UNIT 1 EXAM Flashcards
Intro to Pharmacology
Pharmacology
the study of drugs
Drug
a chemical compound with a specific structure;
derived from from plants or animals;
created by chemical synthesis or biotechnology (recombinant DNA technology);
produces a change in function
Food and Drug Administration (FDA) definition
used in diagnosis, cure, relief, treatment, or prevention of disease in humans and animals
Pharmokinetics
the study of processes that occur as the drug moves through the body;
ADME: absorption, distribution, metabolism, excretion
Pharmacodynamics
the study of action of the drug on the living tissue;
how drugs work in the body;
mechanism of action (MOA)
Pharmacotherapeutics
the study of how a drug treats a disease or a condition
Pharmacy
the study of preparing and dispensing a drug
Posology
the study of the amount of drug required to produce a therapeutic effect;
dosing
Toxicology
the study of the poisonous/ harmful effects of drugs
Two Pharmacology Principles
no drug creates function; it only modifies it;
no drug has a single action; side effects occur
Drug Uses
therapeutic use, preventative use, diagnostic use
Therapeutic Use
control or cure conditions, diseases, or symptoms;
physiological and/or psychological
Preventative Use
prevent the occurrence of symptoms, conditions, or diseases
Diagnostic Use
provide evidence of disease
What to know prior to administering a drug
use;
correct dose/form;
methods of administration;
side effects/ adverse effects;
drug interactions;
precautions/ contraindications;
symptoms of overdose;
evidence and control of abuse;
patient allergies
Rights of Administering a Drug
RIGHT patient;
RIGHT medication;
RIGHT dosage;
RIGHT time;
RIGHT route of administration;
RIGHT form;
RIGHT response;
RIGHT documentation
Effects of Drugs
therapeutic effect;
side effect;
lethal effect;
allergic reaction;
adverse effect;
idiosyncratic effect;
toxic effect;
iatrogenic effect
Therapeutic Effect
desired/ intentional effect of the drug (drug indication);
when a drug should not be used it is called a contraindication
Side Effect
undesirable effect in addition to the desired effect;
not an allergy
Adverse effect
undesired effect; possibly harmful
Toxic Effect
side effect that can be harmful or life-threatening to the body;
ex: drug poisoning
Lethal Effect
an effect that kills
Allergic Reaction
previous exposure, sensitization occurs, formation of antibodies;
antigen-antibody
Sensitization
repeated administration of a stimulus resulting in a progressive amplification of response
Antigen
a foreign substance that enters the body
Antibody
a protein that is produced by the immune system to fight off antigens
Anaphylaxis
a severe, life-threatening allergic reaction;
respiratory difficulty, decrease in blood pressure, cardiac arrest, death
Dose
exact amount of drug administered per order;
only a dose separates a drug from a poison
Site of Action
location where the drug exerts its therapeutic effect;
ex: hypothalamus;
not all sites of action are known
Mechanism of Action (MOA)
how a drug produces its effects;
(anesthetics interrupt nerve conduction)
Receptor Site
a specific location on the site of action where a drug binds to a cell in order to cause an effect
Affinity
propensity of a drug to bind to a given receptor site;
how strong the bond is
Lock and Key
a drug must fit
Agonist Drug
a drug binds and produces an effect; mimics
Antagonist Drug
drug binds and prevents other substances from producing an effect;
blocking drug, blocker, or inhibitor
Competitive Antagonist
competes for the same binding site with an agonist;
binding is mutually exclusive
Dose Response Curve
as the dose (the exact amount of drug given) increases, the response (or effect) increases;
reaches its limit (100% response): maximal response/ ceiling effect;
doses above ceiling effect lead to undesirable and toxic effects;
can compare potency of similar drugs
Potency
strength to produce effect
Time-Plasma Drug Concentration Curve or Time-Response Curve
onset of action - first observable effect;
duration of action - length;
continued metabolism and excretion - decreased drug levels, decreased drug response;
frequency
Food and Drug Administration (FDA)
governs approval and use of all drugs;
1. efficacy/ proof of effectiveness
2. safety:
- animal testing and controlled human testing
- LD50 - lethal dose is determined, dose that will kill 50% of animals tested
- ED50 - dose producing therapeutic effect that is 50% of the maximal response;
- therapeutic index (TI) is determined - estimate of safety of a drug —> LD50/ED50
Drug Nomenclature
chemical names;
generic names (lowercase);
brand names (uppercase; trademark symbol);
prescription drugs;
non-prescription drugs/ OTC (Over The Counter): BTC (Behind The Counter) - pharmacist assesses age and intentions
