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New Drugs 2010-2011

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Overview

In 2010, the FDA approved 21 new molecular entities (NMEs) down from 25 in 2009. A few of these are potential blockbusters including fingolimod (GilenyaTM), the first oral multiple sclerosis drug, and dabigatran (Pradaxa®), the first warfarin alternative. In addition to these NMEs, this issue reviews several more that are likely to be of interest to community-based practitioners including dalfampridine (AmpyraTM), denosumab (ProliaTM, XgevaTM), liraglutide (Victoza®), ulipristal (Ella®), and a new combination dextromethorphan /quinidine (NuedextaTM). Each review summarizes the drug’s role in therapy, usual dose, precautions and drug interactions. Useful and practical patient counseling points are highlighted separately for easy access. Combination products are becoming more commonplace, especially in the chronic disease arena (e.g., high blood pressure and diabetes). A brief summary of the advantages and potential disadvantages of fixed combinations is provided in this issue. Practical tables outline other NMEs, new combination products and significant new dosage forms you are likely to encounter in practice.

Details

Publication Date: 03/01/2011
Expiration Date: 03/01/2014
CE Credit: 2.0 (0.2 CEU)
Type of Activity: Knowledge-based

This program was developed by The Rx Consultant and published by Continuing Education Network, Inc. The Rx Consultant accepts no advertising or financial support from the pharmaceutical industry and is funded solely by the purchase of programs. The Rx Consultant is dedicated to providing unbiased, balanced information to health care practitioners.

Programs developed by The Rx Consultant are written by health care providers with expertise in the topic area, peer-reviewed, extensively edited, and fact-checked. This development process was created to insure that every program presents information that is current, accurate, relevant to "real world" health care providers, and written in an easy reading, "plain English" style.

Authors

James Chan, PharmD, PhD, Pharmacy Quality and Outcomes Coordinator, Kaiser Permanente, Oakland, CA and Assistant Clinical Professor, School of Pharmacy, University of California, San Francisco, CA, and Angie S. Graham, PharmD, FCSHP, Medical Communications Scientist, Genentech, Inc., South San Francisco, CA.

Disclosure Statement

Dr. Chan and Dr. Graham report no financial or personal relationship with any commercial interest producing, marketing, reselling, or distributing a product or service that appears in this issue.

Target Audience

This accredited program is targeted to pharmacists and nurses.

Goals & Objectives

At the conclusion of this program, participants will be able to:

    1. For each of the new drugs reviewed, list the FDA approved indication(s).
    2. Describe the mechanism of action, significant side effects and drug interactions for each of the new drugs reviewed. Provide 2-3 patient counseling tips.
    3. Discuss the potential role in therapy for each of the new drugs reviewed.
    4. For each drug listed in Table 2,list the generic name, brand name if applicable, and FDA approved indication(s).

Accreditation Statements

The Rx Consultant is a publication of Continuing Education Network, Inc.

Continuing Education Network, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education as a provider of continuing pharmacy education.

Continuing Education Network is approved by the California Board of Registered Nursing, Provider Number CEP 13118. Programs approved by CA BRN are accepted by most State Boards of Nursing.

ACPE Universal Activity Number: 0428-0000-11-103-H01-P


Exam & Credit Statement Procedures

Upon successful completion of this program and the post test (70%), 2.0 hours of continuing education credit will be awarded. To receive credit and your exam score, please complete the exam questions and program evaluation.

Editorial and Review Board

Chief Editor and CE Administrator


Terry M. Baker, PharmD

Managing Editor


Tracy Farnen, PharmD

Associate Editors


James Chan, PharmD, PhD
Pharmacy Quality and Outcomes Coordinator
Kaiser Permanente
Oakland, CA

Associate Clinical Professor
School of Pharmacy
University of California San Francisco
San Francisco, CA

Richard Ron Finley, B.S. Pharm.,R.Ph.
Clinical Pharmacist (volunteer faculty)
University of California, San Francisco (UCSF) Memory and Aging Center
Lecturer (Emeritus) UCSF, Department of Clinical Pharmacy
Health Sciences Clinical Professor, UCSF School of Pharmacy
San Francisco, CA

Consultant Pharmacist
Ray Dolby Brain Health Center, Sutter Health/CPMC
San Francisco, CA

Consult Pharmacist Aging and Adult Health Services
San Francisco Health Department
San Francisco, CA

Julio R. Lopez, PharmD, FCSHP
Chief of Pharmacy Service
VA Northern California Health Care System

Adjunct Clinical Professor
College of Pharmacy
Touro University
Vallejo, CA

Assistant Clinical Professor
School of Pharmacy
University of California, San Francisco
San Francisco, CA Adjunct Professor
Thomas J. Long School of Pharmacy
University of the Pacific
Stockton, CA

Visiting Associate Professor and Lecturer
Nursing School
Samuel Merritt University
Oakland, CA

Pamela Mausner, MD

Helen Berlie, Pharm.D. CDE, BCACP
Clinical Assistant Professor, Pharmacy Practice
Wayne State University
Detroit, MI

Ambulatory Care Specialist - Diabetes
Health Centers Detroit Medical Group
Detroit, MI

Senior Editorial Advisor


Gerard Hatheway, PharmD, PhD

Editorial Advisors


Belinda M. Danielson, RPh
Christopher M. DeSoto, PharmD
Angie S. Graham, PharmD
Cynthia Chan Huang, PharmD, MBA
Fred Plageman, PharmD

Editorial Advisor and Clinical Practice Consultant for Nurse Practitioners


Emily K.
Meuleman, RN, C, MS

About the Rx Consultant

The Rx Consultant is a monthly publication dedicated to providing health care professionals with the information they need to educate patients about drugs and manage drug therapy. The reader is responsible for confirming the information presented here and interpreting it in relation to each patient's specific situation before utilizing the information.

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