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The Drug Supply Chain Security Act (DSCSA): Improving Integrity Through Track and Trace
This activity is for pharmacist is sponsored by Postgraduate Healthcare Education, LLC (PHE).
There has been no commercial support for this activity.
Marsha K. Millonig, MBA, BPharm
President & CEO
Catalyst Enterprises, LLC
Marsha K. Millonig, MBA, BPharm hereby states that she has no relevant affiliation or financial relationship or relationship to products or devices with a commercial interest related to the content of this activity to disclose.
The following reviewer, Laura K. Stinson, PharmD, states that she has no financial relationship or relationship to products or devices with a commercial interest related to the content of this activity to disclose.
Susanne Batesko, RN, BSN, and Robin Carrino, as well as the planners, managers, and other individuals, not previously disclosed, who are in a position to control the content of Postgraduate Healthcare Education (PHE) continuing education (CE) activities hereby state that they have no relevant conflicts of interest and no financial relationships or relationships to products or devices during the past 12 months to disclose in relation to this activity. PHE is committed to providing participants with a quality learning experience and to improve clinical outcomes without promoting the financial interests of a proprietary business.
Postgraduate Healthcare Education, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Credits: 1.0 hour (0.10 ceu)
Type of Activity: Knowledge
Fee Information: $6.97
Estimated time to complete activity: 60 minutes
October 10, 2019
September 25, 2022
This accredited activity has been designed for pharmacists.
HOW TO EARN CREDIT
During the period October 10, 2019 through September 25, 2022 participants must 1) read the learning objectives and faculty disclosures; 2) view the educational activity; and 3) complete the posttest and evaluation form directly after the activity within a maximum of 60 days of participating in the activity. To answer the questions, click on your selected choice for each answer then proceed to the next question. Once completed, click on the Grade Exam button at the bottom of the page. Your posttest will automatically be graded. If you successfully complete the posttest (score of 70% or higher), your statement of participation will be made available immediately. Click on the View Statement of Participation link and print the statement for your records. If you receive a score lower than 70%, you will receive a message notifying you that you did not pass the posttest. You will have 2 opportunities to pass the posttest. To receive credit, you must provide your date of birth and NABP number. All Credit information will be uploaded into CPE monitor within 30 days.
The Drug Quality and Security Act (DQSA), was signed into law by President Obama on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the US. Also referred to as, "Track and Trace", by 2023 the system will facilitate information exchange at the individual package level about where a drug has been in the supply chain. The goal is to improve product integrity, allow faster identification of counterfeit products and make drug recalls more efficient. During the next four years as full implementation of the Act occurs, pharmacists and pharmacy technicians need to be aware of the Act's requirements and possibilities for creating operational efficiencies.
At the conclusion of this session, the pharmacist will be able to:
- Explain how the DSCSA is supposed to improve the drug supply distribution chain's integrity.
- Describe the "track and trace" language in the Drug Supply Chain Security Act (DSCSA).
- List the law's requirements and timeframe for implementation.
- Explain potential operations that could be improved as the pharmacy meets compliance requirements.
REQUIRED COMPUTER HARDWARE/SOFTWARE
Please ensure the computer system you plan to use meets the following minimum requirements:
- Operating System: Windows 98 or higher & Macintosh 2.2 or higher
- Internet Browser (Mac &/Windows): Internet Explorer 6.0 or higher, Google Chrome, Safari 5.0.6 or higher, Firefox 3.0.3 or higher & Opera 5 or higher
- Broadband Internet connection: Cable, High-speed DSL & any other medium that is internet accessible
- Monitor Screen Resolution: 320 x 480 or higher
- Media Viewing Requirements: Adobe Reader, Microsoft PowerPoint, Flash Player & HTML5
Disclosure of Unlabeled Use and Disclaimer
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of Postgraduate Healthcare Education, LLC. Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without an evaluation of their patients' conditions and current medications, including the identification of possible contraindications regarding the dangers of use and a review of any applicable manufacturer's product information, as well as a comparison with the recommendations of other authorities.
The author, sponsor, and publisher of this continuing education activity have made all reasonable efforts to ensure that all information contained herein is accurate in accordance with the latest available scientific knowledge at the time of acceptance for publication. However, because information regarding drugs (their administration, dosages, contraindications, adverse reactions, interactions, special warnings, precautions, etc.) is subject to constant change, the reader is advised to check the manufacturer's package insert for information concerning recommended dosages and potential problems and cautions prior to dispensing or administering the drug. Special precautions should be taken when a drug is new, or highly toxic, or is unfamiliar to the dispenser or administrant. This educational activity may contain discussion of published and/or investigational uses of agents that are not approved by the U.S. Food and Drug Administration (FDA). Neither the publisher nor sponsor promotes the use of any agent outside of approved labeling. Statements made in this monograph have not been evaluated by the FDA. Nutritional products discussed are not intended for the diagnosis, treatment, cure, or prevention of any disease.