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When reviewing information about the Orphan Drug Program, which of the following would the nurse expect to find? Select all that apply.
- A. The program encourages the development and marketing of products to treat rare diseases.
- B. The program grants provisional approval with a written commitment from the drug company to formally demonstrate client benefits.
- C. The program provides for incentives, such as research grants, protocol assistance, and special tax credits, to develop products to treat rare diseases.
- D. The program grants 7 years of exclusive marketing rights to the manufacturer if approved.
- E. The program accelerates approval of drugs based on preliminary evidence before formal demonstration of client benefits.
Correct Answer: A,C,D
Rationale: The Orphan Drug Program encourages the development and marketing of products used to treat rare diseases. The program provides incentives to encourage manufacturers to develop orphan drugs, and if approved, the manufacturer has 7 years of exclusive marketing rights. Accelerated programs involve provisional approval and approval based on preliminary evidence.
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A group of nursing students are reviewing information about drug development in the United States in preparation for an exam. The students demonstrate understanding of this material when they identify testing of which of the following as one of the first steps?
- A. Small group of healthy volunteers
- B. People who have the disease
- C. Live animals
- D. Large numbers of patients
Correct Answer: C
Rationale: Initially, drug testing begins with testing in an artificial environment such as a test tube, and then this testing is followed by testing on live animals. Next, clinical testing occurs with each phase involving a larger number of people. First, a small group of 20 to 100 healthy volunteers are tested; then testing is performed on people who have the disease or condition. Last, the drug is given to large numbers of patients in medical research centers.
After teaching a group of nursing students about the half-life of a drug, the instructor determines the need for additional teaching when the students identify which of the following as true? Select all that apply.
- A. Half-life can be decreased in clients with renal disease.
- B. Half-life can help determine dosing frequency.
- C. Half-life does not change throughout a client's life.
- D. Layer disease can increase half-life.
- E. Half-life is the measure of the rate at which drugs are removed from the body.
Correct Answer: A,C
Rationale: Half-life is the measure of the rate at which drugs are removed from the body, and any difficulty in excreting a drug increases half-life, including liver or kidney disease or advanced age.
A patient has been using sleeping pills every night for the past several months. Now admitted to the hospital, he is prescribed his usual dose of sleeping pill. After administration, the patient continues to be restless and is wide awake. The nurse notifies the health care provider, who prescribes an increased dose. After receiving the new dose, the patient falls asleep. The nurse interprets this as which of the following?
- A. Drug idiosyncrasy
- B. Cumulative drug effect
- C. Drug tolerance
- D. Toxic reactions
Correct Answer: C
Rationale: The patient has developed drug tolerance and has to be administered an increased dosage of the drug to achieve the desired effect. Cumulative drug effect occurs when the body is unable to metabolize and excrete one (normal) dose of a drug before the next dose is given. Drug idiosyncrasy is a term used to describe any unusual or abnormal reaction to a drug. Toxic reactions are caused when blood concentration levels exceed the therapeutic levels of a drug.
A nursing instructor is preparing a teaching plan for a group of nursing students about pharmacology. When describing this topic, the instructor would focus the discussion on which of the following as an essential aspect?
- A. Drug name
- B. Drug class
- C. Drug action
- D. Drug source
Correct Answer: C
Rationale: Pharmacology is the study of drugs and their action on living organisms. Thus, an essential aspect of pharmacology is drug action. An understanding of the drug name, drug class, and drug source is important, but the most critical aspect related to pharmacology is how the drug acts in the body.
A group of nursing students are reviewing information about the process of drug development in the United States. The students demonstrate understanding of this process when they identify that which of the following categories are assigned by the Food and Drug Administration to newly approved drugs? Select all that apply.
- A. Metabolic
- B. Noncontrolled substance
- C. Prescription
- D. Nonprescription
- E. Controlled substance
Correct Answer: C,D,E
Rationale: Once drugs are approved for use, the FDA assigns the drug to one of the following categories: prescription, nonprescription, or controlled substance. Metabolite refers to the inactive form of the drug. Noncontrolled substance is a term that is not used.