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- University of Toledo
- Pharmacy Practice
- Pharmacy Practice 4070
- Chicken
- Drug product availability & ID
Drug product availability & ID
Pharmacy Practice 4070 with Chicken at University of Toledo
About this deck
By: Maureen Converse
Created: 2011-10-22
Size: 39 flashcards
Views: 1
Created: 2011-10-22
Size: 39 flashcards
Views: 1
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background information: drug product availability
name of drug, correct spelling
what its used for (therapeutic use)
source of drug name (verification)
investigational or approved?
country of origin
what its used for (therapeutic use)
source of drug name (verification)
investigational or approved?
country of origin
background information: identification
physical characteristics, inscriptions
manufacturer
brand name vs generic name
foreign drug vs usa drug
therapeutic use
reason for identity
manufacturer
brand name vs generic name
foreign drug vs usa drug
therapeutic use
reason for identity
drug product availability sample questions
strengh does it come? size does it come in? doasage form? can I split it? is there a generic?what products look similar?has it been discontinued? can i get it in the US? who makes it?
drug ID sample questions
what is this pill? this looks different, what is it? what color is the __mg? does it contain a dye? does it have any __ in it? do i need a prescription for __, is __ a schedule drug?
NDC
national drug code
unique 10 digit number for human drug products
unique 10 digit number for human drug products
NDC has ___ segments
three segments- zeros often used as placeholders
1. labeler - FDA unique ID
2. product - company picks
3. package size - company picks
1. labeler - FDA unique ID
2. product - company picks
3. package size - company picks
00667 1265 10
labeler - roxanne labs
product - oxycodone with acetaminophen
500's
product - oxycodone with acetaminophen
500's
Ident-a-drug
book (2 parts)
1. codes that start with numbers
2. codes that start with letters
<> codes on opposite sides of pill
description, generic ing, strength
manufacturer name, partial NDC code (labeler and product)
1. codes that start with numbers
2. codes that start with letters
<> codes on opposite sides of pill
description, generic ing, strength
manufacturer name, partial NDC code (labeler and product)
Identa drug online
search by drug name or NDC - some have photographs
facts and comparisons online
search by drug name or NDC - some pictures
clinical pharmacology
search by drug name or NDC
lexi comp online
photographs available for some
micromedex
search by drug name or NDC
some photographs
some photographs
daily med
some product ID - photographs for some drugs
FDA approved labeling info, package inserts for drugs
FDA approved labeling info, package inserts for drugs
drug names
1. proprietary name
2. non proprietary name
2. non proprietary name
proprietary name
owned by an individual or corporation under a trademark or patent (brandname)
non-proprietary name
generic, common "active ing"
USAN
united states adopted name
generic - could be investigational or foreign (being looked into)
officially recognized
generic - could be investigational or foreign (being looked into)
officially recognized
INN
international non-proprietary name
world health organization
generic
world health organization
generic
BAN JAN
british approved
japanese accepted name
japanese accepted name
USP dictonary of USAN and international drug names
dictonary of drug names officially recognized in the US, even if not on the market
alphabetically by generic name
official pronunciation
chemical name, structure, CAS registry #, therapetuic use, manufacturer
brand name, if exists, investigatiaonal drugs may be listed
alphabetically by generic name
official pronunciation
chemical name, structure, CAS registry #, therapetuic use, manufacturer
brand name, if exists, investigatiaonal drugs may be listed
index nominum
book and in micromedex: international
ID drugs by the INN and proprietary name
chemical name, sturucture, therapeutic use and ATC code index
ID drugs by the INN and proprietary name
chemical name, sturucture, therapeutic use and ATC code index
martindales
book and part of F and C and micromedex
30 countries worldwide
2 indexes: nonproprietary and foreign proprietary name
foreign manuactures contact info
30 countries worldwide
2 indexes: nonproprietary and foreign proprietary name
foreign manuactures contact info
european drug index
22 european countries
lexi.com
canadian brandnames/forein brand names
pharmaceutical eq
FDA says they are if:
same act ing
same strength
same route of admin
same dosage form
same act ing
same strength
same route of admin
same dosage form
pharmaceutical eq can differ in
shape, scoring, release mechanisms, packaging, excipeints (coloring, flavoring, preservatives)
therapeutic eq
pharmaceutical eq + same clincial effect and safety profile when administered to patients under conditions specified in lableling
generic eq
no durg can be if listed by FDA as having proven bioequivalence problems
references to determine therapeutic eq
FDA electronic "orange book"
therapeutic eq ratings: AB ratings
search brand or active ing
can search products taken of market
therapeutic eq ratings: AB ratings
search brand or active ing
can search products taken of market
AB ratings step 1
determine category a drug has be placed into
if first letter of the code = B
the FDA at this time, consideres the drug NOT to be therapeutically eq to other products
often problem is with specific dosage forms, not active ing
often problem is with specific dosage forms, not active ing
if first letter is A
FDA considers the drug to be therapeutically eq to another
AB
actual or potential problesm = resolved
AA ANAO AP or AT
no known bioeq problems...depending on dosage form
step 2...after first letter
use the A codes to locate product
codes need to be identical (AT, AT)
codes need to be identical (AT, AT)
3 part code
if ingredient has multiple brands and multiple generics
AB1 AB1
AB2 AB2 (ER tablets, patent product..wont act the same)
AB1 AB1
AB2 AB2 (ER tablets, patent product..wont act the same)
AWP
average wholesale price
a standard reference for pricing/cost of a drug
a standard reference for pricing/cost of a drug
orphan drug
rare disease or condition - affects less than 200,000 people
About this deck
By: Maureen Converse
Created: 2011-10-22
Size: 39 flashcards
Views: 1
Created: 2011-10-22
Size: 39 flashcards
Views: 1
About StudyBlue
STUDYBLUE makes things that make you better at school.
Things like online flashcards with photos and audio.
Things like personalized quizzes and friendly reminders about when (and what) to study next.
Think of it as a digital backpack™: access to all of your study materials online and on your phone.
STUDYBLUE exists to make studying efficient and effective for every student, for free. Join us.
“Simply amazing. The flash cards are smooth, there are many different types of studying tools, and there is a great search engine. I praise you on the awesomeness.”
Dennis
Dennis