When there is a conflict between Federal and State Law, which must be
chosen to follow?
The stricter law or regulation
Which laws usually correspond to authorization of prescribing
depending on the healthcare professional?
State laws
Can a legit prescriber write a script for his/herself?
Self-prescribing is acceptable in most states, but some states
prohibit self-prescribing of controls
List the reasons why a pharmacist may refuse to refill a prescription
Prescription is a suspected forgery or fictitious
Pharmacist would be violating a law if he/she fills the
prescription The drug/drug product is not in stock
The pharmacist believes the drug product may be harmful to the
patient
A prescription that has been written using the name and info of a
legitimate prescriber
Forged
Prescription that someone has prepared by creating information based
on a nonexistent prescriber
Fictitious
The MMA requires prescription records to be kept for how many years?
10
This is based upon the use of larger letters in a drug name to make
the drug name more easily distinguishable from drugs that have similar spelling:
Tall Man Lettering
This term is used to describe the dating of drug products that are
dispensed by pharmacists:
Beyond-use date
What products are exempted from the requirement of expiration dating?
Homeopathic
If a unit dose product does not have an expiration date, it would be
considered what?
Misbranded
True or False: Expiration dating for individual prescriptions being
dispensed by a pharmacist is a federal law.
False; there is no federal law concerning this type of dating.
However some states have est. their own guidelines
Since 1973 the PPPA has been under supervision of whom?
CPSC (Consumer Product Safety Commission)
All new and refilled prescriptions must be dispensed in
child-resistant containers unless:
The prescriber specifies that none is to be used The
patient indicates they do not want such a closure The drug
is being used in a hospital or similar institution being
administered by healthcare professionals
True or False: The prescriber can provide a waiver for the use of a
child-resistant container for multiple prescriptions at a time.
False; one script at a time
True or False: Patients can determine a blanket waiver for
child-resistant containers for multiple prescriptions.
TRUE
When a pharmacist refills a script, what must be replaced?
The body and closure of the plastic container
What is the exception to replacing the body and closure?
If the container body is constructed in glass
The CPSC administers testing protocols for child-resistant packaging
(CRP). These test panels consist of what two groups?
Children under 5 years Adults 50-70
A package will consider to fail the CRP if how many children can open
the package in 10 minutes?
0.2
A package must meet adult-friendly requirements to pass as well, out
of 100 adults being tested, what percent should be able to open and
close the package in 5 minutes?
0.9
After several incidents of deliberate contamination of OTC products,
Congress enacted which law?
Federal Anti-Tampering Act 1982
Essentially the Federal Anti-Tampering act required packages to have what?
Barriers to limit access (if disturbed the package will show signs of entry)
True or False: Pharmacies are not required to dispense medications in
child proof containers in a nursing home?
False; this can only be done in hospitals corresponding to inpatients
Many potentially dangerous drugs must be dispensed with what?
PPI (Patient Package Insert)
List some drugs that require a PPI
Accutane Statin drugs
Estrogen/Progestin-containing products
If prescribers dispense meds at their office are they exempt from
issuing a PPI?
NO
In 2006 the FDA revised the PPI guidelines so that a PPI must include
what major things?
Table of Contents Initial Product Approval Date
Toll-free number Internet address
The FDA released what to provide patients with comprehensive info
about drug products they've been prescribed?
MedGuides (1995)
When does the FDA require MedGuides for products?
Patient labeling could prevent serious adverse effects
the product has serious risks relative to benefits
patient adherence to directions is crucial
These ensure that the benefits of the drug outweigh the risks
REMS (Risk Evaluation and Mitigation Strategy)
REMS are associated with which law?
Food and Drug Administration Amendments Act of 2007
MedGuides are assoc. w/ which program?
REMS
In order for a substitution for a drug to occur what is required?
That the original prescribed drug and the substituted drug are
PHARMACEUTICALLY EQUIVALENT
Pharmaceutical equivalence relates to what?
Same active ingredient Same dosage form Same
route of administration Identical dosage strength or
conc.
THERAPEUTIC equivalence is used to denote drugs that are:
Pharmaceutically equivalent and bioequivalent
Drugs that meet bioequivalent standards follow what pathway?
ADME
ADME stands for what?
Absorption Distribution Metabolism
Elimination
Pharmaceutical alternatives may consist of different:
Salts Esters or complexes Dosage forms
Strengths
When the pharmacy has the right to substitute a different drug for a
prescribed drug without having to contact the prescriber is known as what?
