a. A pharmacist may order a baseline SCr per protocol

Transcription

1 UNITYPOINT HEALTH - MARSHALLTOWN Marshalltown, Iowa PHARMACY POLICY AND PROCEDURE Subject: Anticoagulant Therapy Per Practice Protocol (Formerly Anticoagulant therapy #NPSG ) Inpatient Warfarin Dosing Protocol (Allen Hospital) Oral Anticoagulation Emergent Reversal Protocol (Allen Hospital) APPENDIX A Warfarin Non-emergent Reversal Protocol (Allen Hospital) APPENDIX B Anticoagulant Therapy Per Practice Protocol (Marshalltown Hospital ONLY) Policy #: IAC (3)D 1. Pradaxa (dabigatran) a. A pharmacist may order a baseline SCr per protocol. 2. Lovenox (enoxaparin) a. Baseline renal function and Platelets b. A pharmacist may order a baseline SCr and Platelets per protocol 3. Heparin a. A pharmacist may order a baseline aptt and CBC per protocol b. A pharmacist may order ongoing aptts and CBCs per protocol i. Monitoring of aptt daily in a.m. (for aptt 46-85) and 6-8 hours after a rate change ii. Monitoring of CBC every 4 days c. A pharmacist will adjust dosing of heparin based on the following medical staff approved indicators i. For the purpose of DVT/PE prophylaxis, standard dosing for the patient admitted to the medical unit is 5,000 units every 8 hours 1. If age >75 years and/ or weight <50kg heparin will be dosed at 5000 units every 12 hours 2. Pharmacy will document in the patient s chart the new dose, with the comment Pharmacy dose adjustment per Protocol 4. Arixtra (fondaparinux) a. A pharmacist may order a baseline SCr per protocol 5. Xarelto (rivaroxaban) a. A pharmacist may order a baseline SCr per protocol 6. Eliquis (apixaban) a. A pharmacist may order a baseline SCr per protocol Inpatient Warfarin dosing Protocol (Marshalltown and Allen Hospitals) 1. Physician writes order for pharmacy to dose warfarin, including indication and desired goal INR on order. 2. Pharmacist completes warfarin monitoring sheet using information from the patient s chart and the following guidelines. If the physician does not provide an indication or desired goal INR, the pharmacist will contact the physician to obtain this information.

2 Recommended Therapeutic Range for Oral Anticoagulant Therapy Indications INR Prophylaxis of venous thrombosis (high-risk surgery) Treatment of venous thrombosis Treatment of PE Prevention of systemic embolism Tissue heart valves AMI (to prevent systemic embolism)* Valvular heart disease AF Mechanical prosthetic valves (high risk) Bileaflet mechanical valve in aortic position * If oral anticoagulant therapy is elected to prevent recurrent MI, an INR of 2.5 to 3.5 is recommended, consistent with US Food and Drug Administration recommendations. 3. Pharmacist determines initial (Day 1) warfarin dose using the following guidelines, and records it in the patient s chart. Increase INR Alcohol Amiodarone* Azole antifungals Cimetidine Corticosteroids Macrolides (rarely azithromycin) Metronidazole* Omeprazole Phenytoin (initially) Propafenone* Rofecoxib Tamoxifen* Thyroid TMP/ SMX* *strong warfarin potentiation DRUG INTERACTIONS Decrease INR Barbiturates Carbamazepine Methimazole Phenytoin (> 1 week) Propylthiouracil Rifampin

3 Possibly/ Rarely Increase INR** Acetaminophen (>2275 mg/ week) Allopurinol Celecoxib Glyburide HMG CoA Reductase Inhibitors Propoxyphene Quinidine Quinolones Ranitidine SSRIs (fluoxetine>paroxetine>sertraline) Tetracyclines Vitamin E (>300 IU/ day) Zafirlukast Zileuton ** In the majority of cases, should not require any initial adjustment of warfarin dosing. Impair Absorption (decrease INR) Calcium supplements Cholestyramine Fiber supplements Sucralfate Tube feeding Increase INR CHF Diarrhea Hyperthyroidism Infection/ fever Liver disease Malnutrition Pain Chronic alcoholism Chemotherapy DISEASE-STATE INR EFFECTS Decrease INR Chronic alcoholism Edema Hypothyroidism Tobacco use FACTORS PREDICTING WARFARIN REQUIREMENTS > 5 MG/DAY Age < 55 years Male gender African American ethnicity Vitamin K intake (> 400 mcg/day) Body weight 91 kg 4. Pharmacist monitors PT/ INR daily and adjusts warfarin dose. INRs are to be ordered daily for all patients on warfarin therapy. Patients in the Acute Rehab and Mental Health units may have longer intervals between INR draws as per the clinical judgment of the prescriber/pharmacist managing the patient s anticoagulation therapy. The following guidelines are not absolute. Clinical judgment is required, especially in patients of advanced age, of low body weight, or on drugs that may potentiate warfarin. For patients starting warfarin therapy: Higher Dose for Low Lower Dose for High

