Venable, Drug Therapy In Nursing, Chapter 1 & 2

Front 1

What are the six main elements of core drug knowledge?

Back 1

1.) Pharmacotherapeutics
2.) Pharmacokinetics
3.) Pharmacodynamics
4.) Contraindications and precautions
5.) Adverse effects
6.) Drug interactions

Front 2

What are pharmacotherapeutics?

Back 2

The desired therapeutic effects of the drug.

Front 3

What are pharmacokinetics?

Back 3

The changes that occur to the drug while it is inside the body.

Front 4

What are pharmacodynamics?

Back 4

The effects of the drug on the body.

Front 5

What are contraindications and precautions?

Back 5

Conditions under which the drug should not be used, or must be used carefully with monitoring.

Front 6

What are adverse effects?

Back 6

Unintended and usually undesired effects that may occur with use of the drug.

Front 7

All drugs are known by at least three names...

Back 7

1. Chemical name
2. Generic name
3. Trade name

Front 8

The two principal acts of law governing drug safety are...

Back 8

1. Pure food and Drug Act, (1906).

2. Federal Food, Drug, and Cosmetic Act (1938). (A.K.A. FFDCA).

Front 9

What are drug interactions?

Back 9

Effects that may occur when the drug is given along with another drug, food, or substance.

Front 10

The generic drug name is also called the ... name.

Back 10

non-proprietary

Front 11

Each drug has ... which identify the drug's ... .

Back 11

... only one generic name

... active ingredient.

Front 12

The first letter of a generic drug name is/is not capitalized.

Back 12

IS NOT capitalized

Front 13

What are the five key CORE PATIENT VARIABLES?

Back 13

1.) Health status.
2.) Life span and gender.
3.) Lifestyle, diet, and habits.
4.) Environment.
5.) Culture and inherited traits.

Front 14

Patents run ... years on drugs.

Back 14

... 17 years

Front 15

The ... assigns a drug's official (generic) name.

Back 15

... United States Adopted Names Council

Front 16

What is important about ENVIRONMENT in core patient variables?

Back 16

1.) If in hospital vs home compliance quality of administration may vary.
2.) Properties of physical environment may alter drug's effect, induce advers effects, or limit administration in that setting.
3.) Exposure to harmful substances may exist, or pathology may be induced requiring therapy.

Front 17

Official (generic) names are published in ... and ... .

Back 17

... The United States Pharmacopeia

... The National Formulary

Front 18

What are important about LIFESTYLE, DIET, AND HABITS in core patient variables?
(Hint: 7 items)

Back 18

1.) Activity/exercise
2.) Sleep/wake patterns
3.) Financial resources
4.) Eating preferences/patterns.
5.) Use/abuse of substances.
6.) OTC drug use, alternative health practices.
7.) Literacy.

Front 19

The first letter of a drug's trade name is/is not capitalized.

Back 19

IS capitalized.

Front 20

A drug's trade name is usually followed by a ... or ... .

Back 20

...Ⓡ

... Ｔｍ

Front 21

I will check a drug name at least ... times!

WHEN?

Back 21

... three!

1. before obtaining
2. while obtaining
3. after obtaining

Front 22

Name three ways drugs are classified (assigned to families).

Back 22

1. By chemical composition.

2. By physiologic effect on body systems.

3. By therapeutic actions (clinical indications).

Front 23

Classify morphine sulfate -
... physiologically,
... therapeutically,
... chemically.

Back 23

physiological - CNS DEPRESSANT

therapeutic - OPIOID NARCOTIC ANALGESIC

chemical - OPIATE or OPIOID

Front 24

Every state has its own ... that fully describes nursing activities involving drug therapy.

Back 24

Nurse Practice Act

Front 25

The ... is the current authoritative source for drug standards, revised every ... years.

Back 25

...United States Pharmacopoeia (USP)

... five years.

Front 26

The FDA was established by ...

Back 26

... the Federal Food, Drug, and Cosmetics Act of 1938.

Front 27

Name two advantages of synthetic chemical drugs.

Back 27

1. Pure chemicals, unaffected by pharmacodynamic changes (deterioration of potency, stability).

2. Cheaper to produce.

Front 28

Why are genetically engineered drugs superior to animal-based drugs?

Back 28

*** PURITY ***

No foreign proteins thus no antibody production.

Front 29

Give five examples of animal-based drugs.

Back 29

1. insulin
2. pituitary hormones
3. some vitamins
4. antibiotics
5. vaccines/serums

Front 30

Today _____ _____ hormones are rapidly replacing ______-______ drugs.

Back 30

genetically engineered

animal-based

Front 31

What are RESINS?

