36C25019R0093-018.pdf

VA NORTHERN INDIANA HEALTH CARE SYSTEM (VANIHCS)

September 2016 POLICY NO. 119-10-16

ANTICOAGULATION POLICY

1. PURPOSE: To define procedures and responsibilities for anticoagulation throughout VA Northern Indiana Health Care System (VANIHCS). This Policy will help ensure compliance with The Joint Commission (TJC) National Patient Safety Goal (NPSG) requirement 3E on anticoagulation therapy management. A coordinated and focused approach to the management of anticoagulation therapy by a specialized program can improve clinical outcomes (compared to “routine or usual medical care”) by improvement of therapeutic control and lessening of the frequency of hemorrhage or thrombosis.

2. POLICY: The Policy of VANIHCS is that eligible Veterans receiving anticoagulation therapy will be closely monitored for safety, effectiveness, and potential complications of therapy by the anticoagulation provider. Communication between the patient and the health care provider, as well as patient and family education, will be given high importance.

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 Clinical Executive Board (CEB), and follow the guidance included in the related 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 (UFH) 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 Department of Veterans Affairs (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, UFH, low molecular weight Heparin (LMWH), other parenteral anticoagulants (e.g., Fondaparinux or Argatroban), and direct oral anticoagulants (DOAC) such as Dabigatran, Rivaroxaban, or Apixaban. For purposes of this Policy, the term “anticoagulant” refers to anticoagulation therapy or long-term anticoagulation prophylaxis (e.g., atrial fibrillation)

POLICY NO. 119-10-16

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. Anticoagulation Provider: The term anticoagulation provider refers to a provider who is currently trained and skilled in in managing anticoagulant therapy.

Anticoagulation providers may be Clinical Pharmacy Specialists (CPS), Advanced Practice Registered Nurses (APRN), Physician Assistants (PA), and/or physicians. The anticoagulation provider is an active member of the anticoagulation management program, is responsible to monitor the quality of his or her clinical practice, and has prescriptive authority defined in their scope of practice or clinical privileges that includes anticoagulants.

e. Anticoagulation Management Program: The term anticoagulation management program, often commonly referred to as an “anticoagulation clinic" (ACC), refers to a coordinated program where anticoagulation providers manage anticoagulants for inpatients and outpatients within the facility. In addition to the clinical practice aspect, the program also encompasses broader functions including coordinating Policy and Quality Assurance (QA) relevant to anticoagulation management at the facility.

f. Facility Anticoagulation Program Manager: The anticoagulation program manager is an anticoagulation provider that serves as the 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. The anticoagulation program manager is generally a CPS with a scope of practice; however, other providers may be designated based on local facility needs.

g. Anticoagulation Support Staff: Anticoagulation support staff refers to a group of professionals assigned to the anticoagulation management program that perform day-to-day operational support functions. Anticoagulation support staff may include, but are not limited to, pharmacy technicians, nurses, 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. Independent Practitioner: The term “independent practitioner” is any individual permitted by law (the statue which defines the terms and conditions of the practitioner’s license) and the facility to provide patient care services independently; i.e., without supervision or direction, within the scope of the individual’s license, and in accordance with individually granted clinical privileges. This is also referred to as licensed independent practitioner (LIP).

i. Mid-level Practitioner: The term “mid-level practitioner” refers to an associated health professional that is not an independent practitioner and is directly providing management of the anticoagulant therapy (e.g., clinically evaluating and acting on test results, adjusting doses, or prescribing medication).

j. ACC Technician: ACC Technician refers to Clinical pharmacy technicians who work in collaboration with pharmacists in conducting POC International Normalized Ratio (INR) testing, interviewing and triaging patients, managing clerical operations and following policy guidelines set forth by those providing clinical oversight.

k. INR: INR is a standardized measure of the prothrombin time (PT), which is used to determine the clotting tendency of blood for a patient receiving Warfarin therapy. The INR is the ratio of a patient's PT to a normal (control) sample, raised to the power of the International Sensitivity Index (ISI) value for the reagent system used.

l. 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. 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.

n. 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 (periprocedural bridging).

o. Parent Facility: The term parent facility, also called the primary facility, refers to a

VA medical facility that has a three-digit station number. A parent facility may be a standalone medical facility or it may be the parent facility of an integrated set of facilities, often called a health care network.

p. DOAC: A DOAC encompasses several drug classes and includes, but is not limited to, Dabigatran, Rivaroxaban, and Apixaban. DOAC refers to oral anticoagulant medications that target one or more specific steps in the coagulation cascade.

