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?