a. Schedule I: Extremely high potential for abuse, no accepted medical use (e.g., heroin, cocaine).
b. Schedule II: High abuse potential which may lead to severe psychological or physical dependence (e.g., methadone, oxycodone, morphine).
c. Schedule III: Less abuse potential than Schedules 1 and 2, but may lead to psychological or physical dependence (e.g., hydrocodone combination products).
d. Schedule IV: Low potential for abuse relative to Schedule 3 substances (e.g., alprazolam).
e. Schedule V: Low potential for abuse relative to Schedule 4 substances (e.g., cough preparations containing minimal codeine).
G. Omnibus Budget Reconciliation Act of 1990 required pharmacists to perform a drug therapy review and offer medication counseling to patients or their caregivers for all prescriptions filled.
H. Health Insurance Portability and Accountability Act (HIPAA) of 1996 required that health care providers ensure patient confidentiality.
- Pharmacy technicians should follow HIPAA laws to ensure that a patient’s protected health information is not disclosed inappropriately.
I. Combat Methamphetamine Epidemic Act of 2005 subjected pseudoephedrine and other agents used in the illegal manufacture of methamphetamine (“crystal meth”) to restricted sales, storage, and recordkeeping requirements.
- Sales of pseudoephedrine were limited to 3.6 g/day or 9 g/30-day period.
J. USP <797> established procedures and quality assurance requirements for facilities involved in the preparation, storage, or dispensing of sterile products to help ensure product sterility and decrease contamination. USP <795> established procedures and quality assurance requirements for nonsterile compounding. Section IV contains more information on these standards and guidelines.
K. The Resource Conservation and Recovery Act provides guidance for disposal of hazardous and nonhazardous waste. Pharmacies must comply with these guidelines when disposing of pharmaceutical waste. Depending on the type of waste stream, additional federal or state regulations may apply. Section VI contains more information on these guidelines.
L. State Pharmacy Practice Acts provide additional rules and laws for pharmacy practice that differ in each state. Pharmacy technicians should familiarize themselves with laws affecting pharmacy practice within their state.
- A state’s Pharmacy Practice Act governs how generic and brand product substitutions are made and how principles of therapeutic equivalence are applied under state law. Chapter 1 contains more detailed information on therapeutic equivalence.
For example, many states adopt a “positive formulary” approach, in which brand and generic products listed as therapeutically equivalent in the FDA’s Orange Book can always be substituted for one another. Other states utilize a “negative formulary” approach, in which they identify a defined list of branded products that cannot be substituted with generics without prescriber approval.
III. Pharmacy Regulatory Agencies
A. Regulatory agencies are established to enforce standards set forth in pharmacy-related laws, ensure public safety, and supervise the regulation of the pharmacy profession.
B. Centers for Medicare and Medicaid Services (CMS) oversee Medicare and Medicaid.
C. The DEA enforces prescriber and pharmacy compliance with the Controlled Substances Act.
D. The FDA oversees drug purity, safety, and effectiveness; issues and monitors drug recalls if products are adulterated or misbranded; regulates patient package inserts; and reviews applications for new and investigational drugs.
E. Accrediting bodies set standards and grant accreditation to promote patient safety and quality of care. The Joint Commission, previously known as Joint Commission on Accreditation of Healthcare Organizations (JCAHO), sets standards and grants accreditation to health care organizations to promote patient safety and quality of care. The Center for Pharmacy Practice Accreditation develops and implements accreditation programs for community pharmacies.
F. State Boards of Pharmacy (BOP) regulate pharmacy practice within each state. The National Association of Boards of Pharmacy (NABP) is made up of all of the state BOPs.
IV. Pharmacy Recordkeeping Requirements
A. Records of all prescriptions must be kept on file either as hard copies or electronically, as required by state law. Federal and state laws also require separate records to be maintained for some drug products, including controlled substances, recalled medications, repackaged products, and investigational drugs.
B. Controlled Substances
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