◉ if there is only one managing pharmacy how many hours per day
can they be absent? Answer: 2 hours for meals.
◉ can pharmacist fill controlled substance from prescription issued
by out of state prescriber? if so what do they have to do Answer: Yes.
Record this in the computer
- name of person spoke to about rx
- date and time of convo
- date and time the patient was physcially examined by prescriber of
the controlled substance.
◉ where do we keep the refill record of controlled substance?
Answer: A record of each refill of a controlled substance prescription
must be kept on the back of the original prescription or
in a bound book or separate file."
◉ if during break a pharmacist leaves the pharmaicst what do they
have to do (2)? Answer: close and secure the pharmacy
post a sign that is visible to the public stating the time the rph will
return from meal
,◉ during meal break can pharmacy accept rx? Answer: Yes two ways
1. rx is placed by patient or agent in secure container that ensures it
can not be seen, removed or damaged
2. authorized employee accepts the rx and secure it outside of the
closed pharmacy
◉ what is the definition of "new drug"? Answer: if it is not generally
recognized as safe and effective (GRASE) by experts. only new drugs
need approval
◉ definition of adulteration Answer: occurs when
an article is contaminated or
has been held under conditions
where it might have
become contaminated.
◉ definition of misbranding Answer: occurs when
an article has labeling that is
false or misleading, or when
required disclosures have not
been made.
,◉ If dispense Rx only drug without Rx is it misbranding? Answer:
Yes
◉ How many days do FDA have to approve NDA? Answer: 180 days
◉ drug importation overseas to an individual is it okay? can we do it
for businesses?
what are circumstances Answer: overseas is illegal unless for
individuals as long as not exceed 3 months.
◉ how many days do manufacturing have to report serious ADE to
FDA? Answer: within 15 days
and follow up with invstigation within 15 days
◉ when do we give PPI for estrogen, progestin and OCs? Answer:
with each rx
◉ when do we give PPI for institutionalized patients Answer: on first
dose and then every 30 days after
◉ What does OBRA-90 do? Answer: establishes standards for
participation in MEdicaid
- prospective DUR
- retrospective DUR
, - education programs
◉ how long we have to keep medicare Rxs on paper for? electronic
total? Answer: 3 years paper, 7 years electronic
◉ can prescriber prescribe C3 for self? Answer: no, an individual
practitioner may not dispense a substance included in C2-4 for his
own personal use except in a medical emergency
◉ for emergency can prescriber can we take Cii oral prescription?
what do we have to do? Answer: Yes
◉ oral C2 orders how long they have to get actual rx Answer: 72
hours
◉ you get a CII prescription and they forgot address of patient, do
we need to add that on there if its readily available? what do we have
to do? Answer: if its available then dont add on it. just put initials
with everything we add in and for the addresses just put RA or in
files, also we have to intiitial date and time it was approved for the
addition or change.
◉ what may a pharmacist not change on a CII for the doctor?
Answer: - name of patient
- name of control substance