OSU Guide Flashcards
Define counterfeit drug
A drug whose container or label bears trademark, trade name or other identifying mark, imprint or device, likeness…
Without legal authorization
What are the official compendia of the US?
United States Pharmacopoeia/ National Formulary (USP/NF)
•
Homeopathic Pharmacopoeia of the United States
What two types of products can the FDA remove from the market?
adulterated or misbranded
Define “adulterated drugs”
If it consists in whole or in part of any filthy, putrid or decomposed substance
•
If it has been prepared, packed or held under unsanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health
•
***If the strength differs, or quality or purity fall below label standards
In order for a pharmacy to compound for resale pharmacies, they must first register as …
an oursourcing facility (via FDA) In order to do so they must... – Must comply with CGMP requirements – Will be inspected by FDA according to a risk-based schedule – Must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound.
T/F a drug is considered misbranded if it does not comply with GMP
false, it is considered adulterated
T/F pharmacies are not subject to GMP unless they are an outsourcing facility
true
Define misbranded drugs
Its labeling is false or misleading
•
The label fails to contain the name and address of the manufacturer, packer, or distributor and an accurate statement of the quantity;
•
Any required wording is not prominently displayed as compared with other wording, or is not clearly stated;
•
Its label does not bear adequate directions for use including warnings against use in certain pathological conditions or by children where its use may be dangerous in health or against unsafe dosage, or methods, or duration of administration or application;
•
The drug’s generic name is not prominently printed in type at least half as large as that used for any proprietary name.
Compare label and labeling
Label: Display of written material on the product’s container and on the outside container or wrapper, if any.
•
Labeling: All labels and other written, printed, or graphic matter on any container or wrapper or material accompanying the product (package insert, advertising)
black boxed warnings are found on the…
labeling usually, specifically package insert
FDA can demand addition to label
What are 4 examples of REMS measures?
med guides (package inserts as well)
communication to healthcare professionals
elements to assure safe use
provider/pt/pharmacy registery
What are 6 organizations that can be used to report med errors/ADRs?
Drug Quality Reporting System (FDA) • MedWatch (FDA) • Vaccine Adverse Event Reporting System (FDA) • MEDMARx (USP) • Institute for Safe Medication Practices (ISMP) • Oregon Patient Safety Commission
What is required for a pharmacy to compound for an in-state pharmacy or for office use?
shared pharmacy services agreement, if not it is considered manufacturing
If a drug is sold that is not approved in the US, it is considered…
manufacturing
Define the following orange book terms AA AB AT BC BT BX B*
AA - no bioequivalence problems • AT - topical - no problems • AB - drugs meeting necessary bioequivalence requirements • BC - Extended release with problems • BT - Topical with problems • BX - insufficient data • B* - No determination will be made until other questions answered
Some drugs may be exempt from safety caps such as …. under …..
NTG, OC’s, unit dose, OTC meds
under poison prevention packaging act
Who may request non safety caps and under what circumstances?
MD or patient
must sign waiver 1st
T/F OBRA 90 requires pharmacists to only provide counseling to medicare recipients
false, requires DUR and counseling
States have broadened this to apply to all patients
What schedule is vimpat?
V
what schedule is pregabalin?
V
Oregon requires a CS inventory to conducted…. and stored….
CSA require a CS inventory every ….
Oregon = 1 year, store for 3 yrs CSA = 2 yr
In which setting is a perpetual CS inventory required?
LTCF and institutional
According to Oregon, a CS inventory is to be taken on what date?
PIC choice, but must be the same every year
What counts as an inventory of CS’ received?
III-V = invoices II = DEA 222 (back) or CSOS reports
For each item in the 222 form, what is required? (5)
drug name dosage form strength qty number of containers
T/F 222 forms require NDC of the ordered items
false
T/F if using CSOS, a company can share CII ordering systems
false, each location needs its own system
DEA 41
returned items to DEA
How should hospitals, LTCF and clinics dipsose of controls?
witnessed and documented destruction (unrecoverable) and retained for 3 yrs
What practitioners are registered w/ the state and DEA in OR?
MD, DO, DVM (vets), DDS (doc of dental surg), NP, PA, ND (neuropathic doc)
How long do practitioners have to present a copy of an emergency Rx?
7d
T/F there is a limit to the qty of CIII a patient can receive on a single Rx
false, there is only a refill and time limit
T/F a pharmacist can change the date of issue on a post dated Rx
true, after consulting prescriber (anything but pt name, drug and doc’s signature)
T/F when transferring from pharmacy to pharmacy in w/ a real time system, the sending pharmacy must invalidate the physical Rx
false, not defined as a transfer, but the system needs to track that one is invalid
Under what circumstances are CII Rx’s considered originals?
home infusion/IV pain meds
LTCF (if filed and delivered by pharmacy)
hospice patients
T/F to mail drugs, the courier must be registered w/ DEA
false
How to validate a DEA
1st letter is meaningless 2nd letter is practitioner's name 1st + 3rd + 5th digit + 2 x (2nd + 4th + 6th) = a number who's second digit is the 7th digit SO AS 1234563 1+3+5 =9 2x(2+4+6) = 24 9+24=33, 3 is the 2nd digit which matches the 7th
What is the difference to ORS and OAR?
