Following is a P and T Committee update (from the September 25th meeting).  Starting date for specific programs is October 1^st, 2013, 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.

lorcaserin (Belviq) – This new anti-obesity drug is an oral C-IV agent and works as a serotonin 2C receptor agonist in the hypothalamus. The recommended dosage is 10 mg bid, and if a 5% weight loss is not achieved by week 12, the drug should be discontinued.  Dose titration and tapering is not needed, and there is the potential for serotenergic drug interactions.    The cost of this agent is about $6/day.   This drug was perceived as unnecessary to take during hospitalization, and was classified as non-formulary, not stocked.  Due to it being a C-IV agent, use of the patient’s home medication is not permitted.  Initiation should occur in the outpatient setting. 

varicella zoster immune globulin (Varizig) – This product is approved for post-exposure prophylaxis in persons at high risk for severe disease who lack evidence of immunity. This high risk population includes immunocompromised persons, premature infants during hospitalization, and pregnant women.  The dose is weight based and costs about $4,000 for an adult.  The drug should be administered within 10 days of exposure.  Varizig was classified as a formulary agent, but not routinely stocked, as rare use is expected.  

influenza virus vaccine, inactivated (Fluzone Quadrivalent) – This version of the flu vaccine includes antigens to 2 influenza A strains, and 2 influenza B strains. Immunology studies show  the quadrivalent vaccine non-inferior to the trivalent vaccine, except better immunologic response to the additional B strain;  it is currently unknown how the additional B strain coverage will effect influenza prophylaxis.  The CDC currently does not recommend one vaccine over the other.  The quadrivalent vaccine is twice the cost of the regular trivalent product.  The quadrivalent was classified as non-formulary, not stocked.

influenza virus vaccine, inactivated (Flublok) - This is a new version of the trivalent influenza vaccine that does not contain egg protein, and is approved for persons age 18 – 49 years. According to the CDC, people who can safely eat lightly cooked eggs like scrambled eggs, should receive the regular influenza vaccine, and people whose only allergy symptom is hives after consuming eggs should receive the regular trivalent vaccine and observed for 30 minutes.  Flublok costs 3 times the amount as the regular trivalent flu vaccine.   Approximately 0.2% of the population has a significant egg allergy.  This vaccine product was approved for formulary status, with a small supply stocked during flu season for egg-allergic patients.

delavirdine (Rescriptor) – This older anti-HIV drug is an NNRTI used in combination therapy to treat AIDS. The drug is associated with various adverse reactions and drug interactions.  The product has not been used at Huntsville Hospital for several years, and it was approved to delete it from the formulary.  If on the rare occasion an inpatient is taking the drug chronically, they should use their own supply in the hospital. 

indinavir (Crixivan) – This older anti-HIV drug is a protease inhibitor used in combination therapy to treat AIDS. The drug is associated with various adverse drug reactions and drug interactions.  The product has not been used at Huntsville Hospital for several years, and it was approved to delete it from the formulary.  If on the rare occasion an inpatient is taking the drug chronically, they should use their own supply in the hospital.

dabrafenib (Tafinlar) – This new oral drug is approved for treatment of unresectable or metastatic melanoma in patients with BRAF-v600e mutation as detected by an approved test. It is a kinase inhibitor and is dosed 150 mg bid, with dosage reduction for toxicities.  It interacts with various other drugs through P-450 3A4, 2C8, 2C9, and 2C19, and the cost is about $170.day.  Rare use is expected.  This drug was classified as non-formulary, not stocked, and initiation should be deferred to the outpatient setting.

alglucosidase alfa (Lumizyme) – This agent is approved for replacement therapy with late-onset Pompe disease and no evidence of cardiac hypertrophy. The dose is 20 mg/kg via intravenous infusion every 2 weeks, and the infusion is administered over 4 hours or longer if adverse effects develop.  There are various adverse effects that may occur associated with the drug including infusion reactions, anaphylaxis, decreased hearing, and musculoskeletal pain.  Each dose costs about $23,000.  Education and certification is required for the health care team members involved with the drug use process.  It is planned to administer this agent in the Outpatient Medical Department.   The drug was approved for use in the requesting patient, the drug will be prepared by the IV Room and this is expected to be long-term therapy.

Food-Drug Interaction Program - This program involves monitoring and patient education involving lithium, tetracycline, and MAO inhibitors by dieticians, provision of warfarin meal tray cards, pharmacist discharge education including food-drug interactions upon consult, anti-diabetic medication education by the Diabetes Control Center personnel upon consult, and provision of discharge information on newly started drugs to be continued in the outpatient setting by the nurse.   After program evaluation, it was approved to continue this same program. 

Stress Ulcer Prophylaxis MUE – This program involves using patient risk factors for stress ulcers to determine appropriate PPI usage, and will currently focus on 7-North patients for that indication. An risk evaluation form will be used to assess each patient, and will be left in the chart with a recommendation to discontinue the PPI if appropriate.  If the physician does not indicate to continue the PPI within 24 hours of the chart notice, the PPI will be discontinued by the project pharmacist.  After review, this program was approved.

Intravenous Infusion Standard Concentrations – New standard concentration updates were approved for the following drugs: argatroban, dexmedetomidine, diltiazem, furosemide, norepinephrine, PENTobarbital, and phenylephrine.