Ch3. Pharmacy Law and Ethics of Technicians Flashcards
Legislative
congress
executive
president
FDA
Food and Drug Administration
Judicial
Supreme Court
Kefauver-Harris Amendment of 1962
Effective and safe
Durham-Humphrey Amendment of 1951
Prescription and nonprescription drugs
Food, Drug, and Cosmetic Act of 1938
new drug application
Controlled Substances Act of 1970
drug schedule
A DEA number consists of a two-letter prefix followed by
seven digits
Who creates the standards for child-resistant packaging, as required by the Poison Prevention Packaging Act (PPPA)?
Consumer Product Safety Commission (CPSC)
An oral testimony taken by a court reporter at a location outside the courtroom, subject to the same requirements for truth as court testimony is called
deposition
Pharmacies should make a complete and accurate record of all stocks of controlled substances on hand every
2 years
The Pure Food and Drug Act of 1906 was believed inadequate for the following reasons, EXCEPT
a manufacturer could not make false statements about a drug
branch of the Department of Health and Human Services that controls all drugs for legal use
food and drug administration
creates standards for child-resistant packaging
consumer product safety commission (CPSP)
federal agency that provides facilities and services for the investigation, identification, prevention, and control of disease
Center for Disease control and prevention (CDC)
federal agency whose mission is to enforce the controlled substance laws and regulations
Drug Enforcement Administration (DEA)
mission is to ensure workplace safety and a healthy environment within the workplace
Occupational Safety and Health Administration (OSHA)
Which of the following laws is an extension of the Patriot Act?
Combat Methamphetamine Epidemic Act
The “Administrative Simplification” provision of the Health Insurance Portability and Accountability Act (HIPAA) consists of
Both Electronic Transactions and Privacy Standards
The maximum amount of items that may be ordered on DEA Form 222 is
10
Patient counseling, as required by the Omnibus Budget Reconciliation Act (COBRA) of 1990, should include
the name and description of the drug
What regulatory agency is responsible for the approval of drugs, over-the-counter (OTC) and prescription labeling, and standards for drug manufacturing?
Food and Drug Administration (FDA)
The agency deeply involved in the war against the human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) is the
Centers for Disease Control and Prevention (CDC)
Which of the following amendments or acts required manufacturers to register and list their products?
Medical Device Amendment
The branch of the government that is responsible for creating laws is the
legislative branch
A Class II Drug Recall is one in which
the use or exposure to the product may cause temporary or medically reversible adverse health hazards
The Model State Pharmacy Practice Act (MSPPA), which can provide a greater degree of uniformity between states in regards to the practice of pharmacy, was developed by the
National Associations of Boards of Pharmacy (NABP)
When a controlled substance is stolen or lost from a pharmacy, the nearest DEA office must be notified using which of the following DEA forms?
106
A pharmacist must be registered with the DEA if he
owns a pharmacy as a sole proprietor
A pharmacist must be registered with the DEA if he
owns a pharmacy as a sole proprietor
The official DEA form that pharmacies use to document the destruction of controlled substances is form
DEA-41
The study of values or principles governing personal relationships is called
Ethics
Which drug is an example of a Schedule V drug that requires a prescription?
Lomotil
Doctors and pharmacists are now required by the FDA to register and use a specific Web site in order to receive which of the following medications?
isotretinoin (Accutane)
Which act prohibits the reimportation of a drug into the United States by anyone but the manufacturer?
Prescription Drug Marketing Act
Prescriptions for Schedule II controlled substances can be refilled
No refills are allowed.
Dishonest and deceitful practices undertaken in order to induce someone to part with something valuable or a legal right
fraud
defamatory spoken words
slander
improper use of equipment, a substance, or a service
abuse
failure to use a reasonable amount of care to prevent injury or damage to another
negligence
defamatory writing such as published material that injures the reputation of another
libel
Applications for re-registration for a DEA license should be mailed approximately how many days prior to the expiration date?
60 days
Which schedule is the opiate morphine, which may result in severe psychological and physical dependence when abused?
Schedule II
Schedule IV controlled substances include drugs with
a low abuse potential such as certain hypnotics and minor tranquilizers
laws that result from court decisions
judicial law
governs the relationship of the individual to society as a whole
criminal law
governs the relationship between individuals within society
civil law
results from action by the legislature
statutes
the rules and regulations established by agencies of the federal government
Administrative law
requires that drug products—both prescription and nonprescription—must be effective and safe
Kefauver-Harris Amendment 1962
controls the manufacture, distribution, and dispensing of controlled substances
Comprehensive drug abuse prevention and control act 1970
prohibits dispensing of legend drugs without a prescription
durham-humphrey amendment 1951
placed the burden of proof squarely on FDA in regard to the safeness of dietary supplements
Supplemental Health and education act 1994
prohibits the reimportation of a drug into the United States
prescription drug marketing act of 1987
prohibits the interstate distribution or sale of adulterated and misbranded food and drugs
pure food and drug act 1906
offers tax breaks for companies to undertake the development and manufacture of drugs for uncommon diseases
orphan drug act of 1983
created the Food and Drug Administration (FDA) and required pharmaceutical manufacturers to file a New Drug Application with the FDA
food, drug, and cosmetic act of 1983
Orphan drugs are used for all of the following disorders or conditions, EXCEPT
peptic ulcer
Which information does not have to be included on a DEA Form 222 when ordering controlled substances?
social security number
An example of an intentional tort is
battery
Prescriptions for Schedules III and IV controlled substances can be refilled
up to five times in 6 months
