KPGA Formulary Update August 2012

u Formulary Additions . . .
u Medicare Formulary . . . .
u New Standing Orders . . .
u Floorstock Additions . . .
u Policy Reminders . . . . . . .
u Spacer Devices . . . . . . . . .
u Clinical Updates . . . . . . .
u Medications Reviewed At
ISSUE 4
1
2
2
2
3
3
4
P&T, But Not Added To The
Formulary . . . . . . . . . . . . . 4
V O LU M E 6
AU G U S T 2 0 1 2
Formulary
Update
A P U B L I C AT I O N O F T H E G E O R G I A P H A R M A C Y A N D T H E R A P E U T I C S ( P & T )
C O M M I T T E E . The Formulary Update contains information regarding formulary additions,
deletions, exclusions, brief descriptions of products, and current drug related news. It also lists items
to be discussed at upcoming P&T meetings. Please refer to the web site http://kpnet.kp.org:81/ga/
healthcare/formularies.html or providers.kp.org for the full KP GA Drug Formulary. If you have
Lexi-Comp PDA access to the KPGA Online Formulary, remember to sync
your device for the most current
information.
Formulary Additions
Montelukast (generic Singulair) 4 mg & 5 mg chewable
tablets and 10 mg tablets are currently available on the
National MPD Formulary as Tier 2, generic, and were
added to the Commercial Formulary effective August 21,
2012. Montelukast is a leukotriene receptor agonist (LTRA) FDA
approved for the prophylaxis and chronic treatment of asthma,
prevention of excercise-induced bronchospasm (EIB), and relief
of symptoms of allergic rhinitis. Inhaled corticosteroids (ICS) remain the preferred first
line treatment option for asthma. Montelukast may be appropriate for use in patients
with mild asthma who are unable to tolerate or who have contraindications to ICS
therapy. Additionally, montelukast is an option of add-on therapy to an ICS in patients
with persistent asthma who are not controlled with low- to medium-dose ICS. For
allergic rhinitis, nasal corticosteroids remain the first line treatment option as they are
the most effective medication for controlling symptoms of allergic rhinitis.
Avonex (interferon beta-1a) 30 mcg Pen Kit is currently
available on the National MPD Formulary as Tier 5, specialty,
and was added to the Commercial Formulary effective August
21, 2012. Avonex is FDA approved for the treatment of relapsing forms
of multiple sclerosis. Avonex 30 mcg prefilled syringe is currently available
on the Formulary. Avonex Pen Kit is a self-contained administration
device that delivers a set dosage of the medication available for the same
contracted price as the Avonex prefilled syringe. Extavia (interferon beta-1b) remains
the preferred formulary treatment option for relapsing forms of multiple sclerosis.
Ofloxacin 0.3% otic solution is currently available on
the National MPD Formulary as Tier 5, specialty, and
was added to the Commercial Formulary effective
July 11, 2012. Ofloxacin otic solution is FDA approved for the
treatment of otitis externa, chronic suppurative otitis media, and
acute otitis media. Ofloxacin ophthalmic solution remains on
the formulary. Ofloxacin otic solution recently became available
generically. It is comparable in price to the ophthalmic solution and is now also
available on the formulary.
Page 1
National Medicare Part D Formulary
Kaiser Permanente has a National Medicare Part D (MPD) Formulary. Each regional P&T
Committee reviews drugs and decides on tier status Regional P&T chairs are voting members of an
interregional committee that addresses the relatively few drugs for which regional decisions differ.
This committee is called MPD Formulary Reconciliation Committee (MPD FoRCe). MPD FoRCe
resolves differences in formulary decisions. Regional P&T chairs convey the decision(s) back to
their respective regional P&T Committees to finalize the National MPD Formulary decision(s).
