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IDD Best Practices

NANS16th Annual Meeting

Las Vegas 2012

Kathy Clagg RN ONCThe Center for Pain Relief Tristate

Huntington, WV

Gail McGlothlen APRN MS CNSNapa Pain Institute

Napa, CA

Introduction In early 2006, Medtronic received an increase in the rate of spontaneous reports of patient death within 3 days of implant and initiation of intrathecal drug therapy. From 1998-2007 a total of 88 patients died within 3 days of pump implant, refill, replacement, reprogramming, dose change or catheter revision. An investigation identified multiple factors which contributed to the adverse events; device malfunction was not the cause of these adverse events.

Problem: Patients receiving IT morphine for non-cancer pain experience a higher mortality rate.

Significance: Most deaths were preventable.

Action: Identify & mitigate contributing factors that resulted in patient deaths to improve the safety of IT morphine.

(Coffey et al., 2009)

Brian Bruel, MD Houston, TXEric Buchser, MD Morges, SwitzerlandDavid Caraway, MD Huntington WVMichael Cousins, MD Sydney, AustraliaTimothy Deer, MD Charleston WVMarilyn Jacobs, PhD, PsyD Los Angeles, CA

Robert Levy, MD, PhD Chicago, ILGail McGlothlen, APRN-BC CNS Napa, CAJoshua Prager, MD, MS Los Angeles, CA Richard Rauck, MD Winston Salem, NC Peter Staats, MD Shrewsbury, NJLisa Stearns, MD Scottsdale, AZ

IDD Best Practices PanelFebruary 2011

Goal: Improve Clinical Practice

Objectives:• Identify Key IDD Safety Issues along the

Clinical Care Continuum• Review IDD Best Practices Panel

Recommendations• Discuss Strategies to Integrate

Recommendations into Clinical Practice

Patient selection Trialing Pump

ImplantationStarting IT

MedsTherapy

management

•Respiratory depression• Local infection• IT dose equivalence•Downward titration of systemic opioid• Patient monitoring• Trialing procedures

IDD Steps

Issues

Dosing and medication adjustments

• Psychosocial• Co-morbidities• Obesity/ sleep apnea• Appropriate diagnosis• Systemic medications

Pump replacement

or restart

Diagnosis of inadequate analgesia

•Respiratory depression• Local infection• Potential drug-drug interactions with anesthesia• Pump and catheter placement•Pump programming

• Current systemic meds • IT dose equivalence and conversion• Respiratory depression • Respiratory arrest• Ziconotide SE’s• Hypothalamic pituitary axis suppression

• Respiratory depression • Drug withdrawal• Catheter dislodgement or fracture• Inflammatory mass detection and prevention• Inflammatory mass complications

•Respiratory depression• Drug withdrawal• Pump complications•Pocket fills

Pump Refills

Catheter Revision or failure

• Respiratory depression• Drug-drug interactions• Catheter dislodgement or fracture

MRI Studies: abstinence

syndrome and other issues

Prager, J.

Identify Key IDD Safety Issues along the Clinical Care Continuum

• Inadequate Monitoring• Dosing Errors• Synergism with Concomitant Systemic Drugs• Reservoir Refills and Pocket Fills

IDD Trialing: Inadequate Monitoring and Dosing Decisions

• Recommendations:– Patients considered for IDD should have a trial– Single-Shot trials not considered Best Practice – Observed in a monitored environment during the course of the trial

• Integration:– Co-morbidities should be well controlled prior to the trial: coag

status– Review the patient’s daily morphine equivalent with the physician– Patients with OSA should bring their equipment to the trial– Appropriate monitoring– Patients with cancer pain may forego a trial prior to implant

Pump Implant: Inadequate Monitoring, Dosing, Concentration

Errors & Infection• Recommendations:

– Pumps must be implanted and managed by Physicians trained and skilled in IDD therapy with working knowledge of:• Pump mechanics • Pharmacotherapy• Pump programming

– Overnight observation for initiation of opioids or baclofen• Start low and go slow• Opioid conversion tables not appropriate for determining dose

– Clinicians must practice vigilance and well-established aseptic tech to prevent SSI

