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Volume 20, Number 10 November/December 2006 & Therapy B � U � L � L � E � T � I � N

PRESCRIBING FORMULARY UPDATE The and Therapeutics Collect before you treat: Committee met October 17, 2006. 2 drugs were added in the Formulary, obtaining cultures before and 1 was deleted. 2 drugs were designated nonformulary and not antibiotic treatment available. There was 1 criteria-for- use change and 3 interchanges hen treating infections, health- ate that antimicrobial therapy should approved. Wcare providers realize the impor- be reassessed once these organisms tance of initiating antibiotic therapy as have been identified in order to more soon as possible. It is also recognized accurately direct therapy.1 ◆ ADDED that tailoring pharmacologic therapy Obtaining cultures after antimicro- to the organism(s) responsible for the bial therapy has been started can cause Methoxsalen infection is equally important. When inconclusive results because organisms ® (UVADEX by Therakos) initiating therapy, standard of care calls that would otherwise be detected may not necessarily grow after exposure to (Chantix® by Pfizer) for the use of broad-spectrum antibiot- ics to cover the organisms usually asso- an antibiotic agent. The administration ◆ DELETED ciated with the infection being treated. of antimicrobials before the collection Therapy is streamlined after cultures of samples may decrease blood culture Mivacurium and sensitivities are available. Delaying yields. (Mivacron® by Abbott)* therapy when infectious processes are The American Heart Association encourages acquiring blood cultures *Nonformulary and not available suspected is not an option, but similar- ly, obtaining adequate cultures before promptly when diagnosing infective 2 ◆ CRITERIA-FOR-USE CHANGES administering antibiotics is equally endocarditis. In fact, a positive blood important. In these situations, timing culture is a major diagnostic criterion Clonidine Injection (Duraclon® is key. Obtaining appropriate cultures for infective endocarditis. Most patients by Xanodyne Pharmaceuticals) before initiating antimicrobial therapy with infective endocarditis will yield a plays an important role in patient care. positive culture. However, low-grade ◆ INTERCHANGES Why is this so important? The bacteremia (less than 50 colony-form- prompt identification of offending ing units per milliliter of blood) is a ® SR for Wellbutrin XL organisms will influence diagnosis, common occurrence.2 In these cases Guaifenesin Liquid for Mucinex®* therapy, and prognosis. This will not of low-grade bacteremia, the adminis- only benefit the patient by providing tration of antibiotics before obtaining ® *Mucinex designated nonformulary more appropriate and definitive treat- blood cultures may affect bacterial and not available ment, but will also help control the growth in the sample and hinder the Paroxetine IR for Paxil® CR† emergence of antibiotic resistance by ability to appropriately tailor therapy minimizing the use of broad-spectrum to the offending pathogen. † 1 mg = 1.25 mg (eg, 20 mg = 25 mg) agents, when possible. Appropriate antibiotic therapy plays Obtaining cultures before antibiotic an important role in the prevention of use improves the chances of identifying antibiotic resistance. The Centers for Methoxsalen is a naturally oc- the offending microorganism, which Disease Control and Prevention (CDC) curring photoactive agent. It is in a improves patient care. Inappropriate outlines that in order to help control class of compounds known as pso- antibiotic use can result in prolonged antibiotic resistance and effectively ralens. Psoralens react upon activa- hospital stays and increased costs, but diagnose and treat infections, it is very tion to ultraviolet (UV) light in the it can also have adverse consequences important to obtain cultures in order to 315-400 nm wavelengths (ie, UVA). on the patient’s prognosis. target antimicrobial therapy to suscep- Although their exact mechanism The Surviving Sepsis Campaign (continued on page 3) of action is unknown, psoralens Guidelines state that antibiotic therapy covalently bond to DNA and inhibit should be initiated within 1 hour of ◆ cellular replication. recognition of severe sepsis.1 These INSIDE THIS ISSUE In extracorporeal photopheresis guidelines state that appropriate (ECP), white blood cells (WBCs) are cultures should be obtained in order ◆ Annual index separated from the patient’s whole to identify causative organisms before ◆ Pharmacokinetic consults (continued on next page) starting therapy. The guidelines reiter- Formulary update, from page 1 Hospitalized patients are particu- mivacurium for marketing reasons blood. The WBCs are placed in the larly good targets for smoking cessa- and has no plans to resume