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|Newsletters: Drug Shortages and You|
Reprinted from "Parenteral Nutrition Product Shortages: The A.S.P.E.N. Strategy,” by Jay Mirtallo, Beverly Holcombe, Marty Kochevar and Peggi Guenter (Nutrition in Clinical Practice, April 2012) with permission © American Society for Parenteral and Enteral Nutrition 2012.
This article has been written by Oley staff in close collaboration with the American Society for Enteral and Parenteral Nutrition (A.S.P.E.N.). It quotes heavily from "Parenteral Nutrition Product Shortages: The A.S.P.E.N. Strategy,” by Jay Mirtallo, Beverly Holcombe, Marty Kochevar and Peggi Guenter (Nutrition in Clinical Practice, April 2012), with permission from A.S.P.E.N.
What’s in your home parenteral nutrition (HPN)? Are you missing anything? And would you know if you were? With an increasing number of sterile injectables (such as those used in the preparation of PN) in short supply, it is perhaps more important than ever to know what is in your bag and what your doctor has prescribed. It’s not just PN that is affected by drug shortages, by any means. "Drug shortages have affected every drug product category, including chemotherapeutic, antimicrobial, and gastrointestinal agents,” says Jay Mirtallo et al in a recent article in Nutrition in Clinical Practice ("Parenteral Nutrition Product Shortages: The A.S.P.E.N. Strategy,” April 2012).
Shortages Affect Patients
The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) has requested that their members (health care professionals) share their experiences with shortages, in particular the shortage of nutrition products. Here are some of their responses:
What you can do: Know what your PN prescription is and how to read your PN label. Keep a copy of your PN label. Note any inconsistencies and ask questions.
Consequences of Shortages
Clinicians noted increased hospital and home care company staff time spent filling orders; increased expense of preparing HPN; and restrictions on who gets what when. Several noted that they are only administering MVI (IV Multivitamins) three times a week instead of every day. Others, like this respondent, note deficiencies: "PN dependent patients have low serum or plasma levels [of] Se [selenium] and Cu [copper]. Some of our patients cannot take Se PO [by mouth] and therefore the clinical deficiency persists.”
Mirtallo et al note: "The complexity of PN formulations predisposes patients to many real or potential safety issues when products are not available.” The worst outcome was reported in 2011 when nineteen patients were infected with, and nine died from, Serratia linked to a contaminated amino acids product manufactured by an infusion pharmacy because commercial amino acids were in short supply. "In addition to the complications outlined [in the table below], infectious problems are likely when venous catheters are used more frequently for electrolyte replacements.” Hospitalization to treat electrolyte disorders or infections is also likely, he notes.
"The PN system is very complex and has many processes prone to errors even without the shortage issue,” Mirtallo continues. "PN product shortages have demonstrated how fragile this system is related to safe provision of care.”
What you can do: Be aware that increased monitoring (of your blood or serum levels, for example) may be necessary as PN formulations are adjusted. Discuss with your health care provider.
A.S.P.E.N. has been proactive in establishing recommendations practitioners can follow when shortages strike. Mirtallo et al write: "Having these recommendations available in this manner allows A.S.P.E.N. to provide timely, accurate recommendations for conserving a product in short supply and alternative to IV nutrient therapy.” These recommendations are available on A.S.P.E.N.’s Web site.
Safety Issues Related to Parenteral Nutrition (PN) Product Shortagesa
What you can do: Share these recommendations with your health care provider if you feel it would be helpful. Updates are also posted online at www.oley.org.
A.S.P.E.N. has also formed critical relationships with the Food and Drug Administration (FDA), product manufacturers, the American Society of Health-System Pharmacists (ASHP), and the Institute for Safe Medication Practices (ISMP). Further, "A.S.P.E.N. experts serve as a resource to the manufacturer related to appropriate product use (such as repackaging into smaller volumes to conserve supply) during a shortage,” writes Mirtallo et al. Oley has also been active with the FDA, particularly in FDA workshops, where Oley members have shared their stories of how shortages have impacted them. Oley is also in close communication with A.S.P.E.N. regarding the shortages.
Central to A.S.P.E.N.’s dialogue with the FDA, Mirtallo et al continue, has been "timely information on how the shortages have affected patients and clinicians….It is in this area where A.S.P.E.N. staff, volunteer leaders, and members have the most influence.” This is one place YOU, the HPN consumer, can get involved as well, and it is here that you can have a great impact. It is important that the FDA and decision makers recognize HPN as "medically necessary”—as critical to your health and survival. Oley applauds those who have responded to our appeals to share their stories and/or meet with their elected officials to help put a face to the therapy (we’ve shared several examples in recent past issues of the newsletter) and encourage all members to continue reaching out with their experiences—to Oley, local media, A.S.P.E.N., and local and federal representatives.
Mirtallo et al write, "The information from clinicians about the type of patients seriously affected by the shortage as well as the impact on health systems has greatly assisted A.S.P.E.N. in linking the shortages to real-life situations and accentuated the real or potential safely issues created by PN product shortages. The actions the FDA may take once a product is in shortage is to request other manufacturers of the product to ramp up production to meet the national needs, review products in quarantine, and devise ways that they may be released for use (ie, release product with particulate matter with the requirement that it be filtered). The FDA can also request a manufacturer resume making a product it has discontinued. Finally, the FDA may look into the importation of the product from outside the United States.”
What you can do: Share your stories with Oley, A.S.P.E.N., the FDA, and elected officials. Oley can pass your story on to A.S.P.E.N. and others (anonymously, if you’d prefer).
In previous issues of the newsletter, we have addressed the legislation that has been proposed to address drug shortages. There have been several bills introduced in the House and Senate, such as S 296, Preserving Access to Life Saving Medications, and its companion bill, HR 2245, Preserving Access to Life-Saving Medications Act of 2011, introduced by Sen. Amy Klobuchar (D-MN) and Rep. Diana DeGette (D-CO) respectively; and HR 3839, The Drug Shortage Prevention Act, introduced by Rep. John Carney (D-DE) and Larry Bucshon (R-IN). What has evolved from this push is that the Senate HELP Committee (Health, Education, Labor, and Pension) and the House Subcommittee on Health under the House Energy and Commerce Committee have developed drug shortage language as part of the Prescription Drug User Fee Act (PDUFA) Reauthorization bills. These are S2516 and HR5651. While the full House and Senate are expected to approve a reconciled bill before the current law expires September 30, 2012, it’s critical to show our support now for inclusion of drug shortage legislation in the final version.* For more information on drug-shortages related legislation, click here.
In addition to the proposed legislation, in October 2011, President Obama issued an executive order aimed at resolving the growing number of shortages. This shows that the administration is taking drug shortages seriously.
What you can do: Contact your U.S. Senators and Representatives to let them know the importance of these bills—and your HPN—to your health and survival. (Click here for Sample letter.) Please copy Oley on your letters so we have them as a reference. Also, ask your clinicians and home infusion companies to contact A.S.P.EN. and/or Oley with their stories. Together, we really can make a difference.
*Note that since this article was published in early June, the Prescription Drug User Fee Act (PDUFA) Reauthorization bill has been signed into law. Please see the update here.
LifelineLetter, May/June 2012
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