D20 LOCAL ANTICOAGULATION THERAPY POLICY.docx

DEPARTMENT OF VETERANS AFFAIRS

VETERANS HEALTH ADMINISTRATION

G.V. (SONNY) MONTGOMERY VA MEDICAL CENTER

Medical Center Policy Number: F-119-66 Date: May 10, 2017

Anticoagulation Therapy Monitoring

I. Purpose: The purpose of this policy is to outline the necessary procedures to achieve individualized maximum therapeutic effectiveness for Veterans on anticoagulation therapy at the G.V. (Sonny) Montgomery VA Medical Center and its affiliated Community Based Outpatient Clinics (CBOCs).

II. Policy: Provides protocols and guidelines for monitoring and managing veterans receiving anticoagulation therapy through the G. V. (Sonny) Montgomery VA Medical Center and its affiliated CBOCs. This policy has been established as a means to assure maximum effectiveness of anticoagulation therapy with minimal risk. It is the policy of this Medical Center and the affiliated CBOCs to manage all Veterans on anticoagulation therapy in accordance with the current American College of Chest Physicians Guidelines on Antithrombotic Therapy and prevention of Thrombosis (CHEST) guidelines. For those Veterans whose anticoagulation therapy is managed by a Clinical Pharmacist Specialist, diagnostic evaluation and therapeutic goals are the responsibility of the primary provider and that he/she will alert the Clinical Pharmacist Specialist of any therapeutic consideration outside the scope of this policy.

III. Definitions: None.

IV. Responsibilities:

A. VA Medical Center Director The VA Medical Center Director is responsible for ensuring:

i. A Medical Center policy exists at the Center that meets all required standards. An interprofessional approach should be utilized in accordance with this policy to ensure the safe management of anticoagulation therapy.

ii. The Medical Center has an established anticoagulation management program for management of inpatients and outpatients on anticoagulants.

iii. An Anticoagulation Program Manager has been designated to lead the Medical Center’s anticoagulation management program and has been provided with appropriate time to fulfill these duties consistent with the complexity of the local anticoagulation program.

iv. Adequate staff and resources are allotted for the anticoagulation management program to include anticoagulation providers, nurses, pharmacy technicians, registered dietitian/nutritionists, program administration, and information technology support, as appropriate. This includes ensuring anticoagulation providers have adequate anticoagulation support staff to work at the top of their license and maximize operational efficiency. For an anticoagulation management program to be successful, active leadership and ongoing maintenance is required.

v. The anticoagulation management program has an appropriate staff-to-patient ratio to provide safe and appropriate care.

vi. Competencies specific to anticoagulation management are established for anticoagulation providers and clinical staff directly involved in caring for patients receiving anticoagulation therapy. Competencies, at a minimum, must include knowledge of standard terminology, pharmacology of anticoagulants, monitoring requirements, dose calculations, common side effects, nutrient interactions, and drug to drug interactions associated with anticoagulation therapy.

vii. The Medical Center ensures care is coordinated for traveling patients on anticoagulants in accordance with VHA Handbook 1101.11, Coordinated Care Policy for Traveling Veterans, or subsequent policy issue.

viii. The Medical Center uses programmable infusion pumps for inpatients receiving parenteral anticoagulants, including, but not limited to unfractionated heparin, argatroban, and bivalirudin.

ix. The Medical Center employs standardized, evidence-based, algorithms for the management of patients on anticoagulants.

x. Anticoagulants are included on the Medical Center’s list of high-alert medications.

B. Chief of Staff and Associate Director for Patient Care Services The Chief of Staff and Associate Director for Patient Care Services (ADPCS) are responsible for:

i. Ensuring that a physician is identified as anticoagulation management champion, to be actively involved in defined components of the anticoagulation management program. This champion will serve collaboratively with the pharmacy anticoagulation management champion to advocate for, provide consultation on anticoagulation issues, and support anticoagulation initiatives at the Center level.

ii. Ensuring that all Medical Center policies governing the provision of anticoagulation management are approved by the Clinical Executive Board (CEB). Anticoagulation providers will collaborate in the development of Medical Center guidelines/algorithms for anticoagulants.

iii. Ensuring that clinical staff directly involved in caring for patients receiving anticoagulation therapy (e.g., nurses, clinical pharmacists, pharmacy technicians, registered dietitian/nutritionists, Advanced Practice Registered Nurses (APRN), physician assistants, and physicians) are educated on the importance of anticoagulation safety and its associated risks, as well as the principles of anticoagulation management, as appropriate.

iv. Reviewing quality assurance (QA) information for the Center anticoagulation management program at appropriate and regular intervals through the Pharmacy and Therapeutics (P&T) Committee (or appropriate Center governing body) and CEB, as appropriate.

v. Ensuring the competency of non-pharmacist anticoagulation providers and clinical staff directly involved in caring for patients receiving anticoagulation therapy to include minimum components as outlined in VHA directive 1033.

vi. Ensuring that anticoagulation providers have adequate anticoagulation support staff (e.g., pharmacy technicians or other anticoagulation staff) to maximize operational efficiency.

C. Chief of Medicine

i. Provides oversight for the Inpatient Anticoagulation Services.

ii. Assists Inpatient Clinical Pharmacy Specialists in managing anticoagulation services for complex Veterans.

iii. In conjunction with the Veteran’s primary provider, helps to assess the risk versus benefit of continued anticoagulation therapy, when necessary, in complex Veterans (i.e. compliance problems).

