Safety in parenteral nutrition compounding.
compounding
parenteral nutrition
parenteral nutrition formulas
safety
Journal
Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition
ISSN: 1941-2452
Titre abrégé: Nutr Clin Pract
Pays: United States
ID NLM: 8606733
Informations de publication
Date de publication:
Dec 2023
Dec 2023
Historique:
revised:
15
07
2023
received:
29
05
2023
accepted:
17
07
2023
medline:
7
11
2023
pubmed:
16
8
2023
entrez:
16
8
2023
Statut:
ppublish
Résumé
Parenteral nutrition (PN) compounding is a complex process that requires knowledge and training to ensure the safety and efficacy of this form of nutrition support therapy. Unfortunately, errors and lack of adherence to safe PN compounding recommendations and sterile compounding requirements have resulted in patient injury and death. These lapses in the safe provision of PN have been the result of various factors, including a lack of understanding of PN compatibility, stability, and sterility requirements, as well as drug product shortages and order entry errors. This review will describe the current challenges with the education and training regarding PN compounding, compatibility and stability of PN admixtures, simultaneous administration of nonnutrient medications with PN admixtures, and specific challenges with special populations such as neonates, pediatrics, and those receiving home care.
Substances chimiques
Pharmaceutical Preparations
0
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
1253-1262Informations de copyright
© 2023 The Authors. Nutrition in Clinical Practice published by Wiley Periodicals LLC on behalf of American Society for Parenteral and Enteral Nutrition.
Références
McKinnon BT. FDA safety alert: hazards of precipitation associated with parenteral nutrition. Nutr Clin Pract. 1996;11(2):59-65. doi:10.1177/011542659601100259
Grissinger M. A fatal zinc overdose in a neonate: confusion of micrograms with milligrams. P T. 2011;36(7):393-409.
Gupta N, Hocevar SN, Moulton-Meissner HA, et al. Outbreak of Serratia marcescens bloodstream infections in patients receiving parenteral nutrition prepared by a compounding pharmacy. Clin Infect Dis. 2014;59(1):1-8. doi:10.1093/cid/ciu218
Centers for Disease Control and Prevention. Multistate fungal meningitis and other outbreaks. Published October 30, 2015. Accessed May 28, 2023. https://www.cdc.gov/hai/outbreaks/meningitis.html
Drug Quality and Security Act. 21 USC §301 et seq (2013). https://www.congress.gov/113/plaws/publ54/PLAW-113publ54.pdf
United States Pharmacopeial Convention. Pharmaceutical compounding-Sterile preparations <797>. In: United States Pharmacopeia and National Formulary. United States Pharmacopeia; 2008.
Daley BJ, Cherry-Bukowiec J, Van Way 3rd CW, et al. Status of nutrition training in graduate medical education from a survey of residency pogram directors: a formal nutrition education course is necessary. JPEN J Parenteral Enter Nutr. 2016;40(1):95-99. doi:10.1177/0148607115571155
Adams KM, Butsch WS, Kohlmeier M. The state or nutrition education at US medical schools. J Biomed Educ. 2015;2015:357627-7. doi:10.1155/2015/357627
Crowley J, Ball L, Hiddink GJ. Nutrition in medical education: a systematic review. Lancet Planetary Health. 2019;3(9):e379-e389. doi:10.1016/S2542-5196(19)30171-8
Bassin SR, Al-Nimr RI, Allen K, Ogrinc G. The state of nutrition in medical education in the United States. Nutr Res. 2020;78(9):764-780. doi:10.1093/nutrit/nuz100
Flannery AH, Soric MM, Benavides S, Bobbitt LJ, et al. 2019 Update to the American College of Clinical Pharmacy Pharmacotherapy didactic curriculum toolkit. J Am Coll Clin Pharm. 2020;3(2):455-464.
