Form 1315, Drug Shortage Notification and Expedited Formulary or Preferred Drug List Request

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Documents

Effective Date: 2/2024

Instructions

Updated: 2/2024

Purpose

For pharmacy staff, prescribing providers, managed care organization (MCO) staff, drug manufacturers, and the general public to request expedited formulary coverage, an expedited preferred drug list change, or notify HHSC about potential drug shortages impacting prescribing choice and pharmacy claims processing. 

Backorder, allocation, or drugs in short supply may have a continual adverse impact on people enrolled in Medicaid if not resolved in a timely manner. The form provides space for alternative recommendations with the supply chain in mind to address formulary request changes and drug shortages. Providing more information on the form assists HHSC to determine an appropriate plan of action.

Procedure

When to Prepare or Update

To request expedited formulary coverage, an expedited preferred drug list change, or notify HHSC about drug shortages impacting prescribing choice and pharmacy claim processing. 

Detailed Instructions

  1. Stakeholder Information: Include your name, organization, and email address. Make sure to include whether you are at the pharmacy level, corporate level, provider level, MCO level, manufacturer level, or other professional organizations.
  2. Drug Information: Be specific about strengths, dosage forms, and include all national drug codes (NDCs) impacted by the drug shortage or for the expedited formulary or preferred drug list status change. 
  3. Drug Shortage and Expedited Formulary or Preferred Drug List Change Request Information:
    • Drug Shortages:
      • Reason for Reporting a Drug Shortage: Is the shortage due to a backorder, allocation, short supply, recall, discontinuation by the manufacturer or another reason?
      • Extent of Shortage: Is the impact local, wholesaler, statewide, nationwide or another reason?
      • Estimated Length of Issue: What is the estimated time frame of the shortage? What are your sources of information? Are they website links, email with manufacturer or something else?
      • Drug Information: Has the shortage been verified with FDA, ASHP, drug manufacturer, or any other resources? Include  website links, verification date, or manufacturer contact information if applicable.
    • Formulary Additions or Preferred Drug List Status Changes
      • Formulary Addition or Preferred Drug List (PDL) Status Change: Is the request for a drug addition to the formulary? Is the request to recommend a change in the PDL status of a drug? Provide a rationale for the request of a PDL status change.
      • Product NDC change: Did the manufacturer change the drug’s NDC or did the drug’s NDC change for other reasons? Include the discontinued and new NDC.
      • Alternatives: Provide alternative drug (and NDC) suggestions and recommendations for formulary addition.   

Transmittal

Questions

Email questions about this form to the Vendor Drug Program at  vdp_formulary@hhsc.state.tx.us.