Jan. 2014
Angelina College
Health Careers Division
PHRA 1102: Pharmacy Law
Tentative General Syllabus
I.
BASIC COURSE INFORMATION
A. Course Description: Overview of federal and state laws governing the practice of pharmacy. The legal and
ethical constraints governing technician and pharmacist responsibilities in practice settings. One-hour credit.
(16hrs) Co-requisites: PHRA 1345, 1349, 1441, and 2366. Prerequisites: PHRA 1313, 1305, 1301, 1266, 1309
and BIOL 1409.Learning Outcomes: Distinguish between the responsibilities of pharmacy technicians and
pharmacists in pharmacy settings. Apply federal and state regulations governing safety, storage and dispensing
of medication.
B. Intended Audience: First –year students already enrolled in the Pharmacy Technology Program.
C. Instructor: Elaine Young
Office Location: HC II Room 222E
Office phone: 936-633-5433
Office email: eyoung@angelina.edu
Office hours: Thursday 12:00-2:00pm or Friday 8:00-12:00 noon
II. INTENDED STUDENT OUTCOMES:
A. Core Objectives – (Basic Intellectual Competencies-Tentative)
1. Critical Thinking Skills: Includes creative thinking, innovation, inquiry, and analysis, evaluation and
synthesis of information.
2. Communication Skills: Includes effective development, interpretation and expression of ideas through
written, oral, and visual communication.
3. Empirical and Quantitative Skills: Includes the manipulation and analysis of numerical data or
observable facts resulting in informed conclusions.
4. Teamwork: Includes the ability to consider different points of view and to work effectively with others to
support a shared purpose or goal.
5. Personal Responsibility: Includes the ability to connect choices, actions, and consequences to ethical
decision making.
6. Social Responsibility: Includes intercultural competence, knowledge, and civic responsibility, and the
ability to engage in regional, national, and global communities.
B. Course Objectives for all sections –
1. Differentiate between responsibilities of pharmacy technician and pharmacist.
2. Identify penalties associated with failure to practice within scope.
3. Apply knowledge of state and federal law to dispense medication and maintain prescription records in
compliance with state laws.
4. Demonstrate knowledge of product substitution laws in determination of product selection.
5. Apply knowledge of regulations pertaining to controlled substances to dispense medication.
6. Recognize errors of omission on hard copies.
C. Course Objectives as determined by the instructor –
1. Explain the importance of pharmacy legislation.
2. Relate the meaning of schedule to the CSA of 1970 and the criteria for placing a medication in a
particular schedule.
3. Differentiate between an initial inventory, biennial inventory, and perpetual inventory as they relate to
pharmacy.
4. Describe the methods of filing prescription and pharmacy records.
5. Explain the requirements issued by the CMS for Medicaid Tamper Resistant prescription pads.
6. Identify regulatory agencies and their role in the practice of pharmacy.
7. Identify the role of the state board of pharmacy in each state and the National Association of Boards of
Pharmacy.
5/9/2011
III. ASSESSMENT MEASURES OF STUDENT LEARNING OUTCOMES:
A. Assessments for the Core Objectives –
1. Critical Thinking Skills: Includes creative thinking, innovation, inquiry, and analysis, evaluation and
synthesis of information.
2. Communication Skills: Includes effective development, interpretation and expression of ideas through
written, oral, and visual communication.
3. Empirical and Quantitative Skills: Includes the manipulation and analysis of numerical data or
observable facts resulting in informed conclusions.
4. Teamwork: Includes the ability to consider different points of view and to work effectively with others to
support a shared purpose or goal.
5. Personal Responsibility: Includes the ability to connect choices, actions, and consequences to ethical
decision making.
6. Social Responsibility: Includes intercultural competence, knowledge, and civic responsibility, and the
ability to engage in regional, national, and global communities.
B. Assessments for Course Objectives for all sections –
SCANS Skills
Assessments
Foundation Skills
Required Reading
Written Assignments
Decision making & Problem Solving
Workplace Competencies
Acquires and Evaluates Information
Organizes and Maintains Information
Applies technology
Participates as a Team Member
Demonstrated Competency in Practium
C. Assessments for the Course Objectives as determined by the instructor –
Non-applicable
IV. INSTRUCTIONAL PROCEDURES:
A. Methodologies common to all sections
Discussion, demonstration, return demonstration/performance, video.
Additional methods designed for remediation or enrichment may be individually tailored as needed.
B. Methodologies determined by the instructor-The methods of instruction used in this course includes but
not limited to: 10-3 lecture. Discussion, performance, audiovisual, computer assisted instruction, group work,
and case studies.