4. RESPONSIBILITIES:

a. Facility Anticoagulation Program Manager: The facility anticoagulation program manager is responsible for the following functions related to the anticoagulation program at the facility level:

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

(2) Developing medical facility 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.

(3) Promoting learning and unified practice for the anticoagulation management program through activities such as educational initiatives, regular staff meetings, and journal clubs.

(4) Coordinating and reporting QA activities and results for the anticoagulation management program through the P&T Committee (or appropriate facility governing body) and CEB, as appropriate.

(5) Coordinating the facility 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, PAs, and physicians).

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

b. Primary Care Provider (PCP) is responsible for the Veteran’s routine primary care

c. The Facility Anticoagulation Providers are responsible for:

(1) Managing anticoagulation patients in accordance with facility and Veterans

Health Administration (VHA) Policy including, but not limited to, coordination of anticoagulation management for patients transitioning between care settings (e.g., inpatient to outpatient), periprocedural anticoagulation, and traveling Veterans.

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

(3) 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.

(4) 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.

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

(6) 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.

d. The ACC Pharmacist is responsible for:

(1) Communicating with PCPs regarding special instances, including non-compliant or uncooperative patients, discharge of patients from the clinic, perceived hemorrhagic or thromboembolic complications to treatment, and appropriateness of or need for continued anticoagulation therapy.

(2) Notifying PCPs of the occurrence of critical level anticoagulation (INR greater than five [5]) in their assigned patients and a treatment plan for managing the situation.

(3) Referring triaged patients with complications to anticoagulation therapy or other health care-related issues to proper areas or individuals for evaluation, treatment, and/or education.

(4) Consulting with PCPs regarding formulation of a treatment plan for their patients who plan to undergo an invasive dental or surgical procedure and assistance in the establishment of a periprocedural treatment plan when requested by the PCP. In addition in high-risk and complex patients, consultation with the specialty provider related to the patient's anticoagulation is strongly encouraged.

(5) Directly supervising CPS in-training/students working in the ACC and co-signing student notes. For billing purposes, the CPS is responsible for entering a separate note.

e. Chief, Nutrition & Food Service (N&FS) is responsible for ensuring that:

(1) Warfarin is included in the N&FS established food and medication interaction program.

(2) Process is established to notify N&FS of patients receiving meal services that are also receiving Warfarin therapy.

(3) N&FS 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 Service (PALMS) is responsible for:

(1) Ensuring a critical INR value is established and listed in the Laboratory

Veterans Health Information System and Technology Architecture (VISTA) software package.

(2) Establishing a Standard Operating Procedure (SOP), in conjunction with the anticoagulation program manager, for the communication of critical INR results from the Laboratory to the ordering 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 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.

(5) 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.

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

(8) Educating staff providing clinical services in an outpatient ACC and staff involved in home anticoagulation therapy management on national and local Laboratory Policies related to POCT and patient self-testing.

g. The Facility Ancillary Testing Coordinator is responsible for:

(1) Assessing the competency of staff involved in ancillary testing, and

(2) Documenting training, authorization, and annual competency evaluation for all staff that perform ancillary testing.

h. Program Support Assistant (PSA) is responsible for:

(1) Maintaining current telephone numbers and addresses in VISTA for all patients enrolled in the ACC.

(2) Appropriate and prompt scheduling or rescheduling of new or return ACC appointments as ordered by ACC professional staff or Primary Care staff.

(3) Referring all telephone requests for cancellation/change of ACC appointments (when the change exceeds a three-day period) to ACC professional staff or Primary Care staff.

(4) Initiating follow-up contact with patients who cannot be reached by ACC staff or Primary Care staff through use of usual and customary methods. This may include an “after-hours” telephone search and/or written communication requesting that patients call back during regular work hours to review Laboratory results with an ACC professional staff member or Primary Care staff member.

i. The Medical Center Director is responsible for ensuring:

(1) A medical facility Policy exists at the facility that meets all standards identified in the Anticoagulation Therapy VHA Directive 1033 Attachment. 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) An Anticoagulation Program Manager has been designated to lead the medical facility’s anticoagulation management program and has been provided with appropriate time to fulfill these duties consistent with the complexity of the local anticoagulation program. NOTE: The role of the anticoagulation program manager involves a considerable time commitment and the dedicated effort of a highly committed individual ensures a program that is high functioning, successful, and sustainable.

