Neonatology

Original Paper

Prescription Drug Shortages: Impact on Neonatal Intensive Care

Ziesenitz V.C.a,b · Fox E.c,d · Zocchi M.e · Samiee-Zafarghandy S.f · van den Anker J.N.a,g · Mazer-Amirshahi M.h,i

Author affiliations

aDivision of Pediatric Pharmacology and Pharmacometrics, University of Basel Children’s Hospital, Basel, Switzerland
bDepartment of Pediatric Cardiology, University Children’s Hospital, Heidelberg, Germany
cDrug Information Service, University of Utah Health, Salt Lake City, UT, USA
dCollege of Pharmacy, University of Utah, Salt Lake City, UT, USA
eCenter for Healthcare Innovation and Policy Research, George Washington University, Washington, DC, USA
fDivision of Neonatology, Department of Pediatrics, McMaster University, Hamilton, ON, Canada
gDivision of Clinical Pharmacology, Children’s National Health System, Washington, DC, USA
hDepartment of Emergency Medicine, MedStar Washington Hospital Center, Washington, DC, USA
iGeorgetown University School of Medicine, Washington, DC, USA

Keywords: Drug treatmentNeonatal intensive careNeonatal intensive care unitNeonatePreterm and term infantExtremely low birth weight infantsDrug shortage

Related Articles for ""
Neonatology 2019;115:108–115
https://doi.org/10.1159/000493119

Log in to MyKarger to check if you already have access to this content.




Forgot your password
Sign up to MyKarger

Buy

  • FullText & PDF
  • Unlimited re-access via MyKarger
  • Unrestricted printing, no saving restrictions for personal use
read more
CHF 38.00 *
EUR 35.00 *
USD 39.00 *

Select

KAB

Buy a Karger Article Bundle (KAB) and profit from a discount!


If you would like to redeem your KAB credit, please log in.

Save over 20% compared to the individual article price.

Learn more

Rent/Cloud

  • Rent for 48h to view
  • Buy Cloud Access for unlimited viewing via different devices
  • Synchronizing in the ReadCube Cloud
  • Printing and saving restrictions apply
Rental: USD 8.50
Cloud: USD 20.00

Select

Subscribe

  • Access to all articles of the subscribed year(s) guaranteed for 5 years
  • Unlimited re-access via Subscriber Login or MyKarger
  • Unrestricted printing, no saving restrictions for personal use
read more

Subcription rates

Select
* The final prices may differ from the prices shown due to specifics of VAT rules.

Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: April 30, 2018
Accepted: August 22, 2018
Published online: November 01, 2018
Issue release date: March 2019

Number of Print Pages: 8
Number of Figures: 1
Number of Tables: 5

ISSN: 1661-7800 (Print)
eISSN: 1661-7819 (Online)

For additional information: https://www.karger.com/NEO

Abstract

Background: Prescription drug shortages have increased significantly during the past two decades and also impact drugs used in critical care and pediatrics. Objectives: To analyze drug shortages affecting medications used in neonatal intensive care units (NICUs). Methods: Drug shortage data for the top 100 NICU drugs were retrieved from the University of Utah Drug Information Service from 2001 to 2016. Data were analyzed focusing on drug class, formulation, reason for shortage, and shortage duration. Results: Seventy-four of the top 100 NICU drugs were impacted by 227 shortages (10.3% of total shortages). Twenty-eight (12.3%) shortages were unresolved as of December 2016. Resolved shortages had a median duration of 8.8 months (interquartile range 3.6–21.3), and generic drugs were involved in 175 (87.9%). An alternative agent was available for 171 (85.8%) drugs but 120 (70.2%) of alternatives were also affected by shortages. Parenteral drugs were involved in 172 (86.4%) shortages, with longer durations than nonparenteral drugs (9.9 vs. 6.4 months, p = 0.022). The most common shortage reason was manufacturing problems (32.2%). Conclusions: Drug shortages affected many agents used in NICUs, which can have quality and safety implications for patient care, especially in extremely low birth weight infants. Neonatologists must be aware of current shortages and implement mitigation strategies to optimize patient care.

