ch2

What are the federal acts that govern the practice of pharmacy?

Examples include the Pure Food and Drug Act of 1906, the Federal Food, Drug, and Cosmetic Act of 1938, the Drug Enforcement Administration (DEA) guidelines, and the Health Insurance Portability and Accountability Act (HIPAA).

What are the three classes of drug recalls as defined by the FDA?

Class 1: Serious risk or death; Class 2: Temporary health problem; Class 3: Minor defect or condition.

What is the function of the Health Insurance Portability and Accountability Act (HIPAA)?

HIPAA protects patients' rights, establishes standards for electronic health care communication, and ensures the security and privacy of health data.

Under the Durham-Humphrey Amendment, how are prescription drugs defined?

Prescription drugs require a prescriber's order and are labeled 'Caution: Federal law prohibits dispensing without a prescription.'

What is a Boxed Warning?

A Boxed Warning is the strongest warning by the FDA indicating a significant risk of serious or life-threatening side effects.

Who can prescribe medications according to federal laws?

Practitioners such as physicians, dentists, and nurse practitioners can prescribe medications, but it varies state by state regarding the scope of their prescribing authority.

What constitutes a controlled substance?

Any drug or other substance that is scheduled I through V and regulated by the DEA; includes substances with potential for abuse.

What is drug diversion?

The intentional misuse of a drug intended for medical purposes, such as recreational use of a prescription or scheduled drug.

What is the purpose of the Drug Quality and Security Act (DQSA)?

The DQSA enhances FDA oversight of drug compounding and establishes a national tracking system for drugs.

What is the purpose of The Joint Commission (TJC)?

The TJC accredits hospitals and health care organizations to ensure quality and safety in the delivery of care.

What is a drug monograph and what does it typically contain?

A drug monograph is comprehensive information on a medication, including indications, dosage, side effects, and warnings.

What is the significance of the National Drug Code (NDC)?

The NDC is a unique 10-digit number that identifies specific drugs by the manufacturer, product, and package size.

The __________ is the federal agency responsible for regulating drug approval and safety in the United States.

Food and Drug Administration (FDA)

The __________ Act established standards for the labeling of prescription and over-the-counter medications.

Federal Food, Drug, and Cosmetic Act

__________ substances are those that have a high potential for abuse and are classified as Schedule I.

Controlled

A __________ is a document required when dispensing a controlled substance to ensure it is used legally.

prescription

The __________ classification system categorizes drugs based on their potential for abuse and medical use.

scheduling

A medication that is labeled with a __________ warning must be used with caution due to the risk of severe health consequences.

boxed

The Drug Enforcement Administration (DEA) oversees the __________ of controlled substances in the United States.

registration and distribution

The __________ Amendment regulates the advertising and distribution of prescription drugs to ensure they are not misleading.

Durham-Humphrey

__________ information is essential for pharmacists to provide safe and effective medication therapy management.

Drug monograph

A __________ recall indicates that a product may cause temporary health issues but is not likely to cause severe consequences.

Class II