Pharmacy Newsletter - St. Mary's Hospital

Pharmacy
Newsletter
August
2011
New Delirium Order Set Debuts September 13
Kate Rotzenberg, PharmD and Joel Jones, PharmD
Inside this issue:
On September 13, 2011, a new delirium order set will be available for use. The order
set is a result of multidisciplinary collaboration, headed by Dr. Wendell Bell and
Dr. Debbie Jones and includes input from Nursing, Pharmacy, and Epic.
The new order set is substantially different from the current order set and includes:
• Updated monitoring parameters for the use of intravenous haloperidol.
These updates were prompted by FDA recommendations. Daily EKG and telemetry
are required for the use of intravenous haloperidol; the only exception is when obtaining
or initiating these measures is technically infeasible due to the patient’s status
(i.e. emergent treatment of a combative patient). Nurses are instructed to contact
the physician when the QTc interval is greater than 500 msec. The maximum frequency
of PRN administration is 30 minutes in the ICU (or while arranging transfer to
ICU) and 2 hours for non-ICU which reflects appropriate Nursing assessment expectations
in these areas. Concomitant medications that can prolong the QTc interval
can be found at http://www.azcert.org/medical-pros/drug-lists/browse-drug-list.cfm;
the pharmacist will be reviewing the patient’s profile and contacting the physician as
necessary.
• Initial bolus and PRN dose recommendations for haloperidol based on the
patient’s severity of delirium and age. Weight-based dosing is also a consideration
for emergent treatment of patients. Linked orders are used to allow flexibility with
route of administration.
• Second-line medication recommendations for patients with prolonged QTc
interval or those refractory or intolerant of haloperidol. These are classified by
hyperactive subtype, hypoactive subtype, and refractory use.
• Rescue medications in the event of torsades de pointes.
Nursing staff throughout the hospital have received training on the use of CAM as a
screening tool to better identify patients with delirium. This screening tool also provides
the criteria for when to treat delirium with medication. From the order set, PRN
doses of antipsychotics are used for any symptom of delirium including: agitation,
combativeness, increased confusion, hallucination, delusion, illusion, or insomnia.
Nursing staff have also been trained on environmental and clinical interventions to
prevent delirium such as frequent re-orientation, maintenance of routine schedule,
encouraging use of glasses and hearing aids if available, and providing a calm environment
with minimal unnecessary stimuli.
Pharmacy and
Therapeutics
Committee Actions
Pharmacy Residents:
Class of
2012
Featured Drug:
Fidaxomicin
(Dificid®)
Shared Governance
Begins in
Pharmacy Department
Status of Drug
Shortages
2
2
3
4
4

Pharmacy and Therapeutics Committee Actions
Kate Rotzenberg, PharmD
From the May 25th meeting:
Additions from Dean Formulary: none
Additions to St. Mary’s Formulary:
• The commercial preparation of hydroxyprogesterone
caproate injection
will not be added to formulary.
Patients will continue to use their
own supply compounded by local
pharmacies.
• C1 esterase inhibitor (Cinryze®)
was added to formulary for treatment
of acute attack of hereditary angioedema.
MUE will be conducted in the
future to ensure appropriate usage.
Full monograph available on St.
Mary’s Intranet.
Drug Class Reviews
• Nasal Steroids: Therapeutic Interchange
approved to use fluticasone
propionate for majority of patients
and reserve budesonide for use by
pregnant or potentially pregnant patients.
Implementation date pending.
Policy Changes
• Argatroban, lepirudin, and magnesium
(for OB only) have been added
to the high-risk drug list requiring
dual sign-off.
• Updated Multi-dose and Single-dose
injectable container Policy.
From the July 27th meeting:
Additions from Dean Formulary:
• Lurasidone (Latuda®) - Tier 3
• Dextromethorphan/quinidine
(Nuedexta®) - Tier 2 with PA
Additions to St. Mary’s Formulary:
• Fidaxomicin (Dificid®) was added
to formulary, restricted to use by
Infectious Disease, for the treatment
of C. difficile infection. MUE is
planned in the future with focus on
readmission rates. Full monograph
available on St. Mary’s Intranet.
Drug Class Reviews
• Thiazide Diuretics: Therapeutic
Interchange substituting chlorthalidone
with hydrochlorothiazide was
removed based on review of literature.
Chlorthalidone 25 mg tablet
added to formulary. Full review available
on St. Mary’s Intranet and will
be featured in next newsletter.
Policy Changes
• Updated Monitoring of Refrigerator
Temperature Policy to reflect
changes due to Pharmacy remodel.
