Abstract
As a result of the widely publicized tragic events related to the New England Compounding Center Pharmacy contamination of compounded preparations as well as the response from the US Food and Drug Administration (FDA) and State Regulatory Agencies, practitioners shall become informed on requirements for safe and accurate compounding of intrathecal medications. The advances in technology, techniques, and standards for proper sterile compounding are detailed in the information below. The standards and requirements for compounding intrathecal preparations differ and, in some ways, are far more stringent than those for other sterile compounded medicines. The standards and requirements include the nature of the physical space where compounding takes place, environmental monitoring of that space, personnel training, and regular testing to ensure adherence to proper procedure is followed at every step of the compounding process. This chapter presents the current considerations of these critical aspects of compounding intrathecal pharmaceuticals for continuous infusion.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Multistate outbreak of fungal meningtis and other infections -Case countshttps://www.cdc.gov/hai/outbreaks/meningitis-map-large.html.
LaWall CH. Four thousand years of pharmacy: an outline history of pharmacy and the allied sciences. Philadelphia, PA: J.B Lippincott Co.; 1927.
Convention USP: Chapter 797, United States Pharmacopeia U.S 2015 Ed.
Buchanan EC, Schneider PJ. Compounding sterile preparations. 3rd ed. ASHP; 2009.
Prescription Requirement Under Section 503 A of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry April 2016, FDA.
Meltzer T, Jornitz M. Pharmaceutical filtration: the management of organism removal. River Grove, IL: DHI Publishing, LLC; 2006.
Sharp J. Good pharmaceutical manufacturing practice: rationale and compliance. CRC Press; 2005.
Williams K. Endotoxins: pyrogens, LAL testing, and depyrogenation. In: Drugs and the pharmaceutical sciences, vol. 111. 2nd ed. CRC Press, Taylor and Francis Group; 2001.
SitaramBR TM, Rawicki HB, Lam S, Courage P, et al. Stability and compatibility of baclofen and morphine admixtures for use in an implantable infusion pump. Int J Pharm. 1995;118(2):181–9.
Hildebrand KR, Elsberry DE, Anderson VC. Stability and compatibility of hydromorphone hydrochloride in an implantable infusion system. J Pain Symptom Manag. 2001;22(6):1042–7.
Xu QA, Trissel LA, Pham L. Physical and chemical stability of low and high concentrations of morphine sulfate with clonidine hydrochloride packaged in plastic syringes. Int J Pharm Compd. 2002;6(1):66–9.
Classen AM, Wimbish GH, Kupiec TC. Stabillity of admixture containing morphine sulfate, bupivacaine hydrochloride, and clonidine hydrochloride in an implantable infusion system. J Pain Symptom Manag. 2004;28(6):603–11.
Bianchi F, Ginggen A, Tardy Y. Stability and compatibility of drug mixtures in an implantable infusion system. Anaesthesia. 2008;63(9):972–8.
Shields D, Montenegro R, Aclan J. Chemical stability of admixtures combining ziconotide with baclofen during simulated intrathecal administration. Neuromodulation. 2007;10(Suppl 1):12–7.
Shields D, Montenegro R, Ragusa M. Chemicalstability of admixtures combining ziconotide with morphine or hydromorphone during simulated intrathecal administration. Neuromodulation. 2005;8(4):257–63.
Shields D, Montenegro R, Aclan J. Chemicalstability of an admixture combining ziconotide and bupivacaine during simulated intrathecal administration. Neuromodulation. 2007;10(Suppl 1):1–5.
Shields D, Montenegro R. Chemical stability of ziconotide – clonidine hydrochloride admixtures with and without morphine sulfate during simulated intrathecal administration. Neuromodulation. 2007;10(Suppl 1):6–11.
http://www.newsweek.com/2015/04/24/inside-one-most-murderous-corporate-crimes-us-history-322665.html.
Gupta N, Hocevar SN, Moulton-Meissner HA, et al. Outbreak of Serratia marcescens blood stream infections in patients receiving parenteral nutrition prepared by a compounding pharmacy. Clin Infect Dis. 2014;59:1–8.
Judge: victims in Massachusetts compounding scandal can sue health providers. Boston Business J. 2013
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2023 Springer Nature Switzerland AG
About this chapter
Cite this chapter
Stuart, W.A. (2023). Compounding for Intrathecal Targeted Drug Delivery: A Comprehensive Guide. In: Yaksh, T., Hayek, S. (eds) Neuraxial Therapeutics. Springer, Cham. https://doi.org/10.1007/978-3-031-39558-1_15
Download citation
DOI: https://doi.org/10.1007/978-3-031-39558-1_15
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-031-39557-4
Online ISBN: 978-3-031-39558-1
eBook Packages: MedicineMedicine (R0)