Parenteral Nutrition Multivitamin Product Shortage Considerations

Plogsted, Steve; Adams, Stephen; Allen, Karen; Cober, M. Petrea; Greaves, June; Mogensen, Kris M.; Ralph, Amy; Ward, Ceressa T.; Ybarra, Joe; Holcombe, Beverly

doi:10.1177/0884533616647718

Cited by 26 publications

(24 citation statements)

References 18 publications

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“…Data in Table were obtained from the Food and Drug Administration (FDA) website and from Plogsted et al …”

Section: Marketed Drugs That Lack An Ndamentioning

confidence: 99%

“…Multiple-trace-element (multi-TE) PN preparations in the United States are examples of "marketed unapproved products" (Table 4). Patients receiving PN in the United States currently can receive TEs either by the addition of ready-made multi-TE solutions of 4 or 5 TEs (copper, Table 5 were obtained from the Food and Drug Administration (FDA) website 13 and from Plogsted et al 29 Abbreviation: NDA, new drug application. a This product must be spelled with periods ("M.V.I."…”

Section: Marketed Drugs That Lack An Ndamentioning

confidence: 99%

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Tutorial on How the US Food and Drug Administration Regulates Parenteral Nutrition Products

Tabor

2020

J Parenter Enteral Nutr

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Parenteral nutrition (PN) products are regulated in the United States by the Food and Drug Administration (FDA). The FDA regulates PN products as “drugs,” and the approval of a new product depends on there being “substantial evidence” of safety and efficacy obtained from “adequate and well‐controlled studies.” The processes by which the FDA approves PN products in the United States are designed to protect patients from unsafe or ineffective products, but they may also contribute to delaying and preventing access to certain valuable new products. This tutorial is designed to inform the PN community about FDA processes with regard to PN products, including the structure of FDA review teams, requirements for investigational studies, applications for marketing approval, postapproval clinical trial requirements, and requirements for studies in pediatric populations. Knowledge of how the FDA process works and how the FDA regulates PN products can help the PN community work together in advancing the development of new products.

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“…Data in Table were obtained from the Food and Drug Administration (FDA) website and from Plogsted et al …”

Section: Marketed Drugs That Lack An Ndamentioning

confidence: 99%

Section: Marketed Drugs That Lack An Ndamentioning

confidence: 99%

Tutorial on How the US Food and Drug Administration Regulates Parenteral Nutrition Products

Tabor

2020

J Parenter Enteral Nutr

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“…An inappropriate substitution may result in inadvertent complications or compromised PN compatibility. Guidelines for managing specific PN product shortages are available that provide alternative plan considerations (see Table ) . Use of an oral nutrient supplement is often recommended as an alternative to an injectable form that is unavailable.…”

Section: Home Infusion Challengesmentioning

confidence: 99%

Challenges and Obstacles of Long‐Term Home Parenteral Nutrition

Kumpf

2019

Nut in Clin Prac

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Patients receiving long‐term home parenteral nutrition (HPN) and clinicians managing their care face complex challenges not fully addressed by existing clinical practice guidelines. This review aims to increase awareness of some of the challenges encountered when managing patients receiving HPN and provide strategies for management. The ability to optimally manage these patients starts with involvement of a qualified team of clinicians, which is sometimes difficult to find. There are unique challenges related to the parenteral nutrition (PN) prescribing and compounding process that are not typically encountered with inpatient use. Clear communication is required between the HPN prescriber/team and the home infusion pharmacist to prevent errors related to misinterpretation of the order and PN product shortages. Dependency on HPN and living with chronic disease create a number of psychosocial, financial, and other lifestyle restrictions that can negatively impact a patient's quality of life. HPN nonadherence is a challenge that complicates the clinician's ability to accurately assess and make appropriate adjustments to therapy. HPN adherence may be improved by incorporating a patient‐centered approach to care that allows patients to prioritize those issues most meaningful and valuable to them. Patient‐centered care also encourages self‐care and relies on a high level of HPN education. Clinicians are encouraged to use an interactive interview style when engaging patients to prioritize goals of care and make self‐motivated decisions for change. In spite of challenges, HPN therapy has allowed patients the ability to maintain adequate nutrition and thrive in the home setting when the oral/enteral route fails.

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“…ASPEN provides strategies for managing shortages of individual PN components, including amino acids, lipid injectable emulsion, electrolytes and minerals, trace elements, vitamins, and L‐cysteine. Each shortage management consideration provides recommendations specific to the individual PN component as well as general strategies for managing shortages of PN components . The 2014 ASPEN Parenteral Nutrition Safety Consensus Recommendations include guidance for every step of the PN use process to improve the safety of PN therapy during shortages of PN components.…”

Section: Strategies and Resources For Managing Drug Shortagesmentioning

confidence: 99%

“…Each shortage management consideration provides recommendations specific to the individual PN component as well as general strategies for managing shortages of PN components. [29][30][31][32][33][34] The 2014 ASPEN Parenteral Nutrition Safety Consensus Recommendations include guidance for every step of the PN use process to improve the safety of PN therapy during shortages of PN components. 35 The final phase is the contingency plan and includes guidelines for managing a complete outage of a drug or if the drug is only available from compounding pharmacies or nontraditional sources such as the gray market or from a foreign manufacturing source.…”

Section: Strategies and Resources For Managing Drug Shortagesmentioning

confidence: 99%

Drug Shortages: Effect on Parenteral Nutrition Therapy

2018

Self Cite

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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. (Nutr Clin Pract. 2018;33:53-61)

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Parenteral Nutrition Multivitamin Product Shortage Considerations

Cited by 26 publications

References 18 publications

Tutorial on How the US Food and Drug Administration Regulates Parenteral Nutrition Products

Tutorial on How the US Food and Drug Administration Regulates Parenteral Nutrition Products

Challenges and Obstacles of Long‐Term Home Parenteral Nutrition

Drug Shortages: Effect on Parenteral Nutrition Therapy

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