Question 1

During the rise of patent medicines in America in the 1800s,there were few attempts to regulate drugs.Which statements accurately depict this situation?
Select all that apply.

Accepted Answer

- A) Patent medicines were indeed branded, which helped in their marketing and widespread recognition.- B) These medicines were notorious for making broad, often unfounded claims about their efficacy in treating a wide range of ailments.- C) While some patent medicines were simply ineffective and did not cause direct harm, their lack of efficacy could indirectly harm individuals by delaying proper treatment.- D) It's well-documented that many patent medicines contained substances like alcohol, opium, and cocaine, leading to addiction among unsuspecting consumers.

Question 2

One of the first standards used by pharmacists for preparation and potency of drugs was a formulary.What did early formularies contain?

Accepted Answer

Early formularies contained lists of pharmaceutical products and drug recipes. This allowed pharmacists to standardize the preparation and dosage of drugs. The formularies also provided information on the properties and uses of different drugs.

Question 3

Which statements regarding the role of the U.S.Food and Drug Administration (FDA)are true?
Select all that apply.

Accepted Answer

The FDA is responsible for ensuring the security and availability of safe and effective human drugs, taking action against unsafe supplements, and facilitating the availability of safe drugs.

Question 4

A client says to the admitting nurse,Why do you need to know the names of all the over-the-counter supplements I take? They aren't drugs." Which responses by the nurse are the most appropriate?
Select all that apply.

Accepted Answer

The answer of A client says to the admitting nurse,Why...

Question 5

The nursing student is studying how priority drugs receive accelerated approval by the Food and Drug Administration (FDA)as part of the FDA modernization.Which conditions are the priority drugs used to treat?

Accepted Answer

Priority drugs are drugs used to treat serious and life-threatening conditions that lack effective treatments. These drugs undergo an accelerated approval process by the FDA under the FDA Modernization Act of 1997 to expedite their availability to patients in need.

Question 6

The Pure Food and Drug Act (PFDA)of 1906 was significant in that it gave the government the power to prohibit drug labels from claiming false therapeutic benefits.However,there were still several weaknesses in the legislature of this act.Which statements most accurately describe these weaknesses?
Select all that apply.

Accepted Answer

The PFDA of 1906 did not require drug manufacturers to prove the efficacy of their drugs, and it did not prevent drugs from being marketed for any disease. While the law did require drug labels to accurately describe their contents, it did not require adequate testing for safety prior to marketing. Additionally, the law did not specifically encourage the development of drugs for rare or unusual disorders.

Question 7

Which was the greatest problem with patent medicines in early America that lead to drug legislation?

Accepted Answer

The greatest problem with patent medicines in early America was that they often contained dangerous or addictive substances, such as opioids, cocaine, and alcohol. This led to widespread addiction and health problems among the population, which in turn led to the need for drug legislation to regulate the ingredients and labeling of these products.

Question 8

The nurse explains to the client that during the Food and Drug Administration (FDA)drug approval process,clinical investigators from many different medical specialties address concerns.What concerns are addressed?

Accepted Answer

During the FDA drug approval process, clinical investigators from different medical specialties address concerns regarding the safety of the drug. The other options mentioned, such as whether an NDA should be filed, the marketability of the drug, and the cost of the drug, are not primary factors addressed during the approval process.

Question 9

The client was taking a prescription medication that is now available over the counter.The client asks the nurse,"Why do some medications become available over the counter and other medications remain prescription drugs?" Which response by the nurse is the most appropriate?

Accepted Answer

Medications that have a high safety margin are more likely to become available over the counter. This is because drugs that are less likely to cause harm to individuals can be safely taken without the need for a healthcare provider's supervision. Additionally, other factors considered include the drug's complexity, potential for abuse, and potential for adverse reactions. The FDA reviews all over-the-counter drug applications and determines the safety and efficacy of each drug before granting approval. The length of time the drug is on the market and payment to the FDA are not factors in reclassification.

Question 10

The client says to the nurse,"I wonder if I am considered a drug addict.I went to pick up my medication from the drug store and the pharmacist told me that the drug was a controlled substance." Which response by the nurse is the most appropriate?

Accepted Answer

This response provides accurate information about controlled substances and their restrictions without implying that the client is an addict or will become one. It also addresses the client's concern about the pharmacist's perception without making assumptions about their personal behavior.

Question 11

A nurse educator is preparing a lecture regarding prescriptive authority for advanced practice registered nurses (APRNs).Which statement is appropriate for the educator to include in the lecture regarding this topic?

Accepted Answer

Prescriptive authority for APRNs is determined by state regulations, not federal, local, or physician supervision. Each state has its own set of rules and regulations dictating what APRNs can prescribe and under what circumstances. It is important for APRNs to be familiar with their state's regulations in order to practice safely and legally.

Question 12

The client receiving a newly released medication is experiencing adverse effects.Why does the nurse report these adverse effects as part of the postmarketing surveillance stage of the drug approval process?

Accepted Answer

Postmarketing surveillance is the stage of the drug approval process where harmful effects in the larger population continue to be monitored. This ensures that any adverse effects or safety concerns are caught and addressed as soon as possible. Individual client responses are not compared with clinical trial data in this stage, as the focus is on larger population data. The efficacy of the drug is determined in earlier stages, and while clinical trials may still be ongoing, they would not be collecting new data on adverse effects specifically.

Question 13

Which statements regarding the preclinical research stage of drug development are true?
Select all that apply.

Accepted Answer

The answer of Which statements regarding the preclinical research stage...

