About this Course
This course is a recorded (home study version) of the CE Finale Encore Webinars.
Learning Objectives
Upon completion of this application based CE Activity, a pharmacist will be able to:
1. Define the term "off-label" in terms of drug promotion, prescribing, and use.
2. Distinguish between the use of unapproved drugs and unapproved uses of approved drugs.
3. List at least two reasons why off-label drug promotion could be harmful to patients.
4. Explain whether a pharmacist has an obligation to dispense (or not dispense) a drug prescribed for an off label
use.
5. Identify potential liabilities for pharmacists who recommend off-label use of a drug.
Release and Expiration Dates
Released: December 15, 2023
Expires: December 15, 2026
Course Fee
$17 Pharmacist
ACPE UAN
0009-0000-23-037-H03-P
Session Code
23RW37-ABC28
Accreditation Hours
1.0 hours of CE
Additional Information
How to Complete Evaluation: When you are ready to submit quiz answers, go to the BLUE take test/evaluation button.
Accreditation Statement
| The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. |  |
Pharmacists and Pharmacy Technicians are eligible to participate in this application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs) for completing the activity ACPE UAN 0009-0000-23-037-H03-P, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission.
Grant Funding
There is no grant funding for this activity.
Faculty
Jennifer A. Osowiecki, RPh, JD
Cox & Osowiecki, LLC
Suffield, Connecticut
Faculty Disclosure
In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.
- Attorney Osowiecki has no relationships with ineligible companies
Disclaimer
The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.
Content
Post Test (for viewing only)
Post Test
2023 CE Finale – LAW: Off-Label Drug Use and the Pharmacist’s Role
1. Which of the following statements about off-label drug use is TRUE?
a. Connecticut’s Pharmacy Practice Act prohibits a pharmacist from dispensing a drug for a use other than its FDA-approved indication.
b. Drug companies have a First Amendment (“free speech”) right to promote FDA-approved drugs for unapproved indications.
c. Pharmacists who have declined to fill a prescription for an unapproved use have been found liable for interfering with the prescriber-patient relationship.
2. According to the FDA, which of the following statements about unapproved drugs and unapproved uses of approved drugs is FALSE?
a. Unapproved drugs have not been cleared as safe and effective by the FDA.
b. All drugs compounded pursuant to a prescription are unapproved drugs.
c. The importation and use of an unapproved drug is prohibited in all circumstances.
3. According to the Agency for Healthcare Research and Quality (AHRQ), off-label prescribing accounts for approximately what percentage of all prescriptions in the United States?
a. 3%
b. 20%
c. 40%
4. A patient asks the pharmacist to mix up some “Magic Mouthwash” consisting of two FDA-approved OTC medications (such as Benadryl liquid and Mylanta) to treat mouth sores. What should the pharmacist tell the patient?
a. The pharmacist needs to do some research; if research indicates this product is effective, he can make it.
b. A prescription is needed because the pharmacist is compounding two FDA-approved drugs for an unapproved use.
c. The pharmacist can make Magic Mouthwash because both medications are OTC (not prescription-only).
5. Which of the following statements about pharmacist responsibilities when dispensing FDA-approved drugs for an unapproved use is TRUE?
a. Unless it’s a prescription for a compounded drug, a pharmacist is obligated to verify the intended use of each drug that is dispensed pursuant to a prescription.
b. When a pharmacist recognizes that a prescription is for an off-label use, the pharmacist is obligated to inform the patient that the use is not approved by the FDA.
c. If a pharmacist recommends an off-label use of a drug to a prescriber, the pharmacist should be aware of evidence-based support for the use.
Handouts
VIDEO