Following is a P and T Committee update (from the May 28^th meeting).  Starting dates for specific programs listed below is June 3^rd, 2013, unless otherwise noted.  This information should be available soon 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” 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.

ARIPiprazole (Abilify Maintena) ER injection -  This product is indicated for maintenance treatment of schizophrenia in adults and is dosed as 400 mg intramuscularly once monthly.  After the first dose, oral aripiprazole therapy should be continued for 14 days with dosage at 10 – 20 mg daily.  The cost is about $1,400 for one dose.  This product was classified as “Non-formulary, not stocked”, and if an order is received for an inpatient, the physician should be called, and alternative therapy discussed.  We continue to participate in the Invega Sustenna Voucher Program, where both the patient and hospital receive the drug at no cost.  If Abilify Maintena is desired, administration should be deferred to the outpatient setting.

tobramycin-dexamethasone (TobraDex ST) Ophth. Susp. – This new product is a revised version of the combination of tobramycin 0.3% / dexamethasone 0.1% ophthalmic suspension that is available generically now and is used for inflammatory ocular conditions where superficial bacterial ocular infection or its risk exists.  This new version has increased ocular bioavailability and the dexamethasone strength is reduced to 0.05%.  In vitro data shows some higher ocular drug levels over a given time period vs regular TobraDex, but there appears to be little clinical difference in outcomes between the 2 products.  The new ST version is much more expensive than the older product.  TobraDex ST was classified as non-formulary, not stocked, and should be interchanged to regular TobraDex on a 1:1 dosage ratio.

dorzolamide-timolol (Cosopt PF) ophth sol. -  This is a revised, preservative free version of Cosopt Ophth Sol., which is a combination of dorzolamide and timolol used to treat ocular hypertension and open-angle glaucoma.   The older product is available generically at a much lower cost, and ophthalmic preservatives usually don’t cause problems when used short term.  Cosopt PF was classified as non-formulary, not stocked, and should be interchanged to the generic combination product on a 1:1 dosage ratio.  The patient may use their own supply of Cosopt PF if needed.

canagliflozin (Invokana) – This new oral anti-diabetic agent is the first sodium-glucose co-transporter-2 (SGLT2) inhibitor on the market.  The kidneys reabsorb glucose via the sodium-glucose co-transporters mechanism, and this inhibition decreases renal glucose absorption and increases urinary glucose excretion.  The dose is 100 – 300 mg once daily, but if CrCl is between 45 and 60, not over 100  mg daily should be given, and if the CrCl is less than 45, the drug is not indicated.   The cost is about $7/day, versus about $0.10/day for glipizide, glyburide, or metformin.  This drug was classified as a formulary agent, with an automatic pharmacist dose adjustment to 100 mg daily if CrCl is between 45 – 60;  if <45, the pharmacist should contact the physician to discuss discontinuation and alternative therapy options (fyi -you may want to add a note about this renal adjustment in your Pharmacist Quick Reference Guide).

mipomersen (Kynamro) – This drug is approved for treatment of homozygous familial hypercholesterolemia (HoFH), which is a rare disorder.  It is used as adjunctive treatment and dosed as 200 mg subcutaneously once weekly.  There is a strict REMS program requiring physician and pharmacy certification, patient registration and education, and monitoring, related to a black box warning on hepatotoxicity.  The cost is over $800 / day, and is distributed only through a specialty pharmacy, and the hospital cannot order the drug specifically.  It was classified as non-formulary, not stocked, the inpatient should use their own supply if needed, and therapy initiation should be started in the outpatient setting.

ado-trastuzumab emtansine (Kadcyla) – This new intravenous infusion agent is approved for treatment of HER2 positive metastatic breast cancer in patients who have already received trastuzumab or taxane therapy.  The dose is weight-based, given every 3 weeks, and is adjusted for various situations.  There is a black box warning on hepatotoxicity.  This agent costs about $9,000 per dose and rare inpatient use is expected.  It was classified as non-formulary, not stocked, as use is expected to be in the outpatient setting.

GI Cocktail Update – Due to the inavailability of lidocaine viscous 15 mL unit for use, the content formula was changed to lidocaine viscous 20 mL, Maalox 30 mL, and Donnatal 10 mL.  

Loop Diuretics – Standard Administration Times – In order to reduce the number of doses given in the evening (which causes increased nighttime voiding, disrupts sleep and increases fall risk), it was approved to administer regularly scheduled doses of  these agents at the following times:  once daily – at 9 am, twice daily - at 9 am and 5 pm. 

Extravasation Management Guidelines – An order set, policy, and flow chart were approved, addressing treatment of extravasation involving different non-chemotherapy related drugs (there is a separate policy in regards to chemotherapy agents).  The order set directs use of hyaluronidase and cold compresses for various drugs, and phentolamine and warm compresses for vasopressors.  Techniques for prevention are also included.

Pharmacist Route Conversion for Oral to NG/OG/G Tube – A revised policy was approved for automatic pharmacist conversion of dosage forms and doses under these situations. .  The policy discusses various situations, including crushing tablets, converting from tablets to liquid, changing from sustained release preparations, pharmacokinetic and bioavailability considerations, drugs not to automatically convert, and other issues.

Delirium Protocol in Critical Care – A protocol to help manage delirium in the ICU setting was approved.   The protocol addresses evaluation for drugs that could cause delirium, and environmental and orientation issues.  Haloperidol and quetiapine are front-line drugs for use, with ziprasidone as an alternative.  The order set includes a method for delirium assessment.

Prophylactic Antimicrobial Dosing Guideline Update – Guidelines for antibiotic dosing were approved.  For pre-op dosing in patients weighing over 80 kg. the recommended dose is usually higher than otherwise. The intraoperative re-dosing with consideration of renal function is also addressed. 

Huntsville Compounding Center – A  site visit was recently conducted and procedures were found to be within good pharmacy practice standards for the types of compounded products prepared. This pharmacy was approved as an appropriate outsource medication provider.

ADE Report – There were 109 ADE reports in March and April 2013, with 6 (5.5%) being preventable.  The drugs most commonly involved in these reports were morphine, levofloxacin, insulin, and vancomycin.  Insulin was the drug most often reported with preventable ADEs, and excessive dosing was the most common cause. 

ISMP Report – Issues reported included naloxone-nalbuphine mix-up, potential confusion of generic name of Kadcyla (ado-transtuzumab emtansine versus transtuzumab – Herceptin), chemotherapy overfills, GLP-1 ADRs, and risperidone-ropinirole mix-up.   

Drug Shortages – Drugs that are currently on national shortage include:  acyclovir inj., aminophylline inj., bumetanide inj., calcium gluconate and chloride inj., chromium inj., dobutamine vials, dopamine vials, fosphenytoin, furosemide inj., magnesium sulfate inj., methyldopa inj., nalbuphine inj., and sodium bicarbonate inj.   Current drug shortages include many drugs not listed here.