U pcoming
F ormulary
D ecisions
National MPD Formulary Tier changes are listed below with their corresponding
effective date:
Medication Name
Tier
Effective Date
Deleted -- Product
Discontinued
Pending
Rilpivirine HCL (Edurant) 25 mg tablet
Tier 3
07/03/2012
Levetiracetam NaCl 5 mg/ml, 10 mg/ml, & 15 mg/
ml solution
Tier 3
07/03/2012
Etravirine (Intelence) 25 mg tablet
Tier 3
07/03/2012
Mebendazole 100 mg chewable tablets
Tier 1 = Value Generic
Tier 2 = Generic Tier 3 = Brand
Tier 4 = Non-Preferred Brand Tier 5 = Specialty
Tier 6 = Injectable Part D Vaccine
New Standing Orders
Approved standing orders are written instructions issued by medical practitioners, in accordance
with the regulations, authorizing pharmacy personnel at pharmacies owned or operated by Kaiser
Foundation Health Plan to supply and administer specified medications under circumstances
specified in the order.
Sulfacetamide/Sulfur Wash Substitution: Prascion (sulfacetamide/sulfur) 10-5% wash is
on manufacturer back order with no estimated release date. Zencia (sulfacetamide/sulfur) 9-4%
wash is an acceptable therapeutic alternative per the TSPMG Chief of Dermatology. Since Prascion and Zencia are not therapeutic alternatives, a standing order was developed to aid in the
substitution of the two products.
QVAR 40 mcg to QVAR 80 mcg: A standing order has been developed to convert patients
currently taking QVAR 40 mcg 2 to 4 puffs to QVAR 80 mcg 1 to 2 puffs. With this conversion, patients would remain on an equivalent dosage of the medication, but would be taking fewer puffs
per dose. Since both QVAR inhalers contain 120 puffs, conversion to fewer puffs of the higher
concentration will result in additional doses available per canister for the same co-payment.
Epzicom and Trizivir Substitution: Abacavir (generic Ziagen) recently became available on
the market and is available to members for a generic co-payment. Epzicom (abacavir/lamivudine)
and Trizivir (abacavir/lamivudine/zidovudine) are combination antiretroviral regimens which are
only available as branded products. A standing order was endorsed by the TSPMG Chief of Infectious Disease and approved by the P&T committee in which Epzicom and Trizivir patients will be
converted from the branded combination products to the equivalent generic products. Patients
will be paying two lower cost generic co-payments for the medications instead of one higher cost
brand co-payment. With the standing order, patients taking Epzicom (abacavir/lamivudine) once
daily would be converted to abacavir once daily PLUS lamivudine once daily. Patients taking Trizivir (abacavir/lamivudine/zidovudine) twice daily would be converted to abacavir twice daily PLUS
lamivudine/zidovudine twice daily.
An important aspect of the
formulary
process
is
the
involvement of all practitioners.
So that each of you has an
opportunity to participate in the
process, upcoming P&T agenda
items are listed below. Please
contact your P&T Committee
representative or your clinical
service chief by September 15, 2012
if you wish to comment on any
of the medications, class review,
or other agenda items under
consideration. To make formulary
addition requests, you must submit
a Formulary Additions/Deletions
Form and Conflict of Interest Form
to Drug Information Services or call
(404) 949-5331.
Formulary Reviews
(October 2012):
• Formulary status of the
following medications will be
reviewed: Arcapta Neohaler,
Combivent
Respimat,
&
Tudorza Pressair
Medication Class Reviews
Laxatives
Antidiarrheal
Antacids
Ulcer drugs
Medical devices
Antidotes
Cardiotonics
Medical Office Floorstock Additions
The medications below will be added to the electronic floorstock ordering forms on the intranet:
Page 2
Department Name
Medication Added
Rheumatology
Methylprednisolone 80 mg/ml, 1 ml vial
Urology
Botox DS 200 unit vial
Estrogens
Oral Contraceptives
Progestins
Oxytocics
Vaginal Products
Chemicals
Q uestions and
C oncerns ?
If you have any questions or
concerns, please contact any of the
following P&T Committee members
and designated alternates:
P&T Chair:
Daniel Lee, MD, FACS
Physician Program Director of
Pharmacy
P&T Committee Members:
Seeme Ahmad, MD*
Behavioral Health
Marcus Griffith, MD*
Behavioral Health
Debbi Baker, PharmD, BCPS
Clinical Pharmacy
Gary Beals, RPh
Director of Pharmacy
Policy Reminder: Pharmaceutical Sales
Representatives
The Pharmaceutical Sales Representative (PSR) policy is intended to clarify the relationship between Kaiser and PSRs and ensure the accountability of PSRs in KPGA medical facilities. Below are
reminders of key points from the policy:
• No PSR is allowed to meet with on the property of any KPGA medical facility
• Sampling of any drug products, including OTC products, is prohibited in KPGA medical offices. Samples of limited wound care supplies and pediatric formulas are permitted, but the
department is responsible for meeting all regulatory and storage requirements.
