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Targeted Drug Delivery

  • Education and Training
  • Efficacy
  • Products and Procedures
  • Reimbursement and Practice Management
  • Indications, Safety, and Warnings
  • Patient Selection

    There are many factors critical to the success of intrathecal drug delivery (also known as targeted drug delivery). One of the most important is patient selection.

    Videos

    In the videos below, clinician panel members discuss aspects of Targeted Drug Delivery Best Practices recommendations. These recommendations are described in detail in “Best Practices for Intrathecal Drug Delivery for Pain,” published in Neuromodulation in 2014. Learn about the panel members.

    Additional videos about patient selection can be viewed in the Approaches to Targeted Delivery video library on this website.

    Managing Patient Expectations

    Mutual Agreement on Therapy Goals: David Caraway, M.D., PhD

    The patient may have different expectations of the therapy than the physician. It’s important to have a mutual agreement and understanding of therapy goals for managing chronic pain.

    Unrealistic Patient Expectations: Marilyn Jacobs, PhD, A.B.P.P.

    Chronic pain patients may have unrealistic expectations of what targeted drug delivery can provide to them.

    Establishing Realistic Expectations: Gail McGlothlen, A.P.R.N., M.S., C.N.S.

    It’s important to establish realistic expectations for your patient when initiating therapy. It may take several months for the therapy to stabilize, and patients can get discouraged very easily.

    Patient As Partner: Tim Deer, M.D.

    Patients have responsibilities when they choose to have an intrathecal drug delivery system implanted.

    Psychological Evaluation

    Requirements of the Psychologist: Joshua Prager, M.D., M.S.

    The psychologist who evaluates the patient prior to implant surgery should understand the trial and implant process, the expected outcome, and how the modality works.

    A Psychologist Should Be Part of the Assessment Team: Marilyn Jacobs, PhD, A.B.P.P.

    The Best Practices Consensus Panel unanimously agreed that a psychologist should be part of the team assessing a patient for an intrathecal drug delivery device.

    Why Psychological Evaluation Is Essential: Marilyn Jacobs, PhD, A.B.P.P.

    The perception of pain is influenced by psychological factors relating to emotion and cognitive functioning. Patients who have a co-existing mental disorder, or problems with functionality, will not do as well with this intervention.

    Role of the Psychologist: Marilyn Jacobs, PhD, A.B.P.P.

    The psychologist functions in two ways: conducting the evaluation, and serving as a coach to encourage and motivate the patient to resume functionality.

    Titration for the Trial

    Titrate Cautiously: Peter Staats, M.D., M.B.A.

    For patients undergoing the trial, there is widespread agreement on the need to significantly reduce doses of systemic medications.

    Patient Monitoring During the Trial

    Monitoring Patients Overnight: Lisa Stearns, M.D.

    Any patient who has been on oral opiates is subject to possible respiratory depression and other complications, and it makes sense to monitor the patient overnight during a trial.

    Monitoring Patients At Risk for Respiratory Depression: Lisa Stearns, M.D.

    Dr. Stearns describes patients who may be at risk for respiratory depression during the screening trial.

    Ziconotide: Another Option

    Ziconotide as an Option: Tim Deer, M.D.

    Ziconotide works in a different mechanism than an opioid.

    Psychiatric Risk of Ziconotide Therapy: Marilyn Jacobs, PhD, A.B.P.P.

    If ziconotide is being considered, the patient should be seen for a psychological evaluation and be monitored weekly during escalation of the ziconotide dosage, to make sure that there is no development of severe psychiatric symptomatology.

    Cancer Pain Referral Guidelines

    For many cancer patients, oral analgesics may be adequate; however, those cancer patients with intractable pain who meet any of the criteria listed below may be appropriate for more advanced pain management techniques. Consider referring those patients to a pain management specialist for an evaluation, and to learn about options for chronic pain control using intrathecal opioids. Pending a successful intrathecal morphine trial, a permanent intrathecal catheter and Medtronic SynchroMed® II programmable pump could be implanted for chronic pain control.

    • Symptoms of pain due to advanced stage cancer at presentation, with a minimum life expectancy of >3 months.3,4,9,10
    • Refractory to conventional pain management because of intractable drug adverse effects or unsatisfactory analgesia.3,4,9,10
    • Visual analog scale (VAS) of ≥ 5, despite 200 mg/day of oral morphine or the analgesic equivalent.*3,9,10

      Consider patients on lower doses if opioid side effects are refractory to conservative treatment and severe enough to prevent upward titration. 3,9,10

      *200 mg oral morphine or equivalent was used as enrollment criterion in a pivotal randomized clinical trial published in 20023; and has since been referenced as a criterion in additional clinical studies related to cancer pain and intrathecal drug delivery.9,10
    • Consider early evaluation of intrathecal drug delivery for those with pelvic tumors who may have eventual nerve compression.

