Download 2004-July/August

PHARMACY SERVICES
NEWSLETTER
JULY/AUGUST 2004
A FORUM FOR THE DISSEMINATION OF MEDICATION-RELATED INFORMATION
THROUGHOUT THE ST. LUKE’S HEALTH NETWORK
PHARMACY AND THERAPEUTICS COMMITTEE ACTIVITY
THROUGHOUT THE NETWORK – JULY/AUGUST 2004
The following is a summary of medication-related actions taken at the Pharmacy and Therapeutics
Committee during July and August:
ALLENTOWN/BETHLEHEM:
The P&T Committee met on July 6, 2004 and August 3, 2004. The following is a summary of
actions taken. The next meeting of the Committee will be September 7, 2004.
JULY
TIOTROPIUM BROMIDE INHALATION POWDER (SPIRIVA™) APPROVED FOR
FORMULARY – Tiotropium bromide inhalation powder (Spiriva™ HandiHaler), a long-acting
inhaled anticholinergic agent for treatment of chronic obstructive pulmonary disease (COPD), was
approved for formulary inclusion by the Committee. This drug has a much longer duration of
action than ipratropium bromide (Atrovent™), allowing for a single daily dose instead of four doses
per day. In clinical trials, tiotropium was shown to be superior to placebo, ipratropium, and
produced a more sustained response over time than salmeterol (a long-acting, beta-2 agonist). Side
effects are typical anticholinergic (xerostomia, constipation, tachycardia, blurred vision, urinary
retention, narrow angle glaucoma). Dose is 18 micrograms (the contents of one inhalation capsule
via the HandiHaler device) via inhalation once daily. Net cost to the institution is reduced in drug
cost and labor required to observe or administer four doses of ipratropium (Atrovent™) compared
to a single dose of tiotropium.
INJECTABLE N-ACETYLCYSTEINE (ACETADOTE™) APPROVED FOR
MANAGEMENT OF ACETAMINOPHEN INTOXICATION – The first FDA-approved
intravenous form of N-acetylcysteine (Acetadote™) was approved by the Committee as an antidote
to acetaminophen intoxication. Acetadote®, administered intravenously within 8 to 10 hours after
ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen
hepatic injury. The agent is administered as follows, in a 21-hour protocol: 150mg/kg LOADING
DOSE, administered over 15 minutes; then 50mg/kg, infused over 4 hours, then 100mg/kg
administered over 16 hours. This approved protocol reduces significantly the treatment time when
compared to the oral protocol (using N-acetylcysteine inhalation product) of 72 hours or the
previously utilized IV protocol (45 hours) utilizing a cold-sterilized inhalation solution for the
intravenous product. PLEASE NOTE: the intravenous formulation WILL NOT be utilized to
prevent radiocontrast-induced renal impairment – we will continue to use the inhalation product via
the oral route for this indication.
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AUGUST
NETWORK STANDARD FOR INSULIN INFUSION CONCENTRATION APPROVED – In
an effort to reduce the potential for medication misadventures with insulin infusion (designated as a
high-risk medication), as well as create a standard to guide insulin infusion algorithms throughout
the network, the Diabetes Advisory Committee has endorsed one concentration for insulin infusions
throughout the St. Luke’s Health Network. By standardizing these infusions, we can reduce
medication errors related to pump settings and concentration differences as a patient moves from
one level of care to another within the system. The standard concentration for insulin infusions will
be:
50 UNITS REGULAR HUMAN INSULIN/100mL 0.9% SODIUM CHLORIDE INJ
(0.5 UNITS/mL)
This concentration will facilitate accurate pump programming for a standard insulin infusion
algorithm, currently being piloted in critical care areas of the Bethlehem campus. It is anticipated
that this insulin infusion algorithm will be the Network standard.
CHANGE IN ADMINISTRATION TIMES FOR SELECTED ANTIPARKINSONIAN
AGENTS – Carbidopa-levodopa (Sinemet®), Ropinirole (Requip®), Pramipexole (Mirapex®), and
Pergolide mesylate (Permax®) will be dosed 1 hour before meals. Evidence suggests that the
administration of these agents 1 hour before meals facilitates better patient functioning in activities
of daily living (ADL) in patients with Parkinson’s Disease. This may or may not be due to
achievement of a more rapid peak concentration.
