Medications not yet evaluated by P&T are considered NON-FORMULARY . . . . . Always check 2 unique patient identifiers - NAME and DATE OF BIRTH - at every step! . . . . . Please be sure to document all clinical activities daily.
P & T Update Memo January 2013

Following is a P and T Committee update (from the January 22nd meeting).  Starting dates for specific programs listed below is January 28th 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 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.

aclidinium (Tudorza Pressair) – This is a new long-acting inhaled anticholinergic drug similar to tiotropium that is available in a 30 day dry powder inhaler, and dosed 400 mcg bid.   With limited information, it appears generally similar to tiotropium with efficacy and safety.   A 30 day inhaler costs $261, com-pared with a 5 day supply of tiotropium costing about $65.  For most admissions, this 30 day inhaler would result in considerable waste.  Aclidinium was approved as a formulary agent, but routinely interchanged to tiotropium inhalation unless “no substitution” is written with the original order.   The dose conversion is : Aclidinium 400 mcg bid interchanged to tiotropium 18 mcg once daily. 

linaCLOtide (Linzess)This new drug is a guanylate cyclase-C agonist that stimulates GI motility and transit, and has been recently approved for irritable bowel syndrome with constipation (IBS-C) and for chronic idiopathic constipation (CIC).  It has minimal systemic absorption and is dosed either 290 mcg orally once daily (for IBS-C) or 145 mcg orally once daily (for CIC).  There is a contraindication currently for pediatric use.  The drug costs about $6.80 /day.   linaCLOtide was classified as a formulary agent.

tofacitinib (Xeljanz) This is a new oral, non-TNF alpha biologic DMARD for moderate to severe rheumatoid arthritis in patients intolerant to or not responding well to methotrexate.  Due to some severe adverse effects, GI effects, increased LFTs, neutropenia, and opportunistic infections, it is currently viewed as a 3rd line agent, and other biological agents should be tried first.  The dose is 5 mg bid, and the daily cost is $82.  This drug was classified as a formulary agent.

ondansetron (Zofran ODT) Currently, this dosage form is restricted to use by outpatient urgent care, pediatric emergency, anesthesiology, and oncology.  It is now available generically at a low cost of $0.20 to $0.30 per dose.   It was re-classified as a general formulary agent without restrictions.

enzalutamide (Xtandi) This new oral drug is approved for metastatic, castration-resistant prostate cancer in patients already treated with DOCEtaxel.  The dose is 160 mg once daily, it is category X pregnancy rating, and is associated with various serious adverse effects and drug interactions.  The cost is about $250 per day, and rare inpatient use is expected.  It was classified as non-formulary, not stocked, and the patient should use their own supply if ever needed while in the hospital;  initiation should be deferred to the outpatient setting where a financial and distribution management plan can be established for the patient.

icosapent (Vascepa) Ethyl – This drug is a fish-oil product approved as an adjunct to dietary therapy in the treatment of severe hypertriglyceridemia.  Unlike many fish-oil products, Vascepa does not contain significant amounts of DHA, which has been linked to increased LDL with long-term therapy.  The dose is 2 grams (2 capsules) bid with food.  The cost of Vascepa per day is $5.84, versus about $0.12 for regular fish oil capsules.  Vascepa was classified as non-formulary, not stocked, and it should be interchanged to regular fish oil capsules on a 1 gram: 1 gram basis ( Vascepa 2 grams bid is interchanged to regular fish oil 2 grams bid). 

Meperidine PCA Due to this product being unavailable for several months, as well as safety concerns involving use in elderly and renally impaired patients, accumulation of normeperidine with large or multiple doses, drug interactions, and others issues, it was classified as non-formulary, not stocked. 

New P and T Physician Members – In January, the physician membership for hospital committees is changed for the 2013 – 2014 period.  Dr Humphrey will continue as the P and T Committee Chair.  Returning MD members include LeRoy Harris, Farrah Iberhim, Daniel Ingram, Rachel Kruspe, Joseph McCarty, Stephan Moran, Norman Sabio, and Larry Walker.  New members are:  Stephen Clark, Michael DeGraaff, Heather Haley, Joshua Krasnow, and Catherine O’Shea.

Formulary and Drug Bulletin – The FDB is “going green”, and February will be the last issue that hard copies are printed and mailed out to readers.  The FDB will continue to be published monthly and distributed electronically via e-mail. 

New VTE Order Set – Various aspects of the revised order set were discussed.  The order set includes risk assessment, pharmacologic prophylaxis, mechanical prophylaxis, risk stratification, and potential contraindications, and it serves as a guideline.

paliperidone (Invega Sustena) --> Order Set This order set documents when different strengths of the drug are to be given, and should help with continuity of care issues.  Schedule date for the 117 mg dose to be given as outpatient is included and will be listed in ICare for medication reconciliation purposes, but this dose will not be given at the hospital.

ADE Report – There were 84 ADEs reported in Nov. and Dec. 2012, with 7 (8.3%) being preventable.  Levofloxacin and morphine were associated with the most reports (25% of all reports), but most of these were non-serious.  Narcotics, antibiotics, and insulin were the drug groups associated with preventable reactions.

ISMP Report – Recent issues include new sterile compounding safety guidelines, heparin and morphine inj. labeling, safe injection practices, and Benadryl – vitamin mix-up. 

Drug Shortages – Drugs that are on major shortage include 5-FU, caffeine inj, bumetanide inj,  chromium inj., sodium phosphate inj, methyldopa inj., vitamin A inj., thiotepa,  mepivacaine 2%, propofol, and others.






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