Which 1962 federal law was the first to require drug manufacturers to prove that a drug is effective as well as safe?
Kefauver-Harris Amendments
✓
Durham-Humphrey Amendment
Sherley Amendment
Food, Drug, and Cosmetic Act
Correct Answer
Kefauver-Harris Amendments
The Kefauver-Harris Amendments of 1962 added the requirement that manufacturers show proof of effectiveness, not only safety, and set rules for reporting adverse effects. The Durham-Humphrey Amendment separated prescription from nonprescription drugs. The Sherley Amendment banned false or misleading label claims. The Food, Drug, and Cosmetic Act of 1938 required safety testing but not proof of effectiveness.
Category: Federal Drug Laws
Question 2
Which 1952 law gave the FDA the authority to classify drugs as prescription or nonprescription?
Kefauver-Harris Amendments
Durham-Humphrey Amendment
✓
Pure Food and Drug Act
Controlled Substances Act
Correct Answer
Durham-Humphrey Amendment
The Durham-Humphrey Amendment of 1952 gave the FDA power to decide which drugs require a prescription and which can be sold over the counter. The Kefauver-Harris Amendments added the requirement for proof of effectiveness. The Pure Food and Drug Act of 1906 began federal regulation of drug labeling and interstate sale. The Controlled Substances Act regulates habit-forming drugs.
Category: Federal Drug Laws
Question 3
The Controlled Substances Act of 1970 led to the creation in 1973 of which federal agency that enforces rules on habit-forming drugs?
Food and Drug Administration
Centers for Disease Control and Prevention
Drug Enforcement Administration
✓
Agency for Healthcare Research and Quality
Correct Answer
Drug Enforcement Administration
The Drug Enforcement Administration was created in 1973 to enforce the controls on manufacturing, distributing, and prescribing controlled substances. The Food and Drug Administration grew out of the 1906 Pure Food and Drug Act and oversees drug safety and approval. The Centers for Disease Control and Prevention focus on public health and disease control. The Agency for Healthcare Research and Quality supports research on health care quality and safety.
Category: Federal Drug Laws
Question 4
Under a 1994 federal law, herbal remedies, vitamins, minerals, and amino acids sold for health purposes are regulated as which category of product?
Prescription drugs
Controlled substances
Over-the-counter drugs
Dietary supplements
✓
Correct Answer
Dietary supplements
The Dietary Supplement Health and Education Act of 1994 placed herbal products, vitamins, minerals, and amino acids in the dietary supplement category, which is regulated differently from drugs. Prescription drugs require a prescriber's order and FDA approval. Controlled substances are habit-forming drugs regulated under the Controlled Substances Act. Over-the-counter drugs are FDA-regulated medicines sold without a prescription.
Category: Federal Drug Laws
Question 5
Which 2009 federal law used incentive payments to encourage hospitals and providers to adopt electronic health records?
HITECH Act
✓
HIPAA
Affordable Care Act
Drug Supply Chain Security Act
Correct Answer
HITECH Act
The Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 promoted electronic health record adoption through meaningful use incentives to improve the quality and efficiency of care. HIPAA, passed in 1996, set standards for protecting health information. The Affordable Care Act of 2010 expanded access to health insurance. The Drug Supply Chain Security Act of 2013 requires tracing of certain prescription drugs through the supply chain.
Category: Health Care Legislation
Question 6
A nurse's friend asks whether a neighbor was admitted to the nurse's unit. Which response by the nurse follows HIPAA?
Confirm the admission but not the diagnosis
Decline to share any information
✓
Share details because the friend is not a stranger
Ask the neighbor's provider for permission to share
Correct Answer
Decline to share any information
Protected health information, including the fact that a person is a client, is shared only with those who need it for care or as the law allows, so the nurse should not confirm or share anything. Confirming the admission but not the diagnosis is still a disclosure the nurse has no reason to make; directory questions go through the facility's own process. Sharing details because the friend is not a stranger ignores the need-to-know rule. Asking the neighbor's provider for permission to share does not make the disclosure appropriate, because the friend has no treatment-related need to know.
Category: Privacy and Confidentiality
Question 7
A state board of nursing exists for which central purpose?
Negotiating nurses' wages
Accrediting hospitals
Protecting the public
✓
Writing federal drug laws
Correct Answer
Protecting the public
Each state's nurse practice act creates a board of nursing whose focus is protecting public welfare by licensing competent nurses and acting against unsafe practice. Negotiating nurses' wages is the work of unions or employers, not the board. Accrediting hospitals is done by organizations such as The Joint Commission. Writing federal drug laws is the role of Congress.
Category: Nursing Regulation
Question 8
After hearing the risks and benefits of a prescribed drug, a competent client decides not to take it, and the nurse respects that choice. Which ethical principle is the nurse upholding?
Beneficence
Justice
Veracity
Autonomy
✓
Correct Answer
Autonomy
Autonomy is the client's right to make informed, uncoerced decisions about their own care, including refusing a medication. Beneficence is the duty to act for the client's good. Justice is fair and equal access to treatment and resources. Veracity is the duty to tell the truth.
Category: Ethical Principles
Question 9
A nurse works to make sure that every client on the unit receives fair and equal access to treatment and resources. Which ethical principle does this reflect?
Justice
✓
Autonomy
Nonmaleficence
Fidelity
Correct Answer
Justice
Justice is the ethical principle of treating clients fairly and equitably, including fair access to care and resources. Autonomy is the client's right to make their own choices. Nonmaleficence is the duty to avoid causing harm. Fidelity is the duty to keep promises and commitments.
Category: Ethical Principles
Question 10
Expected drowsiness that occurs when a client takes an antihistamine at a normal therapeutic dose is an example of which type of drug effect?
