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Course Information
Health Careers Education
HL00120
Pharmacy Law and Ethics
15.00
Upon completion of this course, the student will comprehend state and federal laws and regulations regarding controlled substances, storage and dispensing of controlled substances. The agencies that regulate pharmacy practice will also be studied.
Lara Skaggs
405.743.5106
lskag@okcareertech.org
A. Describe the major Pharmacy Laws and understand their impact of the practice of pharmacy.

1. Explain the Pure Food and Drug Act of 1906.
2. Explain the Food, Drug, and Cosmetic Act of 1938.
3. Explain the Duham-Humphrey Amendment to 1962.
4. Explain the Kefaufver-Harris Amendment of 1962.
5. Explain the Comprehensive Drug Abuse Prevention and Control Act of 1970.
6. Explain the Poison Prevention Act of 1970.
7. Explain the Drug Listing Act of 1972.
8. Explain the Orphan Drug Act of 1983.
9. Explain the Drug Price Competition And Patent-Term Restoration Act of 1984.
10. Explain the Prescription Drug Marketing Act of 1987.
11. Explain the Omnibus Budget Reconciliation Act of 1990 (OBRA-90).
12. Explain the FDA Modernization Act.
13. Explain the Dietary Supplement Health and Education Act (DSHEA) of 1994.

B. Describe State and Federal Laws and Regulations Pertaining to Controlled Substances

1. Describe the classifications of controlled dangerous substances.
2. Explain Schedule I (C-I).
3. Explain Schedule II (C-II).
4. Explain Schedule III (C-III).
5. Explain Schedule IV (C-IV).
6. Explain Schedule V (C-V).

C. Dispensing and Reordering Controlled Dangerous Substances.

1. Explain partial filling and refilling regulations for different schedules of CDS.
2. List procedures for storing the different schedules of CDS.
3. List procedures for ordering the different schedules of CDS.
4. List procedures for maintaining inventory of the different schedules of CDS.
5. List the FDA requirements for "stock bottle" labels of CDS.
6. List the different filing schemes for hard copy prescriptions.

D. Health Insurance and Portability. (HIPPA)

E. Explain Difference Between Pharmacist and Pharmacy Technician Job Duties.

1. Understand legal and ethical consequences of performing duties only allowed by pharmacist.
2. Explain how state laws and regulations determine what activities associated with collection of patient specific information can be delegated by the pharmacist to technicians.
3. Explain how state laws and regulations determine what activities associated with receiving and screening prescription/medication orders for completeness and authenticity can be delegated by the pharmacist to
technicians.
4. Explain how state laws and regulations determine what activities associated with preparing medications for distribution can be delegated by the pharmacist to technicians.
5. Explain how state laws and regulations determine what activities associated with verifying the measurements, preparation and/or packaging of medications reproduced by other technicians can be delegated by
the pharmacist to technicians.
6. Explain how state laws and regulations determine what activities associated with patient counseling to optimize the use of medication, equipment and devices can be delegated by pharmacists to
technicians.

F. Explain Insurance Fraud.

1. Discuss prevention.
2. Discuss legal and ethical consequences.

G. Explain the Role of Boards of Pharmacy.

H. Recognize and Understand the Functions of the Agencies That Regulate and Effect Pharmacy Practice.

1. Food and Drug Administration (FDA).
2. Drug Enforcement Agency (DEA).
3. National Association of the Boards of Pharmacy (NABP).
4. State Board of Pharmacy.

I. Demonstrate Knowledge of Pharmacy Law.

1. Give examples of policies and procedures related to the practice of pharmacy.
2. Describe the difference between statutes, rules, regulations and quasi-legal standards.
3. Identify several state and regulatory agencies.
4. Explain the rules, regulations and reasons for practice standards in health institutions.
5. State the need for the Food, Drug, and Cosmetic Act.
6. Discuss quasi-legal standards thatdefine accepted professional practice.
7. State reasons for OSHA regulations.
8. State the intent of the Poison Prevention Packaging Act of 1970.
9. List the exemptions and describe the method of enforcement of the Poison Prevention Packaging Act of 1970.
10. State the history of the Omnibus Budget Reconciliation Act of 1990 (OBRA 90).
11. List the counseling guidelines, documentation requirements, standards, and methods of enforcement of OBRA 90.
12. State the history of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
13. List the guidelines, documentation requirements, standards and method of enforcement of HIPAA.
14. List the prescription, prescription label, refill and record requirements associated with medications.
15. Describe who may prescribe medications.

J. Legal Implications

1. Understand legal responsibilities and limitations.
2. Analyze implications of actions.
3. Implement problem solving techniques when confronted with legal issues.
4. Explain practices that could result in malpractice, liability, and/or negligence.
5. Apply procedures for accurate documentation and record keeping.
6. Implement established procedures based on risk management criteria.
7. Understand an incident report.
8. Summarize non-discriminatory laws.
9. Interpret healthcare facility policies and procedures.

K. Legal Practices


1. Implement mandated standards for Health Insurance Portability and Accountability Act (HIPAA).
2. Recognize common threats to confidentiality.
3. Summarize clients' rights according to the Patients' Bill of Rights.
4. Understand informed consent.
5. Compare licensure, certification, registration, and legislated scope of practice of a healthcare professional.
6. Explain mandated standards for harassment, labor, and employment laws.

L. Legal and Ethical Boundaries

1. Differentiate between morality and ethics.
2. Differentiate between ethical and legal issues impacting healthcare including confidentiality.
3. Compare personal, professional, and organizational ethics.
4. Recognize ethical issues and their implications related to healthcare.

M. Ethical Practice


1. Apply ethical behaviors including honesty and integrity in a healthcare setting.
2. Apply procedures for reporting activities and behaviors that affect the health, safety and welfare of others.

N. Cultural, Social, and Ethnic Diversity

1. Understand religious and cultural values as they impact healthcare services.
2. Demonstrate respect for individual diversity.


Pharmacy Technician - CTTC

http://www.okcareertech.org/testing/Skills_Standards/Health_Career_Cluster.htm



Pharmacy Technician - PTCB

http://www.pearsonvue.com/ptcb/
Pharmacy Technician Certification Board
Pharmacology Skills - CIMC

http://www.okcimc.com


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Career Majors That Sequence This Course
Career Cluster Pathway Career Major
Health Science Therapeutic Services Advanced Pharmacy Technician
Health Science Therapeutic Services Pharmacy Clerk
Health Science Therapeutic Services Pharmacy Technician