From the VSHP Legislative Committee

 

VSHP CALL FOR COMMITTEE VOLUNTEERS FOR 2017-2018

VSHP's mission is to help our members become better practitioners. We work towards fulfilling our mission every year through education of our members via region meetings, statewide meetings, newsletters, and our website; fostering professional standards; educating the public about the role of health system pharmacists; monitoring legislative issues that affect pharmacy; and by promoting health system pharmacy as a career path for future pharmacists. The majority of our Society's work is done by member volunteers working through our committees. You can play a vital role by serving on one of our committees.
What will you get out of it? It looks good on your resume. You will meet and get to know many of the current and future pharmacy leaders in Virginia, make new friends, and maybe make a good impression on a future employer. Also, you will have the professional satisfaction of helping shape and advance health system pharmacy in Virginia.

If you are interested in serving on a committee for VSHP, please fill out the form at https://www.surveymonkey.com/r/2017vshpcommittee.  

The Committee Chair will contact you regarding upcoming meetings or other opportunities to participate.  

COMMITTEE FUNCTIONS AND CHARGES:  
COMMUNICATIONS: The Communications Council and Editorial Board is responsible for the direction, development, and quality control of all VSHP publications, including the VSHP web site.  
EDUCATIONAL AFFAIRS: The Educational Affairs Committee is responsible for planning, coordinating, and evaluating educational content of the 2 statewide VSHP meetings.

GRANTS: The Grants Committee will review requests from individuals and groups in need of grant funding for specific programs or program elements which match the mission of VSHP.
LEGISLATIVE AFFAIRS: The Legislative Committee is responsible for informing the VSHP membership and Board of Directors of important legislation and regulations and how they will impact pharmacy practice in organized health care settings in Virginia.

MEMBERSHIP ENGAGEMENT:  The Membership Engagement Committee reviews and suggests ways for the membership of VSHP to become more engaged in VSHP.

MENTORSHIP: The Mentorship Committee is responsible for the administration of the VSHP Mentorship Program.  (Pharmacists only for this committee please)
ORGANIZATIONAL AFFAIRS: The Organizational Affairs Committee reviews and analyzes the VSHP organization and make recommendations to increase its effectiveness.  

PAC:  The Political Action Committee works to raise monies for the VSHP PAC and determines the best uses for the funds raised.
STUDENT and RESIDENTS COMMITTEE: The Student and Residents Committee provides input to VSHP on how to get students interested in health-system pharmacy practice and how to get them interested and involved in VSHP.

TECHNICIAN TASK FORCE:  The Technician Task force provides input to VSHP on how to increase technician membership in VSHP and membership activities to provide VSHP.

Make a commitment to get involved with a VSHP Committee.

New Drug Update: Valbenazine (Ingrezza™)

 

Kevin M. Bozymski, PharmD, BCPS; PGY2 Psychiatric Pharmacy Resident, VCU Health System

 

Tardive dyskinesia (TD) is a disorder of involuntary, repetitive, purposeless movements of the orofacial region, trunk, and extremities, thought to primarily result from dopaminergic hypersensitivity in the nigrostriatal pathway due to long-standing D₂ receptor blockade.¹ It is for this reason that users of first-generation antipsychotics (e.g. haloperidol, fluphenazine) and certain antiemetics (e.g. metoclopramide) have a higher incidence of TD. For decades TD has been considered irreversible, with mixed evidence and expert opinion suggesting to either minimize use of the offending agent or switch to a theoretically less offending agent (i.e. second-generation antipsychotics).² Unfortunately, decreasing doses or changing medications altogether are not always possible for individuals living with advanced disease.

 

Valbenazine (Ingrezza^TM) is the first medication indicated by the US Food and Drug Administration (FDA) for the treatment of adults with TD, receiving approval on April 11, 2017. Its mechanism of action is thought to result from reversible inhibition of vesicular monoamine transporter 2 (VMAT2), which regulates reuptake of monoamine into synaptic vesicles for storage; in other words, valbenazine allows more dopamine to remain available for neurotransmission.³ The only other VMAT2 inhibitors available on the US market are tetrabenazine (Xenazine^®) and deutetrabenazine (Austedo^TM), FDA approved in 2008 and 2017, respectively, for treating chorea associated with Huntington's disease.^4,5

 

Of the three clinical trials conducted with valbenazine for TD, only two have been reported in primary literature. The first is a phase II, multicenter, randomized, double-blind, placebo-controlled, dose-titration study ("KINECT 2") in which valbenazine 25 mg/day (titrated up to maximum of 75 mg/day) was compared to placebo. The study population included adults with a diagnosis of schizophrenia, schizoaffective disorder, or mood disorder with antipsychotic-induced TD as defined by DSM-IV criteria, or GI disorder with metoclopramide-induced TD. The primary efficacy endpoint was the change in the Abnormal Involuntary Movement Scale (AIMS) score from baseline to week 6 (See Table 1). In the modified intent-to-treat population of 89 subjects, the least squares mean change in total AIMS score for valbenazine was significantly more than placebo (-2.6 vs. -0.2, p=0.0005).⁶ The most common adverse effects for valbenazine were fatigue, headache, and decreased appetite.

 

The other trial is a phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study ("KINECT 3") comparing valbenazine 40 mg/day, valbenazine 80 mg/day, and placebo. The study population was similar to that of the published phase II trial, though the diagnosis of TD had to be present for at least 3 months prior to screening. The primary efficacy endpoint was the change in AIMS score from baseline to week 6 for the valbenazine 80 mg/day group compared to the placebo group. In the intent-to-treat population of 225 subjects, the least squares mean change in total AIMS score was significantly more than placebo for both the valbenazine 80 mg/day group (-3.2 vs. -0.1, p<0.001) and valbenazine 40 mg/day group (-1.9 vs. -0.1, p=0.002); these results translate into numbers needed to treat of 4 and 7, respectively.⁷ The most common adverse effects for valbenazine were somnolence, akathisia, and dry mouth.

 

The initial starting dose of valbenazine is 40 mg by mouth once daily, with an increase to the recommended dose of 80 mg by mouth once daily after the first week.³ The recommended maximum dose of valbenazine is 40 mg/day for individuals with moderate/severe hepatic impairment or concomitant use of strong CYP3A4 inhibitors, and reductions should be considered for individuals who are poor CYP2D6 metabolizers or also receive strong CYP2D6 inhibitors. The half-life of valbenazine and its active metabolite is 15-22 hours. Use is not recommended with strong CYP3A4 inducers (e.g. carbamazepine), severe renal impairment (i.e. creatinine clearance < 30 mL/min), or congenital long QT syndrome; however, there are no boxed warnings or contraindications.³

 

References