Transcript News You Can Use…

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