EPLERENONE (INSPRA™) DENIED FORMULARY APPROVAL – Eplerenone (Inspra™),
an aldosterone antagonist indicated for the treatment of hypertension and in the management of
heart failure, was denied approval as a formulary agent by the Committee. Its place in therapy
would be for those patients (approximately 10%) who cannot tolerate spironolactone. Denial was
based on the ability of the Pharmacy to procure this medication within 24 hours of the order for
those patients described above.
BUPROPION HCl EXTENDED-RELEASE TABLETS (WELLBUTRIN-XL™) APPROVED
FOR FORMULARY – This agent was approved by the Committee based on less frequent dosing,
with the possible replacement of the SR forms of the drug. Prescribers should be aware of the
similarities in strengths (both the SR and XL forms come in a 150mg strength tablet) when writing
medication orders and prescriptions for these medications. The cost of therapy with the newer
product is less expensive that the SR form of the name brand (on a mg/day basis), and slightly more
expensive that the generic version of the SR form.
QUAKERTOWN CAMPUS:
The P&T Committee at Quakertown convened on July 23, 2004. The following is a summary of
actions taken. The next meeting of the Committee will be October 22, 2004.
TIOTROPIUM BROMIDE INHALATION POWDER (SPIRIVA™) APPROVED FOR
FORMULARY – Please refer to the discussion under Allentown/Bethlehem above.
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INJECTABLE N-ACETYLCYSTEINE (ACETADOTE™) APPROVED FOR
MANAGEMENT OF ACETAMINOPHEN INTOXICATION – Please refer to the discussion
under Allentown/Bethlehem above.
LEVOFLOXACIN IV APPROVED AS THERAPEUTIC INTERCHANGE FOR
CIPROFLOXACIN IV – The Committee approved the therapeutic interchange of Levofloxacin IV
for Ciprofloxacin IV as outlined below:
IF PRESCRIBER ORDERS…
CIPROFLOXACIN 400MG IV Q12H
CIPROFLOXACIN 400MG IV Q24H
CIPROFLOXACIN 200MG IV Q12H
CIPROFLOXACIN 400MG IV (SINGLE DOSE,
ie PRE-OP)
CIPROFLOXACIN 200MG IV (SINGLE DOSE,
ie PRE-OP)
PHARMACY WILL DISPENSE…
LEVOFLOXACIN 500MG IV Q24H
(see below for 750mg IV recommendations)
LEVOFLOXACIN 250MG IV Q24H
LEVOFLOXACIN 500MG IV (SINGLE DOSE, ie PREOP)
LEVOFLOXACIN 250MG IV (SINGLE DOSE, ie PREOP)
Levofloxacin is also approved in a 750mg IV Q24H regimen for nosocomial pneumonia (7-14
days, including Methicillin-susceptible S aureus, P aeruginosa, S marcescens, E coli, K
pneumoniae, H influenzae, or S pneumoniae), complicated skin and skin structure infection (714 days) and community acquired pneumonia (5 days).
Levofloxacin dosage must be adjusted in those patients with renal impairment. The following
dosage adjustments must be made in these patients:
CREATININE CLEARANCE (ML/MIN)
LEVOFLOXACIN DOSE
20-49 (ABECB, CAP, UNCOMP SSSI,
500mg Initially, then 250mg IV Q24H
CHRONIC PROSTATITIS)
10-19, HD, CAPD – for above indications
500mg Initially, then 250mg IV Q48H
20-49 (COMP SSSI, NOS PNEU, CAP)
750mg Initially, then 750mg IV Q48H
10-19, HD, CAPD – for above indications
750mg Initially, then 500mg IV Q48H
COMP SSSI=complicated skin and skin structure infection; ABECB=acute bacterial exacerbation of chronic bronchitis;
CAP=community-acquired pneumonia; NOS PNEU=nosocomial pneumonia; HD=hemodialysis; CAPD=continuous
ambulatory peritoneal dialysis.
To facilitate the smooth provision of antibiotic therapy and to minimize unnecessary calls to
the prescriber, all intravenous orders for ciprofloxacin will be substituted to levofloxacin. If
ciprofloxacin is ordered as ORAL therapy for the same patient population, it will be dispensed as
ordered. The auto-substitution applies only to the intravenous form of ciprofloxacin (CIPRO™).
Also, if intravenous ciprofloxacin is clinically indicated, the prescriber may indicate “do not
substitute” on the order sheet. IV to PO conversion will take place with levofloxacin in accordance
with current policy.
POLICIES AND PROCEDURES MODIFIED – The following policies and procedures were
approved as revised:
Policy 04.01 Ordering Drugs for Patients – Expands “medication name” to include either
the brand name or generic name as acceptable for all medication orders.
