Chapter 1&2 Exam

Question 1

Omnibus Budget Reconciliation Act 1990

Answer 1

• Mandates that OTC drugs be documented as part of a medical record
• Mandates that pharmacists provide drug use review and patient counseling

Question 2

Pure Food and Drug Act 1906

Answer 2

• First attempt to establish consumer protection in drug and food manufacture
• Required drugs to meet minimal standards of strength, purity, and quality
• Demanded labeling for preparations containing dangerous ingredients
• Established United States Pharmacopeia (USP) and National Formulary (NF)

Question 3

Federal Food, Drug, and Cosmetic Act 1938

Answer 3

-Established more specific regulations for preventing adulteration of (tampering with) drugs, foods, and cosmetics

• Example: “Warning” labels must be present on certain preparations
• “May cause drowsiness,” “may cause nervousness,” “may be habit-forming,” etc.

Question 4

Orphan Drug Act

Answer 4

• Gives financial incentives to develop medications for diseases that affect a small number of people (orphan drugs that would otherwise be of a low profitability

Question 5

Controlled Substances Act 1970

Answer 5

• Established the Drug Enforcement Administration (DEA)
• Set tighter controls on depressants, stimulants, psychedelics, narcotics, and anabolic steroids
• Demanded security and accountability of controlled substances
• Set limitations on the use of prescriptions
• Demanded each prescriber of these substances register with the DEA and obtain a DEA registration number
• Isolated the abused and addicting drugs into 5 levels or schedules, according to their medical value, harmfulness, and potential for abuse and addiction
• Refer to Table 1-1, textbook
• C-I, C-II, C-III, C-IV, and C-V
• C on a drug package indicates a controlled substance
• the roman numeral indicates the schedule level

Question 6

C-I definition

Answer 6

High abuse potential, not approved for medical use in the United States, are illegal

Question 7

C-I Examples

Answer 7

heroin, LSD, ecstasy,

Question 8

C-II definition

Answer 8

High abuse potential; may lead to severe dependence, written Rx only, in emergency it can be phoned in by physician, but handwritten Rx must be provided to the pharmacy within 7 days

Question 9

C-II Examples

Answer 9

morphine, codeine, Oxycontin, Ritalin, Demerol

Question 10

C-III definition

Answer 10

May lead to moderate dependence, Rx written, faxed, or verbal (phoned in) by physician only, can be refilled up to 5x’s in 6 months

Question 11

C-III examples

Answer 11

codeine & hydrocodone with Tylenol, anabolic steroids

Question 12

C-IV definition

Answer 12

Lower abuse potential than the previous schedules, Rx may be written out by health care practitioner, but must be signed by the physician, can be phoned in or faxed, can be refilled up to 5x’s in 6 months

Question 13

C-IV Examples

Answer 13

Valium, Ativan, Xanax, phenobarbital, Ambien,

Question 14

C-V definition

Answer 14

Low abuse potential, medication consists primarily of preparations for cough suppressants containing codeine and preparations for diarrhea

Question 15

C-V examples

Answer 15

promethazine with codeine, Lomotil

Question 16

FDA stands for …

Answer 16

food and drug administration

Question 17

FDA responsibilities

Answer 17

• Oversees drug testing before release
• Inspects plants where foods, drugs, medical devices or cosmetics are made
• Reviews new drug applications and petitions for food additives
• Investigates and removes unsafe drugs from the market
• Ensures proper labeling of foods, cosmetics, and drugs

Question 18

DEA stands for…..

Answer 18

Drug Enforcement Administration

Question 19

What does the DEA do?

Answer 19

• Oversees drug testing before release
• Inspects plants where foods, drugs, medical devices or cosmetics are made
• Reviews new drug applications and petitions for food additives
• Investigates and removes unsafe drugs from the market
• Ensures proper labeling of foods, cosmetics, and drugs

Question 20

Generic Name

Answer 20

 Common/general name, initial lowercase letter-never capitalized (always begins with a lowercase letter), assigned by USAN

Question 21

Trade Name

Answer 21

 name assigned by the Pharmaceutical company, copyrighted, capitalize the first letter

Question 22

Chemical Name

Answer 22

 Exact molecular formula, usually long and difficult to pronounce, of little concern to the health care practitioner

Question 23

Official Name

Answer 23

 Official name used in USP/NF, generally the same as the generic name

Question 24

OTC Drug

Answer 24

 No purchasing restrictions by the FDA; Medication available without a prescription;

Question 25

Legend Drug

Answer 25

 Prescription drug; determined unsafe for over-the-counter purchase because of possible harmful side effects if taken indiscriminately
 Includes birth control pills, antibiotics, cardiac drugs, and hormones

Question 26

Controlled Substance

Answer 26

 Drug controlled by prescription requirement because of the danger of addiction or abuse
 Indicated in references by schedule numbers C-I, C-II, C-III, C-IV, or C-V

Question 27

Therapeutic Use

Answer 27

 Most useful way to classify drugs from the standpoint of health care professionals.

Question 28

Adverse Reactions

Answer 28

 List of possible unpleasant or dangerous secondary effects, other than the desired effect

Question 29

Cautions

Answer 29

Precautions; steps to take to prevent errors

Question 30

Contraindications

Answer 30

 List of conditions for which the drug should not be given

Question 31

Classifications

Answer 31

Broad subcategory for drugs that affect the body in similar ways
 Most helpful grouping: according to therapeutic use

Question 32

indications

Answer 32

List of conditions for which a drug is meant to be used

Question 33

actions

Answer 33

A description of the cellular changes that occur as a result of the drug