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Use the following case study for questions 1-5:
Maria G. is a 35-year-old Hispanic woman who is visiting the public health clinic for a dental checkup and a prophylaxis. She indicates on her health history that she is enrolled in a phase III clinical trial for the U.S. Food and Drug Administration (FDA) for her rheumatoid arthritis (RA). She also states that she has problems with dry mouth. Her vital signs are within normal limits, and she states that she is having minor dyspepsia from her medication but no other adverse effects, and her RA symptoms seem to be improving.
1. Which describes the purpose of Maria's FDA clinical trial testing?
A.Drug safety only on healthy human volunteers
B.Drug adverse effects and effectiveness on healthy human volunteers
C.Drug adverse effects and effectiveness on persons who have the condition for which the drug is indicated
D.Drug adverse effects and effectiveness in patients taking the drug after its release
C.Drug adverse effects and effectiveness on persons who have the condition for which the drug is indicated
2. The improvement in her RA is an absolute indication that she is receiving the test medication and not a placebo. The dosage is determined in this phase of the clinical study.
A.Both statements are true and related.
B.Both statements are false and related.
C.Both statements are true and unrelated.
D.The first statement is true; the second statement is false and unrelated to the first statement.
E.The first statement is false; the second statement is true and unrelated to the first statement.
E.The first statement is false; the second statement is true and unrelated to the first statement.
3. Maria's dentist writes a prescription for a saliva substitute to treat her symptoms of dry mouth. Which information is contained in the body of the prescription?
A.The patient's name, the prescribing physician's name, and the age of the patient
B.The symbol Rx, the name, dose, amount dispensed, and directions to the patient
C.The prescribing physician's signature and directions on substitution
D.The name and address of the pharmacy where the prescription is filled
B.The symbol Rx, the name, dose, amount dispensed, and directions to the patient
4. While Maria is getting her prescription from her dentist for her saliva substitute, she asks whether the dentist can also give her a prescription to relieve her upset stomach. Which of the following reasons are legally valid for the dentist's refusal to write that prescription?
A.Maria is a patient of record
B.The drugs may have a harmful interaction.
C.The additional medication may skew the clinical studies.
D.The medicine for her upset stomach is not a dental indication.
D.The medicine for her upset stomach is not a dental indication.
5. If this medication achieves FDA approval and is made available to the public, which agency or act is responsible for regulating advertising claims?
A.Food and Drug Administration (FDA)
B.Federal Trade Commission (FTC)
C.Drug Enforcement Administration (DEA)
D.Omnibus Budget Reconciliation Act (OBRA)
A.Food and Drug Administration (FDA)
Use the following case study for questions 6-10:
Nate F. is a 56-year-old man who is visiting the dental clinic for treatment of an abscessed tooth. He was diagnosed with hepatitis C in 1996, which he contracted from his intravenous heroin addiction. He has been through a detoxification process and is currently taking Rebetron (an antiviral drug) to slow the damage to his liver. He is in severe pain and needs pain medication, as well as a local anesthetic for the endodontic therapy.
6. The clinic dentist has prescribed 800 mg of aspirin for his pain. Which of the following dose alterations should be made?
A.The dose should be increased.
B.The dose should be decreased.
C.No change in dose is indicated.
D.A different medication should be prescribed.
B.The dose should be decreased.
7. The clinic dentist administered a larger-than-usual dose of local anesthesia because of Nate's extreme pain. The dentist was correct in not prescribing an opioid because of the patient's history of substance abuse.
A.Both statements are correct and related.
B.Both statements are incorrect and related.
C.The first statement is true, and the second statement is false; the statements are related.
D.The first statement is false, and the second statement is true; the statements are related.
A.Both statements are correct and related.
8. In addition to the kidney, other pathways that will allow the aspirin and Rebetron to be excreted include all except which of the following?
A.Lungs
B.Tears
C.Biliary excretion through the feces
D.Sweat
B.Tears
9. Nate's local anesthetic is administered by which route?
A.Enteral
B.Parenteral
C.Biliary
D.Subcutaneous
B.Parenteral
10. Nate takes his Rebetron by mouth. Advantages of this method of drug administration include all except which of the following?
A.Large area of absorption in the intestine
B.Convenient for patient
C.Simple to administer
D.Blood levels are less predictable than parenteral administration
D.Blood levels are less predictable than parenteral administration
Use the following case study for questions 11-15:
Simone J. is a 40-year-old dental hygiene student who suffers from migraine headaches and clinical depression. She is currently taking paroxetine (Paxil) for the depression, oral contraceptives, and propranolol as needed for her migraines. She agrees to be a patient for her classmate, and when her vital signs are taken in the clinic, her blood pressure is 160/100 mm Hg, although it has always been in the normal range in the past. During questioning, she tells her clinician classmate that she recently switched types of oral contraceptives because of weight gain. She also reports that her mouth is dry.
11. When reading the drug information handbook, the clinician discovers that elevated blood pressure can occur when one is taking this brand of oral contraceptive. What is the term for this type of drug reaction?
A.Drug interaction
B.Idiosyncratic reaction
C.Adverse drug reaction
D.Toxic reaction
E.Allergic reaction
C.Adverse drug reaction
12. Simone has not had a migraine headache since she switched oral contraceptives, but while she is in the dental chair, she has an aura and asks the clinician if she can take a propranolol. Shortly after taking the drug, she complains of dizziness and loses consciousness. Which of the following is the most likely cause of this reaction?
A.Drug interaction
B.Idiosyncratic reaction
C.Adverse drug reaction
D.Toxic reaction
E.Allergic reaction
A.Drug interaction
13. Paxil is a U.S. Food and Drug Administration category D drug. If Simone becomes pregnant, she should discontinue taking her antidepressant.
True or False?
True
14. The prevention of pregnancy by administration of oral contraceptives is termed the
A.idiosyncratic effect.
B.hypersensitivity reaction.
C.local effect.
D.teratogenic effect.
E.therapeutic effect.
E.therapeutic effect.
15. Simone reads in her dental hygiene textbook that dry mouth is a common condition in patients who take Paxil. Which term describes this condition?
A.Idiosyncratic effect
B.Hypersensitivity reaction
C.Adverse effect or side effect
D.Teratogenic effect
E.Therapeutic effect
C.Adverse effect or side effect