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 Drugs@FDA

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 Ordered Product 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) HFA Albuterol 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