Study of Drug Use and Addiction chapter 3

Phase Two

of the human studies involves patients who have the condition the candidate drug is designed to treat. These studies involve a few hundred patients who are chosen because the new agent might help them

opioids and cocaine

1914 Harrison "Narcotics" Act regulated what?

pharmaceutical manufacturing and sales

1906 Pure Food and Drugs Act regulated what?

1983 Orphan Drug Act

Congress passed this act offering tax incentives and exclusive sales rights for a guaranteed seven years for any company developing a drug for rare disorders afflicting no more than 200,000 people

the pharmaceutical industry

After determining that many violations of the 1906 Pure Food and Drugs Act were unintentional, the FDA began developing assay techniques for various chemicals and products and collaborated extensively with _________ to improve standards

there are large differences in penalties

Although the basic categorization of illicit drugs in schedules is similar in most American states, ______________________.

morphine or heroin (readily available and inexpensive)

As more laws came about for the use of opium, its black market price increased and lower-class opium users started using _________ or ________

Public School Students

As of 2012, the legality of random, suspicion-less urine testing for _____________ has not been established at the federal level

the use of opioids and cocaine was effectively criminalized

Between 1919 and 1929, the Narcotics Division in the US charged users in possession of opioids and cocaine who could not produce a valid prescription with violating the Harrison Act; thus, for the first time, ____________.

minority racial groups

During the period after the Civil War in the United States, concerns about drunkenness, crime, drug misuse and other forms of deviant behavior came to be associated with __________. "real" Americans aristocratic upper crust members members of the elite class minority racial groups

smugglers and opium dens

Early enforcement efforts of the Harrison Act, prior to the 1920's, focused on ____________

Ineffective

One of the major concerns of the US Senate in the late 1950's was that some of the most widely sold over-the-counter medicines were probably ________, and there was no law against this.

users should be cured rather than repeatedly jailed

In 1929, Congress viewed the enormous expenditure for imprisoning drug offenders as an indicator that something was wrong with the current system and decided that _________.

Bureau of Narcotics

In response to the end of Prohibition and to changes of corruption in the previous Narcotics Division, Congress formed a ___________ in the Treasury Department in 1930.

Opium

In the early 1800's, the most reliable and effective medicine of medical doctors, used for a variety of conditions but most notable as a pain reliever, was ___________.

10 to 15 percent

It is estimated that _________________ of the illegal drug supply in the US is seized by federal agencies every year.

True

T/F The largely unsubstantiated fear that cocaine use was responsible for an increase in violent crimes was important in building support for federal drug-control laws amount Southern senators and congressmen in the US despite their opposition to increasing federalism

Hypodermic syringes

The 1850's in the US saw the introduction of ___________, which was a potent delivery system for morphine that led to increasing medical recognition of the negative aspects of "morphinism"

interstate commerce in adulterated or misbranded food and drugs

The 1906 Pure Food and Drugs Act prohibited ______________________.

do not engage in a "consistent pattern of gross violations" of human rights

The United States is providing increased military aid in the form of helicopters, "defensive" weapons, uniforms, and other supplies to be used in combating drug trafficking, plus military training to both army and police agencies. This program is supposedly restricted to countries that __________

Longer sentences, mandatory minimums, and no-parole provisions

The introduction of __________ by the 1986 Anti-Drug Abuse Act has contributed greatly to a huge growth in prison populations over the past 20 years.

effective for the illnesses mentioned on the label

The most important change brought in by the 1962 Kefauver-Harrison amendments was one requiring that every new drug be demonstrated to be ____________________. therapeutic for a wide variety of disease and disorders effective for the illnesses mentioned on the label Toxic only to certain demography of people habit forming in order to sustain the market for these drugs

nadir (lowest point)

The period between 1890 and 1920 is called the ___________ of race relations in the US

18th Amendment

The single most important legislation that has shaped the federal government's approach to controlled substances wasn't a "drug law" at all but rather, this prohibited the use of alcohol.

Symbolic impacts

These cause people who promote such laws to gain immediate social status by being identified with political power and as supporting goodness, morality, and decency

Instrumental impacts

These refer to the consequences to those affected by the implementation of such laws, including those who are arrested and their families, and those whose livelihood depend upon the implementation of these laws

The Department of Agriculture

This department administered a law aimed at ensuring that drugs were pure and honestly labeled

The Treasury Department

This department was responsible for taxing alcohol, and it would later be responsible for enforcing Prohibition

1956 Narcotic Control Act

Under this law, any offense except first-offense possession had to result in a jail term, and no suspension, probation, or parole was allowed. Anyone caught selling heroin to a person younger than 18 could receive the death penalty

were adulterated or didn't properly list any important ingredients

Until 1912, the US Food and Drug Administration tested products and pursued any that ______________.

Mandatory minimum penalties were discontinued Drug control was based on both a health and law enforcement perspective The death penalty was eliminated

What changes were introduced by the Comprehensive Drug Abuse Prevention and Control Act of 1970? (All that apply) The Drug Enforcement Agency was dissolved Penalties for simple possession were greater than for making controlled substances Mandatory minimum penalties were discontinued Drug control was based on both a health and law enforcement perspective The death penalty was eliminated

The group of laws that regulates the practices of entities that manufacture or dispense LEGAL drugs

What class of drug laws is similar to laws that regulate the safety of other products such as automobiles, furnaces, and toys?

The Harrison Act of 1914

What is otherwise known as "An Act to provide for the registration of, with collectors of internal revenue, and to impose a special tax upon all persons who produce, import, manufacture, compound, deal in, dispense, or give away opium or coca leaves, their salts, derivatives, or preparations, and for other purposes?"

When it is ready to study the effects of a compound on humans

When does a pharmaceutical company, desiring to introduce a new drug, supply to the FDA a "Notice of Claimed Investigational Exemption for a New Drug" (IND)? When it has tested a compound on volunteers and students of medicine When it is about to start clinical tests on at least two species of animals When it has conducted clinical trials of a compound on people with a disorder When it is ready to study the effects of a compound on humans

Morphine

a narcotic, the primary active chemical in opium. Heroin is made from morphine

Phase Three

administers the drug to larger numbers of individuals (typically, 1,000 to 5,000) with the disease or symptom for which the drug is intended. If the compound proves effective in phase three, the FDA balances its possible dangers against the benefits for patients before releasing it for sale to the public

Misbranding

any statement, design, or device regarding... a drug, or the ingredients or substances contained therein, which shall be false or misleading in any particular

Phase One

encompasses studies with relatively low doses of the drug on a limited number of healthy people—typically, 20 to 80 company employees, medical school personnel, and others who volunteer for such trials. At this stage the researchers are primarily interested in learning how their drug is absorbed and excreted in healthy people, as well as the side effects it may trigger

patent medicines

medicines sold directly to the public under various trademark names. Primarily associated with the period before 1906 **broadest impact on drug use in the US came from the widespread legal distribution of ________

NDA "new drug application"

this is what a a company must send to the FDA that includes "full reports of investigation which have been made to show whether or not such a drug is safe for use"

alchohol

what prohibition was ratified in 1918 and implemented in 1919?