D.16 36C26126R0014 SOP 119-40_Anti Coag Therapy Management.doc

VA Northern California Health Care System

Policy Statement 119-40

November 13, 2018

ANTICOAGULATION THERAPY MANAGEMENT

1. PURPOSE:

To establish procedure and responsibilities within the VA Northern California Health Care System (VANCHCS) for the proper management and monitoring of patients receiving therapeutic anticoagulation therapy. This policy is in accordance with Veterans Health Administration (VHA) Directive 1033, Anticoagulation Therapy Management, dated July 29, 2015.

2. POLICY:

The anticoagulation therapy responsibilities and procedures described in this policy will be utilized to individualize patient care provided and reduce the likelihood of patient harm associated with the use of anticoagulants.

3. DEFINITIONS:

a. Algorithm: The term algorithm refers to a standardized care process which outlines steps used to manage a patient’s anticoagulation therapy and utilized across the facility. Algorithms must be evidence-based, approved by the Pharmacy and Therapeutics (P&T) Committee and Medical Executive Committee and follow the guidance included in this directive. An algorithm may contain protocols which are outlined in policy that outline specific actions to be implemented based on patient parameters by designated individuals for anticoagulation patient care management, e.g., unfractionated heparin protocols by nursing staff. Any actions or processes outlined in algorithms or protocols must be within the scope of practice of the individual performing the function and competency must be assessed on an ongoing basis as appropriate.

b. Ancillary Testing: Ancillary testing is defined as laboratory testing or services performed within a VA medical facility or its outreach functions (clinic, et al.), but outside the physical facilities of the main clinical laboratory. It is often referred to as point-of-care testing (POCT).

c. Anticoagulant: The term anticoagulant refers to a medication that inhibits blood coagulation. Anticoagulants include, but are not limited to, warfarin, unfractionated heparin, low molecular weight heparin, other parenteral anticoagulants (e.g., fondaparinux, argatroban), and direct oral anticoagulants (DOACs) such as dabigatran, rivaroxaban, apixaban and edoxaban. For purposes of this Policy, the term “anticoagulant” refers to anticoagulation therapy or long-term anticoagulation prophylaxis (e.g., atrial fibrillation) and does not include routine situations in which short-term prophylactic anticoagulation is used for venous thromboembolism prevention (e.g., related to procedures or hospitalization). In addition, medications whose primary purpose is to inhibit platelet function are not included under this definition.

d. Anticoagulant Management Program: The term “anticoagulant management program” (commonly referred to as an “anticoagulation clinic”) means a program, specified in writing, for individualizing anticoagulation therapy for each patient. This program involves the use of standardized practices and patient involvement, and is specifically designed to reduce the risk of adverse drug events associated with the use of heparin (unfractionated), LMWH, warfarin, and other anticoagulants.

e. Anticoagulation Provider: The term anticoagulation provider refers to a provider who is currently trained and skilled in managing anticoagulant therapy. At NCHCS this provider is usually a clinical pharmacy specialist working in an anticoagulation outpatient clinic. The anticoagulation provider is an active member of the anticoagulation management program, responsible to monitor the quality of his or her clinical practice, and has prescriptive authority defined in their scope of practice that includes anticoagulants.

f. Anticoagulation Program Manager: The anticoagulation program manager is a clinical pharmacy specialist anticoagulation provider who serves as a leader for the anticoagulation management program and is responsible for ensuring that the program meets all elements in this policy. This individual maintains a high standard for continuing education in the area of anticoagulation therapy and serves as a local subject matter expert regarding anticoagulation management. The anticoagulation program manager collaborates with other services to ensure that the anticoagulation management program meets all standards outlined in this policy.

g. Anticoagulation Support Staff: Anticoagulation support staff refers to a group of professionals assigned to the anticoagulation management program who perform day-to-day operational support functions. Anticoagulation support staff may include, but are not limited to, pharmacy technicians, health technicians, and clerical associates. Anticoagulation support staff may assist with many of the technical issues associated with the anticoagulation management program under the supervision of an anticoagulation provider. All anticoagulation support staff must have functional statements, coupled with a competency assessment that accurately reflects the job responsibilities and tasks they perform. Responsibilities may include, but are not limited to, answering and triaging patient telephone calls, contacting patients who have missed appointments, sending letters to patients, communicating with outside laboratories, and other similar tasks.

h. Bridge Therapy: Bridge Therapy is the temporary use of a short and immediate acting injectable anticoagulant (usually a heparin) during periods when the INR level is sub-therapeutic (e.g., when warfarin therapy is started) or when warfarin is being held in order to perform invasive procedures (peri-procedural bridging).

i. Geometric Mean PT: The Geometric Mean PT is a calculation of the mean PT for the laboratory patient population using the current Thromboplastin Reagent. It is used to calculate the INR.