    Note: It is important to consider increased assessment and referral vigilance for women,1,2,5,7 minorities,2,3,5-7 and the elderly,2,3,5,6 who have been shown to be at increased risk for inadequate analgesia.


    Contraindications

    Infection; implant depth greater than 2.5 cm below skin; insufficient body size; spinal anomalies; drugs with preservatives, drug contraindications, drug formulations with pH ≤3, use of catheter access port (CAP) kit for refills or of refill kit for catheter access, blood sampling through CAP in vascular applications, use of Personal Therapy Manager to administer opioid to opioid-naïve patients or to administer ziconotide.

    References
    1. Cleeland CS, Gonin R, Hatfield AK, et al. Pain and its treatment in outpatients with metastatic cancer. N Engl J Med. 1994;330:592-596.
    2. Cleeland CS. Undertreatment of cancer pain in elderly patients. JAMA. 1998;279(23):1914-1915.
    3. Smith TJ, Staats PS, Deer T, Stearns LJ, 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.
    4. Stearns L, Boortz-Marx R, Du Pen S, Friehs G, 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.
    5. 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. Downloaded at http://archive.ahrq.gov/downloads/pub/evidence/pdf/cansymp/cansymp.pdf on 03/15/11.
    6. Bernabei R, Gambassi G, Lapane K, Landi F, et al. Management of pain in elderly patients with cancer. JAMA. 1998;279(23):1877-1882.
    7. Cleeland CS, Gonin R, Baez L, Loehrer P, Pandya K. Pain and pain treatment in minority outpatients with metastatic cancer. Ann Intern Med. 1997;127:813-816.
    8. Doleys DM, Olson K. eds. 2007. Psychological assessment and intervention in implantable pain therapies. Medtronic, Inc. Minneapolis, MN.
    9. Smith TJ, Coyne PJ. Implantable drug delivery systems (IDDS) after failure of comprehensive medical management (CMM) can palliate symptoms in the most refractory cancer pain patients. J Pall Med. 2005;8(4):736-742.
    10. Brogan, SE. Intrathecal therapy for the management of cancer pain. Curr Pain Head Rep. 2006;10:253-259.

    Chronic Intractable Pain Guidelines

    Patient selection for the treatment of chronic intractable pain requires a closer examination of criteria. In most cases, a psychological evaluation is indicated to examine factors such as patient expectations, psychosomatic components of the pain, and secondary gain motivation.

    Selection guidelines for patients with chronic intractable pain include:

    • Patient experiences inadequate pain relief and/or intolerable side effects from systemic opioid therapy
    • Patient has objective evidence of pathology
    • Patient obtains psychological clearance
    • Patient has no untreated substance abuse
    • Patient has sufficient body size to accept the bulk and weight of the pump
    • Clear therapy goals and realistic expectations have been established
    • No contraindications to surgery or the therapy exist
    • Patient has a favorable response to the screening test

    Contraindications

    Infection; implant depth greater than 2.5 cm below skin; insufficient body size; spinal anomalies; drugs with preservatives, drug contraindications, drug formulations with pH ≤3, use of catheter access port (CAP) kit for refills or of refill kit for catheter access, blood sampling through CAP in vascular applications, use of Personal Therapy Manager to administer opioid to opioid-naïve patients or to administer ziconotide.

    Patient Assessment

    The key steps involved with patient selection and screening tests are:

    • Review patient selection criteria
    • Qualify the patient
    • Provide patient and caregiver education
    • Conduct the screening test

    Qualify the Patient

    When evaluating a patient with chronic intractable pain for intrathecal drug delivery, there are four primary assessments on which to focus:

    • Pain
    • Functional
    • Psychological
    • Medical and radiographic

    The table below provides a checklist of assessments for use during patient selection for intrathecal drug delivery.

     
    Pain Assessment
    • Complete baseline pain assessment
      Assessment of pain is difficult to standardize. As the pain state changes, the patient's baseline usually changes as well.
    • Review patient's current situation
      For example, is the patient receiving oral, intravenous, or intramuscular opioids without adequate pain relief at reasonable doses? Does the patient have pain relief but with side effects that limit the desired activity level?
    • Obtain supplemental opiate and non-opiate history
    • Assess signs and symptoms
      Consider the intensity, distribution, and impact of pain
    Functional Assessment
    • Obtain patient functional history
      Consider using a questionnaire that inquires into personal care, sleeping, sex life, social life, and mobility
    Psychological Assessment
    • Complete psychological evaluation of patients with chronic intractable pain
    • Establish diagnosis
    • Establish patient has realistic expectations of the therapy, no secondary gain intentions, and no untreated psychological conditions that would be contraindicated for an implantable therapy
    Medical Assessment
    • Evaluate for medical contraindications to surgery
    • Conduct physical examination
    • Evaluate radiographically for patient spinal canal, if indicated

