Graduate Course Proposal Form Submission Detail - PHA6277
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Approved by SCNS
Submission Type: New
Course Change Information (for course changes only):
Comments: To GC - required for Proposed MS in Nanopharmacy. Appd 3/6/15; to USF 8/28/15;Cleared concurrence 9/7/15; To UGS for SCNS 9/21/15. Nmbr 6160 approved as 6277 Effective 10/1/15. Updated to both online and face-to-face delivery 5/18/16
- Department and Contact Information
Tracking Number Date & Time Submitted 5190 2015-02-03 Department College Budget Account Number Medical Sciences RX Contact Person Phone Shyam Mohapatra 8139748568 firstname.lastname@example.org
- Course Information
Prefix Number Full Title PHA 6277 Ethics in Pharmaceutical Practice and Research Is the course title variable? N Is a permit required for registration? Y Are the credit hours variable? N Is this course repeatable? Y If repeatable, how many times? 1 Credit Hours Section Type Grading Option 1 C - Class Lecture (Primarily) - Abbreviated Title (30 characters maximum) Ethics in Pharmacy Research Course Online? Percentage Online O - Online (100% online) 0
This course will cover the ethical considerations which control and influence pharmacy practice and research. Professional ethics will also be covered in this course.
A. Please briefly explain why it is necessary and/or desirable to add this course.
Needed for new program/concentration/certificate
B. What is the need or demand for this course? (Indicate if this course is part of a required sequence in the major.) What other programs would this course service?
Currently there is no course here that reflects ethics in Pharmacy Research and state and federal regulations that govern research related drug discovery.
This course would not service any other program.
C. Has this course been offered as Selected Topics/Experimental Topics course? If yes, how many times?
D. What qualifications for training and/or experience are necessary to teach this course? (List minimum qualifications for the instructor.)
Ph.D, MD, PharmD, D.O.
- Other Course Information
This course provides students with an overview of major ethical issues in Pharmacy and Pharmaceutical practice. This is a required course for the proposed M.S. in Pharmaceutical Nanotechnology & future Ph.D. Also electives in several Grad Certificates.
The course will familiarize graduate students in Pharmacy with the basic ethical issues associated with pharmacy research and practice so they can abide by the regulations and laws that protect pharmacy practice in the field and while conducting research.
B. Learning Outcomes
Upon completion of this course, students will be able to:
• Conduct pharmaceutical research with the highest ethical values.
• Manage and use resources within the healthcare system they work
to insure complete ethical support to their industry.
• Promote health improvements, wellness, and disease prevention
with the utmost integrity and principles
• Promote the same ethical values to patient care and/or student
teaching in pharmacy with respect and values as described above
within pharmacy and research practice.
• Analyze problems using legal and ethical frameworks.
• Synthesize legal and ethical principles with experiential knowledge
of their practice setting to make informed, rational, and responsible
• Evaluate a moral dilemma and then develop a process by which to
“best resolve” the dilemma.
• Synthesize knowledge of ethical theory with individual values to
determine appropriate professional behavior.
• Analyze federal and state pharmacy regulations to determine
strategies for effective delivery of patient care.
• Synthesize legal and ethical principles within the context of
pharmaceutical care to facilitate effective drug design.
• Discuss legal and ethical issues and cases studies on the course
• Effectively explain the legal and ethical issues involved in pharmacy
healthcare and research.
• Exhibit intellectual curiosity; take responsibility for developing
abilities and conduct continual self-assessment in order to develop
an understanding of various areas of pharmacy and research law
through legal history, terminology, and case studies.