Therapeutic substitution
Single specific name assigned to a drug by USAN
Generic name
Unique name selected by a pharmaceutical company:
Brand or Trade name
A drug product that is manufactured by a single manufacturer is known
as what?
Single Source Product
When more than one manufacturer has a drug product on the market,
this is known as:
Multisource product
Drug Bioequivalence info resource that can be used and is updated regularly
The Orange Book
List some other sources that can be used to determine specific drug products:
U.S. Pharmacopeia Dispensing Info (USP/DI) Facts and
Comparisons FDA website
Manufacturer's that want to dispense a duplicate drug that is on the
market require the submission of what to the FDA?
ANDA (Abbreviated New Drug Application)
Products that are determined to be bioquivalent to the innovator's
drug product and are thus "therapeutically equivalent" to
the brand or reference product
A" rated products
Products that aren't found to be bioequivalent to the innovators drug product:
B" rated products
Which rated products can be substituted?
A" rated
Can B products be substituted?
NO
If a product meets "necessary bioequivalence requirements"
it is classified as what?
AB
Why are some drugs not listed in The Orange Book?
They were Grand-fathered
The Electronic Orange Book uses the abbreviation RLD to indicate what?
The drug product is used as the reference standard
A Biologic License Application (BLA) which involves a full evaluation
of purity, safety, and potency.
351 (a) pathway
A Biosimilar Application which invokes an abbreviated evaluation of
purity, safety, and potency.
351 (k) pathway
One of the 1st biologic therapy created drugs was?
Humulin
The shipment of drug products to a foreign country:
Exportation
Implies a drug product is being brought into the U.S. from another
country for distribution:
Importation
Refers to a drug product that is manufactured in the U.S. with
FDA-approved labeling, shipped to a foreign country, and shipped back
to the U.S.
Reimportation
Reimportation can only be done legally by whom?
Original Manufacturer
Can pharmacists fill prescriptions that are foreign that involve
controlled medications?
No, because federal regulations require that only practitioners
licensed to practice in the U.S. may write scripts for controlled substances
A drug that is not generally recognized by qualified experts as safe
and effective for use under the conditions recommended in the drug�s labeling
New drug
Examples of a new drug:
New molecular entity Drug already approved by the FDA
with: New active ingredient New therapeutic
indication New formulation or manufacturer New
dosing schedule or route of administration New
combination of products
List the steps to the approval process:
Pre-clinical studies2 Investigational New Drug
Application Clinical Trials (Phase 1, 2, 3) New Drug
Application Post-marketing Surveillance (Phase 4)
Is FDA approval required for pre-clinical studies?
No
First application form sponsor must submit to the FDA prior to
administering the �new drug� to humans
IND Application
Is it legal to distribute a drug that hasn't been approved with an IND?
No, this is illegal
The FDA has how long to decide whether or not the investigational
drug is suitable for testing?
30 days
Used to assess the therapeutic effects and safety of a substance on
animal subjects
Pre-clinical studies
Give the examples of information that is required to be on an IND:
Drug name Composition Methods of
manufacturing and quality control Pharmacologic and
pharmacokinetic data
The Clinical trials portion of the approval process has how many phases?
3
Is intended to protect both the rights and safety of humans
IND Application
Who has the authority to terminate and IND at any time during a trial?
FDA
Investigators and sponsors are required to follow Good Laboratory Practices
Pre-clinical studies
A patient or representative must provide what in each phase?
Informed Consent
Which phase of Clinical Trials focuses on the SAFETY of medication?
Phase 1
Allows for the administration of an investigation drug to patients
not enrolled in clinical trial
Treatment IND
Which phase has hundreds of patients who actually have the disease
the drug is intended to treat?
Phase 2
Includes information collected through pre-clinical students in
addition to a complete description of methodology for human testing
IND Application
Phase of clinical trials associated with hundreds to thousands of subjects
Phase 3
Which phase of the clinical trials is used to determine the EFFICACY
of the drug and the doses associated with the efficacy?
Phase 2
Must have safety and efficacy data and be in Phase II or III clinical trial
Treatment IND
A Treatment IND can only be tested if the drug corresponds with what?
A disease that is imminent, life-threatening, no cure, or where
present drugs don't seem effective.