    Early on in the patient evaluation, clinicians should:

    • Obtain patient history and conduct physical examination
    • Assess and document patient’s pain-related symptoms
    • Evaluate other appropriate and less invasive therapies
    • Assess patient motivation and commitment to intrathecal drug delivery therapy

    Reasonable goals for intrathecal drug delivery should be established and documented and may include:

    • Reduction in pain
    • Reduction in use of oral medication and side effects
    • Improved function
    • Improved quality of life
    Setting Patient Goals
    View

    Dr. Caraway: Setting Patient Goals

    (2:28, 30.3 MB)

    Dr. David Caraway optimizes therapy outcomes through setting patient goals and expectations, paired with a psychological exam.

    View more Approaches to Targeted Drug Delivery videos

    Preparing patients for the psychological assessment helps reduce resistance and promote cooperation.8 During the evaluation, clinicians should communicate that the psychological assessment:8

    • Is used to explore contributing factors of the pain and is not intended to prove that the pain is “all in the patient’s head”
    • Will help select the right treatment for managing the pain and related symptoms (e.g. fatigue, depression)
    • Use validated assessment tools

    Especially for chronic intractable pain patients, consider if:

    • Patient will benefit from the pain relief that the pump provides
    • Concurrent behavioral, coping, or other therapies would provide a better outcome

    Clinicians should:

    • Assess existence of significant psychological signs, drug addiction or behavioral problems, and unresolved issues of secondary gain
    • Identify and treat psychological co-morbidities prior to therapy
    • Evaluate patient willingness, understanding, and competency to actively participate in their intrathecal drug delivery therapy
    • Establish a baseline against which to measure improvement

    Patient and caregiver expectations should also be realistic. Candidates for intrathecal drug delivery must:

    • Be able to determine specific, measurable goals and expectations for intrathecal drug delivery
    • Want a decrease in pain and an improvement in the ability to function
    • Understand that pain has multiple components
    • Express realistic expectations about treatment outcomes
    • Be able and willing to participate in therapy and rehabilitation when appropriate

     

    Provide Patient and Caregiver Education

    Patient education is critical to managing patient expectations and the long-term success of intrathecal drug delivery. Education begins at the initial assessment and continues throughout all phases of intrathecal drug delivery. Equally important to the clinical selection of the patient, is the time to allow the patient to make an educated decision concerning his or her therapy.

    The patient, family, and caregiver need to understand the need for commitment to intrathecal drug delivery, including the importance of keeping refill appointments, and reporting unusual or unexpected symptoms. They need to be aware of the signs and symptoms of opioid and sedative drug overdose and be instructed to seek emergency medical assistance when signs or symptoms first appear.

    Patient Education
    View

    Dr. Hatheway: Patient Education

    (1:55, 23.6 MB)

    Dr. John Hatheway explains why educating the patient on targeted drug delivery and opioid taper helps ensure an informed decision.

    View more Approaches to Targeted Drug Delivery videos

    Clinicians should make sure the patient understands:

    • The goal of intrathecal drug delivery is to reduce rather than eliminate pain
    • Resuming activities that the patient cannot currently perform is a good outcome
    • Supportive medical treatment (e.g. adjuvant non-opioid medication) may be required

    Refer to the SynchroMed Programmable Infusion Systems Clinical Reference Guide for detailed information and procedures on patient selection for intrathecal drug delivery. The Patient Education Checklist for Trial, located in the appendix of the Clinical Reference Guide, provides a detailed list of educational topics for use during patient selection for intrathecal drug delivery.

    References
    1. Cleeland CS, Gonin R, Hatfield AK, et al. Pain and its treatment in outpatients with metastatic cancer. N Engl J Med. 1994;330:592-596.
    2. Cleeland CS. Undertreatment of cancer pain in elderly patients. JAMA. 1998;279(23):1914-1915.
    3. Smith TJ, Staats PS, Deer T, Stearns LJ, 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.
    4. Stearns L, Boortz-Marx R, Du Pen S, Friehs G, 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.
    5. 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. Downloaded at http://archive.ahrq.gov/downloads/pub/evidence/pdf/cansymp/cansymp.pdf on 03/15/11.
    6. Bernabei R, Gambassi G, Lapane K, Landi F, et al. Management of pain in elderly patients with cancer. JAMA. 1998;279(23):1877-1882.
    7. Cleeland CS, Gonin R, Baez L, Loehrer P, Pandya K. Pain and pain treatment in minority outpatients with metastatic cancer. Ann Intern Med. 1997;127:813-816.
    8. Doleys DM, Olson K. eds. 2007. Psychological assessment and intervention in implantable pain therapies. Medtronic, Inc. Minneapolis, MN.
    9. Smith TJ, Coyne PJ. Implantable drug delivery systems (IDDS) after failure of comprehensive medical management (CMM) can palliate symptoms in the most refractory cancer pain patients. J Pall Med. 2005;8(4):736-742.
    10. Brogan, SE. Intrathecal therapy for the management of cancer pain. Curr Pain Head Rep. 2006;10:253-259.

