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NCPDP Responds to FDA on the Naming of Biological Products

NCPDP provided comments to FDA’s Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability (Docket – FDA-2013-D-1543) and Designation of Official Names and Proper Names for Certain Biological Products; Proposed Rule (Docket – FDA-2015-N-0648) with the submission of a single letter to both dockets. Click here for the letter.

NCPDP Letters on Nonproprietary Naming of Biologics, Biosimilars, and Interchangeable Biologics

NCPDP has commented to Food and Drug Administration (FDA) in writing and in a face-to-face meeting with FDA staff about serious concerns it has with any deviation from recognized naming standards such as the USAN and INNs for biosimilars. Copies of letters sent may be downloaded here.

HHS/FDA Letter on Nonproprietary Naming of Biologics, Biosimilars, and Interchangeable Biologics

NCPDP has commented to Food and Drug Administration (FDA) on several occasions in writing and in a face-to-face meeting with FDA staff about serious concerns it has with any deviation from recognized naming standards such as the USAN and INNs for biosimilars. On January 7, 2015, FDA’s Oncology Drugs Advisory Committee (ODAC)  unanimously recommended for approval the first biologic (Sandoz’s filgrastim, Zarxio®) submitted under an abbreviated licensure pathway for biological products shown to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product (Amgen’s filgrastim, Neupogen®; the “reference product”). Of concern is the fact that FDA stated in its Briefing Document to the Committee that it still “is continuing to consider its approach to nonproprietary naming of biosimilar biological products,” setting the stage for potentially approving a name for this product before issuing its proposed naming policy for public comment and before the Federal Trade Commission ) issues its report. On February 27, 2015 NCPDP sent another letter of concern to Health and Human Services Secretary Sylvia M. Burwell and FDA Commissioner Margaret A. Hamburg, MD.  This letter can be downloaded here.

Prescription Drug Monitoring Programs (PDMP)

Nearly all states have enacted laws to establish PDMPs, electronic databases to collect data on controlled substances dispensed or prescribed within their jurisdictions. However, the absence of business rules governing or allowing sharing of information from state to state and across pharmacies, lack of interoperability among the operational PDMPs, and variation in the timeliness of data reporting make it difficult for states and law enforcement to prevent misuse, abuse and fraud.

In March 2013, NCPDP published a white paper (NCPDP Recommendations for Improving Prescription Drug Monitoring Programs) detailing a plan to help nationally standardize PDMPs to better track and deter abuse of controlled substance prescriptions. The plan leverages NCPDP’s Telecommunication Standard in use industry wide and best practices to improve prescriber and pharmacy clinical decision making at point-of-care, and support real-time access to PDMP data across state lines. It integrates the prescription monitoring process into workflows and provides timely clinical data to prescribers and pharmacists, which also helps ensure access for patients with a valid medical need for controlled substances. Read more

State PMP Tracking Document

All states, except Missouri, currently have a prescription monitoring program (PMP). In the absence of a national program, NCPDP Work Group 9 Government Programs created and maintains a document, which provides information on all state PMPs. Information includes the PMP name, schedules monitored, format, batch/on-line, submission methods, reporting frequency, processor, overseeing agency and contact information. This State PMP Tracking Document is updated quarterly.

Electronic Prior Authorization

NCPDP’s collaborative effort to provide the industry with a standard for real-time electronic prior authorization (ePA) has yielded results that will help ensure patients get the medications they need when they need them. NCPDP published the new ePA transactions in July 2013, following approval by the membership and the NCPDP Board of Trustees. NCPDP worked with all stakeholders to automate the coordination of ePA. Eight new transactions included in the NCPDP SCRIPT Standard will streamline a frustrating and time-consuming manual prior authorization process.

NCPDP’s Work Group 11 ePrescribing and Related Transactions developed the ePA transactions through its Prior Authorization Workflow to Transactions Task Group. In addition to expediting patient’s receipt of their medications, the new ePA transactions will create administrative efficiencies that reduce healthcare costs. NCPDP has been developing and refining ePA standardization since 2006. In October 2011, NCPDP convened a focus group to identify stakeholder needs and issues related to electronic prior authorization, and implement a pilot using NCPDP standards that address the concerns of all affected parties. Based on the recommendation of the focus group, WG11 ePrescribing and Related Transactions re-formed its ePA Workflow to Transactions Task Group. Read more

Risk Evaluation and Mitigation Strategies (REMS)

NCPDP provided oral comments to the FDA at its July 25 -26, 2013 public meeting on REMS Standardization and Evaluation about the critical importance of establishing as a priority project, the implementation of a standardized, highly structured and codified electronic submission requirement for REMS using the structured product labeling (SPL) model and public access via DailyMed. See NCPDP Comments on REMS Standardization Using SPL. Read REMS Comment Summary. NCPDP provided follow up written comments.

NCPDP has two task groups working to help ease the implementation and appropriate use of Risk Evaluation and Mitigation Strategies (REMS) that impact the pharmacy industry. There is currently no standardized or electronic process for implementing REMS, a U.S. Food and Drug Administration (FDA) mandated tool to help ensure that the benefits of certain drugs outweigh the risks and to manage safety concerns through appropriate use. The mandate poses a daunting challenge for pharmacists, prescribers and pharmaceutical manufacturers that will intensify as more specialty drugs enter the market. The NCPDP task groups are addressing various aspects of REMS, including data communication standards, a central repository for REMS components, and incorporation of REMS requirement into the SCRIPT Standard for ePrescribing. Read more

Implementation Timeline Discussions

Electronic Prior Authorization Transactions: The NCPDP prior authorization transactions are part of an approved, published standard – the NCPDP SCRIPT Standard. The industry has requested the adoption of the NCPDP SCRIPT Standard version 2013101 prior authorization transactions under the appropriate regulatory requirements. Per OESS in August 2014, a notice of proposed rulemaking (NPRM) is going through the approval process, with an expected publication of early 2015. WG11 Prior Authorization Workflow to Transactions Task Group provided a recommended implementation timeframe for the regulation to OESS. See the WG11 November 2014 documentation for the recommendation letter. Read more


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