Deck 2: Drug Regulations

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:
1)"The drug is was very expensive to develop and to bring to market."
2)"The drug companies spend too much money on marketing, and the cost gets passed on to you."
3)"It is expensive, but your insurance company will probably pay for it."
4)"I agree with you, you would think they could lower the cost of the drug."

Answer 1

1

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?
1)The U.S.incorporates the private and government sectors; Canada uses only the government sector.
2)There is little difference; they both rely extensively on government resources.
3)The U.S.has much stricter guidelines than Canada for approving drugs for the public.
4)Canada has much stricter guidelines than the U.S.for approving drugs for the public.

Answer 2

1

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:
1)Diseases for which the community raises money for treatment.
2)Serious and life-threatening conditions that lack effective treatments.
3)Diseases that affect only a small percentage of the population.
4)Diseases that previously were treated with older and less popular drugs.

Answer 3

2

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:
1)"You are not an addict, but the Drug Enforcement Agency (DEA)will be watching your prescription drug habits now."
2)"Do you think that you are addicted to your medication?"
3)"If you continue on this medication for a long time, you will become addicted to it."
4)"You are not an addict.The Drug Enforcement Agency (DEA)does restrict drugs that have a high potential for abuse."

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?
1)"Is this a drug in clinical trials? Only those drugs don't have to have FDA approval."
2)"Your company must be involved in academic research if they don't need FDA approval."
3)"Any pharmaceutical company must have FDA approval before marketing a drug."
4)"Is this an OTC drug? They do not need FDA approval."

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:
1)"A placebo is a drug that has been tested before."
2)"A placebo is an over-the-counter drug."
3)"A placebo is an inert substance."
4)"A placebo is similar drug that is safe."

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?
1)Biologics
2)Herbal preparations
3)Dietary supplements
4)Food supplements

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:
1)Whether a New Drug Application must be filed.
2)Whether or not the drug is effective.
3)Whether the application should be reviewed again.
4)The marketability of the drug.

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:
1)Natural products do not have to be monitored.
2)Dietary supplements do have to be monitored.
3)Herbal products are not monitored in Canada.
4)Prescription medications are often sold over the counter in Canada.

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:
1)False claims of a drug's therapeutic effect are prohibited by law.
2)Advertisements are not legally binding, and can be misleading.
3)Manufacturers have some ability to change things when advertising drugs.
4)All drugs must be advertised in media to inform the public.

Question 11

One of the first standards used by pharmacists for preparation and potency of drugs was a formulary.Early formularies contained:
1)Names of patent medicines and natural drugs.
2)Lists of pharmaceutical products and drug recipes.
3)Lists of various drugs' potency based on geographic region.
4)Lists of various drugs' strengths based on individual pharmacies.

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:
1)"The longer the drug is on the market, the better its chance of going over the counter."
2)"Drugs with the least amount of side effects can become over-the-counter."
3)"Drugs that have a high safety margin may be reclassified to over-the-counter."
4)"If the pharmaceutical company pays the FDA a large amount of money, they can have their drug reclassified."

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:
1)Individual client response is compared with the clinical trial data.
2)The efficacy of the drug is determined for new drugs.
3)The clinical trials are continuing to collect new data.
4)Harmful effects in the larger population are monitored.

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?
1)"We should not take any over-the-counter medications without first calling our primary provider."
2)"We must read all the label directions and call our provider if the directions are not clear."
3)"Over-the-counter medications are safe; otherwise, they would require a prescription."
4)"Over-the-counter medications are safe, as long as we don't take them at the same time as our prescription 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:
1)"This is an addictive drug, so I should try not to take it."
2)"I should call the office three days before I need a refill called in to the pharmacy."
3)"I will need to see the provider each time for my refill."
4)"After the first prescription, my daughter can pick up my refills."

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?
1)They only smelled like medicine.
2)They had dangerous or addictive substances.
3)They could be made only out of natural products.
4)They were only distributed in elixir format.

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?
1)It helped to standardize the quality of prepared food, drugs, and cosmetics.
2)It gave the government the power to change labeling content of medications.
3)It prevented the sale of drugs that had not been tested before marketing.
4)It prohibited the sale of drugs labeled with false therapeutic claims to defraud the public.