Following is a P and T Committee update (from the July 23rd meeting).  Starting date for specific programs listed below is July 29th, 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.

bupivacaine liposome Injection (Exparel) – This new dosage form is indicated for single-dose infiltration into the surgical site to produce post-surgical analgesia. The normal dose used is 266 mg. and this agent is promoted as acting longer than regular bupivacaine.   Exparel is currently restricted to Plastic Surgery usage, with these physicians agreeing to discontinue use of the On-Q pump which is error-prone.  Studies with Exparel typically have many weaknesses, and comparisons to regular bupivacaine injection have not shown much advantage in outcomes.  However, Exparel is much more expensive.  At the request of Stephen Clark, MD, and William Nuessle, MD, pilot Exparel use was approved for colo-rectal surgery use, specifically in colorectal surgeries including hemorrhoidectomy.  Laparoscopic colorectal surgeries in the pilot will focus on risk patients only (i.e. obese, elderly, history of narcotic use).  It was approved to conduct the pilot use as described above.  Safety issues with Exparel include look-alike/sound-alike names, very similar appearance to propofol in OR as both are in lipid base, and nursing unit practitioners being unaware of patient receiving in OR after being admitted to nursing unit;  safety precautions will be put in place with pilot use.   An MUE will be conducted by a pharmacy resident and students to collect data on pilot usage and determine what benefits may be offered with Exparel.  Date of pilot program to be announced

alogliptin (Nesina) – This oral drug is a new DPP-IV inhibitor used to improve glucose control in type II diabetics, and can be used as monotherapy or in combination. The dose is 25 mg once daily and is adjusted with CrCl less than 60 ml/min.  The cost is $7.50 - $8 per day.  Alogliptin was approved as a formulary agent, with a pharmacist renal dose adjustment.

alogliptin-pioglitazone (Oseni)- This is a combination of alogliptin and pioglitazone available in 6 different strengths, dosed once daily, and indicated for the treatment of type II diabetes. The cost for all strengths is about $8/dose.  Rare inpatient use is expected.  Oseni was classified as non-formulary, not stocked, and the individual agents will be used in place of the combination product.

alogliptin-metFORMIN (Kazano) - This is a combination of alogliptin and metFORMIN in 2 different strengths, dosed twice daily, and indicated for the treatment of type II diabetes. The cost for both strengths is about $8/day.  Rare inpatient use is expected.  Kazano was classified as non-formulary, not stocked, and the individual agents will be used in place of the combination product. 

Oral Potassium Product Update – The oral potassium product interchange program was recently updated and approved. K-lyte 25 meq packet/tablet was omitted from the formulary due to low use.  The KCL liquid preparations were standardized to the 10% oral solution (20 meq/15 mL). Kaon liquid (gluconate salt) was omitted from the formulary as it is no longer manufactured. Potassium gluconate tablets 595 mg was added to the formulary as a gluconate product option.

albuterol-ipratropium (Combivent Respimat) Inhaler – Due to CFC propellant issues, Combivent inhaler has been reformulated to a new inhaler product, Combivent Respimat. Both are inhaler combinations of ipratropium and albuterol. The normal dose of the old Combivent inhaler is 2 puffs qid, but for the Respimat it is 1 puff qid;  these are equivalent doses based on bioavailability differences.  The Respimat is not compatible with ventilators.  It was approved to automatically interchange Respimat to ipratropium and albuterol nebulization in ventilator patients.  Also, doses of the old Combivent inhaler were up to 4 puffs qid.  Some confusion can result from orders for “Combivent Inhaler 2 puffs qid”, and whether the prescriber meant the old Combivent inhaler at the normal dose, or the Combivent Respimat at the higher dose.  In these cases, patient medication history or medication reconciliation data may help to clarify which regimen is appropriate.  If after history review the intended dose is still unclear, or if the situation is a new order, the prescriber should be contacted for clarification.  Practitioners are being asked to write orders in terms of “Combivent Respimat”  in the future.

estradiol (Minivelle) - This is a small size estrogen patch available in several different strengths, dosed twice weekly. The formulary estrogen patch is available in the same strengths, but applied once weekly.  Minivelle was classified as non-formulary, not stocked, and will be interchanged to the equivalent strength of the formulary generic estrogen patch applied once weekly.

Vapocoolant Formulary Interchange – Because ethyl chloride is a flammable product, limitation of stocking and use is desirable. Pain-Ease is an alternative non-flammable product composed of pentafluoropropane and tetrafluoroethane that has similar uses.   Pain-Ease was approved as the frontline formulary agent with an interchange from ethyl chloride to Pain-Ease.  Ethyl chloride use is restricted to use in Emergency Department at HH Main, Woman and Children’s Hospital, and Madison Hospital.

GI Cocktail Update – The HH GI Cocktail formula has traditionally been Maalox 30 ml, Viscous lidocaine 15 ml, and Donnatal 10 ml. However, lidocaine unit dose cups in specific volumes have been on national shortage recently.  It was approved to interchange the lidocaine viscous volume in the GI Cocktail formula to 15 ml or 20 ml depending on product availability. 

Novo-Seven MUE – MUE data was presented showing an overall % compliant use with approved criteria at 72.3%. Physician practice areas using the drug on at least 3 different patients in 2012 were:  CV Surgery, ER, Neurosurgery, OB/GYN, and Trauma.  There were a few cases where several doses were used on one patient.  It was recommended that a protocol revision include that after 2 doses within 48 hrs, a hematology physician be consulted prior to another dose, and a clinical pharmacist follow these patients.  Revisions to the protocol will be presented at a future date. 

Peds – Protocols– An adolescent Prophylaxis protocol was approved, the protocol form will be placed on the chart of all patients age 14 yrs and older admitted to the pediatric units. The admitting physician will address the need for VTE prophylaxis in each patient.  Also, a pediatric specific version of the extravasation protocol was approved.   Implementation to be announced.

Peds – H2 Blockers – An automatic interchange for nizatidine liquid to raNITIdine liquid on a 1:1 dosage ratio was approved. Implementation to be announced.

ID – Antibiotic Allergies – Data suggest that clinical cross-reactivity between penicillin and carbapenems appears to be much lower (e.g. 1%) than would be expected with skin test data. Pharmacists should notify the physician if a carbapenem is prescribed in a patient with a penicillin allergy, if the allergic reaction is documented to be the immediate type (i.e. anaphylaxis-laryngeal edema, bronchospasm, hypotension, urticaria, or the accelerated type (urticarial, angioedema, asthmatic breathing, others).  If the type of reaction to penicillin cannot be determined, the physician should be notified; however, it is not necessary to notify the physician in this situation if the reaction was only rash (non-urticaria).  Physicians may write on their orders “penicillin allergy noted” if they wish not to receive a call from Pharmacy about this potential safety problem with a certain patient.

ADE Report – There were 76 ADEs reported in May/June 2013.  Drugs most frequently involved in these reports were morphine, vancomycin, and radiocontrast.  Six cases were judged preventable (8%), with causes including documented allergy/reaction, drug interaction, and excessive dosing.