You are leaving Medscape Education
Cancel Continue
Log in to save activities Your saved activities will show here so that you can easily access them whenever you're ready. Log in here CME & Education Log in to keep track of your credits.
 

 

CE

What Does Every Pharmacist Need to Know About REMS for Alosetron?

  • Authors: Carl N. Kraus, MD
  • CE Released: 4/10/2012
  • THIS ACTIVITY HAS EXPIRED
  • Valid for credit through: 4/10/2013
Start Activity


Target Audience and Goal Statement

This activity is intended for pharmacists.

The goal of this activity is to educate pharmacists on the REMS required for Lotronex®(alosetron).

Upon completion of this activity, participants will be able to:

  1. Describe why a risk evaluation and mitigation strategy (REMS) is required for alosetron
  2. Summarize the requirements of the REMS for alosetron that relate to the responsibilities of pharmacists


Disclosures

As an organization accredited by the ACCME, Medscape, LLC, requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest. The ACCME defines "relevant financial relationships" as financial relationships in any amount, occurring within the past 12 months, including financial relationships of a spouse or life partner, that could create a conflict of interest.

Medscape, LLC, encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration, at first mention and where appropriate in the content.


Author

  • Carl N. Kraus, MD

    Vice President of Medical Affairs, Medscape, LLC

    Disclosures

    Disclosure: Carl N. Kraus, MD, has disclosed no relevant financial relationships.

    Dr Kraus does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

    Dr Kraus does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Editor

  • Sarah Williams, PhD

    Scientific Director, Medscape, LLC

    Disclosures

    Disclosure: Sarah Williams, PhD, has disclosed no relevant financial relationships.

CME Reviewer(s)

  • Nafeez Zawahir, MD

    CME Clinical Director, Medscape, LLC

    Disclosures

    Disclosure: Nafeez Zawahir, MD, has disclosed no relevant financial relationships.


Accreditation Statements

    For Pharmacists

  • Medscape, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

    Medscape, LLC designates this continuing education activity for 0.5 contact hour(s) (0.05 CEUs) (Universal Activity Number 0461-0000-12-050-H05-P).

    Contact this provider

For questions regarding the content of this activity, contact the accredited provider for this CME/CE activity noted above. For technical assistance, contact [email protected]


Instructions for Participation and Credit

There are no fees for participating in or receiving credit for this online educational activity. For information on applicability and acceptance of continuing education credit for this activity, please consult your professional licensing board.

This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity online during the valid credit period that is noted on the title page. To receive AMA PRA Category 1 Credit™, you must receive a minimum score of 70% on the post-test.

Follow these steps to earn CME/CE credit*:

  1. Read the target audience, learning objectives, and author disclosures.
  2. Study the educational content online or printed out.
  3. Online, choose the best answer to each test question. To receive a certificate, you must receive a passing score as designated at the top of the test. Medscape Education encourages you to complete the Activity Evaluation to provide feedback for future programming.

You may now view or print the certificate from your CME/CE Tracker. You may print the certificate but you cannot alter it. Credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period you can print out the tally as well as the certificates by accessing "Edit Your Profile" at the top of your Medscape homepage.

*The credit that you receive is based on your user profile.

CE

What Does Every Pharmacist Need to Know About REMS for Alosetron?

Authors: Carl N. Kraus, MDFaculty and Disclosures
THIS ACTIVITY HAS EXPIRED

CE Released: 4/10/2012

Valid for credit through: 4/10/2013

processing....

Under the US Food and Drug Administration (FDA) Amendments Act of 2007, the FDA has the authority to require a manufacturer to implement a risk evaluation and mitigation strategy (REMS) for any drug or biologic agent.[1] The primary goal of a REMS requirement is to ensure that the benefits of the drug or biologic agent outweigh the risks. The complexity and the specific components of a REMS program vary. In many cases a medication guide is the only requirement, but some programs have additional components, such as elements to assure safe use, which may involve special training or certification or a restricted distribution process.[2]

The FDA has determined that a REMS is necessary for a number of prescription drugs, one of which is alosetron hydrochloride. Alosetron is marketed as Lotronex® (alosetron hydrochloride) tablets by Prometheus Laboratories Inc. This review will summarize the REMS requirements for this product, with a particular focus on what pharmacists need to know and, in fact, what they are responsible for, according to the REMS program for Lotronex that was approved by the FDA in September 2010.[3] The primary source of the information provided below is the Prescribing Program for Lotronex Pharmacist Education Slide Deck.[4]

  • Print