D.12 MCM 119-20 - ANTICOAGULATION THERAPY MANAGEMENT - ATTACHED.docx
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- Q201-- VASDHS Primary Care El Centro CBOC Federal contract opportunity
- Solicitation number
- 36C26225R0004_1
About this file
This document is a memorandum providing policy and procedures for the management of anticoagulation therapy at the VA San Diego Healthcare System. The key details include:
The memorandum establishes policies and responsibilities for providers, nurses, and pharmacists involved in ordering, monitoring, and administering anticoagulation medications such as warfarin, heparin, and direct oral anticoagulants (DOACs). It covers procedures for medication management, INR monitoring, treatment of supratherapeutic INRs, management of bleeding events, patient education, and quality assurance. The memorandum references relevant VA directives, standard operating procedures, and national guidelines to be followed. It also requires the tracking and reporting of key anticoagulation safety metrics to the Pharmacy & Therapeutics Committee and Medical Executive Committee.
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D.12 MCM 119-20 - 36C26225R0004
VA SAN DIEGO HEALTCHARE SYSTEM MEMORANDUM 119-20
SAN DIEGO, CA July 1, 2022
D. 12 MCM 119-20 - ANTICOAGULATION THERAPY MANAGEMENT
TICOAGULATION THERAPY MANAGEMENT
1. PURPOSE: To establish policy and procedures for anticoagulation therapy management.
2. POLICY: To individualize patient care and reduce the likelihood of patient harm associated with the use of anticoagulants.
3. DEFINITIONS:
a. International Normalized Ratio (INR): INR is a standardized measure of the prothrombin time (PT), which is used to determine the intensity of anticoagulation effect.
b. Anti-Xa assay: A chromogenic assay which measures heparin levels indirectly. This measurement is also known an unfractionated heparin level.
c. INR Alert Value: An INR greater than 4.5
d. Direct Oral Anticoagulant (DOAC): DOAC is a class of oral anticoagulants that bind directly to clotting Factor Xa (rivaroxaban, apixaban, edoxaban) or clotting Factor IIa (dabigatran).
e. Low-Molecular-Weight Heparin (LMWH). LMWH is a class of parenteral anticoagulants used for rapid anticoagulation, to prevent embolic complications.
4. RESPONSIBILITIES:
| a. | The Chief of Staff/Medical Director is responsible for ensuring providers with clinical privileges are accountable for ordering, monitoring, and discontinuing anticoagulation therapy as clinically indicated. |
| b. | The Associate Director, Patient Care Service/Nurse Executive or designee(s): is responsible for ensuring: |
(1) Registered Nurses and Licensed Practical Nurses follow these procedures.
(2) These employees document the administration of medication.
(3) Nursing Education Section is responsible for ensuring all nurses receive training in the subcutaneous and IV administration of anticoagulation drugs as well as warfarin administration.
c. The Chief, Pharmacy Service, is responsible for ensuring pharmacists are accountable for order verification based on available laboratory data and current clinical status of the patient.
5. PROCEDURES:
a. Oral unit dose products, pre-filled syringes, or pre-mixed infusion bags for anticoagulant medications will be utilized for inpatients when these types of products are available.
b. Programmable infusion pumps will be utilized for inpatients for intravenously-administered heparin.
c. Approved, evidenced-based, protocols will be utilized for the initiation and maintenance of anticoagulation therapy appropriate to the medication used, condition being treated, and the potential for medication interactions.
1) Invasive procedure and peri-procedural bridge therapy
(a) Warfarin will be held 5 days prior to invasive procedures unless directed otherwise by the surgeon or provider performing the procedure. The Anticoagulation Clinic pharmacist will contact the primary care provider, surgeon or specialist to determine if bridging is necessary when warfarin is held for procedures. If bridging is necessary, the Anticoagulation Clinic Pharmacist will provide bridging instructions based on Appendix A of SOP 17, prescribe low-molecular-weight heparin (LMWH), and provide LMWH teaching to patients/family as needed. Modifications to the bridging plan can be made if necessary.