D. Associate Chief of Staff, Primary Care

i. Provides oversight for the Outpatient Anticoagulation Services.

ii. Assists Anticoagulation Clinic Providers in managing complex Veterans.

iii. In conjunction with the Veteran’s primary provider, helps to assess the risk versus benefit of continued anticoagulation therapy, when necessary, in complex Veterans (i.e. compliance problems).

E. Primary Providers

i. Determine if Veteran is a candidate for anticoagulation therapy. For example, if a Veteran requires warfarin, the provider should determine whether the Veteran is able and willing to comply with the requirements of warfarin therapy to help achieve a positive outcome. We recognize that not all Veterans are able or willing to adhere to safe anticoagulation therapy practices.

ii. Order and assess all necessary baseline labs, initiate anticoagulation therapy, if desired, complete a consult to the Anticoagulation Clinic or Inpatient Anticoagulation Service, and coordinate anticoagulation therapy with the Veteran’s other medical treatments and medical conditions. If consulting Anticoagulation Services, the referring provider should communicate any change in clinical status or concurrent medications during anticoagulation therapy that may contribute to clinical decisions.

iii. Assess the continued need for anticoagulation annually or more often when indicated.

iv. Assess the bleeding risk index for Veteran annually or more often when indicated.

v. Discontinue anticoagulation treatment when indicated.

F. Chief, Pharmacy Service The Chief, Pharmacy Service, is responsible for:

i. Ensuring that a clinical pharmacist anticoagulation provider is identified as the pharmacy anticoagulation management champion to be actively involved in defined components of the anticoagulation program at the Center level. This champion may be the anticoagulation program manager and serves to advocate for and support anticoagulation initiatives at the Center.

ii. Assessing the competency of clinical pharmacist anticoagulation providers and pharmacy technicians who serve in the anticoagulation management program to include the minimum components as outlined in VHA Directive 1033.

iii. Ensuring clinical pharmacists that serve as anticoagulation providers have adequate anticoagulation support staff to work at the top of their license and maximize operational efficiency. Tasks that support the duties of the clinical pharmacist may be performed by pharmacy technicians or other anticoagulation support staff to maximize time for clinical pharmacists to perform direct patient care.

iv. Ensuring that only oral unit dose products, pre-filled syringes, or pre-mixed infusion bags for anticoagulants are dispensed for inpatients when these types of products are available.

v. Ensuring that the number of concentrations and quantities of heparin vials stocked in patient care and procedural areas are limited to the minimum needed to meet patient care needs. No multi-dose heparin product more concentrated than 5,000 units per milliliter is stocked without the prior approval of the Chief of Pharmacy.

vi. Ensuring the safe storage of anticoagulants in automated dispensing devices if the Medical Center uses automated dispensing devices to store anticoagulants. If multiple strengths or concentrations of the same anticoagulant are stored in the same automated dispensing device they need to be stored in separate drawers (or single access cubie) and clearly labeled as high alert medications.

G. Associate Chief, Clinical Pharmacy Services

i. Overseeing the proper operation of the Pharmacy Anticoagulation Services by performing the following tasks:

1. Supervising Anticoagulation Program Manager and Clinical Pharmacist Specialists assigned to the Anticoagulation Services, including annual competency evaluation;

2. Assuring that the Clinical Pharmacist Specialists have the appropriate training for prescribing and monitoring of anticoagulant therapy (i.e. warfarin, continuous infusion heparin, low-molecular weight heparins, and argatroban);

3. Assuring Clinical Pharmacist Specialists perform duties within their scope of practice.

H. Anticoagulation Program Manager The Medical Center Anticoagulation Program Manager is responsible for the following functions related to the anticoagulation program at the Center level:

i. Serving as a leader or co-leader and subject matter expert in the oversight, design, implementation, and function of the anticoagulation management program.

ii. Developing Medical Center policy related to use of anticoagulants. This encompasses policies to govern practice within the anticoagulation management program, but may also include policies relating to the use of anticoagulants in other areas (e.g., surgical or specialty areas), as directed by the CEB. A multidisciplinary approach to policy development should be employed to include meeting with all disciplines involved in caring for patients receiving anticoagulants to assist with unified practice and education to patients.

iii. Promoting learning and unifying practice for the anticoagulation management program through activities such as educational initiatives, regular staff meetings, and journal clubs.

iv. Coordinating and reporting quality assurance activities and results for the anticoagulation management program through the P&T Committee (or appropriate Center governing body) and CEB, as appropriate.

v. Coordinating the Medical Center educational program for clinical staff directly involved in caring for patients receiving anticoagulation therapy (e.g. clinical pharmacists, pharmacy technicians, registered dietitians/nutritionists, nurses, APRNs, physician assistants, and physicians).

vi. Ensuring availability of appropriate patient education materials and classes, as applicable.

vii. Assists the Associate Chief, Clinical Pharmacy Services with updating the anticoagulant therapy policies.