j. International Normalized Ratio (INR): INR is a standardized measure of the prothrombin time (PT), which is used to determine the clotting tendency of blood. The INR is the ratio of a patient's PT to a mean of a normal (control) sample, raised to the power of the ISI value for the reagent system used.

k. International Sensitivity Index (ISI): ISI is a measure of Thromboplastin sensitivity to an international standard. Each lot number of Thromboplastin used in Prothrombin or INR testing is assigned its own unique ISI value from the manufacturer.

m. Direct Oral Anticoagulant: A Direct Oral Anticoagulant (DOAC), formerly called a Target Specific Oral Anticoagulant (TSOAC), encompasses several drug classes, and includes, but is not limited to, dabigatran, rivaroxaban, edoxaban and apixaban. DOAC refers to oral anticoagulant medications that target one or more specific steps in the coagulation cascade.

4. RESPONSIBILITIES:

a. The Facility Director is responsible for ensuring:

(1) A medical facility policy exists at the facility that meets all standards identified in VHA Directive 1033, Anticoagulation Therapy Management, and its Attachment A. An inter-professional approach should be utilized in accordance with this policy to ensure the safe management of anticoagulation therapy.

(2) The medical facility has an established anticoagulation management program for management of inpatients and outpatients on anticoagulants.

(3) A Physician Anticoagulation Management Champion and Pharmacist Anticoagulation Program Manager have both been designated to lead the medical facility’s anticoagulation management program and both have been provided with appropriate time to fulfill the duties consistent with the complexity of the VANCHCS anticoagulation program.

(4) Adequate staff and resources are allotted for the anticoagulation management program to include anticoagulation providers, pharmacy technicians, program administration and information technology support, as appropriate. This include 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.

(5) The anticoagulation management program has an appropriate staff-to-patient ratio to provide safe and appropriate care as defined in Attachment A of VHA Directive 1033, Anticoagulation Therapy Management, dated July 29, 2015.

(6) 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 requirements, dose calculations, common side effects, nutrient interactions, and drug to drug interactions associated with anticoagulation therapy.

(7) The medical facility ensures care is coordinated for traveling patients on anticoagulants in accordance with VHA Handbook 1101.11, Coordinated Care Policy for Traveling Veterans.

(8) The medical facility uses programmable infusion pumps for inpatients receiving parenteral anticoagulants, including, but not limited to unfractionated heparin, argatroban, and bivalirudin.

(9) The medical facility employs standardized, evidence-based, algorithms for the management of patients on anticoagulants as defined in Attachment A of VHA Directive 1033, dated July 29, 2015.

(10) Anticoagulants are included on the medical facility’s list of high-alert medications.

b. Chief of Staff is responsible for ensuring:

(1) A physician is identified as the Anticoagulation Management Champion, to be actively involved in defined components of the anticoagulation management program. This physician champion will serve collaboratively with the pharmacy anticoagulation management champion/ program manager to advocate for, provide consultation on anticoagulation issues, and support anticoagulation initiatives at VANCHCS.

(2) All VANCHCS policies governing the provision of anticoagulation management are approved by the Medical Executive Committee (MEC). Anticoagulation providers will collaborate in the development of VANCHCS guidelines/ algorithms for anticoagulants.

(3) Clinical staff directly involved in caring for patients receiving anticoagulation therapy (e.g. clinical pharmacist, pharmacy technicians) are educated on the importance of anticoagulation safety and its associated risks, as well as the principles of anticoagulation management, as appropriate.

(4) The review of quality assurance (QA) information for the VANCHCS anticoagulation management program as appropriate and regular intervals through the Pharmacy and Therapeutics (P&T) Subcommittee and MEC, as appropriate.

(5) Anticoagulation providers have adequate anticoagulation support staff (e.g. pharmacy technicians or other anticoagulation staff) to maximize operational efficiency.

c. Chief, Pharmacy Service is responsible for ensuring:

(1) A clinical pharmacist anticoagulation provider is identified as the pharmacy anticoagulation management champion to be actively involved in the management of the anticoagulation program at the facility level. The pharmacist champion may be the anticoagulation program manager and serves to advocate for and support anticoagulation initiatives at the facility

(2) Assessing the competency of clinical pharmacist anticoagulation providers and pharmacy technicians who serve in the anticoagulation management program. At a minimum, competencies include knowledge of: standard terminology, anticoagulant pharmacology, monitoring requirements, dose calculations, common side effects, and nutrient and drug-drug interactions with anticoagulants

(3) Clinical pharmacists that serve as anticoagulation providers have adequate anticoagulation support staff. 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.

(4) Ensuring the anticoagulation management program has an appropriate staff-to-patient ratio.

(5) Only oral unit dose products, pre-filled syringes, or pre-mixed infusion bags for anticoagulant medications are dispensed for inpatients when these types of products are available.

