Parenteral nutrition: a call to action for harmonization of policies to increase patient safety


Unsafe medication practices and medication errors are leading causes of injury and avoidable harm worldwide and are highest in vulnerable groups. In 2017, the World Health Organization launched the third Medication Without Harm Global Patient Safety Challenge to try to reduce risks related to medical treatment. Parenteral nutrition (PN) is in the unique position that, although licensed products are available from manufacturers, formulas may be prepared ad hoc for first-line use that might not be subject to the same regulatory oversight. Safety issues around PN can arise through lack of harmonization in practices, misinterpretation and product unfamiliarity and can occur at any stage from prescription to preparation to administration. Government legislation and regulation vary considerably, with PN not explicitly handled in many countries. We therefore call on policy leaders in all countries to establish policies that ensure patient safety, and that these include PN along with medicines. The available evidence supports obtaining industry prepared PN as first-line therapy for reasons of safety, primarily, and of cost. If a suitable industry prepared ready-to-use PN is not available, standardized all-in-one PN admixtures should be the next line of care, with individualized PN being reserved for patients whose complex nutritional needs cannot be met using standardized admixtures.

Access options

Rent or Buy article

Get time limited or full article access on ReadCube.


All prices are NET prices.

Fig. 1: World Health Organization harm reduction framework for Medication Without Harm.
Fig. 2: Summary of selected policies, regulations and guidelines on compounding of medicines and PN.


  1. 1.

    Donaldson LJ, Kelley ET, Dhingra-Kumar N, Kieny M-P, Sheikh A. Medication without harm: WHO’s third global patient safety challenge. Lancet. 2017.

  2. 2.

    Riskin A, Picaud J-C, Shamir R. ESPGHAN/ESPEN/ESPR/CSPEN guidelines on pediatric parenteral nutrition: Standard versus individualized parenteral nutrition. Clin Nutr. 2018;37:2409–17.

    Article  PubMed  Google Scholar 

  3. 3.

    Singer P, Reintam Blaser A, Berger MM, Alhazzani W, Calder PC, Casaer MP, et al. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019;38:48–79.

    Article  Google Scholar 

  4. 4.

    Boullata JI, Gilbert K, Sacks G, Labossiere RJ, Crill C, Goday P, et al. A.S.P.E.N. clinical guidelines: parenteral nutrition ordering, order review, compounding, labeling, and dispensing. J Parenter Enter Nutr. 2014;38:334–77.

    Article  Google Scholar 

  5. 5.

    Williams DJP. Medication errors. J R Coll Physicians Edinb. 2007;37:343–6.

    Google Scholar 

  6. 6.

    Cousins DH, Gerret D, Warner B. A review of medication incidents reported to the National Reporting and Learning System in England and Wales over 6 years (2005-2010). Br J Clin Pharm. 2012;74:597–604.

    Article  Google Scholar 

  7. 7.

    Lewis PJ, Dornan T, Taylor D, Tully MP, Wass V, Ashcroft DM. Prevalence, incidence and nature of prescribing errors in hospital inpatients: a systematic review. Drug Saf. 2009;32:379–89.

    Article  PubMed  Google Scholar 

  8. 8.

    Cowley E, Williams R, Cousins D. Medication errors in children. A descriptive summary of medication error reports submitted to the United States Pharmacopeia. Curr Ther Resid. 2001;26:627–40.

    Article  Google Scholar 

  9. 9.

    Sears K, Ross-White A. The incidence, prevalence and contributing factors associated with the occurrence of medication errors for children and adults in the community setting: a systematic review. JBI Libr Syst Rev. 2010;8:1–12.

    Google Scholar 

  10. 10.

    Keers RN, Williams SD, Cooke J, Ashcroft DM. Causes of medication administration errors in hospitals: a systematic review of quantitative and qualitative evidence. Drug Saf. 2013;36:1045–67.

    Article  PubMed  PubMed Central  Google Scholar 

  11. 11.

