PHT 187 - Pharmacy Law and Ethics

1. Discuss the history and development of current pharmacy laws.
2. Describe legal terms associated with pharmacy practice such as rules, regulations and statutes.
3. Differentiate between the roles of a pharmacist and a pharmacy technician in the pharmacy setting.
4. Describe the limitations of the pharmacy technician in the state of Arizona.
5. Describe the legal requirements for ordering and record keeping of controlled substances in the State of Arizona.
6. Summarize the functions and responsibilities of the Arizona State Board of Pharmacy.
7. Describe the patient’s bill of rights.
8. Describe the prescribing and dispensing requirements and restrictions in the state of Arizona.
9. Analyze the selected pharmaceutical acts relating to state and federal regulatory agencies including the differences between criminal and civil law.
10. Describe the legal separation between compounding and manufacturing.
11. Summarize the code of ethics for pharmacists and pharmacy technicians.
12. Discuss the process of pharmaceutical ethics, its development and who is ultimately responsible in the pharmacy setting.
13. Describe the process of obtaining the National Pharmacy Technician Certification (PTCB).
14. Describe the process of obtaining both a permanent and trainee license from the Arizona State Board of Pharmacy.
15. Explain the advantages of participating in local, state, national, and other pharmacy technician organizations.

1. History and Development of Current Pharmacy Laws
   1. Developments leading to legislation
   2. Topics dealt with by federal government
   3. Topics dealt with by state governments
   4. Roles of state and federal governments
   5. 20th Century changes
2. Legal Terms Associated with Pharmacy Practice
3. Roles of Pharmacy Personnel
   1. Roles of the pharmacist
   2. Roles of the pharmacy technician
4. Limitations of the Pharmacy Technician
   1. Permissible activities
   2. Non-permissible
5. Ordering and Record Keeping of Controlled Substances
   1. Who may place orders
   2. Records kept by the pharmacy
   3. Records kept by an institution (hospital, nursing home, clinic etc.)
   4. Records kept by a practitioner
6. Arizona State Board of Pharmacy
   1. Functions
   2. Licensing for pharmacy technicians to include both PTCB certification as well as both the permanent and the trainee licenses
7. Patient’s Bill of Rights
8. Prescribing and Dispensing Requirements and Restrictions in the State of Arizona
   1. Who may prescribe?
   2. DEA numbers for prescribes
   3. Purpose of the prescription
   4. Addiction treatment restrictions
   5. Requirements and restrictions for the prescription form
   6. Labeling requirements and exemptions
   7. Dispensing controlled substances
   8. Mailing controlled substances
   9. Transferring of prescriptions and refills between pharmacies
   10. Early misbranding of medications
   11. Sophistication and complexity of new drugs
   12. Habit forming and dangerous drugs
9. State and Federal Regulatory Acts & Agencies
   1. Federal regulatory agencies
      1. The U.S. Food and Drug Administration (FDA)
      2. The U.S. Consumer Product Safety Commission (CPSC)
10. B            State regulatory agencies
    1. Arizona State Board of Pharmacy
    2. Hospital and Long Term Care Facilities
11. Institutional Regulation
    1. Pharmacy and Therapeutics Committee
    2. Joint Commission on Accreditation of Health Care Organization (JCAHO)
12. State and Federal Regulatory Pharmacy Acts
    1. Federal Food, Drug and Cosmetic Act
    2. Orphan Drug Act
    3. Controlled Substances Act
    4. Omnibus Budget Reconciliation Act
    5. Health Insurance Portability and Accountability Act (HIPPA)
    6. Federal Hazardous Substances Act.
13. Separation between Compounding and Manufacturing
    1. Descriptions of compounding and manufacturing
    2. Legal issues
14. Ethical Considerations in the Pharmacy Setting
    1. Code of ethics for pharmacists and technicians
    2. Development of pharmaceutical ethics (background and progression)
    3. Patient counseling
    4. Ethical responsibility
15. Pharmacy Organizations: Local, State, National, Other