Pharmaco Ch. 1: Evolution of Medicinal Drugs

Elimination Of Many Outlandish Drug Preparations.

Advancement of pharmacy & chemistry achieved w/ the compilation of the first London Pharmacopoeia in 1618.

Pharmacologic Effect

Action of a drug on the systems of a living being (i.e. the body's cells & tissues).

C-I

DEA schedule controlled substance; a drug w/ the highest potential for abuse, which may be used only for research under a special license.

Chemical Name

Drug name that describes a drug's chemical composition in detail.

Generic Name

Drug name that identifies a drug independently of its manufacturer; sometimes denotes a drug that is not protected by a trademark; also referred to as a USAN (United States Adopted Name).

Clinical Trial

Drug testing on humans, used to determine drug safety & efficacy.

Legend Drug

Drug that may be sold only by prescription & must be labeled "Caution: Federal Law prohibits dispensing w/o perscription" or "Rx only".

Over-The-Counter (OTC) Drug

Drug that may be sold w/o a prescriptioin.

Prophylactic Drug

Drug that prevents or decreases the severity of a disease or condition.

Therapeutic Drug

Drug that relieves the symptoms of a disease or condition.

Category C

FDA Pregnancy Drug Category: Caution Is Advised

Category D

FDA Pregnancy Drug Category: Definite Risk

Category X

FDA Pregnancy Drug Category: Do Not Use

Category A

FDA Pregnancy Drug Category: No Risk

Category B

FDA Pregnancy Drug Category: Risk Cannot Be Rulled Out

MedWatch

FDA's Medical Products Reporting Program where medical professionals & consumers can report serious adverse reactions to drugs.

Whole Grains

Food ingredients for which manufacuturers may make health claims regarding disease-fighting & cancer-fiting action/benefits.

Soy

Food ingredients for which manufacuturers may make health claims regarding reduction of the risk of coronary heart disease.

Apothecary

Forerunner of the modern pharmacists; also refers to the shop.

Pharmakon

Greek word meaning: "magic spell", "remedy", or "poison" that was used in early records to represent the concept of a drug.

Placebo

Inactive substance w/ no treatment value.

Pharmacist

Individual who is licensed to prepare & sell/dispense drugs & compounds & to fill prescriptions.

Pharmacy Technician

Individual working in a pharmacy who, under supervision of a licensed pharmacist, assists in activities not requiring the professional judgment of a pharmacist.

Drug

Medicinal substance or remedy used to hcange the way a living organism functions... a.k.a. medication.

American Pharmaceutical Association (APhA)

Organization established in 1852 to counter the encroachment of other medical areas into pharmacy & facilitating individual growth & increased professional stature of pharmacists.

A/B Rating System

Rating system devised by the FDA to establish the therapeutic equivalancy of generic drugs in comparison to their related innovator drug.

Pharmacology

Science: Study of drugs & thier interactions w/ the systems of living beings (i.e. the body's cells & tissues).

Medication Guide

Specific information abt certain types of drugs that is required by the FDA to be made available to the patient.

Pharmacognosy

Study & identification of natural sources of drugs.

Homeopathy

System of therapeutics in which diseases are treated by administering minute doses of drugs that, in healthy patients, are capable of producing symptoms like those of the disease being treated.

1861-1865 (American Civil War)

Time frame of American history when the boundaries betw. physician & pharmacist became clearly defined.

Alternative Medicine

Use of herbs, dietary supplements, & homeopathic remedies rather than pharmaceuticals.

New Drug Application (NDA)

Vehicle thru which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale & marketing in the United States.

Pharmacopoeia

book containing the official listing of drugs & other medicinal preparations, with instructions for proper identification & use.

Pharmacy Technician Certification Board (PTCB)

national Organization that develops pharmacy technician standards & serves as the credentialing agency for pharmacy technicians.

arsphenamine (Salvarsan)

1st chemical agent used to treat an infectious disease. Introduced in 1907, this rudimentary antimicrobial was used to treat syphilis.

Food & Drug Administration (FDA)

Agency of the federal government that is responsible for ensuring kthe safety of drugs & food prepared for the consumer market.

