Kaiser Permanente Georgia 1

u Formulary additions . . . . . .1

ISSUE 7 VOLUME 8 FEBRUARY 2014

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

Tobramycin (generic Tobi) 300 mg/5 mL oral inhalation solution will be added to the Commercial Formulary effective March 19, 2014. Tobramycin is an aminoglycoside antimicrobial that is indicated for the management of cystic fibrosis patients with P. aeruginosa. Tobramycin inhalation solution has

been shown to be non-inferior in lung function improvement and resulted in lower incidence of cough, dysphonia, and dysgeusia compared to tobramycin inhalation powder (Tobi Podhaler) when used twice daily for three 28-day treatment cycles in cystic fibrosis patients. Tobramycin inhalation solution is a cost-effective treatment option compared to Tobi Podhaler.

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

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

u Floorstock additions . . . . .3

Etanercept (Enbrel) 25 mg/0.5 mL prefilled syringe will be added to the Commercial Formulary effective March 19, 2014. Enbrel is a tumor necrosis factor blocking agent indicated for use in moderate to severe rheumatoid arthritis, moderate to severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, moderate to severe plaque psoriasis, and active ankylosing spondylitis. Enbrel 25 mg/0.5 mL prefilled syringe is now available as an alternative to the Enbrel dosage forms currently available on the Commercial Formulary, which include the 50 mg/mL SureClick prefilled syringe and 25 mg/mL vial.

Formulary Additions

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

u national medicare Part d negative changes . . . . . . . . . 3

u aPPendix a: coBB county dePartment Floorstock list . . 5

At A Glance

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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 March 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 OrderApproved 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. Doxazosin (generic Cardura) will be changed to terazosin (generic Hytrin) via stand-ing order. Terazosin is an alpha-1 adrenergic receptor blocker that provides comparable efficacy to the other agents in this class at the therapeutically equivalent dosages. Doxa-zosin and terazosin also have a similar side effect profile including headache, fatigue, edema, dyspnea, and orthostatic hypotension.

Tamoxifen (generic Nolvadex) 20 mg tablets will be changed to equivalent doses of tamoxifen 10 mg tablets via standing order. Tamoxifen is a selective estrogen receptor modulator indicated for the treatment and prevention of breast cancer. There is currently a national shortage on tamoxifen 20 mg tablets. In response to this shortage, patients will be converted to an equivalent tamoxifen dose using 10 mg tablets (20 mg = 2 x 10 mg). Patients should be counseled about the change in dosing instructions. Once supplies return to normal, the patient will be switched back to 20 mg tablets.

One Touch Ultra 2 meter, test strips, and B-D insulin syringes will be added to the Qualified Health Plan Formulary effective March 19, 2014. The One Touch Ultra 2 meter, test strips, and B-D insulin syringes are indicated for blood glucose testing and insulin administration in diabetic patients. They are currently the preferred formulary diabetes testing and insulin administration supplies at Kaiser Permanente.

Doxazosin (generic Cardura) 2 mg and 8 mg tablets will be removed from the Commercial Formulary effective April 16, 2014. The effective date for the removal of the 1 mg and 4 mg tablets is pending. According to the American Urological Association guidelines on management of BPH, there are slight differences in the adverse event profiles of alfuzosin, doxazosin, tamsulosin and terazosin, but their expert Panel believes that all four agents have equal clinical effectiveness in the treatment of lower urinary tract symptoms secondary to BPH. The cost of doxazosin has significantly increased and there are more cost-effective agents for the treatment of BPH available on the Commerical Formulary including terazosin (generic Hytrin), prazosin (generic Minipress), tamsulosin (generic Flomax), and finasteride (generic Proscar).

Doxycycline hyclate 100 mg tablets and 50 mg and 100 mg capsules will be removed from the Commercial Formulary effective March 19, 2014. Due to the nationwide shortage of doxycycline, both the doxycycline hyclate and monohydrate dosage forms were maintained on formulary. Supplies have now stabilized and the doxycycline monohydrate dosage form will be the preferred formulary agent. Both doxycycline hyclate and monohydrate are equally effective and doxycycline monohydrate may potentially have reduced side-effects compared to doxycycline hyclate. A standing order will be emplaced to convert patients from doxycycline hyclate to doxycycline monohydrate.

