University of Maryland Student Society of Health- System Pharmacy. General Body Meeting January 21, :00 1:50 PM

Transcription

1 University of Maryland Student Society of Health- System Pharmacy General Body Meeting January 21, :00 1:50 PM

2 Spring Events Overview GBMs February 16, 1PM March 20, 12PM April 20, 1PM ASHP HQ Tour Million Hearts Fair Script Your Future UMB Wellness Fair March 25, 10AM IPMC 4 th Year Panel Residency Forum Match Party

3 Elections! Interested in holding a officer position next year? Get involved with our events Ask our officers about their positions Election period: March to April

4 Clipboards and Cardholders Missed your chance last semester? Korean BBQ Whitecoat clipboards Business cardholders

5 Student Advocate Training and Legislative Day Tuesday February 3 Wednesday February 4 Washington D.C.

6 ASHP Headquarters Tour ASHP Headquarters located in Bethesda SSHP Chapter tour in February or March Contact: Christina Jeon

7 Million Hearts Campaign APhA-ASP Operation Heart initiative Blood Pressure Screening February 13 10AM 2PM Contact: Jonathan Meyer

8 Interprofessional Patient Management Competition Interested in interprofessional collaboration? Participating schools: Medicine, Nursing, PT, Law Social Work, Dental, Pharmacy Case-based competition 2-day format 2 hour written group case Oral presentations for Top 3 teams Contact: Jeanne Do or Jonathan Meyer

9 Patient Care Challenge Case-based relay Problem identification Therapeutic selection Patient counseling or monitoring Winning team wins gifts cards!

10 March 30 th GBM Residency application process and preparation Recently matched 4 th year students Contact: Jeanne Do

11 Match Party Match Day: Friday, March 20 th Come celebrate and help us congratulate all newly matched 4 th year students! Volunteers to help plan event Contact: Jonathan Meyer

12 Annual Residency Forum Forum discussion with Residency Directors and PGY1 residents Video conferencing with Shady Grove Volunteers to help contact panelists and plan Contact: Susan Giang or Jeanne Do

13 Janet Mighty, BS Pharm, MBA Assistant Director Investigational Drug Service The Johns Hopkins Hospital

14 Research Pharmacists University of Maryland School of Pharmacy Janet Mighty Assistant Director Investigational Drug Service, Johns Hopkins Hospital February 25,

15 Objectives Review of research terms IDS Pharmacist role Compliance and Regulations Opportunities and Challenges The path from graduation to IDS

16 Definitions Research According to DHHS, research is a systematic investigation, including development, testing and/or evaluation, designed to develop or contribute to generalizable knowledge. Human Subject A human subject is a living individual about whom an investigator conducting research obtains: Data through intervention or interaction with the individual, or Identifiable private information.

17 Definitions Investigational New Drug (IND) a new drug or biological drug that has not been approved by the FDA or a marketed drug that has not been FDA approved for the use being studied. Study Drug an IND or non-ind that is used in a clinical trial February 25,

18 Definitions Investigator an individual who actually conducts a clinical investigation (i.e., under whose immediate direction the drug is administered or dispensed to a subject). At JHM the investigator must be a faculty member. Sponsor a person who takes responsibility for and supports a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. February 25,

19 Definitions Subject a human who participates in an investigation, either as a recipient of the investigational new drug or as a control. The IRB is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects February 25,

20 FDA Drug Approval Process Martin S et al, From Idea to Market: The Drug Approval Process, J Am Board Fam Med. 2001;14(5) 20

21 Research Team Composition Principal Investigator Study Coordinator Study Nurse PHARMACIST Certified Pharmacy Technician Statistician Others 21

22 Investigational Drug Service (IDS) at Johns Hopkins Hospital Division of the Department of Pharmacy There are two IDS pharmacies Central IDS: (6 pharmacists, 2 technicians) Non-oncology studies Manages approximately 280 studies Weinberg IDS: (4 pharmacists, 2 technicians) Oncology studies only Manages approximately 350 studies

23 Pharmacists as Members of the Research Team Protocol review & consultation Study drug dispensing Study drug inventory management Study drug blinding Patient education and medication adherence Committee membership (IRB & others) Audit: investigator controlled studies (QA &QI) International clinical trials research pharmacy development February 25,