4 Risk Patient Risk Patient (>65 yrs, liver disease, significant drug interactions) INR Value Warfarin Dose (mg) Warfarin Dose (mg) Day mg 5mg Day 2 < mg 5 mg mg 2.5 mg mg 1.25 mg > mg 0 mg Day 3 < mg 5 mg mg 2.5 mg mg 1.25 mg > mg 0 mg Day 4 < mg 7.5 mg mg 5 mg mg 2.5 mg > mg 0 mg Day 5 < mg 7.5 mg mg 5 mg mg 2.5 mg > mg 0 mg Day 6 < mg 10 mg mg 7.5mg mg 3.75mg > mg 0 mg For patients previously stable on warfarin therapy: INR Goal INR Weekly Dosage Adjustment < 1.6 Increase maintenance dose by 10-25% Increase maintenance dose by 5-15% No dosage adjustment necessary unless 2 consecutive INR values in this range; if dosage adjustment necessary, increase dose by 5-15% No dosage adjustment necessary No dosage adjustment necessary unless 2 consecutive INR values in this range; if dosage adjustment necessary, decrease dose by 5-15% Decrease maintenance dose by 5-15% Hold 1 dose and decrease maintenance dose by 10-20% Hold 2 doses and decrease maintenance dose by 10-25% > 5.0 Hold warfarin; consider Vitamin K if high bleeding risk > 9.0 Hold warfarin; see Vitamin K protocol

5 INR Goal INR Weekly Dosage Adjustment < 1.6 Increase maintenance dose by 10-25% Increase maintenance dose by 10-25% Increase maintenance dose by 5-15% No dosage adjustment necessary unless 2 consecutive INR values in this range; if dosage adjustment necessary, increase dose by 5-15% No dosage adjustment necessary No dosage adjustment necessary unless 2 consecutive INR values in this range; if dosage adjustment necessary, decrease dose by 5-15% Decrease maintenance dose by 5-15% Hold 1 dose and decrease maintenance dose by 10-20% Hold 2 doses and decrease maintenance dose by 10-25% > 6.0 Hold warfarin; consider Vitamin K if high bleeding risk > 9.0 Hold warfarin; see Vitamin K protocol 5. The following criteria may be useful for deciding when to hold warfarin. Goal INR Actual INR Suggested Action > Decrease dose by 25-75% >4.0 Hold > Decrease dose by 25-75% > 4.5 Hold 6. Vitamin K protocol A. Standard Reversal: No active bleeding and no surgery planned within 24 hours. 1. Hold warfarin 2. Daily INR 3. Give Vitamin K as follows a. INR 9 Vitamin K 5 mg po b. INR > 5 and < 9 Vitamin K 2.5 mg po c. INR 3 and 5 No Vitamin K d. INR < 3 Discontinue protocol B. Rapid Reversal: INR 10 or active bleeding or surgery/ procedure within 24 hours. 1. Hold warfarin 2. INR every 6 hours 3. Give Vitamin K as follows a. INR > 10 Vitamin K 10 mg IV b. INR 5 but 10 Vitamin K 5 mg IV c. INR 2.5 but < 5 Vitamin K 2 mg IV d. INR < 2.5 but > 1.5 Vitamin K 2 mg IV e. INR < 1.5 Discontinue protocol C. Consider use of fresh frozen plasma for rapid reversal. D. The intramuscular route of vitamin K administration should be avoided due to the possibility of hematoma formation and dermatological reactions. E. There is concern of anaphylaxis with Vitamin K given IV. If chosen, dilute and administer slowly over 30 minutes. F. Use of high doses of vitamin K (> 10 mg) may cause warfarin resistance. 7. Oral Anticoagulation During Invasive Procedures

