D.05 (local policy) Multidisciplinary Outpatient Anticoagulation Clinics.docx

MULTIDISCIPLINARY OUTPATIENT ANTICOAGULATION CLINICS

MCP 119-19

Month Day, Year MCP 119-19

New Mexico VA Health Care System Albuquerque, New Mexico Signatory Authority:

Andrew M. Welch, MHA, FACHE Director Responsible Owner:

Clinical Coordinator, Pharmacy Service

Rescinded Document:

MCM 119-19

Effective Date:

Month Day, Year Recertification Date:

Month Day, Year

1. POLICY

This medical center policy (MCP) revises policies regarding outpatient anticoagulation clinics at the New Mexico VA Health Care System.

2. JUSTIFICATION

This MCP establishes policy to ensure compliance with VHA Directive 1033, Anticoagulation Therapy Management, dated July 29, 2015; and The Joint Commission standard NPSG.03.05.01.

3. DEFINITIONS/ACRONYMS

a. C/CBOC. Contract/Community-Based Outpatient Clinic.

b. DOAC. Direct Oral Anticoagulant.

c. INR. International Normalized Ratio.

d. PCP. Primary Care Provider.

4. RESPONSIBILITIES

a. PCP or referring provider. The PCP or referring provider is responsible for:

(1) Providing preliminary anticoagulation patient education or requesting assistance for education from Nursing or Pharmacy Service prior to Anticoagulation Clinic referral. Education must be performed within a reasonable timeframe of starting anticoagulation, preferably before the first dose. Education must include benefits and risks of, and alternatives to, oral anticoagulant therapy.

(2) Assessing the potential for unintended pregnancy including effective contraceptive use for women of reproductive age who will be prescribed anticoagulants, and obtaining a baseline pregnancy test prior to initiating warfarin or a DOAC.

(3) Ordering required baseline labs within a reasonable timeframe prior to initiating oral anticoagulation per VHA Directive 1033.

(4) Performing a risk vs. benefit assessment at least annually, with documentation in the electronic medical record, of the decision and rationale for continuing or discontinuing anticoagulation therapy.

(5) Contacting the Anticoagulation Clinic, or ensuring the patient knows to contact the Anticoagulation clinic, with any new medications added to the medication regimen.

(6) Being available, or designating a surrogate to be available by phone or pager for further consultation from the Anticoagulation Clinic.

(7) Entering the Anticoagulation Clinic Consult including the indication(s), INR range if using warfarin, and duration of anticoagulation.

(8) Providing the Anticoagulation Clinic current clinical data to support any INR range outside of national guidelines.

(9) Entering Non-Formulary Consults for anticoagulant use outside of national, evidence-supported guidelines or VA Pharmacy Benefits Management Services Criteria For Use.

b. Anticoagulation Clinic staff. Anticoagulation Clinic is responsible for:

(1) Adhering to Pharmacy SOP #PHARM/CL-13, Pharmacy Outpatient Anticoagulation Clinics, dated October 31, 2019.

(2) Directly providing management of the anticoagulant therapy without PCP co-signature (e.g. clinically evaluating and acting on test results, adjusting doses, or prescribing anticoagulation or “bridging” medications), as allowed per functional statements and scope of practice.

(3) Completing training specific for anticoagulation therapy management prior to engaging in management of anticoagulation.

(a) Competencies specific to anticoagulation management are completed upon hire and repeated as needed based on updated guidelines and/or new anticoagulants, and may include knowledge of the standard terminology, pharmacology of anticoagulants, monitoring requirements, dose calculations, common side effects, nutrient interactions, dietary considerations, and drug to drug interactions.

(4) Providing services for Veterans enrolled in the Anticoagulation Clinic including anticoagulation education to patient and/or family, outpatient follow-up for long-term oral anticoagulant use (more than 6 weeks’ duration).

(5) Providing comprehensive peri-procedural anticoagulant management to enrolled Veterans.

(6) Utilizing standardized note titles in the electronic medical record and monitoring tools as outlined in Pharmacy SOP #PHARM/CL-13, Pharmacy Outpatient Anticoagulation Clinics, dated October 31, 2019.

(7) Ensuring the Veteran understands the requirements for Anticoagulation Clinic enrollment and continued monitoring.

(8) Contacting the Anticoagulation Clinic Medical Director and/or PCP if it is medically dangerous to continue anticoagulant therapy, or if unusually problematic situations occur where it is not possible for the Anticoagulation Clinic to treat or follow up appropriately.

(9) Alerting non-VA care staff of STAT non-VA lab consults if outside venipuncture INRs are needed for INRs 4.1 or greater.

