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Volume 27, Number 5 May 2013

PRESCRIBING FORMULARY UPDATE The and Therapeutics The route less traveled Committee met April 16, 2013. No were added in the Formu- he rectal is when the rectal route is an alterna- tive to an , if patients are not lary, 2 drugs were deleted, and 5 T underused. The “per ” (PR) hospitalized. Diazepam is available in a drugs were designated nonformulary route offers a convenient and cost effec- tive option. There are few true contra- formulation that is instilled rectally and not available. 2 interchanges were indications. A ’s route of admin- using a prefilled . approved and 4 drugs had criteria for istration is limited by the formulations Terminally ill patients commonly lose use changes. available. Formulations are dependent their ability to take drugs orally. This on the innate physical and chemical can be due to absorptive impairment, ◆ ADDED properties of drugs. mental status changes, or an obstruc- By mouth or “per os” (PO) is the most tion. Utilizing the rectal route can None common route of drug administration. ensure adequate pain control, minimize Most currently approved drugs are adverse effects, and maximize comfort. ◆ DELETED administered PO, either as a oral One of the concerns from health care (eg, or ), professionals is the perception that rec- Amyl Nitrite Ampule/Inhalant orally disintegrating tablet, buccal or tal absorption is erratic. Drug absorption (Generic)* sublingual route, or as an oral . may be delayed or prolonged as the rate *Nonformulary and not available These drugs are convenient, can be of rectal absorption is affected by sev- self-administered, and are often less ® eral factors. The formulation determines 25-mg Tablets (Viagra )* expensive compared to parenteral (ie, the time to liquification of the sup- *Nonformulary and not available; “nonenteral”) routes. pository. The rate is also affected by the interchanged to 20-mg However, some oral drugs are sus- volume, retention, and the concentra- ceptible to first-pass effect, which can ◆ NONFORMULARY AND tion of the . Data are lacking reduce . The properties of that show the variability in absorption NOT AVAILABLE the active ingredients may not withstand impacts therapeutic outcomes. Carfilzomib (Kyprolis®)* acid. In emergent situations, the Is the rectal route less effective or is onset of action may be too slow or not *May be used in the BMT Outpatient the effect delayed? A study by Karbasi Clinic & Infusion Center practical in an unconscious patient. and colleagues compared the effective- Alternative routes of drug administra- ness of oral and rectal acetaminophen Clozapine (Versacloz®) tion include , parenteral, as an antipyretic in 60 febrile children. nasal, and rectal. The transdermal route Children aged 6 months to 6 years who Crofelemer (Fulyzaq®)* can increase compliance but can cause presented to an emergency department *Patients may use their own supply dermatitis. Adverse events can occur were randomly assigned to receive 15 when patches are not removed before mg/kg acetaminophen rectally or the Hydrocodone-Chlorpheniramine placing a new patch. Parenteral agents same orally. Temperature was (Vituz®) are convenient and have a quick onset of recorded at baseline and 1 and 3 hours action. Obtaining intravenous access can Ospemifene (Osphena®)* after administration. In the rectal group, be a challenge, and can lead to infection. mean decrease in temperature, 1 and 3 *CANNOT USE IN INPATIENT SETTING The rectal route of administration is hours after administration of acetamino- underused and underappreciated. Few phen, was 1.1˚C and 1.7˚C, respectively, ◆ INTERCHANGES drugs can be administered rectally and and in the oral group it was 2.0˚C and are overlooked as therapeutic options. Oral Phosphate for IV Phosphate 1.7˚C, respectively. Based on this study These drugs are capable of providing lo- and other similar studies that have been Sildenafil 20-mg (Generic) for cal effects or achieving systemic concen- conducted, rectal and oral acetamino- trations, usually within 5 to 30 minutes. Sildenafil 25-mg(Viagra ®) phen preparations have similar anti- The rectal route is ideal when other pyretic effectiveness. routes are impractical or not feasible. ◆ CRITERIA-FOR-USE CHANGES IV promethazine is associated with It is preferred in patients who have significant adverse effects. The Institute ® nausea, , or esophageal ob- Acetaminophen IV (Ofirmev )‡ (continued on page 6) struction. This also applies to patients ‡Neutropenic fever when the oral route is unavailable that are unconscious or uncooperative. ◆ Children are frequently administered INSIDE THIS ISSUE drugs rectally, especially when the oral liquid formulation tastes unpleasant. ◆ Restricted