Off-Label Use of Drugs: What the Pharmacist Needs to Know

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When a pharmacist dispenses a drug approved by the FDA, he or she can be reasonably confident that it will be safe and effective for the population that was studied in the clinical trial and can counsel the patient accordingly. But what if it is prescribed for a different (unapproved) use? Is this practice, known as off-label drug use (OLDU), permissible? How common is it? What are the risks involved? This webinar will review the practice of OLDU and discuss the role of the FDA, the prescriber, the manufacturer, and the pharmacist.

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Course Information

Target Audience

Nurse

Pharmacy Technician

Pharmacist

Knowledge Level

General Overview

This activity will apply to a broad range of learning needs/pharmacy settings. It may include common disease state/therapy overivews and/or general pharmacy needs such as medication errors, immunizations, or law topics.

Learning Objectives

Nurse

Nurse

  • Distinguish between the risks and benefits of on-label and off-label use of drugs.
  • Recognize the rationale and regulatory standing for off-label prescribing.
  • Characterize the legal and non-legal responsibilities of prescriber, manufacturer, and pharmacist for off-label drug use.

Pharmacy Technician

Pharmacy Technician

  • Distinguish between the risks and benefits of on-label and off-label use of drugs.
  • Recognize the rationale and regulatory standing for off-label prescribing.
  • Characterize the legal and non-legal responsibilities of prescriber, manufacturer, and pharmacist for off-label drug use.

Pharmacist

Pharmacist

  • Distinguish between the risks and benefits of on-label and off-label use of drugs.
  • Recognize the rationale and regulatory standing for off-label prescribing.
  • Characterize the legal and non-legal responsibilities of prescriber, manufacturer, and pharmacist for off-label drug use.

Course Accreditation

  • Activity Type:
    Application
  • Financial Support By:
    PharmCon
  • CE Broker
    20-883436
  • Universal Activity Number:
    Pharmacist : 0798-0000-21-135-H03-P
    Nurse : 0798-0000-21-135-H03-N
    Pharmacy Technician : 0798-0000-21-135-H03-T
PharmCon is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

PharmCon, Inc. is an approved course provider for continuing education for nurses by the Florida Board of Nursing. PharmCon is also recognized by the California Board of Nursing as a provider of nursing programs.

Credit for this program is issued by passing the final test hosted at www.RxConsultant.com with a score of 70% or higher.

Technology Requirements

  • Hardware Requirements
    Standard Windows/Mac System
    iPad or iPhone
    Minimum screen resolution: 1024x768
  • Software Requirements
    Standard Windows/Mac System
    iPad or iPhone
    Minimum screen resolution: 1024x768
  • Network Requirements
    Broadband Internet Connection:
    T1, Hi-speed DSL or Cable
    4G cellular connection
Computer sharing is NOT permitted due to accreditation guidelines on activity monitoring. Credit is earned by one user per device.