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16th Annual MeetingLas Vegas 2012IDD Best PracticesKathy Clagg RN ONC Gail McGlothlen APRN MS CNSThe Center for Pain Relief Tristate Napa Pain Institute.Huntington WV Napa CA IntroductionIn early 2006 Medtronic received an increase in the rate ofspontaneous reports of patient death within 3 days of implant andinitiation of intrathecal drug therapy .From 1998 2007 a total of 88 patients died within 3 days ofpump implant refill replacement reprogramming dose change orcatheter revision An investigation identified multiple factors which contributed tothe adverse events device malfunction was not the cause of these.adverse events Coffey et al 2009 Problem Patients receiving IT morphine for non cancer painexperience 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 PanelFebruary 2011Brian Bruel MD Robert Levy MD PhDHouston TX Chicago IL.Eric Buchser MD Gail McGlothlen APRN BC CNSMorges Switzerland Napa CADavid Caraway MD Joshua Prager MD MSHuntington WV Los Angeles CAMichael Cousins MD Richard Rauck MD.Sydney Australia Winston Salem NCTimothy Deer MD Peter Staats MDCharleston WV Shrewsbury NJMarilyn Jacobs PhD PsyD Lisa Stearns MDLos Angeles CA Scottsdale AZ. Goal Improve Clinical PracticeObjectives Identify Key IDD Safety Issues along theClinical Care Continuum Review IDD Best Practices Panel.Recommendations Discuss Strategies to IntegrateRecommendations into Clinical Practice IDD StepsMRI Studies .abstinencePatient Pump Starting IT Therapy syndrome andselection Implantation Meds management other issuesDosing and Pump Diagnosis of Cathetermedication Pump replacement inadequate Revision.adjustments Refills or restart analgesia or failure Respiratory Respiratory Respiratory Psychosocial Current systemic Respiratorydepression depression Respiratory depression Co morbidities Local meds depression. Local IT dose equivalencedepression Drug withdrawal Obesity sleep infection Drug Drug druginfection and conversion Catheterapnea IT dose interactions. Potential Respiratorywithdrawal dislodgement or Appropriate equivalence Pump Catheterdrug drug depression fracturediagnosis Downward complications dislodgement. Systemicinteractions Respiratory arrest Inflammatorytitration of with Pocket fills mass detection or fracturemedications systemic Ziconotide SE sanesthesia Hypothalamic and prevention.opioid Pump and Inflammatory Patient pituitary axiscatheter suppression massmonitoring placement complications Trialing Pump.procedures programmingPrager J Identify Key IDD Safety Issues alongthe Clinical Care Continuum Inadequate Monitoring. Dosing Errors Synergism with Concomitant Systemic Drugs Reservoir Refills and Pocket Fills IDD Trialing Inadequate Monitoringand 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 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 InadequateMonitoring Dosing ConcentrationErrors 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 toprevent SSI Pump Implant Inadequate.Monitoring Dosing ConcentrationErrors 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 ArrestZiconotide 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 MedsITMS Respiratory Depression ArrestZiconotide 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 revisionrequiring discontinuation re initiation of therapy Catheter failure requiring discontinuation re initiationof 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 overnightobservation 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 startpreparations for pump replacement before 6mos. Consider catheter evaluation and granuloma screening prior toscheduled pump replacement Programming Respiratory Depressionas 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. 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 Depressionas 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 distractionfree as possible Do not rush Check double check and triple checkyour math and programming With concentration changes use minimum programmable flow rate.to determine lowest dose Review the programming printout before allowing the patient to Patient Status Changes RespiratoryDepression from Medication Synergismor Health Status Change. Recommendations Patients and family members should report to managing physician or Addition of CNS depressants because this class can alter a stablepatient s response to IT therapies New co morbidities as these may change drug requirements. Any change in neurologic status including new somnolence or Patient Status Changes RespiratoryDepression from Medication Synergism orHealth Status Change Integration. Evaluate for any cognitive changes Review medication list every visit Poly pharmacy evaluate for drugs that compete with samemetabolic 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 verifymedication compliance safety Inadequate Analgesia Respiratory.Depression Drug Withdrawal due toCatheter Mal position Fracture orInflammatory 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 sof 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 undergoingan MRI and follow manufacturer s recommendations Inadequate Analgesia RespiratoryDepression Drug Withdrawal due toCatheter 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 toassure motor stall recovery occurred Missed refill appointment Pump Refills Respiratory Depression or Acute.Withdrawals due toPocket FillIn May 1996 Sept 2010 Medtronic received351 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 AcuteWithdrawals due to.Pocket Fill 1992 MS Seroma Wu Patt 2000 HyCl SQ extrav Frye Vance 2004 HyNeedle dislodg Coyne et al 2011 Medtronic Medical Device Letter. 2011 Cl Unk Johnson et al 2012 Cl Uneventful 2 Perruchoud et al Bent 2012 Cl Septum damage Perruchoud et al Pump Refills Respiratory Depression orAcute 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 airwaymanagement Hypo Hypertension. Re access reservoir port and aspirate contents Determine pocket fill volume by comparing reservoir contents with initialinjectate volume Pump Refills Respiratory Depression orAcute Withdrawals due to.Pocket Fill Integration Minimizing Risk for Adverse Outcomefrom 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 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 orAcute Withdrawals due toPocket 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 timeultrasound guided pump reservoir refill in cadavers Ability to identify pump versus pocket fill. Results predictive values equivocal Easy to master inverted pump distinctly differentappearance Gofeld McQueen 2011 Pump Refills Respiratory Depression orAcute Withdrawals due to.Pocket Fillreservoir accesssurface surface Greher Eichenberger Gustorff 2005 Napa Pain Institute 2012 Pump Refills Respiratory Depression or.Acute Withdrawals due toIn 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.