Generic and Brand Equivalent
pharmaceutically equivalent: same makeup, strength, quality, and purity
therapeutically equivalent: same therapeutic effect - including duration and intensity
Drug References
USP/NF (United States Pharmacopeia/ National Formulary);
American Hospital Formulary Service;
PDR (Physician’s Desk Reference);
Drug Facts & Comparisons;
Handbook of Nonprescription Drugs
USP (United States Pharmacopeia)/ NF (National Formulary)
official drug list recognized by the government;
updated annually
American Hospital Formulary Service
drug information database;
provides detailed drug info, evidence-based foundation for safe and effective drug therapy; regular electronic updates; reprinted annually
PDR (Physician’s Desk Reference)
most widely used by healthcare providers for use in medical practice;
updated yearly;
use/ indications, dosing, administration, contraindications, adverse reactions
Drug Facts & Comparisons
updated monthly;
most current drug info on a regular basis
Pregnancy Safety Categories
issued by FDA;
Category A: no risk to fetus in first trimester (no evidence of risk in later trimesters);
Category B: animal testing shows no risk to fetus; benefits may outweigh risks (no adequate studies done in women)
Category C: animal studies indicate some risk to fetus; benefits may outweigh risks (no adequate studies in women)
Category D: studies show positive fetal risk; in some cases benefits may outweigh risks
Category X: studies show fetal abnormalities and fetal risks; risks clearly outweigh benefits (teratogenic - harmful to fetus or embryo)
Teratogenic
harmful to embryo or fetus
Additional Labeling Info
passed in 2015 by the FDA for drugs placed on the market beginning June 29, 2001;
OTC medication is excluded;
categories:
1) pregnancy (includes labor and delivery)
2) lactation (includes nursing mothers)
3) male and female reproductive potential
Pregnancy (additional labeling info)
dosing and potential risks to a developing fetus;
registry info on how the drug affects pregnant women;
risk summary, clinical considerations, supporting data
Lactation (additional labeling info)
drugs that should not be used during pregnancy;
known human/animal data regarding active metabolites present in breast milk;
clinical effects on infant;
metabolism/excretion data;
risk/benefit section;
timing of breastfeeding to minimize exposure;
risk summary, clinical observations, supporting data
Male and Female Reproductive Potential
the medication’s effects on fertility and pregnancy loss;
relevant information on pregnancy testing and birth control before, during, and after therapy;
risk summary, clinical observations, and supporting data
Controlled Substances
Schedule I - V (based on medical usefulness and potential for abuse)
I - high abuse potential, no accepted medical use (heroin, marijuana, hallucinogens)
II - high abuse potential, accepted medical use; new written prescription (morphine, codeine, amphetamines, Vicodin)
III - moderate abuse potential, accepted medical use, limitations on refills (codeine combo drugs, Tylenol with Codeine)
IV - limited abuse potential, accepted medical use (Valium, Ambien)
V - limited abuse potential, accepted medical use ( narcotics antitussives, antidiarrheals, Robitussin AC)
Schedule II drugs must have written prescriptions.
Schedule III - V drugs must be written, orally communicated, or faxed to the pharmacy
Physical Dependence
physical symptoms occur without the use of a drug (tremors, abdominal cramps, sweating, convulsions)
Psychological Dependence
psychological symptoms occur without the use of a drug (anxiety, tension, stress)
Tolerance
need to take more of a drug to achieve the same effect; increased metabolism of the drug
Addiction
drug dependence causing severe and compulsive behavior
Testing and Approval of the Drug
1) Investigational New Drug Application (INDA):
* chemical analysis
* manufacturing information
* pre-clinical - animal-testing
2) Human Testing (FOUR Human Phases):
* phases 1-3 occur prior to FDA approval
* informed consent (explanation of the study, procedures, and risks)
* PHASE 1: 20 to 100 healthy people or people with disease (determine drug safety and dosage)
* PHASE 2: several hundred volunteers with the condition/disease (determine drug effectiveness and side effects)
* PHASE 3: 300 TO 3000 patients at medical research centers (determine adverse effects and efficacy)
* PHASE 4: several thousand volunteers with the disease/condition (after FDA approval, continued post-marketing safety monitoring)
New Drug Application (NDA)
drug sponsor’s formal proposal requesting FDA approval for drug marketing and sale;
Is the drug safe and effective in it proposed use (s) when used as directed?