    Valentin A, Capuzzo M, Guidet B, Moreno RP, Dolanski L, Bauer P, et al. Patient safety in intensive care: results from the multinational Sentinel Events Evaluation (SEE) study. Intensive Care Med. 2006;32:1591–8.

    Article  PubMed  Google Scholar 

  12. 12.

    Valentin A, Capuzzo M, Guidet B, Moreno R, Metnitz B, Bauer P, et al. Errors in administration of parenteral drugs in intensive care units: multinational prospective study. BMJ. 2009;338:b814

    Article  PubMed  PubMed Central  Google Scholar 

  13. 13.

    Institute for Safe Medical Practices. ISMP list of high-alert medications in acute care settings. Horsham, UK: Institute for Safe Medical Practices; 2018.

    Google Scholar 

  14. 14.

    Koper D, Kamenski G, Flamm M, Böhmdorfer B, Sönnichsen A. Frequency of medication errors in primary care patients with polypharmacy. Fam Pract. 2013;30:313–9.

    Article  PubMed  Google Scholar 

  15. 15.

    Stavroudis TA, Miller MR, Lehmann CU. Medication errors in neonates. Clin Perinatol. 2008;35:141–61.

    Article  PubMed  Google Scholar 

  16. 16.

    Rothschild JM, Landrigan CP, Cronin JW, Kaushal R, Lockley SW, Burdick E, et al. The Critical Care Safety Study: the incidence and nature of adverse events and serious medical errors in intensive care. Crit Care Med. 2005;33:1694–1700.

    Article  PubMed  Google Scholar 

  17. 17.

    World Health Organization. Medication errors: technical series on safer primary care. Geneva: World Health Organization; 2016.

    Google Scholar 

  18. 18.

    National Coordinating Council for Medication Error Reporting and Prevention. About medication errors: what is a medication error? 2019. Accessed 4 June 2019.

  19. 19.

    European Medicines Agency. Recommendations on medication errors. 2015. Accessed June 2019.

  20. 20.

    White R. Parenteral nutrition for adults—an overview of the basic principles. Clin Pharm. 2011;3:183–4.

    Google Scholar 

  21. 21.

    Worthington P, Balint J, Bhechtold M, Bingham A, Chan LN, Durfee S, et al. When is parenteral nutrition appropriate? J Parenter Enter Nutr. 2017;41:324–77.

    Article  Google Scholar 

  22. 22.

    Alfonso JE, Berlana D, Ukleja A, Boullata J. Clinical, ergonomic, and economic outcomes with multichamber bags compared with (hospital) pharmacy compounded bags and multibottle systems: a systematic literature review. J Parenter Enter Nutr. 2017;41:1162–77.

    Article  Google Scholar 

  23. 23.

    Radziwill R. All-in-one vs. single bottle systems. In: Weimann A, Schütz T, Ohlrich S, Fedders M, Grünewald G. Ernährungsmedizin – Ernährungsmanagement—Ernährungstherapie. Weinheim: Ecomed Medizin, 2019:168–72.

  24. 24.

    Holcombe B, Mattox TW, Plogsted S. Drug shortages: effect on parenteral nutrition therapy. Nutr Clin Pract. 2018;33:53–61.

    Article  PubMed  Google Scholar 

  25. 25.

    Chhim RF, Crill CM. Premixed parenteral nutrition solution use in children. J Pediatr Pharm Ther. 2015;20:378–84.

    Article  Google Scholar 

  26. 26.

    Colomb V, Marlowe ML, Bonnot D, Rigo J. Practical use of a new three-chamber bag for parenteral nutrition in pediatric patients. Clin Nutr. 2012;7:e93–e99.

    Article  Google Scholar 

  27. 27.

    Maisonneuve N, Raguso CA, Paoloni-Giacobino A, Mühlebach S, Corriol O, Saubion JL, et al. Parenteral nutrition practices in hospital pharmacies in Switzerland, France, and Belgium. Nutrition. 2004;20:528–35.