Guidance Document for the ASHP Accreditation Standard for Postgraduate Year One (PGY1) Pharmacy Residency Programs. Updated March 2021. Accessed March 24, 2023. https://www.ashp.org/-/media/assets/professional-development/residencies/docs/guidance-document-PGY1-standards.pdf
Chaffee BW, Tharp JC, Clark JS, Kent S. A compounding compliance team at an academic medical center. Am J Health Syst Pharm. 2020;77(11):882-891. doi:10.1093/ajhp/zxaa063
Penzien CE, Tharp JC, Mulzer K, Rurka C, Abbas C, Chaffee BW. Development of a sterile compounding training and competency program at a large academic medical center. Am J Health Syst Pharm. 2020;77(24):2089-2100. doi:10.1093/ajhp/zxaa326
Guenter P, Boullata JI, Ayers P, et al. Parenteral Nutrition Safety Task Force, American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). Standardized competencies for parenteral nutrition prescribing: the American Society for Parenteral and Enteral Nutrition Model. Nutr Clin Pract. 2015;30(4):570-576. doi:10.1177/0884533615591167
Tucker A, Ybarra J, Bingham A, et al. Standards of practice for nutrition support pharmacists. Nutr Clin Pract. 2015;30(1):139-146. doi:10.1177/0884533614550318
Kienle PC. Sterile compounding safety: the pharmacist's responsibility. Am J Health Syst Pharm. 2020;77(11):811-813. doi:10.1093/ajhp/zxaa055
Boullata JI, Gilbert K, Sacks G, et al. American Societry for Parenteral and Enteral Nutrition. A.S.P.E.N. clinical guidelines: parenteral nutrition ordering, order review, compounding, labeling, and dispensing. JPEN J Parenteral Enter Nutr. 2014;38(3):334-377. doi:10.1177/0148607114521833
United States Pharmacopeial Convention. Pharmaceutical compounding-Sterile Preparations <797>. In: United States Pharmacopeia and National Formulary. United States Pharmacopeia; 2023. doi:10.31003/USPNF_M99925_07_01
Updates to USP General Chapters <795> and <797>. The United States Pharmacopeial Convention, Inc. Published 2021. Accessed April 25, 2023. https://go.usp.org/2022_Revisions_795_797
Robinson D, Walker R, Adams SC, et al. Definition of terms, style and conventions used in ASPEN Board of Directors-approved documents. American Society for Parenteral and Enteral Nutrition. Published May 2018. Accessed May 29, 2023. https://www.nutritioncare.org/Guidelines_and_Clinical_Resources/Clinical_Practice_Library/Special_Reports/
Boullata JI, Mirtallo JM, Sacks GS, et al. ASPEN Parenteral Nutrition Safety Committee. Parenteral nutrition compatibility and stability: a comprehensive review. J Parenter Enter Nutr. 2022;46(2):273-299. doi:10.1002/jpen.2306
Driscoll DF. Globule-size distribution in injectable 20% lipid emulsions: compliance with USP requirements. Am J Health Syst Pharm. 2007;64(19):2032-2036. doi:10.2146/ajhp070097
Worthington P, Gura KM, Kraft MD, Nishikawa R, Guenter P, Sacks GS; ASPEN PN Safety Committee. Update on the use of filters for parenteral nutrition: an ASPEN position paper. Nutr Clin Pract. 2021;36(1):29-39. doi:10.1002/ncp.10587
Cogle SV, Martindale RG, Ramos M, et al. Multicenter prospective evaluation of parenteral nutrition preparation time and resource utilization: 3-chamber bags compared with hospital pharmacy-compounded bags. JPEN J Parenter Enter Nutr. 2021;45(7):1552-1558. doi:10.1002/jpen.2045
Nystrom EM, Bergquist WJ, Wieruszewski PM, McMahon MM, Barreto EF. Parenteral nutrition drug shortages: a single-center experience with rapid process change. JPEN J Parenter Enter Nutr. 2019;43(5):583-590. doi:10.1002/jpen.1538
Clinimix. Baxter US Products. Updated April 2021. Accessed April 25, 2023. https://www.baxterpi.com/pi-pdf/Clinimix_PI.pdf
Kabiven. Fresenius Kabi US Products. Updated May 2023. Accessed May 27, 2023. http://editor.fresenius-kabi.us/PIs/Kabiven_PI_FINAL_51723_s.pdf
Institute for Safe Medication Practices (ISMP). ISMP List of high-alert medications in acute care settings. Published 2018. Accessed April 25, 2023. https://www.ismp.org/sites/default/files/attachments/2018-08/highAlert2018-Acute-Final.pdf
Institute for Safe Medication Practices (ISMP). ISMP Medication errors: the year in review. January-December 2022. Pharmacy Practice News. April 12, 2023. https://www.ismp.org/news/medication-errors-year-review-1
Boullata JI, Holcombe B, Sacks G, et al. Parenteral Nutrition Safety Committee, American Society for Parenteral and Enteral Nutrition. Standardized competencies for parenteral nutrition order review and parenteral nutrition preparation, including compounding: the ASPEN model. Nutr Clin Pract. 2016;31(4):548-555.
