United States Adopted Name Council (USAN)
Responsible for designating nonproprietary/generic names
Secretary of Human Health Services
Grants final approval for drug names
Criteria for names
Short, distinctive name, not likely to be confused w/ other existing names
Provides some indication of therapeutic / chemical class
Patent Protection
Allows for cost recovery before generics are marketed
Innovators have _________ of exclusive patent rights to the drug product
20 years
Drug Price Competition and Patent-Term Restoration Act of 1984 (aka
Waxman-Hatch Amendment)
Extended patent protections & granted easier access to approval
for generics
Must prove bioequivalence, not safety or efficacy
Do not have to wait until innovator patent expires to begin research
National Drug Code (NDC)
Required # system that identifies drug products and is used by
third-party payers for reimbursement
10-11 digit code
First 5 digits of NDC
Labeler's code" assigned by FDA
Second 4 digits of NDC
Product code" assigned by manufacturer
Last 2 digits of NDC
Package size" assigned by manufacturer
Where are NDCs published?
Red book, blue book, NDC directory
NDC numbers of discontinued products can be reassigned to another
drug after __________
5 years
Good Manufacturing Practice (GMP)
Set regulations that specify the minimum standards required to
manufacture pharmaceuticals in the US
Designed to assure safety and quality
T/F: GMP compliance is mandatory and a responsibility of the pharmacy
False, it is a responsibility of the manufacturer
How often are manufacturing facilities inspected by the FDA?
Every 2 years
T/F: Manufacturing and production process are included as part of the
IND process.
False, they are part of the NDA process
T/F: Manufacturers must be registered w/ the FDA
TRUE
Bad Ad Program
Designed to educate healthcare providers about misleading/inaccurate
promotion of Rx drugs by manufacturers
Who created the Bad Ad program?
Office of Prescription Drug Promotion (OPDP)
Where does the Bad Ad program solicit help from?
Healthcare providers
Adulteration
Involves composition of the product
Mislabeling
Involves labeling of the product
Label
Written, printed, or graphics appearing on the immediate container of
the drug product
Labeling
Info printed on the label and outside package of drug product (i.e.
package insert)
Info printed by pharmacy on the Rx label for a drug being dispensed
Durham-Humphrey Amendment of 1951
Drugs do not have to have adequate directions for use if they are
intended for dispensing by RPhs provided "Rx only" is
printed on the container label
Manufacturer labeling requirements
Name & address Name of drug Net pkg
qnty Weight of AI in each dosage unit Rx only
Route of administration Storage requirements
Control/lot # Exp date
Considered GMP to list _______________
Inactive adjuvants
T/F: Fragrances and flavors may be listed by common names due to
complexity of ingredients
TRUE
T/F: additives are listed alphabetically alongside active ingredients
False, they must be listed separately from active ingredients
Special Label requirements for Salicylates
Reye's Syndrome
Package Insert Requirements
Description of drug Clinical pharmacology
Indications and usage Contraindications
Warnings Precautions ARs Potential for
abuse/dependence Sympotoms & trtmt for OD Dosage
and admin date of most recent revision of labeling
Recommended/usual dosage
Category A
Adequate, well-controlled studies in pregnant women have not
demonstrated a risk to the fetus
Category B
Animal students failed to demonstrate fetal risk. No adequate
well-controlled studies in pregnant women
Category C
Animal studies have shown adverse effects on the fetus or no studies
have been conducted. No well-controlled studies in pregnant women
Use only if the benefit MAY
outweigh risk
Category D
Positive evidence of fetal risk exists based on investigational or
marketing experience in humans. Potential benefits from the drug might
be acceptable despite the potential risks
Use only if benefit MAY
outweigh POTENTIAL risk
Category X
Animal or human studies have demonstrated fetal risk, and the risk in
pregnant women clearly outweighs any benefit
Do NOT use. Risk outweighs benefit
New" pregnancy warning system
Uses 3 detailed subsections that must be used to describe risks.