V. COURSE REQUIREMENTS AND POLICIES:
A. Required Textbooks, Materials, and Equipment –
Pharmacy Technician Practice and Procedures, Gail Orum-Alexander, James Mizner, Jr. McGrawHill 2011
B. Assignments –
Week 1-3
Unit I Lecture
Unit II Lecture
Unit I Exam
Week 4-6
Unit III Lecture
Unit IV Lecture
Unit II Exam
Week 7-8
Unit V Lecture
Unit III Exam
Week 9-10
Unit VI Lecture
Unit IV Exam
Week 11-14
DEA form 222
Ordering
Case Studies
Week 15-16
Texas Law
Review
Final Exam
C. Course Policies – (This course conforms to the policies of Angelina College as stated in the Angelina
College Bulletin and Pharmacy Tech Program Handbook.)
Academic Assistance – If you have a disability (as cited in Section 504 of the Rehabilitation Act of 1973
5/9/2011
or Title II of the Americans with Disabilities Act of 1990) that may affect your participation in this class, you
should see Karen Bowser, Room 208 of the Student Center. At a post-secondary institution, you must selfidentify as a person with a disability; Ms. Bowser will assist you with the necessary information to do so.
Angelina College admits students without regard for race, color, creed, sex, national origin, age, religion, or
disability. Inquiries concerning sex equity, disability or age should be directed to Dr. Patricia McKenzie at
(936) 633-5201, Angelina College Administration building, Room A105.
Attendance – See Pharmacy Tech Student Handbook 2013-2014 (Attendance Information and Policies).
Students considering withdrawing from the program should speak with the Program Coordinator for
withdrawal and re-entry information.
Additional Policies Established by the Individual Instructor –
VI.
COURSE CONTENT:
A. Required Content/ Topics –
Unit I: Federal Pharmacy Laws 1906-1962
1. 1906-Pure Food & Drug Act
2. 1912-Sherley Amendment
3. 1914-Harrison Narcotic Act
4. 1938-Food, Drug and Cosmetic Act
5. 1952-Durham-Humphrey Amendment
6. 1962-Kefauver-Harris Amendment
Unit II: Federal Pharmacy Laws 1970-1979
1. 1970-Poison Prevention Packaging Act
2. 1970-Occupational Safety & Health Act
3. 1972-Drug Listing Act
4. 1976-Medical Device Amendments
Unit III: Federal Pharmacy Laws 1980-1999
1. 1983-Orphan Drug Act
2. 1984-Drug Price Competition and Patent Term Restoration Act
3. 1987-Prescription Drug Marketing Act
4. 1987-Omnibus Budget Reconciliation Act
5. 1994-Dietary Supplement Health and Education Act
6. 1996-Health Insurance Portability and Accountability Act
7. 1996- Comprehensive Methamphetamine Control Act of 1996
8. 1997-FDA Modernization Act
Unit IV: Federal Pharmacy Laws 2000-present
1. 2003-Medicare Modernization Act
2. 2004-Isotretinoin Safety and Risk Management Act
3. 2004-Anabolic Steroid Control Act
4. 2005-Combat Methamphetamine Epidemic Act
5. 2008-Implementation of Medicaid Tamper Resistant Prescription Pad Law
6. 2010-Affordable Care Act
Unit V-Regulatory Agencies
1. FDA
2. DEA
3. OSHA
4. TJC
5. State Boards of Pharmacy
6. National Associations of Boards of Pharmacy (NABP)
Unit VI-Controlled Substance Act of 1970
5/9/2011
1.
2.
3.
4.
5.
6.
7.
8.
Schedule I drugs
Schedule II drugs
Schedule III drugs
Schedule IV drugs
Schedule V drugs
Destruction of Controlled Substances
Controlled Substance Inventories
Ordering of Controlled Substances
B. Additional Content -none
VII. EVALUATION AND GRADING:
A. Grading Criteria
Class attendance/participation* 50 pts
Unit I Exam (1 & 2)
100 pts
Unit II Exam (3 & 4))
100 pts
Unit III Exam (5)
200 pts
Unit IV Exam (6)
200 pts
DEA form 222 Ordering
100 pts
Case Studies
100 pts
Final Exam
150 pts
(25 pts will be deducted for each excused or unexcused absence)
B. Determination of Grade
900-1000 =A
600-699 = D
800-899 = B
599 & below = F
700-799 = C
VIII. SYLLABUS MODIFICATION:
The instructor may modify the provisions of the syllabus to meet individual class needs by informing the class in
advance as to the changes being made.
5/9/2011