(6) The medical facility includes anticoagulants on the facility’s list of high-alert medications.

(7) 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.

(8) The safe storage of anticoagulants in automated dispensing cabinets such as Pyxis units. If multiple strengths or concentrations of the same anticoagulant are stored in the same automated dispensing cabinet, they need to be stored in separate drawers (or single access cubie) and clearly labeled as high alert medications.

d. Physician Anticoagulant Management Champion is responsible for:

(1) Working closely and collaboratively with the pharmacy anticoagulation management champion to advocate for anticoagulation initiatives and provide consultation on anticoagulation issues.

(2) Collaborating in the development of medical facility guidelines and algorithms for anticoagulants.

(3) Ensuring that clinical staff directly involved in caring for patients receiving anticoagulation therapy (e.g., clinical pharmacists, anticoagulation support staff, registered dieticians) are educated on the importance of anticoagulation safety and its associated risks, as well as the principles of anticoagulation management, as appropriate.

(4) Reviewing quality assurance (QA) information for the facility anticoagulation management program at appropriate and regular intervals through the Pharmacy and Therapeutics (P&T) Committee and ECMS, as appropriate.

e. Chief, Nutrition and Food Services is responsible for ensuring:

(1) Warfarin is included in Nutrition and Food Services' established food and medication interaction program.

(2) A process is established to notify Nutrition and Food Services of patients receiving meal services that are also receiving warfarin therapy.

(3) Nutrition and Food Services responds according to its established food and medication interaction program to patients receiving meal services and warfarin therapy. Meal planning and educational efforts are focused on steady Vitamin K intake, individualized to meet the overall health needs, and supporting an adequate dietary reference intake for Vitamin K.

f. Chief, Pathology and Laboratory Medicine Services is responsible for:

(1) Ensuring a critical INR value is established and listed in the Laboratory VistA software package.

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

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

(4) Ensuring there is documentation of periodic monitoring to ensure the entered value remains accurate.

(5) Ensuring the correct Geometric Mean 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.

(6) Ensuring the availability of reliable testing of heparin levels (i.e. Anti-Xa levels), heparin associated antibodies and a serotonin release assay for the evaluation of heparin induced thrombocytopenia.

(7) Ensure the availability of appropriate laboratory tests for DOACs in special situations (e.g., suspected overdose, bleeding, urgent procedure, etc.).

(8) 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 POCT testing.

g. Anticoagulation Program Manager is responsible for:

(1) Serving as a leader or co-leader and subject matter expert in the oversight, design, implementation, and function of the anticoagulation management program. Developing a local facility policy related to the 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 ECMS.

(2) Ensuring standards in the VHA Directive 1033, Attachment A (“Required Components of the Anticoagulation Management Program”) are included in the facility’s anticoagulation management program.

(3) Collaborating with the Physician Anticoagulation Program Champion to develop policies to govern practice within the anticoagulation management program. Both the anticoagulation program manager and physician champion ensure all medical facility policies governing the provision of anticoagulation management are approved by the Executive Committee of the Medical Staff (ECMS).

(4) Promoting the continued education of providers in the anticoagulation management program through activities such as educational initiatives, regular staff meetings, and journal clubs.

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

(6) Ensuring availability of appropriate patient education materials and classes, as applicable.

(7) Evaluates the anticoagulation management program has an appropriate staff-to-patient ratio per VHA Directive 1033, Attachment A.

(8) Ensuring the anticoagulation management program providers utilize standardized, evidence-based, algorithms for managing patients on anticoagulants.

(9) Assessing the competency of staff involved in ancillary testing. Documents training, authorization, and annual competence evaluation for all staff that perform ancillary testing.

(10) Ongoing monitoring of the facility anticoagulant quality assurance plan and reporting results to P&T Committee annually. Components of the quality assurance plan include:

1. Time in therapeutic range

2. INRs above the critical value and appropriate actions taken within 24 hours through proposed software solutions

3. Subtherapeutic INRs

4. Pathologic bleeding events

5. Thromboembolic events

6. Patient incidents, close-calls, and near misses associated with anticoagulant medications

h. Anticoagulation Providers are responsible for:

(1) Meeting all competencies to maintain their scope of practice in the area of anticoagulation

(2) Managing anticoagulation patients in accordance with facility 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.

(3) Serving as subject matter experts on anticoagulation management to patients and health care professionals throughout the facility.

(4) 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.

(5) 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.

(6) Performing and/or facilitating the day-to-day operations of the anticoagulation management program.

(7) 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 facility Patient Safety Manager (PSM) in accordance with VHA Directive 1070, Adverse Drug Event Reporting and Monitoring, or subsequent policy issue.

(8) Ensuring coordinated care for traveling patients on anticoagulants in accordance with VHA Handbook 1101.11 (“Coordinated Care Policy for Traveling Veterans”).