• Monitoring of Intravenous Haloperidol
Policy reviewed, approval pending
issue clarification.
• Approved Palivizumab per Pharmacy
order for qualifying infants requiring
long-term hospitalization.
Pharmacy Residents: Class of 2012
Kate Rotzenberg, PharmD
If you see these smiling faces around
the hospital, be sure to give them a
warm welcome. Our new pharmacy
residents, Jennifer Klink and Josh Rekoske,
joined our department at the
end of June and will soon be staffing
weekends on CVICU and 5E in addition
to their rotations throughout St. Mary’s.
Jennifer is a 2011 graduate of Creighton
University. She completed rotations
in community outreach/visiting
nurses and home health, drug information,
critical care, acute care, ambulatory
care, cardiology, and community
pharmacy during her fourth year of
pharmacy school. Jennifer is interested
in working on improving documentation
of pharmacist interventions
and is excited to be working with our
staff.
Josh is a 2011 graduate of UW-
Madison School of Pharmacy. During
his fourth year of pharmacy school, he
gained experience in
solid organ transplant
pharmacy, cardiac
ICU pharmacy,
pharmacy benefit
manager Navitus,
and community
pharmacy. Josh had
previously completed
a third-year
rotation at St. Mary’s
working with Randy
Binning in our Emergency
Department.
He is interested in
researching pharmacy
involvement in
discharge counseling
or medication education and potentially
the effect of this intervention on
readmission rates.
Let’s not forget last year’s excellent
resident class—Dominic Porcaro has
stayed on at St. Mary’s as a staff pharmacist
and Catie Brackin is a pharmacist
at Advocate Lutheran General Hospital
in Chicago, IL. We wish them the
best of luck as they move on in their
pharmacy careers.
Page 2
Pharmacy Newsletter

Featured Drug: Fidaxomicin (Dificid®)
Kate Rotzenberg, PharmD
The full monograph that was presented to the Pharmacy
and Therapeutics Committee can be found on St. Mary’s
Intranet under Policies and Procedures, Pharmacy, Pharmacy
& Therapeutics - Medication Summaries. Fidaxomicin
is initially restricted to use by Infectious Disease due to its
substantial cost. A medication use evaluation is planned
for the future to determine appropriate usage and effect on
readmission rates.
Therapeutic Class/Indication: Macrolide antibiotic for
treatment of Clostridium difficile infection
Dosing: 200 mg by mouth twice daily for 10 days
Administration and Storage: May be given with or without
food. Store at room temperature. Information on crushability
is pending.
Monitoring parameters: Clostridium difficile infection resolution
(number of loose stools, abdominal cramping, etc),
nausea/vomiting, rash
Adverse effects/interactions/contraindicated: No significant
drug interactions or contraindications. Do not use for
systemic infection, minimal absorption. Information on
cross-allergenicity is pending.
Similar adverse effects as oral vancomycin in trials: nausea
(11%), vomiting (7%), abdominal pain (6%), GI hemorrhage
(4%), anemia (2%), neutropenia (2%). Adverse effects occurring
in < 2% of patients: additional gastrointestinal disorders,
increased alkaline phosphatase, decreased bicarbonate,
increased hepatic enzymes, decreased platelets, hyperglycemia,
metabolic acidosis, drug eruption, pruritis,
rash.
Pregnancy category/lactation: Category B. No information
on lactation, use caution.
Pharmacokinetics:
• Absorption: Minimally absorbed, do not use for systemic
infections.
• Distribution: Confined to GI tract after oral administration.
After 10 days of dosing, fecal concentrations of
fidaxomicin and its metabolite are significantly higher
than plasma concentrations.
• Metabolism: Transformed by hydrolysis to main and
microbiologically active metabolite, OP-1118. OP-1118
is the predominant circulating compound at therapeutic
doses.
• Excretion: Mainly excreted in feces – more than 92%
of single dose recovered in stool.
Therapeutic efficacy:
In a randomized, controlled trial including 629 patients,
treatment with fidaxomicin resulted in equivalent cure rates
compared to treatment with oral vancomycin in adult patients
with mild-moderate Clostridium difficile infection.
Patients treated with fidaxomicin had significantly lower
recurrence rates compared to vancomycin, however there
was no difference between treatments in recurrence rates
for patients infected with the NAP1/027/BI strain (the
“Quebec” strain, considered hypervirulent). Patients infected
with any other strain of Clostridium difficile had significantly
lower recurrence rates with fidaxomicin compared
to vancomycin.