© 2018 S. Karger AG, Basel



Related Articles:

References

  1. Metzger ML, Billett A, Link MP. The impact of drug shortages on children with cancer—the example of mechlorethamine. N Engl J Med. 2012 Dec;367(26):2461–3.
    External Resources
  2. Mazer-Amirshahi M, Pourmand A, Singer S, Pines JM, van den Anker J. Critical drug shortages: implications for emergency medicine. Acad Emerg Med. 2014 Jun;21(6):704–11.
    External Resources
  3. Hawley KL, Mazer-Amirshahi M, Zocchi MS, Fox ER, Pines JM. Longitudinal Trends in U.S. Drug Shortages for Medications Used in Emergency Departments (2001-2014). Acad Emerg Med. 2016 Jan;23(1):63–9.
    External Resources
  4. Mazer-Amirshahi M, Goyal M, Umar SA, Fox ER, Zocchi M, Hawley KL, et al. U.S. drug shortages for medications used in adult critical care (2001-2016). J Crit Care. 2017 Oct;41:283–8.
    External Resources
  5. Binenbaum G, Bruno CJ, Forbes BJ, Snyder M, Mollen TJ, Schmidt B, et al. Periocular ulcerative dermatitis associated with gentamicin ointment prophylaxis in newborns. J Pediatr. 2010 Feb;156(2):320–1.
    External Resources
  6. G Salazar E, Bernhardt MB, Li Y, Aplenc R, Adamson PC. The impact of chemotherapy shortages on COG and local clinical trials: a report from the Children’s Oncology Group. Pediatr Blood Cancer. 2015 Jun;62(6):940–4.
    External Resources
  7. Tolia VN, Murthy K, McKinley PS, Bennett MM, Clark RH. The effect of the national shortage of vitamin A on death or chronic lung disease in extremely low-birth-weight infants. JAMA Pediatr. 2014 Nov;168(11):1039–44.
    External Resources
  8. Ziesenitz VC, Mazer-Amirshahi M, Zocchi MS, Fox ER, May LS. U.S. vaccine and immune globulin product shortages, 2001-15. Am J Health Syst Pharm. 2017 Nov;74(22):1879–86.
    External Resources
  9. Hsieh EM, Hornik CP, Clark RH, Laughon MM, Benjamin DK Jr, Smith PB; Best Pharmaceuticals for Children Act—Pediatric Trials Network. Medication use in the neonatal intensive care unit. Am J Perinatol. 2014 Oct;31(9):811–21.
    External Resources
  10. Fox ER, Tyler LS. Managing drug shortages: seven years’ experience at one health system. Am J Health Syst Pharm. 2003 Feb;60(3):245–53.
    External Resources
  11. Vail E, Gershengorn HB, Hua M, Walkey AJ, Rubenfeld G, Wunsch H. Association Between US Norepinephrine Shortage and Mortality Among Patients With Septic Shock. JAMA. 2017 Apr;317(14):1433–42.
    External Resources
  12. Zobell JT, Kemper AL, Young DC. The use of doripenem in pediatric cystic fibrosis patients in case of meropenem shortages. Pediatr Pulmonol. 2014 Mar;49(3):E48–51.
    External Resources
  13. Cirillo I, Vaccaro N, Castaneda-Ruiz B, Redman R, Cossey V, Bradley JS, et al. Open-Label Study To Evaluate the Single-Dose Pharmacokinetics, Safety, and Tolerability of Doripenem in Infants Less than 12 Weeks in Chronological Age. Antimicrob Agents Chemother. 2015 Aug;59(8):4742–9.
    External Resources
  14. Glasgow AM, Boeckx RL, Miller MK, MacDonald MG, August GP, Goodman SI. Hyperosmolality in small infants due to propylene glycol. Pediatrics. 1983 Sep;72(3):353–5.
    External Resources
  15. Uthaya S, Modi N. Practical preterm parenteral nutrition: systematic literature review and recommendations for practice. Early Hum Dev. 2014 Nov;90(11):747–53.
