Following is a P and T Committee update (from the Dec. 16th meeting).  Starting date for specific programs is December 22nd, 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.

buPROPion-naltrexone (Contrave) - This is a combination of naltrexone and buPROPion used for chronic weight management in adults with at least one weight related comorbid condition.  Each tablet contains naltrexone 8 mg and buPROPion 90 mg, and the dose is titrated up over 4 weeks to 2 tablets bid.  There is no need for tapering upon discontinuation. The drug is pregnancy category X and costs about $8 / day for the maintenance dose.  Contrave was classified as non-formulary, not stocked, and initiation should be deferred to the outpatient setting.  Inpatients may use their home supply if felt necessary.  Low use is expected.

netupitant-palonosetron (Akynzeo) - This is a combination of palonosetron with the new drug netupitant and indicated for prophylaxis of acute and delayed chemotherapy induced nausea and vomiting.  Netupitant is currently not available separately.  The dose is 1 capsule (palonosetron 0.5 mg / netupitant 300 mg) orally 1 hour prior to chemotherapy on day 1.  It is given with a dexamethasone regimen and costs about $450 per dose, which is more expensive than other similar treatments including aprepitant and palonosetron alone.  Akynzeo was classified as non-formulary, not stocked, and if ordered for an inpatient, the physician should be contacted about using other formulary drugs i.e. ondansetron.  Low use is expected.

pembrolizumab (Keytruda) – This drug is approved for treatment of metastatic melanoma with disease progression following ipilimumab and a BRAF inhibitor, and is administered per intravenous infusion every 3 weeks.  It is being investigated in other types of cancer.  It’s use is associated with a variety of adverse effects.  The cost for one dose for a 75 kg patient is approximately $6,500.  It was classified as non-formulary, not stocked, and use should be deferred to the outpatient setting.

tavaborole (Kerydin) topical solution 5%– This drug is indicated for topical treatment of onchomycosis of the toenails due to Trichophyton ruburm and mentagrophytes, and is applied once daily for 48 weeks.  The cost is about $430 for 4 mL, which is approximately a 6 week supply.   It was classified as non-formulary, not stocked, and use should be deferred to the outpatient setting.  The inpatient may use their home supply if felt necessary.

testosterone (Aveed) undecanoate extended release injection – This injection is indicated for use as testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, and is a C-III substance.  It is associated with a variety of ADRs, and a REMS is in place for serious pulmonary oil microembolism reactions (POME).  With REMS, certification is required for prescribers, healthcare providers, and healthcare sites, the drug must be administered in a setting with emergency equipment and personnel available, and the patient should be monitored at the site for at least 30 minutes post-injection.  Maintenance doses are given every 10 weeks, and the cost of one dose is $825.  Aveed was classified as non-formulary, not stocked.

dapagliflozin-metFORMIN (Xigduo) - This is a combination of dapagliflozin and metformin extended release in 4 different strengths, and is dosed once daily.  Both dapagliflozin and metFORMIN ER are formulary agents.  Xigduo was classified as non-formulary, not stocked, and the 2 drugs should be dispensed separately in the same total daily doses, with metformin ER dosed once daily.

ipratropium (Atrovent HFA) inhaler  – This inhaler used to treat COPD is available in a 30 day supply and is low inpatient use but expensive.  It was approved to interchange Atrovent HFA Inhaler to ipratropium 0.02% nebulization solution (0.5 mg/2.5 mL vial), 0.5 mg given at same frequency as inhaler but a maximum of 4 treatments per 24 hours.  Atrovent inhaler was classified as non-formulary, not stocked.  Information Technology is developing an interchange in ICare.  Date of initiation to be announced.

fenoprofen (Nalfon) – The 300 mg strength has been changed to 400 mg by the manufacturers;  thus, the interchange regimen was revised to permit the 400 mg dose being interchanged to ibuprofen 600 mg at the same dosing interval.   Additionally, the drug was approved for stocking in outpatient clinics.

Risk Factors Associated with Hospital Onset Clostridium Difficile Infections (HO-CDI) – Tony Anderson’s Mid-year poster project was discussed.  Results showed that the greatest risk factors for the development of  HO-CDI were prior antibiotic therapy,  PPI use, and prior hospitalization within the last 90 days. 

Acetylcysteine Oral Protocol for Treatment of Acetaminophen Toxicity – This protocol was approved and includes indications for oral route, loading and maintenance dosing, administration, monitoring, and treatment of ADRs.  Start time to be announced.

NITROglycerin Patch Standard Times – To reduce tolerance, it is generally recommended that NITROglycerin patches be applied for no longer than 12 – 14 hours a day, with a 10 – 12 hour patch-free period.   It was approved for a standard administration time to be 9 am, and removal time to be 9 pm.   If an order is received prior to 7 pm, the patch would be applied until 9 pm and then removed, and re-applied at 9 am the next day.  If the order is processed at 7 pm or after, the dose should be deferred until the next morning.  Now orders will be dispensed as written.  The nurse will be prompted in ICare on when to remove the patch.  Start time to be announced.

Sample Policy Update – Two free drug programs have been determined to be inpatient samples, they are the Abilify Maintena program for treatment of schizophrenia/psychosis, and the Humira Loading Dose program for initiation of this agent for acute excerbations of inflammatory bowel disease (ulcerative colitis and Crohn’s Disease).  These two drugs should be logged in and out on the computer sample log documentation record located as follows:  Pharmacy Shared – Access – Central Pharmacy – and choose “Abilify – Humira Sample Log”, then select appropriate drug section, and complete access screen including lot number and expiration date of the product item being received into stock or dispensed.

ADRs – There were 81ADRs reported in September and October, with 5% being classified as preventable.  Drugs associated with the most ADR reports included vancomycin, levofloxacin, morphine, radiocontrast agents, and insulin.  Insulin, warfarin, and levofloxacin were involved in the four preventable reactions, with excessive dosing and documented allergy being the main cause for inpatient preventable reactions. Two preventable warfarin ADRs occurred in the outpatient setting.