Kaiser Permanente Georgia 1

u Formulary additions . . . . . .1

ISSUE 3 VOLUME 8 JUNE 2014

FormularyUpdateu medications reviewed at P&t, But not added to the Formulary . . . . . . . . . . . . . . 4

The medications below were added to the Qualified Health Plans Formulary effective June 17, 2014.

A PUBL ICAT ION OF THE GEORGIA PHARMACY AND THERAPEUT ICS (P&T) COMMITTEE . 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.

u clinical uPdate . . . . . . . . . 4

u Formulary deletions . . . . . .2

Formulary Additions

u new standing order . . . . . . .2

u new criteria restricted medications . . . . . . . . . . . . . 2

At A Glance

u aPProved comPound list revisions . . . . . . . . . . . . . . . 2

Medication Added

Fluocinonide 0.05% cream Buspirone hcl 15mg tab

Fluocinolone acetonide 0.1% scalp oil Nystatin powder 100,000 units/gm

Tobramycin neb solution 300mg/5 mL Aerochamber Plus Flow Mask

Tretinoin 0.1% cream Enbrel SureClick 50 mg/mL pen

Prednisolone 15mg/5mL syrup Enbrel 25mg/0.5mL prefilled syringes

Cholestyramine 4gm powder Urea 40% cream

Clobetasol propionate 0.05% cream Entacapone 200mg tab

u national medicare Part d Formulary . . . . . . . . . . . . . . 3

u Floorstock additions . . . . . 3

2 Kaiser Permanente Georgia

uPcoming Formulary items

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 July 28, 2014 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.

New Standing OrdersApproved 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.

Pharmacists working in Infusion/Oncology, under the authority of the prescribing Oncologist, will begin small dose rounding for specific chemotherapy infusions, if appropriate, via standing order effective July 1, 2014. A chemotherapy dose rounding policy applies to chemotherapy orders with doses that do not conform to the manufac-turer’s package size or that cannot be measured accurately. For these orders, pharmacists will begin rounding calculated doses up or down 5% for the purposes of 1) adjusting dose to vial size 2) adjusting dose to measurable volume.

Nystatin and triamcinolone acetonide (Mycolog II) cream and ointment will be removed from the Commercial Formulary effective August 6, 2014. Nystatin/triamcinolone ointment and cream are used for the treatment of cutaneous and mucocutaneous fungal infections caused by the candida species. For the treatment of cutaneous candidiasis, the Infectious Diseases Society of America

recommends using a topical antifungal agent, such as clotrimazole or nystatin, and adding on a topical corticosteroid, such as hydrocortisone or triamcinolone, if needed. Most mild to moderate inflammation associated with fungal infections may be resolved without the addition of a steroid component. There is no recommendation in favor of one antifungal or corticosteroid over another.

The cost of nystatin/triamcinolone ointment and cream has increased significantly to approximately 10 times the cost of using 2 separate over-the-counter or prescription products. In agreement with Dermatology’s recommendations, nystatin and triamcinolone remain available as single-ingredient topical products on the Commercial Formulary, however OTC clotrimazole 1% cream and hydrocortisone 1% cream may be used as a cost-effective alternative. KPGA Chief of Dermatology does not recommend routine steroid use when treating a fungal infection. Other Dermatology endorsed options include: OTC Lamisil cream for fungus, ketoconazole cream for yeast infection, or mupirocin ointment for bacterial infections.

Formulary Reviews (August 2014):

Medication class Reviews

Endocrine and metabolic agents - misc

Analgesics - non-narcotic

Analgesics - opioids

Analgesics - antiinflammatory

Vitamins

Multi-Vitamins

Minerals & electrolytes

Hematopoietic agents

Anticoagulants

Hemostatics

Otic

Mouth/Throat/Dental

Antiseptics & disinfectants

Diagnostic products

Skeletal muscle relaxants

Formulary Deletions

KPGA Approved Compound RevisionsOnly 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 medication listed below was removed from the List of Approved Compounds:

• Mupirocin 2 gm/45 mL nasal solutiono Bactroban Nasal 2% ointment should be prescribed as an alternative.

The approved compound listed below was revised:• Sildenafil (generic Revatio) 1.25mg/mL oral suspension, 120ml

o Viagra 25mg tablets cost 45 times as much as sildenafil (generic Revatio) 20mg tablets, and contain the same active ingredient. o The revised compounding recipe utilizes sildenafil (generic Revatio) 20mg tablets and the total volume of the suspension is 120ml. The final concentration remains the same, 1.25mg/ml.

New Crieria Restricted MedicationsCriteria restricted medications require review by Quality Resource Management (QRM) prior to coverage. The prior authorization process and criteria apply to all formularies 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 July 1, 2014.

• Farxiga 5 mg, 10 mg tablets

Kaiser Permanente Georgia 3

Questions and concerns?

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, BCPSClinical Pharmacy

Gary Beals, RPhDirector of Pharmacy

Karen Bolden, RN, BSNClinical Services

Deborah Burzotta, PharmDPharmacy Operations

Alyssa Dayton, MDObstetrics and Gynecology

Carole Gardner, MDElder Care

Patrice Gaspard, MDPediatrics

Marcus Griffith, MD*Behavioral Health

Donald Hanchett, MDAmbulatory Medicine

David Jones, MDPediatrics

Felecia Martin, PharmDPharmacy/Geriatrics

LaJune Oliver, MDAmbulatory Medicine

Rachel Robins, MDHospitalist

Designated Alternates:Jacqueline Anglade, MD

Obstetrics and Gynecology

Lesia Jackson, RNClinical Services

*Attend alternating meetings

National Medicare Part D FormularyKaiser 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 initial tier placements are listed below with the corresponding effective date.

