Question 1

The client is receiving a new and expensive medication.The client asks the nurse why the medication is so expensive compared with other medications.The nurse's best response is:

Accepted Answer

The development and market introduction of new medications often involve significant research, testing, and regulatory approval costs, which contribute to their high prices.

Question 2

The student nurse is studying the difference between the American and Canadian drug approval processes.What is the student nurse's best understanding of the differences between the two governments in regard to the drug approval process?

Accepted Answer

The U.S. drug approval process involves both private and government sectors, while Canada's process is primarily government-driven.

Question 3

The nursing student is studying how priority drugs receive accelerated approval by the FDA as part of the FDA modernization.The student knows that priority drugs are used to treat:

Accepted Answer

Priority drugs are given accelerated approval by the FDA to treat serious and life-threatening conditions that lack effective treatments, providing potentially significant therapeutic advances over existing options.

Question 4

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." The nurse's best response is:

Accepted Answer

Option D is correct because it provides accurate information about controlled substances without making assumptions about the client's behavior or addiction status.

Question 5

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 pharmaceutical company must have FDA approval before marketing a drug. This is a fundamental requirement to ensure that all drugs on the market are safe and effective for public use.

Question 6

The client is enrolled in a clinical drug trial, and is told that he might receive a placebo drug as part of a control group.The client asks the nurse what a placebo is.The nurse's best response is:

Accepted Answer

A placebo is an inert substance, meaning it has no therapeutic effect. It is used in clinical trials as a control to compare the effects of the actual drug being tested.

Question 7

Nursing students are studying which drugs types must have FDA approval before being marketed.The students know that which one of the following must have approval from the FDA before being marketed?

Accepted Answer

Biologics, such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins, must have FDA approval before being marketed. This is because they are used in the prevention, treatment, or cure of a disease or condition, and their safety and efficacy must be thoroughly evaluated. Herbal preparations, dietary supplements, and food supplements, on the other hand, are not strictly regulated by the FDA in the same way and do not require pre-market approval.

Question 8

The nurse explains to the client that during the FDA drug approval process, clinical investigators from many different medical specialties address concerns such as:

Accepted Answer

During the FDA drug approval process, clinical investigators focus on determining whether or not the drug is effective for its intended use. This involves rigorous testing and analysis of clinical trial data to ensure the drug's efficacy.

Question 9

A client plans to obtain his prescription medications from Canada.The nurse recognizes the drug approval processes in Canada and the United States share this similarity:

Accepted Answer

Both the United States and Canada have regulatory systems in place that monitor dietary supplements, ensuring that these products meet safety, quality, and labeling standards. This contrasts with the regulation of other products like herbal and natural products, which may have different levels of oversight.

Question 10

A client is telling the nurse she is not sure about taking a drug that is advertised on television.She states that she does not believe that commercials for drugs tell the truth.The nurse's response is based on the following understanding:

Accepted Answer

False claims of a drug's therapeutic effect are prohibited by law, meaning that drug advertisements must adhere to regulations that prevent them from making untrue claims about the drug's effectiveness.

Question 11

One of the first standards used by pharmacists for preparation and potency of drugs was a formulary.Early formularies contained:

Accepted Answer

Early formularies were essentially collections of recipes for the preparation of drugs, including lists of ingredients and instructions on how to combine them to create pharmaceutical products. They served as a standard reference for pharmacists to ensure consistency and quality in the preparation of medications.

Question 12

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?" The nurse's best answer is:

Accepted Answer

Drugs that have a high safety margin and are considered safe for use without the direct supervision of a healthcare provider may be reclassified to over-the-counter status. This is based on their established safety profile and the low risk of serious side effects when used as directed.

Question 13

The client is receiving a newly released medication, and experiencing adverse effects.As part of the post-marketing surveillance stage of drug approval, the nurse reports these adverse effects because:

Accepted Answer

Post-marketing surveillance is conducted to monitor the safety of a drug in a larger population after it has been released to the market, identifying any harmful effects that may not have been evident in clinical trials.

Question 14

The nurse is teaching a class about medications at a senior citizen center.The nurse is teaching today about over-the-counter (OTC)medications.The nurse knows that the teaching was effective when the center members make which statement?

Accepted Answer

The correct statement reflects the importance of reading label directions carefully and consulting a healthcare provider if there are any uncertainties about over-the-counter (OTC) medications. This approach ensures safe and appropriate use of OTC medications, acknowledging that while they are accessible without a prescription, they still carry risks and potential interactions with other medications.

Question 15

The nurse is working in a cancer treatment center.The client has terminal cancer, and has received a prescription for morphine (MS Contin), a schedule II drug for pain control.The nurse is teaching this client about the medication, and determines that the teaching is successful when the client states:

Accepted Answer

Morphine (MS Contin) is a Schedule II controlled substance, which means it is tightly regulated due to its high potential for abuse and dependence. For Schedule II drugs, a new prescription is required for each refill; thus, the patient will need to see their healthcare provider each time to obtain a refill. This regulation helps ensure the medication is still necessary and being used appropriately.

Question 16

In early America, there were a great deal of patent medicines.Problems with patent medicines led to legislation of drugs.Which one of the following was the greatest problem with patent medicines?

Accepted Answer

The greatest problem with patent medicines was that they often contained dangerous or addictive substances, which could lead to serious health issues or dependency without proper regulation or disclosure of their contents.

Question 17

The student nurse is studying for a pharmacology class.The student is studying about the Food, Drug and Cosmetic Act of 1938.What is most important for the student to remember?

Accepted Answer

The Food, Drug, and Cosmetic Act of 1938 was significant because it required that drugs be tested for safety before they could be marketed, preventing the sale of untested drugs.

Quiz 2: Drug Regulations