• Activity INFORMATION

  Overview

  Drug approval in the U.S. by the FDA is a long and costly process with the goal of ensuring product safety and efficacy. For decades, terminally ill patients with few, if any, treatment options and their advocates have sought to obtain unproven investigational drugs while they are still undergoing clinical trials. The FDA established compassionate use programs in the late 1980s to open up access to drugs in clinical trials, but critics contend that they are still too slow and burdensome, especially for patients with life-threatening conditions. The “Right to Try” Act was enacted in 2018 as a means to access unapproved drugs without requiring the consent of the FDA. This lesson will review the features of the “Right to Try” efforts and the risks and benefits compared with the FDA’s programs and discuss how pharmacists may be helpful to patients. 
  

  Handouts

  • Homestudy PDF :   21095H03.pdf Download

  Financial Support By

  PharmCon

• Learning OBJECTIVES

  Pharmacist

  Compare right to try laws with FDA sanctioned early access programs.

  Identify the elements of right to try laws and the role of the pharmacist.

  Describe the benefits and risks for patients who may take advantage of right to try laws.

  Pharmacy Technician

  Compare right to try laws with FDA sanctioned early access programs.

  Identify the elements of right to try laws and the role of the pharmacist.

  Describe the benefits and risks for patients who may take advantage of right to try laws.

  Nurse

  Compare right to try laws with FDA sanctioned early access programs.

  Identify the elements of right to try laws and the role of the pharmacist.

  Describe the benefits and risks for patients who may take advantage of right to try laws.

• Activity ACCREDITATION

  Activity Type

  Knowledge

  CE Broker

  20-844504

  Universal Activity Number

  Pharmacist 0798-0000-21-095-H03-P
  Pharmacy Technician 0798-0000-21-095-H03-T
  Nurse 0798-0000-21-095-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

  Gerald  Gianutsos, JD, PhD, BS Pharm, MS Associate Professor Emeritus, Department of Pharmaceutical Sciences, University of Connecticut 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).