ORS= statutes, big picture regarding practice and drug distribution OAR = board of pharmacy rules, makes ORS more specific to practice, may not follow anything not allowed in ORS
Members of the oregon BoP are appointed by ….. with a ….. term limit
governor and approved by the senate
undefined term limit (no limit)
Who may the board require fingerprints of?
(1) Applying for a license or certificate that is issued by the board;
(2) Applying for renewal of a license or certificate that is issued by the board; or
(3) Under investigation by the board.
Drug outlets must register with the board at least….
annually
T/F a store that sells nonprescription drugs must register with the board
true (within reason) as a nonprescription drug outlet
The original record of every prescription filled by a pharmacy must be kept on file for _______ at the pharmacy or as specified by State Board of Pharmacy rule.
3 years
Under what circumstances can you substitute a biosimilar product
The biosimilar product has been determined by the United States Food and Drug Administration to be interchangeable with the prescribed biological product;
–
The prescribing practitioner has not designated on the prescription that substitution is prohibited;
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The patient for whom the biological product is prescribed is informed of the substitution prior to dispensing the biosimilar product;
–
The pharmacy or pharmacist provides written, electronic or telephonic notification of the substitution to the prescribing practitioner or the prescribing practitioner’s staff within three business days of dispensing the biosimilar product; and
–
The pharmacy or pharmacist retains a record of the substitution for a period of not less than three years.
Minimum age for immunizations in oregon?
age 7 (changed in 2013) (minimum of 3 if public health iemergency)
Age limit for patients the pharamacist can prescribe OCs to?
at least 18 y old
OR
18 w/ evidence of a previous OC Rx
Under what circumstances can you fill an out of state Rx?
you believe it was a valid pt practitioner relationship
AND
it is authentic
If not prescriber is not known to pharmacist, pharmacist must obtain proof of reasonable validity of the Rx
THC (delta-9-tetrahydocannabinol) is schedule…
II (from federal CI) in oregon
Same w/ marijuana
How often must the following renew their license?
pharmacist
technician
preceptor
all 2 years
T/F certified pharmacy technicians must maintain the national certification
false
The PIC must work a minimum of _______ hours/week
20 at the pharmacy
T/F you can refuse to release a Rx if the patient refuses counseling
true, if judged a risk if counseling is not completed
Who may accept a patient’s request not to be counseled?
only a pharmacist or intern (illegal to have anyone else do it)
What 3 conditions specifically require the offer of counseling under all circumstances?
new Rx to the pharmacy
change in strength/directions
hospital discharge
T/F a pharmacy registered as an institutional pharmacy may not retain registration as a retail pharmacy
false, can do both
ON what date does pharmacy registration expire?
March 31st
t/f an institutional pharmacy requires a PIC
true
How long do you have to report the following;
significant losss
accident affecting labeling
drug theft
loss = 1 day accident = immediately (same with emergency/disaster) theft = 1 day
DEA 106 and who to send it to
report of theft or loss, send 1 copy to DEA and 1 to board
When can you eliminate a physical Rx?
either after 3 year retention periord
OR
after 120 days if electronically stored image is exact (indlcuing notes) AND it is not for a CS
Minimum prescription labeling requirements (11ish)
Name, address and telephone number of the pharmacy;
•
Date;
•
Identifying number;
•
Name of patient;
•
Name of drug, strength, and quantity dispensed; when a generic name is used, the label shall also contain the name of the manufacturer or distributor;
•
Directions for use by the patient;
•
Name of practitioner;
•
Required precautionary information regarding controlled substances;
•
Such other and further accessory cautionary information as required for patient safety;
•
An expiration date after which the patient should not use the drug or medicine. Expiration dates must be the same as that on the original container unless, in the pharmacist’s professional judgement, a shorter date is warranted; and
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Any dispensed prescription medication, other than those in unit dose packaging, shall be labeled with its physical description, including any identification code that may appear on tablets and capsules
what are 2 acceptable methods of EPT patient name labeling
patient name - partner
OR
EPT partner
Who can distribute an EPT Rx?
Pt may give Rx to each unnamed partner for them to fill at a pharmacy
OR
Pt can give all Rxs to one pharmacy who then gives dispensed drugs to each unnamed partner
How long is a board of pharmacy technician license good for?
1 year (requires certification for renewal, then 2 years for certified techs)
