Chapter 3: Drug Regulation and Control

Question 0

Established that manufacturers, pharmacists, importers, and physicians prescribing narcotics should be licensed and required to pay a tax.

Answer 0

1914 Harrison Tax Act

Question 1

Prohibited interstate commerce in adulterated or misbranded food, drinks, and drugs. Government preapproval of drugs is required.

Answer 1

Food and Drug Act of 1906

Question 2

this came into effect because of fatal poisoning from liquid sulfanilamide, it required new drugs to be shown to be safe before marketing

Answer 2

1938 Food, Drug and Cosmetic (FDC) Act

Question 3

This law defines what drugs require a prescription by a licensed practitioner and requires them to include “RX only” on the label

Also known as legend drugs

Answer 3

1951 Durham- Humphrey Amendment

Question 4

Requires drug manufacturers to provide proof of both safety AND effectiveness before marketing the drug.

Answer 4

1962 Kefauver-Harris Amendment

Question 5

Requires all consumer-products in interstate commerce to be honestly and informatively labeled.

Answer 5

1966 Fair Packaging and Labeling Act

Question 6

Requires childproof packaging on all controlled and most prescription drugs dispensed by pharmacies.

Answer 6

1970 Poison Prevention Packaging Act

Question 7

The act that classifies five levels of drugs, controlled substances, that have potential for abuse and therefore we restricts their distribution.

Completely replaced Harrison Act

Answer 7

1970 Controlled Substances Act (CSA)

Question 8

The drug enforcement agency was created and placed under the supervision of the Department of Justice. Control substances are placed in one of five schedules based on a potential for abuse and accepted medical use in the United States.

Answer 8

Comprehensive Drug Abuse Prevention and Control Act of 1970

Question 9

Requires premarket approval for safety and effectiveness of life-sustaining and life-supporting medical devices.

Answer 9

1976 Medical Device Amendment

Question 10

Provides incentives to promote research, approval, and marketing of drugs needed for the treatment of rare diseases

Answer 10

1983 Orphan Drug Act

Question 11

This act allowed for both the extension of drug patent terms and quicker introduction of lower-cost generic drugs.

Answer 11

1984 Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman)

Question 12

Requires pharmacists to offer counseling to Medicaid patients regarding medications.

Answer 12

1990 Omnibus Budget Reconciliation Act (OBRA 90)

Question 13

Restricts distribution of PRESCRIPTION DRUGS to legitimate commercial channels and requires drug wholesalers to be licensed by the states.

Answer 13

1987 Prescription Drug Marketing Act

Question 14

This act was passed to “address the abuse of steroids by athletes, and, especially, youngsters and teenagers.”

Answer 14

1990 Anabolic Steroid Control Act

Question 15

The scope of health information that may and may not be shared among healthcare providers without patient consent and provided for a broad and stringent regulations to protect patients right to privacy.

Answer 15

1996 Health Insurance Portability and Accountability Act (HIPAA)

Question 16

All drugs have pediatric dosing and safety information on their labels if the drug has potential use for pediatric patients.

Answer 16

The pediatric labeling rule established 1994

Question 17

What is the purpose of phase 1 testing

Answer 17

Safety

Question 18

What is the purpose of phase 2 testing

Answer 18

Short-term safety but mainly effectiveness

Question 19

What is the purpose of phase 3 testing

Answer 19

Safety, dosage, and effectiveness

Question 20

During the trial phase, what is a proposed new drug called

Answer 20

Investigational New Drug (IND)

Question 21

How long is a drug patent in effect for

Answer 21

17 years from the date of the drug’s discovery

Question 22

What does OTC stand for

Answer 22

Over-the-counter

Question 23

What are OTC drugs

Answer 23

Drugs which do not require a prescription

Question 24

Sets daily and monthly restrictions on the amount of ephedrine or pseudoephedrine that can be sold to an individual

Answer 24

Combat Methamphetamine Epidemic Act

Question 25

What is the restriction for the combat methamphetamine epidemic act

Answer 25

3.6 g per day and 7.5 g per month

Question 26

What is required of a patient before purchasing ephedrine or pseudoephedrine

What is required of retailers

Answer 26

Present photo identification

To keep personal information about the purchasers for at least two years after each purchase

Question 27

How many control schedules are there for controlled substances

Answer 27

Five

Question 28

Each drug has a high potential for abuse and no accepted medical use in the United States. It may not be prescribed. Heroin, various opium derivatives, and hallucinogenic substances are included on the schedule.

