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Newsletters: Drug Shortages: Up Close and Personal
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Drug Shortages: Up Close and Personal

Drug shortages and parenteral nutrition (PN) safety were in the spotlight when leaders from several organizations and home parenteral and enteral nutrition (HPEN) consumer representatives (including Oley) gathered at two major meetings in the Washington, D.C., area. The first-ever PN Safety Summit, hosted by the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) on September 23, and the public workshop on drug shortages hosted by the Food and Drug Administration (FDA) on September 26, brought clinicians, consumers, advocates, FDA and industry representatives, and legislators together to address issues of critical importance to HPEN consumers.

 

Safety Summit

"A.S.P.E.N.’s goal with the PN Safety Summit is to bring together all of the important stakeholders to develop recommendations to make PN the safest therapy that it can be, in order to improve patient outcomes,” said Peggi Guenter, PhD, RN, A.S.P.E.N.’s Director of Clinical Practice, Advocacy, and Research Affairs. This summit focused on recommendations in the areas of PN order prescribing, order review and verification, and compounding. We hope to summarize the recommendations in the newsletter and on our Web site once they’ve been published.

Also addressed at the summit was the ongoing shortage of vitamins, electrolytes, and other IV nutrition ingredients that has critically impacted HPN consumers nationwide. There are now nineteen PN components on the American Society of Health System Pharmacists’s shortages list.

Oley Executive Director Joan Bishop represented consumer interests at the summit meeting, and came away with the sense that there is no end to the shortages in sight. Oley is working closely with A.S.P.E.N. to help share HPEN consumer stories with the FDA and legislators to impress upon them the seriousness of the situation, and stands behind the recommendations A.S.P.E.N. has developed to address the shortages (see below).

 

FDA Meeting

Critical drug shortages, of course, extend beyond PN ingredients to include other medications HPEN consumers take, such as chemotherapy drugs, antibiotics, and blood pressure medications. A recent study by the American Hospital Association found that drug shortages within a six-month period led to 69 percent of patients receiving a less effective drug and 35 percent experiencing an adverse outcome.

Oley member Davi Cohen was among the many speakers presenting information at the FDA meeting. Davi did an outstanding job sharing her own experiences with HPN product shortages, as well as stories collected from other Oley members. Individually and collectively, the impact of your personal experiences is great. Please continue to forward your experiences to Oley.

More and more frequently, patient experiences are making it into the popular press. A recent story on National Public Radio (NPR), for example, led off with the story of a teenaged HPN consumer who was affected by the shortage of calcium gluconate. As the problem becomes more well-recognized, pressure will mount for the FDA to take action.

Some of the steps A.S.P.E.N. is taking include:

  • Asking the FDA to provide safe alternatives and parameters for monitoring the alternatives.

  • Recommending that the FDA approve importation from global markets, including Europe and Canada, and other drug manufacturers/suppliers that meet FDA requirements.

  • Facilitating communication between leaders and A.S.P.E.N. members concerning patient care–related issues.

  • Developing recommendations on how to manage product shortages, and quickly get them approved and disseminated.

  • Supporting current congressional legislation.

  • Working with the Institute for Safe Medication Practices (ISMP) regarding safety issues and/or patient harm due to shortages.

  • Encouraging A.S.P.E.N. members to report shortages.

In addition to sharing your stories with Oley, please advocate for yourselves by sharing your experiences with your representatives. We can help with sample letters. Please contact Joan Bishop at (800) 776-6539 or bishopj@mail.amc.edu.

LifelineLetter, September/October 2011

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5/6/2017
Oley Regional Conference

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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