36C24419R0052-010.pdf

Department of Veterans Affairs POLICY 119-17-122 Medical Center September 11, 2017

Wilkes-Barre, Pennsylvania 18711

ANTICOAGULATION MANAGEMENT SERVICE

I. SCOPE/EFFECT: This Medical Center Policy affects all practitioners in the following Services, Sections and Programs: Primary Care; Medical; Geriatrics and Extended

Care; Mental Health and Behavioral Medicine; Home Based Primary Care (HBPC);

Surgical; and Pharmacy.

II. PURPOSE: The Medical Center’s Anticoagulation Management Service (AMS) has been designed and organized to improve patient safety and ensure compliance with

The Joint Commission (TJC) Patient Safety Goals to reduce the likelihood of patient harm associated with use of anticoagulation therapy by the following:

A. Provide consultative service to physician/providers initiating anticoagulation therapy. Anticoagulation therapy includes, but is not limited to, heparin, low-molecular weight heparins, direct thrombin inhibitors, factor Xa inhibitors, and warfarin.ams.

B. Assist physician/providers in the management of patients placed on anticoagulation therapy.

C. Maximize the benefits of anticoagulation therapy.

D. Reduce untoward effects in patients who are receiving anticoagulation therapy.

E. Provide in-service programs for Medical, Nursing, and Pharmacy personnel regarding various aspects of anticoagulation and to serve as an educational site for students from colleges of pharmacy.

F. Demonstrate the effect of pharmacist-managed anticoagulation therapy on patient outcomes and cost.

G. Maximize the level of patient satisfaction with their individualized medication therapy and with the Medical Center.

III. DESIGNATIONS:

Anticoagulation Management Champion: Associate Chief, Medical Service

Anticoagulation Program Manager: Associate Chief, Pharmacy Service

IV. FUNCTIONS: If requested, pharmacists who are certified in Anticoagulation Management will be available to follow patients in an outpatient anticoagulation clinic from the time of initiation of anticoagulation therapy until they are discharged.

Consultative services should include, but not be limited to:

A. Assistance in stabilizing the patient’s anticoagulation therapy.

B. Screening for drug-drug interactions before titrating the patient’s dose, as well as screening for drug-food and drug-disease state interactions.

C. Initiating contact with the physician/providers so that he/she is aware of the AMS and ensuring that the patient has the opportunity to be considered for follow-up by the AMS after discharge.

D. It is essential that each patient be educated thoroughly about the appropriate use of anticoagulants and other medications in relation to their anticoagulation. This education will be conducted at the first visit with the AMS. This can also be provided prior to patient discharge if anticoagulation is initiated during admission. This includes precise written and verbal instructions regarding dosage regimens and precautions. The AMS provider will provide various educational materials, and each patient will be assessed periodically to ensure that he/she has an adequate understanding of anticoagulation therapy and his/her role in obtaining a successful outcome. Education will include the following:

1. The need for anticoagulation

2. What is Coumadin (warfarin) or Direct oral anticoagulants (DOAC) and how it works to benefit patient

3. Planned length of therapy and dosing instructions

4. Signs and symptoms of common and serious side-effects

5. Signs of over and under anticoagulation

6. Importance of monitoring of Coumadin (warfarin) by testing PT/INR

7. Importance of monitoring of DOAC

8. Specific storage information if patient is taking dabigatran

9. Time of the day to take anticoagulants and what actions to take if a dose is missed

10. What to do in case of bleeding

11. Avoidance or minimizing the use of Nonsteroidal Antiinflammatory Drugs (NSAIDs)

12. Dietary considerations, including alcohol use

13. ID cards and dosing calendars

14. Process to order refills

15. Contact information for anticoagulation clinic

E. The AMS will provide, upon request, in-service education programs for health system medical, nursing, and pharmacy staff regarding basic principles of anticoagulation and new developments in the field of anticoagulation. The AMS will also be available as an educational training site for all Medical Center pharmacists and for students from colleges of pharmacy, under the supervision of the AMS providers.

F. The AMS providers will be available to assist in research programs relating to anticoagulation.

V. ELIGIBLE PATIENTS FOR ANTICOAGULATION:

A. Outpatient anticoagulation therapy of patients receiving warfarin from the Medical

Center must be managed by the AMS. Exception: Patients enrolled as aid and attendance or through a contracted facility, or the Veterans Choice Program will be followed by the contracted/Choice providers and can receive warfarin from the

Medical Center. At times, exceptions will be made on a case by case basis after review by anticoagulation program manager and/or anticoagulation physician champion.

B. DOAC such as Dabigatran, Rivaroxaban, Edoxaban and Apixaban are available for use in specific patients. Patients’ eligibility will be reviewed based on Computerized Patient Record System (CPRS) consult, clinical presentation and

Pharmacy Benefits Management (PBM) guidance on use and monitoring of the new oral anticoagulants. Case by case review will be conducted when the patients do not meet the pre-specified criteria.

C. Argatroban therapy is indicated for prophylaxis or treatment of thrombosis in patients with diagnosed or suspected heparin-induced thrombocytopenia (HIT). It is also indicated as adjunct therapy to percutaneous coronary intervention in patients with or at high risk of HIT. Contraindications, precautions, and dosing for argatroban are included in Attachment A.

D. Heparin dosing protocol/policies for providers are outlined in Attachment B.

VI. PROCEDURES: Patients can contact AMS providers during normal business hours (8:00 am - 4:30 pm Monday through Friday) by using a dedicated extension staffed by trained administrative personnel who can address calls and forward questions regarding anticoagulation to AMS providers. After normal business hours patients can contact the afterhours nursing line. Patients will be followed in one of the subsequent ways by AMS providers:

A. Patient returns to one of the AMS locations for monitoring and face to face visit with an anticoagulation provider.

B. Patient self-monitoring INR values with point-of-care devices will not be accepted for routine management, nor will they be accepted as a baseline INR value.

C. Patients who will have blood testing done at a Community Based Outpatient

Clinic (CBOC) by a nurse or Telehealth Clinical Technician (TCT) utilizing point of care machine or as a venous lab draw, will be managed by an anticoagulation provider via Video-Teleconference. Upon receipt of the laboratory results, the provider will interview the patient or designee directly via telephone/video conference. The provider will record the information obtained from the interview in the patient’s electronic medical record in CPRS.

