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PRESCRIBING
FORMULARY UPDATE
The Pharmacy and Therapeutics
The route less traveled
T he rectal route of administration is when the rectal route is an alterna-
lary, 2 drugs were deleted, and 5 tive to an injection, if patients are not route offers a convenient and cost effec- hospitalized. Diazepam is available in a gel formulation that is instilled rectally istration is limited by the formulations their ability to take drugs orally. This ◆ ADDED
By mouth or “per os” (PO) is the most ◆ DELETED
professionals is the perception that rec- Amyl Nitrite Ampule/Inhalant
tal absorption is erratic. Drug absorption eral factors. The formulation determines Sildenafil 25-mg Tablets (Viagra®)*
*Nonformulary and not available; pository. The rate is also affected by the ceptible to first-pass effect, which can ◆ NONFORMULARY AND
tion of the suppository. Data are lacking reduce bioavailability. The properties of NOT AVAILABLE
the active ingredients may not withstand Carfilzomib (Kyprolis®)*
stomach acid. In emergent situations, the Is the rectal route less effective or is *May be used in the BMT Outpatient Clozapine Suspension (Versacloz®)
as an antipyretic in 60 febrile children. nasal, and rectal. The transdermal route Crofelemer (Fulyzaq®)*
*Patients may use their own supply Hydrocodone-Chlorpheniramine
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. phen, was 1.1˚C and 1.7˚C, respectively, ◆ INTERCHANGES
Oral Phosphate for IV Phosphate
1.7˚C, respectively. Based on this study and other similar studies that have been Sildenafil 20-mg (Generic) for
cal effects or achieving systemic concen- Sildenafil 25-mg (Viagra
trations, usually within 5 to 30 minutes. ◆ CRITERIA-FOR-USE CHANGES
significant adverse effects. The Institute Acetaminophen IV (Ofirmev®)‡
struction. This also applies to patients ‡Neutropenic fever when the oral route INSIDE THIS ISSUE
drugs rectally, especially when the oral Formulary update, from page 1
Carfilzomib is a potent, selective, and Ado-trastuzumab (Kadcyla®)†
Added in the Chemotherapy Policy Methadone (Generic)§
of action is local in the gut by decreas- Phosphate IV (Generic)§
Amyl nitrite is a rapidly acting
received greater than or equal to 2 prior (days 1, 2, 8, 9, 15, 16). This is followed each 28-day period is 1 treatment cycle. tered at a dose of 20 mg/m2. If tolerated, established in placebo-controlled trials subsequent cycles. Carfilzomib treatment euphoria (ie, “poppers”). Amyl nitrite antiretroviral therapy with a history of in clinical trials were fatigue, anemia, (Cyanokit®) is listed in the Formulary deleted from the Formulary and is not Sildenafil is a phosphodiesterase
lary and not available for inpatient use. It is available for use in the Infusion Center. Versacloz® is an oral suspension of
clozapine. The orally disintegrating
Formulary. They are only available for use via a restricted-distribution system, but they can be purchased for use in the consistent with its required restrictions. Crofelemer, derived from the red sap
of the Croton lechleri plant, is the Carfilzomib is a proteasome
testinal disease. If infectious etiologies als with varying degrees of purification. therapy Policy, but its formulary analytical testing of the final product. Formulary update, from page 2
cancer or a condition that can lead to it. Intravenous (IV) acetaminophen
was added to the Formulary in June rhagic strokes and the incidence of deep Vituz® is a combination of an opioid
include no “as needed” (PRN) orders, (hydrocodone) and an antihistamine
(chlorpheniramine) with a labeled
in the IV-to-PO Policy permitting A critical shortage of intravenous
potassium and sodium phosphate
use. Prescribers have been receiving Epic alerts suggesting oral alternatives, and occasional shipments of limited supplies Formulary. Since this is a controlled are now in “emergency mode.” Without further restrictions, we will exhaust all Ospemifene is an estrogen agonist/
rectal (PR) route, strict enforcement of lished in 3 placebo-controlled, clinical women. The third study is a long-term The use of premixed parenteral Equivalent
K Phos Neutral Tablets
Phosphate Oral Liquid
Sodium Phosphate Oral Liquid
Phosphate
(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)
13.5 mmol
2 tablets x 1
13.5 mmol (4.5 mL) x 1
13.5 mmol (3.3 mL) x 1
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
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
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%
Formulary update, from page 3
indication. For this use only, “as needed” Ado-trastuzumab is a HER2-targeted
antibody and microtubule inhibitor conjugate with a labeled indication for the treatment of breast cancer as a single agent after patients separately or in combination. Ado-trastuzum- ab was referred to as T-DM1 during clinical research. The generic name is ado-trastu- errors by confusing trastuzumab (Herceptin®) 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 Ado-trastuzumab was added in the Chemo- therapy Policy. It will be proactively reviewed 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 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 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 Service, or the Chief of Pain Medicine or his/
POLICIES AND PROCEDURES

High-priority,
restricted-
distribution drugs
I n last month’s Bulletin, various formulary
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 pharmacies 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. Shands at the University of Florida
DRUG INFORMATION SERVICE
Therapeutics Committee.
EDITOR,
DRUGS & THERAPY BULLETIN
Randy C. Hatton, PharmD
DIRECTOR,
PHARMACY SERVICES
Thomas E. Johns, PharmD
CHAIRMAN, PHARMACY &
THERAPEUTICS COMMITTEE
University of Florida, College of Medicine
EDITING, DESIGN, & PRODUCTION
Shands HealthCare’s Publication Svcs.
No portion of the Drugs & Therapy Bulletin may be reproduced without the written consent of its editor.
FOR MORE INFORMATION,
VISIT US ONLINE
Rectal Dose Administration, from page 1
Restricted Distribution Systems, from page 5
They often require that patients receive
SELECTED RESTRICTED DRUG
DISTRIBUTION PROGRAMS
focus on inpatient use. For this reason, System for Thalidomide Education and Prescribing use of a product to specific patients and the number of these restricted distri-bution programs increases, keeping Tysabri® Outreach Unified Commitment for References available upon request
current with all requirements is difficult.
from the Editor.
References available upon request
from the Editor.

Source: https://shands-professionals.sites.medinfo.ufl.edu/files/2011/11/0513.pdf

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