Pharmacy Law: Recent Regulatory and Legal Developments Affecting Practice

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Overview

Recent legal and regulatory developments have a direct impact on pharmacy practice. With the goal of reducing medication-related adverse events, particular attention has been directed to 2 areas: The label on the dispensed medication container, and the written patient information or “consumer medication information” (CMI). Almost half of U.S. adults cannot understand the labels on their prescription drugs. The FDA considers almost one third of CMI leaflets dispensed with new prescriptions “not useful” and many pharmacies do not comply with MedGuides which are required for drugs with serious safety concerns. Complicating this picture are the legal civil rights of limited English proficiency (LEP) patients, which comprise almost 9% of the US population. This issue addresses these developments in addition to recent Drug Enforcement Administration (DEA) developments. Among them is the authorization of electronic prescribing of controlled substances, whether pharmacists can make corrections to written C-II prescriptions; whether nurses (e.g., RNs, LVNs) in long-term care facilities can act as prescribers' agents; and whether compounding a controlled substance according to a prescription and delivering it to the prescriber constitutes manufacturing and distributing.

Publication Date: Sep-1-11
Expiration Date: Sep-1-14
CE Credit: 2.0 (.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

Richard R. Abood, B.S. Pharm., J.D.

Disclosure Statement

Richard R. Abood reports 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. List the USP Advisory Panel recommendations to improve prescription labels.
2. Discuss the FDA's current views regarding consumer medication information (CMI) and MedGuides.Describe the laws and challenges regarding the provision of drug information to limited English proficiency patients.
3. Summarize recent DEA actions concerning pharmacist correction of a C-II prescription.
4. Describe legal situations in which a LTCF nurse can transmit C II-V prescriptions.Describe recent DEA actions concerning the e-prescribing, delivery, and return of controlled substances.