Do the benefits of the drug outweigh the risks?
Is the drug’s proposed labeling (package insert) accurate?
Are the methods used in drug’s manufacturing and the controls used to maintain drug’s quality adequate to preserve drug’s strength, identity, and purity?
National Drug Code (NDC)
universal drug identifier in the US (human use); number found on medication label, each drug has a unique NDC; how drugs are reported to the FDA
Drug Organization
Therapeutic Classification and Pharmacological Classification
Therapeutic Classification
categorized by therapeutic usefulness;
ex: antihypertensive or antihyperlipidemic
Pharmacological Classification
categorized by how the drug works;
ex: diuretics, vasodilators
Food and Drug Administration (FDA)
agency of the US health and human services;
regulates and supervises the effectiveness of all drugs;
protects the public health by ensuring safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices;
ensures the safety of our nation’s food supply, cosmetics, and products that emit radiation
Pure Food and Drug Act (1906)
provides protection from falsified (adulterated) or mislabeled drugs;
drugs must meet standards of strength and purity
Sherley Amendment (1912)
prohibited fraudulent therapeutic claims by drug companies
Harrison Narcotics Tax Act (1914)
kept in check drug addiction or dependence;
established the word “narcotic”;
proved that narcotic drugs produced physical and/or psychological dependence;
charge a tax on all who produce, import, manufacture, dispense, sell, compound, deal in, or give away opium or cocoa leaves, their salts, derivatives, or preparations, and for other purposes;
“Warning -may be habit forming” - direct result
Food, Drug, and Cosmetic Act (1938)
set standard for safety;
manufacturers had to show proof of safety with drug information/ literature
Durham-Humphrey Amendment (1951)
designed the “Birth of the Legend” (classification of prescription vs OTC drugs)
Kefauver-Harris Amendment (1962)
drug products must be effective and safe; testing must be done on several species before it can be tested on humans ; enforced by the FDA
Controlled Substance Act (1970)
created controlled substances categories based on potential for abuse and medical effectiveness;
regulated dispensing of controlled substances;
assigned five categories;
limited the number of prescription refills for controlled substances;
amended in 1990;
enforced by Drug Enforcement Agency
Drug Enforcement Administration (1973)
enforced the Controlled Substance Act of 1970;
enforces the controlled substances laws and regulations of the US
Orphan Drug Act (1983)
provided grants to research companies to develop drugs for rare diseases or conditions
FDA Modernization Act (1997)
gave the FDA authority to expedite the approval process for certain types of drugs
DEA Number
a series of numbers assigned to a health care provider allowing them to write prescriptions for controlled substances;
assigned by the DEA;
to be used for tracking controlled substances;
must be listed on all narcotic prescriptions
HealthCare Professionals who can issue prescriptions
physicians, NP, PA, dentists, veterinarians, podiatrists;
must have a DEA number to write for controlled substances
Types of Drug Interactions
Drug-Drug Interaction;
Drug-Disease Interaction;
Drug-Food/Drink Interaction
Drug-Drug Interaction
drug increases or decreases the effect of another drug or both drugs;
enzyme inhibition - increases the drug’s effect
enzyme induction - decreases the drug’s effect
Drug-Disease Interaction
drug interferes with pathophysiology of a disease
Drug-Food/Drink Interaction
food/drink increases or decreases the effect of a drug
Drug Forms
solutions;
syrups;
elixirs;
capsules;
tablets;
powders;
solid/semi-solid;
lozenges and troches;
enteric-coated;
delayed release;
suppositories;
ointments;
patches;
creams
Parenteral Route of Administration
does mot involve a GI tract; rapid absorption and onset of action;
ex: IM, IV, subcutaneous (sub-Q), intrathecal (spine) injections
Enteral Route of Administration
GI tract;
prolonged absorption;
drug action is delayed (30-60 min);
safest method;
ex: oral, nasogastric (NG) tube;
Percutaneous Route of Administration
through the skin and into the mucous membranes;
ex: topical, transdermal, sublingual/buccal
Parenteral Routes of Administration
Intramuscular (IM) injection;
Intravenous (IV);
Intradermal;
Intra-pleural;
Intra-arterial;
Intracardiac;
Intrathecal (epidural space);
Intraosseous (into the marrow of the bone)
Ampule
usually glass container;
single dose use;
use a filtered needle to draw out the solution;
broken open
Vial
