Ch 1

Black Box warning

Indicates a very serious life-threatening problem

brand or trademark

Registered by manufacturer and is CAPITALIZED

combination

Therapeutic methods are often used in

FDA

Which entity is responsible for monitoring drug safety in the United States?

8-15

____years and can cost up to $1 billion to get a drug to market

Electronic databases

can provide the most up-to-date information to health care providers, unlike printed resources that are published only periodically.

USAN

contains more than 10,000 drug names.

Inventory and dispersion

control records of controlled substances in the hospitals

Schedule I

high abuse potential; no medical use (e.g., heroin)

Schedule III

high abuse potential; some medical use (e.g., codeine)

Schedule II

high abuse potential; some medical use (e.g., pentobarbital)

phychotheraphy

identifies stressors & methods used to reduce stress

generic name

is the official name thats listed by the FDA

Federal Food, Drug, and Cosmetic Act (1938, 1952, 1962) Controlled Substances Act (1970)

legislation regarding drug use

science

logos is greek for

Schedule V

low abuse potential; prescription not needed (e.g., Robitussin)

Schedule IV

low abuse potential; some medical use (e.g., diazepam)

nurses

may not have controlled substances in their possession

chemical name

most meaningful to the chemist

Requirements

must be met to dispense scheduled medications

-The United States Pharmacopeia\National Formulary USP/(NF) -USP Dictionary of USAN and International Drug Names

official source for American drug standard

Nonprescription

over-the-counter (OTC) drugs sold without a prescription

drugs

pharmakon is greek for

Food and Drugs Act (1927) Food & Drug Regulations (1953, 1954, 1979)

protect the public in Canada through the Therapeutic Products Directorate

Prescription

require an order by a health professional licensed to prescribe drugs

USP/NF

sets standards of purity for drugs and lab tests used to determine the purity

package inserts & nursing journals

sources for prescription & nonprescription drugs

brand

there are some dissimilarities in _____ names between Canada and the US

generic & trade

to avoid confusion, which name of a drug should be used when teaching a patient with a new prescription ?

physiotherapy

treatment of natural force, using water, light, and heat

illegal or recreational drugs

used for non-therapeutic purposes; obtained illegally

Parallel tracking

used for patients with life-threatening illnesses who cannot participate in controlled trials and there is no other alternative

Fast tracking

used to expedite drug development and approval for life-threatening illnesses

diet therapy drug therapy physiotherapy psychotherapy

4 therapeutic methods

patient

All individuals involved with controlled substances have responsibilities to ensure the safety of the

sources of drug info in canada

Compendium of Pharmaceuticals and Specialties (CPS) Patient Self-Care: Helping Patients Make Therapeutic Choices Compendium of Self-Care Products (CSCP) Therapeutic Choices

electronic databases

Cumulative Index of Nursing and Allied Health (CINAHL), Lexi-Compe,Pocrates, & DailyMed are examples of

generic, brand

ExGlucotrol XL is an antidiabetic drug. _____ name is glipizide. The _____ name is Glucotrol XL

DEA

Manufacturers, prescribers, and dispensers of drugs must register with the

generic name

NOT capitalized; important to know because its the name listed at pharmacy

Postmarketing Surveillance Stage

Ongoing review of adverse effects of new drugs

therapeutic methods

are approaches to treating illness

Pharmacology

deals with the study of drugs and their actions or effects

Physiologic or chemical

drugs can be classified by _________ actions such as anticholinergics & calcium channel blockers

body system

drugs can be classified by the _______ that they effect like the cardiovascular & gastrointestinal

Therapeutic use or clinical indications

drugs can be classified by their _________ use or _______ indications such as antiacids & antibiotics

schedule I

drugs have the highest potential for abuse and are not currently accepted for medical use in the United States.

Schedule F

drugs that require a prescription and are not under the controlled drugs schedule

chemical generic brand

each drug has three names:

Controlled Drugs and Substance Act (1997)

establishes requirements for the control and sale of narcotics and substances of abuse in Canada