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Reacting to Recent Drug Shortages - A National Health Care Crisis
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Your story is powerful and needed.

Your clinicians and home care providers have probably been dealing with shortages of parenteral nutrition (PN) components for more than a year now and are trying their best to keep you healthy. Adjustments have been made to ensure that the folks who absolutely need specific items get them. You may have noticed some changes in your supplies, infusion schedules, etc. This needs to be resolved—and with your help we’re making progress. More and more legislators are getting on board. Help us keep up the momentum!

 

Contact the FDA

Communicating with the FDA is one tool you have available to you to help minimize shortages in the future. Describing your situation, and how these shortages do—or might—affect you, will have an impact. When contacting the FDA, you should provide:

  • information about the drug and your experience in obtaining or being denied it, or your concern about potential shortage
  • a brief summary of your health status
  • how or why your therapy (HPEN) or medication is necessary

Be specific and share your life experience to give the FDA a sense of who you are and why it is critical that drug shortages are addressed quickly. For example, if you can’t swallow or can’t absorb medications taken orally, note that.

To report a drug shortage to the FDA:

  • e-mail: drugshortages@fda.hhs.gov
  • by phone: CDER Drug Information (888) INFOFDA or (301) 796-3400
  • by US mail: Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 200993-0002
  • If possible, please copy the Oley Foundation on e-mails: bishopj@mail.amc.edu

To report a shortage to the American Society of Health-Systems Pharmacists (ASHP) you may use the Drug Product Shortages Report form. When you use this form, you are reporting a drug shortage to ASHP, not FDA. The FDA partners with ASHP to minimize drug shortages and report rapid accurate drug shortage information. 

 

Contact Your Elected Officials

Be aware that new legislation has been introduced to address the drug shortages issue (more information).

Senate bill S. 296 Preserving Access to Life Saving Medications Act, along with the companion House of Representative bill H.R. 2245, are designed to address drug shortages. Encourage your representatives to support these bills! These bills are posted on the Thomas Legislative Information Web site.

Contact your representatives and help them put a face, YOURS, to homePN therapy and the drug shortage issue. A brief outline of why you require homePN and how this therapy allows you to live your life will help them understand more about homePN and the impact of the shortages. Are you working, enjoying retirement, raising a family? Have you experienced any shortages, changes in your regimen, consequences, etc.? Express your concerns.

Links to legislators, addresses, etc. can be found on www.congress.gov. If your representatives have already signed on in support of these bills, thank them. If they haven’t, encourage them to do so now. Send letters to your representatives at both their District and Washington, D.C. offices.

Send copies of the letters to the chairmen of the Senate and House committees that are considering the bills, along with a note that urges them to report (vote) the bill out of their committee and onto the floor for a vote. If the bills are not voted out of committee, they will not be brought to a vote by the full Senate or House! The committee chairs’ names and addresses are provided below.

Click here for sample letter. Please send copies of your correspondence to Oley Executive Director Joan Bishop. Thank you for helping bring attention to this critical matter. We will continue to keep you updated.

Committee Chairs’ Addresses

Hon. Tom Harkin, Chairman
Committee on Health, Education, Labor and Pensions
731 Hart Senate Office Bldg.
Washington, D.C. 20510

Hon. Fred Upton, Chairman
House Energy & Commerce Committee
2183 Rayburn House Office Bldg.
Washington, D.C. 20515


Updated 12/13/11

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This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.

 

Updated in 2015 with a generous grant from Shire, Inc. 

 

This website was updated in 2015 with a generous grant from Shire, Inc. This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.
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