Applications for an NDA must include:
Full reports of investigations demonstrating drug safety and
efficacy Drug components and composition Methods of
manufacturing, processing and packaging Samples of drug and
components Any proposed labeling
Must submit treatment protocol to FDA
Treatment IND
Applications are usually thousands of pages, very costly and
time-consuming to prepare
NDA
Phase of clinical trials that has 100 or less healthy individuals
Phase 1
If an NDA is denied the applicant has an opportunity for what?
A hearing
Which phase involves meeting the FDA requirements for safety and efficacy?
Phase 3
FDA generally review application for a minimum of 6 months
NDA
If the NDA is approved it is considered "on file" which
means what?
The drug can be marketed by the manufacterer
Phase 4 involves what?
Reports of adverse events on a widespread population
What people are included in Phase 4?
All patients taking that particular drug
Prescriptions written for controlled substances must meet what requirements?
Controlled and Non-controlled
True or False: Regulations are usually more strict for a controlled substance
TRUE
Health care practitioners are licensed
from whom?
State Law
Who was broad prescriptive authority?
Physicians (DO and MD)
Who has narrow prescriptive authority?
Dentists, veterinarians, podiatrists
Who has the most narrow prescriptive authority?
Mid-level practitioners (PA,NP,OD)
A pharmacist has a right to refuse to dispense a prescription if
he/she has moral or religious opposition is known as what?
Conscientious Objection
If a pharmacist makes a conscientious objection, they cannot do what?
Obstruct a patient�s legal right to receive a lawful medication.
Once filled and dispensed, the prescription is legally owned by
Pharmacy
True or False: A copy of the prescription can be provided to a
prescriber or a patient upon request
TRUE
Even if the prescription is for a non-prescription product, the
pharmacist is bound to what on that script?
Refill(s) per the instructions indicated on the prescription
Prescription refills must be indicated by whom?
The prescriber
True or False: States may impose stricter laws regarding refills
TRUE
The FDA requires a script records be kept for how long?
5 years
The MMA requires a script records be kept for how long?
10 years
Only according to the state of GA, how long are script records to be kept?
2 years
Most states require script records be kept for how long?
2-5 years
Who adopted official standards for prescription container labeling.
USP (United States Pharmacopeia)
Prominent Placement refers to what part of the prescription label?
Top of label
What are the requirements for the prominent portion of the
prescription label?
patient name prescription serial number drug
name (full generic and trade name) strength and
clear directions for use
What are the requirements for the less prominent portion of a prescription?
information considered less critical such as expiration date and quantity
Less prominent placement refers to what part of the prescription label?
Bottom of the label
Font on a prescription label must be what?
Familiar (Times New Roman 12/ Arial 11)
True or False: Drug names can be abbreviated on a prescription label
False; must be spelled out
What should be used when adding a purpose for use on the prescription label?
Layman's terms
If a foreign patient comes into your pharmacy, the prescription label
should be in the patient's preferred what?
Language
Can the drug name be in the patient's preferred language?
No, b/c it is important for aid with emergency personnel
The pharmacy name, address, and telephone number should be placed
where from dosage instructions?
Away from
Other components of a prescription label include:
The prescriber�s name The date the prescription was
written and/or dispensed Some states require a refill date
as well Inclusion of expiration date, lot
number, and manufacturer (this decision is left to the discretion of
the individual states)
Designed to reduce medication errors by making a drug name more
easily distinguishable from drugs with similar spelling.
Tall Man Lettering
Who publishes a list of recommended �Tall Man Letters� for common
look-alike and/or sound-alike drugs.
FDA and ISMP
Dating required on manufacturer�s containers
Expiration date
True or False: The BUD may not be greater than the expiration date
TRUE
For a multi-dose container what is the required minimum BUD length on
the label?
1 year from the date the drug is dispensed
Dating of drug products that are dispensed by pharmacists
Beyond-use date
Who enforces the PPPA
Consumer Product Safety Commission (CPSC)
Enacted in 1982 following several incidents of deliberate
contamination of OTC products with poisons.
Federal Anti-Tampering Act
The Anti-Tampering Act required the product label must indicate what?
package is tamper-evident how a consumer can determine
if the package has been disturbed or tampered with
i.e. Reconstituted antibiotic medication (once water has been added
to the powder) ready to be dispensed to the patient
Beyond-use date
True or False: The legality of filling prescriptions written by
prescribers from other states is clear from a federal viewpoint.
