Anticoagulation Safety: Meeting the Challenge of the National Patient Safety Goal 3E Larry Clark, PharmD, MS, BCPS Director of Pharmacy Thomas, McCloskey,

Anticoagulation Safety: Anticoagulation Safety: Meeting the Challenge of the Meeting the Challenge of the National Patient Safety Goal National Patient Safety Goal

3E 3E Larry Clark, PharmD, MS, BCPSLarry Clark, PharmD, MS, BCPS

Director of PharmacyDirector of PharmacyThomas, McCloskey, PharmD, MSThomas, McCloskey, PharmD, MS

Clinical SpecialistClinical Specialist

Objectives of this Presentation

• To describe the implementation expectations of the new National Patient Safety Goal directed at the safe use of anticoagulant medications

• To describe St. Mary’s strategies for planning, design and implementation of our program

• To describe current practices, protocols and guidelines already in place that help meet the new National Patient Safety Goal

• To describe the new guidelines, protocols and order forms associated with the implementation of the program

• To describe the plan for monitoring the program’s performance

2008 National Patient SafetyGoals

• Goal 3 Improve Safety of using medications• One new requirement• Requirement 3E Anticoagulation therapy

– Applicable to hospital and ambulatory settings that provide anticoagulant therapy

– One year phase-in period for planning, development, and testing

– “Milestones” expectations at 3, 6, and 9 months in 2008

– Full implementation January 1, 2009

Requirement 3E ImplementationExpectation Milestones for 2008

April 1, 2008 July 1, 2008 Oct. 1, 2008 Jan 1, 2009

Leadership

assigns

responsibility

for oversight,

coordination of

development

testing,

implementation

of 3E

Work plan in

place that

identifies

adequate

resources,

assigned

accountabilities,

time line for full

implementation

of 3E

Pilot testing

in at least

one clinical

area is under

way

Process fully

implemented

across

organization

Requirement 3E ImplementationExpectations for January 1, 2009

• Defined anticoagulant management program individualized for each patient receiving anticoagulant therapy is implemented

• When available, only oral unit dose and premixed infusions are used to reduce compounding and labeling errors

• When pharmacy services provided, warfarin is dispensed for each patient in accordance with established monitoring procedures


• Use of approved protocols for initiation and maintenance of anticoagulation therapy appropriate to:– Medication used– Condition being treated– Potential for drug interactions

• International Normalized Ratio (INR)– Baseline available for patients started on warfarin– Kept current for use in monitoring and therapy

adjustment for patients receiving warfarin


• When dietary services provided, service is notified of all patients receiving warfarin and responds according to its established food/drug interaction program

• Programmable infusion pumps are used for IV continuous heparin

• Policy addressing baseline and ongoing lab tests required for heparin and low molecular weight heparin therapies is developed and used


• Education regarding anticoagulation therapy is provided to prescribers, staff, patients, families

• Pt/family education includes:– Importance of follow-up monitoring– Compliance issues– Dietary restrictions– Potential for adverse drug reactions and interactions

• Organization evaluates anticoagulation safety practices

Requirements are Expected to Expand

• The intent of 3E is to develop processes which result in safer use of these drugs

• As of 2008, only unfractionated heparin warfarin, and low molecular weight heparins are included in 3E

• It is expected that additional anticoagulants will be added by JCAHO

• Don’t limit your vision to just compliance with the NSPG

Where to Begin?Where to Begin?

• What are the goals of the initiative?– Improve prescribing– Reduce adverse effects– Improve patient outcomes

• Physician champions (Dr’s. Bynum, Dickerson, Lykke)• Determine the scope of services to be provided• What organizational data is available to determine

prioritization?– Adverse event data– Medication error data– Organization-specific sources of risk

Organization needs to assignresponsibility for planning

• Needed to be in place by April, 2008• Multidisciplinary committee was developed• Assessment of organization and external data• Determination of scope• Development of policies, protocols, and

practices• Assigned responsible parties• Establish measurements of performance

Medication Management Process

Selection,Procurement, Storage

Ordering, andTranscribing

Monitoring Administration Preparing & Dispensing

Procurement

• Streamlining of available medications on formulary

• Purchase of unit dose dosage forms when they are available (oral, injection, and admixtures)