I. Anticoagulation Providers The Medical Center anticoagulation providers are responsible for:

i. Managing anticoagulation patients in accordance with Center and VHA policy including, but not limited to, coordination of anticoagulation management for patients transitioning between care settings (e.g., inpatient to outpatient), peri-procedural anticoagulation, and traveling Veterans.

ii. Serving as subject matter experts on anticoagulation management to patients and health care professionals throughout the Center.

iii. Delivering initial and ongoing patient and family education that includes the importance of follow-up monitoring, compliance issues, dietary restrictions, and potential for adverse drug reactions and interactions.

iv. Conducting appropriate and periodic risk-benefit assessments for all patients receiving anticoagulant therapy and communicating recommendations to the original referring provider and/or Patient Aligned Care Team (PACT) provider as appropriate.

v. Performing and/or facilitating the day-to-day operations of the anticoagulation management program.

vi. Reporting, as per local policy, adverse drug events (ADE), close calls, and any unsafe conditions of which they are aware, even though the conditions have not yet resulted in an adverse event or close call to the Center Patient Safety Manager (PSM) in accordance with VHA Directive 1070, Adverse Drug Event Reporting and Monitoring, or subsequent policy issue.

vii. Conduct Veteran assessment at the onset of anticoagulation therapy (or as requested), including assessment of Veteran’s dosage, family history, personal habits/diet, other medications, baseline and current labs, compliance or other factors that may influence anticoagulation management.

viii. Reconcile Veteran’s medications at each evaluation, document this in the Computerized Patient Record System (CPRS), and alert primary provider of any variance with previous documented medications and/or to non-medication issues that may influence anticoagulation management.

ix. Manage and/or monitor Veteran’s anticoagulation therapy via the following means:

4. Review and/or order appropriate laboratory tests for monitoring anticoagulation therapy.

5. Review and/or renew or rewrite CPRS orders for continuing anticoagulation therapy.

6. Make recommendations to or adjust anticoagulation dosage when indicated, using known pharmacodynamics and pharmacokinetic principles or dosing protocols to maintain the Veteran at a safe and effective level of anticoagulation.

7. Screen and assess drug-drug, drug-food, drug-alcohol and drug-disease state interactions, as well as adverse drug effects and Veteran compliance problems at each anticoagulation evaluation.

a. When any of the above interactions are identified, adjustment of anticoagulation therapy may be made using known pharmacodynamics and pharmacokinetic principles or dosing protocols.

b. The Veteran will be monitored closely to insure both resolution of the interaction/concern and maintenance of a safe and effective level of anticoagulation.

x. Alert primary provider regarding any significant changes in the Veteran’s condition, including anticoagulation monitoring values or other abnormal laboratory values, and/or signs/symptoms of bleeding.

xi. Document concerns of potential drug-related problems and refer these to the Primary Provider to insure the Veteran receives appropriate medical attention.

xii. Provide accurate documentation of the Veteran’s anticoagulation management in the progress note.

xiii. Provide Veteran education to ensure each Veteran has a thorough understanding of the safe and appropriate use of outpatient and inpatient anticoagulation medications.

xiv. Provide education programs to medical, nursing, pharmacy and other healthcare system staff concerning the basic principles of the anticoagulation policy and new developments in the field of anticoagulation therapy.

xv. Initiate and conduct research programs relating to anticoagulation as time permits.

xvi. Must have successfully completed a specialty training program in anticoagulation therapy management, or be certified as an anticoagulation care provider (CACP), or completed an on-site anticoagulation training program that includes both experiential and didactic learning strategies.

J. Chief, Nutrition and Food Services The Chief, Nutrition and Food Services is responsible for ensuring that:

K. Chief, Pathology and Laboratory Medicine Service The Center Chief or Director, Pathology and Laboratory Medicine Service is responsible for:

i. Ensuring a critical INR value is established and listed in the Laboratory Veterans Health Information System and Technology Architecture (VistA) software package.

ii. Establishing a Standard Operating Procedure, in conjunction with the anticoagulation program manager, for the communication of critical INR results from the laboratory to the ordering provider (or designee).

iii. Ensuring the correct International Sensitivity Index (ISI) value for the lot number of thromboplastin, currently in use, is entered into the coagulation testing instrumentation.

iv. Ensuring there is documentation of periodic monitoring to ensure the entered value remains accurate.

v. Ensuring the correct Geometric Mean Prothrombin Time (PT) is calculated for the current lot number of thromboplastin and is entered into the coagulation testing instrumentation as required for calculation of the INR. The Geometric Mean PT needs to be recalculated with each change of lot number of thromboplastin reagent.

vi. Ensuring the availability of reliable testing of heparin levels (factor Xa levels), heparin associated antibodies and a serotonin release assay for the evaluation of heparin induced thrombocytopenia.

vii. Ensuring the availability of appropriate laboratory tests for Target Specific Oral Anticoagulants (DOAC) in special situations (e.g., suspected overdose, bleeding, urgent procedure, etc.).

viii. Educating staff providing clinical services in an outpatient anticoagulant clinic and staff involved in home anticoagulation therapy management on national and local Laboratory policies related to point of care testing (POCT) and patient self-testing.

ix. Ensuring the Medical Center ancillary testing coordinator is assessing the competency of staff, documenting training, authorization, and annual competence evaluation.

L. Nursing Service Support Staff:

i. Monitor for signs/symptoms of bleeding which, if seen, will be communicated to the primary provider and documented in Veteran’s electronic chart.

ii. Will order lab tests as per approved anticoagulation protocols and review monitor Provider’s orders for anticoagulation management (labs/medication changes) to insure timely execution of anticoagulation orders.

iii. For inpatients, nursing staff will utilize Bar Code Medication Administration (BCMA) to scan Veteran’s armband and anticoagulant doses before administration of medication. Continuous infusions of heparin will be documented in Veteran’s electronic record and/or ICU flow sheet upon initiation and titration of the infusion. Documentation of changes to heparin continuous infusions in the medical record will include, but not be limited to, the current PTT, the current infusion rate, and the current action taken with the heparin infusion.

iv. Provide anticoagulant education pamphlet to Veteran/caregiver upon discharge and document this in the Veteran’s electronic chart.

