Get all Chapter’s Instant download by email at etutorsource@gmail.com
Haveles: Evolve Resources for Applied Pharmacology for the Dental
Hygienist, 7th Edition
Chapter 01: Information, Sources, Regulatory Agencies, Drug Legislation, and
Prescription Writing
Case Studies
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
ANS: C
Phase III involves the adverse effects of the experimental drug on persons who have the disease
or condition for which the drug is indicated and dosage formulation. Phase I tests drug safety on
healthy adults, phase II tests safety and efficacy, and phase IV involves safety surveillance
postmarketing release.
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.
ANS: E
The first statement is false; the second statement is true and unrelated to the first statement.
A positive response to the clinical trial could be caused by the placebo effect and not necessarily
by receiving the experimental drug. This phase of the trial is when drug dosage is calculated.
Get all Chapter’s Instant download by email at etutorsource@gmail.com
Copyright © 2016 by Mosby, an imprint of Elsevier, Inc.
Get all Chapter’s Instant download by email at etutorsource@gmail.com
Case Studies
1-2
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
ANS: B
The body of the prescription includes the Rx symbol, name and dose size of the concentration of
the drug, amount to be dispensed, and directions to the patient. The heading contains the name,
address, and telephone number of the prescriber; the name, address, age, and telephone number
of the patient; and the date of the prescription. The closing of the prescription contains the
prescriber’s signature, the Drug Enforcement Administration number, if required, and the refill
instructions.
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.
ANS: D
In most states, before a dentist can legally write a prescription for a patient, the following two
criteria must be met: (1) it must be for a patient of record, and (2) the condition for which the
prescription is being prescribed must be a dental-related condition. Because the dentist does not
have a reason to believe that the upset stomach is dental related, he or she would have a valid
legal reason to refuse to write the prescription and may refer Maria to her primary care
physician.
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)
ANS: A
Get all Chapter’s Instant download by email at etutorsource@gmail.com
Copyright © 2016 by Mosby, an imprint of Elsevier, Inc.
Get all Chapter’s Instant download by email at etutorsource@gmail.com
Case Studies
1-3
The Food and Drug Administration (FDA) grants approval of drugs marketed in the United
States. For a drug to achieve FDA approval, it must be determined to be both safe and effective.
The FDA regulates the trade practices of drug companies and prohibits false labeling and
advertising. It determines which drugs may be sold by prescription and over the counter (OTC)
and regulates the labeling and advertising of prescription drugs. The Federal Trade Commission
(FTC) regulates the trade practices of drug companies and prohibits false advertising of foods,
nonprescription drugs, and cosmetics. The Drug Enforcement Administration (DEA) of the
Department of Justice administers the Controlled Substances Act of 1970. This federal agency
regulates the manufacture and distribution of substances with a potential for abuse, including
opioids, stimulants, and sedatives. The Omnibus Budget Reconciliation Act (OBRA) mandates
that beginning January 1, 1993, pharmacists must provide patient counseling and a prospective
drug utilization review (DUR) for Medicaid patients. Many state boards of pharmacy interpret
this law to apply to all patients.
Get all Chapter’s Instant download by email at etutorsource@gmail.com
Copyright © 2016 by Mosby, an imprint of Elsevier, Inc.
We Don’t reply in this website, you need to contact by email for all chapters
Instant download. Just send email and get all chapters download.
Get all Chapters Solutions Manual/Test Bank Instant Download by email at
etutorsource@gmail.com
You can also order by WhatsApp
https://api.whatsapp.com/send/?phone=%2B447507735190&text&type=ph
one_number&app_absent=0
Send email or WhatsApp with complete Book title, Edition Number and
Author Name.