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Over-the-counter (OTC) medications are defined as safe
and effective drugs available to use by the general
public without a doctor’s prescription (FDA).
They play an increasingly vital role in our healthcare
system and are the most prevalent means of treating the
majority of common health problems in the United
States.
There are over 80 therapeutic categories of OTC drugs
which can be grouped in 12 broad therapeutic classes.
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Durham-Humphrey Amendment of 1951
In the US, the term OTC drugs was legalized in
1951 via Durham-Humphrey Amendment.
The law distinguished between legend
(prescription) drugs and over-the-counter (OTC)
(nonprescription) drugs
It also authorized:
verbal prescriptions
prescription refills
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The benefits of over-the-counter availability
include:
Direct, rapid access to effective medicines
Wide availability
Decreased healthcare system utilization (fewer
physician visits, lower healthcare system costs)
Allowing individuals to be in charge of their own
health
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Risks associated with OTC use
Incorrect self-diagnosis delaying diagnosis and
treatment of serious illnesses (delay in seeking advice
from a healthcare professional)
Increased risk of drug-drug interactions.
Increased risk of adverse events when not used
appropriately.
Potential for misuse and abuse
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Important Definitions.
Misuse: An unintentional improper or incorrect use of a
substance by deviating from the prescriber’s directions for
reasons other than the pursuit of a psychotropic or euphoric
effect.
Intentional misuse: An exposure resulting from the
intentional improper or incorrect use of a substance for
reasons other than the pursuit of a psychotropic or euphoric
effect.
Abuse: An exposure resulting from the intentional improper
or incorrect use of a substance where the individual was likely
attempting to achieve a euphoric or psychotropic effect. The
term abuse also applies to intentional or purposeful use of a
drug for an indication NOT approved by the Prescriber for
a perceived benefit that the patient desires. 7
Therapeutic (Medication) error:
An unintentional Preventable deviation from a proper
therapeutic regimen that results in the wrong dose,
incorrect route of administration, administration to the
wrong person, or administration of the wrong substance.
Medication vs Drug (homework)
Dependence Vs Addiction. (homework)
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FDA defines drugs as follows:
A drug is a substance that exerts an action on the
structure or function of the body by chemical action or
metabolism and is intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of disease.
A new drug is defined as one that is not generally
recognized as safe and effective for the indications
proposed.
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A herb is a plant or part of a plant used for its flavor,
scent, or potential therapeutic properties. Includes
flowers, leaves, bark, fruit, seeds, stems, and roots.
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Dietary Supplements (including Herbal
Ingredients):
A dietary supplement is a product taken by mouth that
contains a "dietary ingredient" intended to supplement
the diet. Permitted ingredients of dietary supplements
include vitamins, minerals, herbs or other botanicals,
and amino acids.
Cosmetics:
Cosmetics are “articles intended to be rubbed, poured,
sprinkled, or sprayed on, introduced into, or otherwise
applied to the human body... for cleansing, beautifying,
promoting attractiveness, or altering the appearance."
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Dietary Supplement Health and Education
Act (DSHEA) of 1994
Provided definitions and guidelines on diet
supplements
manufacturers are not required to prove safety,
efficacy, or standardization to the FDA as they are with
prescription and nonprescription drugs
The FDA may only review “false claims”
advertisements and monitor safety of diet
supplements
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Adulteration
(1) If it consists in whole or in part of any filthy, putrid, or
decomposed substance.
(2) If it has been prepared, packed, or held under insanitary
conditions whereby it may have been contaminated with filth, or
whereby it may have been rendered injurious to health.
(3) If it is a drug and the methods used in, or the facilities or
controls used for, its manufacture, processing, packing, or holding
do not conform to or are not operated or administered in
conformity with current good manufacturing practice (CGMP)
(4) If it bears or contains, for purposes of coloring only, a
color additive which is unsafe.
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Misbranding
Occurs when the labeling or advertising is misleading.
The term ''label'' means a display of written, printed, or
graphic matter upon the immediate container of any
article.
The term ''immediate container'' does not include
package liners.
The term ''labeling'' means all labels and other written,
printed, or graphic matter (1) upon any article or any of
its containers or wrappers, or (2) accompanying such
article
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Generally
If a drug is mislabeled—
It is Misbranded
If drug not manufactured according to CGMPs
It is adulterated
If Drug does not conform to compendial standards
and is labeled “USP”
It is adulterated
Drugs can be both misbranded and adulterated at the
same time
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Interesting Facts!
FDA does not use the term “OTC medications,”. The
official term is OTC drugs.
