Question 1

Which of the following acts provided the rootstock on which all the modern U.S. laws regulating pharmaceuticals have been grafted?&#10;A) The Comprehensive Drug Abuse Prevention and Control Act&#10;B) The Food and Drug Administration Safety and Innovation Act&#10;C) The Federal Food, Drug, and Cosmetic Act&#10;D) The Pure Food and Drugs Act

Accepted Answer

The Pure Food and Drugs Act of 1906 was the first major federal law to regulate the manufacture, sale, and distribution of food and drugs in the United States. It was the rootstock on which all the modern U.S. laws regulating pharmaceuticals have been grafted.

Question 2

Which of the following statements is true of phase one of clinical investigations after the United States Food and Drug Administration (FDA) authorizes the testing of a drug in humans?&#10;A) It involves a few hundred patients who are chosen because the new agent might help them.&#10;B) It encompasses studies with relatively low doses of the drug on a limited number of healthy people.&#10;C) It involves patients who have the condition the candidate drug is designed to treat.&#10;D) It 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.

Accepted Answer

Phase one of clinical investigations typically involves administering relatively low doses of the drug to a small number of healthy volunteers to assess its safety, determine a safe dosage range, and identify side effects.

Question 3

In the context of marketing a new drug, which of the following is the significance of the 1997 Food and Drug Administration (FDA) Modernization Act?&#10;A) It required advertisements for prescription drugs (mostly in medical journals) to contain a summary of information about adverse reactions to the drug.&#10;B) It included the requirement that companies seek approval of any testing to be done with humans before clinical trials are conducted.&#10;C) It included the guidelines for annual postmarketing reporting by the companies of adverse reactions to some medications.&#10;D) It tightened the procedures whereby drug company salespeople could provide free samples to physicians.

Accepted Answer

It included the guidelines for annual postmarketing reporting by the companies of adverse reactions to some medications.&#10;

Question 4

Matthew has over 20 years of work experience in the regulation and control of pharmaceutical industries. He prepares a national drug-control strategy and allocates an annual consolidated drug-control budget for all federal agencies involved in the regulation of drugs. He also advises the National Security Council and reports directly to the president. Identify the position held by Matthew.

A) Addiction counselor
B) Green jobs czar
C) Drug counselor
D) Drug czar

Accepted Answer

Matthew's role involves preparing national drug-control strategies, allocating budgets for drug regulation, advising the National Security Council, and reporting directly to the president, which aligns with the responsibilities of a "Drug czar." This position is typically responsible for overseeing all aspects of drug policy, including regulation and control.

Question 5

Which of the following terms is defined as chemicals that are close relatives of controlled substances but not themselves listed on one of the controlled substance schedules?&#10;A) Designer drugs&#10;B) Experimental drugs&#10;C) Investigational new drugs&#10;D) Research chemicals

Accepted Answer

Designer drugs are chemically altered versions of controlled substances, designed to mimic their effects while avoiding classification as illegal.

Question 6

Which of the following statements is true of using saliva samples as a testing method to detect drug use?&#10;A) They are capable of detecting most kinds of drugs for up to three days.&#10;B) They detect the metabolites of marijuana up to five days or more.&#10;C) They detect only fairly recent drug use, up to one day.&#10;D) They are capable of detecting drug use for up to 90 days.

Accepted Answer

Saliva tests are primarily used to detect recent drug use, typically within the past 24 to 48 hours, making them effective for identifying very recent drug consumption but not for longer detection windows.

Question 7

Congress passed the Controlled Substance Analogue Enforcement Act in 1986, saying that any drug or any chemical intended for human use that is substantially similar to a controlled substance should be excluded from the controlled substance schedules.

Accepted Answer

The Controlled Substance Analogue Enforcement Act of 1986 actually allows for chemicals substantially similar to a controlled substance in schedule I or II to be treated as if they are listed in schedule I for the purposes of criminal prosecution, not excluded from the controlled substance schedules.

Question 8

In the context of urine testing for detecting drug use, the higher the amount required for a positive result, the longer the detection time.

Accepted Answer

The amount required for a positive result, often referred to as the cutoff level, does not directly determine the detection time. Detection time is influenced by factors such as the drug's half-life, the user's metabolism, and the type of test used. Lower cutoff levels generally increase sensitivity and may detect drug use over longer periods, but the detection time primarily depends on the drug's persistence in the body, not the test's cutoff level.

Deck 3: Drug Policy