Pump Implant: Inadequate Monitoring, Dosing, Concentration

Errors & Infection• Integration

– Pre-op • R/O infection: check urine & CBC, toenails and skin folds

– Review CDC guidelines for the prevention of SSI• Stabilize coag status

– If anti-coagulated check with hematologist– Review ASRA guidelines for the anti-coagulated patient

• Communicate with Physician patient’s daily morphine equiv– Consider drug concentration that allows for low dosing

– Post-op• Overnight observation• Sterile dressing change (CDC, 1999)

• Recommendations:– Overnight observation– Physician personally oversees initial programming– Start low and go slow for both opioids & ziconotide

• Start ziconotide at 0.5mcg/d and titrate q 1-2 weeks• Opioid conversion tables inappropriate for IT opioids

– Eliminate systemic opioids if possible or reduce by 50%– Caution with any CNS acting drugs – Titrate doses cautiously & monitor for efficacy and side effects

Initiating IT MedsITMS: Respiratory Depression/Arrest

Ziconotide: Confusion/Dizziness

Initiating IT Meds ITMS: Respiratory Depression/Arrest

Ziconotide: Confusion/dizziness

• Integration:– Patient and Family Teaching

• Signs and symptoms of overmedication, including sleepiness and confusion• Importance of reporting all medications to provider at each visit• Keeping all appts for F/U and pump reservoir refills• Alert radiologist to pump when undergoing MRI• No alcohol is the only safe alcohol with IT and systemic opioids

– Titrating doses in F/U• PTM dosing total approximately 20-30% of daily IT opioid dose• Be absolutely sure of all programming• Minimize synergistic drugs

Change in Device Status: Respiratory Depression

• Recommendations– Overnight observation for all patients with:• New intrathecal device• Replacement of pump or pump pocket revision

requiring discontinuation/re-initiation of therapy • Catheter failure requiring discontinuation/re-initiation

of therapy• Replacement of pump with baclofen-filled reservoir for

withdrawal or overdose • Pumps should be replaced at or before the 6mos ERI• Not necessary to replace a functioning catheter

Change in Device Status: Respiratory Depression

• Integration– For prolonged therapy interruption restart infusion at lower dose– Converting from Ziconotide to ITMS should require overnight

observation:• Refill/reprogramming that accounts for the old drug in the pump

tubing and external catheter• Time of drug onset

– Perform meticulous reprogramming– Monitor pump status with each refill noting ERI and start

preparations for pump replacement before 6mos– Consider catheter evaluation and granuloma screening prior to

scheduled pump replacement

Programming: Respiratory Depression as a Result of Programming Errors

• Recommendations:– Expertise in pump construction, functioning, and precise programming.– Meticulous programming and dosage calculations– Initial programming (time of implant)

• Timing of onset of drug effect is delayed if no priming bolus programmed• Delayed respiratory depression can occur at 18-24 hrs after initiation of

therapy• Physician personally oversees initial programming

– Changing drug concentrations• Awareness that inner pump tubing is inaccessible• Accounting for pump and catheter volumes filled with old concentration• Calculate and program bridge boluses accurately

Programming: Respiratory Depression as a Result of Programming Errors

• Integration:– Read technical manual. Request training from your local rep.

Understand and practice the math!– For technical questions, call manufacturer’s tech line.– While programming a pump, keep the environment as distraction

free as possible. Do not rush. Check, double-check and triple-check your math and programming!

– With concentration changes, use minimum programmable flow rate to determine lowest dose

– Review the programming printout before allowing the patient to leave.

