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DESCRIPTIONNANS 16 th 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 - PowerPoint PPT Presentation
Best Practices for Intrathecal Drug Delivery
IDD Best Practices
NANS16th Annual MeetingLas Vegas 2012Kathy Clagg RN ONCThe Center for Pain Relief TristateHuntington, WVGail McGlothlen APRN MS CNSNapa Pain InstituteNapa, CAIntroduction 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, CARobert 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, AZIDD Best Practices PanelFebruary 2011Goal: Improve Clinical PracticeObjectives:Identify Key IDD Safety Issues along the Clinical Care ContinuumReview IDD Best Practices Panel RecommendationsDiscuss Strategies to Integrate Recommendations into Clinical Practice
Patient selectionTrialingPump ImplantationStarting IT MedsTherapy management Respiratory depression Local infection IT dose equivalenceDownward titration of systemic opioid Patient monitoring Trialing proceduresIDD Steps Issues Dosing and medication adjustments Psychosocial Co-morbidities Obesity/ sleep apnea Appropriate diagnosis Systemic medications Pump replacement or restart Diagnosis of inadequate analgesiaRespiratory depression Local infection Potential drug-drug interactions with anesthesia Pump and catheter placementPump programming Current systemic meds IT dose equivalence and conversion Respiratory depression Respiratory arrest Ziconotide SEs 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 complicationsPocket fillsPump Refills Catheter Revision or failure Respiratory depression Drug-drug interactions Catheter dislodgement or fractureMRI Studies: abstinence syndrome and other issuesPrager, J. Identify Key IDD Safety Issues along the Clinical Care Continuum Inadequate MonitoringDosing ErrorsSynergism with Concomitant Systemic DrugsReservoir Refills and Pocket FillsIDD Trialing: Inadequate Monitoring and Dosing DecisionsRecommendations:Patients considered for IDD should have a trialSingle-Shot trials not considered Best Practice Observed in a monitored environment during the course of the trialIntegration:Co-morbidities should be well controlled prior to the trial: coag statusReview the patients daily morphine equivalent with the physicianPatients with OSA should bring their equipment to the trialAppropriate monitoringPatients with cancer pain may forego a trial prior to implant
7Pump Implant: Inadequate Monitoring, Dosing, Concentration Errors & InfectionRecommendations:Pumps must be implanted and managed by Physicians trained and skilled in IDD therapy with working knowledge of:Pump mechanics PharmacotherapyPump programmingOvernight observation for initiation of opioids or baclofenStart low and go slowOpioid conversion tables not appropriate for determining doseClinicians must practice vigilance and well-established aseptic tech to prevent SSI
Pump Implant: Inadequate Monitoring, Dosing, Concentration Errors & InfectionIntegrationPre-op R/O infection: check urine & CBC, toenails and skin foldsReview CDC guidelines for the prevention of SSIStabilize coag statusIf anti-coagulated check with hematologistReview ASRA guidelines for the anti-coagulated patientCommunicate with Physician patients daily morphine equivConsider drug concentration that allows for low dosingPost-opOvernight observationSterile dressing change (CDC, 1999)
Recommendations:Overnight observationPhysician personally oversees initial programmingStart low and go slow for both opioids & ziconotideStart ziconotide at 0.5mcg/d and titrate q 1-2 weeksOpioid conversion tables inappropriate for IT opioidsEliminate 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/ArrestZiconotide: Confusion/dizziness Integration:Patient and Family TeachingSigns and symptoms of overmedication, including sleepiness and confusionImportance of reporting all medications to provider at each visitKeeping all appts for F/U and pump reservoir refillsAlert radiologist to pump when undergoing MRINo alcohol is the only safe alcohol with IT and systemic opioidsTitrating doses in F/UPTM dosing total approximately 20-30% of daily IT opioid doseBe absolutely sure of all programmingMinimize synergistic drugs
Change in Device Status: Respiratory Depression RecommendationsOvernight observation for all patients with:New intrathecal deviceReplacement of pump or pump pocket revision requiring discontinuation/re-initiation of therapy Catheter failure requiring discontinuation/re-initiation of therapyReplacement of pump with baclofen-filled reservoir for withdrawal or overdose Pumps should be replaced at or before the 6mos ERINot necessary to replace a functioning catheter
Change in Device Status: Respiratory DepressionIntegrationFor prolonged therapy interruption restart infusion at lower doseConverting from Ziconotide to ITMS should require overnight observation:Refill/reprogramming that accounts for the old drug in the pump tubing and external catheterTime of drug onset Perform meticulous reprogrammingMonitor pump status with each refill noting ERI and start preparations for pump replacement before 6mosConsider catheter evaluation and granuloma screening prior to scheduled pump replacement
Programming: Respiratory Depression as a Result of Programming ErrorsRecommendations:Expertise in pump construction, functioning, and precise programming.Meticulous programming and dosage calculationsInitial programming (time of implant)Timing of onset of drug effect is delayed if no priming bolus programmedDelayed respiratory depression can occur at 18-24 hrs after initiation of therapyPhysician personally oversees initial programmingChanging drug concentrationsAwareness that inner pump tubing is inaccessibleAccounting for pump and catheter volumes filled with old concentrationCalculate and program bridge boluses accuratelyProgramming: Respiratory Depression as a Result of Programming ErrorsIntegration:Read technical manual. Request training from your local rep. Understand and practice the math!For technical questions, call manufacturers 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 ChangeRecommendations:Patients and family members should report to managing physician or provider:Addition of CNS depressants because this class can alter a stable patients response to IT therapies New co-morbidities as these may change drug requirementsAny change in neurologic status including new somnolence or dementiaPatient Status Changes: Respiratory Depression from Medication Synergism or Health Status ChangeIntegrationEvaluate for any cognitive changes Review medication list every visitPoly-pharmacy: evaluate for drugs that compete with same metabolic pathways or potentiate CNS depressionAsk if there have been any changes in their health since last visitAsk about all OTC drugs especially aspirin containing compoundsAsk about alcohol useConsider UDT /State prescription monitoring programs to verify medication compliance & safety
Inadequate Analgesia: Respiratory Depression/Drug Withdrawal due to Catheter Mal-position, Fracture or Inflammatory MassRecommendations:Catheter tip placed in the Lumbar thecal sac below conusPA/Lat XR, cath eval via sideport for performance of myelogramAll patients should be routinely monitored for prodromal clinical s/s of inflammatory massITMS use the lowest dose possible for the longest time possibleAvoid highly concentrated solutionsAll patients with IDD need to alert the radiologist when undergoing an MRI and follow manufacturers recommendationsInadequate Analgesia: Respiratory Depression, Drug Withdrawal due to Catheter Mal-position, Fracture or Inflammatory MassIntegration: ThinkProgramming error- check the most recent printoutCatheter mal-position or fracture-order catheter evalGranuloma-screening protocol including focused neuro examAnticipate urgent catheter revision for patients on ITBInstruct patients to have their pump read following MRI to assure motor stall recovery occurredMissed refill appointment
Pump Refills: Respiratory D