Distribution Systems (continued on next page) Seizures are an emergent situation Formulary update, from page 1 Carfilzomib is a potent, selective, and Crofelemer is an antidiarrheal with a irreversible proteasome inhibitor with labeled indication for the symptomatic Ado-trastuzumab (Kadcyla®)† antiproliferative and proapoptotic relief of non-infectious diarrhea in †Added in the Chemotherapy Policy activity in multiple myeloma. The drug adults with HIV/AIDS on anti-retrovi- received its indication in relapsed or ral therapy. The proposed mechanism Methadone (Generic)§ refractory myeloma based on a phase II of action is local in the gut by decreas- §Restrictions modified single agent trial of 266 patients with ing gastrointestinal fluid accumula- progressive myeloma. All patients were tion. By inhibiting the secretion of Phosphate IV (Generic)§ responsive to at least 1 prior regimen chloride ions via the cystic fibrosis §Restricted and refractory to their most recent transmembrane regulator chloride therapy; all patients must have also Amyl nitrite is a rapidly acting channels and the calcium activated received greater than or equal to 2 prior vasodilator administered by inhala- chloride channels of the luminal regimens for relapsed disease. Overall tion. A nonspecific smooth muscle membrane of intestinal cells fluid response rate was 23.7% with a median relaxant, it is used for its prominent secretion is decreased. response duration of 7.8 months. Median effect on vascular smooth muscle. Diarrhea is experienced by many overall survival was 15.6 months. The primary user of amyl nitrite has HIV/AIDS patients and is a common Carfilzomib is administered intrave- been the Echocardiography Lab, reason why patients discontinue or nously over 2 to 10 minutes on 2 which has been notified that this switch their antiretroviral therapies. consecutive days each week for 3 weeks product is no longer available. Amyl Patients take crofelemer 2 times a day (days 1, 2, 8, 9, 15, 16). This is followed nitrite has been used in echocardiog- to manage watery diarrhea due to the by a 12-day rest period (days 17-28); raphy to measure provocable left secretion of electrolytes and water in each 28-day period is 1 treatment cycle. ventricular outflow obstruction. the . During cycle 1, carfilzomib is adminis- The safety of crofelemer was Amyl nitrate is very flammable, tered at a dose of 20 mg/m2. If tolerated, which requires special storage. established in placebo-controlled trials the dose is escalated to 27 mg/m2 in involving 696 patients. There were 374 Diversion is also an issue because cycle 2 and continued at 27 mg/m2 in amyl nitrite can be used to cause HIV-positive patients on stable subsequent cycles. Carfilzomib treatment antiretroviral therapy with a history of euphoria (ie, “poppers”). Amyl nitrite may be continued until disease progres- has been used with drugs of abuse. diarrhea lasting 1 month or longer sion or until unacceptable toxicity. enrolled in the ADVENT efficacy trial. It has also been used as an antidote There are no contraindications or for cyanide poisoning. It was a The baseline median number of boxed warnings for carfilzomib. The watery bowel movements was 2.5 per component of the Cyanide Antidote most common adverse reactions noted Kit, which was deleted from the day. Patients who had diarrhea caused in clinical trials were fatigue, anemia, by an infection or a gastrointestinal Formulary in 2007. It induces nausea, thrombocytopenia, dyspnea, methemoglobinemia, which can disease were excluded from participat- diarrhea, and pyrexia. There are ing in the trials. The trial was de- sequester cyanide. Hydroxocobalamin warnings for cardiac arrest, congestive (Cyanokit®) is listed in the Formulary signed to measure clinical response, failure, myocardial ischemia, defined as the number of patients who for cyanide poisonings. pulmonary complications, infusion The only supplier of amyl nitrite had 2 or fewer watery bowel move- reactions, tumor lysis syndrome, ments weekly. Results showed that ampules for has discontin- thrombocytopenia, and hepatic toxicity ued making this product, so it was 17.6% of patients taking crofelemer and failure. experienced clinical response com- deleted from the Formulary and is not Carfilzomib costs approximately available for nonformulary use. pared with 8% taking placebo. In some $10,000 for the first cycle. patients, a persistent antidiarrheal Sildenafil is a phosphodiesterase Carfilzomib was designated nonformu- inhibitor that was first approved in effect was seen for 20 weeks. No dose lary and not available for inpatient use. It modifications are recommended with 1998 for erectile dysfunction as is available for use in the Infusion Center. ® ® respect to CD4 cell count and HIV