Using Pharmacoepidemiology Database Resources to Address Drug Safety Research

‎1. Course Aim ‎
Pharmacoepidemiology requires the utilization of database resources to evaluate drug safety. This course will ‎define the different types of data resources available for pharmacoepidemiology and the selection criteria to ‎select the most appropriate resource. The course focuses on the Guidelines for good database selection and use ‎in pharmacoepidemiology research, provides an overview consideration in selection of databases resources, ‎consideration on the utilization of multiple data resources including linkage of available data resources, and ‎addresses the need for validation. ‎

‎2. Requisites Statement ‎
Intermediate level course. The course assumes attendees have either taken entry level pharmacoepidemiology ‎courses at ISPE or through didactic course work.‎

‎3. Course Objectives‎
‎1.‎ To review the Guidelines for Good Database Selection and use in Pharmacoepidemiology Research with ‎a focus on how to construct computable phenotypes within available resources
‎2.‎ To develop the skills to select an appropriate resource to conduct pharmacoepidemiology research
‎3.‎ To gain an appreciation for the utilization of multiple pharmacoepidemiology data resources through ‎distributed research methods and the available methods for data linkage of diverse data resources
‎4.‎ To examine validation methods for assessing the quality of pharmacoepidemiology data sources

‎4. Syllabus Outline‎
‎1.‎ Overview of Database use in Pharmacoepidemiology {40 minutes} Rosa Gini, PhD
ARS Toscana
The presentation will review the ISPE Guidelines for good database selection and use in ‎pharmacoepidemiology research. The focus will be on application of the guidelines in a topically ‎updated portfolio of pharmacoepidemiology studies. The talk will provide an overview of the methods ‎to define study variables with computable phenotypes.‎

‎2.‎ Selection of Databases for Pharmacoepidemiology Research {40 minutes} Matthew Reynolds, PhD Vice President, Real World Effectiveness at IQVIA
The presentation will review the process of database selection from available resources across an ‎international landscape.‎

‎3.‎ ‎ Database Selection Workshop Activity {20 minutes} Kevin Haynes, PharmD, MSCE, ‎
Associate Director of Epidemiology at Janssen
An interactive coffee break in which participants will be exposed to several pharmacoepidemiology ‎specific aims and asked to provide potential database resources to address the research questions. ‎

‎4.‎ Multiple Pharmacoepidemiology Resource Research {40 minutes} Sudha Raman, PhD‎
Assistant Professor, Department of Population Health Sciences, Duke University
The lecture will provide guidance on two key aspects of multiple pharmacoepidmiology resource ‎utilization 1. Distributed database research and 2. data linkage appropriateness and feasibility.‎

‎5.‎ Data validation approaches in pharmacoepidemiology {30 minutes} Daniel Beachler, PhD, Carelon Research, Inc.‎
An overview of the various approaches available to conduct validation studies. The presentation will ‎ focus on the mechanics of medical record validation studies and the impact on bias analyses within ‎ pharmacoepidemiology studies.‎

Validation Workshop Activity {20 minutes}‎
Participants will work hands on with an on-line tool to determine how to adjust point estimates for ‎outcome misclassification if PPV is known and sensitivity is known or can be assumed.‎