About Targeted Drug Delivery
Medtronic Targeted Drug Delivery (also known as intrathecal drug delivery) uses the SynchroMed® II infusion system to manage severe chronic pain, including intractable cancer pain. An implanted pump releases pain-relieving medication through a catheter directly to the intrathecal space surrounding the spinal cord where pain signals travel, interrupting pain signals before they reach the brain.
The ability to target drug delivery enables patients to experience pain relief with a small fraction of an oral medication dose,1 which can help to minimize the uncomfortable and sometimes intolerable side effects (e.g., drowsiness, dizziness, dry mouth, nausea, vomiting and constipation) that often accompany pain medication taken orally.1-6
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.
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.
- Brogan SE. Intrathecal Therapy for the Management of Cancer Pain. Curr Pain Headache Rep. 2006;10: 254-259.
- Gerber HR. Intrathecal morphine for chronic benign pain. Best Pract Res Clin Anaesthesiol. 2003;17: 429-442.
- Nance P, Meythaler J. Intrathecal drug therapy. Phys Med Rehabil Clin N Am. 1999;10:385-401, viii-ix.
- Ruan X. Drug-related side effects of long-term intrathecal morphine therapy. Pain Physician. 2007;10: 357-366.
- Smith TJ, Swainey C, Coyne PJ. Pain management including intrathecal pumps. Curr Pain Headache Rep. 2005;9: 243-248.
- Winkelmuller M, Winkelmuller W. Long-term effects of continuous intrathecal opioid treatment of chronic pain of nonmalignant etiology. J Neurosurg. 1996;85: 458-467.
Indications and Contraindications
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.
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.
According to a 2011 report from the Institute of Medicine, 100 million Americans are in chronic pain.1 If left unattended, pain can stimulate many 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
For 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 nociceptive and/or neuropathic pain. It directs prescribed pain medications to the spinal cord – affecting primarily the presynaptic and postsynaptic receptors in the gelatinosa of the posterior horn of the spinal cord.
Pain medications delivered directly to the intrathecal space through intrathecal drug delivery are particularly effective because they don't circulate systemically to reach the cerebrospinal fluid (CSF). As a result, effective pain relief may be achieved using much smaller doses than are used in orally administered analgesics, thus reducing the frequency of side effects.2
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, as evidenced by U.S. Centers for Disease Control data, which find nearly three out of four prescription drug overdoses are caused by oral pain medications.3 In 2008, these drugs were involved in 14,800 overdose deaths, which were more than cocaine and heroin-related deaths combined.3
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.
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, increasing the chance of misuse, abuse and/or unintentional overdose. Targeted drug delivery also enables physicians to completely hinder the diversion of oral pain medications by tapering patients off of oral opioids and exclusively delivering pain medication intrathecally and using myPTM® to address intermittent breakthrough pain.
Benefits of treating chronic intractable pain with targeted drug delivery include:
- Clinician control of prescribed medication at all times
- Pain relief for patients whose pain has not been controlled with more conservative therapies
- Reduced side effects such as nausea, vomiting, sedation, and constipation1,3
- Decreased need for oral analgesia5
- Increased ability to perform activities of daily living6
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
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 targeted drug delivery systems.
The targeted drug delivery system consists of a programmable pump, an intrathecal catheter, and an external 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.7,8
Infusion of preservative-free morphine sulfate sterile solution directly to the intrathecal space does not have to circulate systematically to reach the opioid receptors at the dorsal horn of the spinal cord. Significantly lower doses may be needed with targeted drug delivery.9
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 is available to manage variable pain by delivering a physician-prescribed bolus dose of medication from the pump. 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.
Patients may benefit by aggressively addressing intractable cancer pain – particularly neuropathic pain – earlier in the treatment continuum with a therapy like targeted drug delivery.
Intrathecal Drug Delivery Therapy for Uncontrolled Cancer Pain(1:46, 26 MB)
Cancer and end-of-life patients often have high opioid requirements, resulting in significant side effects. Dr. David L. Caraway, MD, CEO and Medical Director, Center for Pain Relief, Tri-State St. Mary’s Regional Medical Center, Huntington, WV speaks about intrathecal drug delivery as an option to manage cancer pain with minimal side effects.
- A majority of patients experience pain at some point during their course of cancer treatment, and cancer pain impairs quality of life and functionality3
- 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 life4-6
- Pain interferes with activities of daily living10
By addressing pain sooner, side effects may be reduced, quality of life may be improved, and there may be cost advantages. One cost model showed the break-even point of intrathecal drug delivery of opioids at 3 to 6 months after the start of pain management. At that point it becomes less expensive to administer opioids with an implanted intrathecal pump rather than an epidural external pump.11
- Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Institute of Medicine. June 2011. Accessed 5/8/13.
- Brogan SE. Intrathecal Therapy for the Management of Cancer Pain. Curr Pain Headache Rep. 2006;10:254-259.
- Carr D, Goudas L, Lawrence D, et al. Management of cancer symptoms: pain, depression, and fatigue. Evidence report/technology assessment No. 61 (prepared by the New England Medical Center Evidence-based Practice Center under contract No. 290-97-0019). AHRQ Publication No. 02-E032. Rockville, MD: Agency for Healthcare Research and Quality. July 2002.
- 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.
- 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(6):399-408.
- Lamer TJ. Treatment of cancer-related pain: When orally administered medications fail. Mayo Clinical Proc 1994;69:473-80.
- Levy, R. Implanted Drug Delivery Systems for Control of Chronic Pain. Chapter 19 of Neurosurgical Management of Pain. New York, NY: Springer-Verlag; 1997.
- Krames ES. Intraspinal opioid therapy for chronic nonmalignant pain: current practice and clinical guidelines. J Pain Sympt Manage. 1996;11:333-352.
- Mystakidou K, Tsilika E, Parpa E, et al.: Psychological distress of patients with advanced cancer: influence and contribution of pain severity and pain interference. Cancer Nurs. Sep-Oct 2006;29(5):400-5.
- Hassenbusch SJ. Cost modeling for alternate routes of administration of opioids for cancer pain. Oncol. May 1999;13(5 suppl 2):63-7.