Appleton Chapter 3: Pharmacy Flashcards
DIRECTIONS (Questions 1 through 203): Each of
the numbered items or incomplete statements in
this section is followed by answers or by comple-
tions of the statement. Select the ONE lettered an-
swer or completion that is BEST in each case.
1. Official standards for individual drugs and
chemicals formulated into dosage forms are
published in
(A) USP/NF
(B) USP DI Volume I
(C) USP DI Volume II
(D) USP DI Volume III
(E) PDR
- (A) Official standards in the form of drug
monographs are presented in the United
States Pharmacopeia/National Formulary (USP/NF).
These monographs may describe therapeuti-
cally active drugs or other ingredients,
known as excipients, that are essential for
formulating a stable drug product. (24:9)
- The agency in the United States responsible
for selecting appropriate nonproprietary
names for drugs is the
(A) AMA
(B) APhA
(C) FDA
(D) USAN
(E) USP
- (0) The United States Adopted Names
(USAN) Council establishes nonproprietary
drug names. The Council is jointly sponsored
by the AMA, United States Pharmacopoeial
Convention, and the APhA. Because the
USAN is not an official government agency,
the chosen names are not formally recog-
nized until they are published in the Federal
Register. (24:32)
- Descriptions of the Federal Controlled Sub-
stances Act, Approved Drug Products with
Therapeutic Equivalence Evaluations, and
USP/NF dispensing requirements may be
found in the
(A) USP DI Volume I
(B) USP DI Volume II
(C) USP DI Volume III
(D) Facts and Comparisons
(E) PDR
- (C) Federal drug laws and regulations are
described in the USP Dispensing Information
(01), Volume III, which also contains listings
of therapeutic equivalent drugs and drugs
that are biologically inequivalent. The latter
information is from the FDA’s “Orange
Book.” (18c:VI-52)
- Prescription drug descriptions expressed in
layperson’s terms and useful as handouts for
patients may be photocopied from the
(A) USP DI Volume I
(B) USP DI Volume II
(C) USP DI Volume III
(D) Facts and Comparisons
(E) Remington’s Pharmaceutical Sciences
- (B) Volume II of the USP DI contains drug
monographs written for the layperson. Phar-
macists have permission to photocopy indi-
vidual drug descriptions for distribution to
the patient when dispensing the drug. Vol-
ume I of the USP DI contains drug informa-
tion for health professionals. It includes more
detailed and more scientific information than
Volume II. (1Sb; 18c)
- According to the USP, the instruction “pro-
tect from light” in a monograph indicates
storage in a
(A) dark place
(B) amber glass bottle
(C) light-resistant container
(D) hermetic container
(E) tight glass container
- (C) A container that reduces light transmis-
sion in the range between 290 and 450
nanometers to the level specified in the USP
90
may be considered light resistant and suit-
able protection from light. The container may
be constructed of glass or plastic. Although
amber units are most common, other colored
or opaque containers may meet the official
requirements. (4:12.6; 18c:VI-5; 24:154)
- According to USP standards, a refrigerator
can be used to store pharmaceuticals that
specify storage in a
I. freezer
II. cool place
III. cold place
(A) I only
(B) III only
(C) I and II only
(D) II and III only
(E) I, II, and III
- (B) A cold place indicates a temperature not
exceeding 8° C (46° F). A refrigerator is a cold
place in which the temperature is maintained
between 2 and 8° C (36-46° F). A cool place
refers to areas maintained between 8 and 15°
C. A freezer is defined as a storage area held
between _10° and -20°. (18c:VI-6; 24:146)
- The expiration date on a pharmaceutical con-
tainer states “Expires July 2005.” This state-
ment means that by that expiration date, the
product may have lost
(A) up to 5% of its activity
(B) up to 10% of its activity the use of extremely small doses of drugs is
(C) up to 20% of its activity known as
(D) up to 50% of its activity
(E) sufficient activity to be outside USP
monograph requirements
- (E) The expiration date for a pharmaceutical
is based on the length of time during which
the product continues to meet the specified
monograph requirements. Requirements are
stated in terms of amount of active ingredient
that is present as determined by suitable as-
say. Most drug products are considered us-
able until approximately 10% of the drug or
drug activity has been lost. However, some
monographs specify other ranges. For exam-
ple, digoxin tablets must assay between 92%
and 108% of label claim. (1:639)
- If a bottle of tablets has an expiration date of “July 2002,” the pharmacist may continue to
dispense the product
(A) up to 1 year after the expiration date several ways.
(B) only through July 1, 2002 of solubility is given in the USP,
(C) only through July 15, 2002
(D) only through July 31,2002 (A) g of solute soluble in 1 mL of solvent
(E) if the pharmacist informs the patient to
discard unused tablets in 6 months
- (0) When expiration dates are expressed
only in terms of month and year, the in-
tended expiration date is the end of the last
day of the stated month. (1:639; 4:4.1)
- A pharmacist has reconstituted a powder (D) mL of solvent required to dissolve 100 g dosage form to form a solution. Which of the of solute
following statement(s) concerning a Beyond- (E) mL of solvent required to prepare 100 Use Date is (are) appropriate when determin- mL of saturated solution ing an expiration date for this product?
I. The beyond-use date is identical to the
manufacturer’s expiration date.
