Following is a P and T Committee update (from the August 26th meeting).  Starting date for specific programs is Sept 3rd, 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.

tedizolid (Sivextro) – This is a new oxazolidinone antibiotic similar to linezolid, dosed 200 mg once daily for 6 days and administered either intravenously or orally.  It is currently approved only for treatment of acute bacterial skin and skin structure infections due to susceptible gram-positive bacteria, including MRSA, and costs $235/day for either the IV or oral dose. Linezolid has more indications, has been used at Huntsville Hospital for many years, and is similar in cost. Linezolid is projected to go generic in the near future, with the cost decreasing substantially at that time.   Tedizolid was classified as non-formulary, not stocked, with an automatic interchange to linezolid if prescribed for an inpatient.   

acyclovir (Sitavig) - This is a 50 mg buccal acyclovir tablet indicated to treat herpes labialis (cold sores) in immunocompetent adults, and is given as just one dose.  The tablet is applied to upper gum for 30 seconds until it adheres to the gum, and then dissolves during the day.  The cost is $142 per one dose regimen.  Regular acyclovir tablets for 5 days, or famcyclovir or valacyclovir are lower cost alternatives.  Sitavig was classified as non-formulary, not stocked, and should be interchanged to valacyclovir 2 grams bid for 2 doses.

vorapaxar (Zonitivity) – This is a new reversible antagonist of the protease-activated receptor-1 (PAR-1) expressed on platelets, and inhibits thrombin-induced and thrombin receptor agonist peptide (TRAP)-induced platelet aggregation in in vitro studies.   It is indicated to reduce thrombotic events in patients with a history of  myocardial infarction (MI) or with peripheral arterial disease.  It has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke, and coronary revascularization.  The dose is 2.08 mg once daily, and the most common adverse effect is bleeding.  The cost is approximately $8 daily.   It was classified as a formulary agent. 

mupirocin (Bactroban) Cream versus Ointment – These 2 topical preparations are used to treat gram-positive skin infections.  They are similar in efficacy and safety issues.  The cream is much more expensive than the ointment currently.  It was approved to automatically interchange orders for the cream to the ointment.  The cream will continue to be formulary status and available with a no substitution order. 

luliconazole (Luzu) – This is a new azole anti-fungal topical cream indicated for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum and Epidermophyton floccosum.  It is used for 1 – 2 weeks, which is a shorter duration than other similar products.  The cost is $360 for a 30 gram tube, versus $6 for a 30 gram tube of a similar azole topical, ketoconazole.  Luzu was classified as non-formulary, not stocked, and it should be interchanged to ketoconazole cream for inpatients.  The patient may use their own supply in the hospital if needed.

umeclidinium-vilanterol (Anoro Ellipta) – This is a combination of  the new long acting beta agonist, vilanterol, and the new long acting anticholinergic, umeclidinium.  It is indicated for the long-term maintenance treatment of airflow obstruction in patients with COPD, and is dosed once daily.  Adverse effects include sinus and lower respiratory tract infections, common cold symptoms, constipation, diarrhea, urinary retention, prolonged QT interval, and others.  It was classified as non-formulary, not stocked, with an interchange to DuoNeb nebulization four times daily.  Unusual inpatient use is expected. 

certinib (Zycadia) – This is a new kinase inhibitor indicated for treatment of anaplastic lymphoma kinase (ALK) positive metastatic non-small cell lung cancer (NSCLC) in patients intolerant to or have progressed with crizotinib.   The normal dose is 150 mg once daily, with dose adjustments recommended in association  with certain drug interactions and adverse effects.  The cost is $540 daily and is mainly available through specialty pharmacy programs.  It was classified as non-formulary, not stocked, initiation should be deferred to the outpatient setting, inpatients needing to continue on the drug in the hospital should use their own supply. 

adalimumab (Humira) Loading Dose Protocol for IBD Exacerbation-  This protocol is designed for adalimumab use in exacerbation situations with Crohn’s Disease and ulcerative colitis and must be prescribed by a gastroenterologist.  The protocol addresses indication, diagnostics, benefit verification (by social worker), medication use, and transition of care to the outpatient setting.  The diagnostics and benefit verification must be completed before the drug is administered.  The drug is provided free for the loading dose only (4 x 40 mg syringes given subcutaneously), and this drug supply is stocked in the Main central pharmacy refrigerator.  The verifying pharmacist should enter the patient in the log located in the Access Central Pharmacy file, and notify Richard Cramer in drug information of the patient’s order.  This will be a drug that will not be administered at order time, but after the diagnostic tests and benefit verification are completed.  The protocol was approved for use.  The date for start of this protocol will be announced.

ADR Report – There were  58 ADEs  reported during May and June.  Drugs most frequently involved in these reports were levofloxacin, vancomycin, and morphine;  5 reactions were judged preventable ( with radiocontrast agent, prochlorperazine, insulin, gabapentin, and cefazolin), 3 of these involving a history of documented allergy/reaction to the drug or a similar drug.  The number of ADR reports have declined and pharmacists are requested to enter ADRs identified into the computer reporting system.

Bupivacaine liposomal (Exparel) – Several orthopedic surgeons have requested to use Exparel based on limited information being circulated by the drug company.  Plans for a pilot program with Exparel use in THA and TKA cases were discussed.  Kristin Hillman will be the focus pharmacist conducting a medication use evaluation where Exparel patients will be compared to a control group.  This project will involve collection of different outcome data that should assist in evaluating Exparel benefits in the orthopedic setting.  This pilot program was approved and will involve primarily Dr. Goodson’s THA and TKA cases.  The date for start of this pilot program will be announced.