    CAS  Article  PubMed  Google Scholar 

  28. 28.

    Mena KDR, Espitia OLP, Bergara JAD. Management of ready-to-use parenteral nutrition in newborns: systematic review. J Parenter Enter Nutr. 2018;42:1123–32.

    Article  Google Scholar 

  29. 29.

    Singh A, Rauch D. Commercial premixed parenteral nutrition and its potential role in pediatrics. Hospital Pediatr. 2016;6:34–36.

    Article  Google Scholar 

  30. 30.

    Simmer K, Rakshasbhuvankar A, Deshpande G. Standardised parenteral nutrition. Nutrients. 2013;5:1058–70.

    Article  PubMed  PubMed Central  Google Scholar 

  31. 31.

    Blanchette LM, Huiras P, Papadoulos S. Standardized versus custom parenteral nutrition: impact on clinical and cost-related outcomes. Am J Health Syst Pharm. 2013;2:114–21.

    Article  Google Scholar 

  32. 32.

    Berlana D, Almendral MA, Abad MR, Fernández A, Torralba A, Cervera-Peris M, et al. Cost, time, and error assessment during preparation of parenteral nutrition: multichamber bags versus hospital-compounded bags. J Parenter Enter Nutr. 2019;43:557–65.

    Article  Google Scholar 

  33. 33.

    Berlana D, Barraquer A, Sabin P, Chicharro L, Pérez A, Puiggrós C, et al. Impact of parenteral nutrition standardization on costs and quality in adult patients. Nutr Hosp. 2014;30:351–8.

    Article  PubMed  Google Scholar 

  34. 34.

    Yu J, Wu G, Tang Y, Ye Y, Zhang Z. Efficacy, safety, and preparation of standardized parenteral nutrition regimens: three-chamber bags vs compounded monobags-a prospective, multicenter, randomized, single-blind clinical trial. Nutr Clin Pr. 2017;32:545–51.

    CAS  Article  Google Scholar 

  35. 35.

    Pironi L, Steiger E, Brandt C, Joly F, Wanten G, Chambrier C, et al. Home parenteral nutrition provision modalities for chronic intestinal failure in adult patients: an international survey. Clin Nutr. 2019;39:585–91.

    Article  PubMed  Google Scholar 

  36. 36.

    Boullata JI, Guenter P, Mirtallo JM. A parenteral nutrition use survey with gap analysis. J Parenter Enter Nutr. 2013;37:212–22.

    Article  Google Scholar 

  37. 37.

    Sacks GS, Rough S, Kudsk KA. Frequency and severity of harm of medication errors related to the parenteral nutrition process in a large university teaching hospital. Pharmacotherapy. 2009;29:966–74.

    Article  PubMed  Google Scholar 

  38. 38.

    Arenas Villafranca JJ, Gómez Sánchez A, Nieto Guindo M, Faus Felipe V. Using failure mode and effects analysis to improve the safety of neonatal parenteral nutrition. Am J Health Syst Pharm. 2014;71:1210–8.

    Article  PubMed  Google Scholar 

  39. 39.

    Bateman R, Donyai P. Errors associated with the preparation of aseptic products in UK hospital pharmacies: lessons from the national aseptic error reporting scheme. Qual Saf Health Care. 2010;19:e29

    Article  PubMed  Google Scholar 

  40. 40.

    MacKay M, Anderson C, Boehme S, Cash J, Zobell J. Frequency and severity of parenteral nutrition medication errors at a large children’s hospital after implementation of electronic ordering and compounding. Nutr Clin Pr. 2016;31:195–206.

    CAS  Article  Google Scholar 

  41. 41.

    Li Q, Kirkendall ES, Hall ES, Ni Y, Lingren T, Kaiser M, et al. Automated detection of medication administration errors in neonatal intensive care. J Biomed Inform. 2015;57:124–33.

    Article  PubMed  PubMed Central  Google Scholar 

  42. 42.