Pregnancy" subsection of new pregnancy warning system
Include dosing Potential risk to fetus
Whether or not a registry exists that collects and maintains
data on drug's use in pregnancy
Lactation" subsection of new pregnancy warning system
Amount of drug in breastmilk and potential side effects on the child
Females and Males of reproductive potential" subsection of
new pregnancy warning system
Pregnancy testing, contraception, and infertility as related to the drug
Black Boxed warning
Required when the use of a drug may lead to death/serious injury
How many Rx drugs currently contain black box warnings?
450-500
When did the FDA start requiring info for the patient (patient
package insert) to accompany all oral contraceptives?
1970 -- Increased popularity of oral contraceptives & relative
unawareness by women of the drugs' potential serious side effects
1996 - Medication Guides (MedGuide) must be distributed when:
Pt labeling could prevent serious adverse effects
Product has serious risks relative to its benefits which the pt
should be aware of Pt adherence to directions is crucial to
drug's effectiveness
Risk Evaluation and Mitigation Strategies (REMS)
Intent is to manage known/potential serious risks of a drug
What did the Food and Drug Administration Amendments Act of 2007 give
the FDA the authority to require from manufacturers?
Evaluation and Mitigation Strategy
Five Levels of Risk Mitigation
Professional Label and package insert REMS -
Medication guide REMS - Communication plan
Elements to assure safe use (ETASU) Implementation
system
Who requires solid oral dosage forms (Rx and OTC) to be imprinted?
Code of Federal Regulations (CFR)
Imprint must permit identification of _________________ and __________________.
Manufacturer; specific drug product
Unit-dose packaging labeling requirements
Established drug name qnty of AI in each unit
Name of manufacturer, packer, or distributer exp
date lot/control # any required compendia
statements
Expiration Date
Established by manufacturer's extensive stability testing
Min acceptable potency level is 90%
Beyond-Use Date (BUD)
Date after which drug should not be used
Must not exceed manufacturer's expiration date
What should you consider when calculating BUD?
Nature of drug product Container used for packaging by
manufacturer characteristics of dispensing container
Expected storage conditions
BUD for unit-dose drug products
25% of the time remaining on the original manufacturer�s package or
12 months�whichever is less
BUD for multi-unit containers
should NOT exceed manufacturer�s expiration date or 1 year from the
date dispensed�whichever is less
Bar coding
Intended to reduce medication errors manufacturers
required to do this to all drug products must contain
drug's NDC Considered part of drug's labeling and is
subject to GMP
Customized Patient Med Packs
Contain several solid, oral dosage forms with directions that
indicate day and time to be taken
Labeling for Customized Patient Med packs requires what?
All unit dose info plus:
serial # for package serial # for each drug
product
BUD for customized patient med packs should not exceed ___________
from preparation date.
60 days
MedWatch
FDA maintained, voluntary adverse event and product defect reporting system
What is MedWatch intended to do?
Educate healthcare providers on importance of being aware of ,
monitoring for, and reporting adverse events Ensure safety
info is rapidly communicated
What are the four MedWatch Goals?
Increase awareness of drug and device disease Clarify
what should/should not be reported Simplify problem
reporting by operating on one system Provide regular
feedback to healthcare providers about safety issues
MedMARx
Developed by USP
Hospitals anonymously report and track medication error data
Who are health care facilities required to report medical device
problems to?
FDA and Product manufacturer
Where are vaccine problems reported to?
FDA/CDC Vaccine Adverse Event Reporting System (VAERS)
Where are veterinary product problems reported to?
FDC's Center for Veterinary medicine
Drug Recalls
Issued when a marketed drug product exhibits problems
Who can order a drug recall?
FDA or manufacturer
Drug Recall Class I
Reasonable probability the product will cause serious adverse health consequences/death
Drug Recall Class II
Product may cause temporary/medically reversible health consequences,
but probability of adverse consequence is remote.
Drug Recall Class III
Product is not likely to cause adverse health consequences