5. PROCEDURES:

a. Patients on anticoagulation therapy in the outpatient setting generally will be followed and monitored by the Anticoagulation Clinic provider in accordance with Attachment B.

(1) Patients on warfarin co-managed by their VA primary care physician and external non-VA provider will have their external laboratory monitoring recorded in CPRS using the “external laboratory result” template so that outside laboratory results may be tracked in CPRS. Frequency of monitoring should be consistent with frequency in patients monitored in anticoagulation clinic.

(2) Patients starting DOAC therapy are generally referred to the anticoagulation clinic for patient education and monitoring for adverse drug events and medication adherence. These patients may be discharged back to their referring provider after 3-6 months if taking the medication correctly and without adverse events.

b. Initiation and Maintenance of Warfarin therapy will be according to Attachment B.

c. Peri-Procedural Management of Anticoagulants will be according to the attached Guideline (Attachment A).

6.

REVIEW, RESCISSION OR REISSUE DATE:

Chief, Pharmacy Service will review this policy for rescission or reissue within five years of the date of issue. Target review date is within five years of the date of issue (November 13, 2023). If the review is not completed within the target review date, this policy will remain active and current, until the review is completed and a new policy is published or the existing policy is rescinded.

7. REFERENCES:

VHA Directive 1033, Anticoagulation Therapy Management, dated July 29, 2015.

VHA Handbook 1108.06, Inpatient Pharmacy Services.

VHA Handbook 1108.05, Outpatient Pharmacy Services.

VHA Handbook 1106.01, Pathology and Laboratory Medicine Service Procedures.

VHA Handbook 1100.19, Credentialing and Privileging.

American College of Chest Physicians Guidelines: Antithrombotic therapy and prevention of thrombosis, 9th ed. CHEST. 2012; 141(2): February Supplement.

Joint Commission Comprehensive Accreditation Manual for Hospitals, Current Edition David Stockwell, MHA Director

Attachment B A. Initiation of Warfarin

1. A baseline CBC and PT/INR must be completed prior to a patient starting warfarin therapy. The baseline PT/INR must be drawn via venipuncture. Baseline PT/INR must not be performed using point of care testing (POCT) devices.

2. New patient warfarin education will be scheduled for the patient as soon as possible (normally within 96 hours from receiving the consult). The patient may receive warfarin education during their first Anticoagulation Clinic (ACC) phone appointment.

3. Documentation of warfarin education must be made in CPRS. Warfarin education topics to be covered are included in section H.3. of this Attachment. Warfarin education handouts will be provided to the patient and/or caregiver.

4. At first contact with the patient and/or caregiver, the CPS will provide the direct phone number for the ACC where the patient/caregiver can reach a CPS or trained ACC administrative personnel during normal business hours Monday through Friday, 08:00 – 16:30. The direct phone number for patients is 916-843-7209.

a) The CPS will instruct patients to contact the VANCHCS Advice Nurse at 1-800-382-8387 for questions regarding anticoagulation outside of normal business hours.

5. All patients initiated on warfarin must have an INR measurement within 7 days of initiation, although INR measurement within 4 days is recommended. Patients currently stabilized on warfarin outside the VA are exempted from this requirement.

6. Providers should use the VHA Clinical Pharmacy Practice Office (CPPO) PBM Strong Practice Recommended Warfarin Management Algorithm, Initiation Phase of Therapy, for guidance on warfarin dose in new start patients (Supplement 1).

7. The INR should be checked every 3-4 days, until the patient has achieved three in-range INR results.

8. Once the patient has achieved three in-range INR results, the provider should reference Supplement 2, VHA CPPO PBM Strong Practice Recommended Warfarin Maintenance Algorithm. The subsequent INR should be checked within 7 days, to assess INR stability before extending follow up. The frequency of ongoing monitoring is defined in Supplement 3 of this Attachment.

9. Whenever possible, patients should only be prescribed one tablet strength of warfarin to minimize risk for confusion. If prescribing only one tablet strength is not possible, the provider must give the patient additional instructions on how to use multiple tablet strengths.

a) A separate orderable item for each warfarin tablet strength is available in CPRS. If the patient requires multiple tablet strengths of warfarin, the patient must have separate orders placed for each strength.

10. Warfarin orders must be placed in CPRS and only the standardized warfarin order must be used. Providers must not “free-text” warfarin orders. The patient instructions “to help prevent clots. Caution: Dose may change after blood test; see most recent dosing information” must appear on the patient’s vial.

11. Ordering of warfarin tablets is limited to ACC providers.

a) Patients on warfarin co-managed by their VA primary care provider and external non-VA provider will have their warfarin tablets ordered by their VA primary care provider. The VA primary care provider is assuming responsibility to ensure the patient will have their external laboratory monitoring recorded in CPRS using the “outside lab results” template so that outside laboratory results may be tracked in CPRS. Frequency of monitoring must be consistent with frequency in patients monitored by the ACC.

b) Warfarin prescriptions are limited to a 60-day supply.

