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Patient Safety: Identifying Adverse Drug
Reactions

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Overview

An adverse drug reaction (ADR) is essentially a harmful effect that occurs with appropriate medication use at normal doses. Some ADRs are predictable based on a medication’s pharmacology (e.g., sedation from a narcotic). Others are unexpected or unpredictable (e.g., rhabdomyolysis linked to certain statins). This second type of ADR is the most concerning.
After a new medication is marketed and used by a large number of patients, previously undetected ADRs are often identified. These may be serious enough to justify restrictions on the use of the medication or result in its withdrawal from the market. Awareness of a serious ADR may not occur until a medication has been on the market for years. Fueling this delay are under-reporting and incomplete reporting of ADRs by healthcare providers and consumers, and the limited ability of the FDA and pharmaceutical manufacturers to analyze large volumes of post-marketing surveillance data. As key reporters, pharmacists as well as consumers can be at the forefront of the patient safety movement. This issue serves as an introduction to the nature of ADRs, the importance of reporting them, and current methods used for their identification and analysis.

Details

Publication Date: 12/01/2011
Expiration Date: 12/01/2014
CE Credit: 2.0 (0.20 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

Charles L. Bennett, MD, PhD, MPP and Zaina P. Qureshi PhD, MPH

Disclosure Statement

Dr. Bennett and Dr. Qureshi 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:

  • Explain the term pharmacovigilance in relation to ADRs and the differences among ADRs, ADEs, side effects, and medication errors.

  • List the FDA's criteria for a serious ADR.

  • Describe the importance of identifying ADRs after FDA approval, and list the benefits and limitations of various organizations that gather and analyze ADR information.

  • Briefly describe the MedWatch program to a patient, including the steps in identifying and reporting an ADR.

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: 0428-0000-11-111-H05-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.

Technical Specifications

Hardware requirements

Any hardware that supports Microsoft Windows, Apple Mac OS, iOS, or Android, and meets the software requirements.

Software requirements

Browser that supports TLS 1.1 + and PDF files.

This includes Microsoft Internet Explorer 11, Google Chrome 38, Google Android OS 5.0 Browser, Apple Safari (version 7 for desktop, 5 for mobile), Mozilla Firefox 27, newer versions of these browsers, as well as some earlier versions that may require additional configuration.

Adobe Acrobat Reader is recommended, and is required for some browsers.

Note: TLS 1.1 and 1.2 support is required for browser security. Click here for TLS browser support details.

Internet Connectivity

Required. Broadband recommended. (T1, DSL, Cable, G4 or higher.)

Contact Us

Exam Processing Inquiries

The Rx Consultant
rxmail@rxconsultant.com
1-800-798-3353

Educational Content Inquiries

The Rx Consultant
editor@rxconsultant.com
1-800-798-3353

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