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Targeted Drug Delivery

  • Education and Training
  • Efficacy
  • Products and Procedures
  • Reimbursement and Practice Management
  • Indications, Safety, and Warnings
  • About Targeted Drug Delivery

    Details

    Medtronic Targeted Drug Delivery (also known as intrathecal drug delivery) uses the SynchroMed® II infusion system to manage chronic pain, including intractable cancer pain. Unlike oral medications that must be absorbed systemically and cross the blood-brain barrier to reach pain signals, targeted drug delivery interrupts pain pathways at their source in the cerebrospinal fluid and spinal cord. An implanted, programmable pump and catheter release prescribed amounts of pain medication directly into the intrathecal space.

    IDD vs Oral
    View image

    Intrathecal drug delivery enables patients to experience pain relief using a fraction of an oral medication dose,1-3 which can help to minimize the uncomfortable and sometimes intolerable side effects (e.g., drowsiness, dizziness, nausea, vomiting and constipation) that often accompany pain medication taken orally.2-5

    Medtronic Targeted Drug Delivery also can provide pain relief in patients who cannot achieve adequate analgesia even with high doses of oral opioid medications.

    Physician Control of Dosing
    View

    Dr. Caraway: Physician Control of Dosing

    (2:32, 31.1 MB)

    Dr. David L. Caraway explains how targeted drug delivery provides flexible physician-controlled dosing in comparison to systemic delivery, which requires patient compliance.

     

    View more Approaches to Targeted Drug Delivery videos

    This therapy is not for everyone. In addition to risks related to a surgical procedure, and drug related adverse events, pump or catheter problems can cause serious or fatal drug overdose or underdose, and may require corrective surgery. For additional safety information, please refer to Indications, Safety, and Warnings.

    References
    1. Grider JS, Harned ME, Etscheidt MA. Patient selection and outcomes using a low-dose intrathecal opioid trialing method for chronic nonmalignant pain, Pain Physician 2011; 14:343-351.
    2. Hamza M, Doleys D, Wells M, et al. Prospective study of 3-year follow-up of lowdose intrathecal opioids in the management of chronic nonmalignant pain. Pain Med. 2012;13:1304-1313.
    3. Ruan X. Drug-related side effects of long-term intrathecal morphine therapy. Pain Physician. 2007;10:357-366.
    4. Noble M, Treadwell JR, Tregear SJ, et al. Long-term opioid management for chronic noncancer pain. Cochrane Database of Systematic Reviews. 2010, Issue 1.
    5. Smith TJ, Staats PS, Deer T, et al. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002;20:4040-4049.

     

    Indications and Contraindications

    Indications

    Chronic intraspinal (epidural and intrathecal) infusion of Infumorph (preservative-free morphine sulfate sterile solution) in the treatment of chronic intractable pain, chronic intrathecal infusion of Prialt (preservative-free ziconotide sterile solution) for the management of severe chronic pain.


    Contraindications

    When infection is present; when the pump cannot be implanted 2.5 cm or less from the surface of the skin; when body size is not sufficient to accept pump bulk and weight; when contraindications exist relating to the drug; drugs with preservatives.

    Drug formulations with pH less than or equal to 3 are known to damage the SynchroMed® infusion system and are contraindicated.

    Treatment

    According to a 2011 report from the Institute of Medicine, chronic pain affects about 100 million American adults.1 If left unattended, pain can stimulate physiological and emotional reactions that can have detrimental effects on the patient and family. Chronic pain that is not managed may:

    • Cause anxiety and depression
    • Lead to economic hardship
    • Increase stress

    Success in helping patients find relief depends on:

    • Understanding chronic pain and its treatment options
    • Educating patients about chronic pain and available treatments
    • Helping patients develop a treatment plan with realistic goals
    • Knowing when a patient should be referred to a pain management specialist or other medical or surgical specialty

    When more conservative therapies have failed, the cost and risks of managing pain rise. Increasingly, many healthcare providers are employing a multi-modal approach to pain that includes a targeted drug delivery system.

