News You Can Use… Jessica Binz, PharmD Pete Koval, PharmD Cone Health Family Medicine September 2014

New Drug Approval Arnuity Ellipta- A once daily fluticasone dry powder inhaler For maintenance treatment of asthma Approved in 100mcg and 200mcg dosing system 8/20/14 FDA News and Events

New Drug Approval The FDA approved Belsomra (suvorexant) an orexin receptor antagonist Approved for as needed treatment of insomnia Doses: 5, 10, 15 and 20mg Controlled substance (Schedule-IV) 8/13/14 FDA News Release

Tentative Drug Approval Lilly and Boehringer’s Basaglar (insulin glargine) received tentative approval by the FDA A 30 month stay due to litigation filed by Sanofi (maker of Lantus). FDA will not issue final approval until mid 2016, unless court finds in favor of Lilly earlier Will be delivered through the KwikPen delivery system Cheaper insulin glargine in 2016??? 8/18/2014 MarketWatch.com and

FDA Advisory Committee Recommends Approval Spiriva (tiopropium) with use of the Respimat device Spiriva is currently available in the HandiHaler dry powder inhaler FDA will rule at a later date 8/14/2014 MarketWatch

In the News An increased risk of cardiac death in those treated with clarithromycin vs penicillin V was seen in an observational study 37 excess cardiac deaths/1 million More studies needed to determine clinical relevance 8/19/2014 BMJ

P&T Committee Approved items: Auto substitution of select MDIs for nebulizer solutions Medication OrderedProduct Interchange Ventolin HFA (albuterol)Albuterol solution 2.5mg Atrovent HFA (ipratropium)Ipratropium solution 0.5mg Combivent Respimat (ipratropium-albuterol) Ipratropium solution 0.5mg + albuterol solution 2.5mg Xopenex (levalbuterol) HFAAlbuterol solution 2.5mg 8/20/2014 Cone Health P&T

MAP Changes MAP will no longer dispense Novolog pens Novolog VIALS ONLY when requesting Novolog from the MAP progam

New Class II Controlled Substance DEA will change all hydrocodone combination products to Schedule II controlled substances Effective October 6, 2014 Rxs written prior to 10/6/2014 will be honored for the duration of the Rx 8/22/14 deadiversion.usdoj.gov