Following is a P&T Committee update (from the February 25th meeting).  Starting date for specific programs is March 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. 

paroxetine (Brisdelle) – This new product is paroxetine 7.5 mg dosed once daily and indicated to treat moderate to severe vasomotor symptoms associated with menopause.  The cost is much more than generic paroxetine 10 mg.  Brisdelle was classified as “non-formulary, not stocked,” with an automatic interchange to paroxetine 10 mg. 

diclofenac (Zorvolex) – This new product is diclofenac available as 18 mg and 35 mg immediate release capsules in which the diclofenac particles are much smaller than the original product, leading to faster dissolution and absorption.  Zorvolex is much more expensive than generic diclofenac and other generic NSAIDs.  There is no evidence of greater clinical benefit of Zorvolex versus similar doses of other NSAIDs.  Zorvolex was classified as “non-formulary, not stocked” with an automatic interchange to the workhorse drug naproxen 275 mg. 

levomilnacipran (Fetzima) – This agent is a new SNRI indicated to treat major depressive disorder, and has relatively greater selectivity for norepinephrine over serotonin compared to other SNRIs.  The starting dose is 20 mg daily, and this is titrated up to response to a maximum of 120 mg daily.  Doses are lowered in renal insufficiency.  The drug was approved for formulary status.

ibrutinib (Imbruvica) – This new oral drug is approved for Mantle Cell Lymphoma, and just recently CLL, both in previously treated patients.  It has important drug interactions through P450-3A4, and is associated with some severe adverse reactions.  In studies, the drug has produced better clinical results than what has been seen with some of the more traditional therapies.   The cost is about $360 - $450 per daily dose.   Rare inpatient use is expected.  This drug was classified as non-formulary, not stocked, and initiation should be deferred to the outpatient setting where a plan can be developed to address financial and insurance concerns, drug availability, outpatient monitoring, patient education, and other related issues.    The patient may take their own drug if ever needed in the hospital. 

Anesthetic Lozenges – There are several products on the market, including Chloraseptic, Cepacol, and Cepastat.  The first 2 contain benzocaine, which in variable doses can cause methemoglobinemia;  thus these products were not selected for formulary status. Halls Cough Drop contains menthol and was selected as the formulary product to represent this group of products.  Other OTC anesthetic lozenges should be converted over to Halls Cough Drops – this is the only product in this category that will be stocked after current supply of other products used.

HYDROcodone-chlorpheniramine (Vituz) - This is a new oral solution indicated for relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults.  It is a Schedule CIII drug and dosed q 4 hours as needed (maximum 4 doses per day). Hydrocodone / Chlorpheniramine Polistrex ER suspension (generic version of Tussionex Liquid) is our formulary agent for this liquid combination, dosed q 12 hrs.  Vituz was classified as non-formulary, not stocked, and  should be interchanged to the formulary product above, with the same daily dose of the 2 drugs but dosed q 12 hrs.

bromfenac (Prolensa) ophthalmic solution 0.07% – This eye drop agent is an ophthalmic NSAID indicated for treatment of post-operative inflammation and reduction of ocular pain in patients who have had cataract surgery.  There are two other bromfenac ophthalmic products on the market in slightly different strengths.  There is a formulary interchange already approved for this class of drugs, with the workhorse formulary agent being ketorolac 0.5% solution. Prolensa was classified as non-formulary, not stocked, with one drop once daily interchanged to ketorolac one drop twice daily.

telavancin (Vibativ) – This is a synthetic lipoglycopeptide antibiotic structurally related to vancomycin, and approved for both complicated skin and skin structure infections caused by susceptible gram-positive bacteria, and hospital acquired or ventilator associated bacterial pneumonia (i.e. with Staph. Aureus), when other agents cannot be used.  Cost is $284 / day versus about $7 with vancomycin.  A pregnancy test must be completed on woman of childbearing age prior to starting this agent, and it can interfere with coagulation lab results.  It was classified as a formulary drug restricted to use by infectious disease physicians only.  The AMT will monitor use of this drug closely. 

Adult Meningitis Order Set – This order set is multidisciplinary in nature, and includes assessments, procedures/labs, nutrition, IV fluids, treatments, procedures/labs, consults, and antibiotic selection and regimens.  It was reviewed and approved for use.  This order set will be implemented in the near future.

Adult Intravenous Heparin Protocol–  The reformatted heparin protocol was approved for use.   A few additions were approved, including the discontinuation of other anticoagulants and omission of the high dose adjustment regimen as an option.  Time of implementation of revised form will be announced.

Papaverine Injection Outsourcing– This injection is currently not available commercially.  Pediatricians desire to use this product for prevention and treatment of arterial vasospasms in arterial lines.  Because this is a high risk compounding procedure with the drug being prepared from non-sterile powder, it was approved to initiate a review regarding the benefit versus risk of this product.  This issue will be referred to the Pediatric Division that is requesting paperavine availability.

Hypertonic Saline 3% Infusion Protocol – This protocol was reviewed and approved with minor changes.  This protocol is required for use of parenteral hypertonic saline 3%.    It provides for intravenous access, initial screening, drug administration, sodium labs, patient monitoring, and when to notify physician.   Date of implementation to be announced.