D. Patients who will have blood testing done via CBOCs, community home health, or HBPC will be managed by an anticoagulation provider.

E. Laboratory accreditation documentation for outside laboratories will be maintained by a community home health nurse. If the patient gets blood work via outside laboratory without community home health involvement, the anticoagulation staff will be responsible to maintain laboratory accreditation information.

F. All International Normalized Ratio (INR) results received by an anticoagulation pharmacist, pharmacy resident, or designated pharmacy technician will be evaluated in a timely manner by the close of the next business day or within 48 hours. Critical

INRs defined as INR levels greater than or equal to 5 will be followed up within 24 hours and appropriate action will be documented in the patient chart. Vitamin K will be prescribed if there are any signs of major bleeding and/or if the INR is greater than 10. AMS providers will notify the primary care provider or covering provider within 24 hours anytime clinically significant signs of thrombosis or bleeding are being reported and anytime they need further clarification of the clinical status of the patient. If a critical INR result is obtained after close of business for the AMS, it will be called to the medical officer on duty in the emergency room who will then be responsible for contacting the patient with instructions and notifying the AMS on the next business day.

G. The INR will be documented in the anticoagulation note for easy retrieval. Upon receipt of the laboratory results, the AMS provider will interview the patient or designee directly via telephone within 48 hours of the received results. If the INR result becomes available after business hours, the AMS provider will interview the patient or designee on the next business day. If a critical INR is obtained after AMS business hours the laboratory will contact Emergency Department staff to correspond with patient regarding the critical INR value.

1. The patient will be interviewed as if they were being seen in person. The pharmacist will record the information obtained from the telephone interview in the patient’s electronic medical record in CPRS.

2. For patients with stable INRs (defined as therapeutic INRs for 3 months on the same dose) that cannot be reached by phone after the second attempt, a letter will be mailed (Attachment C) with dosing recommendations and a follow up lab appointment.

3. In the interest of patient safety, patients who are interviewed via phone and have an unstable INR, will need to be interviewed by an AMS provider. If the patient is not available, the AMS provider will leave the patient a voicemail requesting a return call. If the patient fails to return the AMS provider’s phone call within 48 hours (provider will leave two messages prior to sending the letter), the patient does not have a working phone number, or does not have voicemail, the patient will no longer be followed by phone interview and will need face to face visits at the Wilkes Barre Department of Veterans Affairs Medical Center (VAMC) or nearest CBOC which has a telehealth anticoagulation clinic. A letter will be mailed to the patient advising them that they will no longer be followed via phone interview (Attachment D).

4. The contracted agency will be responsible to communicate the results to the anticoagulation clinic as soon as they are available. The contracted agency will be also responsible for communicating critical INR values. The VA community home health program or PACT team will be responsible for initial patient set-up with outside agencies.

5. Once the patient is set up with the home health agency, AMS will be responsible for future ordering and follow-up of patient’s anticoagulation needs.

6. For patients that are not enrolled in community home health agency or HBPC, exceptions may be made on a case by case basis to follow-up via an external laboratory.

H. For patients on DOACs, the anticoagulation clinic will monitor labs (CBC, renal, and liver function) at baseline, 4 weeks, 3 months, 6 months, and 12 months.

Patients will then be discharged back to their primary care providers, who will be responsible for ordering the DOAC and further monitoring. Any patient who has been on a DOAC on the outside and is now requesting it from the VA will be followed based on the actual duration of therapy. If the patient has been on dabigatran for >1 year than he/she will be followed by a Primary Care Provider

(PCP).

I. For patients on a DOAC for short-term prophylaxis of VTE, pharmacy will review and approve the anticoagulation consult and the ordering provider will be responsible for management.

J. For patients undergoing cardioversion at the WBVA, four consecutive venous INRs (done once weekly) are required prior to the cardioversion based on the cardiology protocol. The INR will be checked once weekly for four weeks following the cardioversion using point of care at the discretion of the cardiologist doing the cardioversion.

K. For patients that are on injectable long-term anticoagulants only, enrollment in anticoagulation clinic is not required. The primary care physician or specialist will prescribe and monitor these medications

L. For traveling veterans managed by our AMS, refer to the Wilkes Barre Veteran’s Affairs Traveling Veteran Policy.

VII. RESPONSIBILITY: Providers’ responsibilities for Anticoagulation Referral:

Patients may be referred to the AMS at any stage of therapy. Physician/Providers need to complete a Pharmacy Anticoagulation Consult.

A. Physician/Provider responsibilities for Inpatient Anticoagulation:

1. Physician/Provider is responsible for the overall anticoagulation needs of the patient admitted to medical floors, intensive care unit, and telemetry.

2. Physician/Provider will be responsible for signing anticoagulation discharge orders and arranging for follow-up with outpatient anticoagulation service.

3. Physician/Provider will be responsible for DVT prophylaxis and treatment for inpatients.

a. Physicians/Providers will observe the warnings and contraindications to enoxaparin use prior to utilization of medication

b. Physicians/Providers will order the appropriate lab tests prior to the use of enoxaparin(lovenox) for DVT prophylaxis

c. Physicians/Providers will order baseline PT/PTT, INR, CBC and CMP

d. Physicians/Providers will order appropriate dose of enoxaparin for desired

DVT prophylaxis indication

e. Follow up PT/PTT and INR is not necessary

f. Follow up CBC daily and CMP as needed for inpatients

g. Stool occult blood tests should be obtained for inpatients

h. Follow up CBC and CMP as needed for outpatients

B. Pharmacists’ responsibilities for Inpatient Anticoagulation:

1. For hospitalized patients, the inpatient clinical pharmacy specialist will work in collaboration with physicians/providers for medical/surgical floors to actively order daily warfarin doses and INRs, alert the physician/provider of any out of range INR during business hours from Monday to Friday. Warfarin would be dosed by medical team during odd tours and on weekends.

2. An AMS provider is responsible for the overall anticoagulation needs of the patient admitted to Mental Health and Community Living Center once consulted by the attending provider.

3. Critical INRs defined as INR levels greater than or equal to 5 will be followed up within 24 hours and appropriate action will be documented in the patient chart.

