Evaluation of appropriate heparin titration dose adjustments after implementation of a dose adjustment calculator Jeremy Andis, Pharm.D. PGY-1 Pharmacy Resident HSHS St. Elizabeth’s Hospital O’Fallon, IL
Conflicts of Interest 2 The speaker has no actual or potential conflict of interest in relation to this presentation.
Objectives 3 • Discuss the risk of heparin-related dosing errors • Review a method to standardize heparin utilization to reduce risk of dosing errors
Special Thanks 4 Reina Shimozono, PharmD, BCPS Josh Schmees, PharmD Chris Herndon, PharmD, BCACP, CPE Dawn Dankenbring, PharmD, BCPS Julia Schimmelpfennig, PharmD, MS, BCPS, CDE Paris Smith, PharmD Rachael Albert, PharmD
HSHS St. Elizabeth’s Hospital 5 • O’Fallon, Illinois • Part of a 15 hospital system • Community Teaching hospital – Saint Louis University Family Medicine – Nursing Residency Program – PGY-1 Pharmacy Residency – PGY-2 Pharmacy Informatics Residency • 160 bed hospital – 20 ICU beds – 22 ER beds
Background: Heparin Medication Errors 6 • Classified as a high alert medication by ISMP – More than 17,000 heparin-related errors reported between 2003 and 2007 by USP • Significant amount of resources have been invested in the safe administration of heparin • Advancement in technology has provided medication safety tools designed to reduce errors with heparin use Santell, J. Improving Heparin Safety. 2008 Mar. San Diego, Ca.
Background: Monitoring of Heparin 7 • Required due to significant interpatient variability • HSHS St. Elizabeth’s Hospital utilizes anti-Xa monitoring for heparin infusions • Therapeutic ranges of anti-Xa: – Cardiac: 0.3-0.5 units/mL – Medical: 0.3-0.7 units/mL Smith ML, Wheeler KE. Am J Health Syst Pharm . 2010;67(5):371 ‐ 374.
Background: Heparin Dosing Protocols 8
Background: Heparin Dosing Protocols 9
Background: Heparin Calculator 10 • December 12 th , 2019 - HSHS St. Elizabeth’s Hospital O’Fallon implemented EPIC-integrated heparin dose adjustment calculator • Purpose was to aide nurse-driven heparin rate adjustment protocol in hopes to reduce the number of heparin-related medication errors
Background: Heparin Calculator 11 Calculator during initial start of heparin drip
Background: Heparin Calculator 12 Calculator during adjustment of heparin rate after result of subtherapeutic anti-xa If Anti-Xa result is Bolus with 60 units/kg and increase less than 0.06: heparin drip rate by 300 units/hour.
Background: Heparin Calculator 13 Calculator after result of therapeutic anti-Xa If Anti-Xa NO CHANGE, AT GOAL and REPEAT level result 0.3 - 0.5: in AM unless this is the first level within range, then REPEAT level in 6 hours.
Background: Heparin Calculator 14 Calculator during adjustment of heparin rate after result of supratherapeutic anti-Xa level If Anti-Xa result HOLD heparin drip for one hour, 0.71 - 1.1: REPEAT STAT LEVEL after 1 hour. If Anti-Xa still greater than 0.7, continue to HOLD infusion and REPEAT STAT level every 1 hour. Once level is less than 0.7, RESTART infusion but DECREASE by 200 units/hour.