V. Procedure:

A. Inpatient Anticoagulation Service:

i. Clinical Pharmacist Specialists will accept consults on any Veteran receiving anticoagulation therapy as requested. Electronic consult requests must be answered within 24 hours (Attachment A). Note that a consult is not required for pharmacy to monitor these Veterans.

ii. Clinical Pharmacist Specialists will utilize approved anticoagulation protocols, but all final-dosing recommendations will be based on the clinical judgment of the Clinical Pharmacist Specialist. (The primary provider will be responsible for the overall anticoagulation orders, including labs and anticoagulant medications, following pharmacy consult recommendations). The Clinical Pharmacist Specialist may assist with this, if necessary. The Clinical Pharmacist Specialist will consult with the primary provider when needed.

iii. Clinical Pharmacist Specialist will evaluate INR results and any pertinent labs and make recommendations accordingly. The Clinical Pharmacist Specialist will contact the provider with these instructions (verbal and/or written contact).

iv. Clinical Pharmacist Specialist may order labs and adjust warfarin therapy as needed, if the provider has not already done so.

v. Clinical Pharmacist Specialist will be responsible for inpatient monitoring for lab parameters (at minimum) for patients on anticoagulation therapy:

1. Required baseline laboratory tests for patients on anticoagulation therapy:

a. Heparin: Complete blood count (CBC), activated partial thromboplastin time (aPTT)

b. LMWH and Factor Xa Inhibitors (Fondaparinux): CBC, serum creatinine

c. Warfarin: CBC, prothrombin time (PT), international normalized ratio (INR)

d. DOAC: CBC, serum creatinine, LFT

2. Required Ongoing Laboratory tests for patients on anticoagulation therapy:

a. Heparin: CBC, aPTT

b. LMWH and Factor Xa Inhibitors (Fondaparinux): CBC, serum creatinine

c. Warfarin: CBC, PT, INR

d. DOAC: CBC, serum creatinine

vi. Clinical Pharmacist Specialist will document all Veteran assessments, drug dosing, recommendations, and monitoring in the Veteran’s CPRS record. This documentation will be e-signed by the primary provider.

vii. Clinical Pharmacist Specialist will notify the provider of record (primary physician/provider, team member or covering physician) for anticoagulant management under the following circumstances:

1. INR value greater than or equal to 5 (warfarin); pertinent labs acutely outside recommended ranges.

2. Clinically significant signs of thrombosis or bleeding are reported or suspected.

3. Further clarification is desired regarding the anticoagulation plan for the Veteran.

viii. The Clinical Pharmacist Specialist will create an initial anticoagulation note in the Veteran’s electronic medical record including assessments, recommendations, anticoagulant dosing and monitoring. Follow-up documentation in the electronic medical record will be completed, as needed to communicate labs, changes in the anticoagulant regimen, drug-drug interactions, drug-food/supplement interactions, adverse effects, and/ or other clinical or medication issues that affect Veteran’s anticoagulant management, and recommendations. All electronic medical documentation by the pharmacist will be alerted to the provider by adding them as an additional signer to the note. The Clinical Pharmacist Specialist will communicate any acute major issues to the provider verbally and place documentation in the electronic medical record, using a template education note.

ix. All anticoagulation therapy education will be documented in the Veterans medical record.

x. For ongoing quality assurance purposes, the Clinical Pharmacist Specialists will report any patient incidents, close calls, and near misses associated with anticoagulation therapy. Adverse drug events (ADEs) involving anticoagulants should be assessed and analyzed in accordance with the Center Pharmacy and Therapeutics (P&T) Committee and VHA Directive 1070, Adverse Drug Event Reporting and Monitoring, or subsequent policy issue.

xi. All Veterans discharged on warfarin should have their INR evaluated within 4 to 7 days of their discharge. Veterans enrolled in a VA Primary Care Clinic will be seen by their Primary Care Provider or an Anticoagulation Clinic Provider. Veterans newly assigned to a Primary Care Clinic or not yet enrolled in a Primary Care Clinic, will report to the ED for monitoring of their anticoagulation therapy until seen for initial PC visit. Veterans who will be managed by their private physician will be instructed to contact that physician upon their discharge for a follow-up appointment within the recommended time.

xii. The inpatient provider is responsible for arranging for outpatient anticoagulation follow-up by entering a consult to the appropriate Anticoagulation Clinic 24-48 hours prior to anticipated discharge and making the Veteran aware of the date and time of his/her follow-up appointment. The Clinical Pharmacist Specialist may assist the provider in coordinating outpatient anticoagulation follow-up to assure:

1. Smooth transition from inpatient to outpatient;

2. Continuity of care including appropriate use of bridging therapy, if needed.

B. Outpatient Services/Home Base Primary Care

i. Anticoagulation Clinic Providers:

1. Anticoagulation Clinic providers will enroll Veterans prescribed warfarin in the clinic on a consult-basis only through the CPRS. Electronic consultation requests must be answered within seven days. “Referral Guidelines for Coagulation Clinics” will be provided to Primary Care Clinics. Outpatient anticoagulation consults shall include all pertinent information related to Veteran’s anticoagulation as well as the HEMORR2HAGES risk score, CHADS2 risk score, and CHA2DS2VASc for atrial fibrillation (See Attachment B).