multi-use container; glass or plastic; sealed; sterilize the top
Syringes
3 mL (0.1 mL markings);
5 mL (0.2 mL markings);
10 mL (0.5 mL markings)
Insulin (units)
100 units of the drug in 1 mL of the solution;
2 units calibration
Tuberculin
1 mL;
0.01 calibration
Gauge
the larger the number, the thinner the needle;
the smaller the number, the thicker the needle
Enteral Routes of Administration
Oral (PO);
Nasogastric (NG) tube;
Rectal (enemas, suppositories);
Buccal (may be percutaneous);
Sublingual (may be percutaneous)
Nasogastric (NG) tube
tube’s integrity is assessed; solutions are preferred; pills must be crushed and mixed with liquid; tube must be flushed after use; do not mix medications
Rectal Route of Administration
enemas; suppositories
Percutaneous Routes of Administration
Transdermal;
Intraocular;
Intra-respiratory;
Intravaginal;
Intrauterine;
Intranasal;
Otic;
Buccal;
Sublingual;
Topical;
Endotracheal
Passage of Drug through the Body
1) Drug Administration
2) Disintegration of the Dosage Form Drug and Drug Dissolution
3) Absorption
4) Distribution
5) Accumulation/Metabolism/Excretion
6) Binding to the Active Site
7) Pharmacological Effects (Therapeutic or Toxic Effects)
8) Excretion
Absorption
entrance of the drug into bloodstream or circulation;
process occurs through
1) filtration (solids and fluids separate)
2) passive transport (diffusion; drugs move from an area of high to an area of low concentration)
3) osmosis (diffusion of water through a semi-permeable membrane from an area of high to an are of low concentration)
4) active transport (requires energy)
Factors Affecting the Rate of Absorption
1) Solubility of Drugs (through the cell membrane; the more lipid soluble the drug, the easier and faster it will pass through)
2) Routes of Administration (liquids absorb more quickly than solids; IV rates are faster than those of tablets;
3) Ionization of Drugs (must be un-ionized (not charged) for absorption
Distribution
drugs are sent to tissues and organs of the body;
* blood flow: the greater the blood flow, the greater the amount of drug
* plasma proteins: many drugs are attached to plasma proteins
* Blood-Brain-Barrier (BBB): lipid barrier protects the brain; most drugs are water-soluble; have to be lipid-soluble to pass into the brain
Metabolism
chemical alteration of the drug/ biotransformation;
liver is the body organ that contains enzymes that break down drugs;
liver - major organ for metabolism
DMMS/ Drug Microsomal Metabolizing System
takes lipid-soluble drugs and alter them to become water-soluble, so they can be taken up by the kidneys and excreted in urine and not repeatedly absorbed
Enzyme Induction
increase in the amount of enzymes produced by the liver;
increases metabolism;
duration of action is reduced;
smaller strength of drug’s action
Enzyme Inhibition
decrease in the amount of enzymes produced by the liver;
slower metabolism;
longer duration of action;
bigger strength of drug’s action
First-Pass Effect
oral;
by mouth administration (PO);
when drugs are transported by the liver and are metabolized before being distributed;
reduces the amount of drug reaching the bloodstream/circulation;
avoided with some routes of administration (IV, IM, inhalation)
Excretion
elimination;
kidneys: water-soluble, ionized;
GI: stool;
lungs: anesthetic gases;
sweat;
milk (lactation) - exposure of nursing infants -> safety categories;
saliva
Bioavailability
percentage of the drug that is actually absorbed;
affected by the drug form and route of administration
Half-Life
the amount of time it takes for the drug concentration in blood to reduce to 50% of what it was initially (upon administering a drug);
determines frequency;
determined by metabolism and excretion
Reconstitution
mixing a powdered drug with a diluent to create a solution
Loading dose
initial higher dose of the drug to rapidly attain therapeutic levels and effects
Maintenance dose
smaller doses of the drug to maintain its levels within the therapeutic range
Incompatibility
cannot mix together;
physical alterations occur when mixed together
Additive Effects
two drugs combined; same effect; same MOA; is equal to the sum of their separate effects
Summation
combined effect of two drugs; same effect; different MOA; is equal to the sum of their individual effects
Synergism
combined effect of two drugs is greater than the sum of their individial effects
Antagonism
combined effect of two drugs is less than the sum of their individual effects
Individual Variations
age;
nutritional status;
weight;
sex and body fat %;
genes;
emotional state;
placebo effect;
other disease conditions;
patient compliance;
polypharmacy (5 or more medications)
