University of Wisconsin–Madison

Updates in Drug-Drug Interactions for Recently Approved Drugs

The goal of this course series is to provide pharmacists with an in-depth understanding of the mechanisms of drug interactions, providing the basis for scientifically justified and clinically sound decisions to prevent or minimize drug interactions.

In this 5-session course, we will explore clinically significant pharmacokinetic drug-drug interactions (DDIs) observed with recently FDA approved drug therapies. The possible mechanisms (e.g., inhibition or induction of metabolizing enzymes and/or transporters, changes in drug absorption, pharmacogenetics, organ impairment) will be reviewed and potential clinical outcomes explained. Mitigation strategies to prevent or minimize the risk of DDIs will be discussed.

Jointly provided by:

  • University of Washington (UW) Drug Interaction Solutions, Department of Pharmaceutics
  • University of Wisconsin-Madison School of Pharmacy, Division of Pharmacy Professional Development
Registration Information

Register

Refund Policy

Course date:Feb 2, 2021 - Dec 31, 2023
Location:
Course fee:

$100

Course Objectives

In this 5-session course, we will explore clinically significant pharmacokinetic drug-drug interactions (DDIs) observed with recently FDA approved drug therapies. The possible mechanisms (e.g., inhibition or induction of metabolizing enzymes and/or transporters, changes in drug absorption, pharmacogenetics, organ impairment) will be reviewed and potential clinical outcomes explained. Mitigation strategies to prevent or minimize the risk of DDIs will be discussed.

At the end of this course, students will be able to:

  • Understand the basic scientific principles of drug metabolism and drug transport and their roles in controlling drug exposure and pharmacokinetic drug-drug interactions;
  • Review the main mechanisms involved in pharmacokinetic drug-drug interactions;
  • Understand the concepts of marker, victim, and perpetrator drugs and know how to extrapolate the results of a marker study to common co-medications;
  • Know the categorization of clinical victim and perpetrator drugs sensitivity and potency (weak, moderate, or strong) and the impact on product labeling recommendations;
  • Describe common drug interactions with recently approved drug therapies;
  • Examine significant drug interactions observed during the drugs’ development and discuss likely mechanism(s) and possible clinical outcomes;
  • Apply mechanistic knowledge gained to predict and prevent drug interactions;
  • Identify relevant resources to develop a risk mitigation strategy.

Course Outline

Lecture 1

Basic Principles and Main Mechanisms of Pharmacokinetic Drug Interactions

Speaker: Cathy Yeung, PharmD, PhD, MPH, Instructor, University of Washington (UW) Drug Interaction Solutions, Department of Pharmaceutics

This presentation will describe various aspects of pharmacokinetic (PK) related drug-drug interactions (DDI) including substrate sensitivity, precipitant potency, and the most relevant PK measurements for characterizing DDI.  Many case examples will be used to illustrate these principles, and a high-level overview of the top 5 clinically significant drug interactions from recent FDA approvals will be presented.

Lecture 2

Drugs Recently Approved by FDA (2013-2017) - Metabolism-based Drug Interactions

Speaker: Jingjing Yu, MD, PhD,  Principal Investigator and Instructor, University of Washington (UW) Drug Interaction Solutions, Department of Pharmaceutics

This presentation will describe the major drug metabolizing enzymes and their contribution to DDI.  Factors that affect metabolism-based DDI and the in vitro and in vivo methodologies to investigate them will be discussed.  Clinically significant DDI due to the induction and inhibition of drug metabolizing enzymes for recently approved drugs will also be presented along with strategies to manage potential DDI risk.

Lecture 3

Drugs Recently Approved by FDA (2013-2017) - Transporter-based Drug Interactions

Speaker: Jingjing Yu, MD, PhD

This presentation will describe the major transporters involved in drug disposition and the mechanisms of transporter-based DDI.  The interplay between transporters and drug metabolizing enzymes in the context of DDI will be examined.  The challenges and clinical importance of identifying sensitive substrates and strong inhibitors of transporters will also be discussed.

Lecture 4

Drugs Recently Approved by the FDA (2013-2017) – Absorption-based Drug Interactions and Food-Effects

Speaker: Jingjing Yu, MD, PhD

The mechanisms of absorption-based DDI due to acid-reducing agents and food effects will be discussed.  A framework for the evaluation of pH dependent DDI and examples using recently approved drugs will be presented.  Guidelines for investigating food-effect are highlighted and examples using recent drug approval are given. 

Lecture 5

Impact of Patient Factors: Pharmacogenetics, Organ Impairment, and Natural Product-Drug Interactions

Speaker: Cathy Yeung, PharmD, PhD, MPH

The concept of gene-drug interactions and their clinical relevance will be introduced.  Examples of gene-drug interactions and strategies for managing risk will be discussed.  Guidelines for conducting hepatic and renal impairment studies is presented along with several examples of the effects of organ impairment on PK for recently approved drugs.  Lastly, an overview and examples of natural product-drug interactions will be provided.

   

Instructors

Cathy Yeung, PharmD, PhD, MPH, Instructor, University of Washington, School of Pharmacy, Drug Interaction Solutions, Department of Pharmaceutics, Seattle, WA

Jingjing Yu, MD, PhD,  Principal Investigator and Instructor, University of Washington, School of Pharmacy, Drug Interaction Solutions, Department of Pharmaceutics, Seattle, WA

Planning Committee

Leslie Dickmann, PhD, MPH, Program Director, Division of Pharmacy Professional Development, UW-Madison School of Pharmacy, Madison, WI

Isabelle Ragueneau-Majlessi, MD, MS, Senior Advisor, University of Washington, School of Pharmacy, Drug Interaction Solutions, Department of Pharmaceutics, Seattle, WA

Policy on Disclosure

It is the policy of the University of Wisconsin–Madison Interprofessional Continuing Education Partnership (ICEP) to identify, mitigate and disclose all relevant financial relationships with ineligible companies* held by the  speakers/presenters, authors, planners, and other persons who may influence content of this accredited continuing education (CE).  In addition, speakers, presenters and authors must disclose any planned discussion of unlabeled/unapproved uses of drugs or devices during their presentation.

For this accredited continuing education activity, all faculty, planners, and other persons who may influence content of this activity have no relevant financial relationships with ineligible companies to disclose and will not discuss unlabeled/unapproved uses of drugs or devices during their presentations.

*Ineligible companies are those whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on, patients.

CE Credit

ICEP LogoAccreditation Statement

In support of improving patient care, this activity has been planned and implemented by the University of Wisconsin–Madison ICEP and University of Washington. The University of Wisconsin–Madison ICEP is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Credit Designation Statements

Accreditation Council for Pharmacy Education (ACPE)

The University of Wisconsin-Madison ICEP designates this enduring knowledge-based activity for 4 hours (0.4 CEUs) of CPE credit. Credit can be earned by successfully completing the assessment (70% or better score) and evaluation. There will be no partial credit awarded for partial completion.

Enduring (home study): JA0000358-9999-21-068-H04-P
Release Date: 2/02/2021 Expiration Date: 12/31/2023

Continuing Education Units (CEUs)

The University of Wisconsin–Madison ICEP, as a member of the University Professional & Continuing Education Association (UPCEA), authorizes this program for 0.4 CEUs or 4 hours.

Program Coordinator

Leslie Dickmann, PhD, MPH

Division of Pharmacy Professional Development
777 Highland Avenue
Madison, WI 53705
(608) 262-2431 FAX
(608) 265-8249
ljdickmann@wisc.edu