• Participation in external surveys or questionnaires, with or without compensation, that seek
information on prescribing practices at KPGA is prohibited.
• Preprinted prescription blanks, stickers and rubber stamps are discouraged and require approval by the P&T Chair prior to use.
• Any industry developed patient education or other literature must be made available to the
drug information specialist and requires review and approval prior to distribution.
Spacer Devices
The best way to get the most medication from a metered dose inhaler (MDI) is with the use of a
spacer. Spacers are recommended for use in all patients who are unable to demonstrate excellent
MDI technique. Spacers are available with a mouthpiece or mask. For patients who are unable to
hold the spacer with mouthpiece, a mask spacer may be needed. The mask spacers are available
in small (0-18 months), medium (1-5 years) and large (>5 years) to accommodate patients of different ages and sizes. Patients should be transitioned to a mouthpiece spacer as soon as they are
able, generally around 5 years of age. However, some patients may be adverse to using the mask
after the age of 2 and may need education on how to properly use the device without the mask.
Providers can include instructions on how to use an MDI in the After Visit Summary by entering
the .piinhaler or .pimdi dotphrase.
Spacers are available from the KP outpatient pharmacies for a co-payment. A prescription is required for a spacer to be dispensed from the pharmacy. The spacer can be ordered on its own or
within a panel in conjunction with an MDI. Please see screen shot below of order panels available
in KPHC.
Karen Bolden, RN, BSN
Clinical Services
Deborah Burzotta, PharmD
Pharmacy Operations
Alyssa Dayton, MD
Obstetrics and Gynecology
Carole Gardner, MD
Elder Care
Patrice Gaspard, MD
Pediatrics
LaJune Oliver, MD
Ambulatory Medicine
Donald Hanchett, MD
Ambulatory Medicine
David Jones, MD
Pediatrics
Felecia Martin, PharmD
Pharmacy/Geriatrics
Susan Moon, MD
Hospitalist
To Use a Spacer:
1. Shake the inhaler well before use (3-4 shakes)
2. Remove the cap from your inhaler, and from your spacer, if it has one
3. Put the inhaler mouthpiece into the spacer
4. Breathe out, away from the spacer
5. Bring the spacer to your mouth, put the mouthpiece between your teeth and close your lips
around it
6. Press the top of your inhaler once
7. Breathe in very slowly until you have taken a full breath. If you hear a whistle sound, you are
breathing in too fast. Slowly breath in.
8. Hold your breath for about ten seconds, then breath out.
*Attend alternating meetings
Designated Alternates:
Jacqueline Anglade, MD
Obstetrics and Gynecology
Lesia Jackson, RN
Clinical Services
Page 3
Clinical Updates
MedSafety Alert: Ondansetron (Zofran) IV - QT Prolongation. Preliminary results from a
recently completed clinical study suggest that a 32 mg single IV dose of ondansetron may affect
the electrical activity of the heart (QT interval prolongation), which could pre-dispose patients to
develop an abnormal and potentially fatal heart rhythm known as Torsades de Pointes.”
N ew KPGA
A pproved
C ompounds
The ondansetron label has been revised removing the 32 mg single intravenous dose. Additionally, the revised label states that ondansetron can continue to be used in adults and children with
chemotherapy-induced nausea and vomiting at the lower intravenous dose recommended in the
drug label, a dose of 0.15 mg/kg administered every 4 hours for three doses; however, no single
intravenous dose should exceed 16 mg.
Recommendations: The new FDA information on QT prolongation does not change any of the oral
dosing regimens for ondansetron.
• The use of a single 32 mg IV dose of ondansetron should be avoided and no single IV dose of
ondansetron should exceed 16 mg.
• Patients who may be at particular risk for QT prolongation with ondansetron are those with
congenital long QT syndrome, congestive heart failure, bradyarrhythmias, or patients taking
concomitant medications that prolong the QT interval.
• Electrolyte abnormalities should be corrected prior to the infusion of ondansetron.
