patients on insulin and/or oral hypoglycemic agents. Ultimately, this study will provide an updated and contemporary medication safety framework for care in ambulatory settings, which practices can readily adopt and which future studies can use to devise and implement further actionable strategies to improve patient safety.