PHT 51: PHARMACY LAW FOR PHARMACY TECHNICIANS
Foothill College Course Outline of Record
|Effective Term:||Summer 2021|
|Hours:||2 lecture per week (24 total per quarter)|
|Degree & Credit Status:||Degree-Applicable Credit Course|
|Grade Type:||Letter Grade Only|
Student Learning Outcomes
- Identify and utilize the naming systems, source, use, biotransformation and biodynamics,variables in drug responses and record keeping of available pharmaceutical supplies.
- Demonstrate handling and mandatory record keeping for durgs requiring special handling(scheduled drugs,BTC's,IND's,etc.).
The student will be able to:
A. Learn the legal definitions of drugs and learn how to differentiate among drugs that are either natural products, semi-synthetic, or synthetic.
B. Pharmacologically classify a drug after having been presented with its generic name, brand (trade) name and chemical name.
C. Explain the graphical presentation of the dose-response relationship, potency, bioequivalence and efficacy.
D. Demonstrate an awareness and implications of various drug interactions, side/adverse effects, and drug-drug and drug-food interactions.
E. Recognize the pregnancy risk registry.
F. Interpret current federal and state legislation and agencies regulating the practice of pharmacy.
G. Describe all schedules of controlled substances.
H. Identify methods of record keeping, dispensing, transfer and inventory of controlled substances.
I. Define and describe verification of DEA numbers.
J. Explain the Five Rights of Medication Administration.
K. Define investigational drugs, new drug applications, patent rights, orphan drugs, generic substitution, black box warnings, MedGuides and Risk Evaluation and Mitigation Strategies (REMS) for drugs with FDA alerts.
1. Learn the legal definitions of drugs
2. Learn how to differentiate between different sources of drugs: natural, semi-synthetic, synthetic
B. Classification of drugs
1. Learn and understand how to use drug nomenclature: brand name, generic name, organic name, official name, synonyms, acronyms and combination drugs
2. Learn nomenclature specific for categories of drugs, such as prescription drugs, over-the-counter drugs, behind-the-counter drugs, dietary supplements, controlled substances
C. Uses of drugs
1. Blood concentration dose-response curves
2. Potency and efficacy
3. Pharmaceutical equivalents
4. Therapeutic equivalents
D. Assessment of therapeutic use and drug effects and interactions (assignment)
1. Therapeutic effect
2. Side/adverse effects
4. Black box warnings
E. Review pregnancy risk registry and terminology
F. Federal and state legislation regulating the practice of pharmacy
1. Federal laws and agencies
a. Federal Food Drug and Cosmetic Act
b. Durham-Humphrey Amendment of 1951
c. Kefauver-Harris Amendment of 1963
d. Occupational Safety and Health Act of 1970
e. Controlled Substances Act
f. Hazardous Substances Labeling Act
g. Poison Prevention Packaging Act
h. Drug Enforcement Administration
i. Resource Conservation and Recovery Act of 1976
l. Anabolic Steroid Control Act
m. Dietary Supplement Health and Education Act of 1994
o. Medicare Modernization Act
p. The Combat Methamphetamine Epidemic Act of 2005
q. The HITECH Act
r. The Affordable Care Act
2. State laws and regulations
a. California Pharmacy Law and Regulations
b. California Hazardous Substances Act
c. California State Board of Pharmacy
d. Department of Consumer Affairs
G. Controlled substances
1. Schedule I, II, III, IV and V
a. Federal laws
b. California laws (when stricter)
2. General requirements and types of drugs
3. Drugs assigned to each controlled substance schedule
H. Record keeping, dispensing and transfer of controlled substances
1. Ordering and using Form 222 for Schedule II drugs
2. Record keeping for Schedule II drugs
3. Ordering and record keeping for Schedule III, IV and V drugs
4. Schedule II prescriptions
a. Requirements of a legal written prescription
b. Requirements for a legal electronically transmitted prescription
5. Schedule III-V prescriptions
a. Federal refill schedules
b. California refill schedules
6. State exemptions for emergency situations
7. Transfers between registrants
8. Reporting requirements for loss or theft situations
9. Inventory policy for controlled substances
I. DEA numbers
2. Entities that may have DEA numbers
3. Determination of authenticity of a DEA number
J. Five Rights of Medication Administration
1. The right patient
2. The right drug
3. The right dose
4. The right route
5. The right time
K. Pharmaceutical terminology
1. Investigational new drugs
2. New Drug Application
3. Abbreviated New Drug Application
4. OTC drugs
5. Legend drugs
6. Generic drug substitution
8. REMS guides
9. Black box warnings
Special Facilities and/or Equipment
Method(s) of Evaluation
Method(s) of Instruction
Lecture presentations and classroom discussion regarding topics
Small group recitation sessions to discuss concepts
Representative Text(s) and Other Materials
American Pharmacists Association, Perspective Press. The Pharmacy Technician, 7th ed.. 2020.
Moini, Jahangir. Law and Ethics for Pharmacy Technicians, 3rd ed.. 2018.
Ballington, Don, and Robert Anderson. Pharmacy Practice for Technicians, 6th ed.. 2017.
California Board of Pharmacy. Pharmacy Laws with Rules & Regulations. 2019.
Types and/or Examples of Required Reading, Writing, and Outside of Class Assignments
A. Weekly reading assignments from text and outside sources ranging from 10-15 pages per week.
B. Online research assignments required.