Recorded Presentation from the NCCN Pharmacy Updates: Current Challenges with Investigational Drug Services and Expanded Access Programs

It is necessary to identify the practice gaps in investigational drug services and provide solutions for better process improvement in managing clinical trials. In addition, it is important for pharmacists to be familiar with the steps that are involved in initiating expanded access programs and determine the criteria for successful enrollment and implementation of such programs.

Target Audience

This educational program is designed to meet the educational needs of pharmacists, physicians, nurses, nurse practitioners, physician assistants and other health care professionals who manage patients with cancer.

Learning Objectives

Following this activity, participants should be able to:

  • Discuss best practices and identify current challenges with investigational drug services (IDS) 
  • Illustrate the unique roles of an IDS technician
  • Identify the appropriate expanded access request type
Additional information
Supporters: 

This activity is supported by educational grants from:

  • Daiichi Sankyo 
  • Deciphera Pharmaceuticals
  • GlaxoSmithKline

This activity is supported by an independent medical education grant from Bristol Myers Squibb.

This educational activity is supported by a medical education grant from Karyopharm® Therapeutics.

Course summary
Available credit: 
  • 1.00 AAPA Category 1 CME credit
  • 1.00 ACPE contact hours
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 ANCC contact hours
  • 1.00 Participation
Course opens: 
12/20/2021
Course expires: 
12/16/2022
Cost:
$0.00

Heidi D. Finnes, PharmD, BCOP, FHOPA
Mayo Clinic Cancer Center

Stephen R. Polley, PharmD, MPA, MS, BCPS
The Ohio State University Comprehensive Cancer Center

 

NCCN Continuing Education Disclosure Policy
It is the policy of NCCN that every 12 months, all faculty, moderators, activity planners and all internal planning staff participating in NCCN continuing education activities are expected to disclose any financial relationships with a commercial interest. In addition, all faculty presentations have been reviewed to ensure education is fair and balanced and that clinical content presented supports safe, effective patient care.  Individuals who do not disclose relevant financial relationships will be disqualified from involvement in the CE activity as a content developer, planner, or presenter. 

Definitions  

NCCN continuing education considers financial relationships to create a conflict of interest when an individual has both a financial relationship with a commercial interest and the opportunity to affect continuing education content about the products or services of a commercial interest with which he/she has a financial relationship.

NCCN continuing education considers relevant financial relationships as financial relationships in any amount occurring within the past 12 months that create a conflict of interest. NCCN does not set a minimal dollar amount for relationships to be significant. Inherent in any amount is the incentive to maintain or increase the value of the relationship. 

Faculty Disclaimers

All faculty for this continuing education activity are competent in the subject matter and qualified by experience, training, and/or preparation for the tasks and methods of delivery.

Faculty presentations may include discussion of off-label use. Faculty will disclose that the use in question is not currently approved by the FDA per the product labeling.

Faculty Disclosures

The faculty listed below discloses no relevant financial relationships:

Heidi D. Finnes, PharmD, BCOP, FHOPA
Stephen R. Polley, PharmD, MPA, MS, BCPS

NCCN Staff Disclosures

The NCCN Activity Planning staff listed below discloses no relevant financial relationships:

Mike Abrams; Melissa Esplen; Mark A. Geisler; Kristina M. Gregory, RN, MSN, OCN; Kristin Kline Hasson; Rose Joyce; Karen Kanefield; Lisa Perfidio, MS; Shannon Ryan, CMP; Kathy Ann Smith, CHCP; Sarah Weinstein

The NCCN Clinical staff listed below discloses no relevant financial relationships:
Sharon F. Park, PharmD, BCOP

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In support of improving patient care, National Comprehensive Cancer Network (NCCN) 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.

Physicians
NCCN designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Nurses
NCCN designates this educational activity for a maximum of 1.0 contact hour.

Pharmacists
NCCN designates this application-based continuing education activity for 1.0 contact hour (0.10 CEUs) of continuing education credit. UAN: JA4008196-0000-21-137-H01-P

Physician Assistants 
NCCN has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 1.0 AAPA Category 1 CME credit. Approval is valid until December 16, 2022. PAs should only claim credit commensurate with the extent of their participation.

 

Available for an additional fee ($49):

The Hematology/Oncology Pharmacy Association (HOPA) is accredited by the Board of Pharmacy Specialties (BPS) as a provider of board certification oncology credit (BCOP). A BCOP statement of credit will be issued only upon completion of a post-activity evaluation form and post-test, with a passing grade of 75% achieved.

Disclosure of Conflicts of Interest: The Hematology/Oncology Pharmacy Association (HOPA) assesses conflict of interest with its instructors, planners, managers, and other individuals who are in a position to control the content of CE activities. All relevant conflicts of interest that are identified are thoroughly vetted by HOPA for fair balance, scientific objectivity of studies utilized in this activity, and patient care recommendations. HOPA is committed to providing its learners with high-quality CE activities and related materials that promote improvements of quality in healthcare and not a specific proprietary business interest of a commercial interest.

Reported Areas of Conflict: Hematology/Oncology Pharmacy Association does not view the existence of relationships as an implication of bias or that the value of the material is decreased. The content of the activity was planned to be balanced, objective, and scientifically rigorous. Occasionally, authors may express opinions that represent their own viewpoint. Conclusions drawn by participants should be derived from objective analysis of scientific data. Unlabeled/unapproved uses of drugs. All faculty have indicated that they have not referenced unlabeled/unapproved uses of drugs and devices.

Available Credit

  • 1.00 AAPA Category 1 CME credit
  • 1.00 ACPE contact hours
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 ANCC contact hours
  • 1.00 Participation

Price

Cost:
$0.00
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Required Hardware/software

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    • Internet Explorer is no longer supported
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