Nokea
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.
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After teaching a group of nursing students about nonprescription drugs, the nursing instructor determines that the teaching was successful when the students identify which of the following? Select all that apply.
- A. They require a licensed health care provider's signature.
- B. They are referred to as over-the-counter drugs.
- C. They can be taken without risk to the client.
- D. They have certain labeling requirements.
- E. They should be taken only as directed on the label.
Correct Answer: B,D,E
Rationale: Nonprescription drugs are often referred to as over-the-counter (OTC) drugs. They do not require a prescription (a licensed health care provider's signature) but do not come without risk to the client. The federal government has imposed labeling requirements of OTC drugs and they should only be taken as directed on the label unless under the supervision of a health care provider.
When reviewing the phases of drug development, the nurse finds a discussion about the postmarketing surveillance phase. Which one of the following activities would the nurse expect to find as being carried out during this phase?
- A. Health care providers report adverse effects to FDA.
- B. Healthy volunteers are involved in the test.
- C. In vitro tests are performed using human cells.
- D. The drug is given to patients with the disease.
Correct Answer: A
Rationale: The postmarketing surveillance phase of drug development encourages health care professionals to report adverse effects of drugs to the FDA using MedWatch. Phase 1 of clinical testing involves 20 to 100 healthy volunteers. In vitro testing of the drug on human or animal cells is done in the pre-FDA phase. In Phase 2 of clinical testing, the drug is given to patients with the disease for which the drug is manufactured.
A nurse is assessing a client and notes that the client has developed swelling of the eyelids and lips after administration of a prescribed medication. The nurse interprets this finding as specifically indicating which of the following?
- A. Mild allergic reaction
- B. Anaphylactic shock
- C. Angioedema
- D. Drug idiosyncrasy
Correct Answer: C
Rationale: Angioedema is a type of allergic drug reaction manifested by the collection of fluid in the subcutaneous tissues, most commonly affecting the eyelids, lips, mouth, and throat. Allergic reactions can be manifested by a wide range of signs and symptoms such as itching, rashes, and hives. Anaphylactic shock is a serious allergic reaction that requires immediate medical attention. Drug idiosyncrasy describes any unusual or abnormal reaction to a drug, one that is different from the one normally expected.
When describing the various types of medications to a group of nursing students, a nursing instructor would identify which of the following as a source for deriving medications? Select all that apply.
- A. Plants
- B. Synthetic sources
- C. Mold
- D. Minerals
- E. Animals
Correct Answer: A,B,C,D,E
Rationale: Medications are derived from natural sources, for example, plants, molds, minerals, and animals, as well as created synthetically in a laboratory.
The nurse observes that after administration of a drug the patient has developed itching and a skin rash. The nurse interprets these findings as which of the following?
- A. Toxicity
- B. Allergic reaction
- C. Angioedema
- D. Crystalluria
Correct Answer: B
Rationale: Allergic reactions are manifested by a variety of signs and symptoms including itching, skin rashes, and hives. Swollen eyelids, lips, and mouth are some of the symptoms of angioedema, an allergic drug reaction that may block the airway, causing asphyxia. Toxicity or toxic reactions are caused when blood concentration levels exceed the therapeutic level of drugs. Reduced blood pressure is called hypotension. Crystals in the urine are symptoms of crystalluria.