Vitamin K will be prescribed if there are any signs of major bleeding and/or if the INR is greater than 10. INR will be repeated within 5 days to ensure it is trending downward. Pharmacists will notify the attending provider who consulted the AMS (or covering provider) within 24 hours anytime clinically significant signs of thrombosis or bleeding are being reported and anytime they need further clarification of the clinical status of the patient. If a critical INR result is obtained after close of business for the AMS, it will be called to the attending hospitalist who will then be responsible for adjusting the patient’s warfarin dose until the next business day.

4. The pharmacist will be expected to review all anticoagulation needs of their patients and discuss untreated needs with the physician/provider and document in the chart. The pharmacist will also ensure that the patient has a CBC yearly (either via attending physician orders or ordered by AMS) and if results require further clinical work-up the AMS provider will contact the attending physician.

5. Dosage adjustments will be performed by the AMS provider following known pharmacokinetic and pharmacodynamic principles to maintain the patient at a safe and effective level in accordance with the PBM CPPO Strong Practice Recommended Warfarin Initiation Algorithm for patients which can be accessed at:

http://vaww.infoshare.va.gov/sites/ClinicalPharmacy/Clinical%20Specialty%20Pa ges/Anticoagulation.aspx. (Attachment E) http://vaww.infoshare.va.gov/sites/ClinicalPharmacy/Clinical%20Specialty%20Pages/Anticoagulation.aspx http://vaww.infoshare.va.gov/sites/ClinicalPharmacy/Clinical%20Specialty%20Pages/Anticoagulation.aspx

6. The total duration and intensity of anticoagulation therapy will be determined in consultation by the referring physician/provider.

7. AMS inpatient providers will perform risk benefit assessments on each patient annually. Attending providers will be notified by AMS providers if continued anticoagulation is in question. In addition, if the patient case changes at any point and the AMS provider believes the patient may be at risk, the attending will be contacted to review the risk versus benefit prior to their annual assessment.

C. Physician/Provider responsibilities for Outpatient Anticoagulation:

1. Patients receiving long term low molecular weight heparin as monotherapy will be monitored by their physician/provider. These patients are not enrolled in AMS services. Providers will check a CBC and serum creatinine at baseline and periodically.

2. Patients receiving short term DOACs for DVT prophylaxis status post orthopedic surgery will be monitored by the surgery department.

3. Providers will be responsible for notifying AMS providers of any scheduled procedures which may require interruption of anticoagulants.

D. Physician/Provider’s responsibilities for Outpatient Anticoagulation:

1. Prescriptions received from Choice providers for warfarin, lovenox, and fondaparinux will be dispensed as these are formulary medications . The Choice provider will be responsible for all monitoring for these anticoagulants.

Pharmacy staff processing these medications will add a comment that they are Choice orders in the prescription.

2. Prescriptions received from Choice providers for a DOAC will be reviewed by AMS providers for safety. If approved, the Choice provider will then be responsible for all monitoring of the DOAC. Pharmacy staff processing these medications will add a comment that they are Choice orders in the prescription.

E. AMS Providers’ responsibilities for Outpatient Anticoagulation:

1. The AMS provider will utilize point of care machine for obtaining INR at each clinic visit for patients taking warfarin. The pharmacist will also ensure that the patient has CBC yearly (either via primary care ordered labs or ordered by AMS) and if results require further clinical work-up the AMS provider will contact the primary care provider.

2. The AMS provider will utilize the PBM CPPO Strong Practice Recommended

Warfarin Management Algorithm (Maintenance Phase of Therapy) which can be accessed at:

http://vaww.infoshare.va.gov/sites/ClinicalPharmacy/Clinical%20Specialty%20Pa ges/Anticoagulation.aspx (Attachment F) to manage patient’s warfarin therapy however all final dosing decisions will be based on the clinical judgment of the AMS provider. The pharmacist will seek physician/provider input when needed.

Patients will be provided with written instructions whenever a dosage change is made.

3. Patients who are on a stable dose defined as therapeutic INRs for 3 months without a dose change can have INR monitoring extended to every 6 weeks.

Maximum follow-up interval in between INR monitoring will be 6 weeks with extension given on a case by case visit due to extenuating circumstances

4. The AMS provider will enter orders for new scripts, refills, and renewals of warfarin based on patients’ current warfarin dose. Primary care and specialty physicians may prescribe limited supplies of warfarin usually at the start of therapy, however maintenance prescriptions will be issued by AMS providers at follow up visits.

5. Patients newly started on warfarin will only receive a 30 day supply of warfarin. Coumadin tablet strength will be restricted to one to avoid dosing errors, however on a case by case basis multiple strengths can be provided to patients who require them in special circumstances (such as difficulty with tablet splitting or patients who reside in personal care homes that do not allow tablet splitting).

6. Patients newly started on warfarin will have an INR obtained within seven days. Patients will be appropriately counseled during their first outpatient anticoagulation clinic visit if anticoagulation education was not provided during the patient’s inpatient admission. Patient education will be documented in patients’ electronic medical record under Warfarin Teaching Note or the consultation report using the anticoagulation note. Patients currently stabilized on warfarin outside of the VA are exempted from this requirement. See section

4D for education details.

7. AMS providers must add appropriate ICD Diagnosis Codes to the problem list of patients on long-term anticoagulation therapy. Current diagnosis code ICD 10 code is Z79.01 for “Long-term current use of anticoagulants”.

8. Patients newly started on DOACs will be appropriately counseled during their first outpatient anticoagulation clinic visit or inpatient admission. Patient education will be documented in the patient’s electronic medical record.

9. If a patient needs temporary interruption of warfarin for a procedure, the patient will be bridged with lovenox or fondaparinux (if eligible and based on patient specific factors) (see Attachment G Periprocedural protocol for further information).

http://vaww.infoshare.va.gov/sites/ClinicalPharmacy/Clinical%20Specialty%20Pages/Anticoagulation.aspx http://vaww.infoshare.va.gov/sites/ClinicalPharmacy/Clinical%20Specialty%20Pages/Anticoagulation.aspx

10. Fondaparinux therapy will be approved if a patient needs temporary interruption of warfarin for a procedure and has a history of HIT or thrombocytopenia. Baseline CBC and serum creatinine will be assessed prior to initiation of this medication and monitored periodically.

