Compounding Drugs for Intrathecal Use

  • Shalini Shah


Choosing the correct intrathecal drug medication or combination of medications has historically been an art of trial and error with some historical perspective. More recently, compounding pharmacies have had increased national scrutiny in safety practices. In this chapter, we will review options for intrathecal drug delivery management, as well as explore guides for compounding sterile preparations, and provide the reader with stability data on common compounded formulations of intrathecal drugs.


Compounding Intrathecal Stability Sterile preparation Safety 


  1. 1.
    Stearns L, Boortz-Marx R, Du Pen S, et al. Intrathecal drug delivery for the management of cancer pain: a multidisciplinary consensus of best clinical practices. J Support Oncol. 2005;3:399–408.PubMedGoogle Scholar
  2. 2.
    Weiss N, North RB, Ohara S, et al. Attenuation of cerebellar tremor with implantation of an intrathecal baclofen pump: the role of gamma-aminobutyric acidergic pathways. Case report. J Neurosurg. 2003;99:768–71.CrossRefGoogle Scholar
  3. 3.
    Ho KM, Ismail H. Use of intrathecal midazolam to improve perioperative analgesia: a meta-analysis. Anaesth Intensive Care. 2008;36:365–73.PubMedGoogle Scholar
  4. 4.
    Yaksh TL, Hassenbusch S, Burchiel K, et al. Inflammatory masses associated with intrathecal drug infusion: a review of preclinical evidence and human data. Pain Med. 2002;3:300–12.CrossRefGoogle Scholar
  5. 5.
    Siddall PJ, Gray M, Rutkowski S, et al. Intrathecal morphine and clonidine in the management of spinal cord injury pain: a case report. Pain. 1994;59:147–8.CrossRefGoogle Scholar
  6. 6.
    Convention USP. 2009; Chapter 797, United States Pharmacopeia/National Formulary 1st ed. US Pharmacopeia; 4139.Google Scholar
  7. 7.
    Kastango E. The ASHP discussion guide for compounding sterile preparations: summary and implementation of USP Chapter 797 2004. ASHP Publishing.Google Scholar
  8. 8.
    Outterson K. Regulating compounding pharmacies after NECC. N Engl J Med. 2012;367:1986–72.Google Scholar
  9. 9.
    Yaksh TL, Horais KA, Tozier NA, et al. Chronically infused intrathecal morphine in dogs. Anesthesiology. 2003;99:174–87.CrossRefGoogle Scholar
  10. 10.
    Deer T, Krames ES, Hassenbusch SJ, et al. Polyanalgesic Consensus Conference 2007: recommendations for the management of pain by intrathecal (Intraspinal) drug delivery: report of an interdisciplinary expert panel. Neuromodulation. 2007;10:300–28.CrossRefGoogle Scholar
  11. 11.
    Hildebrand KR, Elsberry DE, Anderson VC. Stability and compatibility of hydromorphone hydrochloride in an implantable infusion system. J Pain Symptom Manag. 2001;22:1042–7.CrossRefGoogle Scholar
  12. 12.
    Deer TR, Serafini M, Buchser E, et al. Intrathecal bupivacaine for chronic pain: a review of current knowledge. Neuromodulation. 2002;5:196–207.CrossRefGoogle Scholar
  13. 13.
    Trissel L, editor. Trissel’s stability of compounded formulations. 4nd ed. Washington, DC: APHA Publications; 2009.Google Scholar
  14. 14.
    O’Neil M, Smith A, Heckelman P, et al., editors. Merck index. 13th ed. New York: Wiley; 2001.Google Scholar
  15. 15.
    Yeager MP, Colacchio TA, Yu CT, et al. Morphine inhibits spontaneous and cytokine-enhanced natural killer cell cytotoxicity in volunteers. Anesthesiology. 1995;83(3):500–8.CrossRefGoogle Scholar
  16. 16.
    Deer TR, Raso LJ, Coffey RJ, et al. Intrathecal baclofen and catheter tip inflammatory mass lesions (granulomas): a reevaluation of case reports and imaging findings in light of experimental, clinicopathological, and radiological evidence. Pain Med. 2008;9:391–5.CrossRefGoogle Scholar
  17. 17.
    Gradert TL, Baze WB, Satterfield WC, et al. Safety of chronic intrathecal morphine infusion in a sheep model. Anesthesiology. 2003;99:188–98.CrossRefGoogle Scholar
  18. 18.
    Coffey RJ, Burchiel K. Inflammatory mass lesions associated with intrathecal drug infusion catheters: report and observations on 41 patients. Neurosurgery. 2002;50:78–86. discussion 86-77.PubMedGoogle Scholar

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© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Shalini Shah
    • 1
  1. 1.University of California, Irvine, Department of Anesthesiology and Perioperative CareIrvineUSA

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