Female individuals are more likely to use OTC
medications. In a 2002 survey, 87% of women reported
the use of an OTC pain medication in the past year
compared to 80% of men.
A study conducted in 2011 confirmed that OTC
medications are American’s most popular treatment
choice for common ailments such as headache,
heartburn, allergies, and colds.
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Poison Prevention Packaging Act of 1970
Passed to prevent accidental childhood poisonings
from prescription and nonprescription products
Enforced by the Consumer Product Safety
Commission
Requires most over-the-counter (OTC) and legend
drugs be packaged in child-resistant containers
cannot be opened by 80% of children under five
can be opened by 90% of adults
Older patients may request a non-child-resistant
container; other exceptions are provided for by law
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Evaluation of OTC Drugs
Over-the-counter (OTC) drugs play an increasingly vital
role in most health care systems. As with prescription
drugs, FDA Center of Drug Evaluation and Research
(CDER) oversees OTC drugs to ensure that they are
properly labeled and that their benefits outweigh their
risks.
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Characteristics of Eligibility for OTC
Approval
OTC drugs generally have these characteristics:(They
have to meet ALL of the characteristics to be eligible for
OTC approval).
Their benefits outweigh their risks
The potential for misuse and abuse is low
Consumer can use them for self-diagnosed conditions
They can be adequately labeled
Health practitioners are not needed for the safe and
Effective use of the product
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Orange Book
The FDA publishes a list of all approved drugs called,
Approved Drug Products with Therapeutic Equivalence
Evaluations, also known as the "Orange Book" because of
its orange cover. It lists marketed drug products that are
considered by the FDA to be safe and effective and provides
information on therapeutic equivalence evaluations for
approved multisource prescription drug products monthly.
The Orange Book rates drugs based on their therapeutic
equivalence. For a product to be considered therapeutically
equivalent, it must be both pharmaceutically equivalent
(i.e., the same dose, dosage form, strength), and
bioequivalent (i.e., the rate and extent of its absorption is
not significantly different than the rate and extent of
absorption of the drug with which it is to be interchanged).
What does FDA do with regard
to OTC drugs?
a) Review OTC products for safety and effectiveness
b) Responsible for establishment of regulations of OTC
drugs labeling
c) Responsible for the reclassifying process of OTC
drugs from prescription status
Drug Reclassification:
Classes of drugs limited to Rx:
Certain habit-forming drugs listed by name;
Drugs not safe for use except under the
supervision of a licensed practitioner because of
toxicity or other potential for harmful effect, the
method of use etc;
Drugs limited to prescription under an NDA
Drug Reclassification:
Rx OTC
Reclassification Criteria:
The indication(s) for which the drug to be used on
an OTC basis should be similar to those on Rx and
must permit easy diagnosis and monitoring by the
patient.
A favourable adverse-event and drug interaction
profiles, relatively low toxicity and a low potential
for abuse.
The drug should not have properties that make it
impractical for OTC use, e.g. narrow therapeutic
index.
The need for NEW labeling?
“switch” from Rx OTC: the need for more
sophisticated self-diagnostic and self-monitoring
evaluation;
The older population is increasing in the USA
The new format helps pharmacists to readily find
information on the label and point it to the patient
OTC “Drug Facts” box
From May 2002: Most OTC medicines manufactured
after this date carried the new Drug Facts label.
However, certain products e.g. sunscreens were not
required until 2006
Many manufacturers voluntarily used the new OTC label
before the effective date
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The new Drug Facts labeling
requirements do not apply to
dietary supplements, which are
regulated as food products, and are
labeled with a Supplement Facts
panel.
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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 Extra-Strength Tylenol!
Tamper-evident Packaging
The FDA defines a 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
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
The agency stresses that “tamper-proof” OR “tamper
resistant” packaging is not possible.
A labeling statement suggesting that the package is
tamper-proof, as contrasted with tamper-resistant will
be considered false and misleading.
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. Vitamins are currently
excluded from tamper-resistant requirements because of
their classification by the FDA as a food.
OTC Drug Labelling
1. Comprehensibility
2. Readability
3. Comprehensiveness
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
Readability:
1. Provision of essential information in the same
order and area
2. Uniformity in print size, pictograms, icons,
colours, numbering, margins etc.
3. Special populations: a threshold print size of 4.5,
has been suggested as minimum, while not
optimal.
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
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
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“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
Marketing Issues
Product Line Extensions
Nonprescription Drug Advertising
(HOME WORK+ quiz)
Product Line Extensions
Reasons for 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