False; it is unclear
A pharmacist must always use what to ensure the prescription is okay
to fill?
Professional Judgement
The FDA does not approve of patient's obtaining prescription drugs
from foreign countries, but appear flexible on what grounds?
Intended use of the drug is unapproved AND is for a serious
condition for which effective treatment is not available
Drug product will not be distributed to others Drug
product does not represent an unreasonable risk Patient
affirms in writing that the drug product is for the patient�s own
use, provides the name and address of the US licensed doctor
responsible for treatment, or provides evidence that the drug
product is for the continuation of treatment initiated in a foreign
country Drug product may be shipped directly to the patient,
their physician, or their pharmacy
Who prohibits the mailing of poisons and alcohol-containing products
that could be considered beverages?
USPS
i.e. Antibiotic powder for reconstitution by the pharmacist
Expiration date
The USPS has no restriction on mailing what?
Rx drugs (including controls)
Controlled substances may be mailed by the following:
Drug manufacturers or their agents Pharmacies
Other authorized handlers when distribution is lawful
Who are "other authorized handlers" that can mail
controlled substances?
Mailer or the addressee is registered with the DEA
Mailer or addressee is exempt from DEA registration as
permissible by law
Are UPS and FedEx required to follow the same rules as the USPS?
No, they make their own rules
Controlled substance USPS packaging standards:
Inner container must be packaged and labeled as required by
law Controlled substance must be placed in a plain outer
container or securely wrapped in plain paper Outside
wrapper or container is free of markings that would indicate the
nature of its contents
Internet pharmacies can only sell what?
FDA approved products
Per FDA guidelines, potentially dangerous drugs must be dispensed
with what?
PPI
Manufacturers must obtain what before distributing their MedGuides?
FDA approval
MedGuides are required for products when:
patient labeling could prevent serious adverse effects
the product has serious risks relative to benefits
Patient adherence to directions is crucial
Regulations of product substitution are determined by state or
federal law?
State law
ntended to provide a lower cost drug product in place of the drug
product prescribed
Product Substitution
In order for a substitution to occur two products must be what?
Pharmaceutically equivalent
Products that are pharmaceutically equivalent are not necessarily....
Therapeutically equivalent
What does it mean for a drug to be pharmaceutically equivalent?
Same ACTIVE ingredient Same dosage form Same
route of administration Identical strength or
concentration
Therapeutically equivalent means a drug is what?
BOTH Pharmaceutically and Bioequivalent
Bioequivalent products have the same what?
Kinetic properties (Absorption, Distribution, Metabolism, and Elimination)
In the State of GA products have to be therapeutically or
pharmaceutically equivalent?
BOTH
An innovator drug product is a.k.a what?
Brand
Bioequivalent of other drugs is a.k.a what?
Generic
What meds were grandfathered and not required in the Orange Book?
Aspirin with Codeine Levothyroxine
Codeine Morphine Digoxin
Nitroglycerin Ephedrine Phenobarbital
Epinephrine Quinine
Drugs with a relatively low difference between the minimum toxic
concentration and the minimum effective concentration.
Narrow Therapeutic Index
List some drugs with NTI
Carbamazepine Levothyroxine Tacrolimus
Cyclosporin Lithium Theophylline
Digoxin Phenytoin Warfarin
A drug product that contains the same therapeutic moiety but may
consist of different:
Salts�Esters or Complexes�Dosage Forms�Strengths
Most states do not allow substitution among what?
Pharmaceutical alternatives
A pharmacist has the �right� to substitute a different drug for the
one that was prescribed without contacting the prescriber corresponds
to what?
Therapeutic substitution
Only the drugs listed may be used corresponds to what?
Closed formulary
Allows unlisted drugs to be used relates to what?
Open-formulary
Who determines which drugs will be included in the formulary?
An institutional committee (P & T Committee)
The intent of a drug formulary is to do what?
save money reduce the need for a large medication
inventory.
Provided an abbreviated pathway for the approval of biologic products
classified as �biosimilar� to an FDA licensed biological product
The Biologics Price Competition and Innovation Act of 2009
What was the first biosimilar drug approved by the FDA?
Zarxio
True or false: biologic drugs are much more difficult to replicate
than chemically produced generics
TRUE
Biologic drugs are much more difficult to replicate than chemically
produced generics, what does this essentially mean?
Identical generics are virtually impossible to reproduce.
A retrospective review is done by whom?
DUR Board
Who are the members of a DUR board?