viral Viagra . In 2005, Revatio was Versacloz® is an oral suspension of approved for the treatment of load, based on the findings in sub- the atypical antipsychotic agent groups of patients defined by CD4 cell pulmonary arterial hypertension. clozapine. The orally disintegrating The P&T Committee has previously count and HIV viral load. Among race (ODT) dosage form of clozapine subgroups, there were no differences determined that the 20-mg and 25-mg ® (Fazaclo ) was designated nonformulary in the consistency of the crofelemer doses of sildenafil are equivalent. and not available in October 2005. ® treatment effect except for the When Revatio (20-mg) was market- Clozapine tablets are listed in the ed, Viagra® and Revatio® were the subgroup of African-Americans; Formulary. They are only available for crofelemer was less effective in same cost, and interchange was not use via a restricted-distribution system, considered. Revatio® is now available African-Americans than non-African- but they can be purchased for use in the Americans. The safety and effective- as a generic, while the 25-mg dosage inpatient setting. Since approximately ® ness of crofelemer have not been form of Viagra remains on patent. 1% of patients can develop agranulocy- established in pediatric patients less The cost savings of using generic tosis, periodic white blood cell counts ® than 18 years of age. Before treating Revatio is approximately $23 per are needed to assure safe use. Current patients with crofelemer, health care tablet. For this reason and equivalent policy assures safe use of clozapine professionals should conduct proper efficacy, the 25-mg dose was deleted consistent with its required restrictions. testing to confirm the diarrhea is not from the Formulary and will be Crofelemer, derived from the red sap caused by an infection or a gastroin- interchanged to 20-mg. of the Croton lechleri plant, is the testinal disease. If infectious etiologies Carfilzomib is a proteasome second botanical are not considered, and crofelemer is inhibitor with a labeled indication for approved by the FDA. A botanical drug initiated based on a presumptive the treatment of multiple myeloma in product is often a complex mixture diagnosis of non-infectious diarrhea, patients who have received at least 2 derived from one or more plant materi- then there is a risk that patients with prior treatment regimens and have als with varying degrees of purification. infectious etiologies will not receive disease progression within 60 days of Manufacturers of a botanical drug the appropriate treatments, and their the most recent treatment. Carfilzo- product must ensure rigorous control of disease may worsen. mib had been added to the Chemo- raw materials, and good agricultural Common adverse effects reported in therapy Policy, but its formulary and collection practices, together with status had not been addressed. analytical testing of the final product. (continued on next page) 2 Formulary update, from page 2 Ospemifene has a boxed-warning extend supplies of parenteral phos- patients taking crofelemer in the alerting women and healthcare profes- phate. About a third of our parenteral clinical trial were upper respiratory sionals that thickening of the endome- phosphate supplies are used to tract infection, bronchitis, cough, trium occurs. Since postmenopausal compound parenteral nutrition. flatulence, and increased levels of the women no longer menstruate, this can Compounded parenteral phosphate enzyme bilirubin. be problematic. Unusual vaginal is still an option. A supply of sterile Crofelemer has been investigated bleeding may be a sign of endometrial parenteral phosphate compounded for several secretory diarrhea in- cancer or a condition that can lead to it. from nonsterile ingredients has been dications including diarrhea-predomi- Ospemifene should be prescribed for ordered and will be available in nant irritable bowel syndrome, acute the shortest duration consistent with early May. infectious diarrhea, and pediatric treatment goals and risk for the Intravenous (IV) acetaminophen diarrhea. Off-label use is a concern. individual woman. was added to the Formulary in June Crofelemer was designated non- The boxed-warning also notes the 2011 and restricted to post-operative formulary and not available; patients incidence of thrombotic and hemor- use up to 24 hours and as a single will use their own supply from home. rhagic strokes and the incidence of deep dose in the ED. Further restrictions Vituz® is a combination of an opioid venous thrombosis (DVT). These rates include no “as needed” (PRN) orders, (hydrocodone) and an antihistamine appear low compared with the risks no inclusion in Epic order sets (except (chlorpheniramine) with a labeled associated with