Chapter 1 - Key Terms Nursing 0311

Adverse Effects

drug effects, sometimes called side effects, that are not the desired therapeutic effects; may be unpleasant or even dangerous

Brand Name

name given to a drug by the pharmaceutical company that developed it; also called a trade name or proprietary name

Chemical Name

name that reflects the chemical structure of a drug

Drugs

chemicals that are introduced into the body to bring about change

Food and Drug Administration (FDA)

federal agency responsible for the regulation and enforcement of drug evaluation and distribution policies in the United States

Generic Drugs

drugs sold by their generic name; not brand name or trade name

Generic Names

the original designation that a drug is given when the drug company that developed it applies for the approval process

Genetic Engineering

process of altering DNA, usually of bacteria, to produce a chemical to be used as a drug

Off-Label Uses

uses of a drug that are not part of the stated therapeutic indications for which the drug was approved by the FDA; uses may lead to new indications for a drug

Orphan Drugs

drugs that have been discovered but would not be profitable for a drug company to develop without outside financial incentives; usually drugs that would treat only a small number of people

Over-The-Counter Drugs (OTC)

drugs that are available without a prescription for self-treatment of a variety of complaints; deemed to be safe when used as directed; often formerly only available by prescription

Pharmacology

the study of the biological effects of chemicals

Pharmacotherapeutics

clinical pharmacology—the branch of pharmacology that deals with drugs; chemicals that are used in medicine for the treatment, prevention, and diagnosis of disease in humans

Phase l Study

a pilot study of a potential drug using a small number of selected, usually healthy human volunteers

Phase ll Study

a clinical study of a proposed drug by selected physicians using actual patients who have the disorder the drug is designed to treat

Phase lll Study

use of a proposed drug on a larger sample of the population of patients who have the disease the drug is thought to treat

Phase lV Study

continuous evaluation of a drug after it has been released for marketing

Preclinical Trials

initial trials of a chemical thought to have therapeutic potential either with in vitro or in vivo techniques; not human subjects

Teratogenic

having adverse effects on all phases of the development inside the womb (zygote, embryo, or fetus)

What are the nursing responsibilties?

Administering drugs

Assessing drug effects

Intervening to make the drug regimen more tolerable

Providing patient teaching about drugs and drug regimens

Monitoring the overall patient care plan to prevent medication errors

Where do drugs come from?

Natural Sources - Plants, Animals, Salts of inorganic Compounds

Synthetic Sources - Man made (usually derived from the original drug)

What does the plant “Digitalis Purpurea(Foxglove)” treat?

Heart Failure

What does the inorganic compound “Aluminium” do?

Decrease Gastric Acid

How are chemicals tested in Preclinical Trials? Why?

In “Vitro” or “Vivo” to 1) see if the effects are presumed or 2) see if there are any adverse effects.

Why are Preclinical Trials important?

Because of the different unique biological differences, there may be many different reactions to the chemicals.

Why are some chemicals discarded after preclinical trials?

The chemical lacks therapeutic activity when used with living organisms.

The chemical is too toxic be worth the risk of developing into a drug.

The chemical is highly teratogenic (causing adverse effects to a fetus).

The safety margins are so small that the chemical would not be useful in the clinical setting.

Why are chemicals dropped from the study after the Phase l process?

They cause unacceptable adverse effects.

They are highly teratogenic.

They are too toxic.

They lack evidence of potential therapeutic effect in humans.

What is different from Phase ll Studies and Phase l studies?

Phase l - Anybody is allowed to volunteer to test the chemical

Phase ll- Anybody who specifically has the disease is allowed to test the chemical out for therapeutic value and it is given in hospitals, clinics and doctor’s offices.

Why might a drug be removed from Phase ll?

It is less effective than anticipated.

It is too toxic when used with patients.

It produces unacceptable adverse effects.

It has a low benefit-to-risk ratio, meaning that the therapeutic benefit it provides does not outweigh the risk of potential adverse effects that it causes.

It is no more effective than other drugs already on the market, making the cost of continued research and production less attractive to the drug company.

1906

Pure Food and Drug Act

Prevented the marketing of adulterated drugs; required labeling to eliminate false or misleading claims

1951

Durham-Humphrey Amendment

Tightened control of certain drugs; specified drugs to be labeled “may not be distributed without a prescription”

1983

Orphan Drug Act

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

1988

Food and Drug Administration Act and Prescription Drug Marketing Act

FDA established at official agency of Department of Health and Human Services. Prescription drugs must go through legitimate commercial channels

Category A:

Excellent, well-controlled studies have been done directly on pregnant women.

Category B:

Studies showed the medicine did not hurt animal babies.

There are not enough strict studies on pregnant women to completely prove it is safe.

Category C:

Tests on pregnant animals showed some harm or risk to the fetus.

There are not enough adequate, well-controlled studies in pregnant women.

Category D:

Strong evidence or real-world data proves this drug can harm a human fetus.

The medicine may still be used if a pregnant person has a life-threatening condition and no safer alternative works.

Category X:

Studies in animals or humans have clearly proven that the drug causes fetal abnormalities or severe harm.

The dangers of using the drug during pregnancy always outweigh any possible health benefit.

What is included on a Drug Label?

Generic Name / Brand name

Dosage

Expiration Date

Warnings

( Some may include route and dosage for administration )

Schedule I (C-I):

High abuse potential and no accepted medical use

Schedule II (C-II):

There is a very high risk that the drug will be misused or abused.

Long-term use can easily lead to severe psychological or physical addiction but can be prescribed by a doctor under strict regulations.

Schedule III (C-III):

It has less potential for abuse.

Misuse can lead to moderate physical dependence or high psychological dependence.

These drugs have currently accepted medical uses and are available by prescription.

Schedule IV (C-IV):

It has a low potential for abuse relative to Schedule III drugs.

Misuse leads to limited physical or psychological dependence compared to Schedule III.

These drugs have accepted medical uses and are widely prescribed for anxiety, sleep, and seizures.

Schedule V (C-V):

This schedule has the lowest potential for abuse among all controlled substances.

Bought directly from a pharmacist without a prescription, provided you meet the age.

What are some risks for OTC Drugs?

Taking these drugs could mask the signs and symptoms of underlying disease, making diagnosis difficult.

Taking these drugs with prescription medications could result in drug interactions and interfere with drug therapy.

Inactive ingredients (dyes, alcohol, or preservatives) can cause adverse reactions.

Not taking these drugs as directed could result in serious overdoses.