• Consider alternate suppliers to avoid look alike packaging

Storage

• Limit concentrations of heparin stored in ADMs and as floorstock

• Consider elimination of heparin flushes for peripheral lines

• Take steps to minimize mix-up of insulin and heparin

Prescribing

• Review consensus guidelines for prescribing of UFH, warfarin and LMWH

• Develop protocols and policies directed at safe use of these agents

• Ensure clinical decision support tools exist for heparin sensitivity/allergy, heparin-LMWH concurrent dosing, availability of lab values

Preparation and Dispensing

• Define the role of the pharmacist in ensuring safe and appropriate use of heparin & warfarin

• Dispense only in unit doses and use premixed heparin

• Develop monitoring forms directed at tracking dose, other medications and outcome measures

Administration

• Use pumps that prevent free flow infusion of heparin (in place)

• Use independent double checks for programming

• Separate heparin and insulin to minimize mix-ups (insulin pens in place)

Monitoring

• Develop a tracking form for managing patients• Develop a policy for initial and ongoing lab tests

required with anticoagulation therapy• Educate patients about food and drug

interactions, signs of bleeding and clot formation• Ensure ready access for professional involved in

monitoring of INR, aPTT, etc• Consider best practices for transition from

inpatient to outpatient care• Inform nutrition services of patients on warfarin

therapy

Planning for PerformanceMeasurement

• Collection of data• What are desired outcomes

– Therapeutic levels– Lack of adverse outcomes

• Bleeding• Medication errors

– Time to therapeutic levels– Time spent in therapeutic– INRs >4-5, other measures of super-therapeutic

levels• Facilitation of data collection

Historical Data - AnticoagulationHistorical Data - Anticoagulation

• Medication Errors & ADRs

• Enoxaparin - one is Harm Category F

Rank Drug Percent

1 Heparin 3.8

2 Cefazolin 3.8

3 Enoxaparin 3.8

4 Vancomycin 2.5

5 Warfarin 2.1

6 Others 84

Historical INR ValuesHistorical INR Values

• For the period 2/13/2008-7/31/2008– 69 INRs in inpatients and outpatients >6– 36 outpatients and 10 inpatients with INRs > 6– At least 6 admissions secondary to

overanticoagulation with warfarin– 5 inpatients overanticoagulated secondary

insufficient monitoring or dose adjustment– 3 patients with drug interactions

MM.8.10Use of data to improve processes:Continuous Process Improvement

• Assess performance data

• Select, based on internal data and external best practices, improvements to make in your organization pertaining to the safe use of anticoagulant medications

• After the change has been made, continue to monitor performance data to ensure that the change was effective

Activities to DateActivities to Date

• Presented to the MEC in January• Assignment of leadership

– Larry Clark– Physicians Recommended by MEC

• P. Oupadia• S. Oupadia• Long• Dickerson• Kelley

• Development of multidisciplinary committee

NSPG 3E: AnticoagulationNSPG 3E: AnticoagulationMeeting the GoalsMeeting the Goals

• Anticoagulation Working Group formed– Active involvement of medical staff (IM, Ortho,

Cardiac Surgery, Hematology, General Surgery)

– Pharmacy, nursing, lab, dietary

• Policies (ordering, monitoring, education)

• Tools (forms, lab changes, software)

• Assessing compliance and quality

Implementation of Defined Implementation of Defined Anticoagulant Management Program to Anticoagulant Management Program to

Individualize CareIndividualize Care

Policy guiding use of anticoagulants in hospital including:

Monitoring of hematology for heparinoidsWarfarin ordering formPharmacist-directed anticoagulation serviceNutrition, nursing, pharmacy roles

Reduce Compounding and Labeling Reduce Compounding and Labeling Errors Using Unit Dose Products and Errors Using Unit Dose Products and

Premixed InfusionsPremixed Infusions

• Insulin dispensed as patient-specific pens• Unit dose oral warfarin in exact dose and supply

extemporaneously-prepared partial doses (e.g., half-tablets) when necessary.

• Brand-name Coumadin or AB rated equiv. dispensed as policy.

• Heparin premixed standard dispensed, use of heparin protocol, minimize the number of heparin concentrations inventoried.

Warfarin is Dispensed in Accordance Warfarin is Dispensed in Accordance with Established Monitoring Procedureswith Established Monitoring Procedures

• Warfarin ordering form and policy specifies laboratory monitoring, defines anticoagulation goal, requires nutrition, pharmacy, and nursing interventions/education, as well as over-anticoagulation algorithm

• Encompasses broad use of warfarin anticoagulation and addresses patient/physician specific needs.

