October Formulary Update

ISS U E 5
u Formulary Deletions . . . . . . 1
u New Criteria Restricted
Medications . . . . . . . . . . . . . 1
u New Standing Order . . . . . . 2
u Floorstock Additions . . . . . 2
u National Medicare Part D
Formulary . . . . . . . . . . . . . . 3
u Lexi-Comp Consumer
Formulary . . . . . . . . . . . . . . 3
u Clinical Update . . . . . . . . .
4
VOLUME 7
OCTOBER 2013
Formulary
Update
Formulary Deletions
Donnatal tablets and elixir will be removed from
the Commercial Formulary effective November
6th, 2013. Donnatal is indicated as adjunctive therapy
in the treatment of irritable bowel syndrome, acute
enterocolitis, and duodenal ulcers. Donnatal has not been found by the FDA to
be safe and effective. Donnatal is a Drug Efficacy Study Implementation (DESI)
drug which is a medication entering the market between 1938 and 1962 that
was approved for safety but not effectiveness, and is excluded from Medicare
Coverage. Other lower cost alternatives on the Commercial Formulary include
dicyclomine (generic Bentyl), hyoscyamine (generic Levsin), chlordiazepoxide
and clidinium (generic Librax). Backoffice Donnatal will still be available. When
ordering the GI cocktail in KP HealthConnect both options are available: GI
Cocktail (Mylanta:Lidocaine) and GI cocktail (Mylanta: Donnatal:Lidocaine).
New Crieria Restricted Medications
A P U B L I C AT I O N O F T H E G E O R G I A
PHARMACY AND THERAPEUTICS (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.
Criteria restricted medications require review by Quality Resource Management
(QRM) prior to coverage. The prior authorization process and criteria applies to
all benefits except the Medicare Part D Formulary. Providers must call QRM to
request authorization consideration at 404-364-7320. A complete listing of prior
authorization medications and their corresponding criteria is available on the
intranet under Healthcare Delivery/Guides & References/Formularies/Criteria
Restricted (QRM) Medications.
The following medication will be added to the list of Criteria Restricted
Medications (QRM) effective November 1st, 2013.
• Procysbi (cysteamine delayed release) 25 mg, 75 mg
capsules
Kaiser Permanente Georgia
1
New Standing Orders
Approved standing orders are written instructions issued by medical practioners, 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.
Viagra, Levitra, Staxyn, and Cialis will be changed to sildenafil (generic Revatio) 20 mg
tablets via standing order for treatment of erectile dysfunction (ED) effective November 1st, 2013.
While generic Revatio is FDA approved for the treatment of pulmonary arterial hypertension, generic Revatio contains the same active ingredient, sildenafil, as Viagra. Sildenafil,
vardenafil and tadalafil are all PDE5 inhibitors used for treatment of ED and are generally
considered comparable in efficacy and safety. They also have similar side-effect profiles
including headache, flushing, rhinitis, and dyspepsia and they are all contraindicated for
individuals taking nitrates. Patients will be allowed to obtain up to 100 20mg doses of sildenafil, which is equivalent to 20 100 mg tablets of Viagra.
