AND ANSWERS GRADED A+
✔✔Wrong drug in bottle is an example of - ✔✔Misbranded and adulterated
✔✔when does controlled substance dispensing need to be reported to the PDMP -
✔✔All CS dispensed by a Rx by a pharmacy, including CS scheduled under IL law,
dispensing info must be turned into DHHS by the end of the next business day
✔✔Schedule of pentazocine
Schedule of pentazocine + APAP - ✔✔Pentazocine: C2
when combined with ASA, APAP, or naloxone it is a C3
✔✔Pentazocine reasons to be C3 - ✔✔<12.5 mg of pentazocine per 325 mg of ASA
< 12.5 of pent per 325 mg of APAP
<50 of pent plus naloxone 0.5 mg per dosage unit
✔✔Which Insulins are available OTC - ✔✔Humulin R, Humulin N, Humulin Ultra Lente
✔✔DESI Drugs - ✔✔Drug Efficacy Study Implementation , this is where FDA reviews all
old drugs that were approved before new FDA standards. (before 1962),
✔✔can DESI drugs be substituted / equialency - ✔✔NO, they are not listed in the
orange book for equivalency purposes and cannot be substituted because they are not
'A' rated.
✔✔Another name for the Orange Book - ✔✔Approved Drug Products with Therapeutic
Equivalence Evaluations
✔✔First letter of therapeutic equivalency in orange book - ✔✔A= Substitutable
B= inequivalent/nonsubstitutable
✔✔Second letter in orange book refers to - ✔✔dosage form
✔✔AB - ✔✔Solid dosage form
✔✔AN - ✔✔solutions and powders for aerosolization
✔✔AO - ✔✔Injectable oil solutions
,✔✔AP - ✔✔injectable aqueous solutions and IV aqueous solution
✔✔AT - ✔✔topical products
✔✔What are illegal kick backs - ✔✔Receiving any time of reward for referral ex;
providing free office space for MD so they agree to send patients to you
coupons are prohibited- thats why most pharmacy chains that issue coupons exclude
participation of patents who have their prescriptions paid for by any state/federal
payment program bc it raises concern for medicare/medicaid patients
✔✔What is federal and state emergency C2 dispensing QTY limit - ✔✔Limit dispensing
that would get the patient through the emergency period. There is no arbitrary # of days
limitation. it is based on the facts and circumstances presented
ex: if patient needs the med, and cannot see the doctor to get a written Rx for 2 weeks,
pharmacy can dispense two week supply if phoned in by MD
✔✔when docs are ordering a c2 for "office use" do they fill out a DEA 222 - ✔✔yes
✔✔Is a pet owners name required to be on a Rx for a pet in addition to the pets name-
Add tom smith or just smith to dogs name - ✔✔Last name is sufficient
✔✔For CS Rx for dogs, what does the Rx require - ✔✔-full name and address of animal
owner, species or common name of the animal being treated
✔✔If you're license expires as a RPH, can you still work - ✔✔no
✔✔at what time can investigators enter pharmacy - ✔✔during regular business hours
they can inspect anything pharmacy issue related
✔✔how long should Rx records be saved - ✔✔5 years , open to inspection at any time
✔✔Do investigators need to be pharmacists - ✔✔Yes, although if the person was hired
before new law took effect and they are not RPH, they can still continue to be
investigators.
✔✔When investigators request information, what is the turn-around time that the
pharmacy must send information to them by? - ✔✔60 days
✔✔Assume the MD gives the patient three Rx on the same appt 5/20, 6/20, 7/20, on
5/21 asks the pharmacists to fill the first Rx and hold the other two for a later fill. is this
legal? - ✔✔NO . post dating a Rx is NOT permitted. the date of issuance must reflect
the date the patient is seen and/or the Rx is written.
,✔✔What if the MD dates the three Rx, 5/20, but writes on Rx do not fill until 6/19/18,
and on the third do not fill until 7/19, is that legal - ✔✔Yes.