11. The patient will be provided written instructions on Bridge Therapy and will also be documented in CPRS Pharmacy Anticoagulation Note.

12. If the INR is greater than or equal to 5, the AMS provider will repeat INR on POC machine and manage/document the critical INR at that visit. The AMS provider will see the patient for follow-up within ten days for appropriate management of anticoagulation. Vitamin K will be prescribed if there are any signs of major bleeding and/or if the INR is greater than 10. For CBOC patients requiring the administration of vitamin K, providers will be contacted by the AMS provider to prescribe vitamin K.

13. If the INR is greater than 8 and undetectable on POC machine, the AMS provider may recheck INR with venous draw. The patient may be instructed to go to the emergency room for evaluation and treatment of the critically high INR based on the patient’s clinical presentation. The patient will be seen for follow-up within ten days.

14. The AMS provider will notify the original physician/provider who consulted the pharmacy for warfarin management , covering provider, or the patient’s primary care provider when:

a. Clinically significant signs of thrombosis or bleeding being reported by the patient will be reported to primary care provider.

b. Further clarification of the clinical status of the patient is needed.

c. Clarification is needed for bridge therapy in patients requiring interruption of anticoagulation therapy for procedure.

d. A patient is experiencing frequent falls, a noticeable change in mental status, a decline of >2g/dL in Hgb, chronic binge drinking, or problem following AMS provider’s directions. A risk benefits assessment may be performed in these cases at the AMS provider’s discretion.

e. The patient has finished the duration of anticoagulation specified on the original consult prior to discontinuation of the patient’s anticoagulant.

15. The AMS provider may consider sending the patient to the emergency room/primary care provider for further evaluation if INR is elevated or otherwise clinically necessary.

16. Chart documentation be titled “Pharmacy Anticoagulation Note” , “TLCP

Pharmacy Anticoagulation” or “TH pharmacy Anticoagulation Note”

17. AMS outpatient providers will perform risk benefit assessments on each patient annually. Primary care providers will be notified by AMS providers if continued anticoagulation is in question. In addition, if the patient case changes at any point and the AMS provider believes the patient may be at risk, the primary care provider will be contacted to review the risk versus benefit prior to their annual assessment.

F. Nurses’ Responsibilities:

1. Monitor for signs and symptoms of bleeding.

2. Utilize BCMA to scan the patients’ band and anticoagulant dose before administering the medication.

G. Nutrition and Food Service Personnel’s Responsibilities:

1. Pull the list of patients on warfarin daily on working business days. There is no restriction of vitamin K in inpatients meals except liver, liverwurst, scrapple, and green tea. The following will not be provided to inpatients: 100% cranberry juice .

2. Dietary/Nutrition services will notify AMS providers when a patient is initiated on a nutritional supplement (i.e. Boost, Ensure) by identifying the AMS providers as an additional signer to the CPRS note or by entering a text order for anticoagulation notification.

H. Pathology and Laboratory Medicine Service Personnel’s’ Responsibilities:

1. Timely collection and turnaround of INR and/or PT values.

2. Alerts in CPRS to ordering physician/provider of critical values and laboratory error.

3. Competency review of point of care machines will be completed and maintained by Laboratory.

4. See Lab policies and procedures, Ancillary Testing, for details on the point of care machine.

VIII. DISCHARGING PATIENTS FROM ANTICOAGULATION MANAGEMENT

SERVICE – CO-MANAGEMENT OF ANTICOAGULATION THERAPY

A. The primary care physician/provider will be contacted for any patient who has completed the duration of anticoagulation for possible discharge from anticoagulation service. The recommendations from the physician/provider will be followed.

B. In almost all cases, the Anticoagulation Clinic will not participate in “co-management” of warfarin anticoagulation therapy. Should it be determined that the patient’s warfarin dosages are being directed by another physician/provider (within or outside the VA), the patient will be informed of the risks of such practice and given the opportunity to comply with the AMS directions. If the patient chooses to be managed by the other physician/provider, the patient’s prescription for warfarin will be discontinued, and the patient will be informed that warfarin cannot be provided by the VA Pharmacy unless the patient is managed by the AMS. NOTE: The exception to this is patients that are managed weekly by an outside provider will only require monthly INR testing at the Wilkes-Barre VAMC. At times, exceptions will be made on a case by case basis after review by anticoagulation program manager and/or anticoagulation physician champion.

C. If a patient has missed a lab or clinical appointment, the standard facility no-show letter will be sent to notify the patient of the missed appointment. After the second missed lab or clinic appointment, the patient will be contacted via telephone. The primary care/referring physician provider will be notified after multiple no shows.

After the third missed lab or clinic appointment, that patient’s anticoagulant prescription will be placed on hold, the patient will be contacted and a letter will be mailed (Attachment H). After the fourth missed lab or clinic appointment, the patient will be discharged from the clinic. If the patient is discharged because of no-show history, then the prescription for warfarin from the VA will be discontinued and the patient will be informed that warfarin cannot be provided by VA Pharmacy unless the patient is managed by the AMS.

D. Any time a patient is discharged from the anticoagulation service because of problems with co-management or history of no-shows, a letter (Attachment I) will be sent to notify the patient. The primary care physician/provider will be made aware of the situation via CPRS alert or email.

E. Patients taking DOACs will be discharged back to their primary care providers after one year of therapy. The primary care providers will then be responsible for ordering the DOAC and further monitoring.

F. If a patient no shows for an appointment and the Medical Support Assistant (MSA) is unable to contact the patient for rescheduling, the MSA sends that patient a non-response letter. Patients who fail to respond to a non-response letter after 14 days will be mailed a letter advising them that their warfarin prescription will be placed on hold (Attachment J). If the patient does not schedule an appointment within one month, AMS will discontinue the warfarin order.

IX. ENSURING FAILSAFE PROCESS FOR PATIENTS ON INTERACTING

MEDICATION: The physician/providers who enter a medication that interacts with

Coumadin in CPRS will be prompted to enter a text order called “Notify Anticoagulation Clinic of New Medication”.

A. The physician/provider who orders the interacting medication is primarily responsible for notifying the AMS providers that an interacting medication has been ordered.

