Pharm PrepU Chapter 1

11 of 20 The client is prescribed a medication that was just placed in phase IV study. The client tells the nurse, "This medication is too expensive. Could Dr. Smith order a generic form of this medication?" What is the nurse's best response? • "You can request the generic form but the binder used may make the drug less effective for this medication." • "Medications are not produced in generic form until the patent expires, which normally takes several years." • "Generic medications are lower-quality drugs, and that would mean you would not be getting the best treatment available." • "The generic form of the medication would not be any less expensive because this is a relatively new medication."

• "Medications are not produced in generic form until the patent expires, which normally takes several years." Explanation: When a new drug enters the market, it is given a time-limited patent; generic forms of the medication cannot be produced until the patent expires. Because no generic version of this drug will exist because it is so new, it is impossible to predict what binder will be used or what the cost would be.

10 of 20 The client asks the nurse why generic drugs would be used and voices concerns that only the brand-name product will be safe. What is the nurse's best response? • "Although initial cost is higher for a brand name it may cost less in the long run." • "Most generic drugs are very safe, are cost effective and have only subtle differences." • "Generic drugs are absolutely identical to brand-name drugs, and less expensive." • "Some significant quality control problems have been found with generic drugs, but they're much cheaper."

• "Most generic drugs are very safe, are cost effective and have only subtle differences." Explanation: Most generic medications are completely safe and may be identical to the brand name drug except generic medications are often less expensive, but this does not address the client's concern about safety. There may be subtle differences between generic drugs and brand name drugs. Although some quality control issues have occurred in the past, this does not address the client's concerns regarding safety or explain why generic drugs are prescribed and used. Although some providers believe initial cost is higher but will cost less over time, this response also does not address the client's concerns.

12 of 20 The client asks the nurse, "Is it safe to take over-the-counter (OTC) medications with prescription medications?" What are appropriate responses by the nurse? (Select all that apply.) • "You should avoid taking any OTC medication when taking prescription drugs." • "OTC medications could mask or hide signs and symptoms of a disease." • "It is important to tell your provider all medications you take, including OTC." • "Taking OTC medications can make your prescription medication more effective." • "OTC medications can interact with prescription medications." SUBMIT ANSWER

• "OTC medications can interact with prescription medications." • "It is important to tell your provider all medications you take, including OTC." • "OTC medications could mask or hide signs and symptoms of a disease." Explanation: OTC medications can interact with prescription medications or other OTC so it is always important to consult your pharmacist and provider for advice. To provide the most accurate instruction, the health care provider must know all medications taken including dietary supplements, OTC, and prescription. OTC medications could mask or hide symptoms of a disease so it is always important to consult a provider if symptoms persist. OTC medications are not prohibited when taking prescription drugs as long as no drug interaction occurs. How an OTC will impact a prescription medication varies depending on the medications involved, so it is incorrect to say it will make the prescription drug more effective.

6 of 20 When asked by a client about the generic name of a drug, what is the nurse's best response? • "The generic name is the drug name registered by the manufacturer." • "The generic name is written in capital letters on the drug container." • "The generic name describes the molecular structure of the drug." • "The generic name is the official name given by the U.S. Food and Drug Administration."

• "The generic name is the official name given by the U.S. Food and Drug Administration." Explanation: The generic name of a drug is the official name given by the U.S. Food and Drug Administration. This name will be used by anyone who markets the drug and is not owned by any agency. The name is written in lowercase letters. The chemical name of the drug describes the molecular structure of the drug. The trade name, not the generic name, is the name registered by the manufacturer.

8 of 20 The newly diagnosed pregnant client was just told she is pregnant and is in her first trimester. She is concerned about what may harm the fetus.The nurse is aware what stage of pregnancy is at most risk for teratogenic effects from a drug? • 36 weeks • 8 weeks • 24 weeks • 16 weeks

• 8 weeks Explanation: A client is at most risk for teratogenic effects from a drug during the first trimester (up to 12 weeks) of pregnancy.