Question 14

The nurse is working in a cancer treatment center.A client diagnosed with terminal cancer has received a prescription for morphine (MS Contin),a schedule II drug for pain control.After medication teaching,which statement by the client indicates appropriate understanding?

Accepted Answer

Schedule II drugs, such as morphine, require a written prescription that cannot be refilled. The client will need to see the provider each time for a new prescription. Option A is incorrect because the client cannot call the office for a refill, as a written prescription is required. Option C is incorrect because while morphine is an addictive drug, the client should still take it as prescribed by their provider. Option D is incorrect because a new prescription is required each time, and the provider cannot simply call in a refill.

Question 15

Clients enrolled in a clinical drug trial are told that they might receive a placebo drug as part of a control group.A client asks the nurse what a placebo is.Which response by the nurse is the most appropriate?

Accepted Answer

A placebo is a substance that has no therapeutic effect, meaning it is not an active drug. It is used in clinical trials as a control group to compare the effects of the actual drug being tested. This helps researchers determine if the new drug is more effective than no treatment or a placebo.

Question 16

A pharmaceutical representative comes to the primary care office and states that his company is marketing a new drug that does not need approval by the Food and Drug Administration (FDA).What is the best response of the nurse?

Accepted Answer

Any drug marketed by a pharmaceutical company must have FDA approval. It is important for the nurse to clarify this point and not accept any claims to the contrary that may be misleading or inaccurate.

Question 17

In the early 1800s,it became clear that the standardization of drug purity and strength was necessary.Which reasons reflected this need?
Select all that apply.

Accepted Answer

The answer of In the early 1800s,it became clear that...

Question 18

Nursing students are studying which drug types must have Food and Drug Administration (FDA)approval before being marketed.The students know that which drugs must have approval from the FDA before being marketed?

Accepted Answer

Biologics are drugs derived from living organisms and are required to have FDA approval before being marketed. Food supplements, herbal preparations, and dietary supplements are not required to have FDA approval before being marketed.

Question 19

A client is talking to the nurse and is expressing doubt about whether to take a drug that is advertised on television.The client does not believe that commercials for drugs tell the truth.Which rationale will the nurse use when responding to the client?

Accepted Answer

False claims of a drug's therapeutic effect are prohibited by law, ensuring that advertisements must be truthful and not misleading.

Question 20

The nurse is teaching a class about over-the-counter (OTC)medications at a senior citizen center.Which statement by a participant indicates the teaching was effective?

Accepted Answer

This statement accurately conveys the importance of consulting with a healthcare provider before taking any OTC medication due to the potential for interactions with prescription medications. It demonstrates an understanding of the potential risks associated with OTC medication use. The other statements are incorrect or incomplete in their understanding of OTC medication safety.

Quiz 2: Drug Regulations

During the rise of patent medicines in America in the 1800s,there were few attempts to regulate drugs.Which statements accurately depict this situation? Select all that apply.

One of the first standards used by pharmacists for preparation and potency of drugs was a formulary.What did early formularies contain?

Which statements regarding the role of the U.S.Food and Drug Administration (FDA) are true? Select all that apply.

A client says to the admitting nurse,Why do you need to know the names of all the over-the-counter supplements I take? They aren't drugs." Which responses by the nurse are the most appropriate? Select all that apply.

The nursing student is studying how priority drugs receive accelerated approval by the Food and Drug Administration (FDA) as part of the FDA modernization.Which conditions are the priority drugs used to treat?

Which was the greatest problem with patent medicines in early America that lead to drug legislation?

The nurse explains to the client that during the Food and Drug Administration (FDA) drug approval process,clinical investigators from many different medical specialties address concerns.What concerns are addressed?

The client was taking a prescription medication that is now available over the counter.The client asks the nurse,"Why do some medications become available over the counter and other medications remain prescription drugs?" Which response by the nurse is the most appropriate?

The client says to the nurse,"I wonder if I am considered a drug addict.I went to pick up my medication from the drug store and the pharmacist told me that the drug was a controlled substance." Which response by the nurse is the most appropriate?

A nurse educator is preparing a lecture regarding prescriptive authority for advanced practice registered nurses (APRNs) .Which statement is appropriate for the educator to include in the lecture regarding this topic?

The client receiving a newly released medication is experiencing adverse effects.Why does the nurse report these adverse effects as part of the postmarketing surveillance stage of the drug approval process?

Which statements regarding the preclinical research stage of drug development are true? Select all that apply.

The nurse is working in a cancer treatment center.A client diagnosed with terminal cancer has received a prescription for morphine (MS Contin) ,a schedule II drug for pain control.After medication teaching,which statement by the client indicates appropriate understanding?

Clients enrolled in a clinical drug trial are told that they might receive a placebo drug as part of a control group.A client asks the nurse what a placebo is.Which response by the nurse is the most appropriate?

A pharmaceutical representative comes to the primary care office and states that his company is marketing a new drug that does not need approval by the Food and Drug Administration (FDA) .What is the best response of the nurse?

In the early 1800s,it became clear that the standardization of drug purity and strength was necessary.Which reasons reflected this need? Select all that apply.

Nursing students are studying which drug types must have Food and Drug Administration (FDA) approval before being marketed.The students know that which drugs must have approval from the FDA before being marketed?

A client is talking to the nurse and is expressing doubt about whether to take a drug that is advertised on television.The client does not believe that commercials for drugs tell the truth.Which rationale will the nurse use when responding to the client?

The nurse is teaching a class about over-the-counter (OTC) medications at a senior citizen center.Which statement by a participant indicates the teaching was effective?