Ch. 3: Drug Policy

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True/False: The Harrison Act criminalized individual use or possession of certain habit-forming drugs.

False

cocaine

the active chemical in the coca plant

IND

"Notice of Claimed Investigational Exemption for a New Drug"; application to investigate a new drug in human clinical trials

Match the years with the laws passed in the US in those years. 1906: 1914: 1918: a) The Pure Food and Drugs Act regulated pharmaceutical manufacturing and sales. b) The prohibition of alcohol was ratified but implemented in the next year. c) The Harrison "Narcotics" Act regulated opioids and cocaine.

1906: a) The Pure Food and Drugs Act regulated pharmaceutical manufacturing and sales. 1914: c) The Harrison "Narcotics" Act regulated opioids and cocaine. 1918: b) The prohibition of alcohol was ratified but implemented in the next year.

Match the departments with the responsibilities allocated to them by the Comprehensive Drug Abuse Prevention and Control Act of 1970. Dept of Health, Education, and Welfare: Justice Dept's Drug Enforcement Agency: a) This was given funding for drug-related research, treatment, and prevention efforts. b) This was given responsibility for controlling certain drugs directly rather than through tax or interstate commerce laws.

Dept of Health, Education, and Welfare: a) This was given funding for drug-related research, treatment, and prevention efforts. Justice Dept's Drug Enforcement Agency: b) This was given responsibility for controlling certain drugs directly rather than through tax or interstate commerce laws.

DEA

Drug Enforcement Administration; a branch of the Department of Justice

_______ is a narcotic and the primary active chemical from which heroin is derived.

Morphine

According to the 1938 Food, Drug, and Cosmetic Act, a company had to submit a(n) ______ _______ ______ (NDA) to the FDA that included "full reports of investigations which have been made to show whether or not a drug is safe for use," which had to be approved before the drug could be marketed.

New Drug Application

NDA

New Drug Application; must be approved before a drug is sold

Once the FDA authorizes the testing of a drug in humans, in which phase of clinical investigation does a company learn about how that drug is absorbed and excreted in healthy people, as well as the side effects it may trigger?

Phase I

Match the impacts of passing laws that criminalize drug use with their descriptions. Symbolic impacts: Instrumental impacts: a) 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. b) 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.

Symbolic impacts: b) 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: a) 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.

Match the departments in the US government with the laws they administered by 1914. The Department of Agriculture: The Treasury Department: a) The 1906 Pure Food and Drugs Act b) The Harrison Act of 1914

The Department of Agriculture: a) The 1906 Pure Food and Drugs Act The Treasury Department: b) The Harrison Act of 1914

True/False: Increased drug-control efforts by federal agencies has resulted in an unquantifiable cost in the loss of individual freedom that is inevitable.

True

True/False: The broadest impact on drug use in the US during the late 19th century and early 20th century came form the widespread legal distribution of patent medicines, which were dispensed by traveling peddlers and were readily available at local stores for self-medication.

True

True/False: The largely unsubstantiated fear that cocaine use was responsible for an increasein violent crimes was important in building support for federal drug-control laws among Southern senators and congressmen in the US despite their opposition to increasing federalism.

True

Match the drug testing methods with the number of days up to which they can detect drug use. Urine testing: Hair testing: Saliva testing: a) It can detect drug use for up to 90 days and is more capable of detecting occasional drug use than other methods. b) It can detect most kinds of drugs for up to three days, but it can also detect frequently used drugs for a couple of weeks after the last dose. c) It can only detect fairly recent drug use, up to one day, in most cases.

Urine testing: b) It can detect most kinds of drugs for up to three days, but it can also detect frequently used drugs for a couple of weeks after the last dose. Hair testing: a) It can detect drug use for up to 90 days and is more capable of detecting occasional drug use than other methods. Saliva testing: c) It can only detect fairly recent drug use, up to one day, in most cases.

morphine

a narcotic; the primary active chemical in opium; heroin is made from it

What were the provisions added by the 1962 Kefauver-Harris amendments to federal law? (All that apply) a) Companies need to seek approval before conducting clinical trials on humans. b) Distributors of habit-forming drugs need to register before legally selling such drugs. c) Advertisements for prescription drugs need to summarize adverse reactions to the drug. d) Labels of drugs need to list the proportion of habit-forming ingredients in the drugs.

a) Companies need to seek approval before conducting clinical trials on humans. c) Advertisements for prescription drugs need to summarize adverse reactions to the drug.