Drug Enforcement Administration (DEA)

Branch of the U.S. Justice Department that is responsible for regulating the sale & use of specified drugs, especially controlled substances.

Double Blind Study

Clinical Trial in which neither the trial participants nor the study staff know whether any particular participant is in the control group or the experimental group.

Clinical Trial - Phase III

Clinical trials phase when drug treatment is compared to commonly used treatments. During this phase, investigators collect information that will allow the drug to be used safely. This phase continues the double-blind, placebo-to0drug comparisons begun in the previous phase. Dose escalations are used to determine the efficacy of the drug in treating the target disease.

Clinical Trial - Phase IV

Clinical trials phase when the drug has been approved for marketing & studies continue testing the drug to collect information abt. its effects in various populations & to identify any side effects associated w/ long-term use.

Clinical Trial - Phase I

Clinical trials phase when the drug is administered to a small group of healthy people (20 - 100) to evaluate safety, determine a safe dosage range, & identify side effects. This phase assesses the most common acute adverse effects & clarifies what happens to the drug in the human body.

Clinical Trial - Phase II

Clinical trials phase when the drug is studied in patients who have the condition the drug is intended to treat. At this point, it is determined whether the drug has a favorable effect on the disease state. Short-term placebo-to-drug comparisons are made in double-blind studies to determine the range & response of various doses.

C-II

DEA schedule controlled substance; a drug w/ a high potential for abuse, for which dispensing is severely restricted & prescriptions may not be refilled.

C-IV

DEA schedule controlled substance; a drug w/ a low potential for abuse & limited dependence, which can be refilled no more than 5 times in 6 months & only if authroized by a physician.

C-III

DEA schedule controlled substance; a drug w/ a moderate potential for abuse, which can be refilled no more than 5 times in 6 months & only if authroized by a physician.

C-V

DEA schedule controlled substance; a drug w/ the lowest potential for abuse, some of which may be sold w/o a prescription depending on state law, but the purchaser must sign for the drug & show identification.

Controlled Substance

Drug w/ potential for abuse; organized into 5 categories or schedules that specify whether & how the drug may be dispensed.

Drug Sponsor

Entity (usually a pharmaceutical company) responsible for testing the efficacy & safety of a drug & proposing the drug for approval.

American Revolution

Event that forced American physicians, durggists, & wholesale distriubtors of drugs to manufacture their own chemically based drugs & to make common preparations of crude drugs.

Pepsin & Thyroid

Examples of drugs from animal products sources.

Silver Nitrate

Examples of drugs from mineral sources.

Digoxin, Ergotamine, & Morphine

Examples of drugs from plant sources.

Contain the same active ingredients as the original brand-name drug; be identical in strength, dosage form, & route of administration; have the same use indications; meet the same batch requirements for identity, strength, purity, & quality; & yield similar blood absorption & urinary excretion curves for the active ingredient.

Generic Drug Requirements.

Patent

Government grant that gives a drug company the exclusive right to manufacture a drug for a certain number of years, & protects the company's investment in developing the drug.

Black Box Warning

Information printed on a drug pkg. to alert prescribers to potential problems w/ the drug.

Food, Drug, & Cosmetic Act of 1938

Law that required all new drugs to be proved "safe" ("nontoxic") before being marketed. Also required drugs to have been the subject of an approved "New Drug Application (NDA)" before being marketed.

Assisting w/ drug studies; Counting, weighing, measuring, & mixing medications; Checking the work of other pharmacy technicians in the preparation of medicine charts; Educating nurses & other healthcare professionals abt. pharmacy-related issues; Establishing & maintaining patient profiles; Helping patients w/ OTC drugs; Making sure patients are counseled by the pharmacist (by asking if there are any questions for the pharmacist); Obtaining laboratory results for pharmacists; Ordering & stocking prescription & OTC medications; Overseeing & maintaining automated dispensing systems; Preparing prescription labels; preparing sterile IVs & chemotherapy compounds; Receiving written prescriptions/requests for prescription refills from patients or their caregivers; Tracking & reporting errors; Transcribing prescriptions over the telephone; Transferring prescriptions; Verifying that the information on the prescription is complete & accurate.

Responsibilities Of A Pharmacy Technician