Download L1,2 OTC 2016

Self-Care
M. Wazaify, PhD
Fall 2016
Brain-Storming!
Self-care, Self-treatment or Selfmedication?
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Smoking cessation
Regular exercise
Healthy eating
Hot-water bottle
A hot drink to sooth a sore throat
2 tablets of paracetamol bought from the
pharmacy without a prescription
1 tablet of diazepam already available at
home
Taking antihypertensive medication
regularly to control BP
The Self-Care Revolution
 Self-care: the type of self-
intervention during which patients
are responsible for their own health
care without referral to the doctor
(Hughes et al., 2001).
Why the pharmacist?
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The community pharmacist is uniquely
qualified
The pharmacist is the most accessible
health professional and the only health
professional who receives formaluniversity-based education and
training in non-prescription drug
pharmacotherapy and is perceived very
favourably by the public.
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Pharmacist-patient interaction is vital
for optimal OTC pharmacotherapy:
big variety of product choices and
misleading marketing message
 unclear, limited and difficult-to-read
package labelling
 comorbidity
 polypharmacy
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OTC DRUGS
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OTC drug products are those drugs that are
available to consumers without a
prescription.
There are more than 80 therapeutic
categories of OTC drugs, ranging from acne
drug products to weight control drug
products.
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Characteristics
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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Health problems most likely to be
treated with OTC drugs
= minor ailments
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Headache
Common cold
Muscle aches and pains
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Dermatological conditions
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Minor wounds (e.g. cuts and scratches)
Premenstrual and menstrual symptoms
Upset stomach
Sleeping problems
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strains)
dandruff, dry skin, athlete's foot
(including sprains &
(acne, cold sores,
Initial encounter with a patient seeking
assistance with OTC drug use:
Pharmacist should:
 Assess, by interview and observation, the
patient’s physical complaint/symptoms
and medical condition
 Differentiate self-treatable conditions
from those requiring medical attention
 Advise and counsel the patient on the
proper course of action (i.e. no treatment
with drug therapy, self-treatment with
OTC products, or a referral).
If self-treatment with one or more
of OTC drugs is appropriate:
1.
2.
Assist in OTC product selection
Assess patient risk factors:
(contraindications, warnings, precautions, age, organ
function)
3.
Counsel the patient regarding proper
drug use: (e.g. dosage, administration, monitoring
parameters)
4.
Maintain a patient drug profile that
includes OTC as well as Rx drugs.
If self-treatment with one or more
of OTC drugs is appropriate:
5.
Monitor drug therapy for:
6.
Discourage the use of fraudulent and “quack”
remedies
Assess the potential of OTC drugs to mask the
symptoms of a more serious condition
Prevent delays in seeking appropriate medical
attention
7.
8.
allergies or
hypersensitivities, ADR, D-D, an appropriate response to
therapy, signs and symptoms of drug use and/or dependency
What does FDA do with
regard to OTC drugs?
1.
2.
3.
Review OTC products for safety and
effectiveness
Responsible for establishment of
regulations of OTC drugs labeling
Responsible for the reclassifying
process of OTC drugs from
prescription status
Drug Reclassification:
Classes of drugs limited to Rx:
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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:
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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.
Why Drug
Reclassification?
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Shift some of the responsibility and
cost of healthcare to consumers
Save GPs’ time for more serious
conditions
Increase patients’ empowerment
Extend the role of community
pharmacists
Selected List of reclassified
drug ingredients (USA):
Ingredient
Chlorpheniramine
maleate
Use
Antihistamine
Cimetidine
Ephedrine sulphate
Ibuprofen
Phenylpropanolamine
Miconazole
Heartburn
Bronchodilator
Analgesic
Decongestant
Antifungal
Source: Handbook of Nonprescription Drugs, APhA. Table 3, page
11, Chapter 1.
Selected agents reclassified
POM OTC (USA)
Ingredient
Year Ingredient
Year
Chlorpheniramine
1976
Clotrimazole (topical) 1989
Cimetidine
1995
Hydrocortisone
1979
Diphenhydramine
1981
Minoxidil
1996
Ibuprofen
1984
Naphazoline/antazoline
1994
Ketoprofen
1995
Permethrin
1990
Nicotine polacrilex
(gum)
1996
phenylpropanolamin
e
1981*
Omeprazole
2003
Xylometazoline
1976
Reference: Basic and Clinical Pharmacology, Katzung (2004). Chapter 64
Selected agents reclassified
POM OTC (UK)
Drug
OTC products
Year of
switch
Ibuprofen
Various (e.g.
Nurofen®)
1983
Dextromethorphan (controlled
release)
Coughcaps®
1989
Nicotine gum 2mg
Nicorette®
1991
Acyclovir
Zovirax®
1993
Cetirizine
Zirtek®
1993
Ranitidine
Zantac 75®
1994
Fluconazole (oral)
Diflucan One®
1995
Levonorgestrel
Levonelle®
2001
adapted from Blenkinsopp and Bradley (1996); Bond, (2001)
Labeling & Packaging
Issues
The need for
labeling?
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NEW
“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
Starting 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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OTC Drug Labelling
1.
2.
3.
Comprehensibility
Readability
Comprehensiveness
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
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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):
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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
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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
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The Tylenol Cyanide crisis!
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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 tamperresistant (?) 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
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e.g.
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“ 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 “tamperproof” 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.
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Tamper-evident Packaging
Examples
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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
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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
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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.
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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
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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.
Marketing Issues
 Product
Line Extensions
 Nonprescription
Advertising
Drug
(HOME WORK+ quiz)
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
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