(4) 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.

(5) The anticoagulation management program has an appropriate staff to patient ratio to provide safe and appropriate care as defined in the Attachment to the Anticoagulation Therapy VHA Directive 1033.

(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 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.

(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, or subsequent Policy issue.

(8) For medical facilities employing INR patient self-testing, a written Policy is in place that includes a systems assessment for safety prior to implementation and is in compliance with all applicable Laboratory accreditation standards and Policies.

(9) The medical facility uses programmable infusion pumps for inpatients receiving parenteral anticoagulants, including but not limited to, UFH, Argatroban, and Bivalirudin.

(10) The medical facility employs standardized, evidence-based, algorithms for the management of patients on anticoagulants as defined in the Attachment to the Anticoagulation Therapy VHA Directive 1033.

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

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

(1) 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 facility level. NOTE:

In the event a facility-level physician lead cannot be identified, a Veterans Integrated Service Network (VISN)-level physician champion may be utilized.

(2) Ensuring that all medical facility Policies governing the provision of anticoagulation management are approved by CEB. Anticoagulation providers will collaborate in the development of medical facility guidelines/algorithms for anticoagulants.

(3) Ensuring that clinical staff who are directly involved in caring for patients receiving anticoagulation therapy (e.g., nurses, clinical pharmacists, pharmacy technicians, registered dietitian/nutritionists, APRNs, PAs, and physicians) are educated on the importance of anticoagulation safety and its associated risks, as well as the principles of anticoagulation management, as appropriate.

(4) Reviewing QA information for the facility anticoagulation management program at appropriate and regular intervals through the P&T Committee (or appropriate facility governing body) and CEB, as appropriate.

(5) Ensuring the competency of non-pharmacist anticoagulation providers and clinical staff directly involved in caring for patients receiving anticoagulation therapy to include minimum components outlined in paragraph 4. a. (6) of the Anticoagulation Therapy VHA Directive 1033.

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

k. The Chief, Pharmacy Service is responsible for:

(1) Ensuring that a CPS anticoagulation provider is identified as the pharmacy anticoagulation management champion to be actively involved in defined components of the anticoagulation program at the facility level. This champion may be the anticoagulation program manager and serves to advocate for and support anticoagulation initiatives at the facility.

(2) Assessing the competency of CPS anticoagulation providers and pharmacy technicians who serve in the anticoagulation management program to include the minimum components outlined in paragraph 4. a. (6) of the Anticoagulation Therapy VHA Directive 1033.

(3) 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.

(4) 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.

(5) 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, Pharmacy Service.

(6) 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 cubicle) and clearly labeled as high alert medications.

5. PROCEDURES:

a. Staffing and Supervision:

(1) CPS: In Fort Wayne, Marion, Muncie CBOC, and Peru CBOC, the clinic will be staffed by CPSs. The training of the anticoagulation pharmacists will be supervised by the Facility Anticoagulation Program Manager. CPSs will be trained to conduct POC INR testing on patients. The additional responsibility of quality control on the POC INR machine may be delegated by lab. CPSs functioning under the Anticoagulation scope of practice are expected to complete continuing education in anticoagulation on an annual basis.

(2) Pharmacy Students: Pharmacy students will work in the clinic during their Ambulatory Care rotation. Students will be supervised by the CPS. Students may initiate notes for signature by CPSs.

(3) Pharmacy technicians will work in the clinic conducting POC INR testing on intended patients, along with completing the patient interview. Other responsibilities include quality control of POC INR machine and inventory management as delegated by responsible departments.

(4) Registered Nurse (RN): Staffing of the South Bend CBOC Coumadin Clinic will include RNs. The RNs will be supervised by the PCP. RNs will use point of care to obtain the INR. Dose adjustments and plans for monitoring will be made after conferring with the PCP. Dose adjustments and monitoring should be made based on the guidelines attached in the Policy.

