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|Newsletters: Tips for Managing PN Component Shortages|
Tips for Managing PN Component Shortages
Beverly Holcombe, PharmD, BCNSP, and Peggi Guenter, PhD, RN
Shortages of parenteral nutrition (PN) components or ingredients are not new to consumers of parenteral nutrition (PN) or health care professionals who provide this therapy. Shortages have been ongoing since the intravenous (IV) adult multivitamins shortage in 1988. Shortages were intermittent and usually short-lived. However, since 2009 almost every PN component has been in short supply.
A number of factors have contributed to the shortages of sterile injectable drugs, which includes PN components. Sterile injectable drugs are produced by only a few manufacturers. Some manufacturers have shut down and others have had quality issues requiring corrective actions. When one company is unable to manufacture a drug, it increases demand on another company, which cannot keep up with the demand for the drug.
The shortage of IV adult, pediatric, and neonatal multi-trace element products and individual trace elements is particularly concerning, as administering PN with less than optimal amounts of trace elements has been associated with deficiencies and patient harm. The Food and Drug Administration (FDA) has approved only two U.S. manufacturers of these trace element products (American Regent and Hospira, Inc.) and release of products has been hindered and sporadic due to manufacturing delays. In 2013, the FDA approved importation of multi-trace and single element products in order to fill the patient need and gaps in the market.
The Clinical Practice Committee Nutrition Product Shortage Subcommittee of the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) was interested in learning more about how clinicians have been managing the prolonged shortage of IV trace elements and evaluating the impact of these shortages on their patients. The Shortage Subcommittee developed a survey to give clinicians who provide PN to adult, pediatric, and neonatal patients the opportunity to share their clinical experiences and shortage management strategies. Less than half of the survey respondents have the U.S. commercially available IV multi-trace element products. When these products are available and prescribed, rationing and conservation dosing regimens are common.
Managing Trace Elements Shortages
Since May 2013, imported European IV adult and pediatric multi-trace element products have been available in the U.S. Although these imported European products are available, they are not widely used by clinicians who are unable to obtain the U.S. products. Even when the imported European product is available to clinicians, not all administer a full dose daily in PNs. About one-third of clinicians responding to the survey indicated they do not use the imported European IV multi-trace element products because individual trace element products are available. For others, the most common reasons for not administering the imported European IV multi-trace element products are concerns about the trace element profile and concerns about compatibility/stability with PN admixtures. Other reported reasons for not using imported products include inability to obtain from supplier/wholesaler or outsource compounding pharmacy, and concerns about the expense.
Approximately half of all clinicians responding to the survey indicated they monitor their patients for trace element deficiencies by assessing clinical signs and symptoms and/or laboratory tests. Although there have been reports of deficiencies in the scientific literature, many of the clinicians responding to this survey did not report any adverse events or suboptimal patient outcomes, even when monitoring for deficiencies.
The lack of observed adverse events/deficiencies and the potential cost savings associated with "partial” dosing of trace elements should not be the impetus to continue this practice of less than optimal dosing of trace elements. Now is the time to evaluate current practices for dosing IV trace elements, review IV trace element requirements for patients/consumers receiving PN therapy, and implement daily dosing regimens to meet the trace element needs for all patients receiving PN.
Questions Consumers Should Ask Their Physician, Homecare Provider, and/or Homecare Team
Beverly Holcombe, PharmD, BCNSP, is Clinical Practice Specialist, and Peggi Guenter, PhD, RN, is Senior Director of Clinical Practice, Quality, and Advocacy, American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). The A.S.P.E.N. Trace Element Shortage Survey report is available here.
LifelineLetter, July/August 2014