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ISSUE 5 VOLUME 6 OCTOBER 2012

FormularyUpdate

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Escitalopram (generic Lexapro) 5mg, 10mg, and 20mg tablets are currently available on the National Medicare Part D (MPD) Formulary as Tier 2, generic, and were added to the Commercial Formulary effective October 18, 2012. Escitalopram is a selective serotonin reuptake inhibitor (SRRI) FDA-approved for the acute and maintenance treatment of major depressive disorder (MDD) in adults and

adolescents as well as for the acute treatment of generalized anxiety disorder. Fluoxetine and escitalopram are the only SSRIs approved for the treatment of MDD in adolescents 12 to 17 years of age. Escitalopram is higher in cost per year compared to other formulary SSRIs, but is more cost effective than venlafaxaine XR.

Paroxetine (generic Paxil) 10 mg, 20 mg, 30 mg, and 40 mg tablets are currently available on the National MPD Formulary and were added to the Commercial Formulary effective October 18, 2012. Paroxetine is a selective serotonin reuptake inhibitor (SSRI) FDA approved for the treatment of depression, obsessive-compulsive disorder, panic disorder, social anxiety disorder and generalized anxiety disorder. Paroxetine may target anxiety symptoms better than other SSRIs. The addition of paroxetine gives providers and patients another low cost option when targeting certain symptoms and/or other SSRIs fail. Paroxetine is the only formulary SSRI which is Pregnancy Category D. Paroxetine should not be prescribed to women in their first trimester of pregnancy or to women of reproductive age, unless other treatment options are not appropriate.

Sumatriptan (generic Imitrex®) 5 mg nasal spray is currently available on the National MPD Formulary as Tier 2, generic, and was added to the Commercial Formulary effective October 18, 2012. Sumatriptan 20 mg nasal spray is currently available on the Commercial Formulary. Sumatriptan is FDA approved for the acute treatment of migraine with or without aura. Recommended dosing for the

nasal spray is 5 mg, 10 mg or 20 mg administered in one nostril at the onset of headache.

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Formulary Additions

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.

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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. 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).National MPD Formulary Tier changes are listed below with their corresponding effective date:

medication name tier eFFective date

Raltegrevir (Isentress) 25 mg & 100 mg chew-able tablet Tier 5 10/02/2012

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

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.Combivent MDI to Combivent Respimat: A standing order has been developed to convert patients with eligible sigs currently taking Combivent Inhalation Aerosol 18/103 mcg 2 inhalations to Combivent Respimat Inhalation Spray 20/100 mcg 1 inhalation at same dosing frequency. Two inhalations of the Combivent MDI is an equivalent dose in medica-tion to 1 inhalation of the Combivent Respimat.

upcoming Formulary decisions

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 (December 2012):

•Formulary status of the following medications will be reviewed: topical corticosteroids

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

Oxycodone/acetaminophen 10-325mg tablets are currently available on the National MPD Formulary as Tier 2, generic, and were added to the Commercial Formulary effective October 18, 2012. Oxycodcone/acetaminophen recommended dosing for severe pain is 10 mg to 30 mg based on the oxycodone content. The 5/325 mg strength does not allow for the administration of higher oxycodone doses for severe pain without increasing the dose of acetaminophen. The extension of this strength to the formulary will allow

higher doses of oxycodone for severe pain without increasing the amount of acetaminophen per dose.

Combivent Respimat (ipratropium and albuterol) 20-100 mcg inhalation spray will be added to the Commercial Formulary effective November 8, 2012. Tier placement on the National MPD Formulary is pending. Combivent Respimat was approved by the FDA for use in patients with chronic obstructive pulmonary disease (COPD). As of January 1, 2014, Combivent Respimat will be the only Combivent product available. Combivent Respimat has a new administration device. Combivent MDI is being phased out because it contains chlorofluorocarbons (CFCs) which deplete the ozone layer. Combivent Respimat is dosed one puff four times daily, whereas, Combivent MDI is dosed two puffs four times daily.

New Standing Orders

Formulary Additions, Continued

The medications below will be added to the electronic floorstock ordering forms on the intranet:

department name medication added

Gastroenterology Glucose meter test stripsSure Step Pro control solution

Orthopedics Bupivicaine 0.25%, 30 ml vial

Vascular Surgery Heparin 5,000 units/ml, 1 ml vialNormal Saline, 1000 ml bag

Medical Office Floorstock Additions

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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

Susan Moon, MDHospitalist

LaJune Oliver, MDAmbulatory Medicine

Designated Alternates:Jacqueline Anglade, MD

Obstetrics and Gynecology

Lesia Jackson, RNClinical Services

*Attend alternating meetings

Clinical UpdatesMedSafety Alert: Revatio (sildenafil): Recommendation Against Use in Children for pulmonary arterial hypertension (PAH). Results from a recent long-term clinical pediatric trial showed that children taking a high dose of Revatio had a higher risk of death than children taking a low dose. The study also showed that the low doses of Revatio are not effective in improving exercise ability.

Treatment of PAH in children with this drug is an off-label use (not approved by FDA) and a new warning, stating the use of Revatio is not recommended in pediatric patients has been added to the Revatio labeling.

Patients and caregivers are advised to not change the Revatio dose or stop taking Revatio without talking to a health care professional. Healthcare professionals are reminded that use of this product, particularly chronic use, in children is an off-label indication, not approved by FDA, and is not recommended.

MedSafety Alert: Codeine Use in Certain Children After Tonsillectomy and/or Adenoidectomy may be associated with a Risk of Rare, But Life-Threatening Adverse Events or Death. The FDA is reviewing reports of children who developed serious adverse effects or died after taking codeine for pain relief af-ter tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome.

