Form 1315, Drug Shortage Notification

Documents

Instructions

Updated: 9/2017

Purpose

For pharmacy staff, managed care organization staff or pharmacy stakeholders to report significant drug shortages that will have continuing adverse impact on people enrolled in Medicaid if not resolved in a timely manner. Form provides space for the recommendation of an alternative with supply chain in mind so extra demand will not cause another shortage.

Procedure

When to Prepare or Update

To notify requestors of a drug shortage and recommend an alternative.

Detailed Instructions

1. Reporter Information: make sure to include whether you are at pharmacy level, corporate level, or other professional organizations, etc.
2. Drug Information: be specific about strength and dosage forms and include all that have been affected by the shortage.
3. Shortage information:
   1. Reason for Reporting: is the shortage due to a recall, discontinuation by the manufacturer or another reason?
   2. Extent of Shortage: local, wholesaler, statewide, nationwide, etc.
   3. Estimated Length of Issue Timeline: how long do you think the shortage will continue?
   4. Product Status Change: did the manufacturer introduced same drug under different NDC or another manufacturer re-patent it with different NDC and packaging, etc.?
   5. Alternative: please suggest drugs (and NDCs) that can be a bridge alternate or replace the drug.Make sure that extra demand will not cause shortage of this drug.
   6. Published Notices: did you verify with FDA, ASHP, or any other resource as to whether this shortage was announced on their website?Please include link to website and date when verified.

Transmittal

• Fax: 512-491-1962
• Email: vdp_formulary@hhsc.state.tx.us

Questions

Questions about this form should be directed to the VDP Pharmacy Benefits Access Help Desk at 800-435-4165.