(5) Licensed medical assistants (MA) and licensed practical nurses (LPN) will work in the clinic conducting POC INR testing on intended patients for the cardiovascular clinics. Other responsibilities include quality control of POC INR machine, scheduling, and inventory management as delegated by responsible departments.

b. Consultation and Referral: All patients with an active prescription for anticoagulants prescribed by VANIHCS providers must be referred to the ACC via electronic consult in the Computerized Patient Record System (CPRS). All fields of the consult must be completed. If there is no mechanism to contact the patient (e.g., no phone or no stable address), the referring provider should perform a risk/benefit assessment prior to initiating Warfarin therapy. Consults will be assigned to the ACC which will determine appointment date. The anticoagulation pharmacist will also complete a chart review prior to the patient’s scheduled appointment, which will be entered as a note in CPRS. Responsibility for monitoring is in the hands of the referring provider until the patient is seen in the ACC. The Emergency Department (ED) or Urgent Care (UC) may be used in the interim for anticoagulation monitoring until the patient is seen in the ACC.

(1) Chart review:

(a) New patients: Clinical information will include diagnosis, pertinent procedures/imaging, pertinent labs, current anticoagulant dosing, past medical history, and current medication list. The chart review will be entered as a CPRS note or consult comment.

(b) Hospital discharge patients not new to Warfarin: Clinical information will include a summary of the patient’s hospitalization, medication changes, pertinent labs/procedures, anticoagulation during hospitalization, INR, and anticoagulant dose at discharge. The review will be entered in CPRS. Additionally, an addendum will be added to the last ACC note alerting to the new chart review. An Anticoagulation New visit will be scheduled at the discretion of the evaluating pharmacist.

(c) Patients transferring care from a non-VANIHCS provider will be scheduled for an Anticoagulation New visit at the discretion of the evaluating pharmacist.

(d) Requests for Periprocedural recommendations.

(2) Criteria for enrollment:

(a) All patients receiving Warfarin from the VHANIHCS pharmacy will be followed in the ACC. If the patient chooses to be managed by an outside provider, the patient’s prescription for warfarin must be obtained from the outside provider and purchased at non-VA pharmacy. VA pharmacy will only provide Warfarin to those patients whose anticoagulation is managed by VA clinics. All patients receiving non-VA Warfarin should have the medication added to their medication list as a non-VA medication for appropriate assessment and review of care.

(b) An entry will be made by the PCP or other ordering physician in the problem list of the medical record indicating that the patient is on anticoagulation and the reason for therapy. SNOMEDcode will be added to the problem list that denotes “Long-term (current) use of anticoagulants”.

(c) Patients must be followed routinely by the ACC and at least annually in a primary care clinic to receive Warfarin.

(d) Ordering of outpatient Warfarin and DOACs will be consult-driven to ensure the ACC team is notified of all new patients to receive anticoagulation therapy.

(3) Criteria for patients excluded/discharged from the clinic (VA will not provide Warfarin):

(a) Patients whose Warfarin therapy is monitored by non-VA health professionals.

(b) Patients who refuse to comply with the anticoagulation participation agreement (see link to Attachment A).

(c) Patients who refuse to comply with the Primary Care treatment plan.

(d) Patients who are not evaluated by their PCP at least annually.

(e) New patients not assigned to a PCP.

(f) Patients assigned to a PCP in a different location than the ACC clinic (i.e., patients with PCP at Indianapolis VA or Marion campus wanting to be followed at Muncie CBOC).

c. Laboratory tests:

(1) Warfarin:

(a) Baseline labs to be completed prior to Warfarin initiation: Complete Blood

Count (CBC), PT, INR.

(b) INR will be measured and put into the patient’s health record at each anticoagulation clinic appointment. CBC without differential will be measured at a minimum of every six months. When appropriate, results will be referred to the patient’s PCP or covering provider for appropriate assessment. Urinalysis (UA), hepatic function panels, and Fecal Occult Blood Test (iFOBT) may be ordered when appropriate.

(c) For a patient to receive Warfarin therapy, a current INR must be available.

(d) If a patient is on a Heparin product (UFH or LMWH) with an INR value

≥2.9, the INR must be confirmed via venous draw.

(e) All INRs >4.99 must be confirmed via venous draw.

(2) Other anticoagulants:

(a) UFH baseline and routine labs to be completed: CBC and a partial thromboplastin time (PTT).

1 Heparin response curves are developed by the Laboratory and are lot number specific. Pharmacy will notify the Laboratory Coagulation Department when new lot numbers of Heparin are received.

2 Baseline and routine labs to be completed are CBC and a PTT.

(b) LMWH or Factor Xa inhibitor: CBC and serum creatinine. (See link to Attachment B for converting new oral anticoagulants from or to Warfarin and other anticoagulants).

