Clayton's Basic Pharmacology for Nurses: Test 1 Ch 1-5

deals with the study of drugs and their actions on living organisms

pharmacology

examples of therapeutic methods include the following:

- drug therapy

- diet therapy

- physiotherapy

- psychological therapy

therapy which focuses on treatment with drugs

drug therapy

therapy which focuses on treatment with diet

diet therapy

therapy which focuses on treatment with natural physical forces (e.g. water, light, heat)

physiotherapy

therapy which focuses on the identification of stressors and methods that can be used to reduce or eliminate stress

psychological therapy

chemical substances that have an effect on living organisms

drugs

therapeutic drugs, used for the prevention or treatment of diseases

medicines

each drug has 3 names:

- chemical name

- generic name

- brand name

describes the drug's chemical composition and molecular structure

chemical name

non-proprietary name, given by the US Adopted Names Council, considered the official name and the one listed by the FDA

generic name

proprietary name, drug has a registered trademark, use of the name is restricted by the drug's patent owner (usually the manufacturer)

trademark/brand name

drugs may be classified by a variety of methods according to:

- the body system they affect

- their therapeutic use or clinical indication

- their physiologic or chemical action

drugs which require an order by a health professional who is licensed to prescribe drugs

prescription drugs

drugs which are sold without a prescription in a pharmacy or in the health section of department or grocery strores

nonprescription/over the counter (OTC) drugs

drugs or chemical substances used for nontherapeutic purposes; obtained illegally or have not been approved for use by the FDA

illegal drugs

a biologic product that is close in structure and function to an existing approved biologic product

biosimilar

drug __________________ provides a legal basis for drug treatments and protects the consumer from false claims made by the drug manufacturer

legislation

the two amendments to the Federal Good, Drug, and Cosmetic Act of 1938

- The Durham Humphrey Amendment of 1951

- The Kefauver-Harris Drug Amendment of 1962

amendment which divides medicines into prescription and nonprescription (OTC) categories based on safety

The Durham Humphrey Amendment

amendment which provides greater control and surveillance of the distribution and clinical testing of investigational drugs and requires that a product be proven both safe and effective before release for sale; result of the thalidomide tragedy

The Kefauver-Harris Drug Amendment

act passed by Congress in 1970, composite law designed to improve the administration and regulation of the manufacturing, distribution, and dispensing of drugs that require control by the government because of their high incidence of abuse

Controlled Substances Act

the basic structure of the Controlled Substances Act consists of ___ classifications, or __________________, of controlled substances

- 5

- schedules

schedule ___ drugs have a very high potential for abuse, are not currently accepted for medical use in the US, and lack of accepted safety for use under medical supervision

I

lysergic acid diethylamide, peyote, heroin, and hashish are all examples of which schedule of drugs

schedule I

schedule ___ drugs have a high potential for abuse, are currently accepted for medical use in the US, have abuse potential that may lead to severe psychological of physical dependence, and do not come with refills

II

amphetamines, morphine, hydrocodone/acetaminophen (Vicodin, Lortab, Norco), methadone, oxycodone/aspirin (Percodan), methylphenidate (Ritalin), and amphetamin/dextroamphetamine (Adderall) are all examples of which schedule of drugs

schedule II

schedule ___ drugs have a high potential for abuse, are currently accepted for medical use in the US, have abuse potential which may lead to moderate or low physical dependence or high psychological dependence, and which have a prescriptions which outdate in 6 months with no more that 5 refills within that month

III

aspirin/codeine (Empirin with codeine), apirin/butalbital/caffeine (Fiorinal), acetaminophen/codeine (Tylenol with codeine) are all examples of which schedule of drugs

schedule III

schedule ___ drugs have a low potential for abuse compared with drugs in previous class, are currently accepted for medical use in the US, have abuse potential that may lead to limited physical or psychological dependence, and which have a prescription which outdates in 6 months with no more than 5 refills

