ULM School of Pharmacy
21 July 2014
PHRD 5002, Pharmacy Law and Ethics II
I.
Contact Information
Course Coordinators
Jeffery Evans, Pharm.D.
Phone: 318-632-2007 x239
Email: jevans@ulm.edu
Office: Claiborne 128 (Shreveport)
Office hours: Mondays 12 - 5
Alexis Horace, Pharm.D.
Phone: 225-219-9660, Ext. 202
Email: ahorace@ulm.edu
Office: Baton Rouge
Office hours: Mondays 12 - 5
II. Course Prerequisites/Corequisites
Prior to registering for the class the student must have completed PHRD 4031 with a grade of C or
better
III. Course Description
This course reviews the principles of ethics as they apply to pharmacy practice. Students will focus
primarily on the law as it applies to drugs, medical devices, and the practice of pharmacy.
IV. Course Objectives and Outcomes
At the completion of this course the student will be able to:
1. Explain the interaction between Federal and State laws.
2. Apply Federal laws to the practice of pharmacy.
3. Understand and explain the relationship between State laws and Board rules.
4. Continue to develop a moral compass to form a decision tree when law disagrees with
moral righteousness.
V. Curricular Outcomes
Provide Comprehensive Patient Specific Pharmaceutical Care.
1. Evaluate the appropriateness of a given prescription or medication order based on patient and
disease-specific factors
4. Compound and/or dispense the most optimal formulation for drug delivery consistent with the
patient needs and in harmony with the law.
Communicate Effectively.
6. Counsel/ educate patients
9. Read, write, speak, listen, and use data, media, and computers to send and respond effectively to
communications for varied audiences and purposes.
Think Critically.
24. Identify, retrieve, understand, analyze, synthesize, and evaluate information needed to make
informed, rational, and ethical decisions.
25. Solve complex problems that require an integration of one’s ideas and values within a context of
scientific, social, cultural, legal, clinical, and ethical issues.
26. Display habits, attitudes, and values associated with mature critical thinking.
Demonstrate Appropriate Interpersonal, Professional, and Ethical Behaviors.
27. Maintain professional competence.
28. Represent the profession in an ethical manner.
29. Identify, analyze, and resolve ethical problems involved in pharmacy practice.
32. Practice in a manner that is consistent with state and federal laws and regulations
VI. Course Topics
The majority of the topics in the class will be focused on laws that impact pharmacy practice and
rules that regulate pharmacy practice. Additionally a brief overview of government setup will occur.
Additionally, topics related to ethics will be covered during the course as law and ethics go hand and
hand.
VII. Instructional Methods and Activities
The course will be primarily taught through didactic lectures given by the course coordinator or
invited guest lectures. Additionally, selected students will be presenting certain parts of the class.
There is a possibility that some classes will be made available in electronic format. Students are
encouraged to attend class regardless if the lecture is available online. Some material online may
replace traditional class time, however this will be at the discretion of the instructor and not the
class. There will be a class blog to discuss specific topics in depth, participation in these discussions
are optional, however material from the blog will available for testing purposes.
VIII.
Evaluation and Grade Assignment
Course grading will be based on the following weighted requirements:
Midterm Exams
60%
Final Exam
40%
Class participation
Pass/fail
Midterm Exams
The Midterm Exams will cover all of the material that has been covered so far in this course and
may include material from PHRD 4031 as this course builds upon that knowledge. These tests may
include both short answer and multiple choice questions.
Final Exam
This exam will be 100% multiple choice questions and will contain 120 questions that will include
material from PHRD 4031
Quizzes/Papers
Potentially throughout the semester, the instructors may issue quizzes or other small assignments.
In Class Participation
The goal of the instructors is to have a two way conversation with the student during the course.
Thus a series of active learning and in class assessment will be occurring. To encourage students to
participate, a simple pass/fail grade will be instituted for participation. Over the course of the
semester, the student will be given an opportunity to interact inside of class and outside of class.
