Following is a P and T Committee update (from the November 19th meeting).  Starting date for specific programs is November 25th, 2013, 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 (Cyclokapron) – This is an older drug used as a hemostatic/antifibrinolytic agnet to reduce or prevent hemorrhage during dental and certain other procedures that may increase bleeding risk.  Off label uses include treatment and prophylaxis for surgical bleeding and traumatic hemorrhage.  A hospital consultant group has recommended its use in trauma surgery, and the surgeons are supportive of using it. aminocaproic acid (Amicar) is a similar drug on the formulary, but has not been studied for use in traumatic hemorrhage. tranexamic acid was approved for restricted use by trauma surgeons and emergency medicine for trauma patients within 3 hours of injury.  The regimen will be a 1 gram bolus dose over 10 min, followed by continuous infusion of 1 gram over 8 hours.  Amicar is less expensive and remains the formulary agent for other uses.

poractant (Curosurf) – This is porcine lung surfactant used for rescue treatment of pre-term infants with respiratory distress syndrome (RDS). Currently, calfactant (Infasurf) is the formulary agent used for this drug class.  Curosurf is less volume per dose, but more expensive, and the neonatalogists would like to pilot Curosurf to evaluate whether the lower volume improves clinical response.  Curosurf was approved for use as a pilot program and MUE data will be collected during the pilot project.  Date of pilot initiation will be announced.

afatinib (Gilotrif) – This new oral anti-cancer agent acts by several different mechanisms and is used to treat non-small cell lung cancer in patients with known EGFR exon -19 deletions or exon-21 substitution mutations. The normal dose is 40 mg once daily, and there are several situations where dosage adjustments should be made, including hepatic and renal insufficiency, drug interactions, and specific adverse reactions.  The cost is about $222 per tablet and rare use is expected.  The drug was classified as non-formulary, not stocked, and if ever needed for inpatient use, the patient should use their own supply, initiation should be deferred to the outpatient setting.

sodium glycerophosphate (Glycophos) – This is “sodium glycerophosphate pentahydrate” approved by the FDA for importation into the USA from Norway during the parenteral phosphate drug shortage. It is used as an intravenous phosphate replacement product, but should not be mixed with other drugs or TPN due to little compatibility information. It is available as 1 mmol phosphate/mL in 20 mL single use vials, and was approved as formulary status during the parenteral phosphate shortage period. 

FDA Importation Approvals for Drug Shortages – In critical shortages, the FDA may temporarily approve importation of a foreign drug product into the S. to help alleviate the drug shortage situation. It was approved that any drug so approved by the FDA for drug shortage purposes would automatically receive temporary hospital formulary status for the drug shortage period.  As soon as possible, a drug review will be presented to the Committee for informational purposes.

albuterol-ipratropium (Combivent Respimat) Update – The Combivent Inhaler (albuterol/ipratropium) containing CFCs will officially go off the market at the end of 2013, and Combivent Respimat is the new updated inhaler product. The Respimat is usually dosed 1 puff qid and costs over $200 for a 30 day inhaler, which results in much hospital waste.  The nebulization solution (DuoNeb) is available for $0.19 per dose or $0.76 per day.  It was approved to automatically interchange Combivent / Combivent Respimat inhaler orders to DuoNeb nebulization treatment.  Combivent Respimat 1 puff qid should be interchanged to DuoNeb 1 vial per nebulization qid.  Respiratory Therapy and pulmonologists both support this program.  This interchange will save approximately $125,000 annually.  Date of starting the program will be announced.

dexmethylphenidate (Focalin XR) – This drug is a methylphenidate derivative that is dosed once daily and is already approved for automatic interchange to equivalent doses of methylphenidate. Two new strengths have recently been marketed, the XR 15 mg and the XR 30 mg.  It was approved to include these strengths in the interchange program, the XR 15 mg interchanged to Ritalin LA 30 mg once daily, and the XR 30 mg interchanged to Ritalin LA 60 mg once daily.

ubiquinone (Co-Enzyme Q) – This OTC product is used for various medical purposes, including treating diabetes, male infertility and cardiovascular diseases, increasing exercise tolerance, stimulating the immune system, preventing statin induced myopathy, and others. It is available in various strengths.  It was approved to stock the 50 mg strength, and use it to provide the 30 mg and 60 mg strengths. 

bupivacaine liposome (Exparel) - This is a liposomal based bupivacaine product used to produce local anesthetic effects and decrease pain in post-surgical situations, and is given as single dose infiltration into the surgical site during surgery.  It costs about $300 per dose versus about $0.25 for a dose of regular bupivacaine.  Currently, the drug is restricted for use by Plastic Surgery, and in a pilot program with colo-rectal surgeons Stephen Clark and William Nuessle.   Dr. Robert Campbell, also a colo-rectal surgeon, has been approved to use Exparel in the pilot program.