Transcript Best Practices for Intrathecal Drug Delivery

NANS
16th Annual Meeting
Las Vegas 2012
IDD Best Practices
Kathy Clagg RN ONC
The Center for Pain Relief Tristate
Huntington, WV
Gail McGlothlen APRN MS CNS
Napa 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. (Coffey et al., 2009)
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.
IDD Best Practices Panel
February 2011
Brian Bruel, MD
Houston, TX
Eric Buchser, MD
Morges, Switzerland
David Caraway, MD
Huntington WV
Michael Cousins, MD
Sydney, Australia
Timothy Deer, MD
Charleston WV
Marilyn Jacobs, PhD, PsyD
Los Angeles, CA
Robert Levy, MD, PhD
Chicago, IL
Gail McGlothlen, APRN-BC CNS
Napa, CA
Joshua Prager, MD, MS
Los Angeles, CA
Richard Rauck, MD
Winston Salem, NC
Peter Staats, MD
Shrewsbury, NJ
Lisa Stearns, MD
Scottsdale, AZ
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
IDD Steps
Patient
selection
Trialing
Pump
Implantation
Therapy
management
Starting IT
Meds
Dosing and
medication
adjustments
MRI Studies:
abstinence
syndrome and
other issues
Pump
Refills
Pump
replacement
or restart
Diagnosis of
inadequate
analgesia
Catheter
Revision
or failure
Issues
• Psychosocial
• Co-morbidities
• Obesity/ sleep
apnea
• Appropriate
diagnosis
• Systemic
medications
•Respiratory
depression
• Local
infection
• IT dose
equivalence
•Downward
titration of
systemic
opioid
• Patient
monitoring
• Trialing
procedures
•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
• Pump
complications
•Pocket fills
• Respiratory
depression
• Drug withdrawal
• Catheter
dislodgement or
fracture
• Inflammatory
mass detection
and prevention
• Inflammatory
mass
complications
• Respiratory
depression
• Drug-drug
interactions
• Catheter
dislodgement
or fracture
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)
Initiating IT Meds
ITMS: Respiratory Depression/Arrest
Ziconotide: Confusion/Dizziness
• 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 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
Pump Refills: Respiratory Depression
or Acute Withdrawals due to
Pocket Fill
•
•
•
•
•
•
1992
2000
2004
2011
2011
2012
• 2012
MS Seroma
Wu & Patt
HyCl SQ/extrav.
Frye & Vance
Hy Needle dislodg.
Coyne et al.
Medtronic Medical Device Letter
Cl Unk
Johnson et al.
Cl Uneventful(2)
Perruchoud et al.
Bent needle(1)
Cl Septum damage
Perruchoud et al.
Pump Refills: Respiratory Depression
or Acute Withdrawals due to
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
Pump Refills: Respiratory Depression
or Acute Withdrawals due to
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
Pump Refills: Respiratory Depression
or Acute Withdrawals due to
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)
Pump Refills: Respiratory Depression
or Acute Withdrawals due to
Pocket Fill
reservoir access
port
pump
surface
(Greher, Eichenberger & Gustorff, 2005)
pump
surface
(Napa Pain Institute, 2012)
Pump Refills: Respiratory Depression
or Acute Withdrawals due to
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
Pump Refills: Respiratory Depression
or Acute Withdrawals due to
Pocket Fill
• Opioids
– Respiratory depression
• Clonidine
– Hypertension
• Baclofen
– Sedation/muscle weakness/seizure
• Ziconotide
– Sedation/cardiovascular instability
• Bupivacaine
– Dizziness/tinnitus/seizure/respiratory depression
(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
References
Coffey, 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
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Coyne, P., Hansen, L., Laird, J., Buster, P. & Smith, T. (2004). Massive hydromorphone dose delivered subcutaneously instead of
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Deer, T. (2010). A critical time for practice change in the pain treatment continuum: We need to reconsider the role of pumps in
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Perruchoud, C., Bovy, M., Durrer, A., Rosato, M., Rutschmann, B., Mustaki, J. & Buchser, E. (2012). Severe hypertension following
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