Ch 3 Flashcards
Food and Drug Administration FDA
Federal agency ensures drugs are safe to use and prescribed drugs will be the same
1906 Pure food and drug act
Forces manufacturers that produce drugs for sale in the US to begin following minimum standards for purity, strength and quality
1938 Federal Food, drug and cosmetic act
Requires that all new rx drugs and OTC drugs be deemed safe by the FDA before marketing drugs, cosmetics and devices to the public
1970 Controlled Substances act (CSA)
Categorizes drugs by medical uses, the potential for drug abuse and/or dependency; requires those with prescribing or distributing privileges have a DEA# to stop fraud
1983 Orphan Drug act
Gives financial incentives to manufacturers that develop drugs to treat rare diseases
Acute pain
Sudden onset of pain
Chronic pain
Prolonged pain
Drug enforcement agency (DEA)
Established to enforce provisions of the 1970 controlled supply act
Drug legend
Statement warning that any distribution without a RX is prohibited by federal law
National Formulary (NF)
Book of preparations and standards for pharmaceuticals
Omnibus budget reconciliation act (OBRA) of 1990
Legislation that mandates pharmacies to ask customers if they would like to be educated about their meds at time of purchase
Over the counter (OTC)
Any meds bought without a prescription
Schedule I
Listing of drugs not currently used in medical treatment that have a high potential for abuse
Schedule II
Listing of drugs that have usage in medical treatment but with severe restrictions because of a high potential for abuse
Schedule III
List of drugs currently used in med treatment that has less of a potential for abuse that drugs in schedules I and II
Schedule IV
Listing of drugs currently used in medical treatment but have a slight potential for abuse
Schedule V
Currently used for medical treatment with less potential for abuse than drugs in schedule IV, slight possibility for abuse and may cause limited physical or psychological dependence
US pharmacopeia (USP)
Collection of drug standards and testing that determines the strength, purity and quality of a drug
US Pharmacopeia and the National Formulary (USP-NF)
A reference compiled by combining the USP and the NF to form one source
Brand names
Proprietary drug name owned by a company
Chemical name
Drug name used to describe the anatomic or molecular structure of a substance
Drug classification
Method used to group drugs in a meaningful way
Formulary
List of medications offered in a particular hospital or health care system
Generic name
Name not owned any a particular pharm company
Official name
Name given by the USP/NF after the drug has been approved for
Pharmacokinetics
Pertains to genetic differences that can cause drug to affect us in different ways, whether therapeutically or adversely
Pharmacogenomics
Analyzes human genes to better understand how an individuals genetics affects the body
Pharmacotherapy
The act of giving drugs targeted to treat disease
Prescription
Written orders for a certain therapy or med; also called scripts
Prototype
Drug that typifies a certain drug classification
Therapeutic level
Preferred level of a drug required to treat disease
Toxicology
Study of a chemicals & pharmacologic actions on the body with poisons and antidotes
Trade name
Proprietary name owned by a pharmaceutical company to market its creation to the public, brand name
Us Adopted Names Council
Group that gives names to generic meds
Absolute contraindication
Med or procedure is life threatening and the benefits don’t outweigh the risks, should not be administered
Adverse reactions
Can occur suddenly or over time & range from patient discomfort to possible death, side effects
American health System Formulary service (AHFS)
Book mostly for pharmacists that covers drug stability and chemical info
Cautions
List of certain pts that have conditions under which a drug should be used with close supervision
Contraindications
List of reasons why a certain drug should not be given
Drug actions
Interactions between a drug & body at the cellular level
Interaction
List of items that can interact & change a drug’s effect
Labeled indications
Uses for what the drug is interested to treat
Non labeled indication
When a drug or med is used to treat a condition for which it is not approved, can be used if research shows it beneficial
Physicians desk reference (PDR)
Collection of specific drug info required by the FDA from drug manufacturer that includes pics of meds
Relative contraindication
Drug or procedure that is only done if benefits outweigh the risks
Side effects
Undesirable experience of meds that can occur fast or over time, adverse reactions
