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Advocacy Updates: Drug Shortages, Medical Nutrition Equity, and Beyond Use Dating for PN
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               Your voice matters in legislative and regulatory issues—and you don’t need to travel to Washington, D.C., to use it. Understanding the importance of educating policy makers and regulators and developing your advocacy skills are the first steps in becoming an effective advocate.


               Two years ago in this newsletter, Oley Ambassador and board member Joy McVey Hugick eloquently wrote,

               Oley members constitute a community of sophisticated consumers, caregivers, and clinicians who can communicate the home parenteral and enteral nutrition (HPEN) consumer experience incredibly well. While we may differ in our diagnoses, we are united by HPEN therapy and we all face challenges regarding access to care and availability of treatment options. Participating in Oley’s advocacy efforts is a great opportunity to have our voices heard and allows us to play an important role in the public policy process. By translating for decision makers how their policies impact our day-to-day lives, we can help inform them to improve access to, and reimbursement for, our national health care system.

Recent Advocacy Efforts

               What are the issues with which Oley is involved, and where do we stand on them? What motivates us as an organization to advocate for or against a certain bill or rule? How can you get involved? At any given time, a number of legislative and regulatory issues that could have an impact on Oley members are on the table—someone’s table, whether it’s the Food and Drug Administration (FDA), the US Pharmacopeia (USP), or another regulatory body; or a state or the federal legislature.

               It’s sometimes difficult to understand how certain regulations or bills might affect different populations, and sometimes something that is good for one reason or to one population has drawbacks for another reason or to another population. Legislation and regulations are seldom simple! Given our small staff, Oley works closely with other organizations—including the American Society for Parenteral and Enteral Nutrition (ASPEN), National Organization for Rare Disorders (NORD), Digestive Disease National Coalition (DDNC), the National Home Infusion Association (NHIA), and others—as we determine our priorities and positions.

               Here are a few of the issues Oley is working on now, along with some possible actions you, as consumers, caregivers, or clinicians, can take.

IV Drug Shortages

               More and more often we are hearing about drug shortages. It’s on the news, in medical journals, and discussed by politicians. The causes and solutions being put forth vary and at this time there is little agreement about either. Oley has sought to offer information and updates to you, home parenteral and/or enteral (HPEN) consumers and caregivers, to help you be aware of the shortages and how they might affect you. Of particular concern to us are the shortages of parenteral nutrition (PN) components.

Some things you can do in regard to IV drug shortages include:

  • If you’re a home PN consumer: Check the label on your PN solution to watch for changes and discuss any changes with your home infusion pharmacy and/or health care provider. Is the change due to a shortage? Is there anything you should know about or watch for in regard to the change?

  • Let Oley know if you have been affected by drug shortages (PN components or otherwise), so we can speak up on your behalf when regulators, legislators, or the media come to us looking for concrete examples of how our members are affected.

  • Look for opportunities to share your HPEN story with legislators and regulators; help them understand that HPEN is your lifeline and why (an opportunity to submit comments to FDA is listed below).

  • Watch “Drug Shortages: Focus on Parenteral Nutrition” by Kathleen Gura, PharmD, BCNSP, at www.oley.org/webinars. Dr. Gura examines why shortages occur, how they affect home PN, and what regulators and health-care providers are doing to minimize the impact on patients.

  • If your health-care provider cares for only a few home PN consumers (or even just you), consider sharing ASPEN resources with them. ASPEN offers guidelines for clinicians on how they can minimize negative outcomes created by shortages of PN components. These guidelines, as well as updated information on the availability or shortages of PN components, can be found on the ASPEN website (www.nutritioncare.org/Guidelines_and_Clinical_Resources/Product_Shortages/Product_Shortage_Management and www.nutritioncare.org/public-policy/product-shortages).

FDA Needs Your Comments on Drug Shortages

               Now through January 11, 2019, the FDA is accepting comments from patients, health-care providers, and members of industry about drug shortages (“Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions,” Docket No. FDA2018-N-3272). They are asking, for example, about clinical and economic impact on patients, and whether shortages seem to occur in some areas (geographic, demographic, or clinical) or during certain times more than others. In November FDA had a meeting on this topic (see sidebar, next page).