II. The beyond-use date is never more than 10 days for reconstitute product’s
III. The beyond-use date for nonsolid dosage forms shall not be greater than one
year from the date of dispensing
(A) I only
(B) III only
(C) I and II only
(D) II and III only
(E) I, II, and III
- (B) Pharmacists are using beyond-use dating
quite often as guidelines when dispensing
prescriptions to limit prolonged use of the
drug by the patient. This date is usually a
shorter time span than the manufacturer’s
expiration date found on the original pack age. The beyond-use date shall be no later
than either the expiration date on the manu-
facturer’s container or one year from the date
of dispensing, whichever is earlier. For recon-
stituted products, the beyond-use date will
be of a significantly shorter duration and is
based on the manufacturer’s recommenda-
tion in the package insert or on the package.
(4:4.1)
- Which one of the following practices would
NOT be classified as “alternative medicine” in the US?
(A) allopathy
(B) chiropractic
(C) naturopathy
(D) nutraceutical
(E) reflexology
- (A) Allopathy is the treating of disease by
using remedies that produce effects on the
body that differ from those produced by the
disease. This new set of conditions is incom-
patible with or antagonistic to the original
symptoms of the disease. The term is now
used when referring to standard or orthodox
medical practice. Naturopathy indicates heal-
ing by the exclusive use of natural remedies
(heat, light, vegetables, fruits, etc.) but no
surgery or drugs. Nutraceutical practice is
one in which foods are used to promote heal-
ing and health. (1:840; 27:69)
- An alternative medical practice that stresses the use of extremely small doses of drugs is
(A) folk medicine
(B) holistic medicine
(C) homeopathic medicine
(D) orthomolecular medicine
(E) faith healing
- (C) Homeopathy involves the use of sub-
stances that produce symptoms similar to the
symptoms of the disease (the law of similars).
The drugs used, mainly herbals, are adminis-
tered as very high dilutions, that is, in ex-
tremely low doses. Holistic medicine refers to
therapies that treat the whole person-both
mind and body. (27:909; 1:840)
- Solubility of a substance may be expressed in
(A) g of solute soluble in 1 mL of solvent
(B) g of solute soluble in 100 mL of solvent
(C) mL of solvent required to dissolve 1 g of solute
(D) mL of solvent required to dissolve 100g of solute
(E) mL of solvent required to prepare 100ml of saturated solution
- (C) For example, boric acid solubility in wa-
ter is expressed as 1:18. This indicates that 1
gram of boric acid added to exactly 18 mL of
purified water will result in a saturated solu-
tion. When compounding, it is advisable to
use excess solvent because saturated solu-
tions are difficult to prepare and may precipi-
tate if there are changes in temperature.
(1:194)
- Which of the following alkaloids exhibit good water solubility?
I. morphine HCl
II. cocaine
III. atropine
(A) I only
(B) III only
(C) I and II only
(D) II and III only
(E) I, II, and III
- (A) Naturally occurring alkaloids, which are
weak organic bases, have relatively poor wa-
ter solubility but are soluble in alcohol. Most
pharmaceutical products use the alkaloid
salts such as morphine Hel, cocaine Hel, and
atropine sulfate to increase the drugs’ water
solubility. (1:398)
- Which of the following forms of the basic drug haloperidol will have good water solubility?
I. hydrochloride
II. lactate
III. decanoate
(A) I only
(B) III only
(C) I and II only
(D) II and III only
(E) I, II, and III
- (C) Haloperidol is a butyrophenone deriva-
tive and the base form has very poor water
solubility (1 g in more than 10,000 mL). The
hydrochloride salt is water soluble, as is the
lactate salt, which is utilized in preparing the
aqueous injection of haloperidol. Haloperidol
decanoate is the ester form that is dissolved
in an oil vehicle. This injection product is in-
jected intramuscularly and has a half-life of
approximately 3 weeks. (1:1184)
- Which one of the following chemicals is NOT
suitable as a drug excipient?
(A) methyl paraben
(B) starch
(C) glycerin
(D) benzocaine
(E) lactose
- (D) Pharmaceutical excipients are selected
for specific characteristics that will improve
the drug formulation. These include solvents
(glycerin), ointment bases (petrolatum), tablet
diluents (lactose), antioxidants (sodium bi-
sulfite), and antimicrobial preservatives (the
parabens). Because they must be relatively in-
ert therapeutically, the local anesthetic benzo-
caine would not be suitable. (24:111)
- Which of the following chemicals may be in-
cluded in a drug solution as a chelating
agent?
(A) ascorbic acid
(B) hydroquinone
(C) edetate
(D) sodium bisulfite
(E) fluorescein sodium
- Which of the following ions may be effec-
tively chelated by EDTA?
I. sodium
II. lithium
III. lead
(A) I only
(B) III only
(C) I and II only
(D) II and III only
(E) I, II, and III
- (B) Edetate calcium disodium (Versenate) is
usually administered by intramuscular par-
enteral injection to reduce blood levels and
depot stores of lead in acute and chronic lead
poisoning and lead encephalopathy. The
chelate formed with lead is stable, water-
soluble, and readily excreted by the kidneys.
The other choices, lithium and sodium, are
monovalent ions and will not complex with
EDTA. (1:935)
- Although most drugs in pharmaceutical
dosage forms are expected to decompose fol-
lowing first-order kinetics, an exception are
drugs formulated in
(A) capsules
(B) oral solutions
(C) oral suspensions
(D) tablets
(E) suppositories
- (C) Drugs in suspensions are likely to follow
zero-order kinetics because the limiting fac-
tor is the amount of drug actually in solution.
The classic example is aspirin suspension.
(12:286)