Program Description:

Bioequivalence is a comparison of two or more products with respect to their bioavailabilities. Bioequivalence of trade and generic products or different dosage forms of the same product needs to be determined before the products can be legally interchanged. Numerous factors can affect bioavailability (and bioequivalence) determinations. Patient factors include variations in absorption power and the pH (or acidity) of the gastrointestinal (GI) tract, gastric emptying rate, intestinal motility, GI tract perfusion, first-pass drug metabolism, age, sex, weight, disease status and interactions with other substances including drugs and rather common food. Thus, there is a great potential for wide variability among the pharmacokinetic profiles among patient populations and bioequivalence determinations. As pharmacists we are in an optimal position to prevent or intervene when a patient is experiencing drug-drug and drug-food interaction resulting in bioavailability alterations with outcomes including sub-therapeutic responses or adverse events. While product interchange between trade and generic medications or between dosage forms of the same product is typically not a problem, this activity is going to highlight some examples of when it is a concern.

Presented By:

Andrew J. Pultz, Jr, PharmD, RPh
Specialty Practice Pharmacist
The Ohio State University Medical Center

Andrew J. Pultz, Jr., PharmD is currently a Specialty Practice Pharmacist with the Ohio State University Medical Center, Department of Pharmacy. He has been a Clinical Specialist for Ohio State for over 20 years with a special emphasis on Physical Medicine and Rehabilitation and Hematology/Oncology. Dr. Pultz, Jr. graduated from Ohio State with a Bachelor of Science in Zoology in 1981; a Bachelor of Science in Pharmacy in 1986; and a Doctor of Pharmacy in 2004.

Joseph F. Dasta, MSc, FCCM, FCCP
Professor
Division of Pharmacy Practice and Administration
College of Pharmacy
The Ohio State University

Joseph F. Dasta, MS, FCCM, FCCP is Professor of Pharmacy Practice at The Ohio State University College of Pharmacy He earned his Master of Science in hospital pharmacy from The Ohio State University College of Pharmacy. Mr. Dasta completed a residency at The Ohio State University Hospital. He received an American Society of Health-Systems Pharmacists Research and Education Foundation grant in 1998 for his work in medication errors and adverse drug events in the intensive care unit (ICU).

An invited lecturer on a national level, Mr. Dasta has lectured on topics such as pharmacoeconomic issues in critical care; pharmacotherapy of severe sepsis; hemoglobin management in acute care; critical care pharmacy development; and sedation, analgesia, and neuromuscular blockade in the ICU. His research initiatives include use of bispectral index in the ICU; cost analysis of erythropoietic stimulating proteins, epidemiology, and costs of acute heart failure; costs are resource of acute renal failure; and an international survey of hospital pharmacy and critical care pharmacy practice. He is a fellow of the American College of Critical Care Medicine and the American College of Clinical Pharmacy.

A recipient of the 2002 Education Award from the American College of Clinical Pharmacy, Mr. Dasta was recently honored by the Society of Critical Care Medicine by having a pharmacy outcomes research grant in his name. In 2005, Professor Dasta was the recipient of the Society of Critical Care Medicine Distinguished Service Award. Professor Dasta has trained ten fellows and 10 residents in critical care pharmacy. He has given over 200 regional or national lectures, authored or co-authored over 100 refereed manuscripts and book chapters and has written 100 abstracts and brief communications. He is an editorial board member for Critical Care Medicine and Annals of Pharmacotherapy.

Sandra L. Kane-Gill, PharmD, MSc
Assistant Professor
Pharmacy and Therapeutics
University of Pittsburgh

Sandra L. Kane-Gill, PharmD, MSc received her baccalaureate pharmacy degree from Wayne State University in 1994. She completed an ASHP accredited pharmacy practice residency at West Virginia University Hospital in 1996. In 1998 she received her Doctorate of Pharmacy from the University of Toledo. Dr. Kane-Gill then pursued her Masters of Science in Pharmacy Administration with emphasis on Pharmacoeconomics and Health Outcomes at the Ohio State University in Columbus, Ohio from 1999-2001. Between 1998-2001 she completed her Critical Care Fellowship at the Ohio State University Upon completion of her training she joined the faculty of the University of Pittsburgh, School of Pharmacy in 2001 with an appointment as Assistant Professor in the Department of Pharmacy and Therapeutics for the Center for Pharmacoinformatics and Outcomes Research.

Dr. Kane-Gill's research interests focus on economic, clinical and humanistic evaluations for critically ill patients; specifically patient safety, quality of life in patients receiving sedatives/neuromuscular blockers, and developing models of cost for acute illness. She has served as Principal Investigator and Co-Investigator on several funded research grants in this area of study. Her research projects spanned the areas of anticoagulation, infectious disease, antidysrhythmics, sedation and adverse drug events. Her work has been presented as both oral and poster presentations at several national and international professional meetings including the Society of Critical Care Medicine (SCCM), European Society of Intensive Care Medicine, Annual American Society of Health-System Pharmacists (ASHP), American College of Clinical Pharmacy (ACCP), as well as local professional meetings. She has published over 30 abstracts and 20 peer-reviewed manuscripts.

Dr. Kane-Gill is very involved in national and international organizations through active membership in ACCP, SCCM, ASHP, International Society for Pharmacoeconomics and Outcomes Research. Currently she holds the appointment of past-chair for the Clinical Pharmacy and Pharmacology Section of SCCM. Also, she has recently been elected as a member of the United States Pharmacopeia Therapeutic Decision Making Expert Committee.

Educational Objectives:

Upon completion of the activity, participants will be able to:

1. Distinguish the differences between bioequivalence and bioavailability.
2. Understand how factors related to the dosage form and patient variables affect drug stability, dissolution capacity, and absorption properties.
3.  Recognize problems that arise with bioequivalence and generic substitution.
4.  Learn which critical patient and disease factors require special consideration for product selection.

Target Audience:

This activity is intended for Pharmacists and Pharmacy Technicians.

Disclosure Policy:

It is the policy of ArcMesa Educators to ensure balance, independence, objectivity, and scientific rigor in all its educational activities. All faculty/authors are expected to disclose any relevant financial relationships they may have with commercial interests in relation to this activity. These relationships, along with the educational content of this program, have been reviewed and any potential conflicts of interest have been resolved to the satisfaction of ArcMesa Educators.

Faculty Disclosures:

Andrew J. Pultz, Jr., Pharm D., R.Ph.- Nothing to disclose

Joseph F. Dasta, MSc., FCCM, FCCP- Nothing to disclose

Sandra L. Kane-Gill, PharmD., MSc.- Nothing to disclose

Disclaimer:

©2007 ArcMesa Educators, LLC / CMEdiscovery.com. All rights reserved. None of the contents may be reproduced in any form without prior written permission from ArcMesa Educators, LLC.

The views and opinions expressed in this activity are those of the faculty. They do not reflect the views of Acorda Therapeutics, any other manufacturer of pharmaceuticals, and/or ArcMesa Educators, LLC.

The recommendations made in this program are based upon a combination of randomized clinical trials, current guidelines, and the clinical practice experience of the participating panelists. Any medications, diagnostic procedures or treatments discussed by the panelists should not be utilized without evaluation of their patient's conditions. Participants are urged to consult the full prescribing information on any drug mentioned in this activity for recommended dosage, indications, contraindications, warnings, precautions, and adverse effects before prescribing any medication.

Fee:

Free!!