               We strongly urge you to submit comments. Share your stories and represent the patient voice. Please share your experiences with us, too, to increase our understanding and to help us represent you to the FDA and others.   

               Go to www.regulations.gov/document?D=FDA-2018-N-3272-0001 for more information and to post comments; or mail written (paper) comments to Dockets Management Staff (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Include the docket number and title (see above). Note that FDA will post these written comments on the website listed above. If you wish to submit a comment that contains confidential information, contact the FDA for instructions.

Reimbursement for Enteral Nutrition

               It is surprising and discouraging to realize how often insurance does not cover enteral nutrition (tube feeding, or EN), even if it is the only source of nutrition a person receives. Paying for formula out-of-pocket can be a huge financial burden on families and individuals. The Medical Nutrition Equity Act (S.1194/H.R.2587) would provide for public and private insurance coverage for medically necessary foods for certain digestive and inherited metabolic disorders. It is hoped that once this bill is passed, it will pave the way for coverage of medical nutrition for additional diseases/disorders (such as swallowing disorders).

               “Medical nutrition” here includes specially formulated and processed products used for the dietary management of individuals who have limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary nutrients or who have other special medically determined nutrient requirements that cannot be sustained by the modification of an ordinary diet. It does not refer exclusively to EN administered through a feeding tube.

               Digestive disorders covered by the bill include: inflammatory bowel disease (e.g. Crohn’s disease and ulcerative colitis); eosinophilic digestive disorders; food protein induced enterocolitis syndrome (FPIES); IgE mediated food allergies; and malabsorption due to liver or pancreatic dysfunction or short bowel syndrome.

               Inherited metabolic disorders covered include: metabolic disorders on the Recommended Uniform Screening Panel Core Conditions list of the Secretary of Health and Human Services’ Advisory Committee on Heritable Disorders in Newborns and Children; and other genetic metabolic disorders requiring special foods.

               The Oley Foundation has joined nearly forty other organizations in the Patients and Providers for Medical Nutrition Equity Coalition (PPMNE) to advocate for this bill’s passage. Other organizations in the coalition include ASPEN, American Academy of Pediatrics, American College of Gastroenterology, Crohn’s and Colitis Foundation, March of Dimes, and NORD.

Some things you can do to help this bill become law include:

  • Attend the PPMNEC Capitol Hill Day, May 6–7, 2019, or DDNC Capitol Hill Day, March 3–4, 2019, in Washington, D.C. For more information, watch www.oley.org or call us at (518) 262-5079.
  • Submit your story to medicalnutritionequityfor.us. Please send your stories to Oley, too, so we can help share your voice.
  • Contact your senators and representatives and either encourage them to co-sponsor the bill or thank them for their sponsorship. Contact can be initiated through medicalnutritionequityfor.us. Current sponsors are also listed on the site.

Beyond-Use Dating for PN

               A “beyond-use date” (BUD) is just what it sounds like: the date after which a product should not be used. The label of each bag of sterile compounded PN contains a BUD. It may say, “do not use after” or “use before.”

               The BUD for PN and other sterile compounded preparations is set by the US Pharmacopeia (USP), which describes itself as “an independent, nonprofit, science-based organization that…[develops] quality standards for medicines, compounded preparations, [etc.]” These standards are recognized in law and are enforceable by the U.S. FDA for medicines and their ingredients imported into or marketed in the United States. (See www.usp.org.)

               In the past, the BUD for PN has been as long as seventeen days (from when the preparation was compounded). The BUD was shortened to nine days after a series of serious problems with compounded sterile preparations, including a fungal meningitis outbreak in 2012, where due to contaminated injectable compounded sterile preparations, “more than 70 people died, and 750 cases of infection were reported in 20 states.” (See www.usp.org, “Ensuring Patient Safety in Compounding of Medicines.”)

               Many home PN consumers feel the shorter BUD has affected them negatively. It means more frequent PN deliveries, which can interrupt work and other activities, and can limit travel. More deliveries mean increased costs to the health-care system, more packaging and waste, and, for some, greater stress.

               Others are concerned that if the BUD is lengthened and their deliveries occur every two weeks, it will be too much for them to unpack at once and to store in their refrigerators. They note, too, that a longer BUD will mean more waste if their PN formulation is changed.