Formulary Reviews (April 2014):

Medication class Reviews

Antiemetics

Digestive aids

Gastrointestinal agents - misc

Dietary products/dietary management products

Pharmaceutical adjuvants

Gout agents

Corticosteroids

Androgen/anabolic

Antidiabetics

Thyroid

Antineoplastics

Ophthalmic agents

Amphetamine and dextroamphetamine mixed salts extended release (generic Adderall XR) 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg capsules will be added to the Qualified Health Plans (QHP) Formulary effective

March 19, 2014. Amphetamine and dextroamphetamine ER capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) and narcolepsy. Amphetamine and dextroamphetamine ER capsules offer a convenient one time daily dosing compared to twice to three times daily dosing with the immediate release tablets, which is also on the QHP formulary.

Pilocarpine 5 mg tablets (generic Salagen) will be added to the Commercial Formulary effective March 19, 2014. Pilocarpine is indicated for the symptomatic treatment of xerostomia caused by salivary gland hypofunction resulting from radiotherapy for cancer of the head or neck or Sjögren’s syndrome.

Formulary Deletions

Formulary Additions, Continued

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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

Mechlorethamine (Valchlor) topical gel 5 11/5/2013

Riociguat (Adempas) 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg tablets 5 11/5/2013

Macitentan (Opsumit) 10 mg tablet 5 11/5/2013

Tobramycin (Bethkis) 300 mg/4 mL nebulization solution 5 11/5/2013

Levomilnacipran (Fetzima) 40 mg, 80 mg, 120 mg capsules 4 12/3/2013

Diclofenac (Zorvolex) 18 mg and 35 mg capsules 4 12/3/2013

Vortioxetine (Brintellix) 5 mg, 10 mg, 15 mg, 20 mg tablets 4 12/3/2013

Fluticasone furoate/vilanterol trifenatate (Breo Ellipta) 100 mcg/25 mcg inhalation powder

4 Pending

Perampanel (Fycompa) 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, 12 mg tablet

4 Pending

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

Medication Name TierEffective

Date

Dabigatran (Pradaxa) 75 mg, 150 mg tablets 3 1/1/2014

Linaclotide (Linzess) 140 mcg, 290 mcg capsules 3 3/1/2014

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 Negative ChangesAfter review of Part D prescription claims submitted to CMS, it was determined that the below list of drugs do not meet the criteria for coverage under Part D. This has been confirmed by CMS and validated by the FDA website. A Part D covered drug is available only by prescription, approved by the Food and Drug Administration (FDA) (or is a drug described under section 1927(k)(2)(A)(ii)or(iii) of the Act), used and sold in the United States, and used for a medically accepted indication (as defined in section 1927(k)(6) of the Act). CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA.

The Food and Drug Administration determined that drugs listed below can no longer be sold in the United States, effective November 1, 2013. Prescriptions for these drugs will no longer receive Part D coverage:

•Ponatinib HCl (Iclusig) 15 mg and 45 mg tablets

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

Department Name Medication Added

Pediatrics Menveo (Menigococcal Diptheria Conjugate Vaccine)

APPENDIX A CONTAINS THE COBB COUNTY DEPARTMENT FLOORSTOCK LIST.

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Clinical UpdatesMedSafety Alert: Risk of Adverse Effects Associated with Use of OTC Sodium Phosphate Products to Treat Constipation. The U.S. Food and Drug Administration (FDA) warns that using more than one dose in 24 hours of over-the-counter (OTC) sodium phosphate drugs to treat constipation can cause rare but serious harm to the kidneys and heart, which in some cases may result in death. OTC sodium phosphate drug products include oral solutions taken by mouth and enemas used rectally. These products are marketed under the brand name Fleet or as store brands and generic products.

The FDA has received reports of severe dehydration and changes in levels of serum electro-lytes, including calcium, sodium, and phosphate, when taking more than the recommended dose of OTC sodium phosphate products. Most cases of serious harm occurred with a single dose of sodium phosphate that was larger than recommended or with more than one dose in a day. Individuals who may be at a higher risk of these adverse events include young children and patients who are over the age of 55, dehydrated, with kidney disease, with bowel obstruction or inflammation, and those using medications that may affect kidney function. These medications include diuretics, angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), and non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, and naproxen.

Providers should instruct patients on the appropriate use of these products and advise them not exceed the labeled dose. Oral products should be used with caution in children 5 years and younger and should not be given without first discussing with a health care professional. The rectal form of these products should never be given to children younger than 2 years.

