Following is a P and T Committee update (from the Sept. 23rd meeting).  Starting date for specific programs is Sept 30th, 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.

tadalafil (Cialis) – This agent is now approved for treatment of BPH, and is a 2^nd-3^rd line drug for this indication.  The BPH dose is 5 mg once daily, and the cost is $5.61 per 5 mg dose, versus $0.05 for terazosin 10 mg.   It was approved for formulary use, restricted to BPH treatment.   Adcirca (tadalafil 20 mg tablet) is also listed on the formulary for restricted use in pulmonary hypertension.  

indomethacin (Indocin) suppository – This dosage form is FDA approved to treat acute gouty arthritis, acute bursitis/tendonitis, and osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Off label uses include treatment of pre-term labor, and with ERCP to prevent pancreatitis post-procedure.  The suppository has been on backorder, and use was restricted to use in pre-term labor and was available through a compounding pharmacy.  Recently, the suppository became commercially available, and a physician wanted to use it routinely with ERCP.  Indomethacin suppository was approved for general formulary use.  There is still a 48 hour duration review in place for use in pre-term labor situations.

bupivacaine liposomal (Exparel) – This agent is currently restricted to use by plastic surgeons, in an orthopedic surgery pilot program with Dr. Goodson, and per a colorectal surgery pilot program.   An additional general surgeon, Dr. Matthew Hunt, was added to the colorectal pilot program.   

ramucirumab (Cyramza) – This is a new VEGRF-2 inhibitor used to treat advanced, resistant gastric cancer or gastro-esophageal junction adenocarcinoma and is given by intravenous infusion once every 2 weeks.  Adverse reactions include hemorrhage, thromboembolic events, severe hypertension, and infusion related reactions.   The cost per dose for a 70 kg patient is approximately $6,000.  The drug was classified as a formulary agent, restricted to hospital outpatient, or clinic/office use by oncologists.  Rare use is expected.

naftifine (Naftin) gel 2% – This is a broad spectrum topical antifungal agent approved for the topical treatment of tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton mentagrohytes, and Epidermophyton floccisum.  It is applied once daily for 2 weeks, and costs $345 for a 60 gram tube. Lamisil AT cream 1% costs $6 for a 12 gram tube.   This naftifine gel product was classified as non-formulary, not stocked, with an interchange to Lamisil AT cream 1% applied bid.

brimonidine (Mirvaso) topical gel 0.33% – This product is a topical alpha-adrenergic agonist indicated to treat persistent erythema of rosacea and acts pharmacologically by direct vasodilation.  It is applied once daily to 5 areas of the face that are usually affected., and costs $250 per 30 gram tube.  Rare use is expected.  It was classified as non-formulary, not stocked, and the patient should use their own supply while in the hospital;  if the home supply is not available, the physician should be contacted and other treatment options on the formulary  reviewed (i.e. topical metronidazole).  Initiation should be deferred to the outpatient setting. 

nepafenac (Ilevro) ophthalmic suspension 0.3% – This agent is FDA approved for treatment of pain and inflammation associated with cataract surgery, and is dosed once daily beginning on day 1 pre-surgery and continuing through the first 2 weeks of the post-op period.  The cost is $164 for a 1.7 mL bottle, and generic ketorolac ophthalmic sol. costs $8.49 for a 5 mL vial.   Currently, ketorolac is the formulary interchange workhorse for this drug class.  Ilevro was classified as non-formulary, not stocked, and will be interchanged to ketorolac ophthalmic solution 0.5% bid. 

L-methylfolate (Deplin) – This is a prescription medical food used in the dietary management of depression, and should be used in combination with antidepressants.  The dose is 7.5 – 15 mg once daily, and the drug does not exert clinical effects for several months after starting.  Folic acid is metabolized to l-methylfolate through a few chemical steps, and it is methylfolate that crosses the blood-brain barrier and may be involved in formation of certain neurotransmitters;  however, some patients produce less available methylfolate than others.  This product was approved for formulary status, restricted to psychiatrists for therapy initiation.

ospemifene (Osphena) – This new drug is a SERM indicated to treat moderate to severe dyspareunia due to symptoms of vulvar and vaginal atrophy secondary to menopause.  The dose is 60 mg once daily, and most safety issues are related to that of estrogens.  The drug costs approximately $5 per day.  It was classified as non-formulary, not stocked, the patient may use their home supply if it is felt this should be continued in the hospital. Initiation should be deferred to the outpatient setting.

lactobacillus acidophilus (Lactinex Granules) – This probiotic product contains L. acidophilus and L. bulgaricus and was added to the formulary, specifically for use when a probiotic is to be administered down a tube, or the patient cannot take oral capsules.   The cost is $0.93 per dose.

lactobacillus acidophilus (RisaQuad) – This is the new OTC probiotic formulary workhorse agent and replaces Flora-Q, which has been discontinued.  It contains the same organisms as Flora-Q did.  Other probiotic products ordered (except for Culturelle and Lactinex Granules) should be interchanged to RisaQuad.   RisaQuad and Flora-Q both contain L. acidophilus, Bifidobacterium, L. paracasei, and S. thermophilus.  This capsule should not  be opened and administered down a tube. The cost is $0.46 per dose.

Abilify Maintena Protocol – This protocol was approved for use with the Abilify Maintena program, and includes evaluation of patient’s prior use of the drug, dosing, pharmacist evaluation of drug interactions, needed dosing adjustment, and transition to outpatient dosing.   Staff education will be conducted before starting to use the protocol.  Start date to be announced. 

Pharmacist Clarification of Home Medications – The following apply regarding clarification of drugs listed on the medication reconciliation list (MRL) after physician signature on the form:

1. For any drugs selected to be continued by the physician:
   • the following fields may be changed automatically by the pharmacist after clarification from the patient, family, pharmacy, MD office, etc.:
     • Dosage form
     • Dose
     • Route 
     • Frequency
     • PRN indication
2. Documentation of above changes:
   • The MRL is signed, dated, and timed by the individual who amended the MRL next to the correction
   • The corrected order is entered into ICare by the pharmacist, using order
   • Mode Q with a comment “Home medication clarification per P and T protocol”
   • The home medication history is corrected in the HCS system.
3.  Exceptions:
   • For any selected medication removed or added to the MRL after the physician signature, the prescriber must be contacted for further clarification.
   • OTC drugs may be added to the MRL except for aspirin and NSAIDs
4. Pharmacists will contact prescriber if concerns about appropriateness of order exist.