Updated Guidelines on Intrathecal Therapy for Pain
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The latest issue of Neuromodulation includes an update to the Polyanalgesic Consensus Conference (PACC) guidelines regarding the treatment of pain via intrathecal therapy (IT).1
The first PACC expert panel formed in 2000 to conduct a literature review and create drug selection algorithms for IT. The group has since met every few years to update the review and algorithms and to address emerging relevant issues; the last update was released in 2012.2
"The field has changed in the 5 years since the last the last PACC guidelines were published," said lead author Timothy R. Deer, MD, DABPM, FIPP, a clinical professor of anesthesiology and pain medicine at West Virginia University School of Medicine in Morgantown. "There is new information on safety and efficacy, and the goal of the PACC is to improve patient care by focusing on these issues," he told Neurology Advisor.
For the new update, participants were selected by a panel from the International Neuromodulation Society, which "strives to improve the practice of medicine as it relates to the treatment of chronic pain with technology," according to Dr Deer, who is also president of the organization. Previous PACC panel members received automatic nominations, and the remaining nominations were based on needed areas of expertise.
The authors conducted a literature review and ranked the evidence and strength of related recommendations, and they used consensus opinion to fill gaps in the available data. In addition, they developed algorithms for "intrathecal medication choices to treat nociceptive and neuropathic pain for patients with cancer, terminal illness, and noncancer pain, with either localized or diffuse pain," as described in the publication.
Dr Deer highlighted the following 5 points as ones clinicians may find most helpful in their practice:
- New guidance on dosing, including reduced starting and maintenance dosing;
- New safety precautions for diagnosing and treating complications;
- New insights on trialing to simplify the process;
- New guidance on dramatically reducing or eliminating opioids in those receiving intrathecal medications; and
- New dosing strategies to use conopeptides more effectively to avoid opioids.
Patient Selection Considerations
- Consensus point 6: Increased vigilance during intrathecal opioid therapy is required for patients who have comorbid conditions affecting cardiopulmonary function.
- Consensus point 7: Although localized, diffuse, and global pain can be treated with IT, data supporting IT for global pain treatment are less clear and should be approached with caution.
- Consensus point 8: The PACC advises that IT "should be used at an appropriate time in the algorithm and not as a salvage treatment."
Medication Selection Recommendations and Considerations
- Consensus point 9: Drugs approved by the US Food and Drug Administration (ziconotide and morphine) should be tried initially, unless they are contraindicated, before off-label drug monotherapy or combination therapy are considered. "In cancer pain, the on-label drugs can be used during the trial phase. If the results are not acceptable due to lack of efﬁcacy or side effects, an admixture with bupivacaine or the primary use of fentanyl is supported by our consensus," wrote the authors.
- Consensus point 11: Although the PACC algorithms are based on available evidence and consensus regarding safety, the physician's clinical judgment should guide patient care on an individual basis.
IT in Neuropathic and Nociceptive Pain States
This section notes that "[n]europathic pain generally responds to ziconotide, opioid plus local anesthetic, local anesthetic alone, clonidine plus opioid, and clonidine alone," whereas nociceptive pain "generally responds to opioid, ziconotide, opioid plus local anesthetic, and local anesthetic alone."
- Consensus point 13: When considering drug titration for patients with cancer pain, clinicians should consider the disease stage and survival time.
- Consensus points 14-16: There is strong evidence supporting the efficacy of ziconotide, and there have been no reported cases of related overdose death or granuloma formation. This should be the first drug selected for noncancer patients unless it is contraindicated.
Recommended Starting Dosages
- Consensus points 17 and 18: Intrathecal opioids and ziconotide should be initiated at the lowest effective dose; if delivered continuously, the dose should be 50% or less of that used in bolus training.
- Consensus point 19: When switching from a single drug to a different one in the algorithm, the primary medication should be weaned and discontinued. Weaning is not necessary with ziconotide and bupivacaine, as they do not carry the risk for withdrawal.
- Consensus point 21: "Medications with signiﬁcant withdrawal syndromes, including clonidine and baclofen, require rescue strategies in the event of abrupt cessation or interruption in intrathecal delivery," the guideline states.
- Consensus points 24 and 25: All noncancer patients receiving IT should undergo a psychological assessment, and counseling and aftercare are recommended when indicated. Although assessment is not required for end-of-life patients, counseling should still be considered.
Educational Requirements for Implanting and/or Managing Intrathecal Drug Delivery System Therapy
- Consensus points 26 and 27: The PACC recommends that physicians in training, nurses, and allied healthcare professionals receive an overview of IT delivery as part of their core training curriculum. In addition, they recommend that "each accredited facility have the ability to evaluate an indwelling implanted device, including pump and catheter system," and that "manufacturers and facilities...collaborate on this important issue with a goal of meeting compliance by the next scheduled PACC in 2019."
- Consensus points 29 and 30: Regardless of primary specialty, physicians offering IT should be supervised in at least 10 implant and/or explant cases. They should also participate in at least 5 cases over the course of 2 years, or receive additional applied certified training, to maintain competency.
- Consensus point 31: Pump management physicians should receive ongoing training that covers current devices approved by the US Food and Drug Administration and devices approved for clinical research, and a national database should be developed "for all intrathecal pump-managing physicians or healthcare professionals as a repository of current pump settings, mediations, efﬁcacy, and side effects," the panel suggested.
Going forward, Dr Deer says research in this area should focus on "new devices to improve safety and new conopeptides and nonopioid drug options."
- Deer TR, Pope JE, Hayek S, et al. The Polyanalgesic Consensus Conference (PACC): recommendations on intrathecal drug infusion systems best practices and guidelines [published online January 2, 2017]. Neuromodulation. doi: 10.1111/ner.12538
- Deer TR, Prager J, Levy R, et al. Polyanalgesic Consensus Conference 2012: recommendations for the management of pain by intrathecal (intraspinal) drug delivery: report of an interdisciplinary expert panel. Neuromodulation. 2012;15:436-464.