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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

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

Answer 2

1914 Harrison Tax Act

Question 3

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

Answer 3

1938 Food, Drug and Cosmetic (FDC) Act

Question 4

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

Answer 4

1951 Durham- Humphrey Amendment

Question 5

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

Answer 5

1962 Kefauver-Harris Amendment

Question 6

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

Answer 6

1966 Fair Packaging and Labeling Act

Question 7

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

Answer 7

1970 Poison Prevention Packaging Act

Question 8

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 8

1970 Controlled Substances Act (CSA)

Question 9

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 9

Comprehensive Drug Abuse Prevention and Control Act of 1970

Question 10

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

Answer 10

1976 Medical Device Amendment

Question 11

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

Answer 11

1983 Orphan Drug Act

Question 12

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

Answer 12

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

Question 13

Requires pharmacists to offer counseling to Medicaid patients regarding medications.

Answer 13

1990 Omnibus Budget Reconciliation Act (OBRA 90)

Question 14

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

Answer 14

1987 Prescription Drug Marketing Act

Question 15

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

Answer 15

1990 Anabolic Steroid Control Act

Question 16

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 16

1996 Health Insurance Portability and Accountability Act (HIPAA)

Question 17

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

Answer 17

The pediatric labeling rule established 1994

Question 18

What is the purpose of phase 1 testing

Answer 18

Safety

Question 19

What is the purpose of phase 2 testing

Answer 19

Short-term safety but mainly effectiveness

Question 20

What is the purpose of phase 3 testing

Answer 20

Safety, dosage, and effectiveness

Question 21

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

Answer 21

Investigational New Drug (IND)

Question 22

How long is a drug patent in effect for

Answer 22

17 years from the date of the drug’s discovery

Question 23

What does OTC stand for

Answer 23

Over-the-counter

Question 24

What are OTC drugs

Answer 24

Drugs which do not require a prescription

Question 25

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

Answer 25

Combat Methamphetamine Epidemic Act

Question 26

What is the restriction for the combat methamphetamine epidemic act

Answer 26

3.6 g per day and 7.5 g per month

Question 27

What is required of a patient before purchasing ephedrine or pseudoephedrineWhat is required of retailers

Answer 27

Present photo identificationTo keep personal information about the purchasers for at least two years after each purchase

Question 28

How many control schedules are there for controlled substances

Answer 28

Five

Question 29

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 29

Schedule I

Question 30

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 30

Schedule II

Question 31

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 31

Schedule III

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 psychological dependence. Compounds containing limited amount of narcotic such as codeine are included in this group.

Answer 32

Schedule V

Question 33

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 33

Schedule IV

Question 34

How long are schedule II records kept

Answer 34

Seven years

Question 35

How long are schedules III, IV, & V kept

Answer 35

Two years

Question 36

Where are schedule II drugs stored

Answer 36

In a locked, tamper-proof narcotics cabinet

Question 37

Where are schedule III, IV, & V drugs stored

Answer 37

storage shelves

Question 38

What is an injunction

Answer 38

When the FDA prevents the manufacturer from distributing the drug

Question 39

How many classes of recalls are there

Answer 39

Three

Question 40

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

Answer 40

Class I Recall

Question 41

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

Answer 41

Class II Recall

Question 42

Where a product is not likely to cause adverse effects

Answer 42

Class III Recall

Question 43

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

Answer 43

Food and drug administration(FDA)

Question 44

Who controls the distribution of drugs

Answer 44

Drug Enforcement Administration (DEA)

Question 45

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

Answer 45

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

Question 46

What is ASHP stand for and who do the represent

Answer 46

American Society of Health-System PharmacistsThe 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 47

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

Answer 47

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 48

What does JCAHO stand for And who are they.

Answer 48

Joint commission on accreditation of healthcare organizationsA 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 49

What does ASCP stand for And what do they do

Answer 49

The American Society for consultant pharmacistsSet standards for practice for pharmacists who provide medication distribution and consulting services to nursing homes.