Transcript - ISpatula

Self-Care & OTC
medications
Self-care
Self-medication
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
Characteristics of OTC
drugs:
OTC drugs 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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The Self-Care Revolution
>100,000 OTC products are
available to consumers in the US to
treat > 400 ailments.
 OTC drugs account for ~ 60% of all
the medications in the US.
 > 100 classes (therapeutic
categories) of OTC drugs
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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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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,
Patients should be
viewed as individuals
with unique backgrounds
and needs
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:
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Monitor drug therapy for:
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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
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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?
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2.
3.
Reviews 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
Food, Drug, and Cosmetic (FD&C) Act
of 1938
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The most important piece of legislation in
pharmaceutical history
Created the FDA
Required pharmaceutical manufacturers to
file a new drug application (NDA) with
each new drug before marketing
Gave FDA the power to conduct inspections
of manufacturing plants to ensure
compliance
Required only that drugs be safe for human
consumption NOT that they be effective or
useful for the purpose for which they were
sold.
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FDA Regulation of Drugs:
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1951: an amendment to the FD&C Act
established two classes of drugs:
prescription and non-prescription (OTC)
Prior to that time, manufacturers were
free to determine to which category their
drug product belonged
Drugs that could be used safely without
medical supervision/adequate labeling for
use marketed without Rx
FDA Regulation of Drugs:
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In 1962: a major amendment to
the FD&C Act required that drug
products be proven not only safe but
also effective for their intended
uses.
As a result: FDA undertook a review of the
effectiveness of the 4500 new drug products,
including the 512 OTC drugs that had been approved
for safety since 1938.
FDA Regulation of Drugs:
1972: FDA initiated a massive
scientific review of 700 active
ingredients in 300,000 OTC drug
formulations to ensure that they
were: safe & effective & bore fully
informative labeling This “OTC
Drug Review” is still underway.
 The aim of the 1972 review is to
establish OTC monographs
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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
Drug Reclassification:
Rx
OTC
(cont’d)
Selected List of reclassified
drug ingredients (USA):
Why clinicians must be
familiar with OTC products?
1.
2.
Many OTC products are effective in treating
common ailments and at less cost,
Many active ingredients contained in OTC
drugs may worsen existing medical conditions
or interact with prescription medication. E.g.
antacids bind many drugs, thus