RNSG 1301 Chapter 1: Introduction to Drugs questions and answers

pharmacotherapeutics

clinical pharmacology—the branch of pharmacology that uses drugs to treat, prevent, and diagnose diseases.

clinical pharmacology addresses two key concerns

drug's effects on the body and body's response to the drug

adverse effects

side effects: negative effects not intended by its original purpose

The Nursing Process

Assessment

Diagnosis

Planning

Implementation

Evaluation

nurse responsibilities (hospital to home)

-Administering drugs

-Assessing drug effects

-Intervening to make drug regimen more tolerable

-Providing patient teaching about drugs and drug regimens

-Monitoring the overall patient care plan to prevent medication errors

The nurse can

refer to a verified drug guide to obtain specific details required for safe & effective use

MAOI

monoamine oxidase inhibitor

CNS

central nervous system

CV

cardiovascular

P

pulse

BP

blood pressure

GI

gastrointestinal

CBC

complete blood count

sources of drugs

natural and synthetic

natural sources

plants, animal products, inorganic compounds

synthetic sources

made in a lab

Ricinus communis

castor oil

Digitalis purpurea (Foxglove)

leaves

Papaver somniferum

opium poppy

juice

unripe capsule

morphine

codeine

papaverine

animal products

replace human chemicals that fail

genetic engineering

the process of altering DNA

inorganic compounds

-Compounds that do not contain carbon

-"salts of various chemical elements"

Ex: inorganic compounds

-Aluminum

-Fluorine (as fluoride)

-Gold

-Iron

Aluminum

-Antacid to decrease gastric acidity

-Management of hyperphosphatemia

-Prevention of the formation of phosphate urinary stones

Fluorine (as fluoride)

-Prevention of dental cavities

-Prevention of osteoporosis (disease weakens bones)

Gold

-Treatment of rheumatoid arthritis (attacks healthy joint cells, causing an inflammatory response)

Iron

-Treatment of iron deficiency anemia

many drugs can

derive from one prototype (chemical structure), but have different effects

prototype

an early sample, model, or release of a product built to test a concept or process

Stages of Development

preclinical trials, phase I, II, III studies

FDA (Food and Drug Administration)

an agency of the U.S Department of Health and Human Services that regulates the development and sale of drugs

Preclinical Trials

Chemicals tested on laboratory animals

Phase I Clinical Trial

small group of usually healthy young men

Phase II Clinical Trial

tested on a small group of individuals with the disease

Phase III Clinical Trial

-Use of the drug in a big clinical market sample

-Prescribers often ask patients to keep journals and record any symptoms they experience

Orphan Drugs

drugs that have been discovered but would not be profitable for a drug company to develop; usually drugs that would treat only a small number of people; these orphans can be adopted by drug companies to develop and use on rare diseases

Generic name

the original designation that the drug was given when the drug company applied for the approval process

Chemical names

names that reflect the chemical structure of a drug

Brand names

the names companies give to drugs; the names by which they are sold

Drug lag

a drug available in another country may not be available until years later in the USA

Phase IV Studies

-On the market, but continued evaluation

-Prescribers obligated to report to the FDA unexpected adverse effects

Trials can be fast tracked if

there is a disease with no cure and deadly

Nurses should become familiar with

the rules and regulation in the area in which they practice. Regulations can vary from state to state and even within a state

(NEW) risk levels for pregnant women

-High risk for pregnancy= studies have shown fetal toxicity

-High risk for lactation= enters breast milk; bad 4 drinking

-Low risk= research has not shown any problems thus far

Regardless of risk levels

pregnant women should NOT take any medication unless absolutely necessary

(OLD) Categories for pregnant women

Category A: Adequate studies in pregnant women have not demonstrated a risk to the fetus in the first trimester of pregnancy, and there is no evidence of risk in later trimesters.

Category B: Animal studies have not demonstrated a risk to the fetus, but there are no adequate studies in pregnant women, or animal studies have shown an adverse effect, but adequate studies in pregnant women have not demonstrated a risk to the fetus during the first trimester of pregnancy, and there is no evidence of risk in later trimesters.

Category C: Animal studies have shown an adverse effect on the fetus, but there are no adequate studies in humans; the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks, or there are no animal reproduction studies and no adequate studies in humans.

Category D: There is evidence of human fetal risk, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.

Category X: Studies in animals or humans demonstrate fetal abnormalities or adverse reactions; reports indicate evidence of fetal risk. The risk of use in a pregnant woman clearly outweighs any possible benefit.

Regardless of the designated pregnancy category or presumed safety, no drug should be administered during pregnancy unless it is clearly needed.

teratogenic

known to have potential to cause developmental defects in the embryo or fetus

Pure Food and Drug Act

1906

Prevented the marketing of adulterated drugs (made impure by addition of foreign substances)

Federal Food, Drug and Cosmetic Act

1938

Mandated tests for drug toxicity

Allowed FDA to recall drugs

Gave FDA the power of enforcement

Durham-Humphery Amendment

1951

Specific drugs now have to be labeled "may not be distributed without a prescription"

Kefauver-Harris Act

1962

Tightened control over the quality of drugs

Gave FDA regulatory power of drug investigations

Controlled Substances Act

1970

Defined drug abuse and made categories for the level of abuse potential

Provided strict controls over the distribution , storage, and use of there drugs

Orphan Drug Act

1983

Provided incentives for the development of orphan drugs for treatment of rare diseases

DEA Schedules of Controlled Substances

Schedule I (C-I) High abuse potential; no acceptable medical use

Schedule II (C-II) High abuse potential; severe dependence

Schedule III (C-III) Less abuse potential than schedule II; moderate dependence

Schedule IV (C-IV) Less abuse potential than schedule III; limited dependence

Schedule V (C-V) Limited abuse potential

When an FDA approved drug is made

it's given a patent (like a copyright) for several years to prevent competitors from the get-go

When a drug's patent expires

-other manufacturers can start reproducing the drug for cheaper, creating generic drug versions of the original

-not 100% the same in terms of adverse effects

DAW

dispensed as written; brand name product be used

Over the Counter Drugs (OTC)

without a prescription

Nursing: Problems related to OTC medication

-could mask signs & symptoms of underlying disease, making diagnosis difficult

-taking them could cause drug interactions and interfere with drug therapy if also taking prescription medications

-not taken as directed can cause an overdose

Nurses should ask questions about

OTC drugs

Package Inserts

paper containing all chemical and study information that led to the drug's approval