Ch1: Information, Sources, Regulatory Agencies, Drug Legislation, Prescription Writing

____________ is the study of drugs and their interactions w/ living cells & systems.

Pharmacology

Drugs are chemical substances that are used in the in ___, ____, ________ and other abnormal conditions.

dx, tx, prevention of diseases

Drugs include synthetically derived compounds, ________, _________ & herbal supplements.

vitamins, minerals

Herbal supplements are marketed as ____________.

food supplements

___________ is a person that studies drug action and development of drugs

Pharmacologist

For dental drugs, __________ provides equivalent therapeutic results at a reduced cost.

generic substitution

Which act allows generic drugs to get expedited approval?

1984 Drug Price Competition and Patent Term Restoration Act

For a generic drug the FDA requires that the active ingreidnet must enter the bloodstream at the same time as the trade name drug, there must be no differences that exist besides ___________.

reduced cost

A ___________ drug meets chemical/physical standards set by regulatory agency.

chemically equivalent

A ___________ drugs means two formulations produce similar concentrations of the drug in the blood and tissues.

biologically equivalent

A ______________ drug has to prove to have equal therapeutic effects in the clinical trial. If a generic drug is shown to biologically equivalent it in turns makes them ______________.

therapeutically equivalent

Drugs can differe in _________ whihc is how the body takes and uses them.

bioavailablity

The ____________ regulates the use of opium, opiates, and cocaine. Marijuana was added in the 1937 but since then 4 US territories have legalized medical THC and 24 states/3 US territories legalized recreational THC use.

1914 Harrisson Narcotic Act

The ___________ required accounting for drugs with abuse potential.

1965 Drug Abuse Control Amendment

The __________ is part of the US Department of Health & Human Services grants approval so that drugs can be marketed in the US. Drug must prove safety & efficacy, determines ____ and _____.

Food and Drug Administration (FDA), OTC and Rx

The _____________ regulates the trade practices of drug companies, false advertising of foods, OTC & cosmetics.

Federal Trade Commission (FTC)

The ___________ regulates the manufacture, distribution of substances that have potential for abuse {Schedule of Drugs}. the US DOJ administers the _____________.

US Drug Enforcement Administration (DEA), Controlled Substance Act of 1970

The ______________ requires pharmascists to provide patient counseling and drug utilization review (DUR) for Medicaid patients; all patients with some states.

Omnibus Budget Reconciliation Act of 1970

The clinical evaluation has to go through preclinical and ____ phases.

4

Habit-forming drugs (Hx) have required ___________.

drug legislation

Schedule drugs must list __________. There must be a ___________ containing safety and potential life threatening concerns.

abuse potential, black box warning

All prescription drugs must have a ___________ containing literature about the drug.

package insert (PI)

________ are drugs that cen bypass government approval so people that have rare medical conditions can get the medication they need.

Orphan drugs

_________ are undesirable effects when taking a medication. Drug action on biological tissues can lack specificity which can cause this.

Adverse effects/reactions

_____________ are clinically desirable actions when taking a medication.

Therapeutic effects

A __________ drug has the highest abuse potential and has no accpeted med use. Only used for experimental purposes and in research. ex heroin

schedule 1

A ___________ drug has a high abuse potential and requires written Rx, prescribers signature, and duplicate/triplicate copy. No refills. Ex oxycodone, morphine, amphetamine, hydrocodone, secobarbital.

schedule II

A _________ drug has moderate abuse potential, Rx can be telephoned, nore more refills than 5x in 6 months. Ex codeine.

schedule III

A _________ drug has a less abuse potential, Rx can be telephoned. Refils are no more than 5x in 6 months. Ex diazepam (valium), tramadol (ultram)

schedule IV

A _________ drug has the least abuse potential and can be obtained OTC in some states. Ex codeine containing cough syrup.

schedule V

whats the abbreviations for immediately?

stat

whats the abbreviations for tablet?

tab

whats the abbreviations for 3 times a day and 2 times a day?

tid, bid

whats the abbreviations for as directed?

ud

In pharmacy the metric system is mostly used. A solid drug is measures in _________, liquids in ________, and occasionally drugs are measured in grams (gms), micrograms, and liter (L). Pharmacists will dispense drugs in metric system but provide intructions for patient in household unit for drug use.

milligrams (mg), milliliters (mL)