• Describe the pharmaceutical ethical code
• Apply ethical concepts to pharmacy practices
C. Major Topics
State Pharmacy Law
Federal Pharmacy Law
Ethical Communication & Counseling
Ethical Pharmacy Practice Experiences
Concepts in Pharm Practice and Research
Advanced Pharm. Practice Experiences
Ethical Research Practices
Ethical Consideration for Animal and Human Subjects
Data Management and analysis
Conflicts of Interest
Misconduct in Research
Authorship & Peer Review
Aparasu, R. R. & Bentley, J. P. (2015). Principles Of Research Design And Drug Literature Evaluation. Burlington, MA:Jones & Bartlett Learning, (ISBN: 1284038793, ISBN-13: 9781284038798)
Reiss B.S. & Hall G.D. (2010). Guide to Federal Pharmacy Law, 7th Edition. Delmar, NY: Apothecary Press. (ISBN-13: 978-0967633268)
E. Course Readings, Online Resources, and Other Purchases
Code of Ethics for Pharmacists as outlined by the American Pharmacists Association at no cost to the student or faculty located at: http://www.pharmacist.com/code-ethics
Drug Enforcement Administration Office of Diversion Control website: http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/ at no cost to the students or faculty.
The U.S. Department of Justice: Drug Enforcement Admin., Office of Diversion Control's Pharmacist's Manual: An Informational Outline of the Controlled Substances Act (revised 2010). Available on line at no cost to the students or faculty at: http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_manual.pdf#search=Drug Enforcement and Pharmacist and An Information Outline of the Controlled Substances Act”
Recommended by not required text for additional reading or information:
Garner BA, ed. Black’s Law Dictionary, 3rd Pocket Edition. St. Paul, MN: West Group; 2001. (ISBN-10: 0314158626; ISBN-13: 978-0314158628).
Abood RR. Pharmacy Practice and the Law, 6th Edition. Sudbury, MA: Jones and Bartlett Publishers5,; 2010. (ISBN-13: 978-0-7637-8129-3).
Veatch RM & Haddad A. Case Studies in Pharmacy Ethics, 2nd Edition. New York, NY: Oxford University Press; 2008. (ISBN-13: 978-0-19-530812-9).
Specific case studies and relative articles will be available as reflected in the syllabus.
F. Student Expectations/Requirements and Grading Policy
Discussion board postings (25% of the final course grade)
Five quizzes at 5% each (25% total of the final course grade)
One written assignment (20% of the final course grade)
Mid-term exam (10% of the final grade)
Comprehensive final exam (20% of the final grade)
G. Assignments, Exams and Tests
The Discussion board:
Students are expected to read and synthesize materials related to this course and provide educated responses to questions posed by professor and respond to at least two other students.
There will be five quizzes related to readings
There will be one written assignment of understanding and comprehension
There will be one mid-term exam
There will be one comprehensive final exam
H. Attendance Policy
Course Attendance at First Class Meeting – Policy for Graduate Students: For structured courses, 6000 and above, the College/Campus Dean will set the first-day class attendance requirement. Check with the College for specific information. This policy is not applicable to courses in the following categories: Educational Outreach, Open University (TV), FEEDS Program, Community Experiential Learning (CEL), Cooperative Education Training, and courses that do not have regularly scheduled meeting days/times (such as, directed reading/research or study, individual research, thesis, dissertation, internship, practica, etc.). Students are responsible for dropping undesired courses in these categories by the 5th day of classes to avoid fee liability and academic penalty. (See USF Regulation – Registration - 4.0101,
Attendance Policy for the Observance of Religious Days by Students: In accordance with Sections 1006.53 and 1001.74(10)(g) Florida Statutes and Board of Governors Regulation 6C-6.0115, the University of South Florida (University/USF) has established the following policy regarding religious observances: (http://usfweb2.usf.edu/usfgc/gc_pp/acadaf/gc10-045.htm)
In the event of an emergency, it may be necessary for USF to suspend normal operations. During this time, USF may opt to continue delivery of instruction through methods that include but are not limited to: Blackboard, Elluminate, Skype, and email messaging and/or an alternate schedule. It’s the responsibility of the student to monitor Blackboard site for each class for course specific communication, and the main USF, College, and department websites, emails, and MoBull messages for important general information.
I. Policy on Make-up Work
Students will be allowed to make up missing coursework only for documented student absences as described in the course syllabus.
Students will be required to abide by USF policy outlined in the University's policy on academic integrity described in course syllabus.
J. Program This Course Supports
Proposed Master of Science in Pharmaceutical Nanomedicine and the future Ph.D. as well as the Graduate Certificates offered by the College of Pharmacy.
- Course Concurrence Information