CHAPTER 1 - INTRODUCTION TO DRUGS - PrepU Practice Questions

What drug category indicates fetal risk where the potential benefit might be acceptable despite the risk? Category B Category A Category X Category D

Category D p. 11, box 1.1 Rationale: Category X drugs carry the risk of fetal abnormalities. The risk of use in pregnant women clearly outweighs any possible benefit. With Category A drugs, adequate studies in pregnant women have not demonstrated a risk to the fetus in the first trimester of pregnancy, and there is no evidence of risk in later trimesters. With Category B drugs, animal studies have not demonstrated a risk to the fetus, but there are no adequate studies in pregnant women. With Category D drugs, there is evidence of human fetal risk, but the potential benefits from the use of the drug in pregnant women may be acceptable despite these potential risks.

After reviewing class material about the natural sources of drugs, the students demonstrate understanding of the material when they identify which as an example of a drug that is derived from inorganic compounds? - penicillin - aluminum hydroxide - insulin - codeine

aluminum hydroxide p. 7 Rationale: Aluminum hydroxide, an antacid, is an example of a drug from an inorganic compound. Codeine is derived from a plant source. Penicillin is derived from organic sources. Insulin is a drug originally derived from an animal source, but more recently has been created synthetically via genetic engineering.

A nurse is preparing to administer digitalis to a client with congestive heart failure. The client asks the nurse, "Tell me something about this drug. Where does it come from?" What is the best response by the nurse? - "This drug comes from the plant called a periwinkle." - "This is a synthetic drug that is chemically constructed in a laboratory." - "This drug comes from a plant called the purple foxglove." - "This drug comes from a plant called the opium poppy."

- "This drug comes from a plant called the purple foxglove." p. 7, table 1.2 Rationale: Drug sources from the plant world date back to primitive times. A common drug from plants is digitalis, which is derived from the purple foxglove.

Which would be a reason for a drug to enter a phase III study? - Determine any unanticipated effects. - Test the potential drug on clients with the disease the drug is designed to treat. - Test the potential drug on laboratory animals. - Test the potential drug on healthy human subjects.

- Determine any unanticipated effects. p. 9 Rationale: Phase III studies test drugs in the clinical setting to determine any unanticipated effects or lack of effectiveness. Phase I studies test potential drugs on healthy human subjects. Phase II studies test potential drugs on clients with the disease the drugs are designed to treat. Preclinical trials involve testing of potential drugs on laboratory animals.

There are many sources of drug formulation. What is the advantage of a synthetic drug over a natural drug? - increased potency of the drug - fewer side effects - increased stability of the drug - increased tolerance of the drug

- increased stability of the drug p. 8 Rationale: Natural drugs are affected by pharmacodynamic changes including potency and stability. Synthetic drugs have fewer side effects than natural drugs. Natural drugs are not tolerated any better than synthetic drugs.

A nurse is administering a drug to clients who have the disease for which a drug is designed to treat. The nurse is most likely participating in a: - phase III study. - phase I study. - preclinical trial. - phase II study.

- phase II study. p. 9 Rationale: In a phase II study, clinical investigators try out the drug in clients who have the disease that the drug is designed to treat. Preclinical trials involve the use of animal testing of a drug. A phase I study involves the use of human volunteers, usually healthy young men, to test a drug. A phase III study involves the use of the drug in a vast clinical market.

During drug evaluation, chemicals that may have therapeutic value are tested on laboratory animals and would be considered in which stage of development? - phase III - preclinical - phase II - phase I

- preclinical p. 8 Rationale: Preclinical trials involve testing potential drugs on laboratory animals. Phase I studies test potential drugs on healthy human subjects. Phase II studies test potential drugs on patients who have the disease the drugs are designed to treat. Phase III studies test drugs in the clinical setting to determine any unanticipated effects or lack of effectiveness.

During which stage of drug development is the drug tested on laboratory animals? - phase III study - phase II study - preclinical trial - phase I study

- preclinical trial p. 8 Rationale: During preclinical trials, drugs are tested on laboratory animals. A phase I study uses human volunteers for testing. A phase II study allows investigators to try out the drug in clients who have the disease that the drug is designed to treat. A phase III study involves the use of the drug in a vast clinical market.

When reviewing the Drug Enforcement Agency schedules of controlled substances, the nurse would understand that the schedule with limited abuse potential is: - schedule III. - schedule II. - schedule IV. - schedule V.

- schedule V. p. 12, Box 1.2 Rationale: Schedule V controlled substances have limited abuse potential. Schedule II drugs have high abuse potential with severe dependence liability. Schedule III drugs have less abuse potential than schedule II drugs and moderate dependence liability. Schedule IV drugs have less abuse potential than schedule III drugs and limited dependence liability.

The nurse reviews various legislation related to drug therapy, including the Kefauver-Harris Act. What aspect of drug therapy is most directly affected by this legislation? - the distribution of controlled substances - the assignment of lDEA number to prescribers - patent system that guides drug research and development - the drug testing process overseen by the FDA

- the drug testing process overseen by the FDA p. 10 Rationale: Thalidomide resulted in the birth of many babies with limb deformities. Public outcry resulted in the Kefauver-Harris Act of 1962, which underlies the FDA approval process. This specific act does not address controlled substances, DEA numbers or patenting.

Drugs are classified according to what features? - therapeutic uses - actions - side effects - name

- therapeutic uses p. 6-8 Rationale: Drugs are classified according to their effects on particular body systems, their therapeutic uses, and their chemical characteristics.

