1. News You Can Use… Phillip Transou, PharmD Candidate Pete Koval, PharmD Cone Health Family Medicine June, 2016

2. New Generic Approvals Crestor ® (rosuvastatin) Now available (released 5/1/16) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm498373.htm

3. New Drug Approval Nuplazid ® (pimavanserin) is an atypical antipsychotic with selective 5-HT 2A antagonism Indicated for treatment of hallucinations/delusions associated with Parkinson’s dementia Dosing: 34mg daily (two 17mg tablets) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm498442.htm

4. New Drug Approval Probuphine ® (buprenorphine) is the first opioid subcutaneous implant Indicated for maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability with buprenorphine Lasts for up to 6 months of treatment http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm498442.htm

5. Cone Health Formulary Update Enozaparin (Lovenox ® ) is replacing heparin for DVT prophylaxis Subcutaneous heparin remains on formulary for renal failure indications, physician choice, & in contraindication to enoxaparin Anidulafungin (Eraxis ® ) is replacing micafungin There is no singularly superior echinocandin. Anidulafungin is currently the most cost- effective. Cone Health P&T May 2016

6. FDA label changes Invokamet (canagiflozin + metformin) FDA approval expanded to include first line treatment for type 2 DM http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm498607.htm http://www.janssen.com/us-fda-expands-indication-invokamet-canagliflozinmetformin-hcl-include-first-line-treatment- adults-type-2-diabetes Brintellix (vortioxetine) name changed to Trintellix to prevent confusion with Brilinta

7. Cardiff Study Decreased mortality and major adverse cardiovascular events were found in insulin + metformin combination therapy versus insulin monotherapy Holden SE, et al. Association between Insulin Monotherapy versus Insulin plus Metformin and the Risk of All-Cause Mortality and Other Serious Outcomes: A Retrospective Cohort Study. PLoS ONE. 2016;11(5):e0153594.

8. Antipsychotic Guideline New APA guidelines for antipsychotic use in dementia are available Recommendations include: Tapering off of antipsychotics 4 months after initiation Using quantitative measures to track response to treatment http://psychiatryonline.org/doi/book/10.1176/appi.books.9780890426807

9. FDA Warnings Olanzapine linked to DRESS 23 cases identified via FDA adverse event reporting system, with 1 death Fluoroquinolones: harms generally outweigh benefits in sinusitis, bronchitis, & uncomplicated UTI Other treatment options are preferred if available/appropriate http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm500123.htm http://www.fda.gov/Drugs/DrugSafety/ucm500143.htm

10. New Studies Pregabalin (Lyrica) linked to 3-fold increase in major birth defects No labeling change implemented yet Unintentional injury/self-harm rates in bipolar disorder found to be lower with lithium vs olanzapine, quetiapine, or valproate. Winterfeld U, et al. Pregnancy outcome following maternal exposure to pregabalin may call for concern. Neurology. 2016. Hayes JF, et al. Self-harm, Unintentional Injury, and Suicide in Bipolar Disorder During Maintenance Mood Stabilizer Treatment: A UK Population-Based Electronic Health Records Study. JAMA Psychiatry. 2016.