Volume 21, Number 10 November/December 2007 Drugs & Therapy B � U � L � L � E � T � I � N POLICIES AND PROCEDURES FORMULARY UPDATE The Pharmacy and Therapeutics Standardized dosing times Committee met October 16, 2007. 2 drugs or dosage forms were added tandard medication administration first dose. For example, a twice daily in the Formulary, and 2 dosage S times have existed for many years. injectable antibiotic order is received at forms were deleted. 3 drugs or These times are in place to improve 1400. The first dose will be scheduled for dosage forms were designated efficiency and communication. The ad- 1500. Subsequent doses will be given at nonformulary and not available. The ministration times have been modified 0300 and 1500. use of 1 drug in the Formulary was recently based on feedback received There will be a series of educational restricted. from the Departments of Nursing and sessions scheduled with the medical and Pharmacy. When dosing times are not nursing staffs to go over the more subtle specified by the prescriber, the default implications of the new policy. These ◆ ADDED times in the table (see below) will be sessions will emphasize to prescribers Cinacalcet used. that “3 times a day” is not the same as (Sensipar® by Amgen) Sodium Chloride Tablets StandardiZED DOSING TIMES (generic) Interval Standard Times ◆ DELETED Daily 0900 2 times a day (BID) 0900, 2100 Lansoprazole Delayed-Release 3 times a day (TID) 0900, 1400, 2100 Suspension 0800, 1200, 1700 (52 Psych) (Prevacid® Packets by 4 times a day (QID) 0900, 1300, 1700, 2100 TAP Pharmaceuticals)* 5 times a day 0500, 0900, 1300, 1700, 2100 Tetracycline Syrup Every 3 hours 0000, 0300, 0600, 0900, 1200, 1500, 1800, 2100 (generic)* Every 4 hours 0100, 0500, 0900, 1300, 1700, 2100 *Nonformulary and not available Every 6 hours 0600, 1200, 1800, 2400 Every 8 hours 0800, 1600, 2400 ◆ NONFORMULARY AND Every 12 hours 0900, 2100 NOT AVAILABLE Every 24 hours Time will default to hour profiled (ie, 1st order processed) Lubiprostone Bedtime 2100 (Amitiza® by Takeda With meals 0800, 1200, 1700 Pharmaceuticals) With meals and at bedtime 0800, 1200, 1700, 2100 Injectable antibiotics Times determined by the time the 1st dose is processed ◆ CRITERIA-FOR-USE CHANGES Corticotropin Repository There are several medications that “every 8 hours.” For oral drugs, every- Injection (Acthar® Gel by have unique specified dosing times: to 8-hour dosing requires that patients be Questor Pharmaceuticals)† allow laboratory values to be evaluated awakened to receive their dose. Waking †Restricted to approval by Pediatric before the dose is given (ie, warfarin , the patient may or may not be neces- Neurology for infantile spasms epoetin, darbepoetin, and filgrastim at sary, depending on the medication. 1800); to avoid meals (ie, oral fluoro- For more information on standardized quinolones at 0600 and 1600 [meals dosing times or to schedule an inservice Cinacalcet was evaluated for are generally given at 0800, 1200, and on this topic, contact Dr. Erin Jones in possible addition in the Formulary 1700]); convention (ie, cyclosporine at the Department of Pharmacy Services at because of high-volume nonformu- 0800 and 2000); for patient convenience 265-0404. lary use. Cinacalcet is an oral calci- (ie, furosemide at 0900 and 1800); and, mimetic agent that was approved to improve efficacy (ie, statins at bed- by the FDA in March 2004. It is the ◆ time). only agent in its therapeutic class. Because injectable antibiotics should INSIDE THIS ISSUE Cinacalcet has labeled indications be started as soon as possible and for use in the treatment of second- ◆ prolonged intervals could affect efficacy, Medical foods? ary hyperparathyroidism in patients the dosage time for injectable antibiot- ◆ Annual index (continued on next page) ics will be determined by the time of the Formulary update, from page 1 The new enteral feeding system used has an FDA-labeled indication for the with chronic kidney disease on dialysis by Dietary Services does not allow the treatment of chronic idiopathic consti- and for the treatment of hypercalcemia addition of specific electrolytes. Extra pation. The labeled dose is 1 capsule in patients with parathyroid carcinoma. sodium chloride must be administered (24 mcg) twice daily with meals. The Chronic kidney disease is associated separately. This is usually done using drug has not been specifically stud- with hyperphosphatemia, hypocalce- sodium chloride 4 mEq/mL injection in ied in patients with hepatic or renal mia, and increased stimulation of the an oral syringe. However, adult and impairment, but the need for dos- parathyroid gland. These alterations older pediatric patients who can take age adjustments is unlikely as it has lead to secondary hyperparathyroid- oral