March 2012 ADVISORY Network Edition

Ohio Region Drug Therapy Issue 3 March 2012 ADVISORY Network Edition

• Changes include removal of routine monitoring of liver Vytorin 10/40mg and 10/80mg to enzymes from statin drug labels and new lovastatin contraindications and dose limitations Atorvastatin 80mg • Healthcare professionals should continue to perform liver (Paul Bandfield, PharmD, Formulary Management Services) enzyme tests before initiating statin therapy in patients and as • Atorvastatin 80mg is now preferred over ezetimibe/simvastatin clinically indicated thereafter (Vytorin) 10/40mg and 10/80mg for members who require high • If serious liver injury with clinical symptoms and/or potency statin therapy hyperbilirubinemia or jaundice occurs during treatment, statin • Kaiser Permanente members receiving Vytorin 10/40mg and therapy should be interrupted 10/80mg are being converted to atorvastatin 80mg • If an alternate cause of symptoms is not found, the statin o The interchange has been approved by Kaiser Permanente should not be restarted (KP) Ohio Region Pharmacy & Therapeutics (P&T) • The FDA revised the labeling for the following reasons: Committee Statin induced hepatic toxicity is extremely rare Endorsed by Ohio Permanente Medical Group (OPMG) o o o Routine monitoring of liver enzymes has not been found to Cardiology be predictive of outcomes KP Department of Pharmacy will convert all patients with an o o Discontinuations of statins due to hepatic enzyme elevations OPMG provider may lead to more cardiovascular events and deaths than o Affected Network providers will be contacted by phone or liver related toxicities prevented fax for authorization to convert and for a new atorvastatin • Updated adverse effect information about the potential for 80mg prescription reversible cognitive side effects and reports of increased blood • A letter is being sent to all patients who have received Vytorin sugar and glycosylated hemoglobin (HbA1c) has also been added 10/40mg or 10/80mg in the past 4 months to inform them of the to statin labels conversion New Lovastatin Contraindications and Dose Limitations • For members with an OPMG provider, direct LDL labs are • Strong CYP3A4 inhibitors now contraindicated with lovastatin being ordered by Clinical Pharmacists for each patient to be o Can increase lovastatin levels and risk of myopathy drawn 6 to 8 weeks after estimated first atorvastatin 80mg Table #1: Drugs Contraindicated or Avoid With Lovastatin prescription date Interacting Drug Previous Label Updated Label • Vytorin 10/80mg will be deleted from the Commercial formulary once conversions to atorvastatin 80mg are completed Strong CYP3A4 inhibitors (e.g., azole anti-fungals, HIV • Continued coverage of Vytorin 10/40mg and 10/80mg for Commercial members will require a formulary exception and Hep C protease Avoid Contraindicated inhibitors, erythromycin, • For Medicare Part D members, all strengths of Vytorin will continue be available at a tier 4 nonpreferred brand copay clarithromycin) Do not exceed • Atorvastatin is available to Commercial and Medicare Part D members at a generic copay Gemfibrozil, cyclosporine lovastatin 20mg Avoid daily • The average member out-of-pocket copay savings for atorvastatin will be approximately $20 per month and over $200 • The revised FDA labeling also includes new lovastatin dose per year compared with Vytorin limitations with other interacting drugs • Both atorvastatin 80mg and Vytorin have been shown to be o New dose limitation of lovastatin 20mg with diltiazem effective in lowering cholesterol o Decreased dose limitation to lovastatin 20mg with verapamil • Simvastatin is still the preferred formulary statin for KP Ohio Table #2: Lovastatin Dose Limitations Region Interacting Drug Previous Label Updated Label • Members who have been receiving simvastatin 80mg for one Do not exceed Verapamil year and are currently at low density lipoprotein (LDL) goal may lovastatin 40mg daily continue therapy and should not be converted to atorvastatin Do not exceed Do not exceed Danazol unless they experience adverse effects or there exist potential lovastatin 20mg daily lovastatin 20mg daily drug-drug interactions No dose limitation • Highest recommended dose of simvastatin for new starts is Diltiazem 40mg per day which lowers the LDL by as much as 41% existed Do not exceed Do not exceed Amiodarone FDA Alert: Statin Drugs Class lovastatin 40mg daily lovastatin 40mg daily • More information can be found at: Safety Labeling Changes http://www.fda.gov/Drugs/DrugSafety/ucm293101.htm (Paul Bandfield, PharmD, Formulary Management Services) (Continues on the reverse side) • On February 28th, the Food and Drug Administration (FDA) approved new safety label changes for statin drugs

