The Lone Star Pharmacist - September 2018

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Page 6 September 2018 The Lone Star Pharmacist New Practitioner Corner Now’s the time to join the TSHP New Practitioner Section Hongmei Wang Justin Shanks Hongmei Wang, PharmD, PhD, BCPS and Justin Shanks, PharmD Are you a recent graduate in your first five years of practicing pharmacy? Are you looking for ways to advance your career? If so, we can help. As a member of the TSHP New Practitioner (NP) Section you have the opportunity to explore mentorship, learn skills & knowledge to tackle workplace challenges, expand your clinical competence, and develop leadership skills. New practitioners have unique needs, interests, and concerns that are often different from more experienced members of the profession. The objective of TSHP’s NP Section is to provide an avenue of support to assist with the many challenges that come with transitioning from a student to a practicing health-system or hospital pharmacist. The volunteer leadership of the TSHP New Practitioner Section Committee (NPSC) strives to serve TSHP and the members of the NP Section through several ongoing initiatives intended to enrich member experiences, benefits, continuing education, and volunteer opportunities. We are excited about the new initiatives launching this year and look forward to you taking advantage of them, as we strive to better serve you and the members of the TSHP New Practitioner Section! Do you feel like you are in over your head trying to advance your career? Learn how to potentially navigate some of these challenges through the TSHP Mentorship Program! Participation in the TSHP Mentorship Program is open to pharmacy students, new practitioner and pharmacist members. It is often considered one of the most valuable initiatives, as it benefits not only new practitioners but students and more experienced members alike. Volunteers from the NPSC match interested mentors with mentees based on practice area interest and location to facilitate a relationship that will hopefully continue to grow through the years. Mentees will learn from the wealth of experience of their mentor and the mentor will benefit from further developing their precepting and coaching skills with matched mentees of similar interests. Additionally, mentees will have direct access to their mentor’s tips, tricks, and best practices that they used to make their career both successful and rewarding. Helping shape the future of pharmacy in Texas! offering content that enriches new practitioner skills, as well as addressing other pertinent issues specific to our career stage. The NPSC actively seeks presenters for CE topics from both inside and outside of the TSHP membership and the new practitioner section. If you are interested in speaking at Annual Seminar or presenting/ proposing a CE topic, please contacting us! We would like input from new practitioners on what CE topics are most pertinent to you, that you believe would benefit other new practitioners. Additionally, the NP section is in the development and planning process of potentially offering more online CE. We know practice can be overwhelming but learning through online CE exercises is one way to brush up on therapeutic topics and expand your knowledge base, another great opportunity for professional topic presentation and collaboration. Are you having trouble meeting colleagues that can help get you where you want to go? Our members have access to many networking opportunities to meet fellow new practitioners and practitioners, as well as TSHP members in leadership/ management positions across the great state of Texas. The TSHP Annul Seminar is the largest gathering of health-system and hospital pharmacy professionals in Texas. The networking and social opportunities at the Annual Seminar may just be the single best resource for you to learn about opportunities you need to navigate up the career ladder. Looking for ways to supplement your CV or improve your teamwork and leadership skills? The New Practitioner Section offers many leadership opportunities to set yourself apart. All NP members are eligible to apply for an opportunity to serve on the New Practitioner Section Committee. This Committee consist of NPs from across Texas who