Pharmacists/ Prescribers
Looks at �ideal� therapy and determines if actual medication use
conforms to the ideal
Retrospective review
Reviews data concerning a patient�s medical record and/or medication
profile before dispensing a medication
Prospective Review
The goal of a prospective DUR is to find what?
Over or under utilization of drugs Therapeutic
duplication Incorrect doses or dosing regimens
How does a pharmacist offer to counsel in a prospective review?
Verbally
Federal DUR Expectations
Name of drug Route of administration and duration of
therapy Use of drug Special directions or
cautions Common adverse effects How to evaluate
effectiveness of therapy Refill information What
to do if a dose is missed
GA DUR expectations
Name and description of drug
Dosage form ,
dose, route of administration, and duration of
therapy Use of drug and expected
results
Special directions for use Techniques for
self-monitoring
Storage information Refill
information What to do if a dose is missed
Any other information the pharmacist deems necessary
How long is the drug approval process normally
10 years
FDA classifies new drugs based on what?
Chemical and Therapeutic characteristics
What usually affects how quickly a drug will move through the NDA process?
FDA Classification
Drug that's given �Priority�
Type P
Drug that is �standard� or �similar�
Type S
Drug classification for an "orphan drug�
Type O
How can a drug be type P?
major therapeutic gain no other effective drugs
available or has significant advantages compared to current
drugs
Type 1 chemical classification:
new molecular entity
Type 3 chemical classification:
new dosage form
Type 6 chemical classification:
new indication
Type 2 chemical classification:
new active ingredient
Type 5 chemical classification:
new formulation or manufacturer
Type 4: chemical classification:
new combination
Fast Track products were granted by which act?
FDA Modernization Act of 1997
Sponsor may request accelerated review if:
Is intended to treat a serious or life-threatening
condition It will fulfill an unmet medical need Is
likely to provide clinical benefit
Fast Track motivated which epidemic?
AIDS
Fast Track requires sponsors must agree to what?
conduct further post-approval studies to validate the product�s use
May be submitted when the �innovator� drug patent expires
ANDA
First applicant to complete ANDA demonstrating its generic product is
equivalent is awarded how long to market the drug?
6 months
ANDA requires less data compared to the IND and NDA, but must prove what?
Bioequivalence
The FDA Modernization ACT encouraged research for new uses of
existing drugs, so what must a manufacturer submit in order to go
about finding a drug's potential use?
SNDA
SNDA is used when a manufacturer wants to make a change a drug product�s:
Synthesis Labeling Production procedure
Dosage form or strength Manufacturing location
Therapeutic indication
Who is responsible for designating nonproprietary or generic names?
USAN
USAN is sponsored by what organizations?
AMA APhA USPC
Who grants final approval for drug names?
Secretary of Human Health Services
Criteria for naming a drug:
Short, distinctive name that is not likely to be confused with
other existing names Provides some indication of
therapeutic or chemical class
Innovators have a patent to their product for how long?
20 years
Which Act extended patent protection?
Waxman-Hatch of 1984
Does a company have to wait until innovator patent is expired to
begin basic research?
No. Waxman-Hatch allows for this
Required number system that identifies drug products and is used by
third-party payers for reimbursement
NDC
First 5 digits of an NDC=
�labeler�s code� assigned by the FDA
Next 4 digits of an NDC=
product code� assigned by the manufacturer
Last 2 digits of an NDC=
�package size� assigned by the manufacturer
Where is a drug's NDC published?
NDC Directory Red Book Blue Book
NDC numbers of discontinued products may be reassigned to another
drug product after how long?
5 years
Is a set regulations that specify the minimum standards required to
manufacture pharmaceutical products in the US
Good Manufacturing Practice (GMP)
GMP is designed to assure what?
safety and quality
Is compliance mandatory involving GMP and a manufacturer?
Yes
GMP requirements:
Manufacturers must be registered with the FDA
Manufacturing and production process included as part of the NDA
process Manufacturer facilities are inspected by the FDA
How often are manufacturer facilities inspected by the FDA?
Every 2 years
Who created the �Bad Ad Program�?
OPDP
Designed to educate healthcare providers about misleading or
inaccurate promotion of prescription drugs by manufacturers
Bad Ad Program
Products can be removed from market if they are what?
Adultered or Misbranded
Adulteration is assoc. w/ what?
Composition of the product
Misbranding is assoc. w/ what?
