Following is a P and T Committee update (from the March 25th meeting).  Starting date for specific programs is April 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.

levalbuterol (Xopenex) – A new therapeutic interchange program has been approved for levalbuterol, as follows:

• levalbuterol MDIs will be automatically interchanged to albuterol MDIs at the same number of inhalations and frequency, unless no substitution is written
• levalbuterol nebulization will be automatically substituted to albuterol nebulization unless no substitution is written
• The dose interchanges are as follows: levalbuterol neb 0.31 mg and 0.63 mg to albuterol neb 1.25 mg, and levalbuterol 1.25 mg to albuterol 2.5 mg.
• levalbuterol nebulization dosed q 8 hr or q 12 hr will be interchanged to albuterol q 6 hrs.
• levalbuterol nebulization dosed q 4 hr or q 6 hr will be interchanged to albuterol at the same dosing frequency.
• levalbuterol no substitution ordered q 4 hrs or q 6 hrs by non-pulmonary physicians will be interchanged to levalbuterol q 8 hrs; if ordered by a pulmonologist no sub, it will be given as ordered.
• For nebulization orders not specifying drug dose, the following drug doses will be used: albuterol 2.5 mg , levalbuterol 1.25 mg, ipratropium 500 mcg., acetylcysteine 100 mg.
• If ipratropium nebulization is ordered with albuterol or levalbuterol nebulization, the ipratropium will be converted to the same dosing frequency as the albuterol or levalbuterol.   Acetylcysteine nebulization dosing frequency should be adjusted to be consistent with any other accompanying nebulized medication.
• Date of implementation to be announced.

Fleet Phosphosoda Enema – The FDA has issued safety information highlighting the risk of hyperphosphatemia and renal failure from using this enema in various patient populations, including patients with inflammatory bowel disease and colitis, renal dysfunction, CHF, unstable angina, CABG, seizure or seizure risk,  taking drugs that effect renal perfusion  i.e. NSAIDs, ACEIs, ARBs, diuretics, over 55 years old, and others.    A recent MUE showed some orders  at HH in these populations, including elderly, and patients with GI and cardiovascular disease.  At recommendation of nephrologists, it was approved to classify Fleet Enema as non-formulary, not stocked, and interchange it to Mineral Oil Enema at the same volume and frequency.  The major physician groups using the phosphosoda enema have agreed to this policy.   Currently, Fleet Phosphosoda Enema is being omitted from standard order sets as these order sets are identified.   Date of implementation to be announced pending using up most of current phosphosoda stock.  A policy for Pediatrics regarding Fleet Phosphosoda Enema will be addressed in the near future.

hyoscyamine – There are several different related products, including a 0.125 mg regular tablet, ODT, and sublingual tablet, a 0.15 mg tablet, a 0.375 mg sustained release tablet, and a liquid (0.125 mg /5 mL).   It was approved to classify the 0.125 mg regular tablet, the sublingual tablet, and the 0.15 mg tablet as non-formulary, not stocked, and interchange them to the 0.125 mg ODT.   The liquid and sustained release tablet will remain formulary items.  

Donnatal Elixir – This product includes very low doses of atropine and scopolamine, and 0.104 mg of hyoscyamine;  thus, hyoscyamine accounts for almost all of the therapeutic effects of the product.  It is an anticholinergic preparation usually used as a GI antispasmodic, and has become very expensive.  The cost of hyoscyamine elixir is much lower.  Donnatal Elixir was classified as non-formulary, not stocked, and hyoscyamine elixir will be automatically interchanged in its place on a 1:1 dosage ratio.   Implementation time will be announced pending using up most of current Donnatal Elixir stock and obtaining hyoscyamine elixir in a unit dose form.

