Pharmacology for Nurses. A
Pathophysiologic Approach Adams -
Holland - Urban (Unit 1)
Pharmacology
Study of medicine; how drugs are administered; where drugs travel in the body,
Response that drugs produce.
drug
A chemical substance that is taken to cause changes in a person's
body or behavior
medication
A substance that is used to treat or prevent disease or relieve pain.
biologics
agents naturally produced in animal cells, in microorganisms, or by the body itself
Mechanism of Action
how a drug produces its physiological effect in the body
Bioavailability
the extent to which the body can absorb and use a nutrient
Therapeutic classification of drugs:
Based on what the drug does clinically
Pharmacologic Classification
Based on the drug's mechanism of action, or how the drug produces its effect
Most Drugs have three names
Chemical, Generic, Trade (CHEMICAL: (1/2)-2-(p-isobutylphenyl) propionic acid;
GENERIC: ibuprofen; TRADE: Motrin)
Generic vs. Trade-Name Drugs
Trade name drugs with exclusive rights cost more. When rights end, competing
companies offer generic form cheaper
prescription drugs
Drugs legally available only with a physician's order.
Over the counter drugs (OTC)
can be purchased without a prescription
Black Box Warnings
One of the primary alerts for identifying
extreme adverse drug reactions discovered
during and after the review
process; 1997 FDA created "Black Box Warnings"
Contraindications
factors that prevent the use of a drug or treatment
why should healthcare professionals be concerned about patients taking herbal
medicines?
patients could be putting themselves at risk, potential herb-drug interactions
, U.S. Pharmacopoeia (USP)
1820; 1st comprehensive publication formulary used in the U.S.; drug purity, strength,
and directions for synthesis.
USP and National Formulary (NF)
1852-1975, two drug standards in the US by the American Pharmaceutical Association
(APhA). 1. USP - all drug products. 2. National Formulary (NF) - pharmaceutical
ingredients.
U.S. Pharacopoeia -National Formulary (USP-NF)
1975 merged into a single publication
Biologic Control Act
1902 standardized serum and blood-related products
Pure Food and Drug Act
1906 - Established government control (FDA) for labeling
medicines
Shirley Amendment
1912 - Prohibited drugs labeled with false therapeutic
claims
Food, Drug, and Cosmetic Act (1938) and amendments
1938- Thorough testing of drug; Proof of safety and efficacy of drug
Dietary Supplement Health and Education Act, 1994
1994-Controls misleading industry claims
Four Stages of Approval for Therapeutic and Biologic Drugs
1. Preclinical investigation (1-3 years, average 18months)
2. Clinical investigation (2-10 years; average 5 years)
3. Review of new drug application (NDA) (2 months -7 years, average 24 months)
4. Postmarketing surveillance (adverse reaction reporting; surveys/sampling/testing;
inspections)
Addiction
The overwhelming feeling that drives someone to use a drug repeated
Dependence
A physiological or psychological need for a substance
Physical dependence
An altered physical condition caused by the adaptation of the nervous system to
repeated drug use.
Psychological dependence
Few signs of physical discomfort when drug is withdrawn, but intense compelling desire
to continue drug use
Controlled Substances
Are restricted by the Controlled Substances Act of 1970. Have a high potential for
addiction or dependence. Have restricted use.
Are placed into one of five schedules:
Schedule I drugs have the highest abuse potential,
Schedule V the lowest
Teratogenic Drug Classification
Five categories of risk that a drug poses to
a fetus in the case of a pregnant woman
Pathophysiologic Approach Adams -
Holland - Urban (Unit 1)
Pharmacology
Study of medicine; how drugs are administered; where drugs travel in the body,
Response that drugs produce.
drug
A chemical substance that is taken to cause changes in a person's
body or behavior
medication
A substance that is used to treat or prevent disease or relieve pain.
biologics
agents naturally produced in animal cells, in microorganisms, or by the body itself
Mechanism of Action
how a drug produces its physiological effect in the body
Bioavailability
the extent to which the body can absorb and use a nutrient
Therapeutic classification of drugs:
Based on what the drug does clinically
Pharmacologic Classification
Based on the drug's mechanism of action, or how the drug produces its effect
Most Drugs have three names
Chemical, Generic, Trade (CHEMICAL: (1/2)-2-(p-isobutylphenyl) propionic acid;
GENERIC: ibuprofen; TRADE: Motrin)
Generic vs. Trade-Name Drugs
Trade name drugs with exclusive rights cost more. When rights end, competing
companies offer generic form cheaper
prescription drugs
Drugs legally available only with a physician's order.
Over the counter drugs (OTC)
can be purchased without a prescription
Black Box Warnings
One of the primary alerts for identifying
extreme adverse drug reactions discovered
during and after the review
process; 1997 FDA created "Black Box Warnings"
Contraindications
factors that prevent the use of a drug or treatment
why should healthcare professionals be concerned about patients taking herbal
medicines?
patients could be putting themselves at risk, potential herb-drug interactions
, U.S. Pharmacopoeia (USP)
1820; 1st comprehensive publication formulary used in the U.S.; drug purity, strength,
and directions for synthesis.
USP and National Formulary (NF)
1852-1975, two drug standards in the US by the American Pharmaceutical Association
(APhA). 1. USP - all drug products. 2. National Formulary (NF) - pharmaceutical
ingredients.
U.S. Pharacopoeia -National Formulary (USP-NF)
1975 merged into a single publication
Biologic Control Act
1902 standardized serum and blood-related products
Pure Food and Drug Act
1906 - Established government control (FDA) for labeling
medicines
Shirley Amendment
1912 - Prohibited drugs labeled with false therapeutic
claims
Food, Drug, and Cosmetic Act (1938) and amendments
1938- Thorough testing of drug; Proof of safety and efficacy of drug
Dietary Supplement Health and Education Act, 1994
1994-Controls misleading industry claims
Four Stages of Approval for Therapeutic and Biologic Drugs
1. Preclinical investigation (1-3 years, average 18months)
2. Clinical investigation (2-10 years; average 5 years)
3. Review of new drug application (NDA) (2 months -7 years, average 24 months)
4. Postmarketing surveillance (adverse reaction reporting; surveys/sampling/testing;
inspections)
Addiction
The overwhelming feeling that drives someone to use a drug repeated
Dependence
A physiological or psychological need for a substance
Physical dependence
An altered physical condition caused by the adaptation of the nervous system to
repeated drug use.
Psychological dependence
Few signs of physical discomfort when drug is withdrawn, but intense compelling desire
to continue drug use
Controlled Substances
Are restricted by the Controlled Substances Act of 1970. Have a high potential for
addiction or dependence. Have restricted use.
Are placed into one of five schedules:
Schedule I drugs have the highest abuse potential,
Schedule V the lowest
Teratogenic Drug Classification
Five categories of risk that a drug poses to
a fetus in the case of a pregnant woman