Back 31

Plant-derived drugs that are water-insoluble and solid or semi-solid. --> usu. laxative or caustic agents.

Front 32

What are OILS?

Back 32

Usu. plant-derived drugs insoluble in water.

Front 33

How many types of OILS are there and what are they?

Back 33

TWO:
1. Volatile Oils
2. Fixed Oils -

Front 34

Describe volatile oils.

Back 34

- strictly from plants and evaporate in air.

Front 35

Describe fixed oils.

Back 35

- from plants and sometimes animals, aka fatty oils, consistency varies with temperature.

Front 36

What are GUMS?

Back 36

Plant-derived drugs that are mucilaginous secretions (usu. polysaccharides) with the ability to attract and hold water.

Front 37

What are GLYCOSIDES?

Back 37

Plant-derived drugs that contain a carbohydrate or sugar molecule.

Front 38

What are ALKALOIDS?

Back 38

Plant-derived alkaline substances that react with body acids to form a salt ---> readily soluble in body fluids.

Front 39

What are the four main sources of drugs?

Back 39

1. Plants
2. Animals
3. Synthetic chemicals
4. Genetically-engineered chemicals.

Front 40

How do core patient vars. affect patient education?

Back 40

1. Medium of education; written, visual with pictures, spoken.

2. Which family member(s) to co-educate.

3. Choice of what is most important to teach.

Front 41

How does drug prototype knowledge help me?

Back 41

1. I learn a group of drugs.
2. Simplifies learning.
3. Allows me to organize drugs logically.

Front 42

What is core drug knowledge?

Back 42

Core Drug Knowledge = Basic Pharmacologic Facts about Drugs

Front 43

How will I use my core drug knowledge?

Back 43

1. To aminister drugs safely.
2. To determine interactions with core patient vars.
3. To devise strategies.
4. To max therapeutic effect.
5. To min adverse effects.
6. To educate patient and family.

Front 44

How do I assess core patient variables?

Back 44

- Interview
- Physical Assessment
- Medical Record

Data is often obtained from more than one source!

Front 45

FDA now requires analysis by ... in all new NDA's.

Back 45

GENDER!
(Because of pharmacokinetic differences primarily due to fat distribution differences.)

Front 46

NDA approval means ... .

Back 46

New drug may be marketed (beginning of phase IV).

Front 47

If drug proves safe and effective in phases I thru III, company applies for ...

Back 47

NDA!
New Drug Application

Front 48

The placebo response can involve both ... and ... .

Back 48

objective and subjective criteria.

Front 49

What is a placebo response?

Back 49

Positive response to any therapeutic intervention by interested and caring professional.

Front 50

Who conducts Phase II trials?

Back 50

Clinical pharmacologists and clinical investigators.

Front 51

Nurses are mainly involved in ... of clinical testing.

Back 51

Phase III

Front 52

The main purpose of Phase III trials is ... .

Back 52

to determine safety and efficacy.

Front 53

Phase III often also includes ... studies, comparing ... with ... .

Back 53

crossover
new drug with existing drug.

Front 54

Phase III is mainly for discovery of... .

Back 54

infrequent or rare side-effects with widespread testing.

Front 55

What kind of study is usually designed in Phase III?

Back 55

Double-blind, neither patient nor researcher knows if placebo was given.

Front 56

How many patients are enrolled in Phase III trials?

Back 56

1,000 to 3,000

Front 57

What is the main purpose of Phase II trials?

Back 57

Therapeutic efficacy and dose range.

Front 58

How many subjects are typically enrolled in Phase II trials?

Back 58

100 to 300.

Front 59

What is the main purose of Phase I trials?

Back 59

- SAFETY
- BIOLOGICAL EFFECTS
- METABOLISM & KINETICS
- DRUG INTERACTIONS

Front 60

Who conducts Phase I trials?

Back 60

Clinical Pharmacologists.

Front 61

When are diseased rather than healthy volunteers used in Phase I trials?

Back 61

When drug has toxicities, i.e. cancer and AIDS therapies.

Front 62

How is Phase I data used?

Back 62

It is used to design well-controlled scientifically valid Phase II studies.

Front 63

In Phase I Clinical Trials, all ... are monitored using ... .

Back 63

metabolic, biologic, and pharmacologic effects

blood, urine, and other samples.

Front 64

In Phase I Clinical Trials Testing, how many healthy human volunteers are given drug?

Back 64

20 to 80

Front 65

Clinical trials in humans typically occur in how many phases, and last how many years?

Back 65

4 Phases
5 to 9 Years

Front 66

What is an IND?

Back 66

Investigational New Drug application to the FDA.

