Drug Shortages: Effect on Parenteral Nutrition Therapy.

Drug shortages continue to be a threat to the health and welfare of numerous patients in the United States. For patients who depend on parenteral nutrition (PN) for survival, these shortages pose an even greater threat. Almost 75% of active drug shortages are sterile injectables, which includes PN components. Providing PN therapy is particularly challenging for clinicians because this is a complex medication and may contain 40 or more individual ingredients, of which multiple components may simultaneously be in limited supply. The availability of PN components must be considered during every step of the PN use process from ordering the PN prescription to administering this therapy to a patient. Alterations to a standardized process can lead to medication errors that can adversely affect patient outcomes and consume healthcare resources.

Impact of the Nationwide Intravenous Selenium Product Shortage on the Development of Selenium Deficiency in Infants Dependent on Long-Term Parenteral Nutrition.

BACKGROUND: For patients dependent on parenteral nutrition (PN), selenium must be supplemented intravenously. A nationwide intravenous selenium shortage began in April 2011. The impact of this shortage on PN-dependent infants was evaluated by examining the provision of selenium, development of biochemical deficiency, and costs associated with the shortage. MATERIALS AND METHODS: This single-center, retrospective study included PN-dependent infants aged ≤1 year who weighed ≤30 kg, received PN for ≥1 month, and had ≥1 serum selenium measurement. The primary outcome was the incidence of biochemical selenium deficiency. Secondary outcomes included severity of biochemical deficiency, clinical manifestations, costs, and relationship between serum selenium levels and selenium dose. RESULTS: The average selenium dose decreased 2-fold during the shortage (2.1 ± 1.2 µg/kg/d; range, 0.2-4.6 µg/kg/d) versus the nonshortage period (3.8 ± 1 µg/kg/d; range, 2.4-6 µg/kg/d; P < .001). A linear relationship between serum selenium concentration and selenium dose was observed (r(2) = 0.42), with a dose of 6 µg/kg/d expected to result in normal serum levels in most cases. Similar proportions of patients developed biochemical deficiency in both groups: shortage period, 59.1%; nonshortage, 66.7%; P = .13. The severity of biochemical deficiency was similar between groups. A significant increase in incremental cost during the shortage was observed. CONCLUSION: This is the first study examining the impact of the intravenous selenium shortage on PN-dependent infants. Both groups exhibited similarly high incidences of biochemical selenium deficiency, suggesting higher empiric doses may benefit this population. However, ongoing shortages limit the ability to provide supplementation.

Zinc Deficiency With Dermatitis in a Parenteral Nutrition-Dependent Patient Due to National Shortage of Trace Minerals.

The shortages of intravenous drugs remains critical, with sterile injectables accounting for 80% of the approximately 300 shortages. The impact is being felt in patients dependent on parenteral nutrition (PN), and severe deficiencies are becoming more commonplace. We report here a man who developed severe zinc deficiency, manifesting as a painful desquamative rash, due to an inability to obtain multi-trace element additives for his PN.

Selenium deficiency in pediatric patients with intestinal failure as a consequence of drug shortage.

BACKGROUND: Parenteral nutrition (PN) is a lifesaving therapy for children with intestinal failure and can now be used chronically without the life-threatening complications of the past. Adequate intravenous trace element supplementation is required as part of a complete nutrition prescription. According to the U.S. Food and Drug Administration (FDA), the number of drug shortages, including sterile injectable agents used as PN components, has increased since 2010. Selenious acid as an individual additive was recently unavailable at our institution for 9 months due to a national shortage. MATERIALS AND METHODS: To assess the impact of the selenious acid shortage, we retrospectively compiled data from existing clinical records for eligible patients. We included children with intestinal failure on full PN support who were older than 1 year at the onset of the selenium shortage. Whole-blood selenium concentrations prior to the selenious acid shortage were compared with concentrations drawn during the shortage. RESULTS: Five patients with intestinal failure and complete PN dependence were identified, and all 5 patients had normal serum selenium concentrations prior to the shortage. All 5 patients developed severe biochemical selenium deficiency in direct correlation with the shortage of selenium. No morbidity associated with selenium deficiency was observed. Selenium concentrations recovered after selenium supplementation was reinstituted. CONCLUSION: A national selenious acid shortage was associated with biochemical selenium deficiency in a cohort of children with intestinal failure. Despite very low selenium concentrations, none of our patients exhibited clinical signs of deficiency.

Anemia and leukopenia in a long-term parenteral nutrition patient during a shortage of parenteral trace element products in the United States.

Recently, drug shortages in the United States have affected multiple components of the parenteral nutrition (PN) solution. A 62-year-old patient with systemic sclerosis who was dependent on home PN due to intestinal dysmotility developed anemia and leukopenia approximately 4 months after parenteral copper was withheld from her PN solution due to drug shortages. The patient was not able to tolerate a sufficient amount of oral multivitamins with trace elements due to severe dysphagia. Her serum copper and ceruloplasmin concentrations were undetectable, confirming the diagnosis of severe copper deficiency. The hematological abnormalities promptly resolved with copper supplementation. This report emphasizes the importance of close monitoring for nutrient deficiencies during drug shortages and supplementing with oral or enteral nutrition when feasible, particularly in high-risk patients such as those with intestinal malabsorption or short bowel syndrome who are dependent on long-term PN.

[A case of home parenteral nutrition therapy associated with some problems in exchanging of a popular TPN one bag solution to a new type one bag TPN solution containing all elements of essential nutritionals].

This case was a 62-year-old female patient who had received a home parenteral nutrition therapy for the past 15 years.In order to simplify a management of home parenteral nutritional therapy, she tried to exchange a current use of popular TPN one bag solution to a new type one bag solution containing all elements of essential nutritionals, which could reduce a number of mixing procedures.However, she unfortunately encountered a new problem increasing a number of solution contained boxes(from 7 popular solution bags per box to 5 bags per box)to be brought into her house.Consequently, her living space was limited with more new boxes in the house.Moreover, a new solution bag was not easy to mix all elements of nutritionals, and a 1, 500 mL bag was too heavy for her to lift.In conclusion, there are many different problems associated with each patient, so that we ought to consider each patient's living environment as one of the important issues.