(c) DOAC:

1 Baseline labs to be completed prior to Target Specific Oral

Anticoagulants (TSOAC) initiation: CBC, Liver Function Test (LFT), and serum creatinine.

2 CBC and creatinine (LFT when clinically indicated; e.g., history of cirrhosis or liver disease) to be monitored at three months after initiation and every six- 12 months thereafter (six months for age≥80 years old and/or CrCl~30-59ml/min).

d. Patient, Family, and Caregiver Interview/Education:

(1) Initial visit (to be performed by the CPS):

(a) Written and verbal educational material will be provided. This includes information on anticoagulant indication, Laboratory definitions, risks of supra- and sub-therapeutic INR values for Warfarin, missed doses, drug/diet/disease/alcohol/tobacco interactions as applicable to the clinical situation, compliance, and “red flag” symptoms for which to seek medical attention. Comprehension of material will be assessed, documented, and will guide future education.

1 If needed, patients may be referred to a Clinical Dietitian for diet education.

2 Patients will be instructed to take Warfarin in a single daily dose at the same time every day, preferably at 5:00 p.m.

3 Warfarin shall be available in 2 mg and 5 mg strengths for outpatient use. If appropriate, clinically-stable patients may remain on other strengths. Additional tablet strengths (e.g., 1 mg, 10 mg, etc.) may be available on a restricted basis for those patients who require very low or high Warfarin dosages. Outpatients will be supplied only one tablet strength of Warfarin.

(b) Review of Clinic Procedures: Clinic procedures will be discussed with the patient and adequate means of contacting the patient will be confirmed (i.e., phone number verification). Contact information (including evening/weekend phone numbers) for the clinic will be given to the patient.

(c) Medication and Social History: A medication and social history will be obtained from the patient and information relevant to anticoagulant therapy will guide dose decisions.

(d) Assessment:

1 Current anticoagulant dose, tablet/capsule strength, and source.

2 Upcoming procedure.

3 Recent ED or UC visits/hospitalizations.

4 Missed doses or departures from their current dose.

5 Unusual bleeding and bruising (expand as warranted).

6 Signs or symptoms of thromboembolic event.

7 Recent falls.

8 Changes in prescription and non-prescription medications and use of herbal and nutritional supplements.

9 Changes in diet, nutritional supplements, alcohol use, tobacco use, recreational drug use.

10 Need for prescription renewal.

(e) Medical alert identification jewelry will be offered and recommended to enrolled patients. A Prosthetics Consult will be placed for new and replacement jewelry.

(f) Patient-Provider Agreement will be reviewed and discussed at the initial visit. The patient and provider will sign the agreement. A copy will be provided to the patient and a signed copy will be scanned into the patient chart. All patients enrolled in the clinic must be presented the agreement (see link to Attachment A)

(2) Follow-up Visits: Educational material will be reinforced as needed in the context of follow-up interviews. At each visit, patients on Warfarin will be asked about the topics:

(a) Current anticoagulant dose, tablet/capsule strength, and source.

(b) Upcoming procedures.

(c) Recent ED or UC visits/hospitalizations.

(d) Missed doses or departures from their current dose.

(e) Unusual bleeding and bruising (expand as warranted).

(f) Signs or symptoms of thromboembolic event.

(g) Recent falls.

(h) Changes in prescription and non-prescription medications and use of herbal and nutritional supplements.

(i) Changes in diet, nutritional supplements, alcohol use, tobacco use, recreational drug use.

(j) Need for prescription renewal

e. Decision making (see link to Attachments C-F):

(1) Diagnosis and appropriate indication is confirmed at each visit.

(2) Determining Desired Therapeutic INR Range: The ACC will use the latest guidelines from the American College of Chest Physicians (ACCP) Consensus Conference on Antithrombotic Therapy unless otherwise specified by the provider/subspecialty responsible for initiating the ACC referral.

(a) Initial Visit: For Warfarin Dose Initiation Recommendation Guidelines, see link to Attachment C.

1 Document baseline lab INR (if available), LFTs, renal function, and CBC in the anticoagulation note.

2 Dose will be determined based on desired therapeutic range, date Warfarin was initiated, information gathered from interview, concomitant disease states/medications, current INR value, other pertinent lab values, and clinical judgment of the provider.

(b) Maintenance Visits: For recommended range of INR and recommended duration of therapy of anticoagulation therapy, see link to Attachment D.