IV

phenobarbital, chlordiazepoxide, diazepam, flurazepam, and temazepam are all examples for which schedule of drugs

schedule IV

schedule ___ drugs have low potential for abuse, are currently accepted for medical use in the US, have an abuse potential of limited physcial or psychological dependence liability compared with other classes, prescription may not be required, and which have a prescription which outdates in 6 months with no more than 5 refills

V

atropine/diphenoxylate (Lomotil, Virtussin AC) is an example of which schedule of drugs

schedule V

organization developed to enforce the Controlled Substances Act, gather intelligence, train officers, and conduct research in the area of dangerous drugs and drugs of abuse

Drug Enforcement Administration (DEA)

nurses may not have controlled substances in their possession unless the following conditions are met:

- the nurse is giving them to a patient under an order from a healthcare provider

- the nurse is a patient for whom a healthcare provider has prescribed scheduled drugs

- the nurse is the official custodian of a limited supply of controlled substances on a unit or for a department of the hospital

it currently takes an average of ___ to ___ years and more than $2 billion in research and development costs to bring a single new drug to market

8 to 15

the Food, Drug, and Cosmetic Act of 1938 charged the FDA with the responsibility of ________________ new drugs

regulating

rules and regulations evolved by the FDA divide new drug development into 4 stages:

- preclinical research and development

- clinical research and development

- New Drug Application (NDA) review

- postmarketing surveillance

phase of new drug development which begins with the discovery, synthesis, and purification of the drug; the goal of this stage is to use laboratory studies to determine whether the experimental drug has therapeutic value and whether the drug appears to be safe in animals

perclinical research phase

only about ___% of the chemicals tested in the preclinical phase advance to the clinical testing phase

20%

phase of new drug development in which humans are first tested

clinical research and development stage

phase of the clinical research and development stage in which studies determine an experimental drug's pharmacologic properties, such as its pharmacokinetics, metabolism, safe dosage range, potential for toxicity at a certain dosage, and safe routes of administration

phase 1

phase of the clinical research and development stage in which a smaller population of patients who have the condition that the drug is designed to treat experiment with various dosages to determine success and rate safety of the drugs intended use

phase 2

phase of the clinical research and development stage in which a larger patient population is used to ensure the statistical significance of the results

phase 3

procedure used by the FDA to expedite the development and approval of drugs for the treatment of life-threatening illnesses through rules which allow certain INDs to receive the highest priority for review within the agency

fast tracking

process used by the FDA to expedite the development and approval of drugs for the treatment of life-threatening illness by conducting studies alongside principal controlled clinical trials but without a concurrent control group

parallel tracking

if safety concerns are identified after a drug is approved for marketing the FDA issues a ________________________________ to the package insert of the product

black box warning

medicines which are developed to treat rare diseases and illness (ex: cystic fibrosis, Hansen's disease, sickle cell anemia, blepharospasm, infant botulism, etc.)

orphan drugs

term used to describe individuals with rare diseases which manufacturers/companies do not research drug therapies for because of inability to recover the cost for reasearch

health orphans

drugs do not create new responses but rather

alter existing physiologic activity in several different ways

specific sites which the drug usually forms chemical bonds with

receptors

a drug only forms a bond with a receptor if:

- the drug and the receptor have similar shapes

- the drug has a chemical affinity for the receptor

the study of the interactions between drugs and their receptors and the series of events that result in a pharmacologic response

pharmacodynamics

T/F: the better the fit between the receptor and the drug molecule the better the response of the drug

T

drugs that interact with a receptor to stimulate a response are known as

agonists

drugs that attach to a receptor but do not stimulate a response

antagonists

drugs that interact with a receptor to stimulate a response but inhibit other responses

partial agonists

3 routes of drug administration:

- enteral

- parenteral

- percutaneous

when using the _______________ route, the drug is administered directly into the GI tract by oral, rectal, or nasogastric route

enteral

when using the _________________ route, the drug bypasses the GI tract with the use of subcutaneous, intramuscular, or intravenous injection

parenteral

when using the ___________________ route, the drug is absorbed through the skin and mucous membranes

percutaneous

after administration, all drugs go through 5 stages:

