Pharmaceuticals and Drug Administration Quiz

Questions and Answers

How are drugs sorted into therapeutic groups and classes?

First by the conditions that they are used to treat, and then by their mechanisms of action.

Bone marrow transplants...

Are a type of stem cell therapy unless the patient's own cells are reinjected.

What does AMA stand for?

American Medical Association (correct)

American Medical Association of Surgeons

Antimicrobial Medical Association

None of the above

What section of a drug's package insert describes situations in which the drug should not be used because the risks outweigh the therapeutic benefits?

Contraindications Signup and view all the answers

What is tertiary care?

Highly specialized medical and surgical care provided by a large medical center for unusual or complex medical problems. Signup and view all the answers

What are vasodilators used to do?

Decrease vascular resistance and increase blood flow. Signup and view all the answers

What is the name of the condition that occurs after a specific dose of a drug is given at such regular intervals that absorption and elimination have become fairly constant?

Steady state. Signup and view all the answers

Ocular administration is used primarily to treat the eye.

True Signup and view all the answers

Which entities invest the most money in pharmaceutical R&D?

U.S. pharmaceutical companies. Signup and view all the answers

How are most drugs excreted?

Via the kidneys. Signup and view all the answers

Over the last few decades, limitations on sales reps discussions about off-label uses have decreased.

True Signup and view all the answers

According to your manual, which of the following is an example of a branding fundamental?

The brand name. Signup and view all the answers

What does it mean if two drugs are 'at parity'?

Both drugs are essentially in a neutral position. Signup and view all the answers

Everyone would benefit equally from electronic sampling programs.

False Signup and view all the answers

When referring to medication dosage, which abbreviation means 'one-half'?

SS. Signup and view all the answers

What is an internist?

A physician who practices internal medicine. Signup and view all the answers

Which of the following is a type of white blood cell?

Lymphocytes. Signup and view all the answers

Novice sales representatives are often placed in charge of negotiating MCO formularies.

False Signup and view all the answers

What proportion of the drugs tested on human subjects are eventually approved by the FDA?

About 70%. Signup and view all the answers

According to a study discussed in your manual, how do most physicians prefer to receive their drug samples?

Directly from sales representatives. Signup and view all the answers

Which of the following is an example of a central value?

I buy Advil to show that I'm a modern consumer. Signup and view all the answers

Which of the following specialties likely has the MOST emergency calls?

Cardiology Signup and view all the answers

What affects the rate of active transport?

The availability of carriers and energy. Signup and view all the answers

Over the last few decades, FDA approval time for new drugs has been shortened to reduce the cost of new drug development.

True Signup and view all the answers

Which of the following would NOT help improve compliance?

Pharmacists understanding how generics differ from brand name drugs. Signup and view all the answers

Which entity chooses a drug's trade name?

The FDA. Signup and view all the answers

What type of stem cells are obtained from embryos and can develop into any cell type?

Totipotent. Signup and view all the answers

As the price a patient pays for a prescription increases, what happens to the likelihood that the patient will fill it?

False Signup and view all the answers

Most involuntary movements come from which type of muscle tissue?

Cardiac and smooth. Signup and view all the answers

Which of the following is NOT one of the body's major organ systems?

Cellular system Signup and view all the answers

How do most drugs exert their primary physiological effects?

By binding to cell receptors that are sensitive to their presence. Signup and view all the answers

What is the most reliable source of information for determining therapeutically equivalent drug products?

Orange Book. Signup and view all the answers

What does subcutaneous mean?

Beneath the outer skin. Signup and view all the answers

What should a sales representative do if all of the prime spaces in a drug cabinet are occupied?

Ask staff for permission to move some of the other products in the cabinet. Signup and view all the answers

Which one of the following testing methods is not commonly used for Allergy Testing?

Urine test Signup and view all the answers

The FDA defines API as the active ___ ingredient in a drug, which produces the desired change in the body.

pharmaceutical. Signup and view all the answers

What are the 2 legal classifications of wholesalers?

Primary and secondary wholesale distributors. Signup and view all the answers

What term describes the usage of a medication for purposes other than the FDA-approved indications on the labeling?

Off-label usage. Signup and view all the answers

What is the acronym for pharmacokinetics?

PK. Signup and view all the answers

Which of the following is not a purpose of the Arthrocentesis diagnostic test?

To monitor joint density Signup and view all the answers

What is typically NOT a characteristic of a pharmaceutical sales rep?

True Signup and view all the answers

What entity grants drug patents?

The U.S. Patent and Trademark Office. Signup and view all the answers

Which of the following refers to all active and inert pharmaceutical ingredients in a drug, including fillers and colors?