    Trial

    A trial is required to assess the effectiveness of intrathecal drug delivery as a treatment option for chronic intractable pain.

    A trial can be performed:1

    • Using epidural or intrathecal administration
    • Using a single bolus injection, multiple bolus injections, or continuous infusion
    • With or without an intraspinal catheter
    Trialing Overview
    View

    Dr. Wellington: Trialing Overview

    (0:49, 10.1 MB)

    Dr. Joshua Wellington describes his trialing method, including site of service, type of dosing, and opioid discontinuation.

     

    View more Approaches to Targeted Drug Delivery videos

    Route of Administration for the Trial

    Morphine can be delivered into either the epidural or intrathecal space of the spine. When the epidural route of administration is used, more time is required for the morphine to cross the dura and reach the dorsal horn in the spinal cord. 

    In contrast, intrathecal morphine binds with opiate receptors in the spinal cord without having to cross the dura. Therefore, intrathecal drug delivery results in faster analgesic action and requires significantly lower doses of morphine to produce the same degree of analgesia as epidural delivery.

    Existing clinical research data do not clearly indicate that one protocol is associated with a better outcome than others. Therefore, the benefits and risks of each possible choice must be weighed.1


    Assessing the Outcome of the Trial

    The following criteria may be used to assess the outcome of the intrathecal drug delivery trial: 

    • Pain Control – Did the trial relieve the patient’s pain?
    • Activities – Did the trial improve the patient’s ability to participate in daily living activities?
    • Medication – Did the need for oral pain medications change during the screening test?

    Refer to the Intrathecal Morphine for Pain Management chapter of the SynchroMed® Programmable Infusion Systems Clinical Reference Guide of the for detailed information and procedures on the patient screening test for intrathecal drug delivery.

    References
    1. Follett KA, Doleys DM. Selection of Candidates for Intrathecal Drug Administration to Treat Chronic Pain: Considerations in Pre-Implantation Trials. Medtronic, Inc. Minneapolis, MN. 2002.

    Tools and Resources

    In the Intrathecal Morphine for Intractable Chronic Pain Management chapter of the SynchroMed® Programmable Infusion Systems Clinical Reference Guide there are several patient selection tools and resources:

    • Patient Education Checklist for Trial
      This detailed checklist of educational topics for use during patient selection for intrathecal drug delivery is found in the appendix of the guide.
    • Patient Selection Information
      Detailed information and procedures on patient selection is included in the Patient Selection and Trials section of the guide.
    • Patient Screening Test
      Detailed information for performing the patient screening test for intrathecal drug delivery is included in the Patient Selection and Trials section of the guide.

    Patient Selection Studies

    Polyanalgesic Consensus Conference-2012: Recommendations on Trialing for Intrathecal (Intraspinal) Drug Delivery: Report of an Interdisciplinary Expert Panel

    "Trialing for intrathecal pump placement is an essential part of the decision-making process in placing a permanent device. In both the United States and the international community, the proper method for trialing is ill defined."

    Deer TR, Prager J, Levy R, Burton A, et. al. Neuromodulation. 2012 Apr 11. doi: 10.1111/j.1525-1403.

    Prospective Study of 3-year Follow-up of Low-dose Intrathecal Opioids in the Management of Chronic Nonmalignant Pain

    "Long-term follow-up with the use of low-dose opioids in intrathecal (IT) drug delivery system (DDS) for the treatment of intractable, severe chronic nonmalignant pain."

    Pain Med. 2012 Oct;13(10):1304-13. doi: 10.1111/j.1526-4637.2012.01451.x. Epub 2012 Jul 30.

    Patient Selection and Outcomes Using a Low-dose Intrathecal Opioid Trialing Method for Chronic Nonmalignant Pain

    "The specific aim of the current study is to report results of patients trialed using a low-dose intrathecal morphine technique in the treatment of chronic noncancer pain."

    Pain Physician. 2011 Jul-Aug;14(4):343-51.

    Consensus Guidelines for the Selection and Implantation of Patients with Noncancer Pain for Intrathecal Drug Delivery

    "Using experience- and knowledge-based expert opinion to systematically evaluate the available evidence, this article provides consensus guidelines aimed at optimizing the selection of patients with noncancer pain for intrathecal therapy."

    Deer TR, Smith HS, Cousins M, et al. Pain Physician. 2010 May-Jun;13(3):E175-E213.

    United States