market- photoactivation bag along with normal tion efforts, since continued smoking ing of mivacurium. There are no saline and plasma, and methoxsalen is could inhibit their recoveries. First-line other manufacturers of mivacurium. added to the bag before being exposed agents for smoking cessation have Therefore, mivacurium was deleted to UVA irradiation. ECP is performed been replacement therapies from the Formulary and designated using either the UVAR® Photopheresis (NRTs) or bupropion in combination nonformulary and not available. System, or the UVAR® XTS™ System. with behavioral modification therapy. The neuromuscular blocking agent The manufacturer outlines the dosage Although quit rates with these treat- with the most similar as 200 mcg if the UVAR® Photophere- ments have been modest, any reduc- and clinical duration of effect listed sis System is used, or a prescribed tion in cigarette smoking is important in the Formulary is vecuronium (ie, dosage specific to treatment volume because of the health consequences of onset 2.5-3 minutes and duration 25- with the UVAR® XTS™ System. The continued smoking. 30 minutes). photoactivated WBCs are then re- Evidence from published randomized Clonidine is a centrally acting al- administered to the patient. The net controlled trials suggests that vareni- pha2 that inhibits sympathet- effect is a modulation of the patient’s cline has equal or better than ic outflow and decreases systemic cellular immune system. bupropion. It has a different adverse vascular resistance. It was originally The current labeled indication for effect profile than bupropion (ie, more marketed with a labeled indication ECP using UVADEX® sterile solution nausea versus less insomnia) and may for hypertension, but the inhibition is for the palliative treatment of cuta- be associated with more weight gain (ie, of sympathetic outflow led to various neous T-cell lymphoma. At Shands at 2-3 pounds). Varenicline has not been di- off-labeled uses (eg, hot flushes, UF, the primary use will be off-label rectly compared with NRT or bupropion withdrawal). It is available as for the treatment of graft-versus-host in combination with NRT. an oral tablet and transdermal patch disease (GVHD). Nausea is a common dose-dependent for these uses. Several publications report the , which may be reduced The only parenteral form of benefits of ECP in patients with by gradually increasing the daily dos- clonidine has a labeled indication treatment-refractory acute and age (eg, taking 0.5 mg once daily for for epidural administration for the chronic GVHD. Some of the benefits the first 3 days, 0.5 mg twice daily for treatment of pain. Clonidine’s alpha2 described in these reports include the next 4 days, and then 1 mg twice agonist effects at the spinal level are complete and partial resolution of daily). In addition, patients should be thought to prevent transmission of cutaneous and visceral manifesta- advised to take varenicline after eat- pain signals to the brain. tions of GVHD. In addition they also ing and with a full glass of water to Low doses (eg, 1 mcg/Kg) of in- demonstrate improved survival rates decrease the risk of developing nausea. travenous clonidine have been used in patients who respond to ECP, Abnormal dreams, constipation, vomit- for several off-labeled indications compared to non-responders. An ing, flatulence, and xerostomia are also including the treatment of post-op- additional advantage of ECP is that associated with varenicline use. Dos- erative shivering and with regional when clinical response is obtained, age reductions can be considered for to decrease general anes- other immunosuppressive therapies patients unable to tolerate the adverse thesia requirements. There is a risk, can be reduced or even discontinued, reactions. Using varenicline with NRT however, for hemodynamic instability thereby reducing their potential for may increase adverse effects. Also, as when intravenous clonidine is used with chronic use. In addition, with any new , whether there are for off-labeled uses; therefore, its use ECP is reported as being well toler- any rare, but serious, adverse effects will be restricted to the OR, PACU, ated by patients. will be determined only with wide- Florida Surgical Center, and to ad- These reports, however, have spread use. ministration by an anesthesiologist. limitations. Randomized controlled The typical dosage for varenicline is When patients are receiving oral or clinical trials would help to define 1 mg twice a day. Lower dosages are transdermal clonidine for hyperten-

