Following is a P and T Committee update (from the June 24^th meeting).  Starting date for specific programs is June 30^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.

perampanel (Fycompa) -  This drug is a new anti-epileptic agent that is thought to act as a non-competitive AMPA glutamate antagonist , and is approved for adjunctive therapy in the treatment of partial-onset seizures in patients aged 12 years and older.  The dose is gradually titrated up to 4 - 12 mg (once daily).  There are various adverse effects including serious psychiatric and behavioral reactions, somnolence, ataxia, fatigue, headache, and others.  The cost for maintenance dosing is about $20 daily.  This drug was approved for formulary status, initiation in the hospital is restricted to neurology physicians.

dalbavancin (Dalvance) – This new drug is structurally related to vancomycin and is indicated for treatment of acute bacterial skin and skin structure infections caused by designated susceptible strains of gram-positive microorganisms, including MRSA.  It exerts concentration-dependent bactericidal activity via interference with cell wall synthesis.   The dose is 1,000 mg intravenously initially, followed by 500 mg one week later, and each dose is administered over 30 minutes;  the dose should be decreased with CrCl < 30 mL/min.  There is little information about use in pediatrics at this time.  The drug was classified as formulary status, restricted to the outpatient setting.  The Anti-microbial Management Team will monitor use.  If prescribed for an inpatient, the physician should be contacted and other similar drugs recommended for use in the hospital (i.e. vancomycin, daptomycin, linezolid, telavancin).  An automatic pharmacist renal adjustment was approved according to the package insert recommendations.  Dalbavancin is expected to be available from wholesalers sometime later in July.

isosulfan blue (Lymphazurin) –  This drug is a blue dye used diagnostically in sentinel lymph node mapping (SLNM) procedures, with methylene blue being a less expensive alternative.  A new physician has requested to use Lymphazurin instead of methylene blue.  Literature and practice patterns at other institutions were presented in support of methylene blue use to this specific physician, and he has decided to use methylene blue as his main drug for SLNM procedures.    He requested to use Lymphazurin in vulvar cancer cases specifically, which will be approximately 5 cases annually.  Thus, lymphazurin was approved as a formulary agent, restricted to Dr Kirby and Dr. Engle for use in vulvar cancer SLNM procedures only.  

ARIPiprazole (Abilify Maintena) - This is a long-acting injectable ARIPiprazole preparation administered once monthly and indicated for the maintenance treatment of schizophrenia in adults.  The normal dose is 400 mg once monthly, but if certain adverse reactions occur or potential drug interactions exist, a lower dose is recommended.  The patient should have a record of tolerating ARIPiprazole before this injection is started, and should continue on some oral antipsychotic agent for 2 weeks after the first injection.  The 400 mg dose costs about $1,425, but the company will provide this drug at no charge to the hospital.  It was approved for formulary use under the Otsuka free drug program, and upon cancellation of this program will be reclassified as a non-formulary agent.  There are various drug interactions with this agent that requires dosage reduction.  An oral aripiprazole test dose should be done on patients not previously exposed to aripiprazole prior to administering the injection, and an oral antipsychotic should be continued for 2 weeks after the first injection.  A protocol will be developed for its use.  Time of implementation of this program will be announced.

bedaquiline (Sirturo) – This new drug is a diarylquinoline anti-mycobacterial agent indicated for treatment of pulmonary multidrug-resistant tuberculosis in combination therapy when other alternatives are not available, and should not be used for latent, extrapulmonary or drug-sensitive tuberculosis.  The initial dose for weeks 1 and 2 is 400 mg once daily, then followed by 200 mg three times weekly from weeks 3 – 24.  The drug should be taken with food to increase bioavailability.  Safety concerns include increased mortality with patients on this drug versus placebo, QT interval prolongation, and hepatic toxicity.   The drug is available only through a specialty pharmacy program where financial planning, insurance issues, and drug availability can be managed.  Sirturo was classified as non-formulary, not stocked;  if a patient needs the drug in the hospital, they will need to use their home supply, initiation should be deferred to the outpatient setting.

phytonadione Vitamin K Oral – Some physicians have been prescribing low doses (i.e. less than 5 mg) of oral vitamin K for inpatients.  The available tablet is 5 mg and there is no available oral liquid.  The recommendation was to round oral doses less than 2.5 mg and from 2.5 to 3 mg, to the 2.5 mg dose (1/2 x 5 mg tablet), and doses between 3 mg and 5 mg  rounded to the 5 mg dose.  This is expected to reduce medication errors that could occur from drawing up small doses of the injection preparation and giving it orally.  However, the P and T Committee cardiologist has recently objected to using this dose rounding protocol with his patients.  This topic was tabled until a future meeting, and pharmacy will discuss the reasons for the dose rounding program with the physician.  If the physician desires to continue to prescribe very low doses, the Committee requested literature documentation for the benefit of these doses. 

Augmentin Tablet to Suspension Conversion – In situations where the suspension is more desirable than the tablet for administration (i.e. N/G tube, G-tube) it was approved that the pharmacist may automatically convert  from the tablet (875 mg/ 125 mg) to the suspension dosage form as follows: 

• Augmentin 875 mg / 125 mg oral tablet bid converted to Augmentin  400 mg/ 57 mg / 5 mL susp., 10 mL bid (total 10 mL susp. Dose would be 800 mg / 114 mg)

Nutrition – The clinical nutrition department is planning on presenting criteria for dietician prescribing in the near future, based on CMS guidelines.

ADE Report – There were 102 ADEs  reported during March and April.  Drugs most frequently involved in these reports were levofloxacin, vancomycin, and morphine;  4 reactions were judged preventable, 3 of these involving a documented allergy/reaction.