Standardized Standardized Warfarin Ordering Warfarin Ordering

FormForm• Meets NSPG 3E requirement for

anticoagulation monitoring, standardizing dosing parameters, pharmacy, nursing, and nutrition services responsibilities

• Exceeds 8th ACCP guidelines for monitoring

• Includes defined guidance for over-anticoagulation reversal but requires specific physician orders following warfarin dose hold.

• Pharmacist-directed protocol pilot with Hospitalist-service patients Oct.1, 2008, option expands to hospital-wide Jan. 1, 2009

ST. MARY’S HOSPITAL & MEDICAL CENTER 2635 N. 7TH ST. GRAND JUNCTION, CO 81502

ADULT Warfarin Ordering Form MEDS Laboratory monitoring/ Warfarin dose* :

Obtain baseline INR and hemogram for all patients, INR on days 2 and 3, then every 2 days until within range and stable (less than 0.3 INR change between days), then every 5 days unless otherwise specified, weekly hemogram. Contact physician for INR above desired range, or hemoglobin/hematocrit result 10% below baseline.

INR (Anticoagulation) goal/ Indication:

INR monitoring as above, warfarin ____________mg PO Daily INR monitoring as above, warfarin ____________mg PO on _______________ alternating with warfarin ____________mg PO on _______________ Daily INR and daily warfarin dose (contact physician with INR). Begin with warfarin ______mg PO today times one dose. Daily INR until change specified by physician, then as re-ordered or every 5 days. Warfarin dosing per pharmacy-directed protocol. (Refer to policy guiding therapy. Any invasive intervention, surgical procedure, etc. requiring discontinuation of warfarin therapy will automatically discontinue protocol.)

Signature______________________________________________ Date __________ *- All INRs will be obtained with AM lab draws and warfarin doses will be given at 18:00 per policy. Single dose orders for warfarin require daily INR confirmation MAR entry (WARFARIN O mg) on patient profile.

Overanticoagulation protocol and anticoagulation reversal will be initiated as described (unless specified otherwise below):

INR greater than 3.5 and less than 5, no signs of bleeding: hold warfarin dose and obtain new dose order. Obtain INR daily until inter-day INR change less than 0.3, then resume INR every 5 days.

INR greater than or equal to 5 but less than 9 with no significant bleeding: hold warfarin dose, contact physician to obtain new warfarin order, INR daily until within therapeutic range, then resume INR every 5 days. Contact physician and obtain order for vitamin K1 as indicated. (Consideration of 1 or 2.5 mg PO x 1 dose.)

INR greater than or equal to 9 with no significant bleeding, hold warfarin, contact physician and obtain dose order for vitamin K1 2.5 or 5 mg orally. (If INR is not significantly improved in 24 hours, additional vitamin K can be given.)

INR greater than 20, obtain repeat INR STAT. If repeat INR confirmed greater than 20, or serious bleeding regardless of the INR, hold warfarin, contact physician immediately and obtain order to give vitamin K1 10 mg by slow IV infusion and for additional orders regarding administration of fresh frozen plasma, and consideration of alternatives.

If a patient has life-threatening bleeding and any elevation of INR, hold warfarin, contact physician immediately and obtain order to give vitamin K1 10 mg by slow IV infusion, supplemented with FFP. Contact physician immediately for orders regarding administration of fresh frozen plasma, consideration of alternatives, and repeat INR.

Contact physician for INR greater than (>) 5 or for significant bleeding.

Nursing, Pharmacy and Nutrition Services:

1.5-2.2 Orthopedic indication (total knee replacement, hip replacement) only. 2-3 Atrial fibrillation, aortic valve replacement (mechanical), VTE, PE, other 2.5-3.5 Mitral valve replacement (mechanical), mitral valve repair, other Other_____ Specify indication:

Use Approved Protocols for Initiation and Maintenance Use Approved Protocols for Initiation and Maintenance Appropriate to the Condition Treated and Potential for Appropriate to the Condition Treated and Potential for

Drug InteractionsDrug Interactions

Warfarin and heparin infusion order forms requirements (monitoring, drug-interactions)

Nursing validation of INR prior to warfarin administration

Coag Clinic® software utilized by outpatient coagulation clinic and potentially in a pharmacist-directed protocol

