Following is a P and T Committee update (from the February 26^th meeting).  Starting dates for specific programs listed below is March 4^th, 2013, unless otherwise stated.  This information should be available soon 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” 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.

apixaban (Eliquis) – This oral, direct-acting, selective factor Xa inhibitor is indicated to decrease risks for stroke or systemic embolism in patients with non-valvular a-fib.  The normal dose is 5 mg bid, but if 2 of the 3 following conditions are met the dose should be reduced by 50%; these conditions are: serum creatinine >1.5, age 80 yrs or more, weight 60 kg or less.  Additionally, the dose should be reduced by 50% if there is concurrent therapy with drugs that are strong duel inhibitors of  CYP-450 3A4 and P-glycoprotein (i.e. clarithromycin, ritonavir, itraconazole, ketoconazole, nelfinavir, saquinavir, conivaptan).   The cost is $7.58 /day for doses of either 5 mg bid or 2.5 mg bid.  This drug was approved as a formulary agent, with an automatic pharmacist dosage adjustment under the circumstances listed above (if 2 of the 3 conditions are met, or if concurrent therapy with any of the above listed 7 drugs). 

carglumic acid (Carbaglu) – This new oral drug is approved as adjunctive acute therapy and maintenance therapy for treatment of hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS).  It is available as a 200 mg tablet, can be used in children and adults, and the dose is weight-based.  The dose is titrated according to plasma ammonia level monitoring.  The cost varies according to patient weight and dose, and a general cost range is from $3,000 to $12,000 per day.  The drug must be discarded one month after opening the stock bottle, so there is a high potential for waste involved.  Rare inpatient use is expected.  Carbaglu was classified as a non-formulary, not stocked agent, and patients should use their home supply while in the hospital.

bupivacaine liposome (Exparel) Inj. – This is a longer-lasting preparation of bupivacaine suspended in lipids, infiltrated into surgical site areas for post-operative analgesia.  The dose may vary according to procedure and may be up to 266 mg.  The cost is $285 per single dose vial, versus less than $3 for most single units of regular bupivacaine.  Caution must be taken to differentiate Exparel from other products containing lipids that may appear similar i.e. propofol.   Exparel was approved as a formulary agent but restricted to use by Plastic Surgeons.  Physicians should have completed a manufacturer-sponsored training program prior to using Exparel.  Currently, the plastic surgeons are using On-Q pumps, which are error-prone, to administer bupivacaine into the surgical site, and with the use of Exparel the On-Q pumps will not be utilized.

PONATinib (Iclusig) – This new oral drug is used as a 3^rd/4^th line agent in patients with resistant CML and PC+ ALL or who have not tolerated other drugs for these conditions.  The normal dose is 45 mg daily, but should be reduced in several different situations including increased LFTs, myelosuppression, pancreatitis, and if used with a strong 3A4 inhibitor.  There is a black box warning involving hepatotoxicity and thromboembolism.  The drug costs $328/day and is only available through specialty pharmacies that mail the drug directly to the patient.  This drug was classified as non-formulary, not stocked.

Phosphate IV to PO – There is currently a critical national shortage of injectable phosphate, and Huntsville Hospital has very little supply left, with no projected date of the drug becoming available.  During this shortage, pharmacists may automatically convert an IV phosphate order to an enterally administered dosage form after review of pertinent information.  Factors to consider include (but are not limited to): the patient’s ability to take enterally administered phosphate, pending surgery status, and serum phosphate level.    Follow-up labs should be scheduled as appropriate.

Morphine Concentrated Oral Solution – The concentrated solution is 20 mg/ml. and has been restricted to oncology and hospice physician use.   It was decided to limit the use of the drug to the type of patient instead of by the physician group.  It was approved to limit the concentrated solution should be reserved for patients meeting the following criteria:

• Patient requires a minimum of 5 mg per dose
• Patient is unable to swallow/tolerate the volume of morphine 2 mg/ml oral solution required for the needed dose.

conivaptan (Vaprisol) / tolvaptan (Samsca) – The use of these drugs are limited to certain physician group prescribers.  It was approved to limit the prescribing of these two agents to the same physician groups:  cardiology, endocrinology, nephrology, and pulmonology/critical care.  Additionally, apixaban and rivaroxaban were added to the list of drugs in the first part of the protocol, that the pharmacist is to inform the physician if they are being given concurrently.  It was also recommended by Dr. Haley and approved that with the pharmacy consult guidelines, the sodium level be checked at 8 hours after dose initiation or increase, rather than the current 12 hour time period.  Gregg will revise the consult guidelines in the near future to reflect this change. 

IVIG and inFLIXimab Dose Rounding – Dose rounding for these 2 drugs were approved for use in Outpatient Medical Dept.  For IVIG, doses will be rounded to the nearest 5 grams for those 18 yrs old and over, and for inFLIXimab, doses will be rounded to the nearest 50 mg for those 18 years and over.

glucarpidase (Voraxaze) --> Protocol –  This drug is an antidote for methotrexate toxicity developing from the use of a high-dose regimen with leucovorin rescue.  A required protocol was approved for the use of this drug, and includes patient selection, dosage and administration.  Rare use is expected.

Post Splenectomy Vaccine Order Set – The update to this order set including the use of Prevnar was approved.

Safety Update – The lists of focus drugs for the following categories were reviewed:  look-alike/sound alike names, high-risk/high-alert drugs, and haz-med drugs.  The following are examples of  new look-alike / sound-alike names that will be added to the lists for safety focus for the upcoming year:

HHM:

• clonidine – clonazePAM, 
• Linezolid – levoFLOXacin, levETIRAcetam
• Zyvox – Zosyn
• Morphine IR and SR  / oxycodone IR / SR

HHWC

• Zyvox – Zosyn
• Ketamine – ketorolac

HH Clinics:

• Pradaxa – Plavix
• Glipizide – glyBURIDE - glimepiride