PBH 435 Chapter 3 Drug Policy

What were the provisions added by the 1962 Kefauver-Harris amendments to federal law?

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

It is estimated that ___ percent of the illegal drug supply is seized by federal agencies each year.

10-15 percent

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

18th Amendment prohibiting alcohol

Identify the important classes of drug laws.

A group of laws that regulated the practices of entities that manufacture or dispense legal drugs. A group of laws that has results in the criminalization of certain types of drug use, possession, and sales.

What did the Jones-Miller Act passed by Congress in 1922 do?

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

Identify the reasons why the new drug application provision under the 1938 Food, Drug, and Cosmetic Act was important.

It reduced the likelihood of companies run by untrained people introduced new drugs. It increased the power and responsibility of the FDA as well as its size.

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 investigation which have been made to show whether or not a drugs safe for use," which had to be approved before the drug could be marketed

New Drug Application

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

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 One

Match the departments in the United States government with the laws they administered by 1914.

The Department of Agriculture - The 1906 Pure Food and Drugs Act The Treasury Department - The Harrison Act of 1914

What changes were introduced by the comprehensive Drug Abuse Prevention and Control Act of 1970?

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

Match the controlled substance scheduled (in the left column) with their criteria (in the right column).

Schedule 1: Has high potential for abuse with no currently acceptable medical use in treatment in the United States Schedule II: Has high potential for abuse that may lead to severe psychological r physical dependence with currently accepted medical use Schedule III: Has potential for abuse that may lead to moderate physical dependence or high psychological dependence Schedule IV: Has low potential for abuse that may lead to limited physical or psychological dependence relative to III Schedule V: Has low potential for abuse that may lead to limited physical or psychological dependence relative to IV

Match the kinds of impacts of passing laws that criminalize behavior like drug use with the things they influence.

Symbolic impacts - these provide status benefits to the supporters of capitalization regardless of how effectively the laws are actually enforced. .Instrumental impacts - these have effects on local, state, and federal budgets.

When the United States imported Chinese workers after the Civil War ended, mainly to help build the rapidly expanding railroads, what did some of them bring with them?

The habit of smoking opium

Identify the cost involved in drug-control enforcement by federal agencies.

The incalculable price of placing federal agents in danger of losing their lives to combat the drug trade. The cost of housing drug-law violations in state prisons and local jails. The cost of crimes committed to purchase drugs at black-market prices

Rank the following in the United States in the order in which they were implemented, beginning with the first to be implemented.

The regulation of pharmaceutical manufacturing and sales. The regulation of opioids and cocaine. The prohibition of alcohol.

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

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

Why were morphine and heroin popular among lower-class opium users when states and municipalities in the United States began to outlaw opium dens?

They were readily available and inexpensive.

One of the precursors to the Pure Food and Drugs Act was the 1906 publication of ________, which exposed the horrible unsanitary conditions in the meatpacking industry and shocked Congress and America.

Upton Sinclair's The Jungle

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 is ready to study the effects of a compound on humans

The largely unsubstantiated fear the _____ was important in building support for federal drug control laws among Southern senators and congressman in the United States despite their opposition to increasing federalism.

cocaine use was responsible for an increase in violent crimes

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 ______.

drug kingpins

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

ineffective

The 1906 Pure Food and Drugs Act prohibited _______.

interstate commerce in adulterated or misbranded food and drugs

Many orphan drugs are extremely expensive, with some costing more that $100,000 per patient per year because of the

limited market for them

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."

misbranding

______________ is a narcotic and the primary active chemical in opium from which heroin is derived.

morphine

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

patent medicines

As of 2012, the legality of random, suspicions urine testing for ____ has not been established at the federal level

public school students

The period between 1890 and 1920 has been called the "nadir" (lowest point) of _______ in the US.

race relations

Early enforcements efforts of the Harrison Act, prior to 1920s, focused on _____.

smugglers and opium dens

After determine 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.

the pharmaceutical industry

Although the basic categorization of illicit drugs in schedules is similar in most american states, ___________________.

there are large differences in the penalties

After the Narcotics Division in the United States arrestees 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

In 1929, Congress viewed this enormous expenditure for drug offenders as an indicator that something was wrong and decided that

users should be cured rather than repeatedly jailed.

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

According to the 1906 Pure Food and Drugs Act, the packaging of drugs had to indicate _____.

what proportion of habit forming drugs they included

Match the drug testing methods with the number of days up to which they can detect drug use.

Urine testing: 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: It can detect drug use for up to 90 days and is more capable of detecting occasional drug use than other methods. Saliva testing: It can only be detected fairly recent drug use, up to one day, in most cases

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

morphine, heroin, and cocaine

Until 1912, the United States Food and Drug Administration tested products and pursued any that __________________.

were adulterated or didn't properly list any important ingredients