July, 2007 Vol. 39

Magic Bullet Suppository Approved for Formulary

The Magic Bullet bisacodyl suppository is in a water-soluble base. For spinal cord injury patients the water-soluble base bisacodyl suppository has been shown to dissolve more quickly and to significantly shorten the time to complete a bowel program compared with the traditional bisacodyl suppository.

Decision: Add Magic Bullet (water soluble bisacodyl) suppository to the formulary.

Ranexa (ranolaxine) 500 mg Tablets Approved for Addition to Formulary with Restrictions

Ranexa is a novel metabolic modulator indicated for the treatment of chronic stable angina in combination with amlodipine, beta blockers, and nitrates. Ranexa shows modest benefits for increasing exercise and time to onset of angina. It is not a first or second line medication but should be used only when all other treatments have been tried. Ranexa is contraindicated in hepatic impairment and renal function must be evaluated. As drug may cause dizziness and orthostatic hypotension, instruct patient to rise slowly from a sitting/supine position. This drug may cause headaches and patients should not eat grapefruit or drink grapefruit juice while taking this drug due to drug interactions. Due to numerous drug interactions there is an increased risk of QTc prolongation beyond just that inherent to Ranexa. See the slide presentation.

Decision: Add Ranexa tablets to formulary with restrictions. Only a cardiologist will be allowed to write for Ranexa; this includes initial orders and patients who are admitted on the medication. An order sheet will be used to assure kidney function, liver function, and potential drug-drug interactions are acknowledged.

Januvia tablets Approved for Formulary

Januvia is a dipeptidyl peptidase IV inhibitor indicated for use in type 2 diabetes mellitus. It protects the endogenous incretin hormones and enhances their actions. It is approved for monotherapy or in combination with metformin or thiazolidinediones. The most common adverse effects include headache, diarrhea, abdominal pain, and hypoglycemia. The dose is 100 mg daily (with or without food) with dosing adjustment needed in renal patients. No dosing change is needed in hepatic or geriatric patients.

Decision: Add Januvia tablets to the formulary.

Warfarin Injection Removed From Formulary

Over the last two years only one person has been treated at each hospital, respectively, with warfarin injection. Discarded or outdated warfarin injection is on the P-list of discarded hazardous waste. The P-list hazardous wastes are regulated under U.S. Federal Regulations and are considered "acutely hazardous" when discarded and are subject to stringent regulations. Physicians are asked to use oral warfarin per feeding tube or injectable heparin or enoxaparin in place of warfarin injection.

Decision: Remove warfarin injection from formulary.

Adult Potassium Replacement Protocol

When the revised Adult Potassium Replacement Protocol was approved in January of this year there was an inadvertent omission of the 48 hour stop time contained in the original protocol. It was not the intent to make the protocol a valid order for the entirety of the patients hospital stay. Obviously, any patient who experiences repeated episodes of hypokalemia while hospitalized needs to be worked up for the cause and the physician needs to be actively participating in the decision making for potassium replacement. The protocol was not intended to be a continuous order which if used as such could delay the physician being notified of changes in the patient's condition.

Decision: The Adult Potassium Replacement Protocol will be updated to reflect a 48 hour expiration at noon two days after the protocol is started. For Example, if the protocol is started on Monday it would expire at 12 noon on Wednesday.

FDA Alert On Propofol (Diprivan) Posted June 15, 2007.

Over the last several months the FDA has received reports of several clusters of patients who have developed fever, chills, and body aches shortly after receiving propofol. The symptoms began 6 to 18 hours after the anesthetic and persisted up to three days. To date all the patients received propofol for sedation in gastrointestinal suites and the propofol was administered from vials intended only for single-patient use but being used on multiple patients. So far there is no evidence the patients had bacterial sepsis or that the propofol vials and prefilled syringes used were contaminated with bacteria or endotoxins. The FDA recommends carefully following the recommendations in the current product labeling. When used for general anesthesia or procedural anesthesia:

Both the vial and prefilled syringe formulations must be used on only one patient
Administration must begin promptly once the vial or syringe has been opened
Administration from a single vial or syringe must be completed within 6 hours of opening
The IV line should be flushed every 6 hours and at the end of the anesthetic procedure to remove any residual propofol in the tubing.
When used for ICU sedation: a vial must be used on only one patient and administration must begin immediately after opening the vial and be completed within 12 hours.
When propofol injection is transferred to a syringe or other container then the product must be discarded after 6 hours and the lines changed.

Insulin Pen Technology Changes Effective July 2, 2007

The feedback on the Opticlik Pen device has led to the discontinuation of using this administration device effective July 2nd. The hospital will continue to carry Lantus in the cartridge and use it as a vial. By keeping the cartridge and not converting back to the vial this will make Lantus insulin the ONLY insulin in a cartridge. As such it will be harder to confuse Lantus with other insulin products.

After reviewing concerns about potential and real incidents with confusion between NovoLIN and NovoLOG insulin the two products will be stocked as either the vial or the pen. NovoLIN will be available only in the vial and NovoLOG will be available only as the Flex Pen Syringe.