meet and collaborate with local, state, and national leaders on our various initiatives designed to serve not only NPs, but all TSHP. One such initiative is our college outreach initiative where Committee members reach out to schools of pharmacy across the state to speak about opportunities within health-system and hospital pharmacy and current pharmacy issues. The Why should I join TSHP New Practitioner Section? • Reduced membership dues the first five years following graduation • Discounted Annual Seminar registration • Leadership and career development • Networking/Mentorship/Menteeship • Publications/Speaker Opportunities presentations include information about the TSHP Annual Seminar, residencies, Mentorship Program, opportunities to serve within TSHP, and more! The NPSC encourages all interested new practitioners to get involved and consider applying for a position during the next Call for Volunteers in the spring. Additionally, we would encourage all practitioners to get involved with one of the many local chapters throughout Texas. This year, the NP Section has begun distributing a section newsletter and monthly brief. This newsletter includes clinical pearls, information about state and local events, accomplishments, membership testimonials, and much more! Members can look forward to continued editions of this communication to stay informed and involved. If you wish to receive this communication and are not a member, please visit www.tshp.org/join or contact one of the NP Section Chairs listed below. We are always looking for new ways to help our fellow new practitioners. The possibilities are endless and the level of commitment is totally up to you. The important thing is to get involved. Help ensure your success and a rewarding career; join the TSHP New Practitioner Section TODAY! If you would like additional information, please feel free to contact us! Chair – Hongmei Wang (hongmei.wang@tsu.edu) Chair-Elect – Justin Shanks (jds117bus@gmail.com) Have you had difficulty continuing to strengthen your clinical practice or teaching skills since finishing pharmacy school or residency? The TSHP NPSC develops educational programming for the TSHP Annual Seminar, specifically aimed at polishing the skills of new practitioners. Annual Seminar CE is planned with the intent of The Official Publication of the Texas Society of Health-System Pharmacists – R&E Foundation
The Lone Star Pharmacist September 2018 Page 7 FDA New Drugs • May ‘18 - July ‘18 Approval Date Drug Name Active Ingredients Submission Classification Review Priority ** Company 5/4/2018 PLENVUNDA #209381 ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; Type 2 - New Active Ingredient Standard SALIX PHARMS INC POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE 5/15/2018 LAMIVUDINE AND TENOFOVIR DISOPROXIL LAMIVUDINE; TENOFOVIR Type 5 - New Formulation or New Manufacturer Standard AUROBINDO PHARMA LTD FUMARATENDA #022344 DISOPROXIL FUMARATE 5/15/2018 RETACRITBLA #125545 EPOETIN ALFA-EPBX HOSPIRA INC 5/15/2018 BENDAMUSTINE BENDAMUSTINE HYDROCHLORIDE Type 5 - New Formulation or New Manufacturer Standard EAGLE PHARMS HYDROCHLORIDENDA #205580 5/16/2018 LUCEMYRANDA #209229 LOFEXIDINE HYDROCHLORIDE Type 1 - New Molecular Entity Priority US WORLDMEDS LLC 5/17/2018 AIMOVIGBLA #761077 ERENUMAB-AOOE AMGEN INC 5/18/2018 LOKELMANDA #207078 SODIUM ZIRCONIUM CYCLOSILICATE Type 1 - New Molecular Entity Standard ASTRAZENECA PHARMS 5/21/2018 DOPTELETNDA #210238 AVATROMBOPAG MALEATE Type 1 - New Molecular Entity Priority AKARX INC 5/22/2018 YONSANDA #210308 ABIRATERONE ACETATE Type 5 - New Formulation or New Manufacturer Standard SUN PHARMA GLOBAL 5/24/2018 PROGRAFNDA #210115 TACROLIMUS Type 3 - New Dosage Form Standard ASTELLAS 5/24/2018 HALOBETASOL PROPIONATENDA #210566 HALOBETASOL PROPIONATE Type 3 - New Dosage Form and Type 4 - New Combination Standard THERAPS INC 5/24/2018 PALYNZIQBLA #761079 PEGVALIASE-PQPZ BIOMARIN PHARM 5/29/2018 IMVEXXYNDA #208564 ESTRADIOL Type 5 - New Formulation or New Manufacturer Standard THERAPEUTICSMD INC 5/31/2018 OLUMIANTNDA #207924 BARICITINIB Type 1 - New Molecular Entity Standard ELI LILLY AND CO 5/31/2018 CONSENSINDA #210045 AMLODIPINE BESYLATE; CELECOXIB Type 4 - New Combination Standard KITOV PHARMS LTD 6/4/2018 FULPHILABLA #761075 