B. The pharmacist who finishes the order will receive the same drug interaction alert as the physician/provider. The finishing pharmacist will ensure the physician/provider entered this text order alerting the anticoagulation clinic of an interacting medication. If the physician/provider did not enter this order then the processing pharmacist notifies anticoagulation clinic via email. The pharmacist serves as safety net/double check. If the physician/provider has entered the text order then the processing pharmacist does not have to do anything.

C. Once the AMS provider receives the alert, he/she will contact the patient and explain that a medication has been ordered that interacts with warfarin and that the patient needs to have their INR checked sooner than initially planned. The anticoagulation pharmacist will empirically reduce the warfarin dose at time of phone call if necessary, and will reschedule the patient to the anticoagulation clinic appropriately. AMS will alert the prescribing provider via co-signature or phone call if additional information is required.

X. QUALITY IMPROVEMENT

A. The prescription for Coumadin will have standard physician/provider instructions:

“Take tablet (S) by mouth every day at 5:00 pm as instructed by the VA anticoagulation clinic (to prevent blood clots); Call clinic at (507)824-3521 x 7870 with any questions or refer to latest anticoagulation clinic dosing sheet”

1. Exception can be made and provide actual patient dose per day for patients residing in skilled nursing facilities in order to comply with CMS standards.

2. Patients being discharged from the VA Medical Center will be given dosing instructions on discharge summary until the day they are scheduled for repeat

INR.

B. Productivity, time in therapeutic tange (TTR), elevated INR’s, major events such as bleeding or thrombosis, are tracked and reviewed monthly at The Pharmacy and Therapeutic Committee meeting.

C. Patients lost to follow up are identified quarterly by the pharmacy staff utilizing the INR >56 day report. Patients identified are contacted and scheduled for a repeat INR if they are still taking warfarin.

XI. HEALTH SYSTEM PERSONNEL EDUCATION: The AMS providers will offer presentations on various aspects of anticoagulation therapy to medical, nursing, or other departments upon request.

A. All clinical staff directly involved in caring for patients receiving anticoagulation will be required to complete basic training on anticoagulation. Continuing medical education and in-services will be provided by the AMS providers annually to other medical staff.

B. Pharmacists directly participating in AMS will also have competencies assessed by the anticoagulation program manager.

C. The results of anticoagulation quality assurance programs and performance improvement activities will be available for review by clinic staff, as appropriate.

XII. ANTICOAGULATION SERVICE STAFF EDUCATION: The AMS provider

(pharmacist) is a trained generalist in medication management. Each provider who will be working in the AMS will receive specialized training in an established AMS clinic location under the guidance of an experienced AMS provider prior to working in the AMS independently. In addition, the provider in training must successfully pass (85%) an AMS certification exam. Specific functions regarding the utilization, monitoring, and reporting capabilities of the CPRS and VISTA systems will be included in the training process. Utilizing their overall pharmaceutical management background, AMS providers will also ensure that all medications are reviewed and education given as needed. They will be responsible for providing information to both the specialist and PCP of the patient. Universal exposure precautions, recommendations, and the procedures for disposal of contaminated blood products and related materials will be carried out according to all VAMC Infection Control policies. Anticoagulation information will be distributed for nursing skills fair. Yearly continuing medical education on anticoagulation and on demand in-services will be provided by pharmacy for education for other healthcare providers.

XIII. CUSTOMER SATISFACTION: The Wilkes-Barre VAMC Anticoagulation

Management Service (AMS) has been designed and organized to improve patient safety and ensure compliance with Joint Commission (JC) Patient Safety Goals to “Reduce the likelihood of patient harm associated with use of anticoagulation therapy.

XIV. REFERRALS: Joint Commission (JC) Patient Safety Goals

XV. RESCISSION: Medical Center Policy 119-14-122, dated October 2, 2015 same subject.

XVI. DISTRIBUTION: Electronic Access for All Employees

XVII. ATTACHMENTS: A, B, C, D, E, F, G, H, I, J

X Russell E. Lloyd

Medical Center Director

POLICY 119-17-122 ATTACHMENT A

ARGATROBAN TREATMENT PROTOCOL

Argatroban Treatment Protocol Wilkes-Barre VA Medical Center

Purpose

To give all healthcare providers in the Wilkes-Barre VAMC guidelines on the effective use of Argatroban with the best safety and monitoring evidence.

Indication

1. Prophylaxis or treatment of thrombosis in patients with diagnosed or suspected heparin-induced thrombocytopenia (HIT)

2. Adjunct to percutaneous coronary intervention in patients with or at a high risk of HIT

Mechanism of Action

Directly and reversibly binds to thrombin’s active site preventing the further conversion of fibrinogen to fibrin.

Pharmacokinetics Metabolism Active form is unchanged argatroban which is the major plasma component. Undergoes hepatic hydroxylation and aromatization.

(0-20% metabolite concentration in plasma with a 3-5 fold weaker anticoagulation effect)

Elimination Elimination half-life is 30-51 minutes in a normal functioning liver and 181 minutes with some form of hepatic impairment. The majority is excreted in feces 65% and some through the urine (22- 24%).

Contraindications

1. Overt major bleeding

2. Hypersensitivity to argatroban or any of the formulations components

Precautions 1. Stop all heparin containing products including infusions, flushes, subcutaneous injections, and low molecular weight heparins (i.e. enoxaparin) if HIT is suspected.

2. If no active thrombosis, wait one hour after discontinuation of all heparin products or 12-24 hours for enoxaparin before starting argatroban

3. Currently there is not a reversal agent available. If excessive anticoagulation occurs hold the argatroban infusion. aPPT should return to normal after 2-4 hour however this will take longer in patients with hepatic impairment. Only use FFP or platelets if life threatening bleeding occurs since patients with HIT are at greater risk of developing thrombosis. Blood transfusions may be necessary.