Baseline & Current INR is Available and Baseline & Current INR is Available and Used to Monitor TherapyUsed to Monitor Therapy

Warfarin order form meets requirementArgatroban order form defines INR monitoring Outpatient coagulation clinic and pharmacist-

directed protocol will be required to meet the standard

Dietary (nutrition) Services is Notified of Dietary (nutrition) Services is Notified of all Patients Receiving Warfarinall Patients Receiving Warfarin

• Warfarin order form triggers Nutrition Services consult for education (food/drug-interaction pamphlet, dietary evaluation

• Meditech report of warfarin orders sent to Nutrition Services to capture all patients on warfarin.

When heparin is administered intravenously and continuously, the organization uses programmable infusion pumpsPolicy has been updated to reflect existing practice

standard.

The organization has a policy that addresses baseline and ongoing lab tests…required for heparin and LMW heparin therapiesHeparin/LMWH monitoring form defines hematologic

parameters to be monitored during therapy.Heparin infusion orders describe anti-Xa/heparin level

monitoring.

NSPG 3E-Meeting the GoalsNSPG 3E-Meeting the Goals

Heparin/LMWH monitoringHeparin/LMWH monitoring• Provisional approval of an

heparin/LMWH monitoring order by P&T Committee

• Meets/exceeds recommendation of 8th ACCP guidelines for monitoring

• Future intent to adopt as a “standard of care” within institution whenever heparinoid therapy administered

ORD

HEPARIN and LOW MOLECULAR WEIGHT HEPARIN MONITORING ORDERS

DATE HOUR Use Ball Point - Press Firmly - You Are Making Multiple Copies Page 1

ATTENDING PHYSICIAN: PRIMARY CARE PHYSICIAN:

Consultant(s): ALLERGIES:

Working Diagnosis:

Monitoring of hemogram is required for all heparin (including heparin flushes in the post-operative patient) and enoxaparin therapy.

Upon initiation of unfractionated heparin or low molecular-weight heparin (enoxaparin/Lovenox) therapy, obtain laboratory values as below:

1. Baseline hemogram (if not obtained or available 48 hours prior to heparin/enoxaparin

order)

2. Hemogram on day 2, 3, 5, 7, 9, 11, 13 and once weekly thereafter or until heparin or low-molecular weight heparin is discontinued.

3. Laboratory will indicate platelet counts of below 100,000 or decreased more than

50% of baseline as “ABNORMAL” or “LOW” on the laboratory reporting form.

Laboratory personnel will contact the physician and nurse for any resulting

platelet count below 30,000

Exclusions from monitoring requirement: Medical patients receiving only unfractionated heparin IV catheter flushes without exposure to unfractionated heparin within the last 100 days or, Medical or Obstetric patients receiving low molecular weight heparin therapy for prophylaxis of venous thromboembolism without exposure to unfractionated heparin within the last 100 days.

PHYSICIAN______________________________________DATE_________TIME________ DO NOT WRITE BELOW THIS LINE


• The organization provides education regarding anticoagulation therapy to prescribers, staff, patients, and family members.

• Patient/family education includes the importance of monitoring, compliance, dietary restrictions, and potential for adverse reactions and drug interactions.

Logicare® software will be implemented for this function. Nursing is to continue providing the information, supplemented by an increased pharmacist presence for education.

Use of informational tools for outpatients through Coag Clinic® software. Continuing education for nursing staff, physicians (through Grand

Rounds presentations, newsletters, etc.). Pharmacists’ requirement for anticoagulation training/certification.

The Organization Evaluates The Organization Evaluates Anticoagulation Safety PracticesAnticoagulation Safety Practices

FMEA scheduled for completion by 2008Retrospective chart review and DUE

proposed for mid-2009Prospective performance review and analysis

of pharmacist-directed anticoagulation protocol

Anticoagulation Working Group recommendations as they are formulated


• JCHAO requires compliance:– Pilot program in place by October 1, 2008– Full institutional compliance by Jan. 1, 2009

• Multidisciplinary approach

• Meet physician needs

• Patient safety and improved care are the ultimate goal.

Documents

Anticoagulation Safety: Meeting the Challenge of the National Patient Safety Goal 3E Larry Clark, PharmD, MS, BCPS Director of Pharmacy Thomas, McCloskey,