solids can be supplemented with minimal systemic availability. Safety ism, a progressive condition that 1-gram sodium chloride tablets (ie, de- and efficacy have not been established eventually results in bone disease livering 17.2 mEq of sodium per tablet). in children or adolescents. A lower and calcification of vascular and soft Prevacid® for Delayed-Release Oral strength of lubiprostone (ie, 8 mcg) to tissues. Suspension Packets will no longer be treat irritable bowel syndrome with Cinacalcet acts on the calcium- marketed by TAP Pharmaceuticals. This constipation is currently under review sensing receptor on the surface of the product is not used much; other dosage by the FDA. chief cell in the parathyroid gland. The forms are more popular. The packets There are no head-to-head studies calcium-sensing receptor is the princi- were deleted from the Formulary and comparing lubiprostone to other agents pal regulator of parathyroid hormone designated nonformulary and not avail- used to treat chronic constipation (ie, (PTH) secretion. By mimicking calcium, able. bulk-forming fiber products or stool cinacalcet increases the sensitivity of Lansoprazole suspension compound- softeners). The approval of lubipros- the calcium-sensing receptor to extra- ed using sodium bicarbonate is a better tone was primarily based on 2 random- cellular calcium and lowers PTH levels. alternative for administering lansopra- ized, double-blind, placebo-controlled, Decreased serum calcium is associated zole down a feeding tube. Prevacid® phase 3 trials that showed moder- with reduction in PTH. After 1 week of Oral Suspension Packets produced a ate improvements in weekly bowel therapy, reduction in serum calcium is thick suspension because it contained movements (ie, an absolute increase seen and maintained. xanthan gum to increase viscosity. This of approximately 2 bowel movements Managing patients, according to the thick suspension often clogged feeding per week [approximately 3 vs 5]). Also, National Kidney Foundation’s Kidney tubes, especially small-bore feeding only approximately 60% of patients Disease Outcomes Quality Initiative (K/ tubes. had a spontaneous bowel movement in DOQI) guidelines on bone metabolism Prevacid® SoluTabs® have a pleas- the first 24 hours of treatment. and disease in chronic kidney disease, ant taste and can be used to administer The most commonly reported ad- can be challenging. Traditional thera- lansoprazole orally in small children who verse effect during clinical trials was pies for stage 5 chronic kidney disease cannot swallow capsules. The SoluTabs® nausea. The incidence of nausea is include phosphate-binders and vitamin can also be dissolved in a small amount dose-related; 8% of patients discontin- D sterols and can be associated with of water and administered down a feed- ued treatment during trials due to nau- hypercalcemia. ing tube. The granules in the SoluTabs® sea. Other common side effects during Evidence from randomized, placebo- do not clump or stick to the feeding tube. trials included diarrhea, headache, and controlled trials in dialysis patients Tetracycline syrup has been discon- abdominal pain or distension. shows that cinacalcet is effective in tinued by its manufacturer. There is no Chronic constipation is primarily reducing intact PTH while also reduc- alternative source. After consulting with treated on an outpatient basis. There ing serum calcium, phosphorus, and the Infectious Diseases Subcommittee, are various low-cost formulary op- calcium-phosphorus product. At the there appears to be no need to recom- tions available for acute treatment of start of these studies, patients had mend an alternative agent. Tetracycline constipation (eg, senna), as well as elevated PTH in spite of treatment syrup was designated nonformulary and fiber products and stool softeners for with phosphate binders and/or vitamin not available. possible prevention. Patients admit- D sterols. At this time, a large prospec- Lubiprostone was evaluated for pos- ted who are already taking lubipros- tive, randomized, placebo-controlled sible addition in the Formulary based on tone may take their own supply or be trial is being conducted to determine if requests for use and potential for inap- treated with other formulary agents cinacalcet reduces the risk of mortality propriate off-label use. for constipation during hospitaliza- or cardiovascular events in hemodialy- Lubiprostone is a member of a new tion. Additionally, discontinuation sis patients. class of bicyclic fatty acids prostaglan- of lubiprostone does not result in a The most common adverse events din E1 derivatives known as prostones. rebound effect and, in fact, shows a associated with cinacalcet use are It increases intestinal fluid secretion via sustained