    External Resources
  16. Hanson C, Thoene M, Wagner J, Collier D, Lecci K, Anderson-Berry A. Parenteral nutrition additive shortages: the short-term, long-term and potential epigenetic implications in premature and hospitalized infants. Nutrients. 2012 Dec;4(12):1977–88.
    External Resources
  17. Mirtallo JM, Holcombe B, Kochevar M, Guenter P. Parenteral nutrition product shortages: the A.S.P.E.N. strategy. Nutr Clin Pract. 2012 Jun;27(3):385–91.
    External Resources
  18. Plogsted S, Adams SC, Allen K, Breen HB, Cober MP, Greaves J, et al.; Clinical Practice Committee’s Nutrition Product Shortage Subcommittee of the American Society for Parenteral and Enteral Nutrition. Parenteral Nutrition Electrolyte and Mineral Product Shortage Considerations. Nutr Clin Pract. 2016 Feb;31(1):132–4.
    External Resources
  19. American Society of Health-System Pharmacists. Drug Shortages Roundtable: Minimizing the Impact on Patient Care. Bethesda, MD; 2017.
  20. Mazer-Amirshahi M, Fox ER. Saline Shortages - Many Causes, No Simple Solution. N Engl J Med. 2018 Apr;378(16):1472–4.
    External Resources
  21. Akinmboni TO, Davis NL, Falck AJ, Bearer CF, Mooney SM. Excipient exposure in very low birth weight preterm neonates. J Perinatol. 2018 Feb;38(2):169–74.
    External Resources
  22. Bogucki B, Jacobs BR, Hingle J; Clinical Informatics Outcomes Research Group. Computerized reminders reduce the use of medications during shortages. J Am Med Inform Assoc. 2004 Jul-Aug;11(4):278–80.
    External Resources
  23. Butterfield L, Cash J, Pham K; Advocacy Committee for the Pediatric Pharmacy Advocacy Group. Drug shortages and implications for pediatric patients. J Pediatr Pharmacol Ther. 2015 Mar-Apr;20(2):149–52.
    External Resources
  24. Fox ER, Birt A, James KB, Kokko H, Salverson S, Soflin DL; ASHP Expert Panel on Drug Product Shortages. ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems. Am J Health Syst Pharm. 2009;66(15):1399–406.
    External Resources
  25. Decamp M, Joffe S, Fernandez CV, Faden RR, Unguru Y; Working Group on Chemotherapy Drug Shortages in Pediatric Oncology. Chemotherapy drug shortages in pediatric oncology: a consensus statement. Pediatrics. 2014 Mar;133(3):e716–24.
    External Resources
  26. Fox ER, McLaughlin MM. ASHP guidelines on managing drug product shortages. Am J Health Syst Pharm. 2018 Jul;ajhp180441.
    External Resources
  27. Reuters: BASF shuts ibuprofen production at U.S. plant due to technical problem. 2018. https://www.reuters.com/article/us-basf-se-ibuprofen/basf-shuts-ibuprofen-production-at-u-s-plant-due-to-technical-problem-idUSKBN1JN1HR (accessed July 2, 2018).

Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: April 30, 2018
Accepted: August 22, 2018
Published online: November 01, 2018
Issue release date: March 2019

Number of Print Pages: 8
Number of Figures: 1
Number of Tables: 5

ISSN: 1661-7800 (Print)
eISSN: 1661-7819 (Online)

For additional information: https://www.karger.com/NEO

Copyright / Drug Dosage / Disclaimer

Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

Article Tools
Article Details

2019, Vol.115, No. 2

March 2019

Article

Recommend This
TOP