2. Pharmacy will utilize approved anticoagulation protocols, but all final-dosing decisions will be based on the clinical judgment of the Clinical Pharmacist.

3. Each Veteran will be extensively interviewed by the clinic provider via face to face or telephone managing his/her therapy. This provides an opportunity for gathering medical and social history, explaining warfarin/enoxaparin therapy, providing written educational material, describing the clinic procedures and policies and providing next appointment information.

4. Pharmacist will document all Veteran assessments, drug dosing, recommendations, and monitoring in the Veteran’s CPRS record.

5. Pharmacist will notify the provider of record (primary provider team member or covering provider) for warfarin management under the following circumstances:

a. INR value greater than or equal to 5;

b. Clinically significant signs of thrombosis or bleeding are reported or suspected;

c. Further clarification is desired regarding the anticoagulation plan for the Veteran.

6. Veterans on warfarin therapy (newly started and established Veterans) will be appropriately counseled. Documentation of Veteran education will be placed in the Veteran’s medical record using a template education note.

7. Appointments

a. Initial Anticoagulation Clinic appointments will be made according to the following categories:

4-7 days – inpatient, to be discharged on warfarin therapy 1 week – outpatient, new to warfarin therapy 1-3 weeks – outpatient, unstable/non-therapeutic 4 weeks – outpatient, stable

b. Subsequent Anticoagulation Clinic appointments will be made based on the clinical judgment of the Anticoagulation Clinic provider.

i. Therapeutic Veterans should be seen back within 30 days.

ii. Therapeutic Veterans who are stable, well controlled, and compliant may be seen back in 4-6 weeks not to exceed 56 days for extenuating circumstances.

iii. Veterans who are not therapeutic, who have changes in interacting medications or who require closer follow up will be scheduled to return sooner based on the discretion and clinical judgment of the Anticoagulation Clinic provider.

c. If a Veteran does not attend a scheduled clinic visit, adequate follow-up will be insured by taking the following steps:

iv. Appointment lists will be reviewed at the end of each day to determine if any Veterans did not keep their scheduled appointments.

v. Rescheduling the Veteran within two to four weeks after the missed appointment.

d. If the Veteran has no-showed two consecutive times and cannot be reached by phone, a certified letter will be sent to the Veteran, informing him of the necessity to reschedule his appointment to prevent being discharged from the Anticoagulation Clinic.

e. If the Veteran has three consecutive no-shows, the Veteran will be discharged from the Anticoagulation Clinic and his/her anticoagulation therapy will be managed by the primary provider.

f. For consistency in documentation and retrieval of information, Veterans need to be encouraged to use the services of this facilities laboratory for PT/INR testing whenever possible. A Veteran requesting to have their PT/INR results faxed to the Anticoagulation Clinic may be accommodated at the discretion of the clinic provider if there are extenuating circumstances and the Veteran is unable to come in to the VA Center. If the clinic provider is willing to provide this service to the Veteran, the following conditions must be met:

vi. The faxed INR result will be scanned into the CPRS and must include the following:

1. Name, address and phone number of the laboratory

2. Date of the test

3. Reference range of the test

vii. The clinic provider must verify the authenticity of the report by reviewing the written report provided by the laboratory that includes the laboratory name, address, telephone number, and reference range.

viii. The clinic provider must only accept outside laboratory results from an accredited (College of American Pathologists, COLA or The Joint Commission) laboratory.

ix. If the clinic provider later determines that in their clinical judgment, this arrangement is no longer safe due to difficulty reaching the Veteran in a timely manner or other problems, a letter may be sent explaining this position.

x. All Veteran visits are to include scheduled same-day laboratory orders for INR, in the outpatient laboratory. The scheduled laboratory time will be 90 minutes prior to Coagulation Clinic appointment.

8. Clinic Visit Procedure

a. Veterans are to report to the main lab for venipuncture as soon as they arrive at the Center.

b. Veteran checks-in with the clerk at the scheduled Anticoagulation Clinic. The Veteran may be assigned a pager, depending on the PC Clinic.

c. Clerk asks the Veteran to complete the Anticoagulation Clinic Worksheet.

d. Veteran answers the questions on the Anticoagulation Clinic Worksheet and gives it back to the clerk.

e. Clerk places the worksheet in the designated file rack for the Anticoagulation Clinic.

f. Veteran should be in the area of the Anticoagulation Clinic about 20 minutes prior to the scheduled appointment time.

g. All Veterans enrolled in Anticoagulation Clinics will be asked to sign the Coagulation Clinic Veteran Agreement (See Attachment C).

9. Discharge from Anticoagulation Clinic

a. Veterans will be discharged from Anticoagulation Clinic when anticoagulation therapy is discontinued. In the event of excessive Veteran non-compliance which is deemed by the Anticoagulation Clinic provider to place the Veteran at unacceptable risk of adverse outcomes, management of the Veteran’s warfarin therapy will be referred back to their Primary Care Provider.

b. The Anticoagulation Clinic will follow the Medical Center’s No-Show Policy.