ECP’s place in the treatment of treat- used in severe renal dysfunction (CLcr sion or other uses and patients can- ment-refractory GVHD. less than 30). Treatment is 12 weeks, not take medications by mouth, there UVADEX® was added in the Formu- which may be repeated once. Vareni- have been instances when clonidine lary to provide patients with treat- cline is roughly the same cost as nico- has been ordered intravenously. ment-refractory GVHD an alternative tine patches, but is twice as expensive The above restrictions prevent this therapy. The use of methoxsalen and as bupropion. conversion. ECP is reserved for patients who Varenicline was added in the Formu- Generic bupropion SR will be have not responded to first-line lary for use with behavioral modifica- automatically interchanged for therapies for GVHD. tion for smoking cessation. There are orders for Wellbutrin® XL giving the Varenicline is an alpha4/beta2 nico- behavior modification programs that daily amount as 2 equally divided tinic partial agonist, which are available in the outpatient setting doses every 12 hours. Bupropion is is a new class of drugs for smoking when patients fill their prescriptions, a unique that is used cessation. By inhibiting smoking- but inpatient behavioral modification for labeled indication of depression induced activation and should be initiated with any pharmaco- and smoking cessation as well as simultaneously providing a moderate logical intervention to aid in smoking various off-labeled uses (eg, post-her- increase in mesolimbic , var- cessation. Behavioral modification in petic neuralgia). It has been on the enicline may counteract the low dopa- combination with drugs like varenicline US market since 1985 and the patent mine levels that occur during smoking is essential to improve “quit rates.” for the “SR” extended-release dosage cessation attempts and, thereby, Mivacurium is a short-acting neuro- form has expired. Bupropion SR is provide relief from the craving and muscular blocking agent (ie, onset 3 given twice a day. withdrawal syndrome. Varenicline minutes, duration 15-20 minutes) used In 2003, the “XL” once-daily has a labeled indication as an aid to to facilitate intubation and relax skel- extended-release dosage form was smoking cessation treatment. There etal muscles as an adjunct to general marketed as the “SR” patent was are no known off-label uses. anesthesia. Abbott has stopped selling (continued on next page) 2 Formulary update, from page 2 was based on the liquid dosage form. As the patent for Paxil® expired, expiring. The main advantage of There is no available evidence to sup- Paxil® CR was marketed. Both are Wellbutrin® XL is that it can be given port the efficacy of extended-release once-daily versions of paroxetine. once daily compared with twice daily guaifenesin. Paxil® CR is marketed as having for bupropion SR. Since it is still a The proposed less gastrointestinal adverse effects brand name dosage form, the “XL” for guaifenesin is by irritating the than immediate-release (IR) generic bupropion is considerably more ex- gastric mucosa, which subsequently in- paroxetine. pensive than the generic SR product. creases respiratory tract secretions. In 3 studies compare the Wellbutrin® XL has been nonformu- theory, sustained-release dosage forms of the “CR” formulation with the lary and not available since Septem- would decrease the efficacy of guaifen- “IR” tablets. 1 study is an observa- ber 2003. esin by decreasing gastric irritation. tional study published in a supple- Guaifenesin liquid will be auto- In the absence of evidence for effec- ment. Another is a short-report of matically interchanged for Mucinex® tiveness for extended-release guaifen- a retrospective observational study tablets using the same equivalent esin and based on the limited efficacy from a claims database. The third dose given every 4 hours while data for liquid guaifenesin, the auto- study is a combination of 2 ran- awake, instead of every 12 hours. matic interchange to liquid guaifenesin domized controlled trials that were Guaifenesin is the most commonly was approved. Mucinex® is nonformu- pooled together. These studies show used expectorant and the only non- lary and not available. Liquid guaifen- small differences in GI effects. In the prescription expectorant on the US esin 200 mg every 4 hours while awake pooled randomized controlled trials, market. Mucinex® is the only extend- replaces Mucinex® 600 mg twice a day. diarrhea was higher in the CR-group. ed-release version of guaifenesin on Generic immediate-release parox- The P&T Committee approved the market. etine will be interchanged for Paxil® automatically changing Paxil® CR Guaifenesin has always had CR. Paroxetine is a commonly used to paroxetine IR using 10 mg IR for questionable efficacy. The limited selective- each 12.5 mg of the CR dosage form. data that FDA used to approve the (SSRI) used for many labeled and off- Paxil® CR has been nonformulary and nonprescription use of guaifenesin labeled uses. not available since October 2003.