A nurse working for a drug company is involved in phase I drug evaluation studies. Which of the following might the nurse be responsible for during this stage of drug development? - Administering investigational drugs to patients - Informing healthy, young volunteer participants of possible risks that could occur from taking an experimental drug - Working with animals who are given experimental drugs - Monitoring drug effects in patients who are selected to participate in a study, who have the disease that the drug is meant to treat

- Informing healthy, young volunteer participants of possible risks that could occur from taking an experimental drug p. 8 Rationale: In phase I studies, a small number of healthy human volunteers are given the drug after blood urine and other appropriate samples are taken to monitor drug metabolism. Sometimes volunteers who have a certain disease are used in phase I instead of healthy volunteers if the drug is expected to have significant toxicity. In phase II, volunteers are given various dosages of the test compound and studied in great detail. Dosage guidelines are usually determined in this phase. Nurses are more likely to be responsible for administering the investigational drugs in phase III than in phases I and II. Phase III studies involve administering investigational drugs to patients in a vast clinical market who are voluntarily enrolled in double-blind studies. Use of animal testing is done in the preclinical trials and would not involve a nurse.

While reviewing a package insert for a drug, what would the nurse identify as the drug's generic name? - Synthroid - Levothyroxine sodium - Levothroid - L-thyroxine

- Levothyroxine sodium p. 10 Rationale: Levothyroxine sodium is the generic name. L-thyroxine would be the chemical name; Levothroid or Synthroid would be the brand names.

During which phase of study are human volunteers used to test drugs? - Phase IV - Phase II - Phase I - Phase III

- Phase I p. 8 Rationale: A phase I study uses human volunteers to test a drug. During phase II, clinical investigators try out a drug with patients who have the disease that the drug is designed to treat. A phase III study involves the use of the drug in a vast clinical market. The Food and Drug Administration (FDA) relies on committees of experts familiar with the specialty area in which the drugs will be used to evaluate drugs that finish phase III studies. After the FDA approves the drug for marketing, the drug enters a phase of continual evaluation, or a phase IV study.

Which of the following reference books provides information from the drug manufacturers' inserts? - Drug Facts and Comparisons - United States Pharmacopeia - Physicians' Desk Reference - American Formulary Service

- Physicians' Desk Reference p. 14 Rationale: The Physicians' Desk Reference is published yearly and contains manufacturers' published inserts for selected drugs. American Formulary Service is an authoritative source of drug information. Drug Facts and Comparisons is an authoritative source of drug information. The United States Pharmacopeia was adopted in 1906 and is issued every 5 years under the supervision of a national committee of pharmacists, scientists, and physicians.

The nurse is reviewing a prescription for a medication with a client. On the prescription, the nurse read "DAW." What should the nurse teach the client? - A generic form of the drug may be provided if available. - The brand name of the drug must be dispensed. - A drug with a similar chemical name can be substituted for the prescribed drug. - The drug is not covered by a current patent.

- The brand name of the drug must be dispensed. p. 12 Rationale: DAW means "dispense as written." That is, the brand name of the product must be used to fill the prescription. A generic form of the drug could not be substituted. Another drug with a similar chemical name could not be substituted. DAW does not denote a particular patent status.

In phase I clinical trials, the potential uses and effects are determined by: - administering doses to people with the disease. - administering in placebo-controlled design. - calculating the risk-to-benefit ratio.

- administering doses to healthy volunteers p. 8 Rationale: Phase I studies allow for the administration of the medication to healthy volunteers to determine safe dosages, routes of administration, absorption, metabolism, excretion, and toxicity. In phase II studies, a few doses are given to a certain number of subjects with the disease or symptom for which the drug is being studied and responses are compared with those of healthy subjects. Placebo-controlled designs are used in phase III studies, in which half of the subjects receive the new drug and half receive the placebo. Calculating the risk-to-benefit ratio is used in phase II studies to determine whether the potential benefits of the drug outweigh the risks.

Which Food and Drug Administration (FDA) pregnancy category indicates that animal studies on the drug have shown adverse fetal effects, but there are no adequate studies in humans? - category D - category B - category A - category C

- category C p. 11, box 1.1 Rationale: Category C drugs are those in which animal studies have shown adverse fetal effects, but there are no adequate studies in humans. With category A drugs, adequate studies in pregnant women have not demonstrated risks to the fetus in the first trimester of pregnancy, and there is no evidence of risk in later trimesters. With category B drugs, animal studies have not demonstrated a risk to the fetus, but there are no adequate studies in pregnant women. With category D drugs, there is evidence of human fetal risk, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.

A group of students are reviewing information about the natural sources of drugs. The students demonstrate understanding of the information when they identify which as a drug derived from inorganic compounds? - castor oil - codeine - thyroid hormone - ferrous sulfate (iron)

- ferrous sulfate (iron) p. 7 Rationale: Ferrous sulfate, or iron, is a drug derived from the iron salt, an inorganic compound. Thyroid hormone, although created synthetically, may be obtained from animal thyroid tissue. Codeine is obtained from the poppy plant; castor oil is derived from Ricinus communis, also a plant.

A client who reports joint pain is being seen in the rheumatology clinic. The nurse understands that which element is used to treat rheumatoid arthritis? - iron - fluorine - gold - aluminum

- gold p. 7, table 1.3 Rationale: Gold has a therapeutic use in the treatment of rheumatoid arthritis. Aluminum has been used to treat gastric acidity and prevent the formation of phosphate urinary stones. Iron is effective in the treatment of iron-deficiency anemia. Fluorine (fluoride) is used to prevent dental cavities.