- liberation

- absorption

- distribution

- metabolism

- excretion

the study of what the body does to the drug

pharmacokinetics

release of a drug from the dosage form to be dissolved in body fluids for absorption

liberation

liberation of a drug within the body can be manipulated by:

- pharmaceutical dosage form used (e.g. solution, suspension, capsule, tablet)

- administering the drug with or without food and water in the patient's stomach

the process whereby a drug is transferred from its site of entry into the body to the circulating fluids of the body for distribution around the body

absorption

the rate at which a drug is absorbed depends on:

- route of administration

- blood flow through the tissue where the drug is administered

- solubility of the drug

the rate of absorption when a drug is administered by a parenteral route depends on the

rate of blood flow through the tissues

absorption of a drug is slowest when administered this way

subcutaneous injection

T/F: after a drug enters a patient's bloodstream, it is still retrievable

F

the absorption of topical drugs that have been applied to the skin can be influenced by:

- drug concentration

- length of contact time

- size of the affected area

- thickness of the skin surface

- hydration of tissue

- degree of skin disruption

when drugs are inhaled, their absorption can be influenced by:

- depth of the patient's respiration

- fineness of the droplet particles

- available surface area of the patient's mucous membranes

- contact time

- hydration state

- blood supply to area

- concentration of the drug itself

refers to the ways in which a drug is transported throughout the body by the circulating body fluids to the sites of action or to the receptors that the drug affects

distribution

organs with the most extensive ______________ supply receive the distributed drug most rapidly

blood

two factors influencing drug distribution:

- protein binding

- lipid/fat solubility

only the _______________ portion of a drug is able to diffuse into tissues, interact with receptors, and produce physiologic effects

unbound

more lipid-soluble drugs have a high affinity for ________________ tissue, which serves as a repository site for these agents

adipose

T/F: the same proportions of bound and free drug are maintained in the blood at all times

T

the process whereby the body inactivates drugs

metabolism

the enzyme systems of the __________ are the primary sites for the metabolism of drugs

liver

the most important factors for the conversion of drugs to their metabolites are:

- genetic variations of enzyme systems

- concurrent use of other drugs

- exposure to environmental pollutants

- concurrent illnesses

- age

the elimination of drug metabolites and, in some cases, of the active drug itself from the body

excretion

the two primary routes of excretion are:

- through the GI tract into the feces

- through the renal tubules into the urine

a patient with renal failure often has a ___________________ in the action and duration of a drug if the dosage and frequency of administration are not adjusted to allow for the patient's reduced renal function

increase

drugs are eliminated from the body by means of:

- metabolism

- excretion

the amount of time requires for 50% of the drug to be eliminated from the body

half-life

drugs with long half-lives need to be administered ___________________, whereas drugs with short half-lives need to be administered every __________________ to maintain therapeutic activity

- once a day

- 4 to 6 hours

in regards to drug therapy, monitoring ________________ or ________________ function is important; whenever laboratory data reflect impairment of either function, the nurse should notify the health care provider

- renal

- hepatic

when the concentration of a drug at the site of action is sufficient to start a physiologic response

onset of action

the time at which the drug reaches the highest concentrations on the target receptor sites, thereby inducing the maximal pharmacologic response for the dose given

peak action

how long the drug has a pharmacologic effect

duration of action

the onset, peak, and duration of action of a drug are often illustrated by a time-response curve which is known as a

drug concentration-time profile

the drug concentration is targeted to be in the mid-range between minimum effective response and the toxic response, this is known as the

therapeutic range

when a drug is circulating in the blood, a blood sample may be drawn and assayed to determine the amount of drug present, this is known as a

drug blood level

the expected response of a drugs use

desired action

unintended drug responses which may affect multiple systems of the body

side effects

any noxious, unintended and undesired effect of a drug which occurs at dosages used in humans for prophylaxis, diagnosis, or therapy

adverse drug reaction (ADR)

mild ADRs

common adverse effects

serious, possibly toxic ADRs

serious adverse effects

an injury resulting from medical intervention related to a drug; medication errors

adverse drug events (ADE)