Formulation. Signup and view all the answers

What is the difference between potency and efficacy?

Potency refers to the drug's strength, while efficacy refers to its effectiveness. Signup and view all the answers

The neurological examination is divided into several components. Which of the below is not one of them?

Heart rate Signup and view all the answers

How many names must a drug have?

At least three. Signup and view all the answers

How has a longer development time increased the cost of bringing a new drug to market?

By increasing the cost of capital. Signup and view all the answers

Senior citizens consume over _____ times as many pharmaceuticals as people under 65.

Three times. Signup and view all the answers

What agency regulates the distribution and use of narcotics?

DEA. Signup and view all the answers

What is passive diffusion?

The use of energy to help a substance pass from a low concentration gradient to a high one. Signup and view all the answers

What are the MAIN categories of drugs under FDA jurisdiction?

Prescription and non-prescription. Signup and view all the answers

Which of the following is a natural uterotonic agent?

Oxytocin Signup and view all the answers

What are all metabolites?

Products of metabolism. Signup and view all the answers

When a drug is administered orally, where does first-pass metabolism occur?

Liver. Signup and view all the answers

What is the medical term for swelling?

Edema. Signup and view all the answers

Which of the following is NOT part of the Seven Step Cascade of Emotion?

Be a consultant, not a rep Signup and view all the answers

Which part of a clinical research paper is frequently referred to as the roadmap?

Abstract. Signup and view all the answers

Which of the following is a main active ingredient in lung surfactants?

Theophylline. Signup and view all the answers

What does parenteral mean?

Injection. Signup and view all the answers

Which term denotes a type of substance that enhances the action of a drug or antigen?

Adjuvant. Signup and view all the answers

If a sales representative's product is placed on the second tier of a standard three-tier formulary, it probably has exclusive preferred status if it is not at parity with any other drugs.

True Signup and view all the answers

Which of the following is NOT one of the four basic transport mechanisms?

Homeostasis Signup and view all the answers

Agonists and antagonists can be used together.

True Signup and view all the answers

What is the study of the effects and movement of drugs in the human body?

Clinical pharmacology. Signup and view all the answers

According to your manual, what is a common complaint that physicians have about traditional sampling methods?

That drug sample supply is too unpredictable. Signup and view all the answers

Which of these entities is formed by two or more hospitals or other healthcare entities to negotiate reduced rates with its aggregated purchasing power?

GPO. Signup and view all the answers

What is another name for a drug derived from a biologic compound?

Large molecule. Signup and view all the answers

What is the most common policy regarding pharmaceutical reps dispensing drug samples in hospitals?

True Signup and view all the answers

Which of the following would help you build trust with a physician?

Asking if he or she is having any problems with the managed care coverage of your products. Signup and view all the answers

What term denotes the difference between the usual effective dose and the dose that induces severe or life-threatening side effects?

Margin of safety. Signup and view all the answers

What are excipients?

The inert ingredients in a drug formulation. Signup and view all the answers

What is another term for the AWP?

List price. Signup and view all the answers

Which of these is the most likely use for a uterotonic agent?

To induce labor. Signup and view all the answers

Ordinary x-rays are the most common imaging test. Which of the following is not a common medical imaging test?

Positron Emission Tomography (PET) Signup and view all the answers

Why are oral drugs often taken on an empty stomach?

To pass through the stomach more quickly. Signup and view all the answers

What is one factor that differentiates community health centers from hospitals?

Community health center formularies are more restrictive. Signup and view all the answers

How does drug sampling provide a social benefit?

Doctors often use drug samples to treat patients who otherwise could not afford it. Signup and view all the answers

Which medical term denotes the use of a stethoscope to listen to the heart?

Auscultation. Signup and view all the answers

What do enteric coatings do?

Prevent dissolution in the stomach. Signup and view all the answers

What is the duration of exclusivity for orphan drugs?

7 years. Signup and view all the answers

What do National Account Managers do?

Negotiate contracts with MCOs and PBMs. Signup and view all the answers

What does it usually mean if a drug recall is voluntary?

The manufacturer has recalled the product on its own but negotiated with the FDA beforehand. Signup and view all the answers

Which phase of clinical trials is also known as the pivotal phase?

Phase III Signup and view all the answers

During which phase of clinical trials is the new drug's safety and effectiveness first tested in the target group?

Phase II Signup and view all the answers

How do antacids work?

By raising gastric pH. Signup and view all the answers

What is one of the biggest time wasters for a pharmaceutical sales rep?