With reference to the marketing of dietary supplements, which of the following was cleared by the 1994 Dietary Supplement Health and Education Act? a) It broadened the definition of dietary supplements to include not only vitamins, minerals, and proteins but also herbs and herbal extracts. b) It instructed companies to demonstrate, through extensive chemical, biological, and human testing, that a product is effective. c) It permitted companies to regularly give their products to animals for a period related to the proposed use of dietary supplements in humans. d) It stated that dietary supplements must be sold with detailed descriptions of the proposed clinical studies of the products in humans.

a) It broadened the definition of dietary supplements to include not only vitamins, minerals, and proteins but also herbs and herbal extracts.

Which law was passed as a reuslt of the poisoning of 107 people by Elixir Sulfanilamide? a) The 1938 Food, Drug, and Cosmetic Act b) The Sherley Amendment of 1912 c) The 1906 Food and Drugs Act d) The Harrison Act of 1914

a) The 1938 Food, Drug, and Cosmetic Act

When the US imported Chinese workers after the Civil War, mainly to help build the rapidly expanding railroads, what did some of them bring with them? a) The habit of smoking opium b) The method of distilling alcohol c) The practice of cultivating tobacco d) The use of the hypodermic syringe

a) The habit of smoking opium

What did the Jones-Miller Act passed by Congress in 1922 do? (All that apply) a) It prohibited physicians from prescribing medicines for drug-dependent patients. b) It officially made the user of illegally obtained opioids and cocaine a criminal. c) It more than doubled the max penalties for dealing in illegally imported drugs. d) It restricted physicians from interacting with drug-dependent patients.

b) It officially made the user of illegally obtained opioids and cocaine a criminal. c) It more than doubled the max penalties for dealing in illegally imported drugs.

Why were morphine and heroin popular among lower-class opium users when states and municipalities in the US began to outlaw opium dens? a) They did not need to be injected like opium. b) They were readily available and inexpensive. c) They were milder than opium but had long-lasting effects. d) They were not derivatives of the outlawed opium.

b) They were readily available and inexpensive.

After the Narcotics Division in the US arrested around 25,000 physicians between 1919 and 1929 for supplying opioids and cocaine to dependent users, ______. a) there were no longer any physicians who stocked narcotics b) there was no legal way to obtain these drugs then c) there were no illicit methods of the distribution of drugs d) there was no opium in all of America

b) there was no legal way to obtain these drugs then

According to the 1906 Pure Food and Drugs Act, the packaging of drugs had to indicate _____. a) how much volume or mass constituted a single serving b) what proportion of habit-forming drugs they include c) which method of consumption they required d) when the product's quality was at its peak

b) what proportion of habit-forming drugs they include

Identify the reasons why the new drug application provision under the 1938 Food, Drug, and Cosmetic Act was important? (All that apply) a) It stipulated that drugs did not need a physician's prescription as long as they were not toxic. b) It eliminated the role of the FDA in reviewing every new drug. c) It reduced the likelihood of companies run by untrained people introducing new drugs. d) It increased the power and responsiblity of the FDA as well as its size.

c) It reduced the likelihood of companies run by untrained people introducing new drugs. d) It increased the power and responsiblity of the FDA as well as its size.

