An Initiative of the Florida Hospital AssociationHospital Improvement Innovation Network
Anticoagulant SafetyA Collaboration with the Florida Society of Health-System Pharmacists
April 9, 2019
FSHP Mission Statement
The Florida Society of Health-System Pharmacists (FSHP) is the professional association of pharmacy practitioners that promotes and supports the continual improvement of pharmaceutical care and the profession of pharmacy as an essential component for the delivery of health care.
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• Adverse Drug Events (ADE)• Catheter-associated Urinary Tract Infections (CAUTI)• Clostridium Difficile Infection (CDI)• Central line-associated Blood Stream Infections (CLABSI)• Hospital-onset MRSA Bacteremia• Injuries from Falls and Immobility• Pressure Ulcers (PrU)• Sepsis• Surgical Site Infections (SSI)• Venous Thromboembolisms (VTE)• Ventilator-Associated Events (VAE/IVAC/PVAP)• Readmissions (12% reduction)• Worker Safety
HIIN Core Topics – Aim is 20% reduction
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Designed to reduce multiple forms of harm with simple, easy-to-accomplish activities that cut across several topics to decrease harm.
Focused on four components:
• SOAP UP: Hardwire Hand Hygiene• GET UP: Mobilize Patients• WAKE UP: Prevent Over-sedation• SCRIPT UP: Optimize Inpatient
Medications
UP Campaign: Spreading Cross Cutting Strategies
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FHA Mission to Care HIIN Website: http://www.fha.org/health-care-issues/quality-and-safety/mtc-hiin/up-campaign.aspx
HIIN Resources & Tools
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FHA Mission to Care HIIN Website: http://www.fha.org/Health-Care-Issues/Quality-and-Safety/mtc-hiin/Focus-Areas/ADE.aspx
Hospital National Patient Safety Goals on Anticoagulation 2019
Nisha Mathew Pharm.D. BCPSPharmacy Clinical CoordinatorCleveland Clinic Martin Health
ObjectivesDiscuss Anti-coagulation Elements of Performance (EP) for NPSG 03.05.01
Describe best practices designed to improve compliance
NPSG.03.05.01Goal
Reduce the likelihood of patient harm associated with the use of anticoagulant therapy
NPGS Update RationaleNew drugs
New oral anticoagulants (NOAC)
Direct Acting Oral anticoagulants (DOAC)
NOAC = DOAC
Comparison Old to NewCharacteristic Warfarin NOACSOnset of action Slow RapidHalf-life Long Short
Drug Food Interactions Yes No
Drug Interactions Many Few
Lab monitoring Yes No
Dosing Variable Fixed based on indication*
Adopted and modified from TJC NPSG webinar April 2, 2019
**NOAC Doses Vary Based on Indication
Effective July 1,2019
Reference: https://www.jointcommission.org/assets/1/6/HAP_DOAC_Prepub_Jul2019.pdfAccessed on 3/7/19
Current EP
Modified EP
Content of new EP Changes
1 7 Use only unit dosed, pre mixed infusions and pre-filled syringes M & R
2 1 Using approved protocols for med selection, dosing, initiation, maintenance, adjustment including Drug-Drug, drug food interactions
C
- 2 EBM & Protocols for bleeding & reversal related to each anticoagulant
NEW
- 3 EBM & Protocols for perioperative management of oral anticoagulants
NEW
3 4 Written policy on baseline & ongoing lab monitoring to adjustanticoagulants
C
4 1 See above C
5 8 For continuous IV heparin, use programmable pumps M & R
6 4 See above C
7 6 Education to patients & families (removed prescribers & staff) on adherence, interactions, monitoring & adverse effects
M & R
8 5 Evaluate safety practices, take action & measure change within a defined time period. Establish process to identify, respond & report ADE outcomes.
M & R
M & R:Moved & Revised; C: Consolidated
Open FDA total reportsWith APIXABAN : 57,088
Reference: Open FDA Dashboard of adverse drug event reports; Accessed at: https://openfda.shinyapps.io/dash/
With RIVAROXABAN : 116,347
Resources• University of Washington Anticoagulation
Excellence Center• Hospital Pharmacy 2016 Chart on
transitioning to & from anticoagulants
Q U E S T I O N S ?
