Chapter 3
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| abbreviated new drug application | aNDA. the process by which applicants must scientifically demonstrate to the FDA that their generic product is bioequivalent to or performs in the same way as the innovator drug
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| active ingredient | the biochemically active component of the drug that exerts a desired therapeutic effect
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| addiction | compulsive and uncontrollable use of controlled substances, especially narcotics
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| adverse drug reaction | ADR. a negative consequence to a patient from taking a particular drug
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| antibiotic | chemical substance that is used in treatment of bacterial infectious diseases and has the ability to either kill or inhibit the growth of certain harmful microorganisms
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| antibody | the part of the immune system that neutralizes antigens or foreign substances in the body
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| antineoplastic drug | a cancer fighting drug
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| bioequivalent | a generic drug that delivers approximately the same amount of a active ingredient into a healthy volunteer's bloodstream in the same amount of time as the innovator or brand name drug
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| biotechnology | field of study that combines the sciences of biology,chemistry,and immunology to produce synthetic, unique drugs with specific therapeutic effects
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| black box warning | warning statement required by the FDA indicating a serious or even life threatening adverse reaction from a drug; warning statement is on the product package insert and in MedGuide
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| deoxyribonucleic acid | DNA. helix shaped molecule that carries genetic code
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| destructive agent | drug that kills bacteria, fungi, viruses, or even normal or cancer cells
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| diet supplement | category of nonprescription drugs that includes vitamins, minerals, and herbals that are not regulated by FDA
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| drug | any substance taken into or applied to the body for the purpose of altering the body's biochemical functions and thus its physiological processes
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| drug recall | process of withdrawing a drug from the market by the FDA or the drug manufacturer for serious adverse effects or other defects in the product
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| drug tolerance | situation that occurs when the body requires higher doses of a drug to produce the same therapeutic effect
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| FDA Online Orange Book | online reference that provides info on the generic and therapeutic equivalence of drugs that may have many different brand names or generic manufacturer sources
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| generic drug | drug that contains same active ingredients as the brand name product and delivers the same amount of medication to the body in the same way and in the same amount of time; a drug that is not protected by a patant
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| genetic engineering | process of utilizing DNA biotechnology to create a variety of drugs
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| genome | entire DNA in an organism, including its genes
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| homeopathic medications | very small dilutions of natural drugs claimed to stimulate the immune system
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| inert ingredient | inactive chemical that has little or no physiological effect that is added to one or more active ingredients to improve drug formulations such as fillers, preservatives, colorings, and flavorings; also called inactive ingredient
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| legend drug | drug that requires a prescription from a licensed provider for a valid medical purpose
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| MedGuide | written patient info mandated by the FDA for select high risk drugs; also known as a patient medication guide
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| MedWatch | voluntary program run by FDA for reporting serious adverse events
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| NDC | national drug code number. unique number assigned to a drug to identify the manufacturer, drug, and packaging size
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| OTC | over the counter drug. without prescription
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| pharmaceutical alternative drug product | drug product that contains the same active therapeutic ingredient but contains different salts or different dosage forms;cannot be substituted without prescriber authorization
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| pharmaceutically equivalent drug product | drug product that ocntains same amount of active ingredient in the same dosage form and meets the same USP-NF compendial standards; can be substituted w/o contacting prescriber
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| pharmacodynamic agent | drug that alters body functions in a desired way
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| physical dependence | taking a drug continuously such that physical withdrawal symptoms like reslessness, anxiety, insomnia, diarrhea, vomiting, and goose bumps occur if not taken
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| PPI | product package insert. scientific info supplied to the pharmacist and technician by the manufacturer with all prescription drug products; info must be approved by FDA
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| prophylactic agent | drug used to prevent disease
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| psychological dependence | taking a drug on a regular basis because it produces a sense of well being; if drug is stopped suddenly, anxiety withdrawal symptoms can result
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| radiophamaceutical | drug containing radioactive ingredients, often used for diagnostic or therapeutic purposes
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| RNA | ribonucleic acid. important component of genetic code that arranges amino acids into proteins
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| semisynthetic drug | drug that contains both natural and synthetic components
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| synthetic drug | drug that is artificially created but in imitation of naturally occurring substances
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| therapeutic agent | drug that prevents,cures,diagnoses, or relieves symptoms of a disease
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| therapeutic effect | desired pharmacological action of a drug on the body
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| vaccine | substance introduced into the body in order to produce immunity to disease
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| VAERS | vaccine adverse event reporting system. postmarketing surveillance system operated by FDA and CDC that collects info on adverse events that occur after immunization
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| Dr. Edward Jenner | experimented first smallpox vaccination
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| Madame Marie Curie | researched radioactivity
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| Sir Frederick Banting and Charles Best | discovered insulin
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| Dr. Alexander Fleming | discovered first antibiotic penicillin
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| Jonas Salk and Albert Sabin | invented vaccines to prevent polio
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| Gregory Pincus and John Rock | discovered the birth control pill
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| What should be on the bottle of OTC drugs? | directions, dose, frequency, precautions and contraindications, and duration of therapy
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| FDA | the food and drug administration. drugs approved should be safe and effective
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| how many phases are in the drug approval process | 4
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| Phase 1 | initial study or trial of new drugs in humans
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| Phase 2 | meant to evaluate the effectiveness as well as the safety of a drug
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| Phase 3 | studies are conducted in larger clinical trials on patients to better assess efficacy and safety of drug
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| Phase 4 | further observation when drug is put on market
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| What is the most serious recall class for drugs? | class 1
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| Class I | use of product will cause or lead to serious adverse health events or death (label mix up on lifesaving drug)
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| Class II | use of product will cause adverse health events that are temporary or medically reversible (understrength)
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| Class III | use of product will probably not cause an adverse health event (container defect,off taste,color in liquid)
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| PDR | physician's desk reference. includes package inserts. useful in identifying unknown drugs by color, shape, and coding. also list black box warnings.
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| Drug facts and comparisons | factual info on products availability, idications, administration and sose, pharmacological actions, contraindications, warnings, precautions, adverse reactions, overdose, patient instruction
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| Trissel's stability of compounded formulations | summarizes specific formulation and stability studies. used in sterile compounding. Contains stability and storage info on compounded drugs
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