Medical Office Floorstock Additions
The medications below will be added to the electronic floorstock ordering forms on the
intranet:
Department Name
Medication Added
Urgent Care
Dextrose 50%, 50 mL syringe
Glucose gel 15 gm
Wond Care
Chlorhexidine topical 4 oz bottle
Procedure Suite Pyxis
Normal saline flush 12 mL syringe
Erythromycin 5 mg/mL ophthalmic ointment
Lidocaine 4% topical solution
Artificial tears 0.5% ophthalmic solution
Artificial tears 0.5% ophthalmic ointment
Clindamycin 600 mg/50 mL D5W premix
Heparin 10 unit/mL IV syringe, 5 mL
Bupivacaine-epinephrine 0.5%-1:200,000 injection solution
Chloroprocaine 2% injection solution, 20 mL
Urology
Testopel 75 mg implant
Interventional
Radiology
Albumin 25%
Orthopedics
2 Kaiser Permanente Georgia
Sodium Chloride 0.9% irrigation solution, 1000 mL
Chlorhexidine topical 4 oz bottle
SureStep Pro #50 test strips
SureStepPro high control solution
SureStepPro low control solution
Bupivacaine 0.25%, 10 ml vial
Bupivacaine-epinephrine 0.25%-1:200,000, 10 ml vial
Bupivacaine-epinephrine 0.5%-1:200,000, 10 ml vial
Dexamethasone 10 mg/ml, 1 ml vial
Dexamethasone 10 mg/ml, 10 ml vial
Supartz 25 mg syringe
Ketorolac 30 mg/ml, 1 ml vial
Ketorolac 30 mg/ml, 2 ml vial
LMX 4% Cream plus
Lidocaine-Epinephrine 1%-1:200,000, 10 ml vial
Lidocaine-Epinephrine 2%-1:200,000, 10 ml vial
Methylprednisolone acetate 80 mg/ml, 1 ml vial
Silver sulfadiazine 1% cream, 20 gm tube
Sodium chloride 0.9%, 10 ml vial
Triamcinolone acetonide 40 mg/ml, 1 ml vial
U pcoming
F ormulary
D ecisions
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 November 24,
2013 if you wish to comment
on any of the medications, class
reviews, 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
(December 2013):
Medication Class Reviews
Vaccines
Antihistamines
Nasal agents
Cough/Cold/Allergy
Respiratory
Antianginal
Beta blockers
Calcium channel blockers
Antiarrhythmics
Antihypertensives
Diuretics
Vasopressors
Antihyperlipidemics
Misc. cardiovascular agents
Compounds
Q uestions and
C oncerns ?
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. The National Medicare Part D
Pharmacy and Therapeutics Committee is charged with reconciling regional differences in
MPD Formulary recommendations through consensus building in order to maintain one
National MPD Formulary for Kaiser Permanente.
National MPD Formulary intial tier placements are listed below with the
corresponding effective date.
Tier
Effective
Date
Perampanel (Fycompa) 2 mg, 4 mg, 6 mg, 8 mg,10 mg, 12 mg
tablets 4
Pending
Levomilnacipran (Fetzima) 40 mg, 80 mg, and 120 mg capsules
5
Pending
Dolutegravir (Tivicay) 50 mg tablets
4
Pending
Mechlorethamine (Valchlor) topical gel
5
Pending
Afatinib (Gilotrif) 20 mg, 30 mg, 40 mg tablets
5
8/27/2013
Medication Name
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
Debbi Baker, PharmD, BCPS
Clinical Pharmacy
Gary Beals, RPh
Director of Pharmacy
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
Marcus Griffith, MD*
Behavioral Health
Donald Hanchett, MD
Ambulatory Medicine
David Jones, MD
Pediatrics
Felecia Martin, PharmD
Pharmacy/Geriatrics
LaJune Oliver, MD
Ambulatory Medicine
Rachel Robins, MD
Hospitalist
Designated Alternates:
Jacqueline Anglade, MD
Obstetrics and Gynecology
Lesia Jackson, RN
Clinical Services
Tier 1 = Value Generic
Tier 2 = Generic Tier 3 = Brand
Tier 4 = Non-Preferred Brand Tier 5 = Specialty
Tier 6 = Injectable Part D Vaccine
National MPD Formulary tier changes are listed below.
Medication Name
Tier
Darunavir (Prezista) 75 mg tablet
3
Raloxifene (Evista) 60 mg tablet
3
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 Consumer Commercial Drug Formulary
Available Online Through Lexi-Comp
The Kaiser Permanente Georgia Region Consumer Drug Formulary
is available on kp.org courtesy of Lexi-Comp. Members can search
for drugs by brand or generic names. Only drugs on the Commercial
Formulary are listed in the Consumer Formulary.
Members can access the online Consumer Drug Formulary at http://
kp.org/formulary, by clicking on the link “Find out what drugs are covered in your area”,
selecting the Georgia Region and then clicking the link named “Search our online drug
formulary.” Through the Consumer Drug Formulary, members are able to see dosage
forms that are on the Commercial Formulary, along with pharmacological category, generic
availability, and brand and generic names.
The Kaiser Permanente drug formulary information contained in the Consumer Formulary
is updated bimonthly to reflect formulary changes approved by the Georgia Regional
Pharmacy and Therapeutics Committee.
