History of Pharmacology

Question 1

Food Drug and Cosmetic Act

Answer 1

drug safety; required review of drugs by FDA for approval

Question 2

Harris-Kefauver Amendment

Answer 2

proof of effectiveness, uniform drug names, standard labeling

Question 3

Controlled Substance Act

Answer 3

established drug categories I-V

Question 4

Accelerated Approval Process

Answer 4

drugs to treat AIDS, cancers, and rare conditions.Mandates rigorous follow-up after approval.

Question 5

USP/ NF

Answer 5

(national formulary)sets high standards for drugs: strength, quality, purity, packaging safety

Question 6

FDA

Answer 6

(food and drug admin) regulates development, sale, abeling, distribution

Question 7

DEA

Answer 7

(drug enforcement) control and distribution of addictive drugs

Question 8

Stages of Drug Testing (5)

Answer 8

1. preclinical( animal testing–> investigational new drug)
2. phase I- healthy volunteers
3. phase II- patients w/ condition
4. phase III- double blind/placebo controlled design
5. phase IV- approval/post-marketing monitoring

Question 9

Issues with drug testing

Answer 9

1. limited studies with women/children
2. effects not seen during trial period
3. limited post-marketing data

Question 10

Drug Names (3)

Answer 10

1. chemical= molecular structure
2. generic= simple, not owned
3. trade= market brand

Question 11

Drug Characteristics (3)

Answer 11

1. effectiveness
2. Safety
3. Selectivity

Question 12

Drug Components (2)

Answer 12

1. active ingredients= desired effects

2. additives

Question 13

Nursing Assessment

Answer 13

1. patient (age, wt, dx, otc meds, hx, allergies)
2. drug (class, indications/contra, mechanism of action, adverse effects, dosage, route, frequency)
3. environment (resources, support)

Question 14

Types of Medication Orders (5)

Answer 14

1. standard/routine
2. prn
3. single order
4. stat (10-15min)
5. protocol/policy (lab value meds)