POLICIES AND PROCEDURES physician-approved protocol t the October P&T Committee PAPs allow licensed healthcare documented in the patient’s medical A meeting, the Pharmacokinetics providers (eg, nurses, pharmacists) to record: For example, Pharmacokinetic Physician-approved Protocol (PAP) was perform specified actions when clearly Consult for Tobramycin to Treat Pneu- re-authorized. Improvements in the defined situations exist. Without a PAP, monia per Protocol. policy were made in the area of dosing the directed actions would require a After an order is written, the unit and monitoring aminoglycosides and physician’s order to initiate “the order.” clerk faxes the order to the appropriate vancomycin in patients on hemodialy- Inherent in PAPs is that physician decentralized pharmacy. This service is sis and CVVH. input and review is required before the covered 24 hours a day, 7 days a week. This PAP allows physicians to protocol can be instituted. When PAPs Appropriate dosage modifications and request pharmacokinetic consults for involve drug therapy, the P&T Com- monitoring is instituted. Notes are vancomycin or aminoglycosides. The mittee reviews the appropriateness written in the Progress Notes section clinical pharmacy specialists who staff of these activities. All PAPs must be of a patient’s chart with the heading, this service order and monitor serum re-authorized every 2 years. Pharmacokinetic Consult. concentrations and write orders to When any PAP is instituted, a adjust dosages. specific order for the protocol must be

Prescribing, from page 1 ner as to avoid contamination;4 collect infections are suspected. It is also tibility results.3 The sepsis guidelines an adequate volume of sample (at least important to remember to obtain also stress the importance of initiat- 10 mL per sample);4 and, ensure that cultures from patients before admin- ing narrower-spectrum antibiotic specimens are collected appropriately istering antimicrobial agents so that therapies in order to minimize the (eg, aerobic vs. anaerobic tubes). more appropriate treatment strategies development of resistant pathogens.1 It is important to note that although can be tailored based on culture and Obtaining samples before the admin- previously outlined examples refer sensitivity results. So remember, col- istration of therapy is essential, so to the collection of blood samples, lect before you treat to ensure optimal that while empiric therapy is being the same principle of early detection patient care. Do not delay therapy administered, culture and sensitivi- applies to infections at other sites. It by delaying cultures. Get cultures ties are being done. is equally important to culture other immediately. Whenever possible, healthcare bodily fluids/sites before the initiation By Maria Rojo, PharmD providers should obtain appropri- of antimicrobial therapy. Therefore, References ate blood cultures before initiating other specimens such as cerebrospinal 1. Dellinger RP, Carlet JM, Masur H, et al. Surviving antimicrobials. Some other general fluid, respiratory secretions, urine, and sepsis campaign guidelines for management of severe sepsis and septic shock. Crit Care Med 2004;32:858-73. considerations when obtaining cul- wounds should be cultured whenever 2. Baddour LM, Wilson WR, Bayer AS, et al. Infective en- tures are: obtain at least 2 samples warranted by clinical presentation. docarditis: diagnosis, antimicrobial therapy, and manage- ment of complications. Circulation 2005;111:394-434 of blood (if the same pathogen is Again, these cultures should be ob- 3. Centers for Disease Control and Prevention. Campaign identified from both samples, it is tained prior to the initiation of antibi- to Prevent in Healthcare Set- tings; Available at http://www.cdc.gov/drugresistance/ more likely that the organism is the otic therapy. healthcare/ha/12steps_HA.htm. cause of the infection);1 ensure that To summarize, the prompt initiation 4. Mermel LA, Maki DG. Detection of bacteremia in samples are obtained in a sterile man- of therapy is very important whenever adults: consequences of culturing an inadequate volume of blood. Ann Intern Med. 1993;119:270-2. 3 Drugs & Therapy SHANDS NON-PROFIT ORG. B � U � L � L � E � T � I � N Shands at the University of Florida U.S. POSTAGE DRUG INFORMATION SERVICE PAID GAINESVILLE, FL Volume 20, No. 10 Nov./Dec. 2006 PO Box 100316 PERMIT NO. 94 This publication is produced by the Gainesville, FL 32610-0316 Drug Information and Pharmacy Re- source Center under the direction of the Department of Pharmacy Services and the Pharmacy and Therapeutics Committee. EDITOR, DRUGS & THERAPY BULLETIN Randy C. Hatton, PharmD DIRECTOR, PHARMACY SERVICES Alan Knudsen, MS, RPh CHAIRMAN, PHARMACY & THERAPEUTICS COMMITTEE Ricardo Gonzalez-Rothi, MD EDITING, DESIGN, & PRODUCTION Shands HealthCare’s Publication Svcs. © Copyright 2006. All rights reserved. No portion of the Drugs & Therapy Bulletin may be reproduced without the written consent of its editor. FOR MORE INFORMATION, VISIT US ONLINE http://shands.org/professional/drugs/ bulletin.htm