(b) The number of days that DOACs will be held prior to invasive procedures, will depend on the DOAC that the patient is taking, the type of procedure, and the patient’s creatinine clearance (CrCl). Refer to Table 11 reference f. Providers may request DOAC peri-procedural recommendations via the Anticoagulation E-Consult and providers are responsible for instituting the recommendations unless otherwise specifically requested to be done by the Anticoagulation Clinic. If LWMH bridging is desired while patients are off DOACs, then a DOAC for Bridging Consult must be entered by the provider.
2) Weight-based heparin bolus and infusion dosing in accordance with approved medical center protocols. The DUE/Medication Safety Committee and the Pharmacy and Therapeutics Committee will review and approve all protocols.
3) Initiation and adjustment of warfarin therapy.
(a) See Pharmacy Standard Operating Procedure (SOP) 17 Anticoagulation Therapy Management – Ambulatory Care
(b) See Pharmacy Standard Operating Procedure 43 for Inpatient Anticoagulation Management.
4) Frequency of INR testing that is consistent with nationally recognized evidenced-based guidelines (e.g., American College of Chest Physicians).
5) Management of supratherapeutic INRs or bleeding for patients on warfarin therapy.
(a) See Pharmacy SOP 17 Anticoagulation Therapy Management
(b) See Pharmacy SOP 43 Inpatient Anticoagulation Management
(c) Warfarin doses may be held for supratherapeutic INRs.
(d) Vitamin K (phytonadione) may be administered. Per 2012 CHEST guidelines:
(1) For patients taking Vitamin K Antagonists (VKAs) with INRs between 4.5 and 10 and with no evidence of bleeding, we suggest against the routine use of vitamin K.
(2) For patients taking VKAs with INRs >10 and with no evidence of bleeding, we suggest that oral vitamin K may be administered.
(e) Patient preferences and clinical assessment of risks of thrombosis and bleeding must be assessed by the Anticoagulation Clinic Pharmacist when determining whether to give vitamin K.
(f) Patients with active bleeding will be referred to the Emergency Department.
6) Management of bleeding events for patients on DOAC therapy.
(a) The appropriate use of anticoagulation reversal agents according to the 2012 CHEST guidelines and the 2017 ACC Expert Consensus Decision Pathway on Management of Bleeding in Patients on Oral Anticoagulants will be used.
(b) VA Pharmacy Benefits Management Service’s Reversal Agents for Direct Oral Anticoagulants (DOACs) Recommendations for Use will be used.
(c) See Pharmacy Standard Operating Procedures #43.
7) DOAC drug selection and dosing, including adjustments for age, renal and liver function, drug-drug interactions and other risk factors, will be guided by the VA PBM DOAC Criteria For Use.
d. Refer to the Non-Formulary (NF)/Mandatory Monitoring Requirements (approved by the Medical Center Drug Use Evaluation/Medication Safety Committee and Medical Executive Committee) for unfractionated heparin, low-molecular-weight heparin and fondaparinux safety and monitoring for baseline laboratory parameters.
e. All INR results will be reviewed and evaluated no later than the close of the next business day or as soon as the results are available.
f. A baseline INR and CBC will be available prior to patients starting on warfarin therapy both as inpatients and outpatients.
g. A baseline serum creatinine and CBC will be available prior to patients starting on DOAC therapy both as inpatients and outpatients.
h. A current INR will be available for all patients receiving warfarin therapy.
i. There will be a standardized process for documenting INR results from non-VA laboratories.
1) The results will be sent to the VA provider.
2) The VA provider will input the data into a progress note and health factor.
3) Documentation of INR will include but not limited to name of the laboratory, laboratory address and telephone number, the date of the test, the INR value and the reference range of the test.
j. Nutrition and Food Services: Receives an automated daily email of all inpatients on warfarin therapy.
1) Nutrition and Food Services will provide food and medication interaction information to patients receiving meal services and warfarin therapy.