1 Indication and need to continue anticoagulation will be reviewed at each visit.

2 VANIHCS CPS will see new patients and patients with INR > 3.0, INR < 2.0, patients recently discharged from hospital, patients pending a procedure that requires Warfarin interruption.

3 Pharmacy technicians will typically see patients where INRs are within the target range and may see patients recently discharged from the hospital at the discretion of the clinical pharmacist.

4 Nurse managed Warfarin clinic: RN will use approved protocol to guide therapeutic decision making.

5 Out-of-range INRs should be followed up with repeat measure in ≤ two weeks. Patients stable on therapeutic dose may be seen at ≤ four weeks. Patients stable for longer than six months on current dose may have extended monitoring frequency of up to eight weeks.

6 INRs will be assessed at each visit; CBC and comprehensive metabolic panel should be assessed every six months and annually respectively, or as needed.

7 All documentation addressing anticoagulation will be cosigned by a clinical pharmacist.

8 All patients with INRs > 4.99 from POC monitor will require a venipuncture CBC and PT/INR. All critical INRs must be addressed within 24 hours.

9 Risk/benefit should be documented initially and then annually thereafter or when circumstances warrant. Assessment may include adherence, time in therapeutic range, risk of bleeding, risk of thrombosis, renal and hepatic function, or changes to fall risk. It will be the responsibility of the ACC provider to notify the PCP when this needs to be done.

f. Communication of Plan: At all visits, patients will be informed of the following:

(1) Current INR reading and its relation to the desired therapeutic range.

(2) Justification for any medication adjustment: If the dose is changed or a new medication is initiated, written instructions via dosing sheets will be provided along with appropriate contact numbers (see link to Attachment G). Approximate time interval for next INR check will be communicated.

(3) Education regarding lifestyle changes will be offered as necessary.

(4) The need for a Warfarin prescription renewal will be assessed.

(5) Risks involved with non-adherence to plan.

g. Prescriptions:

(1) Warfarin prescriptions will be renewed or refilled as needed. In most cases, generic Warfarin and only one tablet strength will be supplied, with either 2 mg or 5 mg strengths primarily being utilized.

(2) No more than one refill will be given per 30 day supply unless another quantity is determined appropriate by the CPS. When patients prefer to purchase Warfarin via outside pharmacy, ACC pharmacist may write a prescription to be filled outside of the VA under the name of the consulting provider, if the provider is licensed in Indiana. In other cases, the PCP will be asked to prescribe the Warfarin. For stable patients, a 90 day supply (0 refills) will be allowed for economic reasons.

(3) The following information will be documented in CPRS: Warfarin tablet strength, directions, quantity, refills, date ordered, prescriber, and contact information of the pharmacy filling the prescription. If a dose adjustment is made, a new prescription will be ordered.

(4) In addition to the above, outpatient prescriptions for Warfarin should also be labeled with the statement, “or as directed by clinic.”

h. Outside Lab Results:

(1) In most cases, if a patient chooses to have their Warfarin monitored via non-

VA outside Laboratory facility, their civilian provider assumes responsibility for monitoring INR and prescribing Warfarin.

(2) Under certain circumstances and at the approval of the VANIHCS ACC provider, patients may be allowed to obtain outside lab testing at their own expense, with VANIHCS monitoring the provision of Warfarin. Patients are responsible for providing outside test results to the ACC within 48 hours of obtaining them. Laboratory values from outside facilities will be entered by medical records in CPRS and designated as a non-VA lab test with the following information: name of Laboratory and date of test. Only lab values from an accredited facility will be accepted.

(3) Patients may have PT/INR drawn at local VA facilities and still have monitoring done by the VANIHCS ACC at the discretion of the VA ACC provider.

(4) Home health care monitoring:

(a) Prior to managing anticoagulation via home health care services, a consult for ACC management of the patient’s Warfarin must be placed. A VA Geriatrics and Extended Care (GEC) consult should also be considered to coordinate home health care services.

(b) Interview shall be conducted with the patient or patient’s caregiver. If interview is performed by home healthcare nurse, the nurse shall complete the nurse questionnaire found in (see link to Attachment H) and fax to the ACC along with the INR result.

(c) Home health care agency must be able to drop off the patient blood sample at the nearest VA facility Laboratory for processing.

(d) Blood sample must be provided to lab Monday through Friday, no later than 2:00 p.m. For Muncie CBOC, blood sample must be dropped off at the clinic only Monday through Thursday, no later than 2:00 p.m.