24 Pharmacists as Members of the Research Team Coordinating Center role Financial management (budget & billing) Orderset development Protection of Human Subjects February 25,

25 Management of Investigational drugs: Compliance & Regulations FDA Code of Federal Regulation (CFR) Good Clinical Practice (GCP) Guidelines: For International Studies Maryland Board of Pharmacy The Joint Commissions United States Pharmacopeia (USP) Chapter <797> pharmaceutical sterile compounding regulations USP Chapter <800> proposed regulations Protocol sponsor Institutional policies

26 Challenges & Opportunities Education and training of new staff Management of electronic systems Compliance with regulations Specialization of practice Maintaining competency Institutional strategic plan Discovery and innovation February 25,

27 Are the services provided really different? Accountable for receiving drug to storing, dispensing, and returning/ destructing IPs (Investigational Products) Accountable to our research patients Documentation is extensive Electronic Manual Consequences of mistakes can be serious. February 25,

28 What might keep an IDS Pharmacist up at night? Protocol compliance Product integrity Temperature monitoring Maintaining the blind Documentation requirements Study Participants February 25,

29 Temperature Monitoring (not as easy as you think) Required for all storage locations Ambient (15-30 C) Refrigerator (2-8 C) Freezer (-20 C, -80 C) Continuous monitoring Monitoring during transport Reporting of excursions

30 Drug Accountability Drug receipt Drug dispensing to subjects Drug returned by study subjects Each dose must be tracked on log Use study drug for study subjects only!

31 DOCUMENT, DOCUMENT, DOCUMENT If it s not documented, it didn t happen.

32 My Path from Graduation to IDS Retail Pharmacist Hospital staff pharmacist Director of Pharmacy Part-time pharmacist Assistant Director IDS February 25,

33 The Path Continues. Professional engagement is essential to professional growth. State society (MSHP) Committees, Board of Directors, President National Society (ASHP) Council, Board of Directors, EVP Search ASHP Research and Education Foundation Vice-chair BOD February 25,

34 Questions & Discussions

35 Asha Tata, PharmD, BCPS Clinical Pharmacy Specialist, Internal Medicine Coordinator, PGY-2 Pharmacotherapy UMMC

36 Asha L. Tata, PharmD, BCPS Internal Medicine Clinical Pharmacy Specialist SSHP Meeting January 21, 2015

37 My Career Path University of Pittsburgh Six-year undergraduate/doctor of Pharmacy program Virginia Commonwealth University/Medical College of Virginia PGY1 Pharmacy Residency PGY2 Adult Internal Medicine Residency University of Maryland Medical Center Internal Medicine Clinical Pharmacy Specialist

38 Internal Medicine Clinical Pharmacy Specialist Jack of all trades...master of none? Not at all variety of disease states and wellrounded pharmacist! Utilize individualized patient-related factors, drug-related factors, and evidence-based medicine to optimize pharmacotherapy Medication reconciliation Discharge counseling

39 Clinical My Various Hats Inpatient internal medicine service Outpatient anticoagulation clinic Teaching/Mentorship Shadowing opportunities APPE 451 students Pharmacy residents (PGY1 Pharmacy, PGY1/PGY2 Pharmacotherapy) Pharmacotherapy Residency Coordinator

40 My Various Hats Administrative Lots of committees and meetings Medication safety, insulin focus group, medication reconciliation, VTE task force, antimicrobial use, residency Scholarlship Presentations, research, publications Professional organizations/leadership MSHP Secretary, ASHP, ACCP Internal Medicine PRN, SHM

41 Typical Day There is no typical day and that's the best part! Mornings s Pre-round on patients Review patients with pharmacy students/residents Attend multidisciplinary rounds Afternoons s Patient follow up Meetings Continuing education Topic discussions Other scholarly activities - read literature, prepare presentations, conduct research, write/edit manuscripts

42 How Do I Get There? Be well-rounded in pharmacy school...it's more than just grades! Hospital internship, variety of rotations, research, publication/poster, presentations, organization involvement and leadership, community service, good communication skills/interpersonal skills Residency Training PGY1 Pharmacy Practice + PGY2 Adult Internal Medicine PGY1/PGY2 Pharmacotherapy

43 Next GBM February 16, 1PM