Travel time. Signup and view all the answers

What happens when equilibrium is reached?

Equal numbers of molecules cross the membrane in both directions. Signup and view all the answers

What are the most common vectors used in gene therapy?

Viruses. Signup and view all the answers

What is the percentage fee that the dispenser pays the wholesaler for distribution?

Upcharge. Signup and view all the answers

What is the difference between a chronic (or continuing) reaction and a delayed reaction?

Chronic reactions persist for a long time whereas delayed reactions take some time to develop. Signup and view all the answers

What is clinical effect?

The response produced by a medication. Signup and view all the answers

Which of the following is an example of noncompliance?

A patient forgetting to take a drug at a specified time of day. Signup and view all the answers

What is the average circulation time of blood?

About a minute. Signup and view all the answers

What is one way in which pharmaceutical selling is different from selling in most other industries?

True Signup and view all the answers

From what types of entities do primary wholesale distributors buy most of their drugs?

Manufacturers. Signup and view all the answers

What is the Office of the Inspector General (OIG)?

An arm of the Department of Health and Human Services. Signup and view all the answers

What are doctors required to consider when deciding whether or not to prescribe a particular drug?

The severity of the disorder being treated and the effect it has on the patient's quality of life. Signup and view all the answers

Which entity assigns a new drug its generic names?

The United States Adopted Name Council. Signup and view all the answers

Drugs can be used _____ days beyond their expiration date.

10 days Signup and view all the answers

What is necessary for a drug to be excreted extensively via the kidneys?

The drug must be water-soluble and not bind too tightly to proteins in the bloodstream. Signup and view all the answers

Study Notes

Drug Classification and Administration

Drugs are categorized by the conditions they treat and their mechanisms of action.
Ocular administration specifically targets eye treatment.
Subcutaneous refers to the administration of drugs beneath the skin.

Medical Treatments and Procedures

Bone marrow transplants are a form of stem cell therapy, particularly if the patient’s own cells are available.
Tertiary care involves specialized medical care from large centers for complex conditions.
Cardiology is the specialty that most often receives emergency calls.

Pharmaceutical Information

The American Medical Association (AMA) is a prominent entity in healthcare regulation.
The FDA defines active pharmaceutical ingredient (API) as the component producing desired therapeutic effects.
The Orange Book is essential for determining therapeutically equivalent drug products.

Drug Approval and Regulation

About 70% of drugs tested on human subjects receive FDA approval.
Legal limitations on discussions about off-label drug uses have decreased in recent years.
Drug patents are granted by the U.S. Patent and Trademark Office.

Pharmacology Basics

Steady state refers to a constant drug plasma concentration achieved through regular dosing.
Potency indicates a drug's strength, while efficacy measures its effectiveness.
The rate of active transport in pharmacology is influenced by carrier availability and energy.

Drug Samples and Compliance

Most physicians prefer receiving drug samples directly from sales representatives.
High prices of prescriptions do not typically affect the likelihood of filling them, as the medicine is often necessary.
Compliance can be improved through strategies other than educating pharmacists on generics versus brand names.

Drug Types and Usage

Drugs can be classified as prescription or non-prescription under FDA jurisdiction.
Off-label usage refers to taking a drug for non-FDA-approved indications.
Uterotonic agents, such as oxytocin, are used to induce labor.

Clinical Trials and Drug Development

Phase II of clinical trials first evaluates a new drug's safety and effectiveness in the target group.
The pivotal phase of clinical trials is known as Phase III.
Orphan drugs have a duration of exclusivity lasting seven years.

Drug Mechanisms and Effects

Antacids function by raising gastric pH to reduce acidity.
Most commonly used vectors in gene therapy are viruses.
Passive diffusion involves substance movement without energy usage from an area of low to high concentration.

Sales and Marketing in Pharmaceuticals

Travel time is a significant inefficiency for pharmaceutical sales representatives.
Building trust with physicians can be accomplished by discussing concerns about managed care coverage.
Pharmaceutical representatives do not sell directly to end users, differentiating this industry from others.

Miscellaneous

Excipients are the inactive ingredients in a drug formulation.
The average blood circulation time is approximately one minute.
The Office of the Inspector General is part of the Department of Health and Human Services, overseeing healthcare integrity.
Drugs may be used for a limited time beyond their expiration dates, but specifics vary by type.

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Description

Test your knowledge on drug classification, administration methods, and pharmaceutical regulations. This quiz covers essential concepts such as ocular and subcutaneous drug delivery, the roles of the AMA and FDA, and the basics of drug approval processes. Enhance your understanding of how drugs are categorized and administered in medical settings.