estrogen alone. in the PACU), and only dosage indication for the relief of cough and Common adverse effects include hot regimens for every-6-hour intervals in flushes/flashes, vaginal discharge, symptoms associated with upper adults and children (ie, no every- muscle spasms, and excessive sweating. respiratory allergies or the common 4-hour regimens). Also, it was added Ospemifene was designated nonfor- cold. This combination drug is a in the IV-to-PO Policy permitting mulary and do not use for possible Schedule III controlled substance. conversion to an oral or enteral safety reasons. In August 2011, the P&T Commit- dosage form when other ® A critical shortage of intravenous tee designated Rezira (hydrocodone- are being given orally or enterally. pseudoephedrine) and Zutripro® potassium and sodium phosphate required dramatic restrictions on their A use evaluation was (hydrocodone-pseudoephedrine- done to evaluate adherence to IV chlorpheniramine) nonformulary and use. Prescribers have been receiving Epic alerts suggesting oral alternatives, and acetaminophen criteria for use. not available. Random samples of adult and There are currently no hydrocodo- oral use increased. The alerts and occasional shipments of limited supplies pediatric patients admitted between ne-containing products listed in the June and December 2011 were Formulary. Since this is a controlled had mitigated the shortage. However, we evaluated. Five of 10 (50%) pediatric substance, patients may not use their are now in “emergency mode.” Without and 6 of 50 (12%) adult patients met own supply. Vituz® was designated further restrictions, we will exhaust all criteria for use. Opportunities for nonformulary and not available. parenteral phosphate supplies. We improvement include more use of the Ospemifene is an estrogen agonist/ currently have no potassium phosphate, antagonist with a labeled indication and an extremely short supply of rectal (PR) route, strict enforcement of for the treatment of moderate to sodium phosphate. the IV-to-PO Policy in patients severe dyspareunia. Dyspareunia is a Alerts have been successful at receiving oral medications, and strict condition associated with declining encouraging oral phosphate use, but enforcement of the restrictions on use levels of estrogen in menopause. there has been confusion about how to beyond 24 hours post-operatively. Lower estrogen levels lead to thinner convert IV to oral formulations. Typi- Only 2 patients in the sample were vaginal tissue that is drier and cally, prescribers convert 1:1, but if neutropenic (which precludes PR more fragile. bioavailability and tolerability issues administration), approximately 80% of Ospemifene is a tablet taken with are considered, the table below patients received oral medications, once a day. It acts like estrogen is recommended. and 26% of orders occurred beyond to thicken vaginal tissue and make it With a subsequent decline in supply the 24-hour post-operative window. less fragile. and increased use of IV phosphate, the Adding another criterion that would Ospemifene’s efficacy was estab- following restrictions were adopted: allow the “as needed” use of IV lished in 3 placebo-controlled, clinical sodium phosphate therapy during acetaminophen in patients with studies of 1,889 post-menopausal CRRT; phosphate replacement in any severe mucositis (unable to take oral women with symptoms of vulvar and patient with a serum phosphorous medications) and who are neutrope- vaginal atrophy. After 12 weeks of below 1; and, phosphate replacement in nic (so unable to take rectal medica- treatment, the first 2 studies showed any patient with a serum phosphorous 1 tions) was considered. a statistically significant improvement to 1.5 where no other oral or enteral The IV acetaminophen criteria were in dyspareunia in ospemifene-treated medications are currently prescribed. modified to include, “fever with women. The third study is a long-term The use of premixed parenteral severe mucositis and neutropenia.” study designed to look at safety. nutrition formulas will be used to There will be a note to call pharmacy

IV Equivalent K Phos Neutral Tablets Phosphate Oral Liquid Sodium Phosphate Oral Liquid Phosphate PO (8 mmol phosphate, 1.1 mEq potassium, (3 mmol phosphate and (4.1 mmol phosphate and Phosphate 13 mEq sodium per tablet) 4.4 mEq potassium per mL) 4.8 mEq sodium per mL)

9 mmol 13.5 mmol 2 tablets x 1 13.5 mmol (4.5 mL) x 1 13.5 mmol (3.3 mL) x 1

15 mmol 22.5 mmol 1 tablet Q 6 hrs x 3 7.5 mmol (2.5 mL) Q 6 hrs x 3 11.5 mmol (2.8 mL) Q 6 hrs x 2

24 mmol 36 mmol 1.5 tablets Q 6 hrs x 3 9 mmol (3 mL) Q 6 hrs x 4 18 mmol (4.4 mL) Q 6 hrs x 2

30 mmol 45 mmol 2 tablets Q 6 hrs x 3 15 mmol (5 mL) Q 6 hrs x 3 14.8 mmol (3.6 mL) Q 6 hrs x 3