(10) Reviewing new consults within 2 business days upon receipt of the consult, and scheduling (or first telephone contact attempt made).

(11) Providing anticoagulation education per Pharmacy SOP #PHARM/CL-13, Pharmacy Outpatient Anticoagulation Clinics, dated October 31, 2019 as soon as possible.

(12) Cancelling Anticoagulation Clinic consults and notifying the provider per Pharmacy SOP #PHARM/CL-13, Pharmacy Outpatient Anticoagulation Clinics, dated October 31, 2019 if:

(a) The consult does not contain all required information.

(b) The Veteran does not meet criteria to enroll in the Anticoagulation clinic, is unavailable for initial appointment, or is unable to be contacted by phone

(13) Managing oral anticoagulant therapy for patients enrolled in the clinic including prescribing, ordering lab tests, adjusting doses, and any associated follow-up with the patient per Pharmacy SOP #PHARM/CL-13, Pharmacy Outpatient Anticoagulation Clinics, dated October 31, 2019.

(14) Following the “Service Agreement between Ambulatory Care, Emergency Medicine Department, and the Outpatient Anticoagulation Clinic” as outlined in Pharmacy SOP #PHARM/CL-13, Pharmacy Outpatient Anticoagulation Clinics, dated October 31, 2019.

(15) Maintaining a Quality Improvement Program for anticoagulation management per Pharmacy SOP #PHARM/CL-13, Pharmacy Outpatient Anticoagulation Clinics, dated October 31, 2019.

c. Anticoagulation Clinic Medical Director. The Anticoagulation Clinic Medical Director is provided by Ambulatory Care Service and is responsible for:

(1) Supervising the clinical services for the Anticoagulation Clinic.

(2) Being available for contact in circumstances where the PCP is unavailable or unresponsive and the patient requires more than basic triage from the clinical pharmacist.

d. C/CBOC staff. C/CBOC staff is responsible for:

(1) Following-up on Return to Clinic orders submitted by the pharmacists for lab draws and contacting patients to schedule them for lab appointments accordingly.

(2) Contacting the C/CBOC Nurse Manager if they are unable to access Fast Bypass or have issues with it.

(3) Verifying which type of anticoagulant the patient is prescribed and ensuring there is a lab order prior to drawing labs, and contacting the Anticoagulation Clinic if there are no lab orders.

(4) Entering POC-PT/INR results into Fast Bypass the same day it is obtained, before the close of business under the Clinical Pharmacy Specialist’s name, or documenting in the electronic medical record with a note titled “Point of Care CBOC/CCBOC” if Fast Bypass cannot be used.

(5) Immediately contacting the Anticoagulation Clinic if the POC-PT/INR is 4.1 or greater via instant messaging or phone, and strongly discourage the patient from leaving until contact has been made with the Anticoagulation Clinic for further instructions.

(6) Entering STAT non-VA lab consults if required by the Anticoagulation Clinic.

e. C/CBOC Nurse Managers. C/CBOC Nurse Managers are responsible for:

(1) Ensuring that all clinic staff are capable of performing POC-PT/INRs and have Fast Bypass access in a timely manner.

(2) Referring new staff members who will be expected to have access to Fast Bypass to NMVAHCS Laboratory for lab training and orientation, if necessary, ideally during New Employee Orientation.

(3) Contacting the C/CBOC Automated Data Processing Application Coordinator and NMVAHCS Laboratory if issues with Fast Bypass occur.

f. Pharmacists verifying anticoagulants. Pharmacists verifying anticoagulants are responsible for notifying the Anticoagulation Clinic of critical drug-drug interactions via addendums in the medical record. Such interactions for warfarin include but are not necessarily limited to: amiodarone, carbamazepine, doxycycline, fluconazole, fluoroquinolones, metronidazole, minocycline, prednisone, rifampin, sulfamethoxazole-trimethoprim. Such interactions for DOACs include but are not necessarily limited to carbamazepine, dronedarone, enzalutamide, itraconazole, ketoconazole, phenobarbital, phenytoin, rifampin, ritonavir, St. John's Wort.

g. Traveling Veteran Coordinator. The Traveling Veteran Coordinator is responsible for:

(1) Coordinating care for traveling veterans per VHA Handbook 1101.11(3), Coordinated Care for Traveling Veterans.

(2) Coordinating labs for Veterans not enrolled in the NMVAHCS Anticoagulation Clinic, ensuring that if the Veteran is enrolled with another VA (“preferred facility”) or another federal facility, arrangements have been made for lab result follow-up and dose adjustments with the primary anticoagulation care provider.