Background: Medication Error Reporting 15 • Colleagues encouraged to submit an “IRIS” for any actual or potential situations that may affect patient care – IRIS: Incident Risk Information System – Utilizes software provided by RLDatix TM • Just Culture program in place to promote event and feedback reporting
Purpose 16 • Retrospective comparison of two methods to adjust heparin dose titrations based off hospital protocol • Impact: to reduce the number of errors that occur when adjusting the rate of heparin infusions based on institution- specific protocols
Methods: Study Design 17 Design: Pre and post implementation, randomized, retrospective chart review Time period: • Pre: June 11, 2019 to December 11, 2019 • Post: December 13, 2019 to January 31, 2020 Inclusion Criteria – Utilization of a heparin dosing protocol Exclusion Criteria – Age < 18 years – Modification of standard heparin dosing protocol – Three or less heparin anti-Xa levels available Data extracted from EMR data repository: • For patients receiving heparin therapy through a heparin dosing protocol, each anti- Xa level that resulted within the designated time period • Each documented use of the EMR-integrated heparin dosing calculator (post implementation)
Methods: Endpoints 18 Primary Endpoint – Rate of heparin infusion rate adjustment errors that occurred Secondary Endpoints – Inappropriate use of protocol – Number of dose adjustment errors that were formally reported in an IRIS – Inappropriate use of calculator
Methods: Statistical Analysis 19 P-value < 0.05 Nominal Data: Chi-Square Test Per-protocol analysis
Results 20 Sample size: Patients Anti-Xa Levels Pre-Implementation (n) 56 386 Post-Implementation (n) 110 805 Pre-Implementation Post-Implementation Number of Rate Adjustments 205 364 Calculator Use - 464 (64.5%) Anti-Xa Levels per Patient (mean) 6.9 7.4 Total anti-Xa levels per month reviewed 64 402.5 June 236 - July 34 - August 18 - September 59 - October 37 - November 0 - December - 286 January - 519
Results 21 Primary Outcome: Pre-Implementation Post-Implementation P-value (n=205) (n=364) Rate Adjustment Errors, No. (%) 23 (11.2) 32 (8.8) 0.376 n: total number of rate adjustments Post-Implementation Evaluation Calculator (n=258)* No Calculator (n=106)* P-value Rate Adjustment Errors, No. (%) 15 (5.8) 17 (16) 0.005 n: total number of rate adjustments
Results 22 Secondary Outcomes: Pre-Implementation Post-Implementation P-value Inappropriate use of protocol, No. (%) 67 (17.4) 110 (14.9) 0.099 Inappropriate bolus dose, No. (%) 4 (5.1) 32 (17) 0.010 Inappropriate monitoring, No. (%) 37 (9.6) 83 (10.3) 0.758 Pre- Post- Total Implementation Implementation Number of errors formally reported, 36 (20*) 21 15 No. (%) * Compared to the total number of errors involving heparin found during chart review
Results 23 Secondary Outcomes: Calculator Assessment Inappropriate use of calculator, No. (%) 10 (2.1) Baseline anti-Xa entered into calculator with start of heparin 3 (0.6) Initiation of heparin infusion with rate adjustment based on baseline anti-Xa 0 (0) Incorrect anti-Xa entered into calculator 1 (0.2) Input of most recent anti-Xa level after holding period of heparin due to 2 (0.4) supratherapeutic level Failure to decrease heparin rate after holding period 2 (0.4)
Conclusions 24 • No statistically significant difference was seen for the primary outcome of heparin infusion rate adjustment errors when comparing pre and post implementation of the calculator – Difference found when looking at calculator vs no calculator use in the post-implementation group – Less than optimal use of calculator • Statistically significant difference seen in appropriate administration of bolus dose – Worse in post implementation group • Smaller sample size in pre implementation group • All other secondary outcomes showed no statistically significant difference
Discussion 25 • Slight improvement in number of rate adjustment errors – Not statistically significant for primary outcome – Factors that may have affected outcome • Small sample size • Low utilization of calculator • Nurse inexperience with calculator • Calculator expected to improve consistency, but new possibilities of errors present with its use – Low rate of errors with calculator use seen – May be falsely low due to data collection bias and difficulty identifying errors in EMR • Low rate of formal heparin-related error reporting present
Discussion 26 • Overall Limitations: – Data collected soon after implementation of calculator • Possible factor in lower than preferred calculator utilization – Majority of pre-implementation data collected during June – Multiple data collectors – Reliance on EMR documentation – Retrospective study design
Future Directions 27 • Nursing education regarding identified errors when using calculator – Computer-based learning programs – Active promotion of calculator utilization by nurse managers • Adjustments to calculator to reduce risk of identified errors – Additional field asking if the previous dose was held • Further evaluation of pre- and post-implementation of heparin dose adjustment calculator – Comparisons of different facilities in health system – Assessment of clinical outcomes (time in therapeutic range, mortality, rate of adverse event occurrence)
Evaluation of appropriate heparin titration dose adjustments after implementation of a dose adjustment calculator Jeremy Andis, Pharm.D. PGY-1 Pharmacy Resident HSHS St. Elizabeth’s Hospital O’Fallon, IL
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