FDA Drug Safety Communication: Methylphenidate ADHD Medications Associated with Priapism Risk.The FDA is warning that methylphenidate products, a stimulant drug used to treat attention deficit hyperactivity disorder (ADHD), may in rare instances cause prolonged erections known as priapism. Priapism can occur in males of any age and happens when blood in the penis becomes trapped, leading to an abnormally long-lasting and sometimes painful erection.

In the FDA’s review of 15 cases, the median age of patients taking a methylphenidate prod-uct who experienced priapism was 12.5 years (range 8 to 33 years). Priapism occurred after dose increases, temporary drug discontinuations, missed doses, and permanent discontinu-ation. It is possible that priapism may be more likely to occur with the use of immediate-release methylphenidate, which has a shorter half-life.

As a result of this data, the FDA has updated the methylphenidate drug labeling and pa-tient Medication Guides to include information about the rare but serious risk of priapism. Patients who take methylphenidate and develop erections lasting longer than four hours should seek immediate medical treatment to prevent long-term problems with the penis. Younger males, especially those who have not yet reached puberty, may not recognize the problem or may be embarrassed to tell anyone if it occurs. All male patients and their care-givers should be taught the signs and symptoms of priapism and the importance of seeking immediate medical treatment if it occurs.

Medications Reviewed, but Not Added to the Formulary•Cysteamine bitartrate (Cystagon) 50 mg and 150 mg capsules, decision pending for the

National MPD Formulary•Fluticasone furoate/vilanterol trifenatate (Breo Ellipta) 100 mcg/25 mcg inhalation

powder, decision pending for the National MPD Formulary•Rivaroxaban (Xarelto) 10 mg, 15 mg, and 20 mg tablets, decision pending for the

National MPD Formulary

additional clinical alerts

Iclusig (Ponatinib): Drug Safety Communication - Increased Reports

of Serious Blood Clots in Arteries and Veins

http://www.fda.gov/Safety/MedWatch/SafetyInformation/

SafetyAlertsforHumanMedicalProducts/ucm370971.htm

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

SafetyInformation/ucm380539.htm

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Appendix ACobb County Department Floorstock List

Category Description NDC

RX ANTIPYRINE/BENZOCAINE 10 ml otic soln (Aurodex) 24208-0561-62 RX ONDANSETRON 8 mg ODT tab (Zofran), #30 62756-0356-64

OTC ACETAMINOPHEN 325 mg UD tab (Tylenol), #100 00904-1982-61RX CEFTRIAXONE 1 gm vial (Rocephin) 64679-0983-02RX METHYLPREDNISLONE SODIUM SUCCINATE 125 mg vial (Solu-Medrol) 00009-0047-22RX DEXAMETHASONE 10 mg/ml, 1 ml vial (Decadron) 00641-0367-25RX NALBUPHINE 20 mg/ml, 1 ml amp (Nubain) 00409-1465-01RX LIDOCAINE 2% viscous solution, 100 ml btl 00054-3500-49RX PROPARACAINE 0.5% ophth drops, 15 ml btl (Alcaine) 61314-0016-01RX HUMULIN R (Insulin, Human) 100 units/ml, 10 ml MDV 00002-8215-01RX CEFTRIAXONE 500 mg vial (Rocephin) 60505-0751-04RX PROMETHAZINE 25 mg/ml, 1 ml amp (Phenergan) 39822-5500-03RX KETOROLAC 60 mg/2 ml SDV (Toradol) 00409-3796-01 RX SILVER NITRATE APPLICATORS 12870-0001-02IV NS 1000ml bags 00338-0049-04IV LACTATED RINGERS 1000ml 00338-0117-04IV D5 1/2NS 1000 ml bag 00338-0085-04 

Vaccine ADACEL (TDAP) 1 ml SDV 49281-0400-10Vaccine ENGERIX-B (hepatitis B vaccine, adult formulation) 20 mcg/1 ml, SDV 58160-0821-11Vaccine PNEUMOVAX 23 ( Pneumococcal Vaccine)0.5ML SDV 00006-4943-00Vaccine FLUZONE 0.5 ml PFS 49281-0413-50 Vaccine PPD (tuberculin purified protein derivative) 1 ml vial 49281-0752-21Vaccine TENIVAC (diptheria and tetanus toxoids, adsorbed (TD for adult use)) PFS 49281-0215-15Vaccine HAVRIX 720U /0.5ML SDV 10 (Hepatitis A) 58160-0825-11

Vaccine ZOSTAVAX (zoster vaccine live) SDV, 10 doses per box 00006-4963-41Vaccine GARDASIL (human papiloma virus vaccine, quadravalent) SDV 00006-4045-41