It's estimated that ______ of the illegal drug supply in the US is seized by federal agencies every year. a) around 60% b) close to 98% c) 2-4% d) 10-15%

d) 10-15%

The single most important legislation that has shaped the federal government's approach to controlled substances was the ______. a) 1962 Kefauver-Harris amendment b) 1st Pure Food and Drugs Act c) 1936 Food, Drug, and Cosmetic Act d) 18th Amendment prohibiting alcohol

d) 18th Amendment prohibiting alcohol

In response to the end of Prohibition and to charges of corruption in the previous Narcotics Division, Congress formed a ______ in the Treasury Department in 1930. a) Amphetamines Division b) Bureau of Dangerous Drugs c) Barbiturates Division d) Bureau of Narcotics

d) Bureau of Narcotics

As part of international efforts aimed at reducing drug supply, the ______ has agents in more than 40 countries assisting the local authorities ineradicating drug crops, locating and destroying illicit labs, and interfering with the transportation of drugs out of those countries. a) Treasury Dept b) Bureau of Narcotics c) FDA d) DEA

d) DEA

The 1906 Pure Food and Drugs Act prohibited ______. a) American citizens from engaging in the Chinese opium trade by exporting opium b) consumers from purchasing and using habit-forming substances c) cures for alcohol or morphine dependence containing habit-forming drugs d) interstate commerce in adulterated or misbranded food and drugs

d) interstate commerce in adulterated or misbranded food and drugs

The people enforcing the Harrison Act changed in 1919, and they believed that the cure for narcotic dependence was to ______. a) eliminate opioids and cocaine from pharmacies b) keep users of opioids imprisoned until they change c) introduce users to other habit-forming drugs d) prevent users from having access to drugs

d) prevent users from having access to drugs

patent medicines

medicines sold directly to the public under various trademark names; primarily associated with the period before 1906

FDA

The US Food and Drug Administration

What are the two main reasons for which private corporations adopt drug tests? (All that apply) a) They believe that drug-free workers will have better productivity. b) They believe that their responsibility is to improve one's creativity. c) They believe that the company will be protected against suits for drug-related negligence. d) They believe that maintaining a drug-free workplace will lead to gender equality.

a) They believe that drug-free workers will have better productivity. c) They believe that the company will be protected against suits for drug-related negligence.

How were physicians, dentists, and veterinary surgeons affected by the Harrison Act of 1914? a) They had to register to be potential lawful distributors of opioids and cocaine. b) They were severely punished for sale of opioids and cocaine even if they paid their taxes. c) They could still buy and sell opioids and cocaine without any restrictions or conditions. d) They had to bid for a limited number of licenses to distribute opioids and cocaine.

a) They had to register to be potential lawful distributors of opioids and cocaine.

According to the 1906 Pure Food and Drugs Act, ______ covered "any statement, design, or device regarding... a drug, or the ingredients or substances contained therein, which shall be false or misleading in any particular." a) misbranding b) mispositioning c) adulterating d) advertising

a) misbranding

Under the Comprehensive Drug Abuse Prevention and Control Act of 1970, Schedule I drugs have ______ in the US. a) no currently acceptable medical use in treatment b) no physical or psychological effects on users c) limited potential for abuse compared to other drugs d) limited current medical use in treatment

a) no currently acceptable medical use in treatment

After determining that many violations of the 1906 Pure Food and Drugs Act were unintentional, the FDA began developing assay tehcniques for various chemicals and products and collaborated extensively with ______ to improve standards. a) the pharmaceutical industry b) consumers of drugs c) the agricultural industry d) retailers of drugs

a) the pharmaceutical industry

Which class of drug laws is similar to laws that regulate the safety of other products such as automobiles, furnaces, and toys? a) The group of laws that has led to the free distribution of certain drugs that are considered addictive b) The group of laws that regulates the practices of entities that manufacture or dispense legal drugs c) The group of laws that's concerned with the behavior of drug users that's not related to drug use itself d) The group of laws that has resulted in the criminalization of certain types of drug use, possession, and sales

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

One of the precursors to the Pure Food and Drugs Act was the 1906 publication of _____, which exposed the horribly unsanitary conditions in the meatpacking industry and shocked Congress and America. a) James Herriot's "All Creatures Great and Small" b) Upton Sinclair's "The Jungle" c) George Orwell's "Animal Farm" d) Jack London's "The Call of the Wild"

b) Upton Sinclair's "The Jungle"