2 of 20 Which statement best defines how a chemical becomes a drug? • A chemical is considered a drug when the FDA approves its release to be marketed. • A chemical must have a proven therapeutic value or efficacy without severe toxicity or damaging properties to become a drug. • A chemical must have demonstrated therapeutic value to become a drug. • A chemical becomes a drug when it is introduced into the body to cause a change.

• A chemical must have a proven therapeutic value or efficacy without severe toxicity or damaging properties to become a drug. Explanation: A chemical must undergo a series of tests to determine its therapeutic value and efficacy without severe toxicity or damaging properties before it is termed a drug. Test results are reported to the FDA, which may or may not give approval.

18 of 20 A client is confused and has stated to the nurse, "I wasn't sure whether I'm supposed to take Tylenol or acetaminophen." To best address the client's concern, the nurse should base the response on what information concerning generic and trade names? • Prescribers should refer solely to generic names in their recommendations and written prescriptions. • Generic names change frequently, but trade names are more consistent. • Prescribers should refer solely to trade names in their recommendations and written prescriptions. • A generic name is independent of any particular drug manufacturer.

• A generic name is independent of any particular drug manufacturer. Explanation: A generic name is related to the chemical or official name and is independent of the manufacturer. Drugs may be prescribed and dispensed by generic or trade name. Generic names do not change, while trade names vary according to time and place.

19 of 20 A client's current medication administration record includes a drug that the nurse recognizes as an Institute for Safe Medication Practices (ISMP) high-alert medication. This designation signals the nurse to what characteristic of the drug? • Administration errors carry a heightened risk of causing significant client harm. • It is currently undergoing Phase 4 testing and is pending full FDA approval. • Administration must be cosigned by a second registered nurse or practical/vocational nurse. • It can only be administered by a health care provider or advanced practice nurse.

• Administration errors carry a heightened risk of causing significant client harm. Explanation: The Institute for Safe Medication Practices (ISMP) identifies drugs that when used in error have a heightened risk of causing significant client harm. Such drugs are not limited to health care provider or advanced practice nurse administration. The drug would have completed the testing and approval procedure, and administration does not necessarily require a cosignature.

3 of 20 Which of the following are ways that drugs are classified? Select all that apply. • Chemical characteristics • Therapeutic uses • Effects on body systems • Dosage • Method of manufacture

• Effects on body systems • Therapeutic uses • Chemical characteristics Explanation: Drugs are classified according to their effects on particular body systems, their therapeutic uses, and their chemical characteristics.

5 of 20 During which phase of study are human volunteers used to test drugs? • Phase I • Phase III • Phase IV • Phase II

• Phase I Explanation: A phase I study uses human volunteers to test a drug. During phase II, clinical investigators try out a drug with 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. 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.

14 of 20 The nurse is preparing a medication that is new to the market and cannot be found in the nurse's drug guide. How should the nurse obtain the most reliable information about this medication? • Read the package insert. • Consult a clinical nurse specialist or an experienced nurse. • Consult the FDA website. • Consult the member of the care team who prescribed the drug.

• Read the package insert. Explanation: The most reliable information about the drug can be found on the package insert supplied by the manufacturer because it was prepared according to strict Food and Drug Administration (FDA) regulations. Asking another nurse or the prescriber is not reliable and cannot be verified as accurate. The FDA website does not list detailed information of individual drugs.

16 of 20 A drug was introduced to the market, where it was well received, and the nurse has learned that generic equivalents will soon be released. The nurse should understand what implication of this fact? • The drug has recently completed phase 3 testing. • The drug was previously an orphan drug, with limited supply. • The manufacturer's patent on the drug has recently expired. • The drug is facing increased competition from OTC drugs.

• The manufacturer's patent on the drug has recently expired. Explanation: Once a brand name drug's patent expires, generic equivalents can be released. This drug would have completed full FDA testing. An orphan drug is not available on the market, usually because it is not financially feasible. The release of generic equivalents is unrelated to competition from OTC drugs.

1 of 20 Which statements would a nurse identify as true regarding herbal preparations? Select all that apply. • They can contain drugs that are not listed on the label. • They have to be tested to prove they are safe and effective before they are sold. • They can change the way prescription and nonprescription drugs work. • They can worsen some health conditions. • They are natural so they are always pure.

