• Activity INFORMATION

  Overview

  This monograph explores regulatory responses to the problem of unsafe use of safe drugs. The monograph reviews mandatory reporting requirements for drug sponsors and voluntary reporting programs for health professionals and members of the public. The Risk Evaluation and Mitigation Strategies (REMS) initiative is explained, including descriptions of the individual Elements to Assure Sate Use (ETASUs) that are authorized under the FDAAA legislation.

   

  This monograph is provided for educational purposes only. It is not intended as legal advice and should not be used as legal advice. For legal advice, a licensed attorney should be consulted.

  
  

  Handouts

  • Homestudy PDF :   19238H03.pdf Download

  Financial Support By

  PharmCon, Inc

• Learning OBJECTIVES

  Pharmacist

  List the mandatory ADE reporting requirements for drug sponsors

  Describe the challenge to promote access to drugs but restrict them to safe and effective uses

  Discuss the elements of REMS and their implication for pharmacy

  Pharmacy Technician

  Describe the challenge to promote access to drugs but restrict them to safe and effective uses

  Discuss the elements of REMS and their implication for pharmacy

  List the mandatory ADE reporting requirements for drug sponsors

  Nurse

  Discuss the elements of REMS and their implication for pharmacy

  Describe the challenge to promote access to drugs but restrict them to safe and effective uses

  List the mandatory ADE reporting requirements for drug sponsors

• Activity ACCREDITATION

  Activity Type

  Knowledge

  CE Broker

  20-564127

  Universal Activity Number

  Pharmacist 0798-0000-19-238-H03-P
  Pharmacy Technician 0798-0000-19-238-H03-T
  Nurse 0798-0000-19-238-H03-N
  

  PharmCon is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

  PharmCon 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.

  In order to obtain a Statement of Credit, participants must score no less than a 70% on the activity's test and complete a program evaluation.

• Activity INSTRUCTION

  Faculty

  David  Brushwood, JD, RPh Senior Lecturer, University of Wyoming School of Pharmacy

This continuing education activity is held as copyright by PharmCon, Inc. Through this notice, PharmCon, Inc. grants permission of its use for educational purposes only. These materials may not be used, in whole or in part, for any commercial purposes without prior permission in writing from the copyright owner(s).