Labeling of the product
Manufacturing label requirements:
Name and address Name of drug Net package
quantity Weight of each active ingredient in each dosage
unit Rx only Route of administration (if not
oral) Storage requirements Control or lot
number Expiration date
Therapeutically Inactive IngredientsLabeling Requirements:
Considered GMP to list inactive adjuvants Fragrances
and flavors may be listed by common names due to complexity of
ingredients Additives listed alphabetically but separate from
active ingredients Coloring agents may be present in oral
and topical dosage forms but prohibited from ophthalmic and
parenterals Inert gases may be present in parenterals for
stability but not listed on the label
What Solicits help from healthcare providers in identifying and
reporting these activities?
Bad Ad program
Warning req. for FD&C Yellow No. 5 (tartrazine) and Sulfites
May precipitate allergies
Warning req. for Aspartame (phenylalanine)
Notice of phenylketonurics
Warning req. for Mineral Oil
Use at bedtime only; avoid use in infants and pregnancy
Warning req. for Wintergreen oil (methyl salicylate)
Products containing >5%, it is dangerous if used other than as
directed; keep out of reach of children
Warning req. for Sodium Phosphate
may not exceed 90mL per OTC container
Warning req. for Isoproterenol inhalation
Do not exceed prescribed dose; contact MD if breathing difficulty persists
Warning req. for Acetophenetidine (phenacetin)
Possible kidney damage when taken in large amount or for a long
period of time
Warning req. for Salicylates (including aspirin)
Reye�s Syndrome
Warning req. for Alcohol
Consult physician before taking if patient consumes ?3
alcoholic beverages per day Required for internal analgesic
and antipyretics Acetaminophen, aspirin, ibuprofen,
naproxen, ketoprofen, etc
Requires special label warnings for specific drugs and adjuvants
FDCA
Warning requirement for Ipecac Syrup:
Boxed statement in RED: �For emergency use to cause vomiting in
poisoning. Before using, call physician, the poison prevention
center, or hospital emergency room immediately for advice.�
Keep out of reach of children Do not use in conscious
persons involving corrosives, petroleum distillates such as
kerosene, gasoline, cleaning fluids, or for strychnine
poisoning Usual dosage is 15mL if > 1yo May only
be sold in 1 ounce (30mL) containers
Adequate, well-controlled studiesinpregnant women have not
demonstrated a risk to the fetus
Category A
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 risksUse only if benefit MAY
outweigh POTENTIAL risk
Category D
Animal studies have shown adverse effects on the fetus or no studies
have been conducted. No well-controlled studies in pregnant womenUse
only if the benefit MAY outweigh risk
Category C
Animal students failed to demonstrate fetal risk. No adequate
well-controlled studies in pregnant women
Category B
Animal or human studies have demonstrated fetal risk, and the risk in
pregnant women clearly outweighs any benefitDo NOT use. Risk outweighs benefit.
Category X
Warning when the use of a drug may lead to death or serious injury
Black-box warning
How many Rx drugs contain black-box warnings
450-500
FDA required information for the patient (Patient Package
Insert...PPI) accompany all oral contraceptives when?
1970
When were MedGuides est.
1996
Medication Guides (MedGuide) must be distributed when dispensing a
drug if one or more of the following exist:
Patient labeling could prevent serious adverse effects
Product has serious risks relative to its benefits which the
patient should be aware of to decide whether or not use the
drug Patient adherence to directions is crucial to the drug�s
effectiveness
Five levels of risk mitigation
Professional label and package insert REMS �
Medication guide (MedGuide) REMS � Communication plan
Elements to Assure Safe use (ETASU) Implementation
System
Prescriber, patient, and pharmacy must be enrolled in which REMS programs?
Thalomid (STEPS) Rosiglitazone Isotretinoin
(iPledge) Clozaril National Registry
Oxycontin REMS Educational Program requires who to be enrolled?
Prescriber
Who requires solid oral dosage forms (Rx and OTC) to be imprinted
Code of Federal Regulations (CFR)
Unit-dose labeling requirements:
Established drug name Quantity of active ingredient in
each unit Name of manufacturer, packer, or distributor
Expiration date Lot or control number Any
required compendia statements
Minimum acceptable potency level is typically considered what?
0.9
Things to consider when calculating BUD:
Nature of the drug product Container used for
packaging by manufacturer Characteristics of dispensing
container Expected storage conditions
FDA guidelines for BUD corresponding to time is what?
