AZ MPJE Questions & Correct Solutions
DEA Form 222 - ANSWER Form used to order CI and CII controlled substances
between registrants
OBRA '90 - ANSWER Federal Omnibus Budget Reconciliation Act of 1990; mandates
that pharmacists (a) provide DUR of prescription orders; (b) offer to counsel patients;
and (c) maintain a written patient history in order for the state to receive federal funds
for Medicaid programs; first effective patient counseling rule
Orange Book - ANSWER the "Approved Drug Products with Therapeutic Equivalence
Evaluations", published by the federal Department of Health and Human Services
DHHS; lists all approved drugs in the US as well as therapeutic equivalence information
Pharmaceutical equivalent - ANSWER drug products that contain the same active
ingredient(s), same dosage form, same route of administration, and are identical in
strength or concentration; they may have different shape, coloring, flavoring, or release
mechanisms
Pharmaceutical alternative - ANSWER drug products which contain the same
therapeutic moiety but are different salts, esters, complexes, dosage forms or strengths
Purple Book - ANSWER The "Lists of Licensed Biological Products with Reference
Product Exclusivity and Biosimilarity or Interchangeability Evaluations" published by
CDER/FDA
Therapeutic alternative - ANSWER drug product containing different therapeutic
moieties but which are of the same pharmacological and/or therapeutic class that can
be expected to have similar therapeutic effects when administered to patients in
therapeutically equivalent doses
Therapeutic equivalent - ANSWER drugs which are pharmaceutical equivalents AND
which can be expected to have the same clinical effect and safety profile when
administered under the conditions specified in the labeling AND which are
bioequivalent; all generic equivalents are therapeutic equivalents; when used by the
FDA, therapeutic equivalent does not mean different therapeutic moieties used for the
same condition
Adulteration - ANSWER Regarding a drug's strength, purity, and quality
Examples:
-consists of any filthy, putrid, or decomposed substance
-prepared, packed, or held under unsanitary conditions or not in conformity with current
GMP
-container is composed of any poisonous substance
,-drug strength, quality, or purity of the drug differs from that on the label
-contains an unsafe color additive
Drug may be deemed adulterated even if it is pure if:
-has been prepared, packed or held in conditions where it MAY have been
contaminated
-it was exposed to a container that may have been contaminated
-it was manufactured under conditions that do not conform to current GMP
Misbranding - ANSWER Regarding representation made by the manufacturer on the
label or labeling
A product is misbranded if:
-Its labeling is false or misleading in any way
-required information is missing from the label or labeling
-established name of drugs (generic names) or both active and inactive ingredients
-adequate directions for use
-adequate information for use
-name and place of business of the manufacturer, packer or distributor
Orphan Drug Act of 1983 - ANSWER Provides tax and exclusive licensing incentives for
the treatment of "rare diseases or conditions" (those affecting fewer than 200,000
Americans)
Can a pharmacy distribute samples? - ANSWER No, except for a hospital or healthcare
entity pharmacy where a practitioner authorizes the sample and adequate records are
kept
Dietary supplement - ANSWER A dietary supplement is a product intended for
ingestion, is intended to supplement the diet, and contains anyone or more of the
following:
-A vitamin
-A mineral
-A herb or other botanical
-An amino acid
-A dietary substance for use by humans to supplement the diet by increasing the total
dietary intake
-A concentrate, metabolite, constituent, extract, or combination of the previous
What are the four claims dietary supplement suppliers are allowed to make under the
Dietary Supplement Health & Education Act (DSHEA) of 1994? - ANSWER 1. A benefit
relating to a classic nutrient deficiency disease; must disclose prevalence of the disease
in the US
, 2. Describe how a product affects any part of the structure of the human body, (e.g.,
"Glucosamine helps promote connective tissue"), or any function of the human body
(e.g., "Echinacea helps support the immune system");
3. Characterize the mechanism of action by which a product acts to maintain body
structure or function;
4. Describers the general well‐being from consumption
Drugs covered under the Poison Prevention Packaging Act (PPPA) of 1970 - ANSWER
-Aspirin and acetaminophen
-Methyl salicylate
-Controlled drugs
-Iron‐containing drugs and dietary supplements
-Lidocaine, dibucaine, and minoxidil
-Human oral prescription drugs
-Drugs switched from Rx to OTC status
What are the exceptions the Poison Prevention Packaging Act (PPPA) of 1970? -
ANSWER OTC Drugs
-One size of an OTC product for the elderly or
handicapped may be in non‐compliant packaging
-Packaging must contain the following statement:
-"This Package for Households Without Young Children"
-or if label is too small, it may contain "Package Not Child‐Resistant."
Drugs dispensed to institutionalized patients
-Hospital, long-term care, nursing home, rehab facility, etc.
