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)
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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
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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
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***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
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The label fails to contain the name and address of the manufacturer, packer, or distributor and an accurate statement of the quantity;
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Any required wording is not prominently displayed as compared with other wording, or is not clearly stated;
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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;
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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.
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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