Transcript package as - iSpatula Pharmacy

Labeling &
Packaging Issues
OTC Drug Labelling
Comprehensibility:
FDA regulations require that OTC drug
labelling contain terms likely to be read
and understood by the average
consumer
 Counselling consumers on how to interpret
product labels properly

OTC Drug Labelling
Readability:
1.
2.
3.
Provision of essential information in the same
order and area
Uniformity in print size, pictograms, icons,
colours, numbering, margins etc.
Special populations: a threshold print size of
4.5, has been suggested as minimum,while not
optimal.
OTC Drug Labelling
Essential Information (In order):
1.
2.
3.
4.
5.
6.
The product’s active ingredients including amounts
Purpose of the active ingredient
The uses (indications) for the drug
Specific warnings including when the product should not
be used under any circumstances, and when it is
appropriate to consult with a doctor or pharmacist. The
warnings section also describes side effects that could
occur and substances or activities to avoid.
Dosage instructions: when, how and how often
The product inactive ingredients
Limitations of package labelling:
A package label can never address the
infinite management issues associated
with drug use,particularly in the
comorbidity or polypharmacy. Thus,
package labelling should acknowledge
and encourage dialogue with health
professionals (pharmacist, doctor).
Expiration Date Labeling
1
Expiration Date: is the date beyond which
the product should not be used because
the stability, potency, strength, or quality
may have been affected over time
 FDA regulations govern how this date is
determined and tested
 Most OTC products are required to
include an expiration date on the labeling


OTC drug products that do not have a
dosage limit and are stable for at least 3
years are exempt from the requirement to
include the expiration date on the label
e.g. topical drugs, skin protectants, lotions,
and astringents
“Can I use it if expired?”
Safety: Rarely does a safety issue arise
 Effectiveness: You should advise
patients that the product probably has
lost some of its ability to work as
effectively as possible of the particular
symptom or medical problem and it
should be discarded

!
!
The Tylenol Cyanide crisis!

In 1982, Johnson and Johnson
experienced a major crisis when it
discovered that numerous bottles of its
Extra-Strength Tylenol capsules had been
laced with cyanide. By the end of this
major crisis, seven people had passed
away from the use of the laced ExtraStrength Tylenol!
Tamper-evident Packaging
 The
FDA defines a tamper-evident
rather than tamper-resistant (?)
package as:
“one having an indicator or barrier to entry
which, if breached or missing, can
reasonably be expected to provide visible
evidence to consumers that tampering has
occurred”
Tamper-evident Packaging



Tamper-resistant packaging may involve
immediate container/closure systems or
secondary container carton systems.
The OTC drug products that are covered by
these regulations include oral, nasal, otic,
ophthalmic, rectal, and vaginal drug products.
Cosmetic products covered include liquid oral
hygiene products (mouthwash), and vaginal
products.
Tamper-evident Packaging
OTC drug products must have one or
more barriers to entry that, if breached or
missing from package, provide consumers
with evidence that tampering may have
occurred
 Packages must have unique designs or
characteristics that can not be duplicated
 A statement that alerts consumers to this
tamper-evident feature

e.g.

“ For your protection, this bottle has an
imprinted seal around the neck”
You should encourage patients to look for
tamper-evident features and if missing or
breached to return the product to the
pharmacy or store.
Tamper-evident Packaging
Examples

Examples of acceptable packaging include but
are not limited to:
Film Wrappers-The film is wrapped around the
entire product and must be cut or torn to open the
package.
 Blister or strip packs-The individual
compartment must be torn or broken to obtain the
product.
 Bubble packs-The product and container is sealed
in plastic and mounted in or on a display card. The
plastic must be torn or broken to remove the
package
Tamper-evident Packaging
Examples


Heat Shrink bands or wrappers-The bands, applied at
the juncture of the cap and the container, must be torn
or broken to open the package. Cellulose wet shrink
seals are not considered an effective tamper-resistant
mechanism.
Foil, paper or plastic pouches-The product is
enclosed in an individual pouch that must be torn or
broken to obtain the product.
Tamper-evident Packaging
Examples

Bottle seals-Paper, foil or thermal plastic is sealed
to the mouth of a container under the cap. The seal
must be torn or broken to remove the product. Bottle
seals applied with a pressure sensitive adhesive are
no longer considered an effective tamper-resistant
mechanism.

Breakable caps-The container is sealed by a plastic or
metal cap that either breaks away completely when
removed from the container or leaves part of the cap
attached to the container. The cap must be broken to
open the container.
Tamper-evident Packaging
Examples




Sealed tubes-The mouth of a tube is sealed and the
seal must be punctured to obtain the product.
Aerosol containers -Aerosol containers are inherently
tamper-resistant.
All Metal and Composite Cans-The container cannot
be pulled apart without visible evidence of entry.
Note: Barriers made from readily obtainable material
such as plain tape, saran wrap, aluminum foil, etc. must
be printed to distinguish themselves from a substitute
available from a retail product. A generic "Sealed for your
protection" print is acceptable. Vitamins are currently
excluded from tamper-resistant requirements because of
their classification by the FDA as a food.
Marketing Issues
 Product
Line Extensions
Product Line Extensions
To capitalize on the loyalty created by
consumer recognition and trust of a brand
name
 New doses, formulations, combinations of
ingredients or even a totally different
therapeutic entity (e.g. device) of a brand
name product that has been originally
marketed as single ingredient at a specific
dose to treat specific symptom

Nonprescription Drug Advertising



Federal Trade Commission (FTC) is
responsible for matters involving claims made
in advertisements for OTC drug products
FDA handles matters involving labeling NOT
advertisements of OTC drugs
1970: FTC Act amended to prohibit advertisers
from using language to describe the therapeutic
benefits of an OTC drug product that differs
from language approved by FDA for use in
labeling of the product
Nonprescription Drug Advertising
FTC Requirements:
 Advertising must be truthful and nondeceptive
 Back up claims with competent and
reliable scientific evidence, including tests,
studies or other objective data
 1973: National Association of
Broadcasters and the Consumer
Healthcare Products guidelines for TV
advertising- updated periodically
TV advertising guidelines for
OTC products
1
Advertisement should:
 Comply with all relevant applicable laws
and regulation
 Urge the consumer to read and follow
label directions
 Contain no claims of product effectiveness
unsupported by clinical or other scientific
evidence, responsible medical opinion or
experience through use
TV advertising guidelines for
OTC products

3
Present no negative or unfair reflections
about competing nonprescription drug
products, unless those reflections can be
supported scientifically, and presented in a
manner so consumers can perceive
differences in the uses.
Dietary Supplements



Are not regulated as “drugs” under the FD& C
Act cause they are not intended to diagnose,
cure or treat a medical disease or condition;
Consequently, they do not follow the Drug
Facts format
They are not regulated by the FDA or any
other state or federal governmental agency,as
stringently as prescription or
OTC drugs
Dietary Supplements

Dietary supplements are regulated under
the federal Dietary Supplement Health and
Education Act of 1994 (DSHEA)