Specific legend & controlled substances exempt (not all inclusive):
-Sublingual nitroglycerin tablets
-Cyclically administered oral contraceptives, conjugated estrogens, and norethindrone
acetate tablets in manufacturer's memory‐aid (mnemonic) dispenser packages
-Preparations in aerosol containers intended for inhalation therapy
-Methylprednisolone tablets containing not more than 84 mg per package (e.g.., Medrol
Dosepak)
-Potassium supplements in unit dose forms, including effervescent tablets, unit dose
vials of liquid potassium, and powdered potassium un unit dose packets containing no
more than 50 mEq/unit dose
Can child resistant containers or closures be reused? - ANSWER Child resistant
containers CANNOT be reused
-exception: glass or threaded containers; if these are reused, a new safety closure
must be used
Who can make a blanket request for non-safe containers? - ANSWER Individual
patients may make a blanket request that all of their prescriptions be filled in non-safe
containers
DEA Form 222 - ANSWER Form used to order CI and CII controlled substances
between registrants
OBRA '90 - ANSWER Federal Omnibus Budget Reconciliation Act of 1990; mandates
that pharmacists (a) provide DUR of prescription orders; (b) offer to counsel patients;
and (c) maintain a written patient history in order for the state to receive federal funds
for Medicaid programs; first effective patient counseling rule
Orange Book - ANSWER the "Approved Drug Products with Therapeutic Equivalence
Evaluations", published by the federal Department of Health and Human Services
DHHS; lists all approved drugs in the US as well as therapeutic equivalence information
Pharmaceutical equivalent - ANSWER drug products that contain the same active
ingredient(s), same dosage form, same route of administration, and are identical in
strength or concentration; they may have different shape, coloring, flavoring, or release
mechanisms
Pharmaceutical alternative - ANSWER drug products which contain the same
therapeutic moiety but are different salts, esters, complexes, dosage forms or strengths
Purple Book - ANSWER The "Lists of Licensed Biological Products with Reference
Product Exclusivity and Biosimilarity or Interchangeability Evaluations" published by
CDER/FDA
Therapeutic alternative - ANSWER drug product containing different therapeutic
moieties but which are of the same pharmacological and/or therapeutic class that can
be expected to have similar therapeutic effects when administered to patients in
therapeutically equivalent doses
Therapeutic equivalent - ANSWER drugs which are pharmaceutical equivalents AND
which can be expected to have the same clinical effect and safety profile when
administered under the conditions specified in the labeling AND which are
bioequivalent; all generic equivalents are therapeutic equivalents; when used by the
FDA, therapeutic equivalent does not mean different therapeutic moieties used for the
same condition
Adulteration - ANSWER Regarding a drug's strength, purity, and quality
Examples:
-consists of any filthy, putrid, or decomposed substance
-prepared, packed, or held under unsanitary conditions or not in conformity with current
GMP
-container is composed of any poisonous substance
,-drug strength, quality, or purity of the drug differs from that on the label
-contains an unsafe color additive
Drug may be deemed adulterated even if it is pure if:
-has been prepared, packed or held in conditions where it MAY have been
contaminated
-it was exposed to a container that may have been contaminated
-it was manufactured under conditions that do not conform to current GMP
Misbranding - ANSWER Regarding representation made by the manufacturer on the
label or labeling
A product is misbranded if:
-Its labeling is false or misleading in any way
-required information is missing from the label or labeling
-established name of drugs (generic names) or both active and inactive ingredients
-adequate directions for use
-adequate information for use
-name and place of business of the manufacturer, packer or distributor
Orphan Drug Act of 1983 - ANSWER Provides tax and exclusive licensing incentives for
the treatment of "rare diseases or conditions" (those affecting fewer than 200,000
Americans)
Can a pharmacy distribute samples? - ANSWER No, except for a hospital or healthcare
entity pharmacy where a practitioner authorizes the sample and adequate records are
kept
Dietary supplement - ANSWER A dietary supplement is a product intended for
ingestion, is intended to supplement the diet, and contains anyone or more of the
following:
-A vitamin
-A mineral
-A herb or other botanical
-An amino acid
-A dietary substance for use by humans to supplement the diet by increasing the total
dietary intake
-A concentrate, metabolite, constituent, extract, or combination of the previous
What are the four claims dietary supplement suppliers are allowed to make under the
Dietary Supplement Health & Education Act (DSHEA) of 1994? - ANSWER 1. A benefit
relating to a classic nutrient deficiency disease; must disclose prevalence of the disease
in the US
, 2. Describe how a product affects any part of the structure of the human body, (e.g.,
"Glucosamine helps promote connective tissue"), or any function of the human body
(e.g., "Echinacea helps support the immune system");
3. Characterize the mechanism of action by which a product acts to maintain body
structure or function;
4. Describers the general well‐being from consumption
Drugs covered under the Poison Prevention Packaging Act (PPPA) of 1970 - ANSWER
-Aspirin and acetaminophen
-Methyl salicylate
-Controlled drugs
-Iron‐containing drugs and dietary supplements
-Lidocaine, dibucaine, and minoxidil
-Human oral prescription drugs
-Drugs switched from Rx to OTC status
What are the exceptions the Poison Prevention Packaging Act (PPPA) of 1970? -
ANSWER OTC Drugs
-One size of an OTC product for the elderly or
handicapped may be in non‐compliant packaging
-Packaging must contain the following statement:
-"This Package for Households Without Young Children"
-or if label is too small, it may contain "Package Not Child‐Resistant."
Drugs dispensed to institutionalized patients
-Hospital, long-term care, nursing home, rehab facility, etc.
Specific legend & controlled substances exempt (not all inclusive):
-Sublingual nitroglycerin tablets
-Cyclically administered oral contraceptives, conjugated estrogens, and norethindrone
acetate tablets in manufacturer's memory‐aid (mnemonic) dispenser packages
-Preparations in aerosol containers intended for inhalation therapy
-Methylprednisolone tablets containing not more than 84 mg per package (e.g.., Medrol
Dosepak)
-Potassium supplements in unit dose forms, including effervescent tablets, unit dose
vials of liquid potassium, and powdered potassium un unit dose packets containing no
more than 50 mEq/unit dose
Can child resistant containers or closures be reused? - ANSWER Child resistant
containers CANNOT be reused
-exception: glass or threaded containers; if these are reused, a new safety closure
must be used
Who can make a blanket request for non-safe containers? - ANSWER Individual
patients may make a blanket request that all of their prescriptions be filled in non-safe
containers
