Following is a P and T Committee update (from the August 27^th meeting).  Starting dates for specific programs listed below is September 4th, 2013, unless otherwise stated.  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” 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.

remifentanil (Ultiva) – This opiate analgesic is used for analgesia/anesthesia/sedation in combination with other medications. It has a shorter half-life (i.e. 3-10 min.) than fentanyl and is currently restricted to anesthesiology for craniotomy use only. remifentanil is a brand name drug and much more expensive than fentanyl.   Due to the short half-life, it has been theoretically proposed that remifentanil may reduce TEE procedure/recovery time and may allow for more patients to receive this procedure in a given time period.  A pilot trial with remifentanil was approved, and an MUE will be conducted with data collection to evaluate remifentanyl’s benefit.   

prothrombin complex concentrate (Kcentra) – This new product is FDA approved for urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy (i.e. warfarin) in patients with acute major bleeding. Off-label, there is information on its use for perioperative prophylaxis of bleeding during warfarin therapy.  It is dosed based on INR value and body weight and vitamin K should be administered concurrently.  It is similar to Profilnine, our PCC formulary agent;  Kcentra contains the same factors as Profilnine, plus Factor VII and proteins C and S, and is more expensive.  It was approved that Kcentra be classified as non-formulary, not stocked, and Profilnine currently continue to be the formulary agent for this drug class.  Novo-Seven can be administered alone with Profilnine if additional Factor VII is needed in given cases. 

Bisphosphonate Intravenous Interchange – pamidronate (Aredia) and zoledronic acid (Zometa) are both intravenous bisphosphonate drugs indicated for hypercalcemia of malignancy.  Pamidronate is available generically and is administered as an infusion over 2 hours or longer, while Zometa is still a branded product usually diluted in 100 mL of fluid and administered over 15 minutes or longer.  A 4 mg dose of Zometa costs about $360, while a 90 mg dose of pamidronate costs about $30.  It was approved to interchange a Zometa 4 mg dose to pamidronate 90 mg for all inpatient uses.  The pamidronate infusion will normally be administered over 2 hours.   Zometa use will be restricted to the outpatient setting only.  Pamidronate use is expected to save about $38,000 annually in drug expenses. 

ezetimibe-atorvaSTATin (Liptruzet) -This is a new combination of ezetimibe (Zetia) and atorvastatin to treat hyperlipidemia and is available in 4 different strengths. Ezetimibe is formulary status, and rosuvastatin is currently the formulary workhorse agent for the more potent statins.  Liptruzet was classified as non-formulary, not stocked, and the two agents should be given separately – the atorvastatin component should be dispensed as rosuvastatin according to the statin formulary dosage interchange nomogram.

Thiazide Diuretic Update – There are over 10 thiazide related diuretic drugs on the market, and HH has used a formulary interchange for these agents for many years, with hydrochlorothiazide (HCTZ) being a “workhorse” formulary drug. Chlorthalidone is one of the drugs interchanged to HCTZ.   Based on the perception of stronger evidenced based studies with chlorthalidone, some practitioners have recommended that this interchange be discontinued for chlorthalidone, and this proposal was approved.  Thus, the interchange from chlorthalidone to HCTZ should be discontinued as of Sept. 4th, 2013.  Chlorthalidone 25 mg tablets will be regularly stocked, a 50 mg dose can be given as two 25 mg tablets. 

Cortisone Tablet Shortage / Interchange – There is a national shortage of cortisone tablets that is expected to last through most of 2013. Hydrocortisone is a very similar drug with approximately equal glucocorticoid and mineralocorticoid activity.  It was approved to automatically interchange oral cortisone to oral hydrocortisone in approximately equivalent doses.

Methylene Blue Inj. Shortage – These is a national shortage of methylene blue inj. that is expected to resolve in the near future. For many of its uses, other stocked dyes can be used  e. topical markings for surgery – use gentian violet, for fill tissue expanders use indigo carmine.  However, for lymph node mapping, isosulfan blue (Lymphazurin) is the only alternative dye used.   Isosulfan blue costs about $500 per dose (vs. about $5 for methylene blue) and is classified as “non-formulary, not stocked”.  However, it was approved to use isosulfan blue when needed for lymph node mapping cases during the methylene blue shortage period.

memantine (Namenda XR) - Memantine is indicated for moderate to severe Alzheimer’s Disease and used off-label for vascular-related dementia.  The starting dose is 5 mg daily and this is titrated up to a general maintenance dose of 20 mg daily.  A new XR form is being marketed in 7 mg, 14 mg, 21 mg, and 28 mg;  however, the half-life of  this new form is 60 – 80 hrs and is similar to the regular tablets, and doses higher than 20 mg have not shown additional efficacy.  Namenda XR was classified as non-formulary, not stocked, and this product should be interchanged to immediate release memantine tablets in similar dosage regimens. 

dexamethasone (Ozurdex) ophthalmic- This new product is dexamethasone intravitreal implant used for treatment of macular edema following retinal vein occlusion. Once implanted, duration of effect is one to three months.  Ozurdex is normally administered as an in-office, outpatient procedure, and is expensive.  This drug was classified as non-formulary, not stocked, and should be deferred to the outpatient setting.

Morphine and Dilaudid Infusion Protocol for Comfort Care – These 2 protocols are designed to provide comfort care for DNR patients who are near the end of life and focus on opioid dosing and monitoring particularly for opioid naïve patients . They were reviewed and approved.

Fentanyl Intravenous Use – Fentanyl doses were approved for regular nursing unit dosage via intermittent intravenous dosing or PCA.  This drug should still only be given by infusion in ICUs.   Starting doses for infusions  are recommended at 25 – 50 mcg/hr, with increases/decreases by 25 mcg/hr at 15 min intervals until adequate clinical effect is maintained.  Maximum dose is generally 200 mcg/hr., but doses vary widely.