Oral absorption of phosphate product is approximately 66% (continued on next page) 3 3

Formulary update, from page 3 to enter a maintenance order for this indication. For this use only, “as needed” dosing will be allowed. Ado-trastuzumab is a HER2-targeted antibody and microtubule inhibitor conjugate with a labeled indication for the treatment of patients with HER2-positive metastatic breast cancer as a single agent after patients have received trastuzumab and a taxane, separately or in combination. Ado-trastuzum- ab was referred to as T-DM1 during clinical research. The generic name is ado-trastu- zumab in an attempt to avoid medication errors by confusing trastuzumab (Herceptin®) with ado-trastuzumab. Ado-trastuzumab has a boxed warning alerting patients and healthcare profession- als that the drug can cause liver toxicity, heart toxicity, and death. It can also cause severe life-threatening birth defects, and pregnancy status should be verified prior to starting ado-trastuzumab treatment. Ado-trastuzumab was added in the Chemo- therapy Policy. It will be proactively reviewed to determine its formulary status. Methadone is a potent synthetic opioid that is difficult to use safely. Methadone has a boxed warning stating that methadone use for acute or chronic pain should be initiated only if the potential benefits outweigh the risks. For these reasons, it has been restrict- ed in both adult and pediatric patients. Methadone restrictions were modified to address conflicts between the pediatric and adult criteria for use. The goal is to limit methadone use to prescribers who can safely prescribe it. The following revised methadone criteria were developed. All orders for methadone must include the indication for use, regard- less of age. Methadone will not be used for acute pain. Use in pediatric patients (less than or equal to 18 years of age) on a pediatric unit for iatrogenic withdrawal would be limited to a standard order set that will note the attend- ing physician approving the use of metha- done and dose. Pediatric patients in adult units will follow adult restrictions. Pediatric use for pain will be approved by a Hematolo- gy-Oncology progress note. Continuation of a home regimen for opioid addiction is allowed. For patients greater than 18 years of age, methadone will not be included in any order set. Continuation of a home regimen for the treatment of opioid addiction continues to be acceptable. Continuation of a home regimen for chronic or cancer pain is allowed. The pre- hospitalization dosage must be verified, and the dose cannot be modified. The initiation for the treatment of withdrawal symptoms requires an Addiction Medicine or Psychiatry consult and approval. This use is permissible, but should rarely be used. Initiation for chronic or cancer pain [or modification of an existing dose] requires approval by the Inpatient Pain Service, Palliative Care Service, or the Chief of Pain Medicine or his/ her designee.

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POLICIES AND PROCEDURES High-priority, restricted- distribution drugs n last month’s Bulletin, various formulary I and nonformulary categories were re- viewed. The term restricted drug distribution program was used, and some readers of the Bulletin were not familiar with this term. Restricted drug distribution programs [or systems] are methods used by drug compa- nies to limit access to drugs, primarily for safety reasons.1-5 These agents are some- times called “limited distribution drugs.” The restrictions or limitations fall under the FDA’s Risk Evaluation and Mitigation Strategies (REMS). Restricting drug access has a long history, and this article briefly explains these heterogeneous programs. When these programs were last reviewed in the Bulletin in 2003, the legal authority to restrict access to FDA approved drugs was questionable.3 In 2007, legal authority was given by the FDA Amendments Act (FDAAA) by establishing REMS, which allows for “re- strictions on distribution.” Prior to 2007, a small number of drugs that offered substantial therapeutic benefits, but significantly increased risks relative to most drugs in that therapeutic area were available only by restriction distribution.3 Clozapine was an early example of this. Clozapine is still the gold standard for treat- ment-resistant schizophrenia. In early clinical trials, it was estimated that approximately 1% of patients treated with clozapine developed agran- ulocytosis. Drugs usually never make the market when 1 in 100 patients are at risk of dying. Yet, in treatment-resistant patients who have white blood cells (WBCs) monitored closely, it can be used safely and provide relief for patients who do not respond to less risky options. Clozapine was only dispensed in small amounts after the patient