25% of the time remaining on the original manufacturer�s package or
12 months...whichever is less
Manufacturers are required to bar code all drug products supplied to who?
Hospitals
Are hospitals forced to utilize bar codes?
No
Barcodes must contain what?
Drug's NDC
True or false: A bar code is considered part of the prescription label?
TRUE
BUD should NOT exceed how many days from preparation date
60
Contains several solid, oral dosage forms and directions indicate day
and time to be taken
MedPacks
Labeling for MedPacks requires all unit dose information PLUS:
Serial # for package Serial # for each drug
product
FDA maintained, voluntary adverse event and product defect reporting system
MedWATCH
MedWatch is intended to:
Educate healthcare providers on the importance of being aware
of, monitoring for, and reporting adverse events Ensure
safety information is rapidly communicated
MedWatch goals are to:
Increase awareness of drug and device disease Clarify
what should and should not be reported Simplify problem
reporting by operating one system Provide regular feedback
to healthcare providers about safety issues
MedMARx is developed by whom?
USP
Health care facilities are required to report suspected medical
device related deaths to who?
FDA Manufacturer
Vaccine problems are reported to whom?
FDA/CDC Vaccine Adverse Event Reporting System (VAERS)
Hospitals anonymously report and track medication error data
MedMARx
Veterinary problems are reported where?
FDA�s Center for Veterinary Medicine
Issued when a marketed drug product exhibits problems
Drug recall
Drug recalls can be ordered by whom?
FDA or initiated by the manufacturer
Which recall class shows the product is not likely to cause adverse
health consequences
Class III
Which recall class shows reasonable probability the product will
cause serious, adverse health consequences or death
Class I
Which recall class shows that the product may cause temporary or
medically reversible health consequences, but probability of serious
adverse consequence is remote
Class II
Manufacturer notifies seller of recall how?
Notice may be letter, phone, sales rep, etc.
Who is responsible for contacting the patient when a recall occurs?
Drug seller
What allows for pharmacy compounding?
FDA Compliance Policy Guide of 1992
FDA Compliance Policy Guide of 1992 did what?
Provided limits related to the type, quantity and distribution
of products that could be compounded Provided regulations
related to ingredients that could be used Restricted
advertising
Stated compounding pharmacies are not manufacturers, and therefore
are exempt from FDA regulation
FDA Modernization Act of 1997
Stated that it is unconstitutional for FDA to restrict pharmacists
from advertising products solely because the products were compounded
US Supreme Court Ruling 2002
FDA Compliance Policy Guide of 2002:
Drafted in response to the US Supreme Court decision
FDA believe an increasing number of pharmacies were engaging in
activities outside of traditional pharmacy compounding FDA
would defer to state authorities for minor violations, but would
consider direct enforcement for significant violations
Wedgewood Village Pharmacy Inc. v. US
FDA obtained a warrant to inspect Wedgewood Village Pharmacy
for compounding �copies� of commercially available products and
using commercial-scale equipment Motion filed by pharmacy
to halt inspection, Court ruled FDA could conduct general inspection
but prohibited inspection of records unless inspection revealed
manufacturing
Warning Letters 2008
Warning letters sent by FDA to certain pharmacies compounding
hormone replacement products Stated claims about safety and
efficacy of products was supported and considered false /
misleading FDA warned against compounding products containing
estriol. Estriol is not FDA approved.
BUD compound guidelines for Non-aqueous liquid and solids:
?25% of the time remaining on the commercial product or a maximum of
6 months, whichever is less
BUD compound guidelines for Aqueous solutions made from commercially
obtained solids
14 days when stored at cold temperature
BUD compound guidelines for All other drugs:
Duration of therapy, not to exceed 30 days
What guides compounding of �home-use sterile drug products� (HSD�s)?
USP/NF 797
Compounding must occur in a defined environment to assure what?
Sterility and safety
Uses commercially available sterile products in a �closed system�
Low-risk
Pooling sterile products for subsequent transfers; preparing infusion
for multi-day use (also referred to as medium risk)
Category I (High risk)
Involves more complex skills and are classified into two categories
High-risk
Transfer solution from commercial vial with needle/syringe is an
example of:
Low-risk
Uses non-sterile drug products; uses an �open-system�
Category II (High Risk)
Greatest risk of contamination; final product is sterilized by compounder
Category II of High-risk