PEGFILGRASTIM-JMDB MYLAN GMBH 6/13/2018 MOXIDECTINNDA #210867 MOXIDECTIN Type 1 - New Molecular Entity Priority MDGH 6/15/2018 LYMEPAKNDA #209844 DOXYCYCLINE HYCLATE Type 5 - New Formulation or New Manufacturer Standard CHARTWELL PHARMA 6/21/2018 NOCDURNANDA #022517 DESMOPRESSIN ACETATE Type 5 - New Formulation or New Manufacturer Standard FERRING PHARMS INC 6/21/2018 ABLYSINOLNDA #207987 ALCOHOL Type 5 - New Formulation or New Manufacturer Standard BELCHER PHARMS LLC 6/25/2018 ZEMDRINDA #210303 PLAZOMICIN SULFATE Type 1 - New Molecular Entity Priority ACHAOGEN INC 6/25/2018 EPIDIOLEXNDA #210365 CANNABIDIOL Type 1 - New Molecular Entity Priority GW RESEARCH LTD 6/27/2018 BRAFTOVINDA #210496 ENCORAFENIB Type 1 - New Molecular Entity and Type 4 - New Combination Standard ARRAY BIOPHARMA INC 6/27/2018 MEKTOVINDA #210498 BINIMETINIB Type 1 - New Molecular Entity and Type 4 - New Combination Standard ARRAY BIOPHARMA INC 6/28/2018 QBREXZANDA #210361 GLYCOPYRRONIUM TOSYLATE Type 3 - New Dosage Form Standard DERMIRA INC 6/28/2018 NUPLAZIDNDA #210793 PIMAVANSERIN TARTRATE Type 3 - New Dosage Form Standard ACADIA PHARMS INC 6/29/2018 ARISTADA INITIO KITNDA #209830 ARIPIPRAZOLE LAUROXIL Type 5 - New Formulation or New Manufacturer Standard ALKERMES INC 6/29/2018 FULVESTRANTNDA #210326 FULVESTRANT Type 5 - New Formulation or New Manufacturer Standard FRESENIUS KABI USA 7/9/2018 Atropine Injection, 2 mg/0.7 mL, ATROPINE Priority RAFA LABLTD Single-Dose AutoinjectorNDA #212319 7/10/2018 VANCOMYCIN HYDROCHLORIDENDA VANCOMYCIN HYDROCHLORIDE Type 5 - New Formulation or New Manufacturer Standard MYLAN LABS LTD #209481 7/11/2018 GLYRX-PFNDA #210997 GLYCOPYRROLATE Type 5 - New Formulation or New Manufacturer Standard EXELA PHARMA SCS LLC 7/12/2018 BORTEZOMIBNDA #209191 BORTEZOMIB Type 5 - New Formulation or New Manufacturer Standard HOSPIRA INC 7/13/2018 TPOXXNDA #208627 TECOVIRIMAT Type 1 - New Molecular Entity Priority SIGA TECHNOLOGIES INC 7/16/2018 INFUGEMNDA #208313 GEMCITABINE 0.9%;SODIUM CHLORIDE Type 3 - New Dosage Form Standard SUN PHARM INDS INC 7/17/2018 SYMTUZANDA #210455 DARUNAVIR;COBICISTAT;EMTRICITAB Type 4 - New Combination Standard JANSSEN PRODS INE;TENOFOVIR ALAFENAMIDE 7/20/2018 KRINTAFELNDA #210795 TAFENOQUINE Type 1 - New Molecular Entity Priority GLAXOSMITHKLINE 7/20/2018 TIBSOVONDA #211192 IVOSIDENIB Type 1 - New Molecular Entity Priority AGIOS PHARMACEUTICALS INC 7/23/2018 ORILISSANDA #210450 ELAGOLIX SODIUM Type 1 - New Molecular Entity Priority ABBVIE INC 7/24/2018 DOXERCALCIFEROLNDA #208614 DOXERCALCIFEROL Type 5 - New Formulation or New Manufacturer Standard HOSPIRA INC 7/27/2018 OMEGAVENNDA #210589 FISH OIL TRIGLYCERIDES Type 1 - New Molecular Entity Priority FRESENIUS KABI USA 7/30/2018 REMODULINNDA #208276 TREPROSTINIL Type 3 - New Dosage Form Standard UNITED THERAP 7/30/2018 AZEDRANDA #209607 IOBENGUANE I 131 Type 5 - New Formulation or New Manufacturer Priority PROGENICS PHARMA INC 7/31/2018 MULPLETANDA #210923 LUSUTROMBOPAG Type 1 - New Molecular Entity Priority SHIONOGI INC * NDA Submission Classifications For details, see FDA/CDER MAPP 5018.2 Type 1 New molecular entity Type 2 New active ingredient Type 3 New dosage form Type 4 New combination Type 5 New formulation or other differences Type 6 New indication or claim, same applicant [no longer used] Type 7 Previously marketed but without an approved NDA Type 8 Rx to OTC Type 9 New indication or claim, drug not to be marketed under type 9 NDA after approval Type 10 New indication or claim, drug to be marketed under type 10 NDA after approval Type 1/4 Type 1, New molecular entity, and Type 4, New combination Type 2/3 Type 2, New active ingredient, and Type 3, New dosage form Type 2/4 Type 2, New active ingredient and Type 4, New combination Type 3/4 Type 3, New Dosage Form, and Type 4, New combination ** Review Priority Priority: Review designation assigned to applications for drugs that treat serious conditions and provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to available therapies Standard: Review designation assigned to applications for drugs that do not meet the priority review designation criteria The Official Publication of the Texas Society of Health-System Pharmacists – R&E Foundation
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