2006 Annual index TOPIC...... ISSUE/PAGE(S) TOPIC...... ISSUE/PAGE(S) TOPIC...... ISSUE/PAGE(S) Alzheimer’s Disease Drug Guaifenesin...... Nov-Dec/1,3 Paricalcitol...... February/1,3 Interactions...... October/1,3 Iloprost...... February/1-2 Paroxetine...... Nov-Dec/1,3 Amyl Nitrite...... June/1-2 Insulin Products...... July-August/2 Patient May Take Own Meds...... June/3-4 ...... September/1-2 Insulin, IV Concentration in Paxil® CR...... Nov-Dec/1,3 Anastrozole...... May/1-2 OB-GYN...... October/1 Pediatric Drug Research...... May/1-2 Antibiotic Cultures...... Nov-Dec/1,3 Insulin, Standardized Pediatric Standardized IV Automatic Stop Orders...... September/4 Concentrations...... January/3 Concentrations...... September/4 ...... February/1-2 Irinotecan...... March/1-2 Pemetrexed...... March/1-2 ...... October/1-3 Isotretinoin...... May/1,3 Pharmacokinetics Protocol...... Nov-Dec/3 Bupropion SR...... Nov-Dec/1-3 Joint Commission...... April/1 Phenylephrine Oral...... September/1,3 Cetuximab...... June/1-2 Kaletra®...... February/1-2 Pneumococcal Vaccine...... September/1 Charity Care Formulary...... February/3 Ketorolac...... February/1,3 Podofilox...... September/2-3 Order Form...... July-August/3-4 Lansoprazole...... April/1-2 Podophyllum Resin...... September/2-3 Chemotherapy Ordering...... July-August/3-4 Leflunomide...... September/2-3 Polygam® S/D...... September/1-2 Cholestyramine Light in Aquaphor...... June/1-2 Lenalidomide...... September/1,3 Pregabalin...... September/1-2 Citalopram...... January/1-2 Lente Insulins...... March/1,3 Preprinted Orders...... February/4 ...... February/3 Lepirudin...... January/1-3 Promethazine...... June/1-2 Clofarabine...... September/2-3 Levetiracetam Injection...... October/1-2 ...... July-August/1-3 Clonidine Injection...... Nov-Dec/1-2 Levofloxacin...... April/1-2 Rifaximin...... October/1-2 Cyclosporine...... March/4 Levofloxacin Ophthalmic...... July-August/1-2 Samples...... October/3 Dasatinib...... September/1-2 Levothyroxine...... May/3-4 Saquinavir...... April/1,3 Dexmethylphenidate ER...... April/1-2 Lindane...... April/1,3 Self-prescribing...... July-August/1-2 Dexrazoxane...... January/1-2 Lopinavir-Ritonavir...... February/1-2 Senna...... September/2-3 Dextran-1...... February/1-3 “Boluses”...... October/2-3 Spectinomycin...... October/1-2 Didanosine...... April/1,3 Medicare Part D...... January/1,3 Standard Dosage Times...... March/4 Dietary Supplements...... June/4 Medication Errors in HIV Patients....January/3-4 Stress Ulcer Prophylaxis...... March/3-4 Doxacurium...... June/1-2 Medication Errors in Pediatrics...... March/1-2 Tacrolimus...... March/4 Drotrecogin...... October/2-3 Medication Use Management...... April/1 Temozolomide...... July-August/1-2 ...... March/4 Mercaptopurine...... September/2-3 Therapeutic Interchange...... April/3-4 Enflurane...... March/1,3 Metadate® CD...... April/1-2 Thiabendazole...... February/1,3 Erlotinib...... March/1-2 Mivacurium...... Nov-Dec/1-2 Tigecycline...... April/1-3 Felodipine ER...... February/3 Moxifloxacin Ophthalmic...... July-August/1-2 ...... February/3 , Standardized Mucinex®...... Nov-Dec/1,3 UVADEX®...... Nov-Dec/1-2 Concentrations...... February/1 Natalizumab...... September/1-3 Vancomycin Capsules...... October/2 Filgrastim...... March/4 Nelarabine...... May/1-2 Varenicline...... Nov-Dec/1-2 Fomepizole...... January/1-2 New Drugs 2005...... February/1,3 Varicella Zoster Immune Fondaparinux...... January/1-2 Nitazoxanide...... October/1-2 Globulin...... July-August/1,3 ...... October/1,3 Nonformulary Drugs...... February/4 Venlafaxine IR...... March/1,3 Gammagard® S/D...... September/1-2 Injection...... April/1-2 Vinorelbine...... April/1,3 Gatifloxacin...... April/1,3 Optison®...... September/1-2 Warfarin...... June/3  Generics Improve Compliance...... June/1 Panglobulin®...... September/1-2 Wellbutrin® XL...... Nov-Dec/1-3