| GMS German Medical Science — an Interdisciplinary Journal | |
| Practical handling of AIO admixtures – Guidelines on Parenteral Nutrition, Chapter 10Praktische Handhabung von AIO-Mischungen – Leitlinie Parenterale Ernährung, Kapitel 10 | |
| Z. Stanga3  C. Franken1  S. Mühlebach2  | |
| [1] Central Pharmacy, University of Dusseldorf, Germany;CSO Vifor Pharma Ltd, VillarssurGlâne, Switzerland;Polyclinic for Endocrinology, Diabetology and Clinical Nutrition, Clinic for General Internal Medicine, University of Berne, Switzerland | |
| 关键词: quality assurance; stability; industrial parenteral nutrition systems; compounding; infusion systems; | |
| Others : 869116 | |
| 实施日期:2009-01-14,发布日期:2009-11-18 | |
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【 摘 要 】
All-in-one admixtures (AIO-admixtures) provide safe, effective and low-risk PN (parenteral nutrition) for practically all indications and applications. Water, energy (carbohydrates and lipids), amino acids, vitamins and trace elements are infused together with PN either as industrially-manufactured AIO admixtures provided as two- or three-chamber bags (shelf life usually more than 12 months) completed with electrolytes and micronutrients where appropriate or as individually compounded ready-to-use AIO admixtures (compounding, usually prepared by a pharmacy on either a daily or weekly basis and stored at 2–8°C). Physico-chemical and microbial stability of an AIO admixture is essential for the safety and effectiveness of patient-specific PN, and its assurance requires specialist pharmaceutical knowledge. The stability should be documented for an application period of 24 (–48) hours. It is advisable to offer a limited selection of different PN regimes in each hospital. For reasons of drug and medication safety, PN admixtures prepared for individual patients must be correctly labelled and specifications for storage conditions must also be followed during transport. Monitoring is required where applicable. Micronutrients are usually administered separately to AIO admixtures. In case compatibility and stability have been well documented trace elements and/or combination preparations including water-soluble or water-soluble/fat soluble vitamin supplements can be added to PN admixtures under strict aseptic conditions. AIO admixtures are usually not used as vehicles for drugs (incompatibilities).
【 授权许可】
© 2009 Mühlebach et al.This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.
【 预 览 】
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【 参考文献 】
- [1]Schmutz C. Microbiological safety and stability of TPN mixtures. In: XVIII ESPEN Congress on Clinical Nutrition and Metabolism. Geneva; 1996.
- [2]Didier ME, Fischer S, Maki DG. Total nutrient admixtures appear safer than lipid emulsion alone as regards microbial contamination: growth properties of microbial pathogens at room temperature. JPEN J Parenter Enteral Nutr. 1998;22(5):291-6. DOI: 10.1177/0148607198022005291
- [3]Durand-Zaleski I, Delaunay L, Langeron O, Belda E, Astier A, Brun-Buisson C. Infection risk and cost-effectiveness of commercial bags or glass bottles for total parenteral nutrition. Infect Control Hosp Epidemiol. 1997;18(3):183-8.
- [4]Flechsenhar K, Müller I, Zutt A. Handhabung eines parenteralen Ernährungsregimes. Schwester Pfl. 1996;6:555-7.
- [5]Frei A, Dinkel R, Kemen M, Senkal M, Zumtobel V. [A new model for economic studies of therapies exemplified by postoperative parenteral nutrition]. Zentralbl Chir. 1997;122(5):358-65.
- [6]Pichard C, Schwarz G, Frei A, Kyle U, Jolliet P, Morel P, Romand JA, Sierro C. Economic investigation of the use of three-compartment total parenteral nutrition bag: prospective randomized unblinded controlled study. Clin Nutr. 2000;19(4):245-51. DOI: 10.1054/clnu.2000.0106
- [7]Schwarz G, Sierro C, Griffiths W. Convenience and Cost-efficiency by the Use of Multicompartment Bags for Total Parenteral Nutrition. In: XVIII ESPEN Congress on Clinical Nutrition and Metabolism. Geneva; 1996.
- [8]von Eiff W. Krankenhaus-Management: Qualität und Wirtschaftlichkeit als Managementherausforderung des Arztes [Hospital management: quality and economy as management challenges for the physicians]. Zentralbl Chir. 1996;121:817-827.
- [9]Petros WP, Shank WA Jr. A standardized parenteral nutrition solution: prescribing, use, processing, and material cost implications. Hosp Pharm. 1986;21(7):648-9, 654-6.
- [10]Armstrong CW, Mayhall CG, Miller KB, Newsome HH Jr, Sugerman HJ, Dalton HP, Hall GO, Gennings C. Prospective study of catheter replacement and other risk factors for infection of hyperalimentation catheters. J Infect Dis. 1986;154(5):808-16.