✔✔A C2 will expire how many days after issuance? - ✔✔90 Days
✔✔Max day supply for C2 - ✔✔30 days supply
✔✔is there a limit regarding the qty a doctor can write on CS Rx - ✔✔No, 30 day supply
for C2
✔✔can Mid level practitioners write for any limit of CS - ✔✔yes, for C3-C5
c2= 30 day supply only
✔✔If a drug is dropped on the ground, is it adulterated? - ✔✔yes
actual contamination is not required for a violation/adulteration
✔✔If there is a fire in the front of the store, but flames don't reach meds, can you use
them? who do you need to notify of fire? - ✔✔even if flames do not reach the pharmacy,
the heat and smoke generated could affect drugs, these drugs are adulterated. doesn't
matter if package is sealed / unsealed. no requirement to notify state or federal agency.
✔✔If you see an impaired RPH on the job, who do you notify and who would discipline
this RPH - ✔✔report the conduct to the Deparment of profession regulation. IDFPR
would discipline this guy. You can be disciplined if you don't report , based on the theory
you have aided this pharmacist in violating the law
there is so much a pharmacist could be disciplined for, so on exam- err to side of
choosing that the RPH can be disciplined
✔✔If a Pharmacy compounds a certain amy of Rx per month is there a max amount it
could compound in anticipation for next month? or do they just compound an
anticipation of that amount? - ✔✔Just compound in anticipation of receiving Rx, based
on historical # of Rx received for that product.
✔✔Is the NDC # required on all OTC products - ✔✔Yes
✔✔is the NDC # required on Rx label - ✔✔No
✔✔NDC # definition - ✔✔10 or 11 digits that are designed to identify MFR, the Drug and
the package size
, ✔✔Can a C2 Rx be postmarked within 7 days of the Emergency C2 fill rather than
receive the Rx within 7 days? and the RPH needs to contact DEA, DHS, and DASA is
not received? - ✔✔Yes, IL: the written Rx may be delivered to the RPH in person, or
mail, but if in mail, it must be postmarked within the 7 day period
same with federal
✔✔according to FDA, do you need a MFR license if you take the OTC products and
repackage them and then sell without a Rx - ✔✔Yes, unless its a hospital for its own
internal use.
if you are presented with a Rx for an OTC product, that is NOT repackaging- that is
dispensing
✔✔If both boxes (substituted and DAW) are checked for a coumadin RX, can the
generic be dispensed without talking to MD? - ✔✔Call the MD, bc even though he said
may not substitute, he is still saying subsitutue
✔✔what does "medically Necessary" on the Rx mean? - ✔✔call the MD to obtain
permission to dispense the generic, bc this is a phrase to prevent substitution in some
states, NOT ILLINOIS YET!
✔✔Is it appropriate to reopen a pharmacy after hours to fill a Rx - ✔✔If its an RPH- no
problem at all
if it is a tech or unlicensed person- that is prohibited
A tech CAN re enter the pharmacy even if its closed, but cannot fill a prescription or
even dispense a previously filled Rx in the absence of the RPH
If RPH was drinking- one drink, cannot reenter the pharmacy to refill the Rx
✔✔If a product such as insulin is frozen then thawed out, is it adulterated? - ✔✔yep
✔✔if a pharmacist consumes any amount of alcohol, can he legally be in the pharmacy
and engage in dispensing - ✔✔even one drink may cause impairment, protect the public
by saying the potentially impaired RPH is not engaged in the practice of Pharmacy
✔✔What law governs the labeling of iron that has been repackaged - ✔✔the FDA
governs labeling, but the poison prevention packaging act also regulates labeling of iron
containing products
✔✔VIPPS - ✔✔verified accredited internet pharmacy provider. this is the seal of
approval given to pharmacies that have internet presence. meets standards by the
NABP and can be trusted