Patient Status Changes: Respiratory Depression from Medication Synergism

or Health Status Change

• Recommendations:– Patients and family members should report to managing physician or

provider:• Addition of CNS depressants because this class can alter a stable

patient’s response to IT therapies • New co-morbidities as these may change drug requirements• Any change in neurologic status including new somnolence or

dementia

Patient Status Changes: Respiratory Depression from Medication Synergism or

Health Status Change

• Integration– Evaluate for any cognitive changes – Review medication list every visit– Poly-pharmacy: evaluate for drugs that compete with same

metabolic pathways or potentiate CNS depression– Ask if there have been any changes in their health since last visit– Ask about all OTC drugs especially aspirin containing compounds– Ask about alcohol use– Consider UDT /State prescription monitoring programs to verify

medication compliance & safety

Inadequate Analgesia: Respiratory Depression/Drug Withdrawal due to Catheter Mal-position, Fracture or

Inflammatory Mass• Recommendations:

– Catheter tip placed in the Lumbar thecal sac below conus– PA/Lat XR, cath eval via sideport for performance of myelogram– All patients should be routinely monitored for prodromal clinical s/s

of inflammatory mass– ITMS use the lowest dose possible for the longest time possible– Avoid highly concentrated solutions– All patients with IDD need to alert the radiologist when undergoing

an MRI and follow manufacturer’s recommendations

Inadequate Analgesia: Respiratory Depression, Drug Withdrawal due to

Catheter Mal-position, Fracture or Inflammatory Mass

• Integration: Think• Programming error- check the most recent printout• Catheter mal-position or fracture-order catheter eval• Granuloma-screening protocol including focused neuro exam• Anticipate urgent catheter revision for patients on ITB• Instruct patients to have their pump read following MRI to

assure “motor stall recovery occurred”• Missed refill appointment

Pump Refills: Respiratory Depression or Acute Withdrawals due to

Pocket Fill

In May 1996-Sept 2010 Medtronic received 351 reports related to pocket fills:

– 8 patient deaths– 270 were serious or life-threatening– 58 required no medical intervention– 15 events severity unknown


Pocket Fill

• 1992 MS Seroma Wu & Patt

• 2000 HyCl SQ/extrav. Frye & Vance

• 2004 Hy Needle dislodg. Coyne et al.

• 2011 Medtronic Medical Device Letter• 2011 Cl Unk Johnson et al.

• 2012 Cl Uneventful(2) Perruchoud et al.

Bent needle(1)• 2012 Cl Septum damage Perruchoud et al.


Pocket Fill • Recommendations:

– Review S/S overdose, underdose & withdrawal with family– Observe for 30 mins after pump refill– Suspected or Known pocket fill rapidly assess patient

» Confusion» Sedation» Respiratory depression which may require narcan/airway

management» Hypo-Hypertension

– Re-access reservoir port and aspirate contents– Determine pocket fill volume by comparing reservoir contents with

initial injectate volume


Pocket Fill • Integration: Minimizing Risk for Adverse Outcome

from a Pocket Fill– Identify patients at risk – Place the patient in an optimal position– Always have the refill needle perpendicular to the surface of the

pump– Always reposition the refill needle when in doubt – Instruct the patient to report any unusual sensation – Check for passive injectate with PFNS– Monitor patients post-refill for 30 mins– Have a plan should a pocket fill occur


Pocket Fill

• 4 case reports using ultrasound to locate reservoir refill access port (Yang et al., 2012; Shankar, 2009; Hurdle, 2007; Greher, 2005)

• 1 preclinical feasibility study that evaluated real-time ultrasound-guided pump reservoir refill in cadavers– Ability to identify pump versus pocket fill– Results: predictive values equivocal– Easy to master, inverted pump distinctly different

appearance (Gofeld & McQueen, 2011)


Pocket Fill

(Greher, Eichenberger & Gustorff, 2005)

reservoir access port

pump surface

pump surface

(Napa Pain Institute, 2012)


Pocket Fill • Integration: Minimizing Injury from Pocket Fill

– Signs/Symptoms of Pocket Fill:• Sleepy/confused/respiratory depression • Hypertension/hemodynamic instability/confusion • Call for help & initiate emergency plan

– Diagnosis:• Aspirate the reservoir contents and compare with the volume of injectate • Discrepancy indicates a pocket or partial pocket fill and volume/dose

– Treatment:• Be prepared to administer narcan, provide airway management & hemodynamic

monitoring• Transfer patient to appropriate monitored setting and supportive care

• Opioids– Respiratory depression

• Clonidine – Hypertension

• Baclofen– Sedation/muscle weakness/seizure

• Ziconotide– Sedation/cardiovascular instability

• Bupivacaine– Dizziness/tinnitus/seizure/respiratory depression


Pocket Fill

(Johnson, Visser & Goucke, 2011)