- [11]Sitges-Serra A, Liñares J, Pérez JL, Jaurrieta E, Lorente L. A randomized trial on the effect of tubing changes on hub contamination and catheter sepsis during parenteral nutrition. JPEN J Parenter Enteral Nutr. 1985;9(3):322-5. DOI: 10.1177/0148607185009003322
- [12]Snydman DR, Murray SA, Kornfeld SJ, Majka JA, Ellis CA. Total parenteral nutrition-related infections. Prospective epidemiologic study using semiquantitative methods. Am J Med. 1982;73(5):695-9. DOI: 10.1016/0002-9343(82)90412-0
- [13]Europäisches Arzneibuch. 6. Ausg. Stuttgart: Deutscher Apotheker Verlag; 2008.
- [14]The United States pharmacopeia, the national formulary. Rockville, Md: US Pharmacopeial Convention Inc.; 2008.
- [15]The British pharmacopoeia. London: Stationary Office; 2008.
- [16]Delanghe M. Good manufacturing in All in One compounding. Nutrition. 1989;5(5):352-4.
- [17]Safe Practices for Parenteral Nutrition Formulations. National Advisory Group on Standards and Practice Guidelines for Parenteral Nutrition. JPEN J Parenter Enteral Nutr. 1998;22(2):49-66. DOI: 10.1177/014860719802200249
- [18]Driscoll DF. Compounding TPN admixtures: then and now. JPEN J Parenter Enteral Nutr. 2003;27(6):433-8. DOI: 10.1177/0148607103027006433
- [19]Hardy G, Ball P, McElroy B. Basic principles for compounding all-in-one parenteral nutrition admixtures. Curr Opin Clin Nutr Metab Care. 1998;1(3):291-6. DOI: 10.1097/00075197-199805000-00010
- [20]Hartmann B, Berchtold W, Aeberhard P, Mühlebach S. Umfang, Rationalität und Qualität der parenteralen Ernährung. Akt Ern Med. 1998;23:43-9.
- [21]Mühlebach S. Heimparenterale Ernährung: Internationale Entwicklungen und Langzeiterfahrungen aus der Schweiz [Home Parenteral Nutrition (HPN): International Background and Long-Term Experience in Switzerland]. Akt Ern Med. 2002;27:425-30.
- [22]Pichard C, Mühlebach S, Maisonneuve N, Sierro C. Prospective survey of parenteral nutrition in Switzerland: a three-year nation-wide survey. Clin Nutr. 2001;20(4):345-50. DOI: 10.1054/clnu.2001.0428
- [23]Steger PJ, Mühlebach SF. In vitro oxidation of i.v. lipid emulsions in different all-in-one admixture bags assessed by an iodometric assay and gas-liquid chromatography. Nutrition. 1997;13(2):133-40. DOI: 10.1016/S0899-9007(96)00387-5
- [24]Dice JE, Burckart GJ, Woo JT, Helms RA. Standardized versus pharmacist-monitored individualized parenteral nutrition in low-birth-weight infants. Am J Hosp Pharm. 1981;38(10):1487-9.
- [25]Allwood MC, Hardy G, Sizer T. Roles and functions of the pharmacist in the nutrition support team. Nutrition. 1996;12(1):63-4. DOI: 10.1016/0899-9007(95)00059-3
- [26]Standards for nutrition support pharmacists. American Society for Parenteral and Enteral Nutrition. Nutr Clin Pract. 1993;8(3):124-7. DOI: 10.1177/0115426593008003124
- [27]Driscoll DF. Roles and functions of the hospital pharmacist on the nutrition support team. Nutrition. 1996;12(2):138-9. DOI: 10.1016/S0899-9007(96)00023-9
- [28]ASHP guidelines on quality assurance for pharmacy-prepared sterile products. American Society of Health System Pharmacists. Am J Health Syst Pharm. 2000;57(12):1150-69.
- [29]Driscoll DF, Bhargava HN, Li L, Zaim RH, Babayan VK, Bistrian BR. Physicochemical stability of total nutrient admixtures. Am J Health Syst Pharm. 1995;52(6):623-34.
- [30]FDA Safety Alert. Hazards of precipitation associated with parenteral nutrition. Rockville, MD: Department of Health and Human Services, FDA; 1994.