10. Patient/Caregiver Education

a. Documentation of Patient/Caregiver education for anticoagulant therapy will be placed in the Veteran’s medical record.

b. Upon initial Anticoagulation Clinic visit and at any time during therapy as deemed necessary by the Anticoagulation Clinic provider, Veterans are to be verbally counseled and given written patient education materials informing them about their warfarin therapy. The verbal counseling and the written information shall contain, but is not limited to, the following information:

xi. Name and indication of the medication

xii. Mechanism of action

xiii. Time and method of administration

xiv. Appearance and strength of the tablet

xv. Drug-food interactions/modified diet with warfarin

xvi. Signs and symptoms of excessive hypocoagulability and procedures to follow in case of bleeding and/or bruising

xvii. Signs and symptoms of excessive hypercoagulability and procedures to follow in case of suspected stroke or blood clot.

xviii. Importance of compliance with regimen

xix. Importance of frequent and timely monitoring

xx. Veteran responsibilities in anticoagulation therapy

xxi. Risks associated with INRs outside therapeutic range

xxii. Importance of notifying the Coagulation Clinic provider of any changes in medications or diet

xxiii. Procedure to follow in case of anticipated dental work or outpatient surgery

xxiv. Importance of notifying Coagulation Clinic provider if warfarin is stopped for any reason

xxv. Importance of notifying Coagulation Clinic Provider if treated by a non-VA physician or admitted to a non-VA hospital

xxvi. The dangers of using warfarin from different sources (i.e., VA and community pharmacy)

xxvii. The management of missed doses xxviii. The risks associated with falling

xxix. At each clinic visit, the Veteran will receive both verbal and written instructions regarding their anticoagulant therapy.

11. Non-Anticoagulation Clinic Providers managing anticoagulation therapy (i.e. Community Based Outpatient Clinic Providers, Primary Care Providers):

12. Primary providers will utilize approved anticoagulation protocols, but all final-dosing decisions will be based on the clinical judgment of the provider.

13. Each Veteran will be extensively interviewed by the provider managing his/her therapy. This provides the opportunity for gathering medical and social history, explaining warfarin /enoxaparin therapy, providing written educational material, describing the clinic procedures and policies and providing next appointment information.

a. Provider will document all Veteran assessments, drug dosing, recommendations, and monitoring in the Veteran’s CPRS record.

b. Veterans on warfarin therapy (newly started and established) will be appropriately counseled. Documentation of Veteran education will be placed in the Veteran’s medical record using a template education note.

14. Appointments

a. Initial anticoagulation management appointments will be made according to the following categories:

4-7 days- inpatient, to be discharged on warfarin therapy 1 week – outpatient, new to warfarin therapy 1-3 weeks – outpatient, unstable/non-therapeutic 4 weeks – outpatient, stable

b. Subsequent anticoagulation management appointments will be made based on the clinical judgment of the provider.

i. Therapeutic Veterans should be seen back within 30 days.

ii. Therapeutic Veterans who are stable, well controlled, and compliant may be seen back in 4-6 weeks not to exceed 56 days for extenuating circumstances.

iii. Veterans who are not therapeutic, who have changes in interacting medications or who require closer follow up will be scheduled to return sooner based on the discretion and clinical judgment of the provider.

iv. If a Veteran does not attend a scheduled clinic visit, adequate follow up will be insured by taking the following steps:

1. Appointment lists will be reviewed at the end of each day to determine if any Veterans did not keep their scheduled appointment.

2. Rescheduling the Veteran within 2-4 weeks after missed appointment.

v. For consistency in documentation and retrieval of information, Veterans need to be encouraged to use the services of our Center’s laboratory for PT/INR testing whenever possible. A Veteran requesting to have their PT/INR results faxed to the clinic may be accommodated at the discretion of the provider if there are extenuating circumstances. If the provider is willing to provide this service to the Veteran, the following conditions must be met:

3. The faxed INR result will be scanned into the CPRS and must include the following:

a. Name, address and phone number of the laboratory.

b. Date of the test

c. Reference range of the test.

4. The provider must verify the authenticity of the report by reviewing the written report provided by the laboratory that includes the laboratory name, address, telephone number, and reference range.

5. The Provider must also accept outside laboratory results only from an accredited (College of American Pathologists, COLA or The Joint Commission) laboratory.

6. If the provider later determines that in their clinical judgment, this arrangement is no longer safe due to difficulty reaching the Veteran in a timely manner or other problems, a letter may be sent explaining this position.

7. Veteran Education

a. Documentation of Veteran education for anticoagulant therapy will be placed in the Veterans medical record using a template education note.

b. Upon initial anticoagulation management visit and at any time during therapy ads deemed necessary, Veterans are to be verbally counseled and given written educational materials. The verbal counseling and written information shall contain, but is not limited to, the following:

i. Name and indication of the medication Mechanism of action

ii. Time and method of administration

iii. Appearance and strength of the tablet

iv. Drug-food interactions/modified diet with warfarin

v. Signs and symptoms of excessive hypercoagulability and procedures to follow in case of bleeding and or bruising

vi. Signs and symptoms of excessive hypercoagulability and procedures to follow in case of suspected stroke or blood clot

vii. Importance of compliance with regimen

viii. Importance of frequent and timely monitoring

ix. Veteran responsibilities in anticoagulation therapy

x. Risks associated with INRs outside of the therapeutic range

xi. Importance of notifying the provider of any changes in medications or diet

xii. Procedure to follow in case of anticipated dental work or invasive procedure

xiii. Importance of notifying provider if treated by a non-VA physician or admitted to a non-VA hospital

xiv. The danger of using warfarin from different sources (i.e., VA and community pharmacy)

xv. The management of missed doses

xvi. The risks associated with falling

c. At each clinic visit the Veteran will receive both verbal and written instructions regarding their anticoagulant therapy.

