Following is a P and T Committee update (from the July 22nd meeting).  Starting date for specific programs is July 29^th, 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.

golimumab (Simponi Aria) IV Infusion – This drug is the intravenous form of Simponi, and is given by infusion over 30 minutes once every 8 weeks to treat rheumatoid arthritis (RA).  Simponi is administered subcutaneously once monthly to treat RA and several other immune diseases.  The drug was classified as formulary status, restricted to hospital outpatient/clinic use.  The cost of a normal maintenance dose is in the range of $3,000 to $6,000 depending on weight.

vedolizumab (Entyvio) – This new biological agent is indicated for the treatment of moderate to severe ulcerative colitis or Crohn’s disease where first line drugs are not good options.  It is administered at the maintenance dose of 300 mg once every 8 weeks and infused over 30 minutes.  Because it acts on a receptor that is concentrated in the GI tract, its systemic effects are believed to be less than many other biological agents.  The drug costs almost $5,000 per dose.  It was classified as a formulary agent, restricted to hospital outpatient/clinic use.   

dextromethorphan-quiNIDine (Nuedexta)- This product is a combination of dextromethorphan (DM) 20 mg and quinidine 10 mg, indicated for treatment of pseudobulbar affect, which involves uncontrollable laughing and crying.  The DM is the active drug, and the quinidine is included as a CYP2D6 inhibitor to slow the metabolism of DM to dextrorphan.  Since DM crosses the blood brain barrier (BBB), and dextrorphan does not, quinidine’s pharmacokinetic action maintains a higher serum level of DM so that more active drug can cross the BBB.   Initially it is dosed once daily, and after 1 week the dose is increased to twice daily.  The drug does not usually exert its clinical effects until 10 – 14 days.  Each dose costs about $8. This drug was evaluated 3 years ago and classified as non-formulary, not stocked, but recently the neurologists have requested to start it here on some patients that would have an additional hospital stay of at least  1 week (due to the drugs slow onset and the need to pre-authorize insurance for some patients).  It was re-classified as a formulary agent, restricted to neurology use on patients expected to remain in the hospital for at least another week.  Any physician may write to order the drug to continue in the hospital from a home medication.  Unusual use expected.

rabeprazole (Aciphex Sprinkle) – This is a new delayed-release capsule form of Aciphex where the capsule is opened and the granules are sprinkled on a small amount of soft food or emptied into a liquid.  The safety and efficacy are similar to other PPI products, but it is more expensive than other PPIs.  This product was classified as non-formulary, not stocked, and will be converted to pantoprazole tablets or lansoprazole solution / Solutabs / sprinkle from capsule powder, whichever is appropriate for patient administration.  The dose conversions are documented in the PPI formulary information. 

Penicillin G K versus Na Injection – Both salts of this injection have been stocked.  However, mix-ups of the 2 salts have led to recent medication errors.  The two salts produce the same clinical results, except for a rare patient not tolerating the extra potassium or sodium load that are contained in the particular version.  It was approved to classify the potassium salt as the workhorse drug, and the sodium salt will automatically be converted to the potassium salt in a 1:1 dosage ratio, unless the practitioner believes the patient will not tolerate the extra potassium;  in that case, the sodium salt may be used.  A small amount of the sodium salt will be stocked for that purpose. 

Lipiodol - This is an iodinated radiocontrast agent composed of ethyl esters of iodized fatty acids, used for diagnostic radiology and interventional radiology indications (i.e. lymphography, liver lesion diagnosis, chemo-embolization procedures, hysterosalpingography).   It is similar to Ethiodol, which was taken off the market.  Lipiodol is the only product available to replace Ethiodol use, and for the last 3 years had to be imported from France under a strict use FDA protocol.  It recently became FDA approved, and was approved for formulary use.  A few vials will be stocked by radiology mainly for interventional radiology use (use restricted to Dr. Alex Johnson and Dr. Robert Tomalty).   Each dose costs $800.

HYDROcodone Bitartrate (Zohydro ER) – This extended-release drug involves a very controversial FDA approval, some states have tried to ban its use, and Congress is considering a bill to remove it from the market.  It is available in 5 strengths ranging from 10 mg to 50 mg tablets, and is dosed twice daily.  It has similar efficacy and safety to that of other long acting opiates, and has a high abuse potential.  This product is not abuse deterrent.  The cost is more expensive than most other oral opiate products, and if stocked will require extra C-II paperwork by the pharmacy and nursing units.  It was classified as non-formulary, not stocked, and with an interchange to MS Contin (generic) in similar dosage regimens.    

nalOXone Auto-Injector System (Evzio) – This is a new injectable dosage form of naloxone designed to be used by first responders, police, patients, and family members, in emergency opiate overdose situations, particularly involving drug abuse.  The auto-injector contains nalOXone 0.4 mg per syringe, is administered intramuscularly or subcutaneously, and includes an electronic voice instruction system.  The cost is over $500 / dose.  It was classified as non-formulary, not stocked, and generic nalOXone injection (cost of $14/dose) will be used in the hospital system when needed. 

bupivacaine liposome (Exparel)– A request for using Exparel in certain surgeries was received from Douglas Downey, MD, at the Madison Hospital.  He was approved to be added to the physician pilot program list, for use of Exparel in colo-rectal surgery procedures only, including hemorrhoidectomy. 

ISMP Report -  Current issues reviewed from the ISMP Newsletter included limiting magnesium sulfate premix to 20 gram bags, mis-identification of alphanumeric symbols in medication orders, phenylephrine injection bolus dose needing dilution prior to administration, NovoLOG insulin written with the abbreviation “SSc” (meaning sliding scale) being misinterpreted as 55 mL, vancomycin injection for oral use being given intramuscularly, and new look-alike/sound-alike drug names  i.e. Brintellix confused with Brilinta.