Pharmacology: Core Concepts
1. Chapter 1: Introduction to Drugs
a. Pharmacology
i. What is it?
1. The study of the biological effects of chemicals
ii. Drugs
1. Are chemicals that are introduced into the body to cause some sort of change
iii. Drug effects can be therapeutic or adverse effect
1. Nurse must know which ones may occur when a particular drug is
administered
2. Therapeutic or helpful
3. Adverse effects are negative or undesirable or potentially dangerous
iv. Nurses deal with?
1. pharmacotherapeutics, or clinical pharmacology, the branch of pharmacology
that uses drugs to treat, prevent, and diagnose disease. Clinical
pharmacology addresses two key concerns: the drug’s effects on the body
and the body’s response to the drug.
b. Nurses’ Responsibilities
i. Administering drugs
1. Got to give it
ii. Assessing drug effects
1. Make sure it is safe to give
iii. Intervening to make the drug regimen more tolerable
1. Help manage side effects or teach ways to make more tolerable
iv. Providing patient teaching about drugs and drug regimens
v. Monitoring the overall patient care plan to prevent medication errors
c. Sources of Drugs
i. To become a drug, a chemical must have a demonstrated therapeutic value or
efficacy without severe toxicity or damaging properties
ii. Natural
1. Plants
2. Animals
3. Inorganic compounds
iii. Synthetic
1. Scientists use genetic engineering to alter bacteria to produce chemicals that
are therapeutic and effective
2. Alter a chemical with proven therapeutic effectiveness to make it better
d. Drug Evaluation
i. Preclinical Trials
1. Tested on laboratory animals
a. Determine whether they have the presumed effects in living tissue
b. To evaluate any adverse effects
ii. Phase I Studies
1. Uses human volunteers to test the drugs
a. Informed consent
1
, Pharmacology: Core Concepts
i. Studies are more tightly controlled
ii. The volunteers are often young healthy men
iii. Women of childbearing potential are sometimes not good
candidates for phase I studies because the risk is too high that
the drug may destroy or alter the ova (eggs).
iii. Phase II Studies
1. Drug is tried out on patients who have the disease the drug is designed to
treat.
2. At the end of this phase the drug may be
a. removed from further investigation
b. if the drug continues to show therapeutic affects it will move on to
Phase III.
iv. Phase III Studies
1. The drug is used in a vast clinical market
2. Prescribers observe patients very closely, monitoring them for any adverse
effects.
v. Phase IV Studies
1. Drug is approved for marketing
2. Continual evaluation
e. Pregnancy Categories: Potential effects on the developing fetus
i. Category A:
1. Adequate studies in pregnant women
2. have not demonstrated a risk to the fetus in the first trimester of pregnancy,
3. no evidence of risk in later trimesters.
ii. Category B:
1. Animal studies have not demonstrated a risk to the fetus but there are no
adequate studies in pregnant women
2. 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
3. There is no evidence of risk in later trimesters
iii. Category C:
1. Animal studies have shown an adverse effect on the fetus but there are no
adequate studies in humans
2. Benefits from the use of the drug in pregnant women may be acceptable
despite its potential risks
3. OR
4. No animal reproduction studies
5. No adequate studies in humans
iv. Category D:
1. 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.
v. Category X:
1. Studies in animals or humans demonstrate fetal abnormalities or adverse
reactions;
2. Reports indicate evidence of fetal risk.
3. The risk of use in a pregnant woman clearly outweighs any possible benefit.
2
1. Chapter 1: Introduction to Drugs
a. Pharmacology
i. What is it?
1. The study of the biological effects of chemicals
ii. Drugs
1. Are chemicals that are introduced into the body to cause some sort of change
iii. Drug effects can be therapeutic or adverse effect
1. Nurse must know which ones may occur when a particular drug is
administered
2. Therapeutic or helpful
3. Adverse effects are negative or undesirable or potentially dangerous
iv. Nurses deal with?
1. pharmacotherapeutics, or clinical pharmacology, the branch of pharmacology
that uses drugs to treat, prevent, and diagnose disease. Clinical
pharmacology addresses two key concerns: the drug’s effects on the body
and the body’s response to the drug.
b. Nurses’ Responsibilities
i. Administering drugs
1. Got to give it
ii. Assessing drug effects
1. Make sure it is safe to give
iii. Intervening to make the drug regimen more tolerable
1. Help manage side effects or teach ways to make more tolerable
iv. Providing patient teaching about drugs and drug regimens
v. Monitoring the overall patient care plan to prevent medication errors
c. Sources of Drugs
i. To become a drug, a chemical must have a demonstrated therapeutic value or
efficacy without severe toxicity or damaging properties
ii. Natural
1. Plants
2. Animals
3. Inorganic compounds
iii. Synthetic
1. Scientists use genetic engineering to alter bacteria to produce chemicals that
are therapeutic and effective
2. Alter a chemical with proven therapeutic effectiveness to make it better
d. Drug Evaluation
i. Preclinical Trials
1. Tested on laboratory animals
a. Determine whether they have the presumed effects in living tissue
b. To evaluate any adverse effects
ii. Phase I Studies
1. Uses human volunteers to test the drugs
a. Informed consent
1
, Pharmacology: Core Concepts
i. Studies are more tightly controlled
ii. The volunteers are often young healthy men
iii. Women of childbearing potential are sometimes not good
candidates for phase I studies because the risk is too high that
the drug may destroy or alter the ova (eggs).
iii. Phase II Studies
1. Drug is tried out on patients who have the disease the drug is designed to
treat.
2. At the end of this phase the drug may be
a. removed from further investigation
b. if the drug continues to show therapeutic affects it will move on to
Phase III.
iv. Phase III Studies
1. The drug is used in a vast clinical market
2. Prescribers observe patients very closely, monitoring them for any adverse
effects.
v. Phase IV Studies
1. Drug is approved for marketing
2. Continual evaluation
e. Pregnancy Categories: Potential effects on the developing fetus
i. Category A:
1. Adequate studies in pregnant women
2. have not demonstrated a risk to the fetus in the first trimester of pregnancy,
3. no evidence of risk in later trimesters.
ii. Category B:
1. Animal studies have not demonstrated a risk to the fetus but there are no
adequate studies in pregnant women
2. 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
3. There is no evidence of risk in later trimesters
iii. Category C:
1. Animal studies have shown an adverse effect on the fetus but there are no
adequate studies in humans
2. Benefits from the use of the drug in pregnant women may be acceptable
despite its potential risks
3. OR
4. No animal reproduction studies
5. No adequate studies in humans
iv. Category D:
1. 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.
v. Category X:
1. Studies in animals or humans demonstrate fetal abnormalities or adverse
reactions;
2. Reports indicate evidence of fetal risk.
3. The risk of use in a pregnant woman clearly outweighs any possible benefit.
2