               The USP posted a draft of its revised “General Chapter <797> Pharmaceutical Compounding—Sterile Preparations,” and invited comments from stakeholders through November 30, 2018. The Oley Foundation urged home PN consumers to consider submitting comments to help the USP understand what life on home PN is like and how they feel about the BUD. Oley Advisory Council member Swapna Kakani had started a petition to draw attention to the issue and to urge the USP to consider extending the BUD from nine to seventeen days.

               Your comments and signatures in cases like this can be the impetus for change. Such input can help the USP and other decision makers understand why it is important to conduct the research needed to determine if the BUD can be safely extended for PN, and under what circumstances. Such a change is a process, and your voice can help get the process started. We’ll keep you updated as we learn more about revisions to USP <797>.

Other Issues

               This is a sampling of the issues with which we are currently involved. Watch for more details online and in future newsletters about these and other important issues, including (but not limited to):

  • Memorandum of Understanding (MOU) between FDA and states that could impact delivery of compounded solutions across state lines: Oley is monitoring developments with the MOU and working with NHIA and others to minimize negative impact on home PN consumers.
  • Patient access to care and insurance coverage: Oley is monitoring legislation that would limit our members’ access to care generally, for example, discrimination against patients with pre-existing conditions, with the DDNC and other groups, and responding accordingly.
  • Step therapy (also called “fail first”) and co-pay accumulators: the first is when insurance says you must start with a cheaper medication and if it is not effective (or you “fail”), then you can try another medication. The second is when, if you use a drug co-pay card to help pay for a medication, the insurance company does not count the payment that the card assists with toward the insurance deductible. There is concern against both of these trends. Oley is joining other groups to raise awareness among consumers and decision makers of the practices’ negative impact, and to affect change.
  • Functional Gastrointestinal and Motility Disorders Research Enhancement Act (H.R.11897): Oley supports this bill, which would bolster research at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and increase awareness of functional GI disorders.

Oley and ASPEN at FDA Drug Shortages Meeting

               On November 27, 2018, the FDA invited stakeholders to a public meeting to discuss the root causes of drug shortages and possible solutions. Oley Executive Director Joan Bishop and Oley Medical Director Dr. Lyn Howard attended, and ASPEN Clinical Practice Specialist Beverly Holcombe spoke. Beverly joined Yoram Unguru, Children’s Oncology Group, and Michael Ganio, American Society of Health-System Pharmacists, to discuss the health impacts and economic consequences of shortages. The discussion questions included:

  • What are the clinical impacts of drug shortages from the perspective of patients; of providers; of pharmacists?
  • What are the economic consequences that drug shortages impose on hospitals and their pharmacies; outpatient centers and retail pharmacies; and patients?
  • What data is being collected to track the severity and duration of adverse clinical or economic consequences?

               This meeting of stakeholders was part of a congressional request that the FDA examine the causes and solutions to drug shortages and develop a report to Congress that includes recommendations the FDA or other federal agencies could implement to end drug shortages. In his welcome, FDA Commissioner Dr. Scott Gottlieb said, “Our aim is to look at every facet of this problem and develop a comprehensive set of proposals for addressing these protracted woes. And our recommendations will look beyond just the regulatory issues that fall within our scope at FDA. We’ll also examine the reimbursement challenges and other market failures. Here’s the charge I gave FDA: cast a wide net. We’ll delve deeply into these issues, to identify the underlying problems, and to propose comprehensive, enduring solutions.”

               A recording of the meeting, which sheds light on the many different aspects of this issue, can be seen at healthpolicy.duke.edu/events/drug-shortage-task-force.



Willing to talk to a legislator, reporter, or another organization? Email or call us with your story and concerns. When an opportunity arises, we can contact you. For example, at the Oley conference in Memphis, conference attendees spoke to a reporter about drug shortages: www.wmcactionnews5.com/story/38516561/conference-looks-for-solution-to-nationwide-iv-shortage.


Visit medicalnutritionequityfor.us to share your story and to contact your elected officials. Plan to attend a Capitol Hill Day organized by PPMNEC or DDNC.


LifelineLetter, November/December 2018

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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