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Course Proficiences
*Note on course proficiences*

YEAR 3
SEMESTER II

Pharmacy Law & Ethics
PHAR 5374

Course Description: The study of federal and state laws, regulations and case law which govern and control the practice of pharmacy. The course will also cover the ethical implications of modern pharmacy practice.

Cr. 3. (3-0).

Prerequisite: Third year standing in the College of Pharmacy or consent of the instructor.

Course Proficiencies: The student will be able to:

1. Distinguish the sources and types of law in the United States.
2. Identify the reasons why society regulates medications and the limits on this regulation.
3. Explain the federal and state legislative process.
4. Explain the structure and function of the judicial system.
5. Distinguish between federal authority and state authority to regulate medications and pharmacy practice.
6. Identify the significant historical events that have shaped the current Federal Food, Drug and Cosmetic Act (FDCA).
7. Distinguish between the definitions of food, drug, cosmetic, device, label, and labeling.
8. Identify the prohibited acts, penalties, and enforcement mechanisms in the FDCA.
9. Identify the situations that may cause a drug to be adulterated or misbranded.
10. Differentiate FDCA requirements for prescription drugs from those for over-the-counter drugs.
11. Identify the rules and procedures pertaining to new drug approval.
12. Distinguish between pharmacy compounding and manufacturing.
13. Identify the scope and implications of the Prescription Drug Marketing Act.
14. Recognize the requirements of the Poison Prevention Packaging Act .
15. List the five schedules of controlled substances.
16. Explain which activities require registration with the Drug Enforcement Administration.
17. Recognize the record keeping requirements under the Controlled Substances Act.
18. Explain the “legitimate medical purpose” doctrine.
19. Recognize the limitations placed on inspections of pharmacies by the U.S. Constitution.
20. Distinguish between a notice of inspection, an administrative inspection warrant, and a search warrant.
21. Discuss the issues related to inspections by state boards of pharmacy.
22. Identify the requirements for drug use review, patient counseling, prescription screening, and documentation by pharmacists as mandated under OBRA 90.
23. Identify the elements of a professional malpractice action against a pharmacist.
24. Describe the legal standard of care for a pharmacist in processing prescriptions and medication orders.
25. Recognize the types of prescription processing errors that can lead to pharmacist liability.
26. Discuss the available defenses to a claim of professional negligence.
27. Describe the purpose of professional malpractice insurance.
28. Describe the recent legal opinions that have imposed expanding legal responsibilities on pharmacists.
29. Explain the pharmacist’s legal responsibility to counsel patients, monitor drug therapy, and resolve potential problems.
30. Explain HIPAA (The Health Insurance Portability and Accountability Act of 1996 regulations.
31. Explain the purpose, membership, responsibilities, and rule-making authority of the Texas State Board of Pharmacy.
32. Explain the provisions of the Texas Pharmacy Act.
33. Discuss incidents or behaviors that constitute “unprofessional conduct”, “gross immorality”, or “fraud, deceit or misrepresentation” in the practice of pharmacy as a grounds for discipline of a pharmacy license.
34. Discuss the goals, objectives, and requirements for the Texas Colleges’ of Pharmacy internship programs.
35. Discuss the Texas Board of Pharmacy’s inventory requirements.
36. Explain the requirements for, and the differences in legal requirements for personnel, security, operational standards, and records in a Class A, Class B, Class C, and Class D pharmacy
37. Explain the Texas Board of Pharmacy Rules relating to:
    1. Requirements of the pharmacist-in-charge
    2. Responsibilities for patient counseling and provision of drug information to patients in Class A pharmacies
    3. Requirements for patient medication records, drug regimen review, and identification of pharmacy personnel in Class A and C pharmacies
    4. Record keeping under a manual system and data processing system
    5. Requirements for written, verbal, and facsimile (FAX) prescriptions
    6. Requirements and restrictions for prescriptions issued by practitioners not licensed in Texas
    7. Requirements and restrictions for prescriptions carried out by registered nurses and physician assistants
    8. Special requirements relating to Class C pharmacies
    9. Special requirements relating to Class D pharmacies
    10. Continuing education requirements
    11. Disposal of dispensed drugs and stock prescription drugs
    12. Regulations concerning generic substitution
    13. Triplicate prescription program
    14. Emergency refill provisions
38. Distinguish legal responsibilities form ethical responsibilities.
39. List the requirements for informed consent.
40. Describe the responsibilities of researchers who experiment with human subjects.
41. Explain the patient’s right of confidentiality with regard to medication records.
42. Define the field of pharmacy ethics.
43. Explain a process of ethical decision making.
44. Distinguish ethically defensible solutions to several moral problems in pharmacy.