    Treatment Option for Chronic Pain of Malignant and Non-malignant Origin

    For over 20 years, Medtronic has produced innovative, implantable, programmable infusion systems that precisely tailor dosing to meet individual patient needs. Medtronic Targeted Drug Delivery – also known as intrathecal drug delivery – can be used with those who experience chronic pain of malignant and non-malignant origin. The implanted pump and catheter release prescribed amounts of pain -relieving medication in close proximity to receptor sites and ion channels located in the dorsal horn of the spinal cord.

    idd vs oral full

    Intrathecal drug delivery is particularly effective because pain medication is released directly into the cerebrospinal fluid (CSF), with only minimal drug levels circulating in the bloodstream.2 As a result, effective pain relief may be achieved using much smaller doses2-4 than are used in orally administered analgesics, which may lead to fewer or more tolerable systemic side effects.2,4-6

    An Alternate Route of Delivery

    While oral pain medications, such as opioids, are a mainstay in the legitimate treatment of chronic pain, they also are widely misused and abused. Inappropriate use of opioid pain medications is reaching epidemic proportions in the United States where nearly three out of four deaths from prescription drug overdoses are caused by oral pain medications.7

    An Alternate Route of Delivery
    View

    Dr Kim: Advantages of Alternate Route

    (1:01, 12.5 MB)

    Dr. Philip Kim discusses how changing the route of delivery for pain medications can benefit both patients and the community.

     

    View more Approaches to Targeted Drug Delivery videos

    Physicians have little control over how patients use oral pain medication prescriptions. Once patients leave the office, they may take the medications at their own discretion. In addition, those prescription medications can be easily sold, stolen, and shared.

    As an alternate route of delivery for providing pain medication to appropriate patients, Medtronic Targeted Drug Delivery can lead to a lower risk of drug misuse and diversion in contrast to pills, which can be easily diverted or otherwise taken inappropriately. Targeted drug delivery also enables physicians to hinder the diversion of oral pain medications by tapering patients off of oral opioids with the aim of exclusively delivering pain medication intrathecally.3,8 Targeted drug delivery with the optional myPTM® programmer allows patient-activated, bolus dosing of morphine – within physician parameters – to control unpredictable pain, and can result in decreased intake of supplemental oral opioids.9

    Benefits of Targeted Drug Delivery

    Benefits of treating chronic intractable pain with targeted drug delivery include:

    • Effective pain relief4,6,8-13
    • Reduced or eliminated use of oral pain medicines3-4,8-10,14
    • Return-to-work data10
    • Reduced side effects compared to oral medication2,4-6
    • Patient satisfaction9-10,13-16
    • Cost benefits17-18

    View clinical data for targeted drug delivery

    Risks of Targeted Drug Delivery

    Surgical complications are possible and include infection, headache, spinal fluid leak, meningitis, and paralysis. Possible complications include the catheter or pump moving within the body or eroding through the skin which may lead to additional surgery. The catheter could leak, tear, kink, or become disconnected. The pump could stop because it has reached end of service or because of failure of another of the part of the infusion system. Any of these situations may cause symptoms to return and may require additional surgery. Device malfunctions may result in clinically significant overdose or underdose. Acute massive overdose may result in coma or fatality. An inflammatory mass can form at the catheter tip and result in serious neurological impairment, including paralysis. The therapy may not meet the patient’s expectations or may lose effect. Electromagnetic interference (EMI) and magnetic resonance imaging (MRI) may cause patient injury, system damage, operational changes to the pump, and changes in flow rate. See product labeling for more information.

    How Targeted Drug Delivery Works

    The targeted drug delivery system consists of a programmable pump, an intrathecal catheter, and an external clinician programmer. The pump is surgically implanted in the patient’s abdominal area, the catheter tip is inserted in the intrathecal space, and the catheter is connected to the pump. Once implanted, the pump and catheter deliver pain medication directly to the patient’s spinal fluid, where it is most effective.

    The implanted pump and catheter release prescribed amounts of pain -relieving medication in close proximity to receptor sites and ion channels located in the dorsal horn of the spinal cord.

    The intrathecal drug delivery pump can be noninvasively programmed to deliver a range of infusion rates, in a variety of dosing patterns to meet individual patient's needs. A handheld personal therapy manager allows patients to self-administer bolus doses of intrathecal morphine within preset limits. The device gives patients some control and the ability to respond to symptoms at onset.

    Since the introduction of intrathecal drug delivery systems in 1991, more than 150,000 patients worldwide have received a Medtronic intrathecal drug delivery system to treat chronic intractable pain.