Answer 28

Schedule I

Question 29

Each drug has a high potential for abuse and may lead to physical or psychological dependence, but also has a currently accepted medical use in the United States. Amphetamines, opium, cocaine, methadone, and various opiates are included on the schedule.

Answer 29

Schedule II

Question 30

is a currently accepted medical use in the US, but abuse may lead to moderate or low physical dependence or high psychological dependence. Anabolic steroids and various compounds containing limited quantities of narcotic substances such as codeine are included on the schedule.

Answer 30

Schedule III

Question 31

Low potential for abuse, there is a current accepted medical use in the US, but abuse may lead to limited physical dependence or psychological dependence. Compounds containing limited amount of narcotic such as codeine are included in this group.

Answer 31

Schedule V

Question 32

Low potential for abuse. there is a current accepted medical use in the US, but abuse may lead to limited physical dependence or high psychological dependence. Phenobarbital, the sedative chloral hydrate, and the anesthetic methohexital are included in this group.

Answer 32

Schedule IV

Question 33

How long are schedule II records kept

Answer 33

Seven years

Question 34

How long are schedules III, IV, & V kept

Answer 34

Two years

Question 35

Where are schedule II drugs stored

Answer 35

In a locked, tamper-proof narcotics cabinet

Question 36

Where are schedule III, IV, & V drugs stored

Answer 36

storage shelves

Question 37

What is an injunction

Answer 37

When the FDA prevents the manufacturer from distributing the drug

Question 38

How many classes of recalls are there

Answer 38

Three

Question 39

Where there is a strong likelihood that the product will cause serious adverse effects or death.

Answer 39

Class I Recall

Question 40

Where a product may cause temporary but reversible adverse effects, or in which there is little likelihood of serious adverse effects.

Answer 40

Class II Recall

Question 41

Where a product is not likely to cause adverse effects

Answer 41

Class III Recall

Question 42

Who is the leading enforcement agency at the federal level for regulations concerning drug products

Answer 42

Food and drug administration

FDA

Question 43

Who controls the distribution of drugs

Answer 43

Drug Enforcement Administration (DEA)

Question 44

Which OTC medications are kept behind the counter even if they do not require a prescription

Answer 44

Medications containing ephedrine and pseudoephedrine; exempt narcotics; and emergency contraceptives.

Question 45

What is ASHP stand for and who do the represent

Answer 45

American Society of Health-System Pharmacists

The 30,000 member Association for pharmacist practicing in hospitals, HMOs, long-term care facilities, home care agencies, and other healthcare systems. It is an accrediting organization for pharmacy residency and pharmacy technician training Program.

Question 46

What does USP stand for and who do they set standards for

Answer 46

United States Pharmacopoeia

A voluntary non-for profit organization that set standards for the manufacture and distribution of drugs related products in the United States. These standards are directly referred to by federal and state laws.

Question 47

What does TJC (JCAHO) stand for And who are they.

Answer 47

The Joint Commission (Joint commission on accreditation of healthcare organizations)

A non-profit independent organization that establishes standards and monitors compliance for nearly 20,000 healthcare programs in the United States, Including hospitals, healthcare networks,HMOs, and nursing homes, among others.

Question 48

What does ASCP stand for And what do they do

Answer 48

The American Society for consultant pharmacists

Set standards for practice for pharmacists who provide medication distribution and consulting services to nursing homes.