New Drugs 2008-2009

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Overview

   In 2008, the FDA approved 21 new molecular entities (NMEs) and 7 significant new biologicals, compared with 17 NMEs and 2 biologic products in 2007. Despite the increase in approvals, there are no apparent blockbuster drugs. While the pharmaceutical industry suggests that “newly approved” means “new and improved,” this is often far from the truth. Many recently approved drugs are not innovations, but rather “me-too” products. In addition to misleading marketing, the true value of new drugs is often obscured by the incomplete and potentially biased state of the published literature. Incomplete post-marketing studies that are requested by the FDA at the time of approval also cloud the real benefits or disadvantages of new drugs. With all these influences, it is essential that providers use a critical eye when sifting through the available information, in order to better educate patients and colleagues. New is not always better.

   This issue reviews 8 new drugs or novel new formulations that you are most likely to encounter in clinical practice including alvimopan (Entereg®), certolizumab (Cimzia®), desvenlafaxine (Pristiq®), fenofibric acid (TriLipix®), fesoerodine (Toviaz®), methylnaltrexone (Relistor®), milnacipran (Savella®), and silodosin (Rapaflo®). The reviews consist of the indication, the drug’s role in therapy, usual dose, precautions, drug interactions, and practical patient counseling points. Handy tables encompass brief overviews for 11 additional new drugs, new formulations you are likely to see in practice, and new combination products.

Publication Date: Apr-1-09
Expiration Date: Apr-2-12
CE Credit: 2.0 (.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 and Angie S. Graham, PharmD, Drug Information Coordinator, Stanford Hospital & Clinics, and Assistant Clinical Professor of Pharmacy, University of California, San Francisco.

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.

Editorial and Review Board

Editor and CE Administrator Terry M. Baker, PharmD Associate Editor and CE Coordinator 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 Ron Finley, RPh Lecturer Department of Clinical Pharmacy University of California San Francisco San Francisco, CA Associate Member of the UCSF Memory and Aging Center Alzheimer's Research Center Consultant Pharmacist to the Institute on Aging-On Lok Senior Health Institute on Aging Alzheimer's Day Care Center Angie S. Graham, PharmD Drug Information Coordinator Stanford Hospital and Clinics Stanford University Medical Center Stanford, 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 Joshua J. Neumiller, PharmD, CDE, CGP, FASCP Assistant Professor Department of Pharmacotherapy College of Pharmacy Washington State University And Elder Services of Spokane Spokane, WA Candy Tsourounis, PharmD Professor of Clinical Pharmacy Medication Outcomes Center Department of Clinical Pharmacy School of Pharmacy University of California, San Francisco San Francisco, CA Senior Editorial Advisor Gerard Hatheway, PharmD, PhD Editorial Advisors Jocelyn Chan, PharmD Belinda M. Danielson, RPh Christopher M. DeSoto, PharmD Cynthia Chan Huang, PharmD, MBA Fred Plageman, PharmD Editorial Advisor and Clinical Practice Consultant for Nurse Practitioners Emily K. Meuleman, RN, C, MS

Accreditation Statements

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

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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Target Audience

This accredited program is targeted to pharmacists and nurses.

Exam and 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.

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