Question 1

Accessory:

Accepted Answer

Any individual who helps a person to violate the law either directly or indirectly.

Question 2

Administrative law:

Accepted Answer

Regulations set forth by governmental agencies, such as the Internal Revenue Service (IRS) and the Social Security Administration (SSA); also called regulatory law.

Question 3

Adulterated:

Accepted Answer

Tampering with or contaminating a product or substance.

Question 4

Barbiturates:

Accepted Answer

Drugs derived from barbituric acid, which act as central nervous system depressants.

Question 5

Bioethics:

Accepted Answer

A discipline dealing with the ethical and moral implications of biological research and applications.

Question 6

Civil law:

Accepted Answer

Rules and regulations that govern the relationship between individuals within society.

Question 7

Crime:

Accepted Answer

A violation of the law.

Question 8

Criminal:

Accepted Answer

An individual who violates the law.

Question 9

Drug Enforcement Administration (DEA):

Accepted Answer

A federal law enforcement agency that combats illegal drug use and smuggling both within the United States and abroad.

Question 10

Felony:

Accepted Answer

A serious crime, such as murder, kidnapping, assault, or rape, that is punishable by imprisonment for more than one year.

Question 11

Food and Drug Administration (FDA):

Accepted Answer

The agency within the U.S. Department of Health and Human Services that is responsible for assurance of the safety, efficacy, and security of drugs used for humans and pets.

Question 12

Law:

Accepted Answer

A rule or regulation established by a governing body.

Question 13

Malpractice:

Accepted Answer

Professional misconduct, or the demonstration of an unreasonable lack of skill, resulting in injury, loss, or damage to a patient.

Question 14

Medical ethics:

Accepted Answer

The discipline in which merits, risks, and social concerns are evaluated concerning the practice of medicine.

Question 15

Misbranding:

Accepted Answer

Fraudulent labeling or marking.

Question 16

Misdemeanor:

Accepted Answer

A crime less serious than a felony, punishable by a fine or imprisonment for less than one year.

Question 17

National Drug Code (NDC):

Accepted Answer

A unique and permanent product code assigned to each new drug as it becomes available in the marketplace; it identifies the manufacturer or distributor, the drug formulation, and the size and type of its packaging.

Question 18

National Formulary (NF):

Accepted Answer

A database of officially recognized drug names.

Question 19

Negligence:

Accepted Answer

A type of unintentional tort alleged when a person has performed, or failed to perform, an act that a reasonable person would, or would not, have performed in similar circumstances.

Question 20

Orphan drug:

Accepted Answer

A drug that is developed for small populations of people in need of the drug.

Question 21

Regulatory law:

Accepted Answer

Regulations set forth by governmental agencies. It is also called administrative law.

Question 22

Standard code sets:

Accepted Answer

Under HIPAA, “codes used to encode data elements, tables of terms, medical concepts, diagnostic codes, or medical procedure.” A code set includes the codes and descriptors of the codes.

Question 23

Standards:

Accepted Answer

Established by authority, custom, or general consent as a model or example; something set up and established by authority as a rule for the measure of quantity, weight, extent, value, or quality.

Question 24

Statutes:

Accepted Answer

Rules and regulations resulting from decisions by legislatures.

Question 25

Tort:

Accepted Answer

A civil wrong committed against person or property.

Question 26

Intentional torts:

Accepted Answer

Person's rights infringed upon purposely.

Question 27

Unintentional torts:

Accepted Answer

Committed inadvertently against someone  (negligence or malpractice)

Question 28

Fraud:

Accepted Answer

Dishonest and deceitful practices.

Question 29

Libel:

Accepted Answer

Defamatory writing.

Question 30

Slander:

Accepted Answer

Defamatory speech.

Question 31

Negligence:

Accepted Answer

Failure to use reasonable care.

Question 32

Abuse:

Accepted Answer

Improper use of equipment, a substances, or a service.

Question 33

The Pure Food and Drug Act of 1906:

Accepted Answer

Enforces accurate labeling, list of ingredients, and Patient Package Insert.

Question 34

The Harrison Narcotics Act of 1914:

Accepted Answer

Enforces documentation for prescriptions and dispensing opium, cocaine,  and derivatives products.

Question 35

The Food, Drug, and Cosmetic Act of 1938:

Accepted Answer

Addressed adulteration and misbranding of drugs; based on the 1906 Pure Food and Drug Act.

Question 36

The Durham-Humphrey Act of 1951:

Accepted Answer

Made the distinction between legend drugs (prescriptions) and over-the-counter (OCTs) medications that do not require a prescription.

Question 37

The Kefauver-Harris Amendments of 1962:

Accepted Answer

Gave the FDA specific authority to approve a manufacturer’s
marketing application before a drug could be available for commercial use.

Question 38

The Controlled Substance Act of 1970:

Accepted Answer

The DEA was formed to enforce the laws concerning controlled
substances and their distribution.

Question 39

Controlled substances are returned using:

Accepted Answer

The DEA Form 222.

Question 40

SDS sheets are:

Accepted Answer

Are for all dangerous chemicals in a workplace.

Question 41

The Orphan Drug Act of 1983:

Accepted Answer

Used to help create medication for a certain diseases with assistance given to the companies that do the research.

Question 42

The Omnibus Budget Reconciliation Act of 1990:

Accepted Answer

Provided better quality care for elderly on Medicare (quality of hospice care went up) and allowed commercial pharmacies
to work with customers who had Medicaid.

Question 43

Health Insurance Portability and Accountability Act (HIPAA):

Accepted Answer

Is in place to make sure that all patient's information is private.

Question 44

DIfferent classes of recalls:

Accepted Answer

Class 1, Class 2, and Class 3.

Question 45

Class 1:

Accepted Answer

With irreversible side effects or death.

Question 46

Class 2:

Accepted Answer

With reversible side effects.

Question 47

Class 3:

Accepted Answer

The medication has a different color smell than normal.

Question 48

Medmarx:

Accepted Answer

Is an Internet-accessible database to track medication errors in hospitals.

Question 49

FDA oversees:

Accepted Answer

MedWatch

Question 50

FDA is responsible for approving:

Accepted Answer

"Tall-Man" letters.

Question 51

ISMP  is responsible for implementing:

Accepted Answer

The error-prone abbreviation list.

Question 52

ISMP  is responsible for:

Accepted Answer

Responsible for overseeing Medmarx.

Question 53

ISMP made recommendations for:

Accepted Answer

Verbal prescriptions.

Question 54

MERP:

Accepted Answer

Has a medication error systems.

Chapt.3 Pharm. Law..

Chapter 3 Pharmacy Law, Ethics, and Regulatory Agencies

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