NUR 106 (UNIT 1) CH 1 Introduction to Drugs

Adverse effects

Drug effects that are not the desired therapeutic effects; may be unpleasant or even dangerous

Brand name (Trade Name)

Name given to a drug by the PHARMACEUTICAL company that developed it; 17 year patent; First letter IS capitalized; if patent is not in place, bio-equivalence can not be guaranteed.

Chemical name

Name that reflects the chemical structure of a drug. chemicals that are produced by companies involved solely in the manufacturing of drugs.

Drugs

Chemicals that are introduced into the body to bring about some sort of change

Food & Drug Administration

Federal agency responsible for the regulation and enforcement of drug evaluation and distribution policies

Generic drugs

Drugs sold by their chemical name; not brand (or trade) name products

Generic name

The original designation that a drug is given when the drug company that developed it applies for the approval process. First letter NOT capitalized. Official name given by US Adopted Name Council

Genetic engineering

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

Orphan drugs

Drugs that have been discovered but are not available for use by those who could benefit from them, usually because they are not financially profitable ex. chemo drugs and antivirals for HIV

Over-the-counter drugs

Drugs that are available without a prescription for self-treatment of a variety of complaints

Pharmacology

The study of the biological effects of drugs

Pharmacotherapeutics

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

Preclinical trials

Initial trial of a chemical thought to have therapeutic potential; uses laboratory ANIMALS, NOT HUMAN subjects

Phase I study

A pilot study of a potential drug done with a small number of selected, healthy HUMAN VOLUNTEERS

Phase II study

A clinical study of a drug by selected physicians using ACTUAL PATIENTS who have the disorder the drug is designed to treat; patients must informed consent.

Phase III study

Use of a drug on a wide scale in the CLINICAL setting with patients who HAVE THE DISEASE the drug is thought to treat

Phase IV study

CONTINUAL EVALUATION of a drug after it has been released for marketing

Teratogenic

Having adverse effects on the fetus

1. Clinical pharmacology is the study of
a. the biological effects of chemicals.
b. drugs used to treat, prevent, or diagnose disease.
c. plant components that can be used as medicines.
d. binders and other vehicles for delivering medication.

b. drugs used to treat, prevent, or diagnose disease.

Phase I drug studies involve
a. the use of laboratory animals to test chemicals.
b. patients with the disease the drug is designed to treat.
c. mass marketing surveys of drug effects in large numbers of people.
d. healthy human volunteers who are often pa

d. healthy human volunteers who are often paid for their participation.

The generic name of a drug is
a. the name assigned to the drug by the pharmaceutical company developing it.
b. the chemical name of the drug based on its chemical structure.
c. the original name assigned to the drug at the beginning of the evaluation proc

c. the original name assigned to the drug at the beginning of the evaluation process.

An orphan drug is a drug that
a. has failed to go through the approval process.
b. is available in a foreign country but not in this country.
c. has been discovered but is not financially viable and therefore has not been "adopted" by any drug company.
d.

c. has been discovered but is not financially viable and therefore has not been "adopted" by any drug company.

The FDA pregnancy categories
a. indicate a drug's potential or actual teratogenic effects, offering guidelines for use of a particular drug in pregnancy.
b. are used for research purposes only.
c. list drugs that are more likely to have addicting properti

a. indicate a drug's potential or actual teratogenic effects, offering guidelines for use of a particular drug in pregnancy.

The storing, prescribing, and distributing of controlled substances�drugs that are more apt to be addictive�are monitored by
a. the FDA.
b. the Department of Commerce.
c. the FBI.
d. the DEA.

d. the DEA.

Healthy young women are not usually involved in Phase I studies of drugs because
a. male bodies are more predictable and responsive to chemicals.
b. females are more apt to suffer problems with ova, which are formed before birth and not formed in later ye

b. females are more apt to suffer problems with ova, which are formed before birth and not formed in later years.

