REMS Standardization via Structured Product Labeling (SPL): … · 2020. 4. 29. · REMS...
Transcript of REMS Standardization via Structured Product Labeling (SPL): … · 2020. 4. 29. · REMS...
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REMS Standardization via Structured Product
Labeling (SPL):
Critical Codification & Structure for Downstream
Automation
Gerald K. McEvoy, Pharm. D.
Lead, NCPDP SPL REMS Requirements Task Group
FDA Pubic Meeting, White Oak, MD
July 25-26, 2013
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What is NCPDP?
• An ANSI-accredited standards development organization
• Provides a forum and marketplace for a diverse membership
focused on health care and pharmacy business solutions
• A member driven organization that has been named in various
government legislation and rulings, such as HIPAA and the
Medicare Part D Regulation
• One of several Standards Development Organizations (SDOs)
involved in Healthcare Information Technology and
Standardization
• Focus on pharmacy services, and has the highest member
representation from the pharmacy services sector of healthcare
• NCPDP standards are used in pharmacy processes, payer
processes, electronic prescribing, rebates, and more
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NCPDP REMS Task Groups
• SPL REMS Requirements Task Group
– Developing template for codified electronic submission of REMS in central
repository within FDA’s structured product labeling (SPL) system
• REMS and ePrescribing Task Group
– Addressing REMS integration into electronic prescribing transactions between
prescriber/pharmacy/intermediary/payer/sponsors/REMS Administrators
• Safe Use Processing (FDA REMS) Task Group
– Defined transaction needs for REMS prescription authorization and
processing in claim and reporting standards
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• No highly structured electronic REMS submission requirement
– Electronic versions of REMS are PDFs & word-processing documents
• No standardized, granular data structure
• No standardized coding mechanism
• No codified connection with labeling
– No codified links between DailyMed SPL & REMS info
– No REMS identifying code within existing SPL (e.g., limitations to use identifier)
• No method to electronically identify and extract REMS requirements for
meaningful use
• Downstream automated prescription authorization and processing
requires highly structured, codified REMS data
The Needs
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Proposed Solution
• Use SPL as highly structured, granular mechanism for REMS submission, maintenance, ready access, & meaningful use
• Apply data format, content, & coding standards
• Use SPL accessed via DailyMed to allow meaningful data extraction
• Develop standards focused on REMS requirements verification for transactions (e.g., ETASU compliance) for seamless – prescription processing
– claims processing
– reporting
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• Need for incorporation into workflow & to minimize burden for prescribers, pharmacies, sponsors, and others
• Need for a reliable, standardized source (SPL document) with required elements to safely and effectively use a medication
• REMS information can be extracted easily, automatically, and electronically from an SPL document
• Patients and their safety are the most important reason to standardize REMS information via SPL
Why Use SPL for REMS?
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• SPL is an existing, adaptable standard already in use for exchanging
meaningful medication information electronically
– It is well suited for highly granular data like REMS
– SPL formatting allows a mix of coding & text
– Highly adaptable substructure
• Existing mechanisms for addressing issues, best practices, standards, &
future development
• Effective publically accessible data repository already exists via
DailyMed
• Existing expertise & infrastructure to support
• Sponsors have extensive experience in submitting SPL data
electronically to central repository
Why Use SPL for REMS?
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• Initial structure for codifying REMS via SPL was drawn by NCPDP from
the Draft FDA Guidance:
“Guidance for Industry: Format and Content of Proposed Risk Evaluation and
Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS
Modifications – Draft Guidance September 2009”
• FDA subsequently identified data requirement gaps relative to draft
guidance & created internal database that can be used as a foundation
for structuring an SPL REMS data standard
• SPL is an existing, adaptable HL7 standard
Where Can a Standard for REMS be Derived?
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• Codification of unique components with SPL is a way to organize,
standardize, and centralize the content associated with a packaged
product (NDC level)
• Would standardize REMS format & content for electronic submission to
FDA
• Standardized, granular REMS requirements simplify integration into e-
prescribing and prescription processing systems
• Standardized REMS format allows easy inclusion within existing
standards such as the NCPDP e-prescribing (SCRIPT) and prescription
adjudication and reporting (Telecommunication) standards
• Allows automatic population of public information sites
• Improves FDA and sponsor tracking
• Meets the goals of PDUFA V for standardization that:
– foster integration into existing & evolving health systems
– reduce the burden to existing & evolving health systems
Why Standardize REMS via SPL?
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Composite REMS SPL
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Adapted from Gary Saner, Reed Technology
REMS
Drug Listing
Labeling
Med Guide
PPI
Pkg Samples
Source Content SPL-LL Document
Content of Labeling
Product Listing Table
Pkg Label, PDP
Patient Counseling,
Med Guide, PPI
Highlights (PLR)
Title
REMS Content
REMS Data
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Composite REMS SPL Process
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Adapted from Gary Saner, Reed Technology
Agency
Submission
FDA
Pharmacists,
Healthcare
Providers,
Public
Life Sciences
NLM
DailyMed
Processed
Data
Composite SPL
with REMS
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REMS Exchanges
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Benefits of SPL Standardization for REMS
• Standardized & more efficient submission of REMS by sponsors
• More efficient & simplified REMS review by FDA
• More efficient & standardized REMS prescription processing
– Documenting certification of prescribers, dispensers, health-care settings, etc
– Qualifying patients
– Prescribing
– Dispensing
– Documenting other elements to ensure safe use (ETASU)
• More efficient & simplified REMS tracking at all levels
• Standardized & optimized REMS reporting and analysis
• Leveraging existing SPL expertise, standards, infrastructure, &
publically accessible central repository
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NCPDP as a Collaborator
• ANSI-accredited standards development organization involved in
electronic prescription workflow
• Widely adopted standards for electronic prescribing and prescription
authorization processing and reporting
• Membership by key stakeholders affected by REMS
• Existing Task Groups have been working with FDA and other
stakeholders on REMS requirements for 2 years
• Originally proposed and investigated SPL standardization solution for
REMS in collaboration with FDA and other stakeholders
• Already engaged broad-based expert & stakeholder feedback
• Already begun modeling & enhancing REMS integration into
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Recommendations
• Adopt SPL as the means for standardizing and providing central
access to REMS data
• Designate development and implementation of SPL standardization of
REMS as one of the 4 PDUFA V priority projects
– All downstream REMS prescription transactions critically depend on
timely achievement to greatly reduce health-system burden
• Designate NCPDP & NLM as collaborators
– Integration into existing e-prescribing & prescription processing standards
– Leverage existing drug information data repository
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