• They can contain drugs that are not listed on the label. • They can change the way prescription and nonprescription drugs work. • They can worsen some health conditions. Explanation: Herbal preparations are not necessarily safe or pure because they are natural. They may contain ingredients and medications not included on the label because they do not have to be tested to prove safety or efficacy before they are sold. Herbal products can alter the way prescription and nonprescription drugs work and can aggravate or worsen some health conditions (cancer, diabetes, epilepsy, glaucoma, heart disease, etc.)

20 of 20 The Joint Commission requires performance measures related to safety in drug administration. Some of these performance measures require specific precautions when administering which drug? • analgesics • antipsychotics • anesthetics • anticoagulants

• anticoagulants Explanation: According to the Joint Commission, health care institutions that provide anticoagulant therapy must establish a defined process that has a positive impact on client safety with this class of medications. This is not necessarily true when considering the other options.

13 of 20 Before administering a prescription medication, the nurse should confirm what information on the drug label? (Select all that apply.) • generic name • drug concentration • therapeutic effects • brand name • adverse effects • expiration date

• brand name • generic name • drug concentration • expiration date Explanation: Prescription drug labels will contain the brand name, generic name, drug concentration, and expiration date. Adverse effects and therapeutic uses will not be listed on drug labels.

15 of 20 A nurse is to administer medications to a pregnant woman. What class of drug would the nurse interpret as being shown to have adverse effects on animal fetuses but no human studies have been done? • category X • category B • category C • category A

• category C Explanation: A drug identified as category A would be safest because studies of such a drug have not demonstrated a risk to the fetus in the first trimester of pregnancy, and no evidence of risk in later trimesters. A category X drug is one in which studies have demonstrated fetal abnormalities or adverse reactions with reported evidence of fetal risks. A drug in this category would be contraindicated for use in a pregnant woman. A category B drug is one in which animal studies have not demonstrated a risk to the fetus but there are no adequate studies in pregnant women, or animal studies have shown an adverse effect but adequate studies in pregnant women have not demonstrated a risk to the fetus during the first trimester of pregnancy, and there is no evidence of risk in later trimesters. Benefit would need to outweigh the risk. A category C drug is one in which animal studies have shown an adverse effect on the fetus, but there are no adequate studies in humans. Benefit would need to outweigh the risk.

17 of 20 A nurse is involved in a phase II study. The nurse should perform what action? • giving oversight to a large number of clients receiving the drug under close observation and monitoring. • giving the drug to clients with the disease that drug is designed to treat • giving the drug to volunteers to test its effect on humans • collaborating with researchers to test on laboratory animals

• giving the drug to clients with the disease that drug is designed to treat Explanation: 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.

9 of 20 A student is preparing to begin a pharmacology course that is focused on nursing needs. The student should anticipate what areas of study? (Select all that apply.) • adverse and anticipated drug effects • impact of drugs on the body • molecular structuring of drugs • chemical composition of drugs • the body's response to a drug

• impact of drugs on the body • the body's response to a drug • adverse and anticipated drug effects Explanation: Nurses study pharmacology from a pharmacotherapeutic level, which includes the effect of drugs on the body, the body's response to drugs, and both expected and unexpected drug effects. Chemical and molecular pharmacology are not included in nursing pharmacology courses.

4 of 20 A client asks a nurse whetherover-the-counter drugs have any disadvantages. What would the nurse cite as potential disadvantages? (Select all that apply.) • developing adverse drug reactions • delaying treatment by a health care provider • choosing an incorrect drug • inaccurate self-diagnoses • running up high costs

• inaccurate self-diagnoses • choosing an incorrect drug • delaying treatment by a health care provider • developing adverse drug reactions Explanation: Disadvantages include inaccurate self-diagnoses and potential risks of choosing a wrong or contraindicated drug, delaying treatment by a health care professional, and developing adverse drug reactions and interactions.

7 of 20 The nurse is researching a medication by its generic name. What is another term for a drug's generic name? (Select all that apply.) • official • brand • nonproprietary • trade • chemical

• official • nonproprietary Explanation: The generic name is also known as the nonproprietary or official name. It may be used in all countries and by all manufacturers.