5. OTHER PARAGRAPHS

a. Outpatient Anticoagulation Clinic Requirements and Policy. Anticoagulation therapy poses risks to patients and often leads to adverse drug events due to complex dosing, requisite follow-up monitoring, and inconsistent patient compliance. The use of standardized practices for anticoagulation therapy that include patient involvement can reduce the risk of adverse drug events associated with the use of oral anticoagulant medications.

(1) The multidisciplinary Anticoagulation Clinic is an outpatient consult service comprised of clinical pharmacists and clinical pharmacy technicians and is available to Veterans who receive their primary care at the NMVAHCS: either at the main Albuquerque facility or the associated NMVAHCS C/CBOCs.

(2) A NMVAHCS PCP must be assigned to the Veteran prior to consulting the Anticoagulation Clinic. The Anticoagulation Clinic only manages Veterans who are assigned to a PCP associated with the NMVAHCS and who have seen thein their NMVAHCS PCP within the previous 13 months, or who are newly discharged from the NMVAHCS with a scheduled PCP appointment. Requests for exemptions will be evaluated on a case-by-case basis and will be approved on a temporary basis only.

(3) Co-management of anticoagulation therapy with a non-VA provider is prohibited to ensure patient safety and program consistency.

(4) Veterans may be discharged from the Anticoagulation Clinic to the PCP if he or she abuses alcohol or illegal substances, do not adhere to the prescribed medication regimen or required labs, do not follow-up with the PCP at least annually, decline Anticoagulation Clinic follow-up modalities, or fail to maintain communication with the clinic.

(5) The Anticoagulation Clinic does not provide parenteral anticoagulant monitoring, but may use parenteral anticoagulants during bridge therapy.

(6) In addition to the above requirements, to be considered eligible for Anticoagulation Clinic monitoring, the Veteran must:

(a) Be able to self-administer medications or have a supervising caregiver able to administer medications to the patient.

(b) Provide verbal consent to participate in follow-up with the Anticoagulation Clinic via phone, voicemail, and/or letter.

(c) Agree to routine lab monitoring and have transportation to the lab or clinic, which may include PT/INR checks up to twice per week for warfarin.

(d) Require long-term anticoagulation (more than 6 weeks’ duration).

(e) Maintain reliable telephone contact with clinic.

(f) Notify the Anticoagulation Clinic in a timely manner of hospitalizations and emergency department visits to ensure appropriate follow-up.

(g) Notify the Anticoagulation Clinic at least 2 weeks in advance of any planned procedures or surgeries.

(h) Notify the Anticoagulation Clinic regarding any changes in medication therapy given the potential for drug-drug interactions.

(i) Verbally agree and acknowledge understanding of the requirements for enrollment in the Anticoagulation Clinic outlined in Pharmacy SOP #PHARM/CL-13, Pharmacy Outpatient Anticoagulation Clinics, dated October 31, 2019.

(7) Veterans are encouraged to present to C/CBOCs before 2:00 PM or as directed due to lab courier transit cut-off times.

(8) The PCP or ordering provider may order the initial prescription, or defer selection of anticoagulant to the Anticoagulation Clinic. However, the Anticoagulation Clinic may change the anticoagulant prescribed.

6. REFERENCES

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

b. The Joint Commission standard NPSG.03.05.01

c. Pharmacy SOP #PHARM/CL-13, Pharmacy Outpatient Anticoagulation Clinics, dated October 31, 2019

d. VHA Handbook 1101.11(3), Coordinated Care for Traveling Veterans, dated April 22, 2015

7. RESCISSION

MCM 119-19, Multidisciplinary Outpatient Anticoagulation Clinics, dated January 9, 2017, is rescinded.

8. REVIEW

At recertification, when there are changes to VHA Directive 1033, Anticoagulation Therapy Management, or The Joint Commission standard NPSG.03.05.01

9. RECERTIFICATION

This MCP is scheduled for recertification on or before the last working day of [Month Year – 5 years from effective date]. This MCP will continue to serve as local policy until it is recertified or rescinded. In the event of contradiction with national policy, the national policy supersedes and controls.

10. SIGNATORY AUTHORITY

Andrew M. Welch New Mexico VA Health Care System Director Date Approved: Month Day, Year NOTE: The signature remains valid until rescinded by an appropriate administrative action.

DISTRIBUTION: Emailed to the ABQ Clin/Admin Svc Chiefs, ABQ Clin Leadership, ABQ Secretaries Distribution List on Month Day, Year. MCPs are available at: The NMVAHCS Document Control Repository