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

2. 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

3. 2008 National Patient Safety Goals 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

4. Requirement 3E Implementation Expectation Milestones for 2008 April 1, 2008July 1, 2008Oct. 1, 2008Jan 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

5. Requirement 3E Implementation Expectations 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

6. Requirement 3E Implementation Expectations for January 1, 2009 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

7. Requirement 3E Implementation Expectations for January 1, 2009 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

8. Requirement 3E Implementation Expectations for January 1, 2009 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

9. 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

10. 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

11. Organization needs to assign responsibility 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

12. Medication Management Process Selection, Procurement, Storage Ordering, and Transcribing MonitoringAdministration Preparing & Dispensing

13. 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

14. 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

15. 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

16. 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

17. 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)

18. 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

19. Planning for Performance Measurement 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

20. Historical Data - Anticoagulation Medication Errors & ADRs Enoxaparin - one is Harm Category F RankDrugPercent 1Heparin3.8 2Cefazolin3.8 3Enoxaparin3.8 4Vancomycin2.5 5Warfarin2.1 6Others84

21. Historical 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

22. MM.8.10 Use 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

23. Activities 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

24. NSPG 3E: Anticoagulation Meeting 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

25. Implementation of Defined Anticoagulant Management Program to Individualize Care Policy guiding use of anticoagulants in hospital including:  Monitoring of hematology for heparinoids  Warfarin ordering form  Pharmacist-directed anticoagulation service  Nutrition, nursing, pharmacy roles

26. Reduce Compounding and Labeling Errors Using Unit Dose Products and Premixed 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.

27. Warfarin is Dispensed in Accordance with 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.

28. Standardized Warfarin Ordering Form 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

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

30. Baseline & Current INR is Available and Used to Monitor Therapy  Warfarin order form meets requirement  Argatroban order form defines INR monitoring  Outpatient coagulation clinic and pharmacist- directed protocol will be required to meet the standard

31. Dietary (nutrition) Services is Notified of all 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.

32.  When heparin is administered intravenously and continuously, the organization uses programmable infusion pumps  Policy 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 therapies  Heparin/LMWH monitoring form defines hematologic parameters to be monitored during therapy.  Heparin infusion orders describe anti-Xa/heparin level monitoring. NSPG 3E-Meeting the Goals

33. Heparin/LMWH monitoring Provisional approval of an heparin/LMWH monitoring order by P&T Committee Meets/exceeds recommendation of 8 th ACCP guidelines for monitoring Future intent to adopt as a “standard of care” within institution whenever heparinoid therapy administered

34. NSPG 3E-Meeting the Goals 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.

35. The Organization Evaluates Anticoagulation Safety Practices  FMEA scheduled for completion by 2008  Retrospective chart review and DUE proposed for mid-2009  Prospective performance review and analysis of pharmacist-directed anticoagulation protocol  Anticoagulation Working Group recommendations as they are formulated

36. NSPG 3E-Meeting the Goals 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.