provided a blood sample that showed that they were tolerat- ing therapy. This “blood for drug” program prevented patients from from a fatal adverse effect, while treating their condition. If clozap- ine was stopped before WBCs dropped too far, the adverse effect was reversible. Many restricted drug distribution systems are administered by specialty like Accredo, Caremark, or CuraScript. These pharmacies limit their activities to high cost/ low volume drugs that are often “high profit” and/or “high risk.” Low patient volumes allow more time to monitor the restrictions placed on the drugs before they are delivered to patients. Not all restricted drug distribution pro- grams are limited to specific pharmacies. For example, any pharmacy willing to abide by the clozapine restrictions can dispense this drug. The safety checks might require special laboratory testing (eg, pregnancy testing for a Category X teratogen) or diagnostic criteria. (continued on next page) 5 SHANDS NON-PROFIT ORG. Shands at the University of Florida U.S. POSTAGE DRUG INFORMATION SERVICE PAID GAINESVILLE, FL Volume 27, No. 5 May 2013 PO Box 100316 PERMIT NO. 94 This publication is produced by the Gainesville, FL 32610-0316 Drug Information and Pharmacy Resource 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 Thomas E. Johns, PharmD CHAIRMAN, PHARMACY & THERAPEUTICS COMMITTEE I. David Weiner, MD Professor of Medicine and Physiology and Functional Genomics University of Florida, College of Medicine EDITING, DESIGN, & PRODUCTION Shands HealthCare’s Publication Svcs. © Copyright 2013. 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://professionals.ufandshands.org/ resources/drug-information-and- pharmacy-resource-center/bulletins/

Restricted Distribution Systems, from page 5 Rectal Dose Administration, from page 1 They often require that patients receive for Safe Medication Practices issued an TABLE. a Medication Guide, which helps pa- SELECTED RESTRICTED DRUG alert warning health care profession- DISTRIBUTION PROGRAMS als of the risk of promethazine causing tients better understand the risks asso- 6 damage to blood vessels and sur- ciated with taking a drug. The program Cayston® Access Program rounding tissues. Using promethazine may also require registration and train- ing of the prescribers and pharmacies. Clozaril® Administration Registry avoids this complication. Enrollment (CARE) A study performed in 99 post-operative These restrictions are not voluntary, adults evaluated the efficacy of rectal and the manufacturer is held account- Entereg® Access Support and promethazine. After discharge, 55% of able for compliance with any REMS, Education (EASE) patients experienced nausea. Of these, including the restricted distribution. Gattex® REMS 48% subsequently used the supposito- Most restricted distribution systems ry, all of which reported some or great are designed for outpatient use of iPLEDGE (isotretinoin) improvement in symptoms. Investiga- drugs. Too often, these programs are OneSource (Soliris®) tors found that suppositories were not well designed for inpatient use ® effective in treating post-operative of drugs. The program for alvimopan Pomalyst REMS nausea and vomiting. (EASE) restricts the use of the drug to ® There are scenarios when the rectal Revlimid REMS the inpatient setting, but most do not route of drug administration should focus on inpatient use. For this reason, Support, Help, And Resources for be avoided. Neutropenic patients are Epilepsy (SHARE) for Sabril® at high risk for the development of patients may have to use their own supply while they are hospitalized… Support Program for Access and infection and should not receive drugs Reimbursement for Korlym® (SPARK) rectally. This may introduce bacteria even if the drug is an injectable. De- into the bloodstream and cause sepsis. pending on the program, they may not System for Thalidomide Education and Prescribing Patients with thrombocytopenia are allow a hospital to purchase product. Safety (STEPS) The manufacturer is trying to limit the also perceived to be at increased risk Tikosyn® in Pharmacy Systems (TIPS) of harm. Active diarrhea would use of a product to specific patients and preclude the use of these agents…for specific prescribers. Tracleer® Access Program (TAP) obvious reasons. One challenge with restricted distri- Transmucosal Immediate Release bution programs is that they change. As Fentanyl (TIRF) REMS by Janet Arrazcaeta, PharmD the number of these restricted distri- ® bution programs increases, keeping Tysabri Outreach Unified Commitment for Health (TOUCH) References available upon request current with all requirements is difficult. from the Editor. ® References available upon request Xolair Access from the Editor. ® 6 Xyrem Success Program