Ainscough LP, Ford JL, Morecroft CW, et al. Accuracy of intravenous and enteral preparations involving small volumes for paediatric use: a review. Euro J Hosp Pharm. 2018;25(2):66-71. doi:10.1136/ejhpharm-2016-001117
Jordan MA, Choksi D, Lombard K, Patton LR. Development of guidelines for accurate measurement of small volume parenteral products using syringes. Hosp Pharm. 2021;56(3):165-171. doi:10.1177/0018578719873869
Amodeo I, Pesenti N, Raffaeli G, et al. Robotic therapy: cost, accuracy, and times. New challenges in the neonatal intensive care unit. Front Pharmacol. 2019;10:1431. doi:10.3389/fphar.2019.01431
Farhan M, McCallion N, Bennett J, Cram A, O'Brien F. Stability and compatibility of parenteral nutrition solutions; a review of influencing factors. Eur J Pharm Biopharm. 2023;187:87-95. doi:10.1016/j.ejpb.2023.04.002
Allwood MC, Kearney MCJ. Compatibility and stability of additives in parenteral nutrition admixtures. Nutrition. 1998;14(9):697-706. doi:10.1016/s0899-9007(98)00063-x
United States Pharmacopeial Convention. Particulate matter in injections <788>. In: United States Pharmacopeia and National Formulary. United States Pharmacopeia; 2012.
Ross EL, Petty K, Salinas A, Her C, Carpenter JF. Physical compatibility of medications with concentrated neonatal and pediatric parenteral nutrition: a simulated Y-site drug compatibility study. JPEN J Parenteral Enter Nutr. 2023;47(3):372-381. doi:10.1002/jpen.2469
Ross EL, Salinas A, Petty K, Her C, Carpenter JF. Compatibility of medications with intravenous lipid emulsions: effects of simulated Y-site mixing. Am J Health Syst Pharm. 2020;77(23):1980-1985. doi:10.1093/ajhp/zxaa299
Robinson CA, Lee JE. Y-site compatibility of medications with parenteral nutrition. J Pediatr Pharmacol Ther. 2007;12(1):53-59. doi:10.5863/1551-6776-12.1.53
Trissel LA, Gilbert DL, Martinez JF, Baker MB, Walter WV, Mirtallo JM. Compatibility of medications with 3-in-1 parenteral nutrition admixtures. JPEN J Parenteral Enter Nutr. 1999;23(2):67-74. doi:10.1177/014860719902300267
Nezvalova-Henriksen K, Nilsson N, Østerberg CT, Staven Berge V, Tho I. Y-Site physical compatibility of Numeta G13E with drugs frequently used at neonatal intensive care. Pharmaceutics. 2020;12(7):677. doi:10.3390/pharmaceutics12070677
Stawny M, Nadolna M, Jelińska A. In vitro compatibility studies of vancomycin with ready-to-use parenteral nutrition admixtures for safer clinical practice. Clin Nutr. 2020;39(8):2539-2546. doi:10.1016/j.clnu.2019.11.014
Adams SC, Gura KM, Seres DS, et al. Safe care transitions for patients receiving parenteral nutrition. Nutr Clin Pract. 2022;37(3):493-508. doi:10.1002/ncp.10861
Guenter P, Ayers P, Boullata JI, Gura KM, Holcombe B, Sacks GS. Parenteral nutrition errors and potential errors reported over the past 10 years. Nutr Clin Pract. 2017;32(6):826-830. doi:10.1177/0884533617715868
Doh J, Hencken L, Mlynarek L, MacDonald N. Utilization of a standardized discharge checklist to improve the transition of care for patients receiving parenteral nutrition. Nutr Clin Pract. 2021;36(4):877-883. doi:10.1002/ncp.10580
Infuvite Adult. Baxter US Products. Updated March 17, 2016. Accessed May 28, 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14c7bfc5-07e8-400f-b8ff-5e4794dd2805
Kirby DF, Mitchell R, Hendrickson E. Noncompliance/nonadherence with home nutrition support: an underrecognized clinical dilemma. Nutr Clin Pract. 2017;32(6):777-781. doi:10.1177/0884533617730001
Kumpf VJ, Tillman EM. Home parenteral nutrition: safe transition from hospital to home. Nutr Clin Pract. 2012;27(6):749-757. doi:10.1177/0884533612464888