Front 67

At a minimum, what must an IND include?
(hint: 5 requirements)

Back 67

1. All known info re biologic, chemical, pharmacologic, toxicologic properties.
2. Precise details re manufacturing and Storage.
3. Name and qualifications of each investigator to be involved.
4. Signed affidavit by each investigator stating adequate supervision and informed consent.
5. Detailed study protocols, route of administration, and observations to be made.

Front 68

What is the ratio of drug candidates entering preclinical testing to drug candidates entering human testing?

Back 68

1000 to 1

Front 69

Preclinical testing lasts about how many years?

Back 69

3 1/2 years.

Front 70

Preclinical testing is conducted on... .

Back 70

Animal subjects.

Front 71

The Kefauver Harris Amendment also authorized the
FDA to establish ..., and in the early 60's, the ... was established.

Back 71

Official Names
United States Adopted Names Council

Front 72

The ... , passed in ... , tightened controls on drug safety, eapecially ... drugs, requiring that ... and ... must be included in literature.

Back 72

1. Kefauver Harris Amendment to 1938 FFDCA.
2. 1962
3. Experimental
4. adverse reactions and contraindications
(THALIDOMIDE DEBACLE!)

Front 73

Who is enrolled in Phase II studies?

Back 73

Carefully selected patients (i.e. with disease).

Front 74

What does Phase II look for?
(Hint: 5 items)

Back 74

1. Dose response
2. Toxicity (incl. terat- carcinogenicity).
3. Pharmacotherapeutic
effectiveness.
4. Establishment of dosage guidelines.
5. Compare with animal studies to determine effects on fertility and reproduction.

Front 75

Give two examples of programs used to ensure adequate postmarketing sureveillance of drugs.

Back 75

MedWatch

Practitioners' Reporting Network

Front 76

The ... regulates medication advertisements aimed at the general pulic

Back 76

Federal Trade Comission (FTC)

Front 77

The ... regulates medication advertisement aimed at medical practitioners.

Back 77

Federal Drug Agency (FDA)

Front 78

The ... Amendment to the ... Federal Pure Food and Drug Act prohibited manufacturers from making fraudulent therapeutic claims.

Back 78

Shirley

1906

Front 79

The ... , passed in ... , legally defined the term narcotic and provided the first effective regulation of drugs known for their abuse potential.

Back 79

Harrison Narcotic Law

1914

Front 80

The ... , also known as ... , was passed in ... .

Back 80

Comprehensive Drug Abuse Prevention and Control Act

Controlled Substances Act

1970

Front 81

The Controlled Substances Act established the ... as the regulatory body responsible for the safe distribution and control of potentially addictive substances.

Back 81

Drug Enforcement Agency (DEA)

Front 82

The CSA established ... categories for drugs according to their abuse potential and medical usefulness.

Back 82

5

Front 83

The abuse potential of a Class V (C-V) drug is highest/lowest.

Back 83

Lowest.

Front 84

A crime occurs when a ... drug is transferred to anyone other than whom it was prescribed.

Back 84

c-II, c-III, or c-IV.

Front 85

A nurse's violation of the CSA may result in fine, imprisonment, and loss of ...

Back 85

nursing license and the right to practice.

Front 86

What is the JCAHO?

Back 86

Joint Commission for Accreditation of Hospitals and Healthcare Organizations, a watchdog group that sets standards for quality of patient care and accreditation of healthcare institutions.

Front 87

Nurses must be aware of both ... and ... constraints on practice.

Back 87

Legal

Institutional

Front 88

Nurses must avoid advising patients on the use of drugs. T/F?

Back 88

True

Front 89

Are nurses legally reaponsible for the drugs they administer, and for their safe administration?

Back 89

Yes.

Front 90

What is a major safeguard for patients in drug therapy?

Back 90

Patient education.

Front 91

Are patient education activities part of the medical record?

Back 91

Yes.

Front 92

What are five key questions to ask before formulating a drug teaching plan for a patient?

Back 92

1.) Allergies or idiosyncratic reactions to drugs or foods.
2.) Chronic conditions.
3.) Drugs or other medications currently used (all).
4.) Pregnancy status and plans.
5.) Use of alcohol, caffeine, nicotine, or street drugs.

Front 93

What are five effective strategies for patient education?

Back 93

1.) Avoid jargon.
2.) Include written information and diagrams/illustrations.
3.) Promote understanding with reoetition and reinforcement.
4.) Relate new information to patient's existing knowledge and experiences.
5.) Highlight and recap important info; ask patient to demonstrate techniques or repeat instructions.

Front 94

What are auxiliary labels?

Back 94

Labels such as "avoid prolonged exposure to sunlight", or "do not take with dairy products".