12. The ACC provider will add the ICD-10 diagnosis code of Z79.01, “long-term current use of anticoagulants” to the patient’s problem list.

13. The VANCHCS Anticoagulation Clinic is not responsible for the management of anticoagulation therapy until the patient has completed their first clinic visit. The referring provider is responsible for monitoring the patient’s anticoagulant until the patient’s first clinic visit.

a) The referring provider is responsible for ordering PT/INRs, making warfarin dose adjustments, and communicating a warfarin dosing plan to the patient until the first clinic visit. The referring provider may contact the ACC for warfarin dosing assistance.

B. Maintenance of Warfarin

1. Providers should use the VHA Clinical Pharmacy Practice Office PBM Strong Practice Recommended Warfarin Management Algorithm, Maintenance Phase of Therapy, for guidance on warfarin dose in stable patients (Supplement 2).

2. All INR results must be reviewed and clinically evaluated no later than the close of the next business day in accordance with VHA Directive 2009-019, Ordering and Reporting Test results. Patients will abnormal INR results will be called via phone. Patients will receive a letter sent via U.S. Mail or secure message sent via computer with their next INR appointment date.

I. Providers must schedule regular INR follow up for patients according to Supplement 3, Frequency of INR testing.

4. A critical INR value (5.0 or above) has been established and listed in the laboratory VistA software package. Procedures for the communication of critical INR results from the laboratory to the ordering provider are described in VANCHCS Policy Statement 11-51, Ordering and Reporting Patient Test Result and attachments.

a) The CPS receiving the critical INR value from laboratory staff must document in CPRS the treatment actions taken in response to the critical INR.

b) The CPS will follow Supplement 4, Management of Supratherapeutic INRs.

c) Patients must be contacted immediately upon receipt of the critical INR result.

(1) During business hours (Mon – Fri 08:00 to 16:30), laboratory staff should contact the ACC at 916-843-7286 to notify of the critical INR result.

(2) Outside of business hours, the laboratory staff should contact the ED physician on duty.

5. Any time a warfarin dose change is made, the ACC provider will give written instructions to the patient either via letter or secure message. The patient may decline the written instructions.

C. Peri-Procedural Management of Anticoagulants

1. Anticoagulants will be managed in the perioperative time according to the guideline in Attachment A.

2. The VA or non-VA provider performing the procedure is responsible to inform the ACC as soon as possible, once a date is confirmed for the patient’s procedure. With input from the VA or non-VA provider performing the procedure and/or PCP, the ACC staff will coordinate a peri-procedural plan for the patient.

3. The ACC will communicate the anticoagulant peri-procedural plan to the patient.

4. The VA or non-VA provider performing the procedure is responsible to advise the patient when to resume their anticoagulation post-operatively. The patient will also be instructed by ACC staff to notify the ACC after their procedure is complete to ensure they resume their anticoagulant appropriately.

5. The VA or non-VA provider performing the procedure is responsible to also advise the ACC with the plan for when the patient should resume their anticoagulant.

D. Laboratory Testing

1. All laboratory tests for anticoagulation management should be performed at a VA laboratory, to ensure accuracy of results and retrievability of information.

a) Should a patient require a laboratory test to be performed outside of a VA laboratory, an ACC provider can order the tests to be performed outside of the VA laboratory. The patient’s PCP may be required to co-sign the outside laboratory orders, if requested by the outside lab.

(1) The ACC provider will fax a signed order to the outside lab. The order will contain contact instructions on how to communicate results to the ACC.

(2) If the lab results are not received by the ACC when they are due, the ACC staff will call the outside lab to fax the results to the ACC.

(3) Once the lab results are obtained, they will be documented in CPRS via the “outside laboratory results” template.

2. Baseline laboratory monitoring are required for each of the following anticoagulation agents, in accordance with ACCP guidelines, as follows:

a) LMWH/Factor-Xa inhibitors: CBC with platelets, serum creatinine

b) Heparin: CBC, aPTT

c) DOACs: CBC with platelets, serum creatinine

d) Warfarin: CBC with platelets, PT/INR

(1) A baseline CBC and PT/INR must be completed prior to a patient starting warfarin therapy. The baseline PT/INR must be drawn via venipuncture. Baseline PT/INR must not be performed using point of care testing (POCT) devices.