    Nguyen M-NR, Mosel C, Grzeskowiak LE. Interventions to reduce medication errors in neonatal care: a systematic review. Ther Adv Drug Saf. 2018;9:123–55.

    Article  PubMed  Google Scholar 

  43. 43.

    Hermanspann T, Schoberer M, Robel-Tillig E, Härtel C, Goelz R, Orlikowsky T, et al. Incidence and severity of prescribing errors in parenteral nutrition for pediatric inpatients at a neonatal and pediatric intensive care unit. Front Pediatr. 2017;5:149

    Article  PubMed  PubMed Central  Google Scholar 

  44. 44.

    Mendes JR, Lopes MCBT, Vancini-Campanharo CR, Okuno MFP, Batista REA. Types and frequency of errors in the preparation and administration of drugs. Einstein. 2018;16:eAO4146

    Article  PubMed  PubMed Central  Google Scholar 

  45. 45.

    De Weerdt E, Simoens S, Hombroeckx L, Casteels M, Huys I. Causes of drug shortages in the legal pharmaceutical framework. Regul Toxicol Pharm. 2015;71:251–8.

    Article  Google Scholar 

  46. 46.

    Guenter P, Worthington P, Ayers P, Boullata JI, Gura KM, Marshall N, et al. Standardized competencies for parenteral nutrition administration: the ASPEN Model. Nutr Clin Pract. 2015;30:570–6.

    Article  PubMed  Google Scholar 

  47. 47.

    Hicks RW, Becker SC, Chuo J. A summary of NICU fat emulsion medication errors and nursing services: data from MEDMARX. Adv Neonatal Care. 2007;7:299–308.

    Article  PubMed  Google Scholar 

  48. 48.

    NHS Improvement. Patient safety alert: risk of severe harm and death from infusing total parenteral nutrition too rapidly in babies. September 2017. Accessed June 2019.

  49. 49.

    Wollitz A, Grissinger M. Aligning the line: an analysis of IV line errors. PA Patient Saf Advis. 2014;11:1–7.

    Google Scholar 

  50. 50.

    World Health Organization. Medication without harm: WHO patient safety challenge. Geneva: World Health Organization; 2017.

    Google Scholar 

  51. 51.

    Cederholm T, Barazzoni R, Austin P, Ballmer P, Biolo G, Bischoff SC, et al. ESPEN guidelines on definitions and terminology of clinical nutrition. Clin Nutr. 2017;36:49–64.

    CAS  Article  PubMed  Google Scholar 

  52. 52.

    Freijer K, Volger S, Pitter JG, Molsen-David E, Cooblall C, Evers S, et al. Medical nutrition terminology and regulations in the United States and Europe—a scoping review: report of the ISPOR Nutrition Economics Special Interest Group. Value Health. 2019;22:1–12.

    Article  PubMed  Google Scholar 

  53. 53.

    US Food and Drug Administration. Human Drug Compounding. 2017. Accessed 4 June 2019.

Download references

Author information




Valery Gallagher: conceptualization, methodology, supervision. David Berlana: writing—review and editing, validation. Mattias Paulsson: writing—review and editing, validation. Rebecca White: methodology, writing—original draft.

Corresponding author

Correspondence to Rebecca Jayne White.

Ethics declarations

Conflict of interest

VG is an employee of Baxter Healthcare and, presently serves as a member of the American Society of Parenteral and Enteral Nutrition’s (ASPEN) Corporate Scientific Advisory Council. MP reports personal fees from InBioPharma US/Baxter, Fresenius Kabi Germany, and B Braun Sweden outside the submitted work. DB reports personal fees from Fresenius Kabi and Baxter SL outside the submitted work. RJW is an employee of Baxter Healthcare and is the communication officer for the British Pharmaceutical Nutrition Group.

Additional information

Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplementary information

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Gallagher, V., Berlana, D., Paulsson, M. et al. Parenteral nutrition: a call to action for harmonization of policies to increase patient safety. Eur J Clin Nutr (2020).

Download citation

Further reading