MedSafety Alert: Finasteride (Proscar & Propecia) - Persistent Sexual Side Effects after Discontinuation of Therapy. Changes have been made to the labels for Propecia (finaste-
ride 1 mg) and Proscar (finasteride 5 mg) to include the list of sexual adverse events reported to
FDA as some of these events have been reported to continue after the discontinuation of therapy.
The new label changes include:
• A revision to the Propecia label to include libido disorders, ejaculation disorders, and orgasm
disorders that continued after discontinuation.
• A revision to the Proscar label to include decreased libido that continued after discontinuation
of the drug.
• A revision to both the Propecia and Proscar labels to include a description of reports of male
infertility and/or poor semen quality that normalized or improved after drug discontinuation.
The most recent changes to the labels were influenced by postmarketing reports of sexual dysfunction that were submitted to the FDA. Sexual side effects were reported by patients during
clinical trials and this information was included in drug labels at the time of FDA approve. These
side effects resolved in patients who stopped finasteride, as well as in most patients who continued
therapy. In 2011, both Proscar and Propecia’s labels were revised to include erectile dysfunction
that continued after drug discontinuation.
A small study published in 2012 by Dr. Michael S. Irwig in the Journal of Sexual Medicine reported
the duration of sexual dysfunction in 54 men, who at baseline, were already experiencing three
or more months of sexual dysfunction after the discontinuation of finasteride (Propecia) for male
pattern hair loss (MPHL). The mean duration of finasteride use in this cohort had been 23 months
at doses ≤ 1.25 mg. Following assessment after a 9-16 month period, persistent sexual side effects
were reported by 20% of patients lasting for a total of six or more years, 19% for three to five years,
44% for one to two years, and the remainder for less than one year.
Recommendations: Healthcare professionals who prescribe finasteride should be aware of these
potential adverse effects and include them in a discussion of risk versus benefits when determining the best treatment option for the patient. Additionally, patients should be made aware of the
potential adverse effects of this medication.
Medications Reviewed, but Not Added to the Formulary
• Rivaroxaban (Xarelto) 10 mg, 15 mg, & 30 mg tablets, not added to the Commercial Formulary,
decision pending for the National MPD Formulary
• Deferiprone (Ferriprox) 500 mg tablet, not added to the Commercial Formulary, decisions
pending for the National MPD Formulary
• Ingenol mebutate (Picato) 0.05% & 0.015% topical gel, not added to the Commercial Formulary,
decision pending for the National MPD Formulary
• Rifapentine (Priftin) 150 mg tablet, not added to the Commercial Formulary, decision pending
for the National MPD Formulary
• Tafluprost (Zioptan) 0.0015% ophthalmic solution, not added to the Commercial Formulary,
decision pending for the National MPD Formulary
• Pertuzumab (Perjeta) injection, decision pending for the National MPD formulary
Page 4
Only medications on the List of
Approved Compounds may be
prepared at Kaiser Permanente
Pharmacies. The Approved list
of Compounds and recipes
are posted on the intranet
under Healthcare Delivery/
Pharmaceutical
Services/
Compounds.
The sterile compounds listed
below were recently added
to the KPGA list of approved
compounds. Sterile compounds
can only be prepared at our
Gwinnett and TownPark Facilities.
Ophthalmic Solutions
•Amikacin 25 mg/ml, 10 ml
•Amphotericin B 2 mg/ml, 10 ml
•Cefazolin 50 mg/ml, 15 ml
•Ceftazidime 50 mg/ml, 10 ml
•Fluorouracil 10 mg/ml, 5 ml
•Mitomycin 0.2 mg/ml, 10 ml
•Mitomycin 0.4 mg/ml, 10 ml
•Tobramycin 1.4%, 7 ml
•Vancomycin 25 mg/ml, 15 ml
•Vancomycin 50 mg/ml, 15 ml
Ophthalmic injections
•Amikacin 0.4 mg/0.1 ml
•Amphotericin 5 mcg/0.1 ml
•Ceftazidime 2.25 mg/0.1 ml
•Fluorouracil 10 mg/0.2 ml
•Vancomycin 1 mg/0.1 ml
Nasal drops
•Amphotericin B 5 mg/ml, 10 ml
•Mupirocin 2 gm/45 ml, 45 ml