Following is a P and T Committee update (from the April 22 meeting).  Starting date for specific programs is April 28^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.

dapagliflozin (Farxiga) – This is a new sodium glucose co-transporter 2 (SGLT2) inhibitor similar to canagliflozin, and is dosed initially as 5 mg once daily, the daily dose can be increased to 10 mg., and it should not be started in patients with GFR less than 60 mL/min. It may contribute to hypoglycemia when used with other drugs that decrease blood glucose, and is expected to have less drug interactions than canagliflozin. There is currently a weak association with drug use and bladder cancer and more research is needed, but the drug should be avoided in patients with bladder cancer.  It is more expensive than canagliflozin.  It was classified as a formulary agent.

sofosbuvir (Solvadi) – This new drug for chronic hepatitis C is used for genotypes 1, 2, 3, and 4, for 12 – 24 weeks, with ribavirin and for types 1 and 4, with ribavirin plus interferon. In clinical studies it has shown very good results in decreasing HCV blood levels to the undetectable category, suggesting a cure. It has important drug interactions through the P-gp system, is dosed once daily, and costs about $1,000 per day. This drug should be targeted to patients that are expected to be very compliant, as resistance develops with non-compliance with the recommended regimen. This drug was classified as non-formulary, not stocked, if needed in the hospital the patient should use their home supply, initiation should be deferred to the outpatient setting where financial management plans can be developed prior to starting on the drug.

simeprevir (Olysio) – This new agent for genotype 1 chronic hepatitis C is administered in combination with peginterferon alfa (alfa-2a and alfa-2b) and ribavirin for the first 12 weeks.  It is dosed once daily, should be administered with food, and  may interact with other drugs via the P450-3A4 and P-gp systems. Clinical results have shown good results with high sustained virologic response rates. The cost is over $750 per day. This drug was classified as non-formulary, not stocked, if needed in the hospital the patient should use their home supply, initiation should be deferred to the outpatient setting where financial management plans can be developed prior to starting on the drug.

elosulfase alfa (Vimizim) – This intravenous infusion drug is indicated for an enzyme deficiency disease that causes mucopolysaccharidosis, which includes accumulation of keratin and chondroitin in tissues and organs, causing organ damage.  This drug replaces the deficient enzyme, is dosed by weight, and administered once weekly over at least 3.5 – 4.5 hours.  It can cause infusion related reactions and anaphylaxis, and premedication is recommended.  The cost for a 40 kg child is about $21,000 / dose.   A patient has requested long-term administration at Huntsville Hospital infusion center.  The drug was approved as a formulary agent, restricted to outpatient status administration; for each patient, a financial management plan will be developed prior to starting the drug at Huntsville Hospital.  Under certain circumstances, the drug may need to be administered at another facility.  A protocol for a pediatric patient was approved, and includes screening, pre-medication, dose and dose titration, administration, and monitoring. 

posaconazole (Noxafil) ER tablets – This is a new extended release dosage form dosed once daily and is indicated for prophylaxis of invasive Candida and Aspergillus infections in adolescent and adult patients, who are at high risk of developing these infections due to being severely immunocompromised.  The oral suspension is already stocked, is approved for broader indications, is dosed bid – tid, and should be taken with food.  The suspension offers more versatile use with indications, flexibility to vary doses, and ability to administer to different populations including patients with NG tubes.  The tablet was classified as non-formulary, not stocked, and will be interchanged to an approximate equivalent dose of the suspension.   

obinutuzumab (Gazyva) – This is a new intravenous drug indicated for treatment of previously untreated CLL in combination with chlorambucil and involves a loading dose cycle and 5 monthly maintenance dose cycles.  The drug can cause severe blood dyscrasias and is associated with various drug interactions.   The loading dose cycle costs approximately $18,000, and each maintenance dose costs approximately $6,000.  It was classified as a formulary agent, with use restricted to the oncology outpatient setting.

sodium chondroitin-hyaluronate ophthalmic (DisCoVisc) – This is an ophthalmic viscosurgical agent containing a mixture of a  chondroitin and a hyaluronate compound, indicated for use during surgery involving the anterior segment of the eye.  It is also used for coating intraocular lenses and instruments during cataract extraction and intraocular lens insertion. DuoVisc, which is a combination of separate syringes of ProVisc (contains hyaluronate) and Viscoat (a hyaluronate-chondroitin combination)  is currently used at Huntsville Hospital System and is indicated for the same uses.  The costs of DiscoVisc and DuoVisc are similar.  DiscoVisc was approved as a formulary agent.

Zipsor and Cambia for Outpatient Clinic – These 2 drug products are low dose diclofenac preparations and several years ago were classified as non-formulary, not stocked for inpatient use.   They were classified as formulary for the outpatient clinic/office setting.  Zipsor samples are currently stocked in the Pain Center.

Papaverine Injection Outsourcing– This injection has been on chronic national shortage and has not been readily available commercially.  CV surgeons desire to use this product for prevention and treatment of arterial vasospasms  Because this is a high risk compounding procedure with the drug being prepared from non-sterile powder, it was re-evaluated for benefits versus risks of use in this situation, and approved for use in CV surgery.   The SCI company was evaluated for compounding record, procedures, product validation, and other issues and found to be a currently acceptable provider of this compounded product.  A small amount of  papaverine injection has recently become temporarily commercially available, and the commercial product will be used whenever possible. 

Linezolid Criteria for Use – A few additions as follows were made to this criteria set:  A change from linazolid to vancomycin will not be recommended if the patient has renal insufficiency, or documented or suspected MRSA pneumonia with vancomycin MIC > 2.

Adult Meningitis Order Set – Since it is a very unusual situation where aztreonam would be used to treat meningitis, it was decided to not include that drug as an option on the protocol.

Antibiogram Update – The antibiogram has been updated with the 2013 data.  Overall, resistance to Streptococcus pneumoniae has increased in a few specific hospital areas, and resistance with vancomycin resistant enterococci (VRE), Staphlococcus epidermidis, and Pseudomonas Aeruginosa have increased.  Enterococcus Faecalis susceptibility remained at about 99% with ampicillin and vancomycin, but levofloxacin susceptibility to Escherichia coli has decreased.  A more detailed summary of susceptibility changes and trends can be found in the May issue of the Formulary and Drug Bulletin.  The new Antibiogram data is available on computer, in the Pharmacist Quick Reference Guide, and will be available in brochure form soon. 

Critical Glucose Level Change – The critical glucose level has been lowered from 50 to 40 mg/dL, housewide education will be completed and modification of specific order sets will be evaluated based on this change.

ADE Reporting –  There were 83 ADEs reported in January/February 2014, with only 1 being judged preventable (morphine – documented allergy).   Morphine and levofloxacin were the most common drugs involved in these reports, and made up 20% of total reactions reported.   The number of ADE reports have decreased over the last few years, the January/February data showed less than 1% of admissions being involved with an ADE report.  Pharmacists are asked to remind the multidisciplinary team to report ADEs via the computer pathway, on the orange card, by calling the Drug Info Center, or by telling the unit based pharmacist.