Students will be tracked to see if they are participating. Students at risk for not meeting the
required number of interactions will be contacted after the first and second exam. If students have
not met an appropriate level of interactions, then they will fail this portion of the class. A student
cannot pass this course without passing the class participation portion . For students
that do not pass the class participation portion of the course, they will be required to write a report
that is at least 7500 words and deals with a person who has instigated changes in laws (legislator,
executor…) and complete that project to the satisfaction of the instructors. When completed, the
student will receive a ‘pass’ for participation.
Grading Scale:
A: >89.499999
B: 89.5 > and >79.499999
C: 79.5 > and >69.499999
D: 69.5 > and 59.4999999
F: 59.6 >
Undergraduate mid-term grades will be posted on-line for students to view via Banner. Mid-term
grades indicate a student’s status at mid-semester only and do not indicate the final performance
outcome of a student.)
IX. Class Policies and Procedures
At a minimum, all policies stated in the current ULM Student Policy Manual & Organizational
Handbook should be followed (see http://www.ulm.edu/pharmacy/documents/ospa/codeofconductv82011.pdf).
Additional class policies include:
A. Textbook(s) and Materials: (Include required and recommended items)
Required: Reiss BS and Hall GD Guide to Federal Pharmacy Law 7th edition, Apothecary Press 2010
ISBN 978-096763326-8
B. Attendance Policy:
The professional educational experience in the College of Pharmacy involves many multifaceted
learning objectives, including professional interactions with faculty and peers, that don’t lend
themselves to traditional testing modalities and assignment of letter grades. As a result, class
attendance is mandatory in all pharmacy courses. Students reported for accumulating more
than three unexcused absences in a course during an academic semester will be
adm inistratively dropped from the course with a “W ” grade. In accordance with
College of Pharmacy policy and procedure, a grade of “W ” will be counted as an “F”
grade with respect to academic standards.
C. Make-up Policy:
Exams will be made up as soon as possible after the student returns. The exam will not be identical
to the exam given to the whole class, however the difficulty of the exam should be similar.
D. Academic Integrity:
Faculty and students must observe the ULM published policy on Academic Dishonesty (see Page 4 in
ULM Student Policy Manual - http://www.ulm.edu/studentpolicy/).
E. Course Evaluation Policy:
ULM Computer 8/2/2013 12:11 PM
Formatted: Font:9 pt, No underline, Font
color: Auto
Students are expected to complete the on-line course evaluation upon completion of the course. In
addition, constructive student feedback is always encouraged, and will be welcome throughout the
semester and after class completion, via email, telephone, meetings, or anonymous correspondence.
The coordinator is learning the same way the students are, through trial and error. Thus please
provide feedback.
F. Student Services:
Information about ULM student services, such as Student Success Center (http://ulm.edu/cass/),
Counseling Center (http://ulm.edu/counselingcenter/), Special Needs
(http://ulm.edu/counselingcenter/special.htm) and Student Health Services, is available at the
following Student Services web site http://ulm.edu/studentaffairs/
If you are having problems with emotional, social, and/or behavioral issues please call any of the
mental health clinics on the ULM campus to make an appointment. All services are free to ULM
students, staff, and faculty, and are strictly confidential.
•
•
•
•
•
COP Office of Student and Professional Affairs: 342-3800
ULM Counseling Center: 342-5220
Marriage and Family Therapy Clinic: 342-5678
Community Counseling Center: 342-1263
ULM HELPS (Helping Educators and Learners Prevent Suicide) Project Office: 342-1335
The University of Louisiana at Monroe strives to serve students with special needs
through compliance with Sections 504 of the Rehabilitation Act of 1973 and the Americans with
Disabilities Act. These laws mandate that postsecondary institutions provide equal access to
programs and services for students with disabilities without creating changes to the essential
elements of the curriculum. While students with special needs are expected to meet our institution's
academic standards, they are given the opportunity to fulfill learner outcomes in alternative ways.
Examples of accommodations may include, but are not limited to, testing accommodations (oral
testing, extended time for exams), interpreters, relocation of inaccessible classrooms, permission to
audiotape lectures, note-taking assistance, and course substitutions.
Title IX of the Education Amendments of 1972 prohibits sex discrimination against any participant in
an educational program or activity that receives federal funds, including federal loans and grants.