Medication Name TierEffective

Date

Elosufase alfa (Vimizim) injection 5 mg/5 mL 5 4/1/2014

Apremilast (Otezla) tablet 30 mg and 5 4/1/2014

Tasimelteon (Hetlioz) capsules 20 mg; titration pack 10/20/30 5 5/6/2014

Droxidopa (Northera) capsule 100 mg, 200 mg and 300 mg 4 Pending

Miltefosine (Impavido) capsules 50 mg 4 Pending

Oralair SL tab 4 Pending

Albiglutide (Tanzeum) subcutaneous injection 30 mg 4 Pending

Ragwitek SL tab 4 Pending

Tier 1 = Value Generic Tier 3 = Brand Tier 5 = Specialty Tier 2 = Generic Tier 4 = Non-Preferred Brand Tier 6 = Injectable Part D Vaccine

National MPD 2014 Formulary tier changes are listed below with the corresponding effective date.

Medication Name TierEffective

Date

Cysteamine (Cystagon) capsule 50 mg, 150 mg 3 5/6/2014

Rimexolone (Vexol) 1% ophthalmic susp 3 5/6/2014

Medical Office Floorstock AdditionsThe medications below will be added to the electronic floorstock ordering forms on the intranet:

Department Name Medication Added

Urology Promethazine HCL 25mg suppositories

Oncology/Oncology Infusion Famotidine 20 mg

Ophthalmology Pyxis Machine Dehydrated Alcohol 98%, 5 ml vial

ACC & CDU Pyxis MachinesClindamycin 900 mg IV premix

Levofloxacin 750 mg IV premix

National MPD 2015 Formulary tier changes are listed below with the corresponding effective date.

Medication Name TierEffective

Date

Diastat AcuDial gel 5-10mg, 12.5-20mg, 2.5mg 3 1/1/2015

Androgel gel pump 1% 4 1/1/2015

Rebif Rebidose inj 22/0.5, 44/0.5 5 1/1/2015

Zubsolv sub 1.4-0.36, 5.7-1.4 4 1/1/2015

Armour thyroid tab 30mg 4 1/1/2015

Treprostinil (Orenitram) ER tablets 0.125 mg, 0.25 mg, 1 mg, 2.5 mg 4 1/1/2015

4 Kaiser Permanente Georgia

Clinical UpdatesFDA MedSafety Alert: Decreased Recommended Starting Dose of Eszopi-clone due to Next-Day Impairment. The U.S. Food and Drug Administration (FDA) issued a warning that Lunesta (eszopiclone), a medication used for insomnia, can cause next-day impairment of driving and other activities that require alertness. As a result, the recommended starting dose of Lunesta has been decreased to 1 mg at bedtime. A study of 91 patients between the ages of 25 and 40 years old found that the previously recommended Lunesta dose

of 3 mg at bedtime caused impairment to driving skills, memory, and coordination the morning after use. Impairment was most severe 7.5 hours after an evening dose, but lasted more than 11 hours post-dose. Patients were often unaware they were impaired, and women and men were equally susceptible to impairment.

Based on the results of this study, the recommended starting dose of Lunesta has been decreased to 1 mg for both men and women. The dose can be increased to 2 mg or 3 mg if needed, but higher doses are more likely to result in next-day impairment. Patients taking a 3 mg dose should be cautioned against driving or engaging in other activities that require complete mental alertness the day after use. The lowest effective dose should be prescribed, and patients should be advised that impairment from insomnia drugs can be present despite feeling fully awake.

FDA Drug Safety Communication: Pradaxa (dabigatran)- Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin. The U.S. Food and Drug Administration (FDA) recently completed a study in Medicare patients comparing the blood thinner Pradaxa to warfarin for risk of ischemic stroke, intracranial hemorrhage, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death in patients diagnosed with Atrial Fibrillation. The new study included a larger and more elderly patient population compared to previous trials assessing the safety and effi-cacy of dabigatran, and more than 134,000 Medicare patients were assessed. Results of this study showed that among new users of blood-thinning medications, dabigatran was associ-ated with an increased risk of major gastrointestinal bleeding, but a lower risk of ischemic stroke, intracranial hemorrhage, and death, compared to warfarin. The MI risk was similar for dabigatran and warfarin.

This study’s findings, except with regard to MI, are consistent with previous clinical trial results comparing dabigatran and warfarin. In the RE-LY trial, an increased risk of MI was observed for dabigatran compared to warfarin. As a result of these findings, the FDA con-siders Pradaxa (dabigatran) to have a favorable benefit to risk profile and has not made any changes to the current medication label or recommendations for use.

Medications Reviewed, but Not Added to the Formulary• Bromocriptine Quick-Release [QR] (Cycloset) 0.8 mg tablets, decision pending for the

National MPD Formulary

additional clinical alerts

FDA Drug Safety Communication: FDA requires label changes to warn of rare but serious neurologic problems after epidural corticosteroid injections for

painhttp://www.fda.gov/Drugs/DrugSafety/

ucm394280.htm

Drug Safety Labeling Changeshttp://www.fda.gov/Safety/MedWatch/

SafetyInformation/ucm396456.htm