Ensuring Safety of Anticoagulation Therapy

Ensuring Safety of Anticoagulation Therapy Abha Agrawal, MD, FACP Chief Medical Officer Kings County Hospital Clinical Associate Dean SUNY Downstate College of Medicine Brooklyn, NY NYACP Webinar April 29 2011

CME Disclosure Abha Agrawal has no relationships with any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients.

Kings County Hospital Center 650-bed academic tertiary hospital Level-1 1 Trauma Center 26,000 discharges 750,000 clinic visits 130,000 ED visits

NYC HHC Largest municipal health system in the country 11 acute care hospitals >100 diagnostic and treatment centers 7,700 beds 23,000 deliveries 227,000 admissions

Agenda Risks of anticoagulants Safety strategies Using health IT to improve anticoagulation safety Case study 1: Electronic anticoagulation protocol Case study 2: Root cause analysis of a medication error

Balancing the Risk Bleeding Thromboembolism

Problem PE remains the commonest preventable cause of hospital deaths. Many at-risk patients don t t receive VTE prophylaxis (Lancet Jun 2008 ENDORSE study): TOTAL: >68,000 patients Surgical 65% at-risk,, medical 42% at-risk Of at-risk patients Surgical 59% received recommended prophylaxis Medical 40% received recommended prophylaxis

VTE Occurs Despite Prophylaxis NEJM PROTECT Apr 7 2011 study Critically ill patients 3764 patients 1873 in dalteparin arm 5.1% had DVT despite prophylaxis 1.3% had PE 1873 in UFH arm 5.8% had DVT despite prophylaxis 2.3% had PE

Risk of Anticoagulants Disturbing Numbers Ahead!!

Medicare OIG study Nov 2010 780 Medicare beneficiaries discharged in Oct 2008 13.5 %: adverse events Additional 13.5% - temporary harm 44% preventable 1.5% - contributed to their deaths = 15,000 Medicare beneficiaries in a month (based on ~ 1 million in a month)

OIG Medicare Study Infections 15% Medications 31% Surgery / Procedures 26% Ongoing Pt Care 28%

Medicare OIG Study (Contd.) Medication events 31% = 40 Excessive bleeding - 12 Delirium or change in mental status - 7 Hypoglycemic event 6 Acute renal insufficiency 4 Severe hypotension 4 Respiratory complications 4 Severe allergic reactions - 3

OIG Medicare Study 12 deaths 7 Meds Related 5 ACs Other 5 2 blood stream infection 2 aspiration 1 VAP Other 2 Hypoglycemic episodes

Drivers

Drivers ISMP: 3 of 14 high alert meds are anticoagulants AHRQ 2011: AC safety as 1 of 11 high impact interventions Leapfrog safety objective #18: march 2006 NPSG: 2011: goal: #3 AC included in IHI 5 million lives campaign

Joint Commission Sentinel Events Sentinel Events Alert #41: 2008 Anticoagulants: One of the 5 drugs associated with patient safety incidents. MEDMARX database: 2001-2006 2006 59,316 anticoagulants related errors reported 60% reached the patient 3% led to harm or death Performance error (e.g. administration is the most common cause of error).

Risk of Anticoagulants Hemorrhagic complications IV UFH: <3% Risk increases with increased dosage and age >70 years LMWH: less major bleeding than UFH Thrombolytic therapy increases the risk of major bleeding 1.5 3X in patients receiving AC therapy Chest 2008: ACCP Guidelines

Why anticoagulants are high risk meds? Narrow therapeutic range Interaction with many common foods and medications Need frequent and timely lab monitoring Special issues exist in the elderly, including bleeding complications associated with falls Special risks in neonates

Why anticoagulants are high risk meds? (contd.) Lack of standardization for the naming, labeling and packaging of anticoagulants creates confusion. Potentially confusing dosing regimens, newer agents. Special risk during transfers and hand- offs.