- [31]Washington C. The stability of intravenous fat emulsions in TPN mixtures. Int J Pharmaceutics. Int J Pharmaceutics. 1999;66:1-21. DOI: 10.1016/0378-5173(90)90379-I
- [32]Schmutz C, Werner R, Keller U, Mühlebach S. Emulsion stability of all-in-one TPN admixtures assessed by microscopy. Comparison of different lipid emulsions and amino acid solutions. Clin Nutr. 1993;12:59-60. DOI: 10.1016/0261-5614(93)90322-U
- [33]Driscoll DF, Bacon MN, Bistrian BR. Physicochemical stability of two types of intravenous lipid emulsion as total nutrient admixtures. JPEN J Parenter Enteral Nutr. 2000;24(1):15-22. DOI: 10.1177/014860710002400115
- [34]Gräflein C. Parenterale Ernährung mit stabilitätsgeprüften, modularen Standardlösungen in der Neonatologie [Dissertation]. Basel: Philosophisch-Naturwissenschaftliche Fakultät der Universität Basel; 2004. Available from: http://pages.unibas.ch/diss/2004/DissB_6720.pdf
- [35]Laborie S, Lavoie JC, Pineault M, Chessex P. Contribution of multivitamins, air, and light in the generation of peroxides in adult and neonatal parenteral nutrition solutions. Ann Pharmacother. 2000;34(4):440-5. DOI: 10.1345/aph.19182
- [36]Steger PJ, Mühlebach SF. Lipid peroxidation of i.v. lipid emulsions in TPN bags: the influence of tocopherols. Nutrition. 1998;14(2):179-85. DOI: 10.1016/S0899-9007(97)00438-3
- [37]Steger PJ, Mühlebach SF. Lipid peroxidation of intravenous lipid emulsions and all-in-one admixtures in total parenteral nutrition bags: the influence of trace elements. JPEN J Parenter Enteral Nutr. 2000;24(1):37-41. DOI: 10.1177/014860710002400137
- [38]Allwood MC, Kearney MC. Compatibility and stability of additives in parenteral nutrition admixtures. Nutrition. 1998;14(9):697-706. DOI: 10.1016/S0899-9007(98)00063-X
- [39]Sobotka L, Allison SP, Fürst P, et al., eds. Basics in clinical nutrition: Edited for ESPEN Courses. Prague, Czech Republic: Publishing House Galén; 2000.
- [40]Dupertuis YM, Morch A, Fathi M, Sierro C, Genton L, Kyle UG, Pichard C. Physical characteristics of total parenteral nutrition bags significantly affect the stability of vitamins C and B1: a controlled prospective study. JPEN J Parenter Enteral Nutr. 2002;26(5):310-6. DOI: 10.1177/0148607102026005310
- [41]Silvers KM, Sluis KB, Darlow BA, McGill F, Stocker R, Winterbourn CC. Limiting light-induced lipid peroxidation and vitamin loss in infant parenteral nutrition by adding multivitamin preparations to Intralipid. Acta Paediatr. 2001;90(3):242-9. DOI: 10.1080/080352501300067433
- [42]Martinelli E, Mühlebach S. Kunststoffumbeutel als Lichtschutz für Infusionen. Ergebnisse einer praxisnahen Untersuchung mit Vitamin K1 als Testsubstanz [Plastic covers as light protective for infusions. Results of a close to practice study using vitamin K 1 as test probe]. Krankenhauspharmazie. 1995;16:286-9.
- [43]Silvers KM, Darlow BA, Winterbourn CC. Lipid peroxide and hydrogen peroxide formation in parenteral nutrition solutions containing multivitamins. JPEN J Parenter Enteral Nutr. 2001;25(1):14-7. DOI: 10.1177/014860710102500114
- [44]Barnett MI, Cosslett AG, Duffield JR, Evans DA, Hall SB, Williams DR. Parenteral nutrition. Pharmaceutical problems of compatibility and stability. Drug Saf. 1990;5 Suppl 1:101-6. DOI: 10.2165/00002018-199000051-00016
- [45]Gikic M, Di Paolo ER, Pannatier A, Cotting J. Evaluation of physicochemical incompatibilities during parenteral drug administration in a paediatric intensive care unit. Pharm World Sci. 2000;22(3):88-91. DOI: 10.1023/A:1008780126781
- [46]Trissel LA, Gilbert DL, Martinez JF, Baker MB, Walter WV, Mirtallo JM. Compatibility of medications with 3-in-1 parenteral nutrition admixtures. JPEN J Parenter Enteral Nutr. 1999;23(2):67-74. DOI: 10.1177/014860719902300267
- [47]Schmid U, Mühlebach S. Interactions of drugs and i.v. lipids: influence of cyclosporin on fat clearance in vitro. Clin Nutr. 2001;20(Suppl 3):27.
- [48]Sobotka L, Allison SP, Stanga Z. Water and electrolytes. In: Sobotka L, Allison SP, Fürst P, et al., eds. Basics in clinical nutrition: Edited for ESPEN Courses. Prague, Czech Republic: Publishing House Galén; 2000.
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