Furthermore, Title IX prohibits sex discrimination to include sexual misconduct, sexual violence,
sexual harassment and retaliation. If you encounter unlawful sexual harassment or gender-based
discrimination, please contact Student Services at 318-342-5230 or to file a complaint, visit
www.ulm.edu/titleix.
G. Emergency Procedures: (Include appropriate emergency information)
In cases of emergency please contact the course coordinator as needed and as soon as possible.
Please review the emergency escape plan in the classrooms and hallways of the Bienville building.
Move quickly and orderly to the appropriate stairwell and exit the building. The meeting place for
this class will be the far end of the north parking lot between Bienville and Broadmoor Blvd. Under
no circumstances is the elevator to be used for emergency evacuation. Any student needing
assistance should notify the professor immediately. For emergencies, to contact University Police,
call 1-911 from landlines and 342-5350 from cell phones.
H. Discipline/Course Specific Policies:
Questions during the exam
The coordinator will not answer any questions regarding test content during the exam. No
clarifications will be given during the exam. If there is an issue with a question, answer it to the
best of your abilities. Then either write down a statement regarding why you feel the question is
problematic, or submit in writing (email counts) your reasoning why the question is flawed. The
coordinator will make the final decision as to if the questions is flawed.
Flawed questions on the exam
It is the goal of the coordinator to present the student with a perfect assessment tool,
however there will be errors in the exam. If a question is determined to be flawed either through
student comments, coordinator review, or statistical analysis the question will be completely thrown
out and no one will receive credit for the question. Thus if a question on an exam is thrown out, the
final grade will include only 39 questions.
Video game testing
In video games, you are often allowed ‘extra lives.’ Meaning, if you fail at some
accomplishment, you are given a second try. The goal is that you obtain the accomplishment. For
the MPJE (and NABPLEX) you are allowed three tries before anything bad truly happens to you.
Thus in this class, we will have a similar mechanism of testing. For each of the midterm exams
(NOT THE FINAL) you will be allowed to take the exam up to three times (you get three lives!) If
you make greater than a 70 on the first attempt, you get to keep your score (I mean grade.) If you
make less than a 70 on the first attempt, you will be provided the option to retake a similar exam,
however you will not be allowed to make a grade of greater than 70 on any re-takes. The
coordinators and the student(s) taking the retakes will coordinate a time.
ExamSoft Testing
All exams, and possibly some other assignments in this course, will be administered through
the Examsoft software. You will be required to provide your own computer to access the software. If
you fail to either register and pay for the software OR do not bring a sufficient computer to class to
run the software during the examination/assignment period , you will receive a zero for the
assignment/exam. If you do not wish to purchase the software at this time, please drop the course.
X. Tentative Course Schedule
A. Schedule:
The dates for tests are firm and will be that date. However, some topics may switch depending on
the availability guest lecturers or the speed in which the material will be covered.
Date
August
19th
August
26th
September
2nd
September
9th
September
16th
September
23th
September
30th
October
7th
October
14th
Topic
Instructor
Evans
Introduction to
Class,
Malpractice and
Advocacy
Evans
The Beginning of
Process of Federal
Regulation
Evans
Requirements for
Marketed Drug
Products
Evans
Filling and
Dispensing
Medications
Evans
Filling and
dispensing finale
Evans
Louisiana
Pharmacy
Practice Act
Exam
Evans
Evans
Controlled
substance - The
beginning
Evans
Controlled
Substance
Lecture II Return of the
narcotics
Reading
Syllabus
October
21st
October
28th
November
4th
Evans
Controlled
Substances IIIThe Phantom
Lecture
Horace/Evans
Medicare
Modernization
Act and the
Affordable Care
Act
Horace/Evans
Special Topics in
Pharmacy Law Research and
Business Law
November
11th
November
18th
Exam
November
25th
Recent and
Interesting Case
Law
Final!!!!
3rd
December
Evans
Horace
Chaps 1, 3, 18,
19, 21, 23, 24, 29,
31, 33 - That's a
lot of chapters
Evans
Evans