D. Community Living Center (Long-term Care):

i. Anticoagulation therapy will be managed by the Primary Provider.

ii. The Inpatient Anticoagulation Service may be consulted for assistance.

E. Use of Anticoagulant Therapy

i. Per Scope of Practice, Anticoagulation Pharmacy Providers cannot initiate or discontinue warfarin therapy. They are allowed to renew warfarin prescriptions and adjust existing warfarin prescriptions based upon prothrombin time and INR measurements.

ii. Per the VHA Directive 2010-020, Anticoagulation Therapy Management, warfarin tablet strengths (for outpatient prescriptions) will be limited to 2 mg and 5 mg tablets. The following exceptions will be made as appropriate:

1. Veterans requiring extremely small doses not accommodated by the 2 mg tablet strength;

2. Veterans with an allergy to the pharmaceutical dyes used, therefore requiring the white 10 mg tablet strength.

3. Veterans will receive no more than a 30 day supply of warfarin with one refill. Anticoagulation Clinic Veterans will not have their anticoagulation therapy co-managed with a non-VA provider.

4. For inpatients, warfarin shall be dispensed as a unit dose packaged product. Only prefilled syringes or premixed infusion bags will be used for anticoagulant medications when these types of products are available.

5. Programmable infusion pumps will be used for intravenously-administered heparin.

iii. See Attachment D: Heparin Protocol

iv. See Attachment E: VHA CPPO Pharmacy Benefits Management (PBM) Strong Practice Recommended Warfarin Management Algorithm (Initiation and Maintenance Phase of Therapy)

v. See Attachment F: Inpatient Monitoring of Warfarin Therapy

vi. See Attachment G: Managing Excessive Prolongation of INR or Bleeding in Patients Receiving Vitamin K Antagonist (VKA).

vii. See Attachment H: Lovenox Usage, Monitoring, and Dosage Adjustments

viii. See Attachment I: Argatroban Use in Heparin-Induced Thrombocytopenia with Conversion to Oral Therapy

ix. See Attachment J: Direct Oral Anticoagulant Consult Form

x. See Attachment K: Dosing Indirect Factor Xa Inhibitors

xi. Monitoring and Evaluation: Veterans will be monitored closely while receiving anticoagulant therapy. Veterans will be interviewed or medical records will be reviewed in order to gather medical and social history pertinent to anticoagulant therapy. The Veteran will also be assessed for signs and symptoms of bleeding.

xii. Laboratory Parameters:

1. LMWH: Hgb, Hct, platelets and serum creatinine. Baseline and ongoing during therapy as indicated. Anti-Xa levels will be monitored for Veterans with renal insufficiency, obesity, weight <45 Kg or probable bleeds related to LMWH use.

2. Warfarin: Hgb, Hct, platelets, prothrombin time (PT), and INR. Baseline and ongoing. Baseline PT/INR must be obtained on all warfarin patients by the prescribing provider prior to initiating warfarin therapy and prior to referral to the anticoagulation clinics. A current INR will be available in the electronic medical record for all Veterans receiving warfarin therapy. Warfarin regimen to be adjusted based on current INR results. INR results will be reviewed and clinically evaluated no later than close of business of the next business day. NOTE: Initial INR shall not be performed using a point-of-care device.

3. Heparin: Hgb, Hct, Platelets and aPTT. Baseline and ongoing.

4. Specifics on lab requirements while the Veteran is in the hospital on warfarin (For other anticoagulants monitored by this service, pertinent recommended lab(s) will be monitored):

a. INR at baseline and daily thereafter or as needed while receiving warfarin as an inpatient.

b. Complete blood count (CBC) with platelets at baseline and every 2 to 3 days thereafter or as needed while receiving anticoagulation as an inpatient.

c. Fecal occult blood test (FOBT), urinary analysis, albumin, periodically or when warranted.

d. Liver function tests (LFT) at baseline and as needed.

5. Oral Direct Thrombin Inhibitors: Routine laboratory monitoring is not recommended with these medications. It is recommended to monitor serum creatinine, BUN, Hgb, Hct and liver function tests.

6. Indirect Factor Xa Inhibitors: It is recommended to monitor Hgb, Hct, platelets, serum creatinine, and BUN.

xiii. Therapeutic Adjustments

1. The goal of warfarin therapy is to maintain the INR within a range based on the latest recommendations of the Committee on Antithrombotic Therapy of the American College of Chest Physicians (ACCP), the American Heart Association/American College of Cardiology, recent reputable literature, physician representatives from cardiology, hematology, urology, and gastroenterology, and upon the direction of the prescribing provider/clinic.

2. Veterans who were previously maintained in good control and who now have INR values outside the therapeutic range will be questioned in an attempt to identify precipitating factors which, if controlled, would obviate the need for maintenance dose adjustment. If no responsible factor can be identified, the warfarin dose will be adjusted in accordance with past dose-response data and pharmacokinetic parameters. More frequent INR monitoring may be necessary until Veteran is once again stable.

