Following is a P and T Committee update (from the October 22nd meeting).  Starting date for specific programs is October 28th 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.

Statin Update – atorvaSTATin (Lipitor) is now available generically at a much lower cost than previously. It was approved to switch our high-potency statin workhorse drug from rosuvastatin to atorvaSTATin due to cost savings.  The dosage ratio is rosuvastatin 5 mg is approximately equal to atorvaSTATin 10 mg.   Also, simvastatin 80 mg will be converted to atorvaSTATin 40 mg instead of rosuvastatin 20 mg.  The other doses of simvastatin, and lovastatin and fluvastatin, should continue to be interchanged to pravastatin.    Date of switch of interchange drug from rosuvastatin to atorvastatin will be announced.

brimonidine-brinzolamide (Simbrinza) ophthalmic- This new eye drop combination drug includes brinzolamide and brimonidine, and is used for reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.   Brinzolamide is a carbonic anhydrase inhibitor and brimonidine is an alpha-2 agonist, and the drug is dosed as 1 drop     Neither of these 2 agents are available generically separately, and the combination is less expensive currently than giving the two separately.  Simbrinza was approved as a formulary agent.

aflibercept (Eylea) ophthalmic– This ophthalmic agent is a vascular endothelial growth factor inhibitor used for treatment of exudative age-related macular degeneration, and administered by intravitreal injection every 1 - 2 months for maintenance therapy. The cost is $1,850 per dose.   Currently, we are using bevacizumab (Avastin) drawn up in small doses  for this indication, which can be prepared for approximately $40/dose.  Eylea was classified as non-formulary, not stocked.   

ferric carboxymaltose (Injectafer)– This is ferric carboxymaltose, a new longer acting intravenous iron product, used to treat iron deficiency anemia. It is dosed as 750 mg for 2 doses, the second dose given 7 days after the first dose. Venofer is our formulary workhorse intravenous iron product for inpatient use, and Venofer and Feraheme are both approved for hospital outpatient use.  Serious infusion-related reactions are rare with all 3 drugs.   Injectafer is more expensive than the other intravenous iron products.  It was classified as non-formulary, not stocked.

trametinib (Mekinist) – This new oral drug is approved to treat unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by a FDA-approved test. The drug has various serious ADRs that are associated with its use.  Rare inpatient use is expected, and it costs about $300 / day.  It was classified as non-formulary, not stocked, initiation should be deferred to the outpatient setting, and if needed for inpatient use, the patient should use their own supply.

chlorTHALidone-cloNIDine (Combipres) – This combination drug contains clonidine 0.1 mg., 0.2 mg., or 0.3 mg., all with chlorthalidone 15 mg, per tablet, usually dosed bid. Both drugs are on the formulary separately, but chlorthalidone as a 25 mg tablet.  Rare inpatient use is expected.  The combination tablet Combipres was classified as non-formulary, not stocked, and if ordered the individual drugs should be dispensed separately, with chlorthalidone 25 mg tablet being used for the 15 mg strength in the combination. 

chlorzoxazone (Lorzone) – This older muscle relaxant formulary drug went by the trade name Parafon Forte, but is now available as a 500 mg generic tablet costing $0.13 per tablet, and “Lorzone” available as 375 mg and 750 mg tablets costing $3.76 and $4.21, respectively. Chlorozoxazone 500 mg was re-approved for formulary status, and Lorzone was classified as non-formulary for inpatient and hospital outpatient status, but formulary for outpatient clinic status.  Lorzone 375 mg and 750 mg orders will be converted over to the 500 mg strength tablet in similar dosage regimens for inpatient and hospital outpatient use.

diclofenac (Pennsaid) topical - This is a topical diclofenac 1.5% solution indicated for treatment of signs and symptoms of osteoarthritis of the knee, with the dose being 1.5 ml qid. We have a topical ointment diclofenac preparation that can be used instead on the formulary, and Pennsaid has been classified as non-formulary, not stocked. However, it is stocked in the pain clinic, so it was approved for formulary status in the clinic setting only.

traMADol (ConZip) – This is an extended release traMADol tablet available in 100 mg, 200 mg, and 300 mg strengths, and dosed once daily. The cost is between $6 - $10 per tablet depending on strength. traMADol 50 mg immediate release tablets cost $0.01 per tablet.  ConZip was classified as non-formulary, not stocked for inpatient use, and a similar regimen of the immediate release tablets will be used for inpatient and hospital outpatient use instead.  ConZip is stocked in the Pain Clinic, so it was approved for outpatient clinic use.

Promethazine to Prochlorperazine Intravenous – Due to potential serious extravasation adverse reactions to promethazine, the FDA several years ago added a black box warning to promethazine injection labeling involving intravenous use, and the P and T Committee approved a ban on its IV use. A shortage of injectable anti-nausea drugs developed in 2011, and some IV promethazine was permitted at that time.  These shortages have now resolved.  It was thus again approved to ban promethazine intravenous use, and these orders should be converted to a similar dose of prochlorperazine intravenously.   The dosage conversion ratio is promethazine 12.5 mg IV is approximately equivalent to prochlorperazine 5 mg IV, and proportionally.   The prochlorperazine stock will be monitored in the future for shortages with that drug. 

Heparin MUE results – The purpose of this MUE was to assess for sustained compliance with current heparin protocol, and identify areas that may benefit from additional education and revision. Fifty patient records were reviewed retrospectively, 70% showed correct use of protocol, and 86% achieved a therapeutic PTT in the first 24 hours. This is an improvement over the last 9 years.   Initial regimen and sliding scale was specified in 49/50  and 50/50 cases, respectively.   The indications with highest use were ACS (15), stroke/TIA (9), and A-fib (9).  Areas for improvement were identified with protocol initiation (bolus and loading dose), dose adjustments, lab duplications, and documentation of patient education.   Improvement plans will be developed by a  multidisciplinary group. 

OXcarbazepine (Oxtellar XR) –This new extended release oxcarbazepine product is used for partial seizures and is dosed once daily, with the dose starting low and titrated up. Cost is between $15 - $40/day depending on dose.  This agent is currently stocked in the Pain Center and was approved for Outpatient Clinic/Office use ONLY.  Inpatient use will be evaluated at a later date.

topiramate (Trokendi XR) - This new extended release topiramate product is used for different types of seizures and is dosed once daily, with the dose starting low and titrated up. Cost is about $40 at the recommended maintenance dose.  This agent is currently stocked in the Pain Center and was approved for Outpatient Clinic/Office use ONLY.  Inpatient use will be evaluated at a later date. 

Lumizyme Protocol – A protocol for administration of Lumizyme, an intravenous infusion drug for Pompe Disease, was approved. The protocol addresses assessement, pre-medication, administration, monitoring, anaphylaxis, and documentation issues. 

Amiodarone Protocol – A protocol update was approved to include transition to oral route or placement of central line after 12 – 24 hours of intravenous infusion.

Sepsis Initiative – This new program was discussed. Issues highlighted included mission statement and aims, sepsis metrics, the Adult Sepsis Order Set, sepsis screening tool, physician education, and marketing and communications.  Ed Eiland, Jonathan Edwards, several physicians, pharmacy residents, and other hospital staff members are involved in leading this program. 

Drug Shortages – Some drugs currently on shortage include acetylcysteine 10% soln, ampicillin 125 mg inj., cefazolin 1 g IVPB, dopamine inj, glycopyrrolate inj., hydroxyzine inj., Venofer 100mg /5 ml., methylene blue inj, Multitrace, paperavine inj, postassium phosphate inj, thiotepa, vitamin A inj., zinc inj.