Using Pharmacoepidemiology Database Resources to Address Drug Safety Research

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 of available resources, addresses the need for outcome validation, and highlights data linkage considerations.

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

Course Objectives
1. To review the Guidelines for Good Database Selection and use in Pharmacoepidemiology Research.
2. To gain an understanding of available pharmacoepidemiology resources
3. To develop the skills to select an appropriate resource to conduct pharmacoepidemiology research
4. To examine validation methods for assessing the quality of pharmacoepidemiology data sources
5. To provide an overview of data linkage of available pharmacoepidemiology resources particularly to patient registry data resources

Syllabus Outline
1. Overview of Database use in Pharmacoepidemiology {30 minutes} Gillian Hall, PhD
Independent Consultant
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.

2. Selection of Databases for Pharmacoepidemiology Research {30 minutes} Kevin Haynes, PharmD, MSCE, Associate Director of Epidemiology at Janssen
The presentation will review available resources updated to reflect the dynamic changes to the availability of 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. Data validation approaches in pharmacoepidemiology {30 minutes} Daniel Beachler, PhD, HealthCore, 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.

6. Validation Workshop Activity {20 minutes} Gillian Hall, Daniel Beachler, Kevin Haynes
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.

7. Linking pharmacoepidemiology resources {30 minutes} Sudha Raman, PhD, Assistant Professor, Department of Population Health Sciences, Duke University
The lecture will provide guidance on key aspects of data linkage appropriateness and feasibility necessary to plan useful and sustainable linkages that advance pharmacoepidemiology and patient safety. The presentation will highlight recent advances undertaken across the society.