IDD Best Practices: Respiratory Depression is the Key Safety Issue

• Deaths from overdose can be prevented • Patient safety and therapy outcomes can be

optimized through: ® Start Low and Go Slow Dosing® Precise Device Programming/Accurate Reservoir

Refilling® Overnight Observation for Device Status Changes® Vigilance in Monitoring for Changes in Patient Status

ReferencesCoffey, R., Owens, M., Broste, S., Dubois, M., Ferrante, F., Schultz, D., Stearns, L. & Turner, M. (2009). Mortality associated with

implantation and management of intrathecal opioid drug infusion systems to treat noncancer pain. Anesthesiology, Vol. 111, No. 4, 881-891.

Coffey, R., Owens, M., Broste, S., Dubois, M., Ferrante, F., Schultz, D., Stearns, L. & Turner, M. (2010). Medical practice perspective: Identification and mitigation of risk factors for mortality associated with intrathecal opioids for non-cancer pain. Pain Medicine, 11, 1001-1009.

Coyne, P., Hansen, L., Laird, J., Buster, P. & Smith, T. (2004). Massive hydromorphone dose delivered subcutaneously instead of intrathecally; Guidelines for prevention and management of opioid, local anesthetic, and clonidine overdose. Journal of Pain and Symptom Management vol 28; 273-276.

Deer, T. (2010). A critical time for practice change in the pain treatment continuum: We need to reconsider the role of pumps in the patient care algorithm. Pain Medicine, 11, 987-989.

Frye, C. & Vance, M. (2000). Hypertensive crisis and myocardial infarction following massive clonidine overdose. Annals of Pharmacotherapy 34: 611-615.

Greher, M., Eichenberger, U. & Gustorff, B. (2005). Sonographic localization of an implanted infusion pump injection port: Another useful application of ultrasound in pain medicine. Anesthesiology 102: 243.

Gofeld, M. & McQueen, C. (2011). Ultrasound-guided intrathecal pump access and prevention of the pocket fill. Pain Medicine 12: 607-611.Hurdle, M. Locketz, A. & Smith, J. (2007). A technique for ultrasound-guided intrathecal drug dellivery system refills. American Journal of

Physical Medicine and Rehabilitation vol. 86, no. 3: 250-251.Johnson, M. Visser, E. & Goucke, C. (2011). Massive clonidine overdose during refill of an implanted drug delivery device for intrathecal

analgesia: A review of inadvertent soft-tissue injection during implantable drug delivery device refills and its management. Pain Meicine 12: 1032-1040

Medtronic. (2011). Medical device correction, important clinical information about pocket fills synchromed ®II and synchromed EL implantable drug pumps.

Perruchoud, C., Bovy, M., Durrer, A., Rosato, M., Rutschmann, B., Mustaki, J. & Buchser, E. (2012). Severe hypertension following accidental clonidine overdose during the refilling of an implanted intrathecal drug delivery system. Neuromodulation 15 (1):31-4.

Perrchoud, C., Bovy, M., Rutschmann, Be., Durrer, A. & Buchser, E. (2012). Silicone septum leakage at the origin of a drug overdose in a patient implanted with an intrathecal pump. Neuromodulation Oct 25. doi: 10.1111/j. ahead of print.

Rathmell, J. & Miller, M. (2009). Death after initiation of intrathecal drug therapy for chronic pain. Anesthesiology, Vol 111, No. 4, 706-708.Shankar, H. (2009). Ultrasound-guided localization of difficult-to-access refill port of the intrathecal pump reservoir. Neuromodulation 12:

215-218.Wu, C. & Patt, R. (1992). Accidental overdose of systemic morphine during intended refill of intrathecal infusion device. Anesthesia &

Analgesia Vol. 75: 130-132.Yang, T., Wang, J., Chiu, J., Lai, C., chan, R. & Lee, S. (2012). Ultrasound-guided refilling of an intrathecal baclofen pump-a case report. Childs

Nervous system . Ahead of print.

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