UTHCPC Procedures-Anticoagulation Policy

Anticoagulation Policy

Date of Last Review: 9/21/10

Date of Last Revision: 12/10/2010
SME: Director of Pharmacy

I. PURPOSE

To establish a procedure for safe anticoagulation therapy that optimizes therapeutic benefits and minimizes associated risks.

II. POLICY

In accordance with National Patient Safety Goal 3E, an anticoagulation protocol will be in place to reduce the likelihood of all patient harm associated with the use of anticoagulation therapy.

III. PROCEDURES

A.	The organization reviews medication errors related to anticoagulants on an ongoing basis and identifies and implements improvement strategies as part of the organization-wide adverse drug event program.
B.	At least annually, prescribers, nurses, and pharmacists receive education on the safe use of anticoagulants.
C.	Baseline laboratory tests (e.g., CBC, platelet count with Heparin and Enoxaparin, INR with Warfarin, aPTT with Heparin) are obtained before anticoagulants are ordered. Nursing and Pharmacy should report abnormal values to the prescriber immediately.
D.	Processes are in place to ensure that patients receiving anticoagulant therapy have laboratory tests ordered and results are available and used to monitor and adjust therapy.
E.	Pharmacy participates in the development and implementation of protocols, guidelines, or procedures for dosing and monitoring anticoagulation therapies. .
F.	Pharmacy participates in a facility-wide effort to evaluate the safety of anticoagulant use.
G. H.	Pharmacy works in collaboration with Dietary services to address drug food interaction review with patients. Pharmacy participates in a facility-wide effort to evaluate the need for and provide patient/family education.

IV. Dispensing

Warfarin

1.	Pharmacists screen warfarin orders for possible drug interactions.
2.	Upon request, pharmacists provide patient education on warfarin, including written information that addresses possible food-drug interactions.
3.	Pharmacists monitor a patient’s INR prior to dispensing a dose.
4.	Pharmacy dispenses single use or unit-dose packages to patient care units.

V. Administration

Warfarin

A standard administration time is established based on patient medication history and intake from the admitting nurse including the patient’s medication from home.

VI. Protocols

Protocols for standard and rapid reversal are established for warfarin (See Anticoagulation Protocol).

VII. Process Improvements

The organization reviews medication errors related to anticoagulants on an ongoing basis and report to the Pharmacy and Therapeutics Committee and identifies and implements improvement strategies as part of the organization-wide adverse drug event program

VIII. References

Ansell J, et al. Pharmacology and management of the vitamin K antagonists. American college of chest physicians evidence-based clinical practice guidelines (8th edition). CHEST2008;133:160S-198S.
Joint Commission National Patient Safety Goals on Anticoagulation
Institute for Safe Medication Practices. ISMP Recommended Safety Improvements for Anticoagulants. ISMP Medication Safety Alert 2007; 12(1)

BLACK BOX WARNING: Warfarin sodium can cause major or fatal bleeding. Bleeding is more likely to occur during the starting period and with a higher dose (resulting in a high INR).

Initiation
Initial Dose: 5mg/day; however 2.5mg (with risk factors below)

Risk Factors:

Older than 65
Weight < 50 kg
Congestive Heart Failure (CHF)
Liver Failure
Recent History (HX) of bleeding

Hemocrit (HCt) < 30
Drug interactions (see Appendix B)
Depleted nutrition (NPO > 3 days)
Patients with history of falls
Recent surgery

Contraindication

Absolute

Chronic or active bleeding diathesis
Non-compliance
Pregnancy

Relative

Uncontrolled hypertension (i.e. SBP> 180mm Hg or DBP>100 mmHg)
Sever liver damage
Recent surgery involving the nervous system, spine or eye

Recommended Therapeutic Goal and INR Range for Oral Anticoagulant Therapy

INR 2.0–3.0 (Target 2.5)

Prophylaxis of VTE (high-risk surgery)
Treatment of VTE
Prevention of pulmonary embolism (PE)

INR 2.5–3.5 (Target 3.0)

Prevention of arterial embolism in
Tilting disk or
Bileaflet mechanical valves
Caged ball or disk mechanical valves
Mechanical prosthetic heart valves
With additional risk factors (Atrial Fibrillation Myocardial Infarction, Low Ejection Fraction, Left Atrial Enlargement)
With system embolism despite a therapeutic INR

Daily Dosing

Initial

5mg daily (results in INR=2.0 in 4-5 days) or 5-10mg on day 1 and 2, then adjust the dose basis on INR
Does not require a loading dose

2.5 – 4mg

Elderly patients with liver disease or impaired nutrition

7.5-10mg

Young, healthy, or obese patients

Monitoring Warfarin Therapy

Regular monitoring of INR should be performed on all treated patients. Those at high risk of bleeding require more frequent INR, monitoring, careful dose adjustment to desired INR, and a shorter duration of therapy