Policy 08.04 Specials Procedures Controlled Substances – Added requirement of the
presence of a witness and initiating appropriate documentation and countersignature for
wastage or disposal of fentanyl transdermal patches.
Policy 09.05 AcuDose – Discrepancies - Improved process for the resolution and
monitoring of discrepancies of both controlled and non-controlled medications in the
AcuDose cabinets.
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MINER’S CAMPUS:
The P&T Committee at St. Luke’s-Miner’s Memorial did not meet in July or August. The next
meeting of the Miner’s P&T Committee will be September 8, 2004.
THERAPY-RELATED NEWS:
WARNINGS WITH NEONATAL EXPOSURE TO VENLAFAXINE - FDA and Wyeth
Pharmaceuticals notified healthcare professionals of revisions to the WARNINGS,
PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of Effexor™ (venlafaxine)
labeling to alert healthcare providers of two important safety issues. Neonates exposed to Effexor,
other SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), or SSRIs (Selective Serotonin
Reuptake Inhibitors), late in the third trimester of pregnancy have developed complications
requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can
arise immediately upon delivery. Patients with major depressive disorder, both adult and pediatric,
may experience worsening of their depression and/or the emergence of suicidal ideation and
behavior (suicidality), whether or not they are taking antidepressant medications. The warning
recommends patients being treated with antidepressants to be observed closely for clinical
worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of
dose changes, either increases or decreases.
DOSING FOSPHENYTOIN (CEREBYX™) – REMEMBER TO USE PHENYTOIN
EQUIVALENTS! – Fosphenytoin (Cerebyx™) is a water-soluble phosphate ester of phenytoin
that has no known pharmacologic activity prior to its conversion to phenytoin. It is rapidly and
completely converted to phenytoin after intramuscular or intravenous dosing. In order to avoid the
need to perform molecular weight-based adjustments when converting between phenytoin and
fosphenytoin, the dose, concentration in dosing solutions and infusion rate of IV fosphenytoin is
expressed as PHENYTOIN SODIUM EQUIVALENTS (PE). In order to minimize dosing errors
and ensure the safe and effective use of fosphenytoin, all doses and dosing rates should be
expressed as PE.
USE OF GLYBURIDE FOR THE TREATMENT OF GESTATIONAL DIABETES
MELLITUS – Hyperglycemia is associated with adverse outcomes of pregnancy in women with
gestational or pre-existing diabetes mellitus. Traditionally, the principal approach to glycemic
control in the gestational diabetic was dietary modification, with insulin added when this modality
is ineffective. Oral therapy with sulfonylureas had been contraindicated due to concerns regarding
teratogenicity and neonatal hypoglycemia. However, Langer and colleagues1 studied 404 women
(between 11 and 33 weeks gestation) who were randomly assigned glyburide or an intense insulin
regimen when diet and exercise were ineffective at maintaining euglycemia. Treatment with
glyburide resulted in similar glycemic control with significantly less risk of maternal hypoglycemia.
From a fetal perspective, there were no significant differences in all parameters – infants large for
gestational age, macrosomia, lung complications, hypoglycemia, admission to NICU, or fetal
anomalies. The cord-serum insulin concentrations were similar in both groups; glyburide was not
detected in the cord serum of any infant in the glyburide.
Based on this study and subsequent data2-4, the Maternal-Fetal Medicine Section of the Division of
Obstetrics has chosen glyburide as first choice for gestational diabetic patients at greater than 14
week gestation when diet and exercise fail to achieve euglycemia. The protocol dosing begins at
2.5mg glyburide twice daily (every 12 hours), increasing as necessary to a maximum of 10mg twice
daily (every 12 hours). If the patient does not reach euglycemia at the maximum dose, they will be
switched over to split-dose insulin. All patients managed by the Perinatal Center, whether dietcontrolled, glyburide or insulin treated, will be followed with the same perinatal management plan
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(Level II ultrasound, follow-up serial growth scans, twice weekly non-stress testing after 32 weeks
gestation, weekly amniotic fluid index measurements).
1. Langer O, Conway DL, Berkus MD, et al. N Engl J Med 2000 ;343 :1134-1138. 2. Conway DL, Gonzales O, Skiver
D. Journ of Maternal-Fetal and Neonatal Medicine 2004;15:51-55. 3. Goetzl L, Wilkins I. Journal of Perinatology
2002;22:403-406. 4. Kremer CJ, Duff P. Am Journ Obstetrics and Gynecology 2004;190:1438-1439.
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