Due to the improved recurrence rate, patients treated with
fidaxomicin also had a significantly improved global cure
rate compared to vancomycin (clinical cure and no recurrence
within 28 days).
There was no significant difference in time to resolution of
diarrhea, although this was numerically shorter with fidaxomicin
treatment compared to vancomycin.
Comparative Cost of Therapy:
Fidaxomicin:
• $134.50 per dose = $2,689.96 per course of therapy
Metronidazole:
• 500 mg by mouth three times daily for 10 days
• $0.04 per dose = $1.20 per course of therapy
Vancomycin (FDA-approved for C. difficile-associated diarrhea):
• 125 mg by mouth four times daily for 10 days
• $1.69 per dose (using IV solution orally) = $67.60 per
course of therapy
Rifaximin “Chaser” (add-on therapy after completing course
of metronidazole or vancomycin to prevent recurrence):
• 400 mg by mouth twice daily for 14 days after standard
therapy (alternative regimen is three times daily for 21
days)
• $15.22 per dose = $426.16 per course of therapy
(twice daily for 14 days) in addition to standard therapy
Nitazoxanide (nonformulary, FDA approved for giardiasis
and cryptosporidiosis):
• 500 mg by mouth twice daily for 10 days
• $19.79 per dose = $395.80 per course of therapy
Estimated admission charge for C. difficile infection at St.
Page 3
Pharmacy Newsletter

Pharmacy
Editor: Kate Rotzenberg, PharmD
Drug Information Pharmacist
Katherine_Rotzenberg@ssmhc.com
700 S. Park St.
Madison, WI 53715
Phone: 608-258-6551
Fax: 608-258-5626
E
Shared Governance Begins in Pharmacy Department
Kate Rotzenberg, PharmD
The Pharmacy Coordinating Council met for the first time last
month to plan the roll out of the Councils: Operations; Patient
Care; and Quality, Education and Safety. The Coordinating
Council, consisting of the Chairs (right), Management, and Drug
Information, discussed the need for a strategic plan and how
the members of each Council should prepare for their roles over
the next few months.
The next steps will be to:
• Develop SharePoint with Catherine Powers; this is the
communication tool that will provide each member of the
department a voice in decisions
• Review preparatory materials (e.g. quality improvement
measures, impact of health care reform, etc) to determine
measurable goals for the department and inform the strategic
plan
• Begin developing a strategic plan with input from each
Council
Pharmacy WSSDM Councils:
• Coordinating Council: Facilitate the integration of the
other Councils, supporting the department’s strategic plan.
Chair: Donna Kieler
• Operations Council: Ensure the optimal use of human,
fiscal, physical, and material resources based on the strategic
plan, budget and best available evidence to support
the delivery of exceptional health care. Chair: John Brown
• Patient Care Council: Define and integrate a comprehensive
approach to exceptional health care services across
the continuum based on best practice and evidence-based
research. Chair: Randy Binning
• Quality, Education and Safety Council: Ensure the integration
of quality, safety, and education standards based
on best practices, utilizing research, and best available
evidence. Chair: Bobbi Aulie
Status of Drug Shortages
Kate Rotzenberg, PharmD
• Erythromycin injection is now available.
• Gentamicin injection is now available.
• Hyaluronidase injection continues to
be unavailable. For medications that
extravasate, continue to use the Extravasation
Policy on the intranet and
follow all steps without hyaluronidase.
• Ibuprofen lysine (Neoprofen®) is
on back order. Indomethacin injection
is being used as an alternative
for PDA closure in neonates.
• Many TPN compounding ingredients
including several IV electrolytes
are short in supply. TPN pharmacists
will adjust patient formulas to minimize
use of ingredients in short supply
when appropriate.
• Calcium gluconate: Extremely
low supply, reserved for use in
TPN and NICU preparations.
Other preparations will be substituted
with calcium chloride to
provide an equivalent amount of
elemental calcium.
• Cysteine: Used to compound
NICU TPN, none available but
estimated release date for one
manufacturer was late July 2011.
• Selenium: None available, no
published release date.
• Sodium acetate: Low supply,
on intermittent backorder and
released when available.
• Sodium phosphate: Low supply,
one manufacturer estimates
a release date of August 2011.
• Trace elements (adult): Low
supply, using alternative agent
which also has limited availability
• Vecuronium injection is on back
order. Cisatricurium is available.
• Vitamin A injection remains on back
order.
Please consult your pharmacist for questions
regarding
drug
shortages.
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Pharmacy Newsletter