Hospital National Patient Safety Goals:Anticoagulants
Gwenesia Collins, Pharm DExecutive Director of Pharmacy, Laboratory and Respiratory Therapy
Adverse Drug Events Statewide Occurrence Q4 2017 – Q3 2018
Drug Class # of ADEs Beneficiaries Rate per 1,000 Beneficiaries
Anticoagulants 19,164 80,456 238.2
Diabetic Agents 10,933 77,615 140.9
Opioids 3,076 73,236 42
Overall 33,173 189,809 174.8
Data provided by Health Services Advisory Group (HSAG)
Statewide Readmission Rates for Beneficiaries on an Anticoagulant
Quarter 30 day Readmits
Discharges
30 day Readmission Rate
Q4 2016 4,842 22,581 21.4%Q1 2017 5,218 23,694 22.0%Q2 2017 5,001 23,097 21.7%Q3 2017 5,002 22,361 22.4%
Q4 2017 5,216 23,589 22.1%Q1 2018 5,600 25,704 21.8%Q2 2018 5,159 23,914 21.6%Q3 2018 4,818 22,504 21.4%
Data provided by Health Services Advisory Group (HSAG)
Elements of Performance 1EP 1
Use only oral unit-dose products, prefilled syringes, or premixed infusion bags when available
EP 2Use protocols for the initiation and maintenance of anticoagulants
**NOAC Doses Vary Based on Indication
EPIC: Require Indication for NOAC at CPOE
• Allows Pharmacist monitoring
- Scoring point based system- renal based adjustment- Heparin infusion Nursing driven- Warfarin dosing consult service- Daily monitoring of therapeutic
anticoagulants
RX Best
Practice Alerts
Rules fire based on individual patient lab results
Anticoagulants & no CBC in 72 hours
Anticoagulants &Hgb < 8, Plts < 100 K
Heparin infusions
Within 12 hours of start If not therapeutic in 24 hours
EP 3Assess the patient’s baseline coagulation status prior to initiating warfarin and adjust per INR per protocol
EP 3 Peri-operative Management
Protocols
Placement of Surgery Order fires an alertRecommends duration of holding & restarting
anticoagulantsCustomized pop-up in Epic
EP 4
Uses resources for warfarin patientsFood and drug interactions Drug / Drug (warfarin) interactions
EP 5
Use programmable pumps when heparin is administered by IV and continuously
EP 6
Drug Warfarin NOACS UFHLAB INR baseline
INR prior to changeH&H daily
Serum ChemistryTo assess renal functionH&H daily
PTT baseline and q 6 hours x 24 hours then dailyH&H dailyPlatelets daily
A policy to address baseline and ongoing lab tests required for anticoagulants
Policy #21700118: Heparin Dosing Per PharmacyPolicy # 00010504: Anticoagulation Safety Policy
EP 7Provide education to prescribers, staff, patients, and families
• Change in process- Newsletter, EHR tips , sign on message
• Onboarding handout
EP 7
Provide education to prescribers, staff, patients, and families
Patient education requires more effort and should be led by the pharmacy team
Evaluate anticoagulation safety practices, improve practices, and
measure the effectiveness
Changes in New Elements of Performance
• Additions:• Use of protocols and guidelines for
anticoagulation reversal and management of bleeding events related to each anticoagulant medication
• Establish a process to identify, respond to, and report adverse drug events
• Use of protocols and guidelines for perioperative management of all patients on oral anticoagulants
Changes in New Elements of Performance
• Revisions:• “Assess the patient’s baseline
coagulation status prior to initiating warfarin; use current INR to adjust therapy in patients already on warfarin” will be consolidated with EP#6
• “Use resources to manage potential food and drug interactions for patients receiving warfarin” will be consolidated with EP#2
Reference• National Patient Safety Goals Effective January
2019. Jointcommission.org. https://www.jointcommission.org/assets/1/6/NPSG_Chapter_HAP_Jan2019.pdf. Published 2019. Accessed March 5, 2019.
Palm Beach Gardens Medical Center NPSG AnticoagulantsBest Practices
Brian Mayhue, Pharm.DDirector of Pharmacy Services
EP3: The hospital uses approved protocols
and evidence-based practice guidelines for
perioperative management of all patients on
oral anticoagulants.
EP5: The hospital/organization addresses
anticoagulation safety practices through the
following:
Establishing a process to identify, respond to,
and report adverse drug events, including
adverse drug event outcomes.
Evaluating anticoagulation safety practices,
taking actions to improve safety practices, and
measuring the effectiveness of those actions in
a time frame determined by the organization.
• Palm Beach Gardens Medical Center• Adverse Incident (addressing EP3 and EP5)
HPI A patient was scheduled for a debridement at 7am on Tuesday
morning. Pt ordered to receive Eliquis 5mg po BID (10am-10pm). Patient received Eliquis 5mg dose on Monday at 10am. At 1pm a call was made to MD to inform her that the patient
had bleeding at IV site. MD informed nurse that the patient was going to surgery Tues
(nurse was unaware). MD told the nurse to hold the morning dose of Eliquis. Night shift hand-off, nurse to nurse, night shift nurse
questioned why evening dose was not held also. Day nurse stated she spoke with MD already. Patient went to surgery in am to have a simple procedure (20
minute debridement) which turned into a 4 hour deepdebridement. Patient bled and was transferred to higher levelof care ICU post procedure.
• Palm Beach Gardens Medical Center• Results of Adverse Incident
New Process As a result of the adverse event the new process was
implemented hospital wide. All patients going to surgery will have a sheet attached to the
front of the chart (see attachment) As part of the OR “time out” the sheet will be reviewed with the
OR team At that time a determination will be made whether to proceed
with surgery as scheduled The back of the sheet gives guidelines as to when to hold and
when to restart anticoagulant depending on bleeding risk ofsurgery
• Palm Beach Gardens Medical Center• Copy of flyer
Last Dose of ANTICOAGULANT!
YES _____ NO _______
MEDICATION NAME:__________________ DATE:_______________ TIME:____________
PATIENT ID LABEL
Conclusion
• Multidisciplinary team work is needed in order to comply with new elements of performance
• Pharmacists are critical to medication safety success
• No incidents since implementation
Questions?