Argatroban Dosing5,6,7

Baseline Labs: CBC, aPTT, INR, Liver function tests (LFTs) **Dosing based on ACTUAL body weight** Standard argatroban admixture: 250mg in 250mL (1mg/mL) in normal saline solution (NSS) or D5W

Initial Dosing Table ** Target aPTT is 1.5-3 times baseline; Max infusion in 10mcg/kg/min*** Based on Renal Function (CrCl in mL/min)

Based on Hepatic Function (ChildPugh Score)

Critically Ill (e.g. Heart failure, severe anasarca or post-cardiac surgery)

> 60 2mcg/kg/min Normal function (or ≤ 6)

2mcg/kg/min Albumin >2.5g/dL

2mcg/kg/min

31-60 1.5mcg/kg/min Moderate Impairment (> 6)

0.5mcg/kg/min Albumin ≤2.5g/dL

0.5mcg/kg/min

< 30 1mcg/kg/min

Argatroban Infusion Rate Titration Chart5

Wilkes-Barre VA Normal aPTT range: 22.9 - 34.1 (Mean 29) seconds *The target aPTT should not exceed 100 seconds*

• Recommended Monitoring – Repeat aPTT 2 hours after initiation or any dose adjustment. If 2 consecutive aPTTs are within the goal decrease monitoring to every 6 hours for 4 doses. If aPTT remains within desired range decrease monitoring to every 24 hours. Monitor platelets daily.

aPTT Seconds

Rate Adjustment For all patients Without Hepatic

Impairment

Rate Adjustment For Hepatic

Impairment/Critically Ill

Monitoring (Next aPTT level after initiation or dose change)

<1.5 x baseline value

Increase by 0.5 mcg/kg/min Increase by 0.1 mcg/kg/min 2 hours

1.5-3x baseline Therapeutic range (NO

CHANGE)

Therapeutic range (NO

CHANGE)

Follow aPTTs as outlined in monitoring

>3-3.5 x baseline value

Decrease by 0.5 mcg/kg/min Decrease by 0.1 mcg/kg/min 2 hours

3.5 x the baseline or exceeds 100 seconds

STOP INFUSION and notify MD STOP INFUSION and notify MD

Recheck aPTT every 2 hours until aPTT in goal range then re-initiate drip at reduced rate as ordered by provider.

Argatroban to Warfarin Conversion

1. Warfarin therapy should not be started until the patient has been treated with therapeutic doses of Argatroban (reflected by aPPT), and substantial platelet count recovery has occurred (> 150 x

109/).

2. If a VKA has already been started when a patient is diagnosed with HIT, vitamin K should be administered.

3. Due to the combined effect of argatroban and warfarin on the INR, loading doses of warfarin should not be used. Warfarin therapy should be started at the expected daily dose not to exceed warfarin 5mg daily.

4. Argatroban and warfarin should be overlapped for 5 days and patient should have two consecutive days of therapeutic INR values prior to discontinuation of argatroban.

The combination of argatroban and warfarin results in a falsely elevated INR. For doses of ≤ 2 mcg/kg/minute of argatroban:

• Argatroban therapy can be stopped when the combined INR on warfarin and argatroban is >4

• Repeat INR measurement in 4-6 hours

• If INR is below therapeutic level, argatroban therapy should be restarted.

• Repeat the above process until the INR is therapeutic with warfarin alone

For doses of >2 mcg/kg/minute of argatroban:

• In order to predict the INR on warfarin alone, reduce dose of argatroban to 2 mcg/kg/minute

• Measure INR for argatroban and warfarin 4-6 hours after dose reduction

• Argatroban therapy can be stopped when the combined INR on warfarin and argatroban is >4.

• Repeat INR measurement in 4-6 hours

• If INR is below therapeutic level, argatroban therapy should be restarted.

• Repeat procedure daily until desired INR on warfarin alone is obtained.

References

1. ACCP Anticoagulation Guidelines 2012; Anti thrombotic Therapy and Prevention of Thrombosis, 9th ed: American

Col lege of Chest Physicians Evidence-Based Clinical Practice Guidelines. February 2012. 141(2 supplement)

2. Argatroban Anticoagulation in Renal Dysfunction: A Li terature Analysis

Marcie J. Hursting Nephron Clin Pract 2008;109:c80-c94

3. Cl inical Experience with Argatroban for Heparin-Induced Thrombocytopenia in a Large Teaching Hospital

Duane Bates Can J Hosp Pharm. 2009 Jul-Aug; 62(4): 290–297.

4. Argatroban Injection Package Insert. Research Triangle Park, NC: Glaxo Smith Kline Inc., Updated March 2009 http://us.gsk.com/products/assets/us_argatroban.pdf

5. Arpina PA, Hallisey RK. Effect of Renal Function on the Pharmacodynamics of Argatroban. The Annals of

Pharmacotherapy 2004;38:25-29.

6. Ansara AJ, Ari f S, Warhurst RD. Weight-based argatrobran dosing nomogram for treatment of heparin -induced thrombocytopenia. Ann Pharmacother 2009; 43(1):9-18.

7. Hoffman WD, Czyz Y, McCol lum DA, et al. Reduced argatroban doses after coronary bypass graft surgery. Ann

Pharmacother 2008; 42(3):309-16.

POLICY 119-17-122 ATTACHMENT B

WEIGHT-BASED HEPARIN PROTOCOL

VA Medical Center Wilkes-Barre, Pennsylvania

Weight-Based Heparin Protocol

Policy:

The heparin protocols discussed in this document are HIGH INTENSITY for thromboembolic events (DVT/PE) and LOW-MEDIUM INTENSITY for acute coronary syndromes and atrial fibrillation.

Initial Assessment:

1. Obtain a baseline PTT, PT/INR, CBC, and platelet count prior to heparin initiation (prior to bolus dose if not done in the previous 24 hours).

2. Initiate therapy with a heparin bolus followed by an initial continuous infusion dose based on TBW using the heparin weight-based dosing nomogram.

3. A bolus is not recommended for treatment of CVA/TIA, progressing ischemic stroke, patients on warfarin with a baseline INR > 1.4, or if the patient has taken warfarin in the last 2 days.

4. If TBW is greater than 30% of the calculated IBW, use dosing weight (DW)

a. IBW (male) = 50kg + [2.3 x (inches over 60 inches)]

b. IBW (female) = 45.5kg + [2.3 x (inches over 60 inches)]

c. DW = IBW + [0.4 x (actual body weight (ABW)-IBW)]

Administration/Monitoring For BOTH (high intensity, low-medium intensity) heparin protocols:

1. All bolus and infusion doses are based on total (actual) body weight in kilograms (patient should be weighed prior to starting the protocol). Weight must be entered into electronic chart prior to ordering heparin.

