HTH Ch 3

Pataasin ang iyong marka sa homework at exams ngayon gamit ang Quizwiz!

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

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

the noteworthy change in the 1988 law

toughen the approach toward drug users, aimed at reducing the demand for drugs (as opposed to efforts to control the drug supply)

"narcotic farms"

treatment of persons dependent on habit-forming drugs (including weed/peyote) who had convicted of violating a federal law. (kentucky, 1935; 1k patients, 2/3rds of them prisoners)

jones-miller act

more than doubled the max penalties for dealing in illegally imported drugs to $5k and 10 years of jail time

which law was passed as a result of the poisoning of 107 people by elixir Sulfanilamide?

the 1938 food, drug, and cosmetic act

what did the jones-miller act passed by congress in 1922 do?

- officially made the user of illegally obtained opioids and cocaine a criminal - it more than doubled the mx penalties for dealing in illegally imported drugs

chemical diversion and trafficking act

allowed DEA to monitor chemicals that are not necessarily precursors, but are required for the illegal manufacturing of drugs (e.g. acetic anhydride used for making heroin)

the 1965 drug abuse control amendments referred to amphetamines, barbiturates, and hallucinogens as ________

dangerous drugs

Bureau of internal revenue

dealers pay for opioids and cocaine to register them annually, pay a small fee, and use special forms provided by ___________

"sulfa" drugs

effective antibiotics that cause kidney poisoning, led to 1938 food , drug, and cosmetic act

when a company submits an application to investigate a new drug in human clinical trails (IND) to the FDA, it is also required to submit all info from ______

preclinical investigations, including the effects of the drug on animals

the people enforcing the harrison act changed in 1919, and they believed that the cure for narcotic dependence was to

prevent users from having access to drugs

evidence that drug control is effective in restricting supply is found in the ________

high prices in the street

NDA (new drug application)

full reports of investigations which have been made to show whether or not such a drug is safe for use

many orphan drugs are extremely expensive, with some costing more than 100k per patient per year because of the _________

limited market for them

The Navy, followed by the other armed forces, were the first to _______ on a large scale in the US

use random urine screening

first groups of american students to be widely subjected to urine screening for drugs were those _____________

involved in team sports

in 1914, it was still

not criminalized to posses these drugs and physicians could still prescribe them

thalidomide

west germany 1957

two basic federal laws had been passed that would influence our nation's drug regulations

- Food and Drug Act (department of agriculture) - Harrison (treasury department)

what are the two main reasons for which private corporations adopt drug tests?

- believe a drug-free worker will have better productivity - believe that the company will be protected against suits for drug-related negligence

costs incurred due to drug control enforcement

- cost of crimes committed to purchase black-market drugs - cost of placing law enforcement officers at risk - cost of improsioning drug-law violators - cost of supporting repressive governments in combating drug trade

1994 dietary supplement health and education act

- fixed: safety/claimed beneficial qualities (mislabel) - includes vitamins, minerals, proteins, herbs and herbal extracts - can't make unbacked up direct claims "cures cancer" but can make general statements about overall health that can be gotten from using it

reasons why the new drug application provision under the 1938 food, drug, and cosmetic act were important

- reduced likelihood of companies run by untrained people introducing new drugs - increased the power and responsibility of the FDA as well as it's size

what are dietary supplements able to do under federal law?

- they don't need to be proved effective for an intended purpose - they are permitted to make general statements about their contribution to overall health

trends set when they cracked down on heroin

- users were criminals at adds w the regulatory agency - the growth of illicit market was responded to w greater penalties and more aggressive enforcement - focus was on trying to eliminated a substance (heroin) as though the drug itself were the problem

how was the NDA provision important?

