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HTH 378 Drug Products and Regulations
Drugs
59
Health Care
02/19/2013

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Term
Current laws trace back to two pieces of legislation from the early
Definition
1900s
Term
Racist fears about deviant behavior, including drug misuse, played a role in the
Definition
development of drug regulation
Term
Laws were developed to regulate
Definition
undesirable behaviors
Term
Fraud in patent medicines that were sold directly to the public included what two things
Definition
False therapeutic claims
Habit-forming drug content
Term
Opium was associated with which ethnic group
Definition
chinese
Term
U.S. was involved in international
Definition
drug trade
Term
Opium smoking brought to U.S. by
Definition
chinese workers
Term
Laws passed against the _______, _______, and ____ of opium
Definition
importation, manufacture, use
Term
Exclusion Act of 1909
Definition
Banned only the smoking of opium
Term
Cocaine was viewed as a cause of increasing
Definition
crime
Term
Did cocaine have racist connections
Definition
yes
Term
1906 Pure Food and Drug Act
Definition
Required accurate labeling and listing of ingredients
Term
1906 Pure Food and Drug Act was later ammended to require
Definition
safety testing and testing for effectiveness
Term
Harrison Act of 1914
Definition
A law that required those who “produce, import, manufacture, compound, deal in, dispense, or give away” certain drugs to register and pay a special tax
Term
Harrison Act of 1914 was later expanded to include
Definition
other federal controlled-substance regulations
Term
What resulted from the Harrison Act of 1914
Definition
Showing your id and signing for medications
Term
The Harrison Act of 1914 imposed a system of
Definition
taxes on opium an coca products and record keeping
Term
The Pure Food and Drugs Act (1906)was passed by the
Definition
U.S. Department of Agriculture
Term
The goal of The Pure Food and Drug Act of 1906
Definition
drugs are pure and honestly labeled
Term
Harrison Act (1914) was passed by
Definition
U.S. Treasury Department
Term
The goal of the Harrison Act (1914)
Definition
taxation of drugs to restrict commerce in opioids and cocaine to authorized physicians, pharmacists, and legitimate manufacturers
Term
Role of the FDA
Definition
The FDA is responsible for regulating, testing, evaluating, approving and recalling all food, prescriptions, OTC drugs, illicit drugs, medical devices, vaccines, animal feed and drugs, cosmetics, and radiation-emitting products.
Term
Three parts of the Regulation of Pharmaceuticals
Definition
purity, safety, and effectiveness
Term
Two parts of purity
Definition
The contents of the product must be accurately labelled
FDA encourages cooperation and compliance
Term
Four parts of safety
Definition
Originally-no legal requirements that medications should be safe
1938 Food, Drug, and Cosmetic Act required pre-marketing testing for toxicity
Companies required to submit a New Drug Application (NDA) to the FDA
-FDA became a gatekeeper and expanded greatly
Directions must be included
-Adequate instructions for consumer OR
-Drugs can only be used only with physician prescription
Term
Amendments of effectiveness
Definition
1962 Kefauver-Harris Amendments
Term
Three parts of the 1962 Kefauver-Harris Amendments
Definition
Pre-approval required before human testing
Advertising for prescription drugs must include info about adverse reactions
Every new drug must be demonstrated to be effective for the illnesses mentioned on label
Term
Three parts of marketing a new drug
Definition
Preclinical research and development
Clinical research and development
Permission to market
Term
Three phases of clinical research and development
Definition
Phase one-low doses, 20-80 healthy volunteers
Phase two-few hundred patients who could benefit
Phase three-typically 1,000-5,000 patients
Term
Marketing a new drug may require ____ years and costs __ billion
Definition
10+
1+
Term
Only __ new drugs approved by FDA in 2008
Definition
31
Term
Orphan Drug Act
Definition
tax and other financial incentives
Term
Prescription Drug Marketing Act 1997
Definition
regulated free samples
Term
FDA Modernizing Act
Definition
guidelines for post marketing reporting, distribution of information on off label uses
Term
Dietary Substances are regulated more like ____ than drugs
Definition
food
Term
Two requirements of marketing supplements
Definition
Labels must be accurate
Products can’t make unsubstantiated direct claims
Term
Two abilities of marketing supplements
Definition
Products can make general health claims
Products can be marketed without first proving safety
Term
Controlled substances have _____ enforcement and ______ penalties
Definition
early, stiffer
Term
Prison vs. ______
Definition
rehab
Term
Two things that regulate controlled substances
Definition
Bureau of Narcotics (Treasury Department)
Drug Abuse Control Act Amendments of 1965
Term
Marijuana Tax Act of 1937
Definition
Anyone attempting to sell marijuana had to pay the transfer tax.
Tax stamp would only be issued to those who were already in possession of the marijuana.
Possession of marijuana without having paid the transfer tax was illegal according to the draft.
Law was written in such a way as to make it impossible to follow.
Term
Comprehensive Drug Abuse Prevention and Control Act of 1970 ______ or _____ all previous laws
Definition
replaced, updated
Term
Drugs controlled by the Comprehensive Drug Abuse Prevention and Control Act of 1970 are under
Definition
federal jurisdiction
Term
Under the Comprehensive Drug Abuse Prevention and Control Act of 1970 _____ and ______ funding increased
Definition
prevention, treatment
Term
Goal of Comprehensive Drug Abuse Prevention and Control Act of 1970
Definition
Direct control of drugs, not control through taxation
Term
Under the Comprehensive Drug Abuse Prevention and Control Act of 1970, enforcement was separated from _______ and ______ decisions
Definition
scientific, medical
Term
Omnibus Drug Act
Definition
Possession and selling penalties
Term
What was established under the Comprehensive Drug Abuse Prevention and Control Act of 1970
Definition
Office of National Drug Control Policy
Term
Difference in _______ from state to state
Definition
penalities
Term
Federal law overrides
Definition
state law
Term
Significant growth in number of Americans in
Definition
prison
Term
Four people who can get drug tested
Definition
Military and federal employees
Transportation workers
Employees at private companies
Public schools employees
Term
Different test = different
Definition
results
Term
Different levels of
Definition
sensitivity
Term
Four types of detection
Definition
Urine
Sweat
Hair
Saliva
Term
Costs of impact of drug enforcement
Definition
Cost of prison population
Crimes committed to purchase drugs
Corruption in law enforcement
Conflicting international policy goals
Loss of individual freedom
Term
About __-__ percent of illegal drug supply is seized each year
Definition
10-15
Term
When supplies are restricted, ______ go up
Definition
prices
Term
Higher ____ and increased difficulty in obtaining drugs may deter some would-be users
Definition
prices