Chap 1 Intro to Drugs

Who________ monitors development of generic medications, which must have same active ingredient, dosage form, route of administration, and safe inactive & packaging /storage.

Who________ monitors development of generic medications, which must have same active ingredient, dosage form, route of administration, and safe inactive & packaging /storage.

FDA

________ (Marinol); contains the active ingredient (delta- 9- terahydrocannbinol) found in Marijuana.

Dronabinol

________ must report adverse effects to the FDA, even if not related to the drug.

Healthcare professionals

________ may be effective in animals but not humans.

Chemicals

________: clinical pharmacology- the branch of pharmacology that deals with drugs; chemicals that are used in medicine for the treatment, prevention, and diagnosis of disease in humans.

Pharmacotherapeutics

Over- the- counter (________) drugs: drugs that are available without a prescription for self- treatment of a variety of complaints; deemed to be safe when used as directed; often formerly only available by prescription.

OTC

________: the process of altering DNA- permits scientists to produce human insulin by altering Escherichia coli bacteria, making insulin a better product without some of the impurities that come with animal products.

Genetic engineering

________: having adverse effects on the fetus.

Teratogenic

________ helps prevent nausea /vomiting in cancer patients w /o adverse effects of smoking marijuana leaf (controlled substance w /high abuse potential)

Drug

Under ________, limited quantities of certain schedule V drugs may be purchased without a prescription directly from a pharmacist.

federal law

________: Have a long history since prehistoric time; they are important sources of chemicals that are developed today.

Plants

________ are made aware of potential benefits and risks and monitored closely, often free of charge.

Patients

________: Many of adverse reactions; could be fatal.

Black box label

The ________, Drug and Cosmetic Act of 1938, which gave the FDA power to enforce standards for testing drug toxicity and monitoring labeling.

Federal Food

The chemical lacks ________ when used with living animals.

therapeutic activity

In the 1960s, ________ (Thalomid) was used as a sleeping aid by pregnant women, causing birth defects.

thalidomide

________: Salts of various elements, like aluminum, fluoride, iron, and gold, have therapeutic effects.

Inorganic Compounds

________ and Cautions: Conditions limiting the use of drug.

Contraindication

Which act ________ gave the FDA control over drug testing and efficacy /safety standards.

Kefauver Harris Act of 1962

________: Chemicals that could be helpful for medicines can come from many different places, like plants, animals, or inorganic materials.

Natural Source

The purchaser must be at least 18 years of age and must furnish ________.

suitable identification

________ and growth hormone preparations also may be obtained from animal thyroid but synthetic preparations are considered to be purer and safer than preparations derived from animals.

Thyroid drugs

Antacid to decrease ________.

gastric acidity

________ study: continuous evaluation of a drug after it has been released for marketing.

Phase IV

________ on the label of a drug is the action of drug on the body.

Therapeutic actions

________; History or physical assessment indicating these conditions.

Assessment points

A(n) ________ involves use of a drug in a clinical market.

phase III study

________ are bioequivalent to brand name, but can affect some people differently.

Generic medications

________ for treating diabetes was obtained exclusively from the pancreas of cows and pigs.

Insulin

The body converts ________ to a false aldosterone- a hormone found in the body- resulting in fluid retention and hypokalemia or low serum potassium levels if large amounts of licorice are consumed.

natural licorice

________ are available without a prescription for self- treatment.

OTC drugs

________: initial trial of a chemical thought to have therapeutic potential; uses laboratory animals, not human subjects.

Preclinical trials

________ are often abandoned after preclinical trials or phase I studies.

Orphan drugs

________: process of altering DNA, usually of bacteria, to produce a chemical to be used as a drug.

Genetic engineering

The ________ regulates drug development and sale, while local laws further regulate distribution and administration.

FDA

________ with abuse potential are called controlled substances.

Drugs

Food and Drug Administration (________): federal agency responsible for the regulation and enforcement of drug evaluation and distribution policies.

FDA

clinical pharmacology-the branch of pharmacology that deals with drugs; chemicals that are used in medicine for the treatment, prevention, and diagnosis of disease in humans

pharmacotherapeutics

a pilot study of a potential drug using a small number of selected, usually healthy human volunteers

phase I study

a clinical study of a proposed drug by selected physicians using actual patients who have the disorder the drug is designed to treat; patients must provide informed consent

phase II study

use of a proposed drug on a wide scale in the clinical setting with patients who have the disease the drug is thought to treat

phase III study

continuous evaluation of a drug after it has been released for marketing

phase IV study

initial trial of a chemical thought to have therapeutic potential; uses laboratory animals, not human subjects

preclinical trials

having adverse effects on the fetus

teratogenic

Many of adverse reactions; could be fatal

Black box label

Salts of various elements, like aluminum, fluoride, iron, and gold, have therapeutic effects

Inorganic Compounds

Names that reflect the chemical structure of a drug

Chemical names

Adequate studies in pregnant women have not demonstrated a risk to the fetus in the first trimester of pregnancy, and there is no evidence of risk in later trimesters

Category A

Animal studies show no risk to fetus; no adequate studies in pregnant women

Category B

Animal studies show adverse effects on fetus; benefits from drug use in pregnant women may be acceptable despite potential risks, or no animal/human reproduction studies

Category C

There is evidence of human fetal risk, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks

Category D

Studies in animals/humans show fetal abnormalities/adverse reactions; reports suggest fetal risk

Category X

High abuse potential and no accepted medical use (heroin, marijuana, LSD)

Schedule I (C-I)

High abuse potential with severe dependence liability (narcotics, amphetamines, and barbiturates)

Schedule II (C-II)

Less abuse potential than schedule II drugs and moderate dependence liability (nonbarbiturate sedatives, nonamphetamine stimulants, limited amounts of certain narcotics)

Schedule III (C-III)

Less abuse potential than schedule III and limited dependence liability (some sedatives, antianxiety agents, and nonnarcotic analgesics)

Schedule IV (C-IV)

Limited abuse potential

Schedule V (C-V)