6 CLINICAL SITUATION Low risk for thromboembolism (no VTE for 3 months, a-fib without history of stroke) Intermediate risk for thromboembolism High risk for thromboembolism (VTE within 3 months, mechanical cardiac valve, old-model cardiac valve i.e. ball/cage) Low risk for bleeding GUIDELINES Discontinue warfarin therapy 4 days prior to surgery and allow INR to return to near-normal levels; if intervention increases risk for thrombosis, begin short-term low-dose heparin therapy (5,000 units SC) and resume warfarin therapy Discontinue warfarin therapy 4 days prior to surgery and allow INR to fall; 2 days preoperatively, give either low-dose heparin (5,000 units SC) or a prophylactic dose of LMWH; postoperatively give low-dose heparin (or LMWH) and resume warfarin Discontinue warfarin therapy 4 days prior to surgery and allow INR to fall; 2 days preoperatively, give full-dose heparin or full-dose LMWH; heparin can be given SC on an outpatient basis, and presurgically, after hospital admission, as a continuous IV infusion, and discontinued 5 hours before surgery; alternatively, continue SC heparin or LMWH therapy until hours before surgery. Lower the warfarin dose 4 or 5 days before surgery, to reach an INR of at time of surgery; resume warfarin therapy postoperatively, supplemented, if necessary, with low-dose heparin (5,000 units SC) 8. Discharge orders are the responsibility of the physician. Dosage recommendations may be made upon request. Additional Information: 1. CMS Survey Procedure a. Standard: Delivery of Service. In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. (CMS A (b)) i. Does the hospital pharmacy have a system of monitoring the effects of medication therapies for cases specified per hospital policy Closing Banner: Originated by: Pharmacy Department Effective date: 10/09 Authorized by: P&T Cmte/ Date: 3/25/2015 Authorized by: Jessica Rosenhamer, Pharmacy Director Revision date: 10/09, 3/15, 07/16, 9/16, 6/17 Review date: References: Joint Commission UpToDate Agency for Healthcare Research and Quality, Society of Hospital Medicine Iowa Pharmacy Law CMS

7 APPENDIX A (Marshalltown and Allen Hospitals) Oral Anticoagulation Emergent Reversal* Protocol General Measures 1. Control bleeding with local hemostatic measures 2. Initiate appropriate resuscitation measures, including blood products 3. Insure adequate urine output 4. STOP any anticoagulant/antiplatelet agent if not already done, and record time of last dose. 5. Laboratory Orders STAT: CBC, BMP, fibrinogen, aptt, PT/INR Lab Action Antiplatelet Agents: Aspirin, Clopidogrel, Ticagrelor, Prasugrel Give Platelet transfusion until clinical evidence of bleeding has stopped AND Give desmopressin 0.3 mcg/kg IV over 15 to 30 minutes Vitamin K Antagonist: Warfarin Direct Thrombin Inhibitors (DTI): Dabigatran INR greater than 1.6 aptt greater than 36 seconds? NO: No additional treatment indicated. Monitor INR as clinical condition warrants. YES: Give vitamin K 10 mg IV over 30 minutes AND Check INR Q4HRS for first 24 hrs, or more frequently based on clinical condition CONSIDER Kcentra (PCC) if INR > 2.0; dose based on body weight and INR. Slow IV infusion given once. Pretreatment INR: 2 to <4 give 25 units/kg (max 2500 units) Pretreatment INR: 4 to 6 give 35 units/kg (max 3500 units) Pretreatment INR >6 give 50 units/kg (max 5000 units) NO: No additional treatment indicated. Monitor clinical condition. YES: Oral charcoal if last dose ingested within 2 hrs AND Idarucizumab (Praxibind ) 5g (2 separate 2.5gm IV doses no more than 15min apart). NO: No additional treatment indicated. Monitor clinical condition. Factor Xa Inhibitors: Rivaroxaban, Apixaban PT greater than 16 seconds? YES: Oral charcoal if ingested w/in 2 to 6 hrs AND Kcentra (PCC) 50units/kg^ slow IV infusion one time (max 5000 units)) rfactor VII of little benefit in data to date *Major Bleeding: usually gastrointestinal or intracranial. May also be significant decrease in H/H resulting in hemodynamic compromise and felt to be related to anticoagulation. ^If higher dose is believed to be necessary, discussion with hem/onc is required. Dose decision based on patient specific factors and consideration of bleed and/or thrombosis risk including but not limited to age, clinical presentation, and comorbidities. No dosing parameters for repeat doses are available. APPENDIX B (Marshalltown and Allen Hosptials)

8 Warfarin Non-Emergent Reversal Protocol General Measures 1. Return patient to therapeutic INR range 2. Monitor patient to insure major bleeding does not occur 3. Minimize over-reversal 4. Laboratory Orders STAT: PT/INR Indication Lab Action Elevated INR but <4.5 Lower dose or omit 1 Monitor daily INR No Bleed INR Omit 1-2 doses Consider: Oral Vitamin K (phytonadione) 1-2.5mg once OR IV Vitamin K 0.5mg Monitor daily INR INR >10 Hold warfarin Administer Oral Vitamin K 2.5-5mg once OR Consider IV Vitamin K 0.5-1mg Monitor daily INR Minor Bleed* Any Elevated INR Hold warfarin Consider: Oral Vitamin K 2.5-5mg once OR IV Vitamin K 0.5-1mg Monitor daily INR Rapid Reversal- Scheduled surgery within 24 hours *Minor Bleeding: nosebleed, etc. (See Action) Hold warfarin INR every 6 hours Give Vitamin K as follows 1. INR >10 = Vitamin K 10mg IV 2. INR 5 but 10 = Vitamin K 5mg IV 3. INR 2.5 but 5 = Vitamin K 2mg IV 4. INR <2.5 but >1.5 = Vitamin K 2mg IV 5. INR <1.5 = Discontinue protocol