3. If the most recent INR is less than the therapeutic range, noncompliance will be suspected first. Other variables that need to be considered include: drug-drug interactions, dietary alterations, and alterations in alcohol or tobacco consumption.

4. If the most recent INR is significantly higher than desired, Veterans fall into two categories: First, those Veterans without evidence of excessive hypocoagulability who require downward adjustment in dose and careful monitoring to regain therapeutic control. Second, those with actual or suspected signs of a hemorrhagic episode whose dose should be downward adjusted and referred to their primary care provider for evaluation. Only in extreme cases should vitamin K be administered because of the inherent problems in reestablishing therapeutic status. (See Attachment E, “VHA CPPO Pharmacy Benefits Management (PBM) Strong Practice Recommended Warfarin Management Algorithm (Initiation and Maintenance of Therapy.” The primary provider will be alerted regarding any significant changes in the Veteran’s condition which will include INR of greater than or equal to 5, signs/symptoms of bleeding or any abnormal laboratory tests ordered by the Anticoagulation provider.

5. Following Veteran evaluation, the provider will document observations, lab data, and the therapeutic plan in the Veteran’s medical record. This will be done within 24 hours of clinic visit. If medications added by other providers present actual or potential drug interactions, the provider will adjust the warfarin dose or will attempt to contact the prescribing provider of the interacting medication. After discussion with the provider, the warfarin regimen will be adjusted or a drug that has not been reported to interact with warfarin will be substituted. The Veteran will be given a written schedule of his/her warfarin regimen and the provider will reinforce patient education regarding precautions to observe during warfarin therapy.

6. Discontinuation of Warfarin for invasive Procedures: This section was developed in conjunction with our medical and surgical services and based on the Eighth ACCP Conference on Antithrombotic and Thrombolytic Therapy: Evidence-Based Guidelines. (Attachment L, Periprocedural Management of Anticoagulation Therapy). The following items are to be used as therapeutic guidelines. It is important to be certain that the Veteran’s condition and indication for warfarin will allow holding warfarin or adding low molecular weight heparin (LMWH) therapy. In special circumstances, it may be necessary to discuss modifications in these guidelines with the Veteran’s primary provider or the provider performing the procedure. The goal is to have the Veteran without anticoagulant therapy for the shortest time possible based on their clinical status and on the planned procedure. See Attachment M for risk stratification for perioperative arterial or venous thromboembolism.

a. Low Risk: For Veterans with a mechanical heart valve or A Fib or VTE at low risk for thromboembolism stop warfarin therapy 5 days prior to the procedure to allow adequate time for the INR to normalize. Warfarin therapy should be resumed 12-24 hours after the procedure and when there is adequate hemostasis as determined by the physician performing the procedure. Consider low-dose subcutaneous LMWH or no bridging over bridging with therapeutic dose subcutaneous LMWH or IV UFH. When bridging with LMWH the final dose should be administered 24 hours prior to the procedure. The physician performing the procedure will determine the appropriate time to resume bridging anticoagulation therapy.

b. Moderate Risk: For Veterans with a mechanical heart valve or A Fib or VTE at moderate risk of thromboembolism, stop warfarin therapy 5 days prior to the procedure to allow adequate time for the INR to normalize. Warfarin therapy should be resumed 12-24 hours after the procedure and when there is adequate hemostasis as determined by the physician performing the procedure. Consider bridging anticoagulation with therapeutic dose subcutaneous LMWH, therapeutic dose IV UFH, or low dose subcutaneous LMWH. When bridging with LMWH the final dose should be administered 24 hours prior to the procedure and if using therapeutic dosing, use one-half of the total daily dose. When bridging with therapeutic dose IV UFH, stop the infusion 4 hours prior to the procedure. The physician performing the procedure will determine the appropriate time to resume bridging anticoagulation therapy.

c. High Risk: For Veterans with a mechanical heart valve or A Fib or VTE at high risk of thromboembolism, stop warfarin therapy 5 days prior to the procedure to allow adequate time for the INR to normalize. Warfarin therapy should be resumed 12-24 hours after the procedure and when there is adequate hemostasis as determined by the physician performing the procedure. Consider bridging anticoagulation with therapeutic dose subcutaneous LMWH or therapeutic dose IV UFH. When bridging with therapeutic dose LMWH the final dose should be administered 24 hours prior to the procedure and use one-half of the total daily dose. When bridging with therapeutic dose IV UFH, stop the infusion 4 hours prior to the procedure. The physician performing the procedure will determine the appropriate time to resume bridging anticoagulation therapy.

d. See Attachment H for information on the current formulary LMWH.

7. For Dental procedures: In Veterans undergoing minor dental procedures (i.e., single or multiple tooth extractions and endodontic procedures) with a need to control local bleeding, we suggest tranexamic acid mouthwash or epsilon aminocaproic acid mouthwash without interrupting anticoagulant therapy.

a. Tranexamic acid mouthwash 4.8 % solution should be applied to the procedure site prior to the procedure and immediately after the procedure.

b. Veterans should be instructed to rinse with tranexamic acid mouthwash 4.8 % solution for 2 minutes and then expectorate four times daily for seven days. They should not eat or drink within the first hour after using the mouthwash.

c. If extensive dental work will be done requiring warfarin to be held for 2 or 3 days, then post procedure LMWH may be required according to risk stratification.

8. Veterans requiring long term LMWH therapy will have their anticoagulation therapy monitored by their PC provider for…