Issue 3 – Network Edition March 2012

(Continued from previous side) Norgestimate and Ethinyl Estradiol Tablets: Recall - Packaging Error, Potential for Incorrect Dosing Regimen Elderly: HEDIS Measure http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAler (Brandi Klaich, PharmD Candidate, PharmD Candidate 2012, The Ohio State tsforHumanMedicalProducts/ucm293385.htm University and Paul Bandfield, PharmD, Formulary Management Services) American Regent Injectable Products: Recall - Visible What is a high risk medication in the elderly? Particulates in Products • The National Committee for Quality Assurance (NCQA) has http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAler listed high risk medications to avoid in the elderly tsforHumanMedicalProducts/ucm242365.htm • High risk medications may lead to increased side effects or Cytarabine for Injection, 1 gm/vial [Bedford Labs]: Recall: drug interactions that are common in the elderly population Risk of Lack of Sterility • Reduction in high risk medication use may lead to decreased http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAler adverse effects and falls in the elderly population tsforHumanMedicalProducts/ucm293132.htm HEDIS, Kaiser, and High Risk Medications • Health Effectiveness Data and Information Set (HEDIS) looks at Initiatives NCQA target medications filled in those ≥ 65 years old as a Inter-Regional Clinical Pharmacy Services measure of appropriate prescribing • There are two HEDIS measures: Subcommittee (ICPSS) Initiatives • Insulin NPH and 70/30 use preferred over Lantus and Levemir o Percentage of Medicare members age 65 and over who received one prescription during measurement year • Dulera use preferred over Advair and Symbicort • Brand Adderall XR capsule preferred ADHD medication o Percentage of Medicare members age 65 and over who received two prescriptions during measurement year • OxyContin use discouraged over other long-acting opioids • Only prescription drugs are measured; medications that are • Generic levofloxacin preferred over brand Avelox purchased over-the-counter are not measured • Skeletal muscle relaxant use discouraged in elderly Measured HEDIS Classes Discouraged in the Elderly • Hydroxyzine use discouraged in elderly • First generation sedating antihistamines (e.g. Pharmacy Conversion Team Projects diphenhydramine, promethazine) • Combivent day supply corrections • Amphetamines (e.g. methylphenidate) • Vytorin to atorvastatin Therapeutic Interchange • Barbiturates (e.g. phenobarbital) • Long-acting benzodiazepines (e.g. diazepam, flurazepam) Current Half-Tab Initiatives Abilify Crestor Brand Lipitor Viagra • Antispasmotics (e.g. dicyclomine, propantheline) • Belladonna alkaloids (e.g. belladonna, hyoscyamine) Brand Aricept Brand Imitrex Nuvigil Brand Zocor Atorvastatin Brand Lamictal Brand Paxil Brand Zoloft • Skeletal muscle relaxants (e.g. cyclobenzaprine, carisoprodol methocarbamol, orphenadrine, metaxalone) Brand Celexa Levitra Provigil • Oral estrogens (e.g. esterified/conjugated estrogens) • For an all-inclusive list of high risk medications to avoid go to: Formulary Changes http://www.ncqa.org/Portals/0/Newsroom/SOHC/Drugs_Avoid The Ohio Regional Pharmacy & Therapeutics Committee approved ed_Elderly.pdf the following formulary changes. Focus on Three High Risk Medication Classes in 2012 • The KP Ohio Region Drug Formulary is available by accessing the • Long-acting benzodiazepines: Lexicomp Online Formulary through the Internet Stop diazepam, flurazepam and chlordiazepoxide (http://online.lexi.com/login using login and password: ohkprx) o • Formulary changes are updated in Lexicomp on their respective o Benzodiazepines are not covered under Medicare Part D . Consider a short-acting benzodiazepine such as effective dates lorazepam or alprazolam Commercial Additions . Control anxiety with a selective serotonin reuptake Drug Effective Date inhibitor, approved serotonin norepinephrine Abiraterone (Zytiga) 250mg Tab 4.3.12 reuptake inhibitor, or buspirone Atorvastatin (generic Lipitor) 80mg Tab 4.3.12 . Encourage member to adhere to good sleep hygiene Colchicine (Colcrys) 0.6mg Tab 3.8.12 or habits Epinephrine (EpiPen JR) 0.15mg/0.3mL Inj 4.3.12 . Help members who still have difficulty sleeping despite Epinephrine (EpiPen) 0.3mg/0.3mL Inj 4.3.12 good sleep “hygiene” with trazodone or mirtazapine Lisdexamfetamine (Vyvanse) 20mg, 30mg, • Skeletal muscle relaxants: 40mg, 50mg, 60mg, 70mg Cap 4.3.12 o Stop methocarbamol, cyclobenzaprine, and orphenadrine Medicare Part D Tier Changes . Consider stopping the medication as the efficacy of muscle relaxants is not widely demonstrated Drug Effective Date-New Tier . Refer patient to a pain specialist if not currently Ticagrelor (Brilinta) 90mg Tab 3.6.12 - Tier 3 managed by one Criteria Updates • Codeine containing antihistamines: HMG-CoA Reductase Inhibitors Revised 04.12 o Stop promethazine and codeine cough syrup Alosetron (Lotronex) and Tegaserod . Try less sedating antihistamines such as loratadine, (Zelnorm) Revised 03.12 fexofenadine or cetirizine . For a cough syrup for short-term use, try over-the- Inquiries counter guaifenesin and codeine Ohio Regional Formulary Management/Drug Information Service (8:30 a.m. – 5:00 p.m. Mon – Fri, excluding holidays) Other FDA Alerts E-mail: [email protected] Statins and HIV or Hepatitis C Drugs: Drug Safety Pager for urgent inquiry: (216) 568-3133 Communication - Interaction Increases Risk of Muscle Injury References are available upon request http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAler tsforHumanMedicalProducts/ucm294294.htm