The Drug Approval Process

Question 1

What phase is this:

Who? NORMAL Volunteers SPECIAL POPULATION ( renal and hepatic Impairment
Why? SAFETY, Biological Effects, metabolism kinetics, DRUG INTERACTIONS
By whom? CLINICAL PHARMACOLOGIST

Answer 1

Phase 1

Question 2

What phase is this:

Who? SELECTED PATIENTS
Why? THERAPEUTIC efficacy, dose range, kinetics, metabolism
By whom? Clinical PHARMACOLOGIST and clinical INVESTIGATORS

Answer 2

Phase 2

Question 3

What phase is this:

Who? LARGE sample of SELECTED populations
Why? safety and efficacy
By whom? Clinical INVESTIGATORS

Answer 3

Phase 3

Question 4

What phase is this:

Who? Patients given drug for THERAPY
Why? ADVERSE reactions, patterns of drug utilization, ADDITIONAL indications DISCOVERED
By whom? All PHYSICIANS

Answer 4

Phase 4

Question 5

In this phase of clinical trials, the MAJORITY of the RISKS ASSOCIATED with the NEW DRUG therapy are identified.

Answer 5

Phase IV

Question 6

prohibited the sale of misbranded or adulterated food and drugs

Answer 6

Pure Food and Drug Acts

Question 7

require that drug products, both prescription and non prescription, must be pure, effective and safe

Answer 7

Federal Food, Drug, and Cosmetics Act of 1938

Question 8

allows FDA to set good manufacturing practices and mandated regular inspections of production facilities. transferred to FDA control of prescription drug advertising

Answer 8

Kefauver-Harris Amendment

Question 9

• United States Pharmacopeia National Formulary (USP-NF)
• The International Pharmacopeia (1951)
• (met high standards for therapeutic use, patient safety, quality, purity, strength, packaging safety, and dosage form)

Answer 9

Drug standards

Question 10

What year?

Food, Drug, and Cosmetic Act

Answer 10

1938

Question 11

What year?

Durham-Humphrey Amendment to the 1938 Act (established two classes of drugs: Re legend and OTC)

Answer 11

1952

Question 12

What year?

Food and Drug Administration Amendments Act mandate post marketing safety studies

Answer 12

2007

Question 13

What year?

Family Smoking Prevention and Tobacco Control Act regulate cigarettes by various measures

Answer 13

2009

Question 14

Patient Protection and Affordable Care Act quality, affordable health care

Answer 14

2010

Question 15

Negligence (GIVING the WRONG drug or drug dose that RESALMS in the patient’s death)

Answer 15

Misfeasance

Question 16

Omission (OMITTING a drug dose that results in the patient’s death)

Answer 16

Nonfeasance

Question 17

Giving CORRECT drug via WRONG ROUTE

Answer 17

Malfeasance

Question 18

The nurse identifies the act that provides for the PRIVACY of patient health information is the —

Answer 18

Health Insurance Portability and Accountability Act.

Question 19

If a nurse administers the wrong medication to a patient and the patient is harmed, the offense is termed

Answer 19

Misfeasance

Question 20

The nurse identifies the primary purpose of federal legislation in drug standards as —

Answer 20

Ensuring Public Safety

Question 21

Which situation regarding controlled substances requires the supervising RN to intervene?

A. The staff keeps a separate controlled-substances record for all required information.
B. Controlled substances are locked away from patients, and all staff members have keys for necessary access.
C. Opioids are kept under double lock to limit access to them.
D. All discarded or wasted controlled substances are countersigned.

Answer 21

D.

Question 22

A nurse administers the correct drug, but by the wrong route, and it results in the patient’s death. The legal term for this offense is —

Answer 22

Malfeasance

Question 23

A nurse is to administer a dose of furosemide (Lasix). The nurse is aware that Lasix is the — for the drug.

Answer 23

Brand name