(e) POC testing should not be accepted from home health care.

(f) All attempts will be made to prevent venous drawn INR from being processed by an outside facility. Per CPS clinical judgment, venous samples may be processed by an outside facility. This must be approved by the ACC provider prior to acceptance or shortly after initiation

1 INRs within the desired therapeutic range will be documented in CPRS and Warfarin prescriptions will be renewed if needed. In most cases, phone calls communicating the therapeutic range will be made under ACC Phone clinic. Patient and provider must mutually agree to make this telephone exchange. Criteria for telephone encounter include reliable communication (e.g., availability after lab drawn, reliable phone number).

2 If the INR result is outside of the desired therapeutic range; multiple attempts will be made to contact the patient within 48 business hours of receiving the lab result. Dosage adjustments will be made at that time with recommendations for next INR check. Telephone encounters will be documented in the electronic medical record and Warfarin prescriptions will be renewed as needed. Unsuccessful attempts to contact the patient will be documented and may lead to discontinuation of outside lab privileges.

(g) Standing orders for INR and CBC along with other labs may be provided to home health care agencies using (see link to Attachment I).

(h) Home Based Primary Care (HBPC): VA HBPC patients may have an INR drawn by the visiting nurse via venous drawn INR. Results will be called to the HBPC pharmacist to manage any anticoagulation therapy.

(i) Home INR monitoring:

1 Patients will not be provided with a home INR monitor or its supplies for self-POC testing.

2 Patients who currently have a home INR monitor must comply with the same procedures as all other Veterans.

3 Patients may not self-adjust Warfarin dose.

4 Patients must present to ACC for INR monitoring as advised by anticoagulation provider.

i. No Shows/Cancellations/Discontinued therapy:

(1) First or second consecutive no-show and/or cancellation:

(a) If the INR is likely to be therapeutic based on previous history, then the patient will be rescheduled into clinic within two weeks and marked as a no-show Documentation regarding the no-show and rescheduling will be documented in CPRS.

(b) If there is a high likelihood the INR will be outside the desired range, the patient will be called and arrangements made to check the INR within one to two weeks.

(2) Third consecutive no-show and/or cancellation without rescheduling: An attempt will be made to contact (via telephone) patients who do not reschedule missed appointments. If patients are unable to be reached, their PCP will be notified of their dismissal from ACC. Warfarin prescription will be discontinued.

(3) Patients who obtain INR check with out-of-range value and leave without being seen by pharmacist:

(a) All will be documented as a no-show for the pharmacist clinic in CPRS.

(b) Multiple attempts will be made to contact the patient within 24 business hours of receiving the INR result. Dosage adjustments are made at that time with recommendations for next INR check. Telephone encounter will be documented in the electronic medical record and Warfarin prescription will be renewed. If contact is not made after multiple attempts, appointment will be rescheduled within one to two weeks and a letter will be mailed to patient.

(c) Patients who frequently no-show or who leave without being seen will be questioned about transportation barriers and referred to Social Services, if appropriate.

They will also be informed about the requirements for ongoing monitoring of INR and instructed that failure to participate may result in discharge from clinic. Patient may be discharged from the ACC after three consecutive no-shows or attendance rate <60% as stated in the ACC Service Agreement. A note will be made in CPRS and forwarded to the PCP, who will be asked to determine the next course of action. Warfarin prescriptions will not be renewed by the ACC.

(d) Lack of monitoring for over eight weeks will usually result in the patient’s

Warfarin prescription expiring due to refill limitations.

j. Periprocedural use of LMWH:

(1) Clinic is notified in the following ways:

(a) Provider may generate an anticoagulation consult notifying ACC of upcoming procedure and need for Warfarin interruption.

(b) Patient questionnaire (see link to Attachment H) may alert ACC of upcoming procedure.

(c) Provider may contact ACC via page, telephone, or as cosigner to a progress note

(2) Need for Warfarin interruption is determined by weighing the risk of bleeding from the procedure.

(3) Need for LMWH is determined by weighing the risk of thromboembolism if

Warfarin is interrupted.

(a) Clinical discretion by the PCP or surgeon may supersede the following periprocedure management recommendations:

(b) Guidelines on when to hold Warfarin and start LMWH are standardized.