International Normalized Ratio (preferred)
Prothrombin Time
Complete blood count (CBC) with differential
Pregnancy test as indicated
Toxicity (See Appendix A)

Anticoagulation Protocol

APPENDIX B

ACCP Guidelines for the Management of Excessive Anticoagulation With or Without Bleeding

Situation	Recommendation
INR above therapeutic range but < 5 No significant bleeding	Lower the dose of the warfarin (i.e. decrease the total weekly dose by 5-20% or omit 1 dose of warfarin) Monitor more frequently (e.g. next INR within 2-8 days) Resume the warfarin when INR is therapeutic If the INR is only minimally above the therapeutic range, no dose reduction may be required
INR ≥ 5 but < 9 No significant bleeding	Omit the next 1 or 2 doses of warfarin Monitor more frequently (e.g. next INR within 1-5 days) Resume warfarin at a lower dose when INR is therapeutic Alternative for patients at increased risk of bleeding: Omit one dose Give Vitamin K 1-2.5 mg orally once# If more rapid reversal is required because the patient requires urgent surgery: Give Vitamin K 2.5-5 mg orally once (with the expectation that a reduction of INR will occur within 24 hours). If INR is still high, additional Vitamin K 1-2 mg orally once# can be given.
INR ≥ 9 No significant bleeding	Hold warfarin therapy Give a higher dose of Vitamin K orally (2.5-5mg) with the expectation that the INR will be substantially reduced in 24-48 hrs Monitor more frequently Use additional Vitamin K if necessary Resume therapy at a lower dose when the INR is therapeutic
Significant bleeding with any elevation of INR	Contact physician immediately (and revert protocol to physician)* Hold warfarin therapy Give Vitamin K by slow infusion (10 mg IVPB over 30 minutes)-Caution: possible anaphylaxis Supplement with fresh frozen plasma, prothrombin complex concentrate, or recombinant factor Vlla (Consult hematology before recombinant factor Vlla use) Vitamin K can be repeated every 12 hours or more often if necessary

DRUG INTERACTIONS WITH WARFARIN (COUMADIN®)

Drugs That Can Diminish the Anticoagulant effect of Warfarin		Drugs That Can Potentiate the Anticoagulant Effect of Warfarin
Carbamazepine		Aspirin		Fluconazole (Diflucan)
Cholestyramine		Acetaminophen		Gemfibrozil
Colestipol		Amiodarone		Isoniazid
Cyclosporine		Cefoperazone		Itraconazole
Dicloxacillin		Cefotetan		Ketoconazole
Ethanol		Celecoxib		Levofloxacin
Griseofulvin		Chloral hydrate		Metolazone
Nafcillin		Cimetidine		Metronidazole
Pentobarbital		Ciprofloxacin		Voriconazole
Phenobarbital		Clarithromycin		Moricizine
Primodone		Clofibrate		Norfloxacin
Rifabutin		Sulfamethoxazole/Trimethoprim		Ofloxacin
Rifampin		Disopyramide		Omeprazole
Sucralfate		Disulfiram		Propafenone
		Erythromycin		Trazodone
		Fenofibrate
Increased Bleeding Effect
Inhibit Platelet Aggregation		Inhibit Procoagulant Factors		Ulcerogenic Drugs
Cephalosporins		Quinidine		Adrenal corticosteroids
Clopidogrel		Quinine		Indomethacin
Indomethacin		*Salicylates*		Potassium products
					Salicylates
Increased Anticoagulant Effect
Displace Anticoagulant		Decree Vitamin K	Inhibit Metabolism		Other
Chloral hydrate		*Oral* antibiotics (can increase or decrease)	Allopurinol		Acetaminophen
Clofibrate			Amiodarone		Fenofibrate
Ethacrynic acid			Azole antifungals		Celecoxib
Miconazole			Cimetidine		Clarithromycin
Salicylates			Sulfamethoxazole		Erythromycin
Sulfonamides					fenofibrate
Sulfonylureas					Gemfibrozil
					Influenza vaccine
					Propranolol
					Propylthiouracil
					Rantidine
					Rofecoxib
					SSRIs
					Tetracyclin
					Vitamin
Decreased Anticoagulant Effect
Enzyme Inducers		Decreased Drug Absorption	Increase Procoagulant Factors			Other
Thyroid antagonist	Nafcillin	Aluminum hydroxide	Estrogens			Griseofulvin
Barbiturates	*Phenytoin*	Cholestyramine	Oral Contraceptives			Spironolactone
Carbamazepine	*Rifampin*	Colestipol	Vitamin K			Sucralfate

Related Standards

	The Joint Commission : National Patient Safety Goals
	Institute for Safe Medication Practices. ISMP Recommended Safety Improvements for Anticoagulants. ISMP Medication Safety Alert 2007; 12(1)

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