Medications Reviewed, but Not Added to the Formulary
• Alogliptin (Nesina), alogliptin and metformin (Kazano), and alogliptin and pioglitazone
(Oseni), decision pending for the National MPD Formulary
• Apixaban (Eliquis) 2.5 mg and 5 mg tablets, not added to the Commercial Formulary;
decision pending for the National MPD Formulary
• Bedaquiline (Sirturo) 100 mg tablet, not added to the Commercial Formulary; decision
pending for the National MPD Formulary
• Ospemifene (Osphena) 60 mg tablet, not added to the Commercial Formulary;
decision pending for the National MPD Formulary
• Varicella Zoster Immune Globulin (Human) (VariZIG) 125 units, not added to the
Commercial Formulary; decision pending for the National MPD Formulary
*Attend alternating meetings
Kaiser Permanente Georgia
3
Clinical Updates
FDA Drug Safty Communication: FDA requires label changes to warn
of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection
The U.S. Food and Drug Administration (FDA) has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be
updated to better describe the serious side effect of peripheral neuropathy. This serious nerve damage potentially caused by fluoroquinolones
may occur soon after these drugs are taken and may be permanent.
The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth
or by injection. The topical formulations of fluoroquinolones are not known to be associated
with this risk.
The FDA recommends patients should inform their healthcare providers if they develop
symptoms of peripheral neuropathy (pain, burning, tingling, numbness, and/or weakness).
If a patient develops these symptoms, they should discontinue the fluoroquinolone and be
switched to another non-fluoroquinolone antibacterial medication, unless the benefit of
continued treatment with a fluoroquinolone outweighs the risk. All patients should receive
the Medication Guide with every prescription.
According to a report, Antibiotics Losing Battle Against Bugs, in the Wall Street Journal,
more than two million people in the U.S. develop infections every year that are resistant to
antibiotics, and at least 23,000 of them die as a result. One of the reasons for greater resistance to antibiotics includes excessive antibiotic use. The CDC calls for more judicious use
of antibiotics and better surveillance of resistant bacteria to avoid prevent such complications.
FDA MedSafety Alert: Arzerra (ofatumumab) and Rituxan (rituximab):
New Boxed Warning, Recommendations to Decrease Risk of Hepatitis
B Reactivation.
FDA approved changes to the prescribing information of the immunesuppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan
(rituximab), creating a new Boxed Warning for Arzerra and amending the
Boxed Warning for Rituxan with information about the risk of reactivation of hepatitis B virus
(HBV) infection. The revised labels also will include additional recommendations for screening, monitoring, and managing patients on these drugs to decrease this risk. In patients
with prior HBV infection, HBV reactivation may occur when the body’s immune system is
impaired. HBV reactivation has occurred in patients with prior HBV exposure who are later
treated with drugs classified as CD20-directed cytolytic antibodies, including Arzerra and
Rituxan. Some cases have resulted in fulminant hepatitis, hepatic failure, and death.
The FDA recommends that health care professionals: screen all patients for HBV infection
before starting treatment with Arzerra or Rituxan by measuring hepatitis B surface antigen
(HBsAg) and hepatitis B core antibody (anti-HBc), consult with hepatitis experts regarding
monitoring and use of HBV antiviral therapy when screening identifies patients at risk of
HBV reactivation due to evidence of prior HBV infection, monitor patients with evidence of
prior HBV infection for clinical and laboratory signs of hepatitis B or HBV reactivation during
Arzerra or Rituxan therapy and for several months thereafter, since reactivations have occurred several months following completion of therapy with these drugs.
In patients who develop reactivation of HBV while on Arzerra or Rituxan, immediately
discontinue the drug and start appropriate treatment for HBV. Also discontinue any chemotherapy the patient is receiving until the HBV infection is controlled or resolved. Because of
insufficient data, no recommendation can be made regarding the resumption of Arzerra or
Rituxan in patients who develop HBV reactivation hepatitis.
4 Kaiser Permanente Georgia
A dditional
C linical A lerts
Important information on Duragesic
(fentanyl) Patches packaging changes
to minimize risk of accidental exposure
http://www.fda.gov/Safety/
MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/
ucm369457.htm?source=govdelivery&utm_
medium=email&utm_source=govdelivery
New boxed warning describing risk of
death when intravenous Tygacil is used.
http://www.fda.gov/Safety/
MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/
ucm370170.htm?source=govdelivery&utm_
medium=email&utm_source=govdelivery