2. Labs:

a. Provider will order TIMED PTT for 6 hours after heparin initiation. An allowance time of plus or minus 1 hour will be considered acceptable to accommodate scheduled lab draws if no signs of bleeding are present. *Note: a second TIMED PTT may be ordered if the first PTT is normal at the pharmacist’s discretion.

b. PTT and CBC qAM while the patient is on the protocol (Pharmacists will check for these labs on daily rounds. Frequency of PTT to be determined by heparin weight based nomogram; it will be obtained at a minimum of once daily.).

c. If platelets < 150,000 or decreased by 30% - Notify physician.

**Low-molecular weight heparins cross-react in people experiencing heparin-induced thrombocytopenia.

3. Order TIMED PTT 6 hours after any change to infusion rate.

4. Call physician if infusion exceeds 2,000 units/hr at any time. Physician will decide if rate can be increased above 2,000 units per hour.

5. If significant bleeding: (signs include but are not limited to bright red blood per rectum (BRBPR), bloody emesis, neurological changes, rapid drop in HCT/Hgb, progressive bleeding from IV sites, epistaxis, hematomas, and guaiac (+) stool)

- STOP heparin infusion immediately

- Order STAT PTT and CBC

- Notify physician

HIGH INTENSITY Weight-Based Heparin Protocol Indications: PE, DVT, or other thromboembolic event

BOLUS HEPARIN: 80 units/kg = _____ units IV IV Heparin infusion: 18 units/kg/hr = _____ units/hr IV

Adjust heparin based on the adjustment table provided (updated yearly, or when PTT reagent is changed, based on a heparin correlation curve calculated by the laboratory service).

ADJUSTMENT TABLE – HIGH INTENSITY:

Therapeutic PTT range: 72-116

(antifactor Xa level 0.3 – 0.7 Units/mL)

PTT (sec)

Heparin Infusion Refer to dosing table

≤50 Bolus with 80 units/kg Increase infusion 4 units/kg/hr

= ______ units = ______units/hr

51-71 Bolus with 40 units/kg Increase infusion 2 units/kg/hr

= ______ units

72-116

No change.

117-172 Reduce infusion 2 units/kg/hr = ______units/hr

≥173 Withhold heparin for 60 minutes.

Reduce infusion 3 units/kg/hr

Consider starting warfarin therapy early for DVT or PE to prevent heparin-induced thrombocytopenia. A four (4) day overlap of heparin + warfarin is advised. Early elevations in the PT/INR are not true indicators the patient is anticoagulated, continue to adjust heparin per protocol. Patients should be therapeutic on warfarin x 2 consecutive days before discontinuing heparin.

LOW-MEDIUM INTENSITY Weight-Based Heparin Protocol Indications: acute coronary syndromes (ACS) and atrial fibrillation

BOLUS HEPARIN: 60-70 units/kg = _____ units IV Maximum initial bolus is 5,000 units (ACS).

Maximum initial bolus is 4,000 units (Acute ST segment elevation MI in conjunction with fibrinolytic agent: bolus = 60 units/kg).

IV Heparin infusion: 12-15 units/kg/hr = _____ units/hr IV

Maximum initial infusion rate is 1,000 units/hr.

(Acute ST segment elevation MI in conjunction with fibrinolytic agent: maximum initial infusion = 12 units/kg/hr).

Adjust heparin based on the adjustment table provided (updated yearly, or when PTT reagent is changed, based on a heparin correlation curve calculated by the laboratory service).

All doses are rounded to the nearest 25 units.

All doses are rounded to the nearest 25 units.

ADJUSTMENT TABLE – LOW-MEDIUM INTENS ITY:

Therapeutic PTT range: 50-72

(antifactor Xa level 0.1 – 0.3 Units/mL)

PTT (sec)

Heparin Infusion Refer to dosing table

≤41 Bolus with 2000 units Increase infusion 2 units/kg/hr

= ______ units

42-49 No Bolus Increase infusion 2 units/kg/hr

50-72

No change.

73-95

Reduce infusion 2 units/kg/hr = ______units/hr

≥96 Withhold heparin for 60 minutes.

Reduce infusion 3 units/kg/hr

LOW INTENSITY HEPARIN PROTOCOL

Heparin Concentration 100 units/mL

Weigh t(Kg)

Bolus

60units/k g

Infusion Rate

12units/kg/hr

PTT < 41

Bolus 2000units + increase infusion rate by 2units/kg/hr

PTT 42 to

Increase infusion rate by 2units/kg/h r

PT

T 50-

PTT 73-95

Decrease infusion rate by 2 units/kg/hr

PTT > 96

Hold infusion for

60mins then decrease infusion rate by 3units/kg/hr

Kg UNITS Units/hr

(ml/hr)

Units/hr

(ml/hr)

Units/hr

(ml/hr)

N

O

C

H

A

N

G

E

Units/hr

(ml/hr)

Units/hr

(ml/hr)

50 3000 600 units/hr (6ml/hr)

100 units/hr (1ml/hr) units/hr (1ml/hr) units/hr (1ml/hr)

150 units/hr (1.5ml/hr)

55 3300 660 units/hr (6.6ml/hr)

110 units/hr (1.1ml/hr) units/hr (1.1ml/hr) units/hr (1.1ml/hr)

165 units/hr (1.6ml/hr)

60 3600 720 units/hr

(7.2ml/hr)

120 units/hr

(1.2ml/hr) units/hr (1.2ml/hr) units/hr (1.2ml/hr)

180 units/hr

(1.8ml/hr)

65 3900 780 units/hr

(7.8ml/hr)

130 units/hr

(1.3ml/hr) units/hr (1.3ml/hr) units/hr (1.3ml/hr)

195 units/hr

(1.9ml/hr)

70 4200 840 units/hr (8.4ml/hr)

140 units/hr (1.4ml/hr) units/hr

(1.4ml/hr) units/hr

(1.4ml/hr)

210 units/hr (2.1ml/hr)

75 4500 900 units/hr (9ml/hr)

150 units/hr (1.5ml/hr) units/hr

(1.5ml/hr) units/hr

(1.5ml/hr)

225 units/hr (2.2ml/hr)

