Real Questions & Correct Answers. Already
Graded A+
4 elements needed to prove negligence - ANS-Duty (counseling, drug product selection,
PPPA)
-Breach of Duty (Failure to warn or perform proper DUR, drug selection error,
inappropriate supervision of techs)
-Proximate cause (breach of duty must have led directly to damages)
-Damages (prove that damages occurred and they were substantial)
A central fill pharmacy must record: - ANS-Date received from originated pharmacy
-Name and address of originating pharmacy
-Date Rx was filled, processed and verified
-ID of RPh responsible for processing & shipping to originating pharmacy or delivery to
patient
-Date shipped to originating pharmacy or to patient
-Method of delivery
Activities that are violations of the FDCA - ANS-Adulteration
-Misbranding
-Placing an unapproved drug into Interstate Commerce
Address or name change needs to be reported to the Board no later than ________
after the change - ANS30 days
Adulterated or Misbranded?:
Any substance mixed w/ the drug to reduce strength, or any substance that has been
substituted for the drug - ANSAdulterated
Adulterated or Misbranded?:
Any word or statement required on label is not prominent, conspicuous and readable -
ANSMisbranded
Adulterated or Misbranded?:
Bears unsafe color additive for purposes of coloring only - ANSAdulterated
Adulterated or Misbranded?:
Consists in whole or in part of filthy, putrid or decomposed substance - ANSAdulterated
Adulterated or Misbranded?:
,Container is composed of poisonous or deleterious substance that may render contains
injurious to health - ANSAdulterated
Adulterated or Misbranded?:
Dosage, frequency, duration or route of admin suggested in the labeling is dangerous -
ANSMisbranded
Adulterated or Misbranded?:
Drug has habit-forming substance and label fails to list name and proportion of
substance and "Warning—may be habit forming" - ANSMisbranded
Adulterated or Misbranded?:
Drug is liable to deterioration and label doesn't warn to that effect - ANSMisbranded
Adulterated or Misbranded?:
Drug is manufactured in facility in violation of cGMPs - ANSAdulterated
Adulterated or Misbranded?:
Drug is not dispensed in a childproof container - ANSMisbranded
Adulterated or Misbranded?:
Drug labeled in official compendium but strength differs from or quality or purity falls
below compendium standards - ANSAdulterated
Adulterated or Misbranded?:
Drug not listed in official compendium and its strength differs from or its quality or purity
falls below what is represented on label - ANSAdulterated
Adulterated or Misbranded?:
False/misleading labeling - ANSMisbranded
Adulterated or Misbranded?:
If established name or mutli-ingredient products don't identify each active ingredient -
ANSMisbranded
Adulterated or Misbranded?:
Misleading container, imitates another drug or offered for sale under the name of
another drug - ANSMisbranded
Adulterated or Misbranded?:
Packaging fails to identify name & address of manufacturer, packager of distributor, and
quantity of drug - ANSMisbranded
Adulterated or Misbranded?:
Pharmacist dispensed a medication without a refill or prescription - ANSMisbranded
,Adulterated or Misbranded?:
Pharmacist dispenses expired products - ANSAdulterated
Adulterated or Misbranded?:
Prepared, packaged or held under unsanitary conditions, whereby it MAY have become
contaminated w/ filth or MAY have been rendered injurious to health (don't have to
prove, just say it MAY have) - ANSAdulterated
Adulterated or Misbranded?:
Re-selling a repackaged medication - ANSMisbranded
Adulteration - ANSFailure of drug or device to satisfy FDA purity standards
An originating pharmacy that uses central fill must record: - ANS-Date transmitted to
CPPP
-Method of transmittal
-ID of RPh responsible for transmittal
-Name and address of CPPP
-Date the delivery pharmacy received the filled Rx was received from CPPP
-Name of pharmacy employee who accepted delivery
-ID of RPh delivering Rx to patient
APAP elixir w/codeine is in which CS schedule? - ANS5
Are Med Guides, PPIs, SE Statements still required to give to the patient if dispensed in
a CPMP? - ANSYes
Are meds dispensed to an assisted living facility EXEMPT from the Poison Prevention
Packaging Act? - ANSNo
Are RPh inititals required on all CS invoices? - ANSYes
Are there limitations to prescribers delegating dispensing power? - ANSYes, delegated
dispensing is limited to a 72 hour supply of the drug(s)
Are there restrictions on the sale of needles or syringes? - ANSNo
Benzodiazepines and benzodiazepine agonists are generally in which CS schedule? -
ANS4
Can a Canadian DDS prescribe non-controlled or controlled substances? - ANSNo.
Can a Canadian MD or DO prescribe controlled substances? - ANSNo.
Can a Canadian MD or DO prescribe non-controlled substances? - ANSYes
, Can a computer send an Rx to a fax machine? - ANSOnly for a non-controlled drug...
and a Michigan electronic signature is needed.
Can a homeopathic doctor, naturopathic doctor (ND), or chiropracter prescribe in
Michigan? - ANSNo.
Can a hospital pharmacy house complimentary starter doses of controlled substances?
- ANSNo.
Can a hospital pharmacy house complimentary starter doses of non-controlled drugs? -
ANSYes, but:
A physician (MD or DO) must delegate in writing to a pharmacist at that hospital that the
pharmacist can receive and dispense the sample.
The pharmacist can then dispense the samples to ANY prescriber (including PA and
NP) in the hospital.
NOTE: Both the RPh's and physician's names must be on the drug sample for the RPh
to receive it.
Can a PA call in an emergency C2? What about an NP? - ANSYes (under delegation);
No
Can a PA or NP prescribe misoprostal to a woman known to be pregnant, for purposes
of abortion? - ANSNo
Can a pharmacy inspector seize drug without a warrant? - ANSYes, if they feel drugs
are an imminent threat to public health or welfare
Can a pharmacy put back to stock and redispense meds from a CPMP that was
returned? - ANSNo, they may not be returned to stock or dispensed to ANOTHER
patient when returned to pharmacy, but can give it back to the SAME patient
Can a pharmacy redispense meds returned from a nursing home? - ANSYes, but only
non-CS drugs because the patient doesn't take possession of it.
CANNOT take back CS drugs from a nursing home!
Can a wholesaler or manufacturer act as a pharmacy? - ANSNo
Can an agent of a prescriber call in a CS Rx? - ANSYes
Can an agent of the prescriber call in an emergency CII? - ANSNo, it must be a
prescriber-to-pharmacist phone call.