GI Cocktail Update -  The current formula for this preparation is:  Maalox 30 mL, viscous lidocaine 15 mL or 20 mL (depending on availability), and Donnatal Elixir 10 mL.  It was approved to substitute hyoscyamine elixir in the place of Donnatal Elixir for this preparation at the same volume i.e. Hyoscyamine Elixir 0.125 mg / 5 mL – 5 mL is used for Donnatal Elixir 5 mL .

adalimumab (Humira) – The manufacturer is offering a Inflammatory Bowel Disease loading dose drug supply at no cost to the hospital for properly selected patients.  GI physicians have indicated a desire to use this loading dose on very selected inpatients (i.e. severe disease exacerbation, have tried other options including a course of intravenous steroids without good response, and patient is expected to remain hospitalized for at least several additional days).  This special drug supply program was approved for formulary status, restricted to the no cost loading dose regimen and restricted to use by GI physicians.   Implementation date to be announced pending obtaining special drug supply, developing a protocol, and creating a computer pathway.

lucinactant (Surfaxin) – This is the only available synthetic neonatal lung surfactant indicated for prevention of respiratory distress syndrome (RDS) in premature infants at high risk of RDS. Calfactant (Infasurf) has been our exclusive formulary agent for many years with this drug class.  Infasurf has a higher concentration of phospholipids per mL, is less expensive, has a lower volume dose, involves less number of doses, and has not been directly studied with this new agent.  Lucinactant was classified as non-formulary, not stocked, and Infasurf will continue to be used. 

enalapril (Epaned) oral solution -  This product is indicated in patients greater than 1 month old for treatment of hypertension.  The cost is greater than similar compounded products or tablets.  Outpatient compounding pharmacies now must have a valid documented reason for compounding this drug since an approved commercial product is available.  Epaned was approved for formulary status, restricted to pediatrics.  For adults, other products or dosage forms can be used instead.

erythromycin Intravenous Dose Standardization – For GI motility use, there has been increased wastage of this prepared product due to short stability time and a wide variety of doses being used.  Doses provided in different references vary from 150 – 350 mg q 6 – 8 hrs to 500 mg q 12 hrs.  To decrease wastage and increase efficiency, it was approved to standardize doses for GI motility indication only (not for use as anti-infective)  to either 250 mg or 500 mg;  100 mg – 399 mg will be dispensed as 250 mg, and 400 mg to 650 mg will be dispensed as 500 mg.   Pharmacists should evaluate erythromycin orders for GI motility usage and adjust to the standard dose if appropriate.  Taxiphylaxis may occur with GI motility use from several days to several weeks after drug initiation, thus if erythromycin appears to be adding no clinical benefit, the pharmacist may recommend discontinuation. 

Hospital Formulary Policy Update – Several sentences were added to the policy describing in more detail the formulary classifications of restricted and non-restricted drugs.  Additionally several phrases were added to explain management of non-formulary requests or use of a drug outside its approved restrictions.  The pharmacist should initially discuss non-approved use with an appropriate clinical specialist and/or a member of pharmacy administration, and then with the prescriber.  If further clarification is needed, the issue will be addressed with the P and T Chair, a P and T Committee member, or the Chief Medical Officer.

Papaverine Injection Outsourcing– This injection is currently not available commercially.  Pediatricians desire to use this product for prevention and treatment of arterial vasospasms in arterial lines.  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, and approved for use in pediatrics.   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.  Some papaverine injection has recently become available, and the commercial product will be used whenever possible. 

Hypertonic Saline 3% Infusion Protocol (Adult) – This protocol was reviewed and approved with some changes and applies in treating hyponatremia.  For use, a nephrology consult is required and this agent must be originally ordered by a physician (but not a nurse practitioner or a UAB medical intern/resident).  For children, it should only be ordered by a pediatric critical care physician.   It provides for intravenous access, initial screening, drug administration, sodium labs, patient monitoring, and when to notify physician.   Date of implementation to be announced pending protocol update and computer prompts. 

Neuromuscular Blocker Shortage – Vecuronium is now a major backorder problem, and the earliest projected availability date is June 2014, so we will be completely out soon.  Other nondepolarizing agents available are rocuronium (Zemuron®) and atracurium.  It was approved to use rocuronium for vecuronium during this drug shortage situation. If vecuronium infusion is ordered, rocuronium should be utilized and if a vecuronium IV push dose is used, rocuronium should be substituted (vecuronium 10 mg IV push = rocuronium 50 mg IV push).   The vecuronium supply during the shortage will be restricted to cardiovascular patients.  Both rocuronium and vecuronium have onsets within the first few minutes, with durations of action of 20 – 30/40 minutes, with rocuronium being a little shorter duration.  Rocuronium may cause blood pressure and heart rate changes and anaphylaxis.  See the special information fact sheet that was emailed out on 3/25/14.