3. Ongoing laboratory monitoring are required for each of the following anticoagulation agents, in accordance with ACCP guidelines, as follows:

a) LMWH/Factor-Xa inhibitors: CBC with platelets, serum creatinine

b) Heparin: CBC, aPTT

c) DOACs: CBC with platelets, serum creatinine

d) Warfarin: CBC with platelets, PT/INR

E. Drug-Drug Interactions

1. The ACC must be notified in a timely manner of critical drug-drug interactions with anticoagulant medications.

a) Providers ordering the medication that interacts with the patient’s anticoagulant must notify the ACC by phone, note with co-signature in CPRS, or secure email.

b) Outpatient pharmacists verifying the prescription order should also notify the ACC by phone, note with co-signature in CPRS, or secure email of the drug-drug interaction.

2. The ACC provider is responsible to assess the drug-drug interaction and to complete the following:

a) Determine if adjustment of the anticoagulant dose is necessary.

b) Communicate to patient the plan for anticoagulant dose adjustment (if necessary) and follow-up laboratory testing. The ACC staff will place orders for any necessary follow-up laboratory testing of the anticoagulant.

F. Quality Assurance

1. The ACC staff will coordinate with the patient’s primary care provider to complete appropriate and periodic risk-benefit assessments for all patients receiving anticoagulant therapy and managed in the anticoagulation management program. Components of the risk-benefit assessment include:

a) Patient adherence to therapy.

b) Degree of control with warfarin, measure by time in therapeutic range (TTR).

c) Risk of bleeding and any major changes to that risk.

d) Risk of thrombosis and any major changes to that risk.

e) Change in patient’s parameters such as kidney and/or liver function.

f) Change in general health, frailty, fall risk, and other possibly relevant considerations.

2. The time in therapeutic range (TTR) is reviewed quarterly at the Pharmacy Quality Improvement meeting. This information is presented quarterly at the Pharmacy and Therapeutics meeting.

3. Patients who have not had an INR in the last 42 days are tracked via the VISN 21 Anticoagulation Performance Measure. This report is monitored by the ACC staff and used to contact patients who are overdue for their INR.

4. The proportion of patients with pathologic bleeding and/or thromboembolic events are presented quarterly at the Pharmacy and Therapeutics meeting.

5. Patient incidents, close calls, and near misses associated with an anticoagulant are presented quarterly at the Pharmacy and Therapeutics meeting.

G. Education Plan for Anticoagulation Clinical Staff

1. On a quarterly basis, the results of the quality assurance program and any performance improvement activities will be shared with the ACC staff. This information may be communicated through the Clinical Pharmacy Practice Council, the Quality Improvement meeting, or other suitable means.

2. Education based on locally identified needs (e.g. new algorithms or polices, emerging information regarding anticoagulation) will be delivered to ACC staff. VA educational programs as options for staff education will be provided to ACC staff.

H. Patient Education

1. Patient and/or caregiver understanding of anticoagulant therapy will be assessed and education will be provided. Anticoagulant education may be done one-on-one or by a group class. Documentation of education will be made in the medical record.

2. Patients will be given or mailed supplemental education materials specific to their anticoagulant. In addition, patient’s will receive an anticoagulation clinic pamphlet detailing how to cancel/reschedule appointments, no-show policy, clinic days/hours of operation, clinic phone number, VANCHCS laboratory locations, and how to plan for times when the patient may be out of town for extended periods of time.

3. Warfarin education will include, but is not limited to:

I. Reason (indication) for taking warfarin and INR goal.

I. Warfarin dosing instructions (exact dose and frequency of administration).

I. Warfarin tablet identification. Each strength of warfarin tablet has a different color. Know the color of your warfarin tablet. This color should not change unless our clinic advises you of a change to your warfarin tablet strength.

I. Proper storage of warfarin tablets (i.e. room temperature).

I. Be sure all health care providers (nurses, physicians, dentists, etc.) know you are taking warfarin.

I. Missing even one dose of warfarin can increase your risk of forming a harmful blood clot. Do not stop warfarin without discussing with your medical provider.

I. Take a missed dose as soon as possible the same day. Do not take a double dose of warfarin the next day to make up for a missed dose. Keep track of missed doses and report to your anticoagulation provider.

I. Warfarin requires regular visits for monitoring by a blood test known as the “PT/INR.” The PT/INR is an important test to ensure you continue to receive the correct warfarin dose.

I. Many drugs interact with warfarin. Avoid aspirin or nonsteroidal anti-inflammatory agents unless directed by your physician. Be sure your pharmacist and physician are aware you take warfarin.

I. Report changes in prescription and over-the-counter medications, vitamins and herbal supplements because many medications and supplements may interact with warfarin. Report these changes to your Anticoagulation Clinic.

I. Vitamin K and major dietary changes can affect the INR. Keep diet steady and consistent in amount of vitamin K rich foods. These include green leafy vegetables such as broccoli, cabbage, collard greens, kale, spinach, salads. Avoid major changes in dietary habits or notify your anticoagulation provider before changing habits.

I. Avoid or limit alcohol as alcohol can increase fall and bleeding risk.

I. Be watchful for signs of a blood clot or stroke.

I. Signs of a blood clot include: arm/leg pain, swelling, increased warmth, sudden onset of shortness of breath or chest pain.

