Rx for Success: Cracking the Code on Pharmacy Regulatory Compliance - Session 1

October 3, 2024

Multiple federal, state and local agencies govern pharmacy regulations.  For pharmacy leaders, keeping abreast of the latest changes as well as implementing new rules and laws can be challenging. This presentation will provide current updates from the Food & Drug Administration (FDA), Drug Enforcement Administration (DEA), Centers for Medicare and Medicaid Services (CMS) and the United States Pharmacopeia (USP) on topics such as the Drug Supply Chain Security Act, Reimbursement for 505(b)(2) Approved Medication, and Sterile Compounding.

Target Audience

  • Pharmacists
  • Pharmacy Technicians
  • Other Healthcare Professionals

Learning Objectives

Pharmacists

At the conclusion of this activity, pharmacists should be able to:

  • Identify current pharmacy regulatory from the FDA, CMS, DEA, and USP.
  • Outline dispenser requirements for DSCSA.
  • Describe the role of GLNs for tracking and tracing.
  • Discuss reimbursement requirements from the Centers for Medicare and Medicaid Services.
  • Explain proposed 2024 changes to Medicare reimbursement with operational changes required to implement them.

Pharmacy Technicians

At the conclusion of this activity, pharmacy technicians should be able to:

  • Identify current pharmacy regulatory from the FDA, CMS, DEA, and USP.
  • Outline dispenser requirements for DSCSA.
  • Describe the role of GLNs for tracking and tracing.
  • Discuss reimbursement requirements from the Centers for Medicare and Medicaid Services.
  • Explain proposed 2024 changes to Medicare reimbursement with operational changes required to implement them.
Course summary
Available credit: 
  • 1.00 ACPE Pharmacist
  • 1.00 ACPE Pharmacy Technician
  • 1.00 General CE - Attendance
Course opens: 
10/03/2024
Course expires: 
12/02/2024
Event starts: 
10/03/2024 - 7:00am CDT
Event ends: 
10/03/2024 - 8:00am CDT
Add to calendar: 

FACULTY & PLANNERS

Faculty

Carolyn Liptak, MBA, BS Pharm
Pharmacy Executive Director
Center for Pharmacy Practice Excellence
Vizient, Inc.

Planning Committee

Madalene Klocke
Project Manager
Pharmacy Aggregation Groups
Vizient, Inc.

Michelle Smith, PharmD, BCPS
Pharmacy Executive IV
Pharmacy Aggregation Groups
Vizient, Inc.

Samantha Gordon, MS 
CE Programs Manager              
Vizient, Inc.

Marilu Kelly, MSN, RN, NPD-BC, CHCP
Director, Continuing Education       
Vizient, Inc.
 

DISCLOSURE

As an accredited provider of continuing education, Vizient, Inc. is dedicated to ensuring this activity presents learners with only accurate, balanced, scientifically justified recommendations, and is free from promotion, marketing, and commercial bias. In accordance with The Standards for Integrity and Independence in Accredited Continuing Education, all planners, faculty, and others in control of the educational content have disclosed the absence or existence of all financial relationships (of any dollar amount) with ineligible companies within the past 24 months.
 
Ineligible companies – those companies whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.
 
It is Vizient’s policy that owners and employees of ineligible companies, and any individuals who refuse to disclose the absence or existence of financial relationships with any ineligible companies are disqualified from participating as planners or faculty.
 
Disclosure Statements
 
Absence of Relevant Financial Relationships
 
None of the planners, faculty, or others in a position to control content for this educational activity have relevant financial relationship(s) to disclose with ineligible companies whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.
 
Statement of Content Validity
 
Vizient, Inc. educational activities are intended to assist healthcare teams advance their professional responsibilities in accordance with the definition of continuing education. It is the policy of Vizient, Inc. to review and ensure that all content and recommendations for patient care within accredited CE is evidenced-based, based on current science and clinical reasoning while ensuring the content is fair and balanced. All recommendations must conform to the generally accepted standards of experimental design, data collection, analysis, and interpretation. Vizient, Inc. does not permit accredited continuing education if it advocates for unscientific approaches to diagnosis or therapy, or if the education promotes recommendations, treatment, or manners of practicing healthcare that are determined to have risks or dangers that outweigh the benefits or are known to be ineffective in the treatment of patients.
 
FDA Off-Label Use
 
Faculty presenters are also expected to disclose any discussion of (1) off-label or investigational uses of FDA approved commercial products or devices or (2) products or devices not yet approved in the United States.
 
Disclaimer
The education provided through this activity is for continuing education purposes only. The views and opinions expressed in this activity are those of the faculty/presenters and do not necessarily reflect the views of Vizient, Inc.

 

Joint Accreditation Statement

In support of improving patient care, Vizient, Inc. is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.

 

Designation Statement(s)

Pharmacists (CPE)

Vizient, Inc. designates this live activity for a maximum of 1.0 contact hours for Pharmacists.
 
Universal Activity Number: JA0006103-0000-24-093-L03-P
 
Pharmacy Technicians (CPE)
Vizient, Inc. designates this live activity for a maximum of 1.0 contact hours for pharmacy technicians.
 
Universal Activity Number: JA0006103-0000-24-093-L03-T
 
Other Healthcare Professionals (General CE Credit)
 
Vizient, Inc. will award all other healthcare professionals who successfully complete the activity a Certificate of Participation.  Various state license boards and credentialing bodies accept certificates of participation from accredited CE activities to meet CE requirements for license renewals and re-certification. It is the responsibility of the participant to contact their state licensing board and/or certifying body for verification on credit eligibility reciprocity.

Available Credit

  • 1.00 ACPE Pharmacist
  • 1.00 ACPE Pharmacy Technician
  • 1.00 General CE - Attendance
Please login or register to take this course.

 

Select the “Obtain Credit” button to access the activity evaluation and to claim CE Credit.
 
Please Note: 
  • If the "Register/Take Course" tab is displayed instead of the "Obtain Credit" tab, you must first login to proceed with the credit claim process.
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Please click here to enter the code you received at the end of the activity to verify your attendance if you have not already done so: https://continuingeducation.vizientinc.com/code

 

 

Required Hardware/software

 

The Vizient CE Learner Portal is compatible with most modern web browsers (such as Firefox, Google Chrome, Microsoft Edge, Apple Safari) and can also be accessed with mobile devices.