A patient has been taking fluoxetine (Prozac) for several years, but when picking up the prescription this month, found that the tablets looked different and became concerned. The nurse, checking with the pharmacist, found that fluoxetine had just become

c. that the law requires that prescriptions be filled with the generic form if one is available to cut down the cost of medications.

Multiple Response: Select all that apply.
When teaching a patient about over-the-counter (OTC) drugs, which points should the nurse include?
a. These drugs are very safe and can be used freely to relieve your complaints.
b. These compounds are called drug

c. Some of these drugs were once prescription drugs, but are now thought to be safe when used as directed.
d. Reading the label of these drugs is very important; the active ingredient is very prominent; you should always check the ingredient name.
e. It i

A patient asks what generic drugs are and if he should be using them to treat his infection. Which of the following statements should be included in the nurse's explanation?
a. A generic drug is a drug that is sold by the name of the ingredient, not by br

a. A generic drug is a drug that is sold by the name of the ingredient, not by brand name.
c. Generic drugs are not available until the patent expires on a specific drug.
d. Generic drugs are usually cheaper than the well-known brand names and some insura

Nurses Responsibilities: Drugs

1. be KNOWLEDGEABLE
2. ADMINISTER drugs
3. ASSESS drug effects and adverse effects
4. INTERVENE to make the drug regimen more tolerable
5. PROVIDE PATIENT TEACHING about drugs and the regimen
6. MONITOR and PREVENT medication errors

Food and Drug Administration (FDA)

Federal agency responsible for the regulation and enforcement of drug evaluation and distribution policies

pharmacogenetics

the study of how clients respond to drugs. Customized medicine dose based on the genetics of the person taking the drug.

placebo

used in phase 2 of drug trials, inert substance that serves as a control for the non treatment group.

Sources of Drugs:

1. PLANTS: alt. therapy movement
2. ANIMAL: hormones, replace human chems.
3. INORGANIC COMPOUNDS: salts of elements: iron or ferrous sulfate
4. SYNTHETIC SOURCES: gen engineer. bacteria to prod chem that are therapeutic: Interferons, Antibiotics

pharmacokinetics

the study of the effect of the BODY on the drug. example: absorption, distribution, metabolism, excretion

teratogenic

Having adverse effects on the fetus

pharmacodynamics

study of the biochemical and physiological effects of drugs. The action and interaction of DRUGS on the body

toxicology

study of poisons, adverse effects, contraindications

drugs

Chemicals that are introduced into the body to bring about some sort of change

The "Three Checks" are:

check the medication label three times while preparing the medication:
1st Check: when you get the medication or dosage package
2nd Check: before putting medication into medication cup or pouring liquid medications
3rd Check: After all of the medication h

The "Five Rights of Medical Administration":

When checking the medication against the MAR you look for:
1. Right Patient
2. Right Medication
3. Right Dose
4. Right Route
5. Right Time
This helps ensure accuracy when administering medication to the patient

MAR

Medical Administration Record

Pure Food and Drug Act 1906

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

Federal Food, Drug and Cosmetic Act 1938

Mandated tests for drug toxicity and provided means for RECALL of drugs; established procedures for introducing new drugs; gave FDA the power of ENFORCEMENT

Durham Humphrey Amendment 1951

Tightened CONTROL of certain drugs; specified drugs to be labeled "may not be distributed without a PRESCRIPTON

Kefauver Harris Act 1962

Tightened control over the QUALITY of drugs; gave FDA regulatory power over the procedure of drug INVESTIGATIONS; stated that EFFICACY as well as SAFETY of drugs had to be established

Controlled Substances Act 1970

Defined drug abuse and classified drugs as to their potential for abuse; provided strict controls over the distribution, storage, and use of these drugs

Orphan Drug Act 1983

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

FDA Pregnancy Categories

The Food and Drug Administration (FDA) has established five categories to indicate the potential for a systemically absorbed drug to cause birth defects. The key differentiation among the categories rests on the degree (reliability) of documentation and t

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

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

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 reaction; reports indicate evidence of fetal risk. The risk of use in a pregnant woman clearly outweighs any possible benefit.

