Week 5 Chapter 14: Pharmacy Law, Regulations, and Standards Key Terms

Biennial Inventory

—DEA- registered pharmacies are required by law to take an initial inventory of all controlled substances on hand upon commencing operations or upon change of ownership, with subsequent inventories conducted every 2 years thereafter.

Biosimilar

—a biologic medication highly similar to a US Food and Drug Administration (FDA)- approved biologic medication (called the reference product). The efficacy and safety of a biosimilar product is clinically identical to the reference product. However, unless additional criteria are met, the reference product and the biosimilar product are not considered interchangeable owing to slight differences in the manufacturing process for biologic medications.

Child- Resistant Packaging

special packaging that children will have difficulty opening. It is used for hazardous products, such as prescription and over- the- counter drugs and household products, to reduce the risk of children ingesting dangerous items. Child- resistant packaging must pass federal tests to ensure that it meets the federal requirements

Controlled Substances

drugs or chemical substances whose possession and use are regulated under the Federal Controlled Substances Act and by state- controlled substance laws and regulations. Controlled substances are subject to stricter controls than other prescription and nonprescription drugs.

Drug Enforcement Administration (DEA)

the federal agency that administers and enforces federal laws for controlled substances, such as narcotics and other dangerous drugs and illegal substances. The DEA is part of the US Department of Justice.

Health Insurance Portability and Accountability Act (HIPAA)

the primary federal law establishing health information privacy. HIPAA protects patients’ individually identifiable health information but allows the use and disclosure of information for patient care, treatment, and healthcare operations.

Initial Inventory

the inventory a pharmacy takes of its stock of controlled substances on beginning the dispensing or distribution of controlled substances

Legend Drug

a drug required by federal law to be dispensed by prescription only. It is the older term for drugs that are now identified as “Rx Only.”

Practice of pharmacy

the duties and responsibilities of pharmacists, including, but not limited to, interpretation, evaluation, dispensing, and/or implementation of prescription drug orders and the initiation and provision of pharmacist care services. The practice of pharmacy is regulated by each state through its pharmacy laws and regulations.

Prescription drug monitoring programs (PDMP)

state prescription drug monitoring programs collect, review, and analyze information received from pharmacies about controlled substance prescriptions dispensed in the state. State law enforcement and regulatory agencies may review the information to assist in identifying and investigating potential diversion and abuse of controlled substance prescriptions.

Protected Health Information (PHI)

any health information that identifies or could reasonably be used to identify a patient.

Regulations (or rules)

an administrative or governmental agency issues regulations (or rules) that establish the requirements that the regulated persons or entities must follow. For example, a state board of pharmacy issues regulations for pharmacy technicians to establish the qualifications that pharmacy technicians must meet to work as a pharmacy technician in a state.