     

    Management of Intractable Cancer Pain

    Cancer patients may benefit from targeted drug delivery, an alternate route of delivering pain medication. For example, based on data from a randomized clinical trial, the proportion of subjects who achieved reductions in pain and opioid-related toxicity was greater in patients who received a SynchroMed drug infusion system compared to those who received comprehensive medical management only.6

    Video

    Managing Cancer Pain with Targeted Drug Delivery

    Dr. David Caraway explains the benefits of using targeted drug delivery for managing cancer pain. Dr. Caraway is the former CEO of the Center for Pain Relief, Tri-State, associated with St. Mary’s Medical Center in Huntington, WV.

    Research shows:

    • A majority of patients experience pain at some point during their course of cancer treatment, and cancer pain impairs quality of life and function
    • The cost of inadequate pain control and the related side effects of pain medications is high, both in terms of impaired function and quality of life
    • Pain interferes with activities of daily living

     

    References
    1. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Institute of Medicine. June 2011. Accessed 1/20/15.
    2. Ruan X. Drug-related side effects of long-term intrathecal morphine therapy. Pain Physician. 2007;10:357-366.
    3. Grider JS, Harned ME, Etscheidt MA. Patient selection and outcomes using a low-dose intrathecal opioid trialing method for chronic nonmalignant pain, Pain Physician 2011; 14:343-351.
    4. Hamza M, Doleys D, Wells M, et al. Prospective study of 3-year follow-up of lowdose intrathecal opioids in the management of chronic nonmalignant pain. Pain Med. 2012;13:1304-1313.
    5. Noble M, Treadwell JR, Tregear SJ, et al. Long-term opioid management for chronic noncancer pain. Cochrane Database of Systematic Reviews. 2010, Issue 1.
    6. Smith TJ, Staats PS, Deer T, et al. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002;20(19):4040-4049.
    7. Centers for Disease Control and Prevention1. Health E-Stats. Trends in drug poisoning deaths involving opioid analgesics and heroin: United States 1999-2012. (December 2014) http://www.cdc.gov/nchs/data/hestat/drug_poisoning/drug_poisoning_deaths_1999-2012.pdf.
    8. Atli A, Theodore BR, Turk DC, Loeser JD. Intrathecal opioid therapy for chronic nonmalignant pain: a retrospective cohort study with 3-year follow-up. Pain Med. 2010;11:1010-1016.
    9. Ilias W, le Polain B, Buchser E, Demartini L for the oPTiMa study group. Patient controlled analgesia in chronic pain patients: experience with a new device designed to be used with implanted programable pumps. Pain Pract. 2008;8(3):164-170.
    10. Deer T, Chapple I, Classen A, et al. Intrathecal drug delivery for treatment of chronic low back pain: report from the National Outcomes Registry for Low Back Pain. Pain Med. 2004;5:6–13.
    11. Raphael JH, Duarte RV, Southall JL, Nightingale P, Kitas GD. Randomised, double-blind controlled trial by dose reduction of implanted intrathecal morphine delivery in chronic non-cancer pain. BMJ Open. 2013;3(7):e003061.
    12. Ellis DJ, Dissanayake S, McGuire D, et al. Continuous intrathecal infusion of ziconotide for treatment of chronic malignant and nonmalignant pain over 12 months: a prospective, open-label study. Neuromodulation. 2008;11:40-49.
    13. Rauck RL, Wallace MS, Leong MS, et al. A randomized, double-blind, placebo-controlled study of intrathecal ziconotide in adults with severe chronic pain. J Pain Symptom Manage. 2006;31:393–406.
    14. Roberts LJ, Finch PM, Goucke CR, Price LM. Outcome of intrathecal opioids in chronic non-cancer pain. Eur J Pain. 2001 5:353-361.
    15. Duarte RV, Raphael JH, Sparkes E, Southall JL, LeMarchand K, Ashford RL. Long-term intrathecal drug administration for chronic nonmalignant pain. J Neurosurg Anesthesiol. 2012;24:63-70.
    16. Winkelmüller M, Winkelmüller W. Long-term effects of continuous intrathecal opioid treatment in chronic pain of nonmalignant etiology. J Neurosurg. 1996;85:458-67.
    17. Brogan SE, Winter NB, Abiodum A, Safarpour R. A cost utilization analysis of intrathecal therapy for refractory cancer pain: identifying factors associated with cost benefit. Pain Med. 2013;14:476-486.
    18. Guillemette S, Witzke S, Leier J, Hinnenthal J, Prager JP. Medical cost impact of intrathecal drug delivery for noncancer pain. Pain Med. 2013;14:504-515.

     

    United States