Many orphan drugs are extremely expensive, with some costing more than $100,000 per patient per year because of the _____. a) cost of advertising them b) limited market for them c) excessive demand for them d) difficulty ofmaking them

b) limited market for them

The greatest discrepancy between state and federal drug laws is in the realm of ______ regulation. a) heroin b) marijuana c) paracetamol d) methamphetamine

b) marijuana

During the period after the Civil War in the US, concenrs about drunkenness, crime, drug misuse, and other forms of deviant behavior came to be associated with ______. a) members of the elite class b) minority racial groups c) aristocratic upper crust members d) "real" Americans

b) minority racial groups

In the early 1800's in the US, physicians prescribed various forms of ______ liberally and with only limited concern about patients developing dependence. a) paracetamol b) opium c) marijuana d) alcohol

b) opium

In the early 1900's, Dr. Hamilton Wright, the father of American narcotics laws, decided the US could gain favored trading status with China by leading international efforts to _____. a) step up the manufacture of cocaine b) reduce opium importation c) double morphine production d) decrease the regulation of heroin

b) reduce opium importation

According to the 1956 Narcotic Drug Control Act, anyone caught ______ could receive the death penalty. a) possessing even small amounts of opium and cocaine b) selling heroin to a person younger than 18 c) prescribing opium to dependent users d) using morphine in a public environment

b) selling heroin to a person younger than 18

Early enforcement efforts of the Harrison Act, prior to the 1920's, focused on ______. a) registered physicians distributing opioids b) smugglers and opium dens c) private physicians and public clinics dispensing opioids d) opium-dependent individuals

b) smugglers and opium dens

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?" a) The Pure Food and Drugs Act b) The Narcotic Control Act of 1956 c) The Harrison Act of 1914 d) The Anti-Drug Abuse Act

c) The Harrison Act of 1914

The largely unsubstantiated fear that ______ was important in building support for federal drug control laws among Southern senators and congressmen in the US despite their opposition to increasing federalism. a) opium smoking was being popularized by Chinese workers b) heroin was actually a potent habit-forming drug c) cocaine use was responsible for an increase in violent crimes d) morphine was inexpensive and readily available

c) cocaine use was responsible for an increase in violent crimes

The 1965 Drug Abuse Control amendments referred to amphetamines, barbiturates, and hallucinogens as ______. a) prescription drugs b) dietary supplements c) dangerous drugs d) opium derivatives

c) dangerous drugs

The 1988 amendment of the Anti-Drug Abuse Act brought back the death penalty for drug-related murders, and a further amendment in 1994 extended the death penalty to ______. a) dependent users b) clinical distributors c) drug kingpins d) underage users

c) drug kingpins

By 1928, individuals sentenced for ______ comprised one-third of the total population in federal prisons in the US. a) homicide b) manslaughter c) drug violations d) liquor violations

c) drug violations

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. a) adulterated b) mislabeled c) ineffective d) poisonous

c) ineffective

The first groups of American students to be widely subjected to urine screening for drugs were those ______. a) who consistently scored well b) who had affluent backgrounds c) involved in team sports d) considered to be multi-talented

c) involved in team sports

When a company submits an appolication to investigate a new drug in human clinical trials (IND) to the FDA, it is also required to submit all information from ______. a) studies of the effects of the drug on people with the disorder it intends to cure b) research on a large sample of the population who use the drug chronically c) preclinical investigations, including the effects of the drug on animals d) clinical trials conducted on medical students and researchers

c) preclinical investigations, including the effects of the drug on animals

The Navy, followed by the other armed forces, were the first to ______ on a large scale in the US. a) distribute opioids and cocaine b) enforce anti-drug abuse laws c) use random urine screening d) legalize the use of medical narcotics

c) use random urine screening

Until 1912, the US FDA tested products and pursued any that _____. a) had positive impacts on health that were not specified on their labels b) were composed of habit-forming ingredients in small proportions c) had nontoxic side effects known to the manufacturers of the products d) were adulterated or didn't properly list any important ingredients

d) were adulterated or didn't properly list any important ingredients


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