Allergic reaction
Side effect
✓
Anaphylaxis
Medication error
Correct Answer
Side effect
A side effect is a known, expected secondary effect of a drug that occurs at therapeutic doses, such as sedation from an antihistamine. An allergic reaction is an immune response to a drug. Anaphylaxis is a severe, life-threatening allergic reaction. A medication error is a preventable mistake in the use of a drug, and none occurred here.
Category: Drug Reactions
Question 11
A client develops itching and a rash caused by an immune response to a newly started antibiotic. Which term describes this reaction?
Side effect
Medication error
Allergic reaction
✓
Drug tolerance
Correct Answer
Allergic reaction
An allergic reaction is an immune response to a drug, and mild reactions commonly cause itching or a rash. A side effect is a predictable secondary drug effect that does not involve the immune system. A medication error is a preventable mistake, and nothing suggests one here. Drug tolerance is a reduced response to a drug after repeated use.
Category: Drug Reactions
Question 12
Which Joint Commission term describes a patient safety event that results in death, permanent harm, or severe temporary harm?
Near miss
Side effect
Latent condition
Sentinel event
✓
Correct Answer
Sentinel event
The Joint Commission calls an event that causes death, permanent harm, or severe temporary harm a sentinel event; the organization is expected to investigate it with a root cause analysis and an action plan. A near miss is an error caught before it reaches the client. A side effect is an expected secondary drug effect at therapeutic doses. A latent condition is a hidden weakness in a system that can contribute to errors.
Category: Medication Errors
Question 13
In the Swiss cheese model of error, when does a medication error reach the client and cause harm?
Gaps in several safety layers line up
✓
One safety layer has a single gap
The client reports a side effect
The pharmacy runs out of the drug
Correct Answer
Gaps in several safety layers line up
The Swiss cheese model pictures each safety barrier as a slice with holes, and harm occurs only when the holes in all the layers line up so the error passes through every check. A single gap in one safety layer is usually caught by the next layer. A client reporting a side effect describes a drug effect, not a path for an error. The pharmacy running out of a drug is a supply problem, not the model's explanation of harm.
Category: Medication Errors
Question 14
Which notation is the correct way to write a dose of one-half milligram in a medication order?
.5 mg
0.5 mg
✓
0.50 mg
.50 mg
Correct Answer
0.5 mg
A leading zero is required before a decimal point so the dose cannot be misread as 5 mg, and trailing zeros are not used in medication orders. The form .5 mg lacks a leading zero, so a missed decimal point turns it into a tenfold overdose. The form 0.50 mg adds a trailing zero, which can be misread as 50 mg. The form .50 mg breaks both rules.
Category: Safe Documentation
Question 15
The Joint Commission prohibits the abbreviation QD in medication orders. What should be written instead?
Every other day
Four times a day
Daily
✓
At bedtime
Correct Answer
Daily
QD is on the Do Not Use list because it is easily confused with QOD or QID, so the word daily should be written out. Every other day is the meaning of the also prohibited QOD. Four times a day is a different frequency. At bedtime describes a time of day, not the meaning of QD.
Category: Safe Documentation
Question 16
During barcode medication administration, what does the nurse scan to identify the client and open the client's eMAR?
The medication package
The room door sign
The bed's control panel
The client's wristband
✓
Correct Answer
The client's wristband
After logging in, the nurse scans the client's wristband barcode to confirm identity and open the eMAR, then scans the medication so the system can check for a match. The medication package is scanned next, after the client is identified, and it does not identify the client. The room door sign and the bed's control panel do not identify the client, since clients can change rooms and beds.
Category: Health Informatics
Question 17
A provider gives the nurse a medication order by telephone. Which action by the nurse verifies that the order was heard correctly?
Repeat the order back to the provider
✓
Document the order at the end of the shift
Ask the pharmacist to call the provider
Give the drug and then confirm the order
Correct Answer
Repeat the order back to the provider
Read-back means the nurse repeats a verbal or telephone order to the provider, who confirms it is correct before it is carried out. Documenting the order at the end of the shift delays the record and does not verify anything. Asking the pharmacist to call the provider shifts responsibility instead of confirming what the nurse heard. Giving the drug and then confirming the order risks giving the wrong drug or dose.
Category: Error Prevention
Question 18
Which medication is classified by the Institute for Safe Medication Practices as high-alert because an error can cause serious bleeding?
Acetaminophen
Heparin
✓
Docusate
Loratadine
Correct Answer
Heparin
Heparin is an anticoagulant on the ISMP high-alert list because an incorrect dose can cause serious bleeding, so many facilities require an independent double-check. Acetaminophen is a pain reliever whose main overdose risk is liver injury, not bleeding. Docusate is a stool softener. Loratadine is an antihistamine for allergy symptoms.
Category: Error Prevention
Question 19
An error that results from a flaw in how a health care system or process is designed, rather than from an individual clinician's action, is called what?
Active error
Side effect
Latent error
✓
Near miss
Correct Answer
Latent error
A latent error comes from system failures or system design, such as confusing storage or packaging, and it can lead many people into the same mistake. An active error is made by an individual clinician at the point of care. A side effect is a secondary drug effect, not an error. A near miss is an error caught before it reaches the client.
Category: Medication Errors
Question 20
When a barcode scanner fails, a nurse types in the client's identification by hand to get past the problem. What is this practice called?
Hard stop
Read-back
Root cause analysis
Workaround
✓
Correct Answer
Workaround
A workaround gets past a problem without fixing it, and it can bypass the safety checks the system was built to provide. A hard stop is an electronic alert that blocks the user until an action is taken. Read-back is repeating a verbal order to confirm it. Root cause analysis is an investigation of the system factors behind an error.
Category: Health Informatics