HTH Ch 3
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