I. Signs of a stroke include: one sided weakness or numbness, sudden vision change, speech difficulty, sudden onset of headache or dizziness.

I. Warfarin may increase the risk of prolonged bleeding. Seek medical attention for signs of bleeding.

I. Report symptoms of bleeding such as nose/gum bleeding, unusual bruising, change in stool to red or black, change in urine color to pink or rusty, prolonged bleeding after cuts to your medical provider or go to the nearest emergency room.

I. Seek medical attention after serious trauma, fall or head injury.

I. During business hours, call the Anticoagulation Clinic for any questions related to warfarin therapy. If you need to cancel or reschedule your INR draw, call the clinic.

I. During non-business hours, call the VETS Connect number 1-800-382-8387 for non-urgent questions/problems related to warfarin therapy.

I. DOAC education will include, but is not limited to:

I. Reason (indication) for taking the DOAC.

I. Name of specific DOAC, both generic and brand.

I. Be sure all health care providers (nurses, physicians, dentists, etc.) know you are taking a DOAC.

I. Proper medication storage. For dabigatran, store in original container and use within 60 days of opening bottle.

I. DOAC dosing instructions (exact dose and frequency of administration).

I. Missing even one dose of DOAC can increase your risk of forming a harmful blood clot. Do not stop DOAC without discussing with your medical provider.

I. Take a missed dose as soon as possible the same day. Do not take a double dose of DOAC the next day to make up for a missed dose. Keep track of missed doses and report to your anticoagulation provider.

I. Kidney and live function are monitored by blood tests while taking this medicine.

I. Some drugs interact with the DOAC. Avoid aspirin or nonsteroidal anti-inflammatory agents unless directed by your physician. Be sure your pharmacist and physician are aware you take a DOAC.

I. Report changes in prescription and over-the-counter medications, vitamins and herbal supplements because some medications and supplements may interact with the DOAC. Report these changes to your Anticoagulation Clinic.

I. Avoid or limit alcohol as alcohol can increase fall and bleeding risk.

I. Be watchful for signs of a blood clot or stroke.

I. Signs of a blood clot include: arm/leg pain, swelling, increased warmth, sudden onset of shortness of breath or chest pain.

I. Signs of a stroke include: one sided weakness or numbness, sudden vision change, speech difficulty, sudden onset of headache or dizziness.

I. DOACs may increase the risk of prolonged bleeding. Seek medical attention for signs of bleeding.

I. Report symptoms of bleeding such as nose/gum bleeding, unusual bruising, change in stool to red or black, change in urine color to pink or rusty, prolonged bleeding after cuts to your medical provider or go to the nearest emergency room.

I. Seek medical attention after serious trauma, fall or head injury.

I. During business hours, call the Anticoagulation Clinic for any questions related to DOAC therapy. If you need to cancel or reschedule your blood draw, call the clinic.

I. During non-business hours, call the VETS Connect number 1-800-382-8387 for non-urgent questions/problems related to DOAC therapy.

I. Patient self-testing of INR

1. Patient self-testing of INR is not permitted at the VANCHCS.

2. Per VHA Directive 1138.01, the VISN Director is responsible to determine whether self-testing will be utilized within the VISN as a means of providing monitoring of INR. Should the VISN 21 Director determine self-testing to be appropriate, the VANCHCS ACC will re-evaluate if self-testing will be implemented locally.

J. Transitions between patient care settings

1. Monitoring for clinical outcomes, laboratory outcomes, food-drug interactions, patient adherence, and coordinated transition across the continuum of care is routinely performed by the provider to ensure that anticoagulation therapy is individualized and the likelihood of adverse events is minimized. In the inpatient setting (Sacramento VA Medical Center and Community Living Center in Martinez), clinical pharmacists in collaboration with the patient’s treating team will be responsible for anticoagulation monitoring. In the outpatient setting, close monitoring is achieved through enrollment in the VA Northern California ACC.

2. At discharge from an inpatient setting, regardless of patient’s disposition, the inpatient clinical pharmacist will notify the ACC. This notification may be done by phone, encrypted email, or by adding the CPS as an additional signer to a note in CPRS of plan to discharge the patient.

3. For patients discharged to home, the ACC will make an appointment to follow-up with the patient within 7 days of discharge. This appointment will review the inpatient stay for any pertinent changes that may affect the INR.

4. For patients discharged to home, a post-discharge INR must be done within 7 days of discharge.

5. Patients discharged to long term care facilities (e.g. skilled nursing facilities, acute rehab, etc.) do not have INR monitoring by the ACC. Once discharged from the long-term care facility, the ACC will schedule the patient follow-up within 7 days of discharge.