80 4800 960 units/hr (9.6ml/hr)

160 units/hr (1.6ml/hr) units/hr

(1.6ml/hr) units/hr

(1.6ml/hr)

240 units/hr (2.4ml/hr)

85 5100 1020 units/hr (10.2ml/hr)

170 units/hr (1.7ml/hr) units/hr (1.7ml/hr) units/hr (1.7ml/hr)

255 units/hr (2.5ml/hr)

90 5400 1080 units/hr (10.8ml/hr)

180 units/hr (1.8ml/hr) units/hr (1.8ml/hr) units/hr (1.8ml/hr)

270 units/hr (2.7ml/hr)

95 5700 1140 units/hr

(11.4ml/hr)

190 units/hr

(1.9ml/hr) units/hr (1.9ml/hr) units/hr (1.9ml/hr)

285 units/hr

(2.8ml/hr)

100 6000 1200 units/hr

(12ml/hr)

200 units/hr

(2ml/hr) units/hr (2ml/hr) units/hr (2ml/hr)

300 units/hr

(3ml/hr)

105 6300 1260 units/hr (12.6ml/hr)

210 units/hr (2.1ml/hr) units/hr (2.1ml/hr) units/hr (2.1ml/hr)

315 units/hr (3.1ml/hr)

110 6600 1320 units/hr (13.2ml/hr)

220 units/hr (2.2ml/hr) units/hr (2.2ml/hr) units/hr (2.2ml/hr)

330 units/hr (3.3ml/hr)

115 6900 1380 units/hr

(13.8ml/hr)

230 units/hr

(2.3ml/hr) units/hr (2.3ml/hr) units/hr (2.3ml/hr)

345 units/hr

(3.4ml/hr)

120 7200 1440 units/hr

(14.4ml/hr)

240 units/hr

(2.4ml/hr) units/hr (2.4ml/hr) units/hr (2.4ml/hr)

360 units/hr

(3.6ml/hr)

125 7500 1500 units/hr

(15ml/hr)

250 units/hr

(2.5ml/hr) units/hr (2.5ml/hr) units/hr (2.5ml/hr)

375 units/hr

(3.7ml/hr)

130 7800 1560 units/hr (15.6ml/hr)

260 units/hr (2.6ml/hr) units/hr

(2.6ml/hr) units/hr

(2.6ml/hr)

390 units/hr (3.9ml/hr)

135 8100 1620 units/hr (16.2ml/hr)

270 units/hr (2.7ml/hr) units/hr

(2.7ml/hr) units/hr

(2.7ml/hr)

405 units/hr (4ml/hr)

140 8400 1680 units/hr (16.8ml/hr)

280 units/hr (2.8ml/hr) units/hr (2.8ml/hr) units/hr (2.8ml/hr)

420 units/hr (4.2ml/hr)

MEDIUM INTENSITY HEPARIN PROTOCOL

Heparin Concentration 100 units/mL

Weigh t(Kg)

Bolus

70units/k g

Infusion Rate

15units/kg/hr

PTT < 41

Bolus 2000units + increase infusion rate by 2units/kg/hr

PTT 42 to

Increase infusion rate by 2units/kg/h r

PT

T 50-

PTT 73- 95

Decrease infusion rate by 2 units/kg/hr

PTT >96

Hold infusion for

60mins then decrease infusion rate by 3units/kg/hr

Kg UNITS Units/hr

(ml/hr)

Units/hr

(ml/hr)

A

N

G

E

Units/hr

(ml/hr)

Units/hr

(ml/hr)

50 3500 750 units/hr (7.5ml/hr)

100 units/hr (1ml/hr) units/hr (1ml/hr) units/hr (1ml/hr)

150 units/hr (1.5ml/hr)

55 3850 825 units/hr (8.25ml/hr)

110 units/hr (1.1ml/hr) units/hr (1.1ml/hr) units/hr (1.1ml/hr)

165 units/hr (1.6ml/hr)

60 4200 900 units/hr

(9ml/hr)

120 units/hr

(1.2ml/hr) units/hr (1.2ml/hr) units/hr (1.2ml/hr)

180 units/hr

(1.8ml/hr)

65 4550 975 units/hr

(9.75ml/hr)

130 units/hr

(1.3ml/hr) units/hr (1.3ml/hr) units/hr (1.3ml/hr)

195 units/hr

(1.9ml/hr)

70 4900 1050 units/hr (10.5ml/hr)

140 units/hr (1.4ml/hr) units/hr

(1.4ml/hr) units/hr

(1.4ml/hr)

210 units/hr (2.1ml/hr)

75 5250 1125 units/hr (11.25ml/hr)

150 units/hr (1.5ml/hr) units/hr

(1.5ml/hr) units/hr

(1.5ml/hr)

225 units/hr (2.2ml/hr)

80 5600 1200 units/hr (12ml/hr)

160 units/hr (1.6ml/hr) units/hr

(1.6ml/hr) units/hr

(1.6ml/hr)

240 units/hr (2.4ml/hr)

85 5950 1275 units/hr (12.75ml/hr)

170 units/hr (1.7ml/hr) units/hr (1.7ml/hr) units/hr (1.7ml/hr)

255 units/hr (2.5ml/hr)

90 6300 1350 units/hr (13.5ml/hr)

180 units/hr (1.8ml/hr) units/hr (1.8ml/hr) units/hr (1.8ml/hr)

270 units/hr (2.7ml/hr)

95 6650 1425 units/hr

(14.25ml/hr)

190 units/hr

(1.9ml/hr) units/hr (1.9ml/hr) units/hr (1.9ml/hr)

285 units/hr

(2.8ml/hr)

100 7000 1500 units/hr

(15ml/hr)

200 units/hr

(2ml/hr) units/hr (2ml/hr) units/hr (2ml/hr)

105 7350 1575 units/hr (15.75ml/hr)

210 units/hr (2.1ml/hr) units/hr (2.1ml/hr) units/hr (2.1ml/hr)

315 units/hr (3.1ml/hr)

110 7700 1650 units/hr (16.5ml/hr)

220 units/hr (2.2ml/hr) units/hr (2.2ml/hr) units/hr (2.2ml/hr)

330 units/hr (3.3ml/hr)

115 8050 1725 units/hr