DEA Schedules of Controlled Substances

The Controlled Substances Act of 1970 regulates the manufacturing, distribution, and dispensing of drugs that are known to have abuse potential. The Drug Enforcement Agency (DEA) is responsible for the enforcement of these regulations. The controlled drug

Schedule I (C-I):

High abuse potential and no accepted medical use (heroin, marijuana, LSD)
*
NP can not prescribe
*

Schedule II (C-II):

High abuse potential with severe dependence liability (narcotics, amphetamines, and barbiturates)
*
NP can not prescribe
*

Schedule III (C-III):

Less abuse potential than schedule II drugs and moderate dependence liability (nonbarbiturate sedatives, nonamphetamine stimulants, limited amounts of certain narcotics)

Schedule IV (C-IV):

Less abuse potential than schedule III and limited dependence liability (some sedatives, antianxiety agents, and non-narcotic analgesics)

Schedule V (C-V):

Limited abuse potential. Primarily small amounts of narcotics (codeine) used as antitussives or antidiarrheals. Under federal law, limited quantities of certain schedule V drugs may be purchased without a prescription directly from a pharmacist. The purch

bioequivalence

two pharmaceutical products are bioequivalent if they are pharmaceutically equivalent and their bioavailabilities (rate and extent of availability) after administration in the same molar dose are similar to such a degree that their effects, with respect

Drug Classifications:

Therapeutic, Pharmacologic, Drug Prototype

Therapeutic Classifications:

What is being treated by the drug: ex: anticoagulant, antihyperlipidemic, antihypertensive, antianginal

Phamacologic Classifications:

How the drug produces its effects on the body: ex: vasodilators (dilates peripheral blood vessels), diuretic (lowers plasma volume), adrenergic antagonist or blocker (blocks physiologic reaction to stress

Drug Prototype

usually the first drug in a class or the drug all others in the class are compared with.

Drug Research:

takes average of $800 million to discover and develop 1 new medicine.
takes 5-15 years to bring new medicine from laboratory to pharmacy use.

Legal Classes of Drugs:

1. Prescription (legend) Drugs: controlled substances
2. Nonprescription (OTC) drugs
3. Orphan drugs
4. Investigational drugs (trial drugs)
5. Illicit (street) drugs

Dispense as Written

must use specific drug used; cannot be substituted with a generic drug

drugs that should not be substituted:

cardiac drugs, seizure drugs, hormones (oral contraceptives)

Narcotic use in hospitals:

narcotics discontinued after 48-72 hrs.

drug misuse:

using drug for something it was not prescribed for (off-label use)

drug abuse:

use of the drug to the point of possible dependence.

commonly abused drugs:

caffeine, alcohol, nicotine, marijuana, stimulants, narcotics, barbiturates, antianxiety, antipsychotic, anabolic steroids

polypharmacy

the use of multiple medications by a patient, especially when too many forms of medication are used by a patient, when more drugs are prescribed than is clinically warranted,[1] or even when all prescribed medications are clinically indicated but there ar

supplement

herbals, not drugs (classified as nutrition), that are not subject to FDA regulation and not tested for safety. (kava kava and st johns wart are BAD examples of these)

OTC drug considerations:

1. can mask the signs and symptoms of disease
2. can interact with prescriptions and interfere with drug therapy or adverse reactions
3. can result in overdoses.

Sources of drug info:

package inserts: prep'd by manufacturer, contains chemical and study info that led to drugs approval.
drug label: specific info that identifies specific drug

single order

one time order to be administered at a specified time

routine order

give within 2 hours of when order is written

STAT order

one time order to be given within 5 minutes

standing order

drug to be administered until discontinued or for a certain number of doses

PRN order

given as needed based on client need and nurses judgement of safety

when to review routine orders?

routine medication orders are reviewed every 7 days.