K. Non-adherence, No-Show, and Discharge Policy

a) The CPS will follow the discharge procedures as outlined in Supplement 5 should a patient display a pattern of no-showing appointments, non-adherence to anticoagulation clinic instructions, or non-adherence to return-to-clinic dates.

L. VANCHCS Anticoagulation Clinic Contact Information

1. The business hours of the clinic are Monday-Friday 08:00 – 16:30.

2. VANCHCS staff may reach the anticoagulation clinic during business hours at 916-843-7286. This number is for internal use only and should not be used by patients.

3. For questions regarding anticoagulation outside of normal business hours, VANCHCS staff may contact the inpatient pharmacy at 916-843-7060.

4. Patients can reach the clinic during business hours at 916-843-7209. Outside of normal business hours, patients can contact the advice nurse at 1-800-382-8387.

Supplement 1: Warfarin Dosing – Initiation Dosing Algorithm

Step 1: Begin with 5 mg or 2.5 mg daily (if patient requires a lower dose).

Lower initial dosing may be appropriate based on the following patient characteristics:

· Age (generally, frail elderly patients are more sensitive to warfarin)

· Weight (generally, low body weight or malnourished patients are more sensitive to warfarin)

· Past medical history (including liver dysfunction, heart failure, end-stage renal disease, hyperthyroidism, or recent major surgery)

· Social history (including alcohol and tobacco use)

· Interacting medications (prescription, herbal, and over-the-counter products)

· Dietary habits and nutritional status (especially dietary vitamin K content)

· Acute illness (including loss of appetite, fever, vomiting, and diarrhea)

· Risk factors for bleeding (including bleeding disorder, history of bleeding, peptic ulcer disease, history of hemorrhagic stroke, high fall risk, and hypertension) Step 2: Follow warfarin dosing adjustments based on INR results

Additional Considerations:

( If patient has not attained an in-range INR result by Day 14, continue Day 11-14 routine until INR is in-range.

( Holding the dose may complicate efforts at dose-finding and is not usually necessary. In our opinion, it should be reserved for INR values above 5.0 in the initiation phase, when bleeding risk is thought to be very high. For less extreme INR elevations, a dose decrease should be sufficient, especially given that follow-up will be quite soon thereafter.

( In some cases, the following may be considered: For patients sufficiently healthy to be treated as outpatients, we suggest initiating VKA therapy with warfarin 10 mg daily for the first two (2) days followed by dosing based on INR measurements (Grade 2C). [CHEST 2012]

( When the patient has achieved three (3) in-range INR results, use the VISN 1 Anticoagulation Management Algorithm (Maintenance Phase of Therapy).

Adapted from the VHA CPPO Pharmacy Benefits Management (PBM) Strong Practice Recommended Warfarin Management Algorithm (Initiation Phase of Therapy).

Supplement 2: Warfarin Dosing – Maintenance Dosing Algorithm Goal of INR 2.0-3.0

Adapted from the VHA CPPO Pharmacy Benefits Management (PBM) Strong Practice Recommended Warfarin Management Algorithm (Maintenance Phase of Therapy). Revised 07/03/2014. Here.

Supplement 2 (continued): Warfarin Dosing – Maintenance Dosing Algorithm Goal of INR 2.5-3.5

2.50-3.50

(in-range)

No change in dose. See Attachment XXX for follow-up guidance.

Adapted from the VHA CPPO Pharmacy Benefits Management (PBM) Strong Practice Recommended Warfarin Management Algorithm (Maintenance Phase of Therapy). Revised 07/03/2014. Here.

Disclaimer/Guide to Use: In a well-designed before and after trial, the use of this algorithm improved percent time in range (TTR) by 6%3 While clinicians will override these recommendations at times, they should keep in mind that when this algorithm was tested, patients whose management conformed most closely to the algorithm had the best TTR. Additional Recommendation: In addition to this algorithm, ACC clinicians are urged to avoid nonstandard target INR ranges such as 2-2.5 or 1.8-2.5. The 2012 CHEST Guidelines state that there should be two target ranges in clinical practice: 2.5-3.5 for patients with mitral prosthetic valves and 2-3 for everyone else.4 In some instances, practitioners may choose a goal of 2.5-3.5 for patients with aortic prosthetic valves with additional risk factors. This is the recommendations from the most recent AHA guidelines and may be used at the recommendation of a referring provider.5 Other target ranges do not provide additional benefit and place patients at higher risk, and should be avoided.

Supplement 3: Frequency of INR Testing Step 1

Every three to four days until INR is stable

Step 2

Weekly until INR stable for two tests

Step 3

Every two weeks until stable for two tests

Step 4

Monthly for three months

Step 5

Every 6-8 weeks in those who have been stable for 3 months

After every unexplained change in INR, the patient starts the cycle over at Step 2 or 3, as appropriate.

Supplement 4: Management of Supratherapeutic INRs