1. changed role of FDA from testing and challenging some of the drugs already being sold to that of a gatekeeper, which much review every new drug before it is marketed. led to power/resoponsi/expansion 2. requirement to conduct safety research before marketing reduced likelihood of new drugs being introduced by small companies run by untrained people

three phases of clinical investigations

1. phase one encompasses study w low does of drug on limited # of healthy people (20-80 employees, med school personal, volunteers) mostly looking for how their drug is absorbed and excreted in healthy people, as well as the side effects it may trigger 2. 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 bc the new agent might help them 3. phase three administers the drug to larger # of ppl (1k-5k) w disease or symptom for which the drug is intended. if it proves effective here, the FDA balances its possible dangers against the benefits for patients b4 releasing it for sale to the public

the single most important legislation that has shaped the federal government's approach to controlled substances was the

18th amendment prohibiting alcohol

Who drafted the bill that later came to be known as the Harrison act?

Dr. Hamilton Wright, father of American narcotics laws

as part of international efforts aimed at reducing drug supply, the _________ has agents in more than 40 countries assisting the local authorities in eradicating drug crops, locating and destroying illicit laboratories, and interfering with the transportation of drugs out of those countries.

Drug enforcement agency

1914

Harrison "Narcotics" Act regulated opioids and cocaine

One of the precursors to the ____________ was President Roosevelt's recommendations in 1905 that a law be enacted to regulate interstate commerce in misbranded and adulterated foods, drinks, and drugs

Pure Food and Drugs Act

when was the first time dealers and dispensers of opioids and cocaine in the U.S. has to register annually, pay a small fee, and use special order forms provided by the Bureau of Internal Revenue

When the hamilton act was passed in 1914

cocaine

a stimulant and the primary active chemical in coca, the pure form of which became available in the US in the mid-1800s

according to the 1956 narcotics drug control act, __________ had to result in a jail term, and no suspension, probation, or parole was allowed

any drug offense except first-offense possession

Notice of claimed investigational exemption for a new drug (IND)

application to investigate a new drug in human clinical trials

narcotics division interpreted the harrison act

but not bc the it was supposed to be like that

patent medicines

dispensed by traveling peddlers and were readily available at local stores for self-medication

the 1988 amendment of the anti-drug act brought back the death penalty to drug-related murders, and a further amendment in 1994 extended the death penalty to

drug kingpins

the most important change brought in by the 1962 kefauver-harris amendments was one requiring that every new drug be demonstrated to be ________

effective for the illnesses mentioned on the label

T/F: The harrison act criminalizes individual use or possession of certain drugs

false

Dr. Hamilton Wright

father of American narcotics laws

1875 San Francisco ordinance

first U.S. law forbidding opium smoking (NY pass a similar law in 1882/1890 fed act let on Americans import/smoke)

morphine

form opium (used in the 1830s); a narcotic, the primary active chemical in opium. heroin is made from it

justice departments drug enforcement agency

given responsibility for controlling certain drugs directly rather than through tax or interstate commerce laws

1930 Bureau of narcotics in the Treasury department

harry anslinger "drug czar" almost total control of federal efforts in drug education, prevention, treatment and enforcement for 30 years 1932-62

change to the law

has to be demonstrated to be effective for the illnesses mentioned on the label; removed 6,133 drugs manufactured by 2,732 companies

The 1906 Pure Food and Drugs Act prohibited

interstate commerce in adulterated or misbranded food and drugs

the greatest discrepancy between state and federal drug laws is in the realm of ________ regulation

marijuana

During the period after the Civil War in the US, concerns about drunkenness, crime, drug misuse, and other forms of deviant behavior came to be associated with

minority racial groups

according to he 1906 pure food and drug act, covered "any statement, deign, or device regarding.... a drug or the ingredients "

misbranding

an international conference met in 1912 to discuss controls on the opium trade. Great Britian wanted _______ included as well, because these were replying opium, which led to several countries agreeing to control international trade and domestic sale and use of these substances

morphine, heroin, and cocaine

According to the 1906 Pure Food and Drugs Act, misbranding referred ________

only to labels, not to general advertising

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

opium

one of the consequences of the 1938 food drug and cosmetic act was that the federal law of the US now recognized a difference between ____________.

over-the-counter and prescription only

2005 combat methamphetamine epidemic act

over-the-counter drugs ephedrine and pseudophedrine are used to make meth, so this act requires identification and a signature for all sales of products containing these drugs in the US

1983 Orphan drug act

passed by congress, 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 200k ppl.