2) Nutrition and Food Services will provide initial and ongoing patient and family education on dietary restrictions for patients that are on warfarin therapy.
k. Warfarin patient education will be provided by Pharmacy Service which includes but is not limited to:
1) Warfarin tablet identification
2) Indication for therapy
3) Interactions (drug, diet, and disease)
4) Daily dosage
5) Monitoring requirements
6) The importance of medication adherence
7) The dangers of using warfarin from different sources (e.g., VA and community pharmacy)
8) The management of missed doses
9) Signs and symptoms of bleeding and thromboembolic events
10) Risks associated with falling
l. Direct oral anticoagulant (DOAC) patient education will be provided by Pharmacy Service which includes but is not limited to:
1) DOAC tablet/capsule identification
2) Indication for therapy
3) Interactions (drug, OTC)
4) Daily dosage
5) The importance of medication adherence
6) Management of missed doses
7) Signs and symptoms of bleeding and thromboembolic events
8) Non-bleeding adverse events
9) Risks associated with falling
10) Proper medication storage
11) Monitoring requirements
m. Staff involved in ancillary testing will have annual competence evaluations.
n. New dependent practitioners will complete initial anticoagulation therapy training within 6 months of obtaining the scope of practice.
o. Dependent practitioners involved in managing anticoagulation therapy will participate in the focused and ongoing professional practice evaluation process and follow all requirements of maintaining a scope of practice.
p. A quality assurance plan will be established to evaluate anticoagulation safety practices. Results will be presented quarterly (or as requested) to the Pharmacy & Therapeutics Committee and the Medical Executive Committee. At a minimum, the plan will monitor:
1) That appropriate action(s) have been taken on critical INRs by the close of the next business day and documentation of action(s) taken
2) Proportion of Veterans with pathologic bleeding events
3) Proportion of Veterans with thromboembolic events.
4) Sub-therapeutics INRs
5) Potential issues associated with anticoagulant medications
6) Perform random audits to assure that documentation of the appropriate diagnosis code (Z79.01) is included in the patient’s problem list.
7) Time in Therapeutic Range (TTR) as determined by the national TTR Report
8) Portion of Veterans on warfarin that have not had an INR in the last 56 days
9) Proportion of Veterans requiring reversal agents
10) Interventions made using DOAC Population Management Tool
q. Pharmacy Service will provide a defined anticoagulation management program that will provide an individualized care plan to transition the patient from inpatient to outpatient status (reference Pharmacy SOP 17 and SOP 43)
1) Outpatients receiving anticoagulation therapy will be followed appropriately with frequent INR testing according to established protocols
2) The anticoagulation management program will address patient follow-up in the following situations:
(a) Addition of a new medication or deletion of a prior medication to a patient’s drug regimen
(b) Adjustment of the anticoagulant dose if needed
(c) Ordering any needed laboratory tests
(d) Educating patients and family with written instructions whenever a dosage change is made.
r. The ICD Diagnosis Code that denotes ‘Long-term (current) use of anticoagulants” will be added to the problem list of outpatients on anticoagulant therapy.
s. Pharmacy Service will review the selection of warfarin strengths available to outpatients and will minimize the use of different pill strengths whenever possible. Patients receiving multiple strength pills of warfarin must be followed by the Anticoagulation Clinic.
6. REFERENCES.
a. VHA Directive 1108.16 Anticoagulation Therapy Management;
b. Pharmacy Service Standard Operating Procedure 17
c. Pharmacy Service Standard Operating Procedure 43
d. Joint Commission National Patient Safety Goals
e. MCM 11-39
f. Guidance for the Practical Management of the Direct Oral Anticoagulants (DOACs) in VTE Treatment. J. Thromb Thrombolysis 2016 41:206-232
g. American Society of Regional Anesthesia and Pain Medicine (ASRA) guidelines.
h. VA Pharmacy Benefits Management Service’s Reversal Agents for Direct Oral Anticoagulants (DOCs) Recommendations for Use
i. VHA Pharmacy Benefits Management – Criteria for use of Direct Oral Anticoagulant Therapy.
j. Tomaselli, GF, et al. 2017 ACC Expert Consensus Decision Pathway on Management of Bleeding in Patients on Oral Anticoagulants. J Am Coll Cardiology.
k. CHEST. Antithrombotic and Thrombolytic Therapy. American College of Chest Physicians. Evidence Based Clinical Practice Guidelines, February 2012.
7. RECERTIFICATION DATE: July 2027.
8 FOLLOW-UP RESPONSIBILTY: Chief, Pharmacy Service (119)
9. RECOMMENDED REVIEW DATE: July 2025.
10. RESCISSIONS: MCM 119-20 dated July 8, 2019,
11. DATE APPROVED BY MEC: October 19, 2022.
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