Chemoinformatics
Use of analytical data about the properties, structure and molecular activities of chemical compounds used to design a drug
Investigational new drugs (IND)
3 step process for a drug to be approved by the FDA for clinical use
Local effect
Stimulation of a certain part or region of the body
Pharmacognosy
Studies the natural sources of pharmaceutical
Semisynthetic
Drug having a natural origin with a chemically altered variation
Synthetic
Chemically manufactured drug
Systemic effect
Effect of a drug on the entire body
Investigational new drugs (IND)
3 step process for a drug to be approved by the FDA for clinical use
Absorption
Drug dissolution into the patient’s bloodstream
Agonist
Subs that binds to a receptor site & causes a response
Additive
Effect that occurs when 2 drugs are taken separately, but at the same time together, summarize effect when 2 drugs are taken together
Potentiation
When 2 or more drugs have increased response or a prolonged effect when given together
Synergism
Effect when 2 or more drugs work together to reach an increased effect much greater than if either drug was given alone
Antagonist
Blocks a desired effect, when 2 drugs are given & they cancel out the desired effect
Bioavailability
Measurement of how much of a drug is found in our bloodstream
Biotransforms
Chemical changes of a drug in the body as a result of metabolism
Cumulative effect
Occurs when a drug is not eliminated from the body & the drug level accumulates
Excretion
Stage at which the drug has been broken down to be eliminated from the body
Ionized
Charged state in which drugs will not be absorbed until they reach a certain environment that allows them to become ionized, then they can be absorbed
Lipid (fat) solubility
Ability to dissolve in lipids. Subs with low fat solubility are absorbed at a slower rate. While those with a high fat solubility are absorbs faster
Metabolized
when a drug is broken down or biotransformed primarily done in the liver
Nonionized
Noncharged state during which drugs can be absorbed through the membranes of the body & into the blood
Ph
For drugs, it’s the range from acidity to alkalinity in the GI tract
Pharmacodynamics
Actions from a drug in the body
Pharmacokinetics
Movement of a drug through the body from absorption to elimination
Prodrugs
Drugs that only become active as they are broken down into metabolites
Selective distribution
Occurs when drugs have a greater affinity to reach a certain area than others, such as a cell or organ in the body
Therapeutic range
Amount of drug present in the blood that gives the desired effect without causing any toxicity or side effects
Volume of distribution (VD)
Areas where a drug can be distributed in the body
Anaphylaxis reaction
A severe & potentially life threatening allergic reaction to a drug
Booster dose
Given to maintain the desired immune response of a primary immuniztion
Dependence
Occurs when a person has a desire or a need for a drug
Half life (T 1/2)
The time for a drug dose to decreases by half after it is administrered
Hypersensitivity
When a pt has an allergic reaction to a substance
Idiosyncratic reaction
Type of adverse drug reaction that is uncommon in reponse to a drug
Lethal dose
Drug dose causing death
Loading dose
Larger Initial dose given to quickly establish the desired therapeutic effect
Maintenance dose
Drug dose given to maintain a desired dose of drug in the blood
Maximum dose
Largest dose without causing a toxic effect
Minimum dose
Smallest dose of a drug required to obtain the desired therapeutic effect
Paradoxical reaction
Drug reaction that does the opposite of what was intended
Pregnancy category A
Category of drug that has been studied & shown to have no adverse fetal effects
Pregnancy category B
Category of drug tested on animals with no adverse effects but not tested on pregnant women
Pregnancy category C
Category of drug with no convincing studies done on animals or pregnant women to determine adverse effects
Pregnancy category D
Category of drugs showing adverse effects to fetus & given only when benefits to mother outweigh fetal risk
Pregnancy category X
Category of drugs showing adverse fetal affects & not to be used under any circumstances
Steady state
Method of drug administration where the same amount of drug is eliminated as administration therefore giving a predictable effect
Teratogenic effect
Drugs that can cause physical malformation in a fetus
Therapeutic dose
The dose needed to obtain the desired effect
Tolerance
Happens when a drug is taken repeatedly & had less effect on the person so a larger dose is required
Toxic dose
Side effects that can results in poisoning the path
