Pharmacology

the study of drugs and their interactions with living systems

First person in office to assess medications

Dental hygienist

Majority of herbal supplements have FDA approval. T/F

False

chemical name of drug

Used when a drug is being investigated by a companyEx: RU-486

Trade name of a drug

-given once a drug is found useful during investigation-used to market commercially-can be interchanged with the brand nameEx: Motrin, Tylenol, Advil

Trade name is registered as a trademark under the _____ ______ ____ and protected for _____ yrs by patent

Federal Trademark Law; 20

Which drug name is capitalized?

Trade name

Generic name of a drug

-given to a drug before marketed-"official" name-one generic name for each drug

Which drug name is not capitalized?

Generic name

Drug name that's selected by United States Adopted Name Council

Generic name

After ____, other companies can market the generic drug under a trade name of their choice.

20 yrs

FDA requires the active ingredients of the _____ ______product enter the bloodstream at the same rate as the ______ _____ product.

Generic name; trade name

Chemically equivalent

When two formulations of a drug meet the chemical and physical standards established by the regulatory agencies

Biologically equivalent

When the two formulations produce similar concentrations of the drug un the blood and tissues

Therapeutically equivalent

When the two formulations prove to have an equal therapeutic effect in a clinical trial

Federal regulations and regulatory agencies

Harrison Narcotic ActFDAFederal Trade Commission (FTC)Drug Enforcement Administration (DEA)Omnibus Budget Reconciliation Act (OBRA)

Many agencies are involved in regulating the ______, ________, _________, ________, and ________ of drugs.

Production; marketing; advertising; labeling; prescribing

Orphan drugs are developed to specifically treat

Opium; opiates; cocaine; 1914

When were marijuana laws added to the Harrison Narcotic Act?

1937

Before the Harrison Act, mixtures and OTC meds could contain what?

Opium & cocaine

Who grants approval so a drug can be marketed in the US?

FDA

Who determines a drug to be both safe and effective and which drugs can be sold by prescription and OTC?

FDA

Who regulates the labeling and advertising of prescription drugs?

FDA

The FDA is part of the ________________

U.S. Department of Health and Human Services (USHHS)

Who regulates the trade practices of drug companies?

Federal Trade Commission (FTC)

Who prohibits the false advertising of foods, nonrescription (OTC) drugs, and cosmetics?

Federal Trade Commission

Which law requires pharmacists provide patient counseling and a prospective drug utilization review for Medicaid patients.

Omnibus Budget Reconciliation Act (OBRA)

Many state boards of pharmacy are interpreting this law to apply to all patients.

Omnibus Budget Reconciliation Act (OBRA)

Part of the Department of Justice and administers the Controlled Substances Act of 1970

Drug Enforcement Administration (DEA)

Regulates the manufacture and distribution of substances that have a potential for abuse, including opioids (narcotics), stimulants, and sedatives

Drug Enforcement Administration (DEA)

Responsible for schedule of controlled substances,

Drug Enforcement Administration (DEA)

Clinical evaluation of a new drug

•Takes almost 12 years and $350 million

Evaluation on a drug is first tested on _____ for ____ years. After this it's tested on ______ with ____ clinical phases

Animals; 3; Humans; 4

Labeled use indicates what?

the FDA has approved the drug for specific use

Off label use is use outside the stated FDA indications. T/F.

True

...

Rare medical conditions

Orphan drugs treat diseases that occur in less than _______ people in the US

200,000

Drugs can be recalled by:

ManufacturerRequest of the FDA Ordered by the FDA

How can a drug get recalled?

Recalled if there is reasonable probability that their use will have serious adverse health consequences or death