(see link to Attachment J). Patient is provided a LMWH starter kit (includes patient education material, alcohol swabs, sharps container or recommended equivalent), instructions with start/stop dates, and prescription for LMWH.

(c) Patients are usually seen within one to two weeks of restarting Warfarin post-procedure based on their risk factors.

(4) The need for bridge therapy with UFH or LMWH will be based on the patient’s thromboembolic risk (low, moderate, or high) (see link to Attachment J).

(5) Patients who require minor dental procedures (single or multiple tooth extractions or endodontic [root canal] treatment) may continue Warfarin around the time of the procedure.

(6) Patients who require minor dermatologic (excisions of basal and squamous cell carcinomas) or ophthalmological (cataract extraction) procedures, may continue Warfarin around the time of the procedure.

(7) For Bridging Protocol and periprocedural management of DOAC, see link to Attachment K. Clinical judgment may supersede protocol.

k. Quality Assurance:

(1) P&T Committee: Ongoing QA will be reviewed on a routine basis at P&T

Committee meetings. Factors reviewed include INRs above the critical value, that appropriate action has been taken on critical INRs within 24 hours of INR testing and documentation of action(s) taken, proportion of bleeding and clotting events, proportion of sub-therapeutic INRs, time in therapeutic range, and patients new to Warfarin scheduled/seen within seven days following discharge. Electronic Patient Incident Reporting System (ePIR) report should be completed to record patient incidents, close calls, and near misses associated with anticoagulant medications and VA Adverse Event Reporting System (VADERS) for adverse reactions or events related to anticoagulant medications.

(2) After hours: If an INR result is reported after administrative hours and is elevated, the Medical Officer of the Day (MOD) will adjust treatment, if needed, and alert the ACC in CPRS. All INR results will be reviewed no later than the close of the next business day.

(3) ACC voicemail: Patients may leave non-emergency messages on the ACC voicemail. Calls will be returned or addressed within one business day. If there is a question by staff regarding therapy for a patient, an anticoagulation consult or drug information consult may be placed or the clinic may be contacted directly during business hours

(4) Management of complications: If bleeding or excessive bruising develops, the PCP will be alerted and/or patient will be referred to the PCP, team member, referring physician, or ED as clinically indicated.

(5) Anticoagulation lost to follow-up: VISN Data Warehouse (VDW) report for DOAC and Warfarin follow-up will be run at least weekly by the ACC clinics to identify patients appearing to be lost to follow-up.

(6) The ACC will be notified by the Pharmacy Service or provider when a medication is ordered that has a critical interaction with Warfarin. Once notified, the ACC will adjust the dose, monitor labs, and/or work with the provider, if needed. The ACC clinic will also run the Warfarin Drug Interactions Report in VISTA at least weekly to identify interactions with Warfarin that require intervention either with follow-up or dose adjustments.

l. Inpatient:

(1) Procedures:

(a) Patients admitted to the inpatient units at VANIHCS may be managed by a

CPS if the provider completes a consult request in CPRS.

(b) During non-business hours, the provider shall calculate and order the initial dose. Order sets or menus for anticoagulation therapy may be available in CPRS to assist the hospitalist with standard orders. Other sliding scales for Warfarin or Heparin dosing will not be accepted. Nursing staff shall follow Heparin sliding scale (see link to Attachment L) ordered by the provider to adjust Heparin dosing based on relevant lab values. All Heparin orders will include weight used for dosage calculation for review by a pharmacist before dispensing. Dose changes will be documented in CPRS. Any questions regarding unusual response or clinically significant findings shall be reported and discussed with the provider or CPS.

(c) Anticoagulation management by the CPS assigned to the inpatient area will include UFH, LMWH, Warfarin, and other anticoagulants and Phytonadione as requested. Management is to include ordering of appropriate lab tests, dosage adjustments, evaluation of medical profile and drug interactions, and timing of additional follow-up lab tests.

(d) All changes, dosage adjustments, and progress notes made by any anticoagulation provider shall be documented in CPRS. CPS will utilize the note, entitled “Anticoagulation Clinic Note” in CPRS.

(e) A dietary consult may be requested, if desired.

(f) Inpatients will be educated on Warfarin and other anticoagulants by pharmacy, nursing, or LIPs and such education will be documented in CPRS.

(g) Inpatients new to Warfarin will be seen in ACC or by their Anticoagulation

Provider within seven days of inpatient discharge.

(2) Products:

(a) There is no restriction on tablet strengths for inpatients.