Following is a P and T Committee update (from the January 28^th meeting).  Starting date for specific programs is February 3rd, 2014, unless otherwise noted.  This information should soon be available in the formulary notebooks, the formulary website, and Formulary One-Source.  Please let me know if you have any questions or comments.  Don’t forget to check the “New Drug Monitoring Spotlight” section of the website, which provides important monitoring information about newly approved drugs.  Also, attached is the updated version of the “Not Stocked, Not Ordered” drug list with the new additions highlighted in red.

Below is the memo with links to the drug monographs, protocols, and formulary documents. Click to access the full P&T packet for this month, or here to access the P&T packet archive.

tranexamic acid (Cyklokapron) – This is an older anti-fibrinolytic agent similar to aminocaproic acid (Amicar) that was approved by the P and T Committee in Nov. 2013 for limited use in trauma surgery.  There is evidence that it can provide benefits in orthopedic surgery (specifically TKA and THA), such as decreasing blood loss and transfusions and providing for a more stable hematocrit.  It was approved for use by orthopedic surgeons in TKA and THA surgery, and a protocol has been developed for its use in these areas.  An MUE investigating beneficial outcomes is planned.  A protocol has been developed for use in TKA and THA, and the physician can select either a 1 dose or 2 dose peri-op schedule.  The protocol will start to be used by Dr . Fambrough in the next several days, and should be posted on pulse soon.   

vortioxetine (BrinTELLix) – This is a new antidepressant that acts by serotonin reuptake inhibition and serotonin receptor activity modulation.  The normal maintenance dose is 10 – 20 mg once daily.  It was approved for formulary status.

hepatitis A adult vaccine – Currently there are 2 products on the market, Havrix (which is the product stocked at HH), and Vaqta.  The Infectious Disease Subcommittee has evaluated these agents and concluded that they are similar enough in efficacy and safety to interchange one to another.  Because of contract cost-savings associated with Vaqta, it was approved to change the formulary agent to Vaqta, and Havrix is classified as non-formulary, not stocked.

vinCRIStine liposomal injection – This new preparation is a long-acting vinCRIStine preparation dosed as 2.25 mg/sq. meter intravenously over 1 hour, once weekly.  It is FDA approved to treat resistant ALL.  It shows decreased incidence of neuropathy compared to the original vinCRIStine product, but can cause the same adverse effects as regular vinCRIStine.   Preparation is very cumbersome, and includes mixing the drug and the liposomal component together in a temperature controlled water bath for approximately 90 minutes.   The cost is nearly $12,000 for 1 weekly dose.  The drug was classified as non-formulary, not stocked for inpatient and hospital outpatient use.  If ever needed, advanced planning will have to take place.

fluticasone-vilanterol – (Breo Ellipta) - This is an inhaler combination of a new long-acting beta agonist, vilanterol, and fluticasone, is dosed once daily, and is more expensive than Symbicort.  Vilanterol is currently only available in the combination form.  It was classified as non-formulary, not stocked, and an interchange to the 2-week Symbicort inhaler was approved. 

multivitamin (Cardiotek-Rx) -  This combination vitamin consists of vitamin B6 50 mg, vitamin B12 500 mcg, folic acid 2 mg, and l-arginine 500 mg.  Foltx is our closest vitamin formulary product, with high dose folic acid and vitamin B12.  Cardiotek Rx contains a low dose of arginine and it should not be a clinical problem omitting the arginine during hospitalization.  Cardiotek-Rx was classified as non-formulary, not stocked, and it should be interchanged to Foltx on a 1:1 dosage ratio.  

tbo-filgrastim (Granix) – This biosimilar drug mimicking Neupogen was approved as the workhorse drug for Neupogen for adult inpatients.  Neupogen should be interchanged to Granix on a 1:1 dose ratio for this population group.  Neupogen will still be used as written in pediatrics, and for outpatients.  Currently, Granix offers a cost advantage for inpatients, but Neupogen is currently less expensive for outpatients.  The oncologists have agreed to this interchange.  If Neupogen is written “no sub”, the intent is in regard to Leukine, and Granix as a biosimilar to Neupogen should still be substituted for Neupogen.

zanamivir (Relenza) Intravenous – This is the intravenous form of Relenza and is currently available through investigational compassionate use for treatment of serious influenza illness.  Usual treatment duration is 5 days, but therapy can be continued longer depending on patient’s condition.  The normal adult dose is 600 mg q 12 hours, with a renal adjustment.  The drug will be used under an investigational compassionate use monitoring program, through the Anti-microbial Management Team.  The physician must be registered to prescribe it and the Committee restricted its use to infectious disease physicians.  A considerable amount of paperwork must be completed for each patient enrolled.  There have already been 5 patients receive intravenous zanamivir at Huntsville Hospital.

Adult Sickle Cell Crisis Order Set – This order set is multidisciplinary in nature, and includes assessments, activity level, treatments, nutrition, pain management, GI medications, vaccinations, procedures/labs, consults, and discharge planning.  It was reviewed and approved for use.

Albumin Dose Standardization – Albumin dose rounding program was approved.  In patients 18 years or older, Albumin doses will be rounded to 12.5 gram increments.