Anticoagulants: Risk Points Lack of critical patient information Ht, wt, allergies missing or dated Lab values PT/PTT/INR missing or didn t see Baseline monitoring Concomitant use of other anticoagulants Renal impairment Transfers and hand-offs

Steps in Medication Process Prescribing 39% CPOE / Decision Support Transcription 12% Dispensing 11% Robots / Pyxis machines Administration 38% Bar-coded med admin Bates, BMJ, 2000 Leape et al. JAMA. 1995

What s s in a name? Error Adverse Event Bates DW et al. J Gen Intern Med. 1993

Medication Errors Sharp End Errors = Active Errors Blunt End Errors = Latent Errors Reason, James. Human Error. Cambridge University Press, 1990

Reason s s Swiss Cheese Model

Human versus Systems: Complexity

I don t t want to make the wrong mistake. Yogi Berra

Case Study 1: Electronic Acute Anticoagulation Therapy Protocol Covers UFH, LMWH and Warfarin Integrated into hospital-wide EHR and CPOE Integrated into bar-cod medication administration module for nurses Used in ED and Inpatient all services Hirsh J et al. Chest June 2008. Antithrombotic and thrombolytic therapy. ACCP evidence-based clinical practice guidelines

Electronic AC Therapy Protocol Methodology Corporate-wide AC Committee Jan 2007 Representation from multiple hospitals Included MD, RN, Lab, Pharmacy, IT, Project Management Reviewed literature, recommended dosing guidelines, defined design specifications and workflow integration, beta testing. Nov 2007: pilot at Bellevue Hospital Next ~ 18 months: corporate-wide rollout

Electronic AC Therapy Protocol Objectives Improving adherence to evidence-based AC guidelines Reducing variations in dosing protocols across HHC Improving safety by providing point-of of-care decision support during ordering process Improving communication between physicians, nurses, and pharmacists

Features Dosing recommendations for UFH, LMWH, Warfarin based on evidence-based guidelines Automated ordering of corollary lab orders such as CBC, aptt and platelet count with medication ordering Trend report, built in the order set, summarizing historic anticoagulation medication and pertinent lab ordering from the last 10 calendar days available from the order entry screen

Point-of of-care Decision Support No weight alert Weight consideration alert if >72 hr old Baseline lab warning Platelet warning <100 k or >50% drop Creatinine clearance calculation and warning Embedded mandatory HIT question

Anticoagulation Order Set

UFH Order Set

Heparin bolus order

Rx / Lab Report

Corollary Orders with Heparin

UFH Adjustment Dose

Decision Support Features

Enoxaparin

Fondaparinux order set

Fondaparinux

Fondaparinux To order fondaparinux, patient must have a cr clearance of >= 30 ml/min, determined from the most recent weight and serum creatinine results. If any of these three are missing or not recent, enter or order the appropriate values.

Coumadin

Warfarin Nomogram

Warfarin Nomogram: : Patient s s INR is 1.2

Select therapy day

Day 5 of the Nomogram

Day 6 of the Nomogram

Case Study 2: Medication Error 74 year old man with multisystem illness in MICU develops PE. Started on heparin infusion develops Heparin- induced thrombocytopenia Prescribed correct weight-based dose of Argatroban. Pharmacist dispenses correct IV mixed bag Nurse mistakenly infuses 20X greater dose of the medication. Patient dies of bleeding complications within 12 hours.

Argatroban Order

Label on the IV bag

Kǘbler-Ross Stages: Medication Safety I - Denial II - Anger The data are wrong The data are right, but it s not a problem III - Bargaining The data are right; it s a problem, but it s not my problem IV - Depression It s my problem, but there is nothing I can do about it V - Acceptance I accept the burden of improvement Adapted from Donald Berwick, MD, IHI 2004 Frontiers of Healthcare conference

Knowing is not enough; we must apply. Willing is not enough; we must do. Johann Wolfgang von Goethe.