The broadest impact on drug use in the US during the late 19th century and early 20th century came from the widespread legal distribution of ________, which were dispensed to traveling peddlers and were readily available at local stores for self-medication.

patent medicines

until the 1920s, following the passage of the harrison act, most users of opioids continued to receive them legally through

private physicians or public clinics

urine testing

standard method, is said to be capable of detecting most kinds of drugs for up to 3 days as the drug, or its metabolites, clears the system

designer drugs

refer to chemicals that are close relatives of controlled substances but not themselves listed on one of the schedules

early enforcement efforts of the harrison act, prior to the 1920s, focused on ______

smugglers and opium dens

controlled substances act

stiffened penalties for selling drugs and reinstitute mandatory min sentences and sentences w/o parole; 500 grams of powered cocaine- but only 5 grams of crack cocaine- are required to trigger a mandatory 5-year prison term

which of the following is more invasive than the rest?

supervised urine testing

two kinds of impact when laws are passed that criminalize a behavior

symbolic and instrumental

Food and Drug Administration (FDA)

test product and pursued any that were adulterated or didn't properly list important ingredients and went after companies for their therapeutic claims

which sedative and sleeping pill caused a disaster in the late 1950s that raised awareness and congressional concern about ineffective medicines in the US causing major reforms to be implemented

thalidomide

1906

the Pure Food and Drugs Act regulated pharmaceutical manufacturing and sales

What happened as more state an municipalities outlaws opium dens in the US?

the cost of black-market opium increased

moral model of dependence

the model viewed morphine-dependent patients as being merely weak-willed or simply seeking pleasure in the drug's effects

after determining that many violations of the 1906 Food and drug act were unintentional, the FDA began developing assay techniques for various chemicals and products and collaborated extensively with _________ to improve standards.

the pharmaceutical industry

1918

the prohibition of alcohol was ratified but implemented in the next year

critics of the effectiveness of drug-enforcement efforts in the US have pointed out that even as expenditures are escalating, agents are increasing in number and supply-education efforts are increasing in variety ________

the supplies of cocaine, heroin, and marijuana appear to have increased

after the narcotics division in the US arrested around 25,000 physicians between 1919 and 1929 for supplying opioids and cocaine to dependent users, _______

there was no legal way to obtain these drugs then

instrumental impacts

these have effects on local, state, and federal budgets

symbolic impacts

these provide status benefits to the supporters of criminalization regardless of how effectively the laws are actually enforced

drug precursors

these refer to raw material that could be made in one step into a controlled substance

What do an 1875 San Fran ordinance, an 1883 NY law, and an 1890 fed act in the US all have in common?

they all regulated the manufacture and use of opium

how were physicians, dentists, and veterinary surgeons affected by the Harrison act?

they had to register to be potential lawful distributors of opioids and cocaine

"drug czar"

this individual ordered by the legislation to prepare a national drug-control budget for all federal agencies involved, to advise the National Security Council, and to report directly to the president

medical model of dependence

this model viewed morphine-dependent patients as having developed a unique disorder requiring continued treatment

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

users should be cured rather than repeatedly jailed

department of health, education, and welfare

was given funding for drug-related research, treatment, and prevention effots

until 1912, the us FDA tested products and pursued any that ___________

were adulterated or didn't properly list any important ingredients

after the 1965 drug abuse control amendments, for the first time, the bureau of narcotics and dangerous drugs faced widespread disregard of drug laws by young people who _______

were not members of the underprivileged and criminal classes

Accord to the 1906 Pure Food and Drugs Act, the packaging of drugs had to indicate _______

what proportion of habit-forming drugs they included


Kaugnay na mga set ng pag-aaral

Internal Combustion Engine Final

View Set

AA Aerosim 737 Study Guide - Sep 2017

View Set

Pharmacology Exam I: Sulfonamides

View Set