These children (ages two to five) had evidence of an inherited (genetic) ability to convert codeine into life-threatening or fatal amounts of morphine in the body. All children had received doses of codeine that were within the typical dose range. High levels of morphine can result in breathing difficulty, which may be fatal. Taking codeine after tonsillectomy and/or adenoidectomy may increase the risk for breathing problems and death in children who are “ultra-rapid metabolizers.”

Health care professionals should be aware of the risks of using codeine in children, particu-larly in those who have undergone tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome. If prescribing codeine-containing drugs, the lowest effective dose for the shortest period of time should be used on an as-needed basis (i.e., not scheduled

New Criteria Restricted (QRM) Medications

Some QRM medication authorizations are for a limited time period and re-authorization is required for continued coverage. Reauthorization is based on compliance with the therapy and documented improvement in your condition based on response to treatment. Pa-tients will now be receiving letters in the mail before the QRM medication authorization expires. The letters advise patients to contact the prescribing physician to discuss therapy continuation. If the decision is to continue therapy, the provider will need to contact QRM at 404-364-7320, option #2, to initiate the reauthorization process. If reauthorization is not submitted, the authorization will expire and the patient will be responsible for the full cash price of the medication. A complete list of medications can be found on the KPGA homep-age under Health Care Delivery, Guides and References, Formularies, Criteria Restricted (QRM) Medications or on Community Provider Portal (providers.kp.org) under Pharmacy, Formulary, Criteria Restricted Medication.

Criteria restricted medications require review by Quality Resource Management (QRM) prior to coverage. The prior authorization process and criteria apply to the Commercial formulary, not the Medicare Part D formulary. Providers must call QRM to request authorization consideration at 404-364-7320 (Option 2). A complete listing of prior authorization medications and their corresponding criteria is available on the intranet under Healthcare Delivery/ Guides & Reference/ Formularies/ Criteria Restricted (QRM) Medications.The following medications will be added to the list of Criteria Restricted Medica-tions (QRM) effective November 1 2012:•Jentadueto (linagliptin/metformin)

Criteria Restricted (QRM) Medications Authorization Expiration Letters

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•Aclidinium (Turdoza Pressair) 400 mcg inhalation power, not added to the Commercial Formulary, decision pending for the National MPD Formulary

• Indacaterol (Arcapta Neohaler) 75mcg inhalation powder, not added to the Commercial Formulary, decision pending for the National MPD Formulary

•Escitalopram (generic Lexapro) 5 mg/5 ml oral solution, not added to the Commercial Formulary

•Carfilzomib (Kyprolis) injection, decision pending for the National MPD formulary

Medications Reviewed, but Not Added to the Formulary

new kpga approved

compounds

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 injections•Bevacizumab 2.5 mg/0.1 ml•Epi-Shugarcaine•Sub-Tenons

around the clock). Parents and caregivers who observe unusual sleepiness, confusion, or difficult or noisy breathing in their child should seek medical attention immediately, as these are signs of overdose.

MedSafety Alert: Over-The-Counter Topical Muscle and Joint Pain Relievers: Drug Safety Communication - Rare Cases of Serious Burns. OTC products that are applied to the skin for the relief of mild muscle and joint pain have been reported to cause rare cases of serious skin injuries, ranging from first- to third-degree chemical burns, where the products were applied. These OTC topical muscle and joint pain relievers are available as single- or combination-ingredient products that contain menthol, methyl salicylate, or capsaicin, and are marketed

under various brand-names, such as, Bengay, Capzasin, Flexall, Icy Hot, and Mentholatum. The various formulations include creams, lotions, ointments, and patches.

Consumers using an OTC topical muscle and joint pain reliever who experience signs of skin injury where the product was applied, such as pain, swelling, or blistering of the skin, should stop using the product and seek medical attention immediately.

When recommending OTC topical muscle and joint pain relievers to patients, healthcare professionals should counsel patients about how to use the products appropriately and inform them about the risk of serious burns.

MedSafety Alert: Mirapex (pramipexole): Ongoing Safety Review, Possible Risk of Heart Failure. Results of recent studies suggest a potential risk of heart failure that needs further review of available data. Because of the study limitations, FDA is not able to determine whether Mirapex increases the risk of heart failure. FDA is continuing to work with the manufacturer to clarify further the risk of heart failure with Mirapex and will update the

public when more information is available. FDA evaluated a pooled analysis of randomized clinical trials and found that heart failure was more frequent with Mirapex than with placebo; however, these results were not statistically significant. FDA also evaluated two epidemio-logic studies that suggested an increased risk of new onset of heart failure with Mirapex use. However, study limitations make it difficult to determine whether excess heart failure was related to Mirapex use or other influencing factors.

At this time, FDA has not concluded that Mirapex increases the risk of heart failure. Health-care professionals should continue to follow the recommendations in the drug label when prescribing Mirapex. Patients should continue to take their Mirapex as directed and should contact their health care professional if they have any questions or concerns.

FDA Update: Budeprion XL 300 mg Not Therapeutically Equivalent to Well-butrin XL 300 mg. Kaiser Permanente does not use the Impax/Teva bupropion HCl extended-release product. The U.S. Food and Drug Administration (FDA) has reviewed new data that indicate Budeprion XL 300 mg (bupropion hydrochloride extended-release tablets), manufactured by Impax Laboratories, Inc., and marketed by Teva Phar-maceuticals USA, Inc., is not therapeutically equivalent to Wellbutrin XL 300 mg. FDA has changed the therapeutic equivalence rating for this product in the Agency’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) from AB to BX, signifying that Budeprion XL 300 mg fails to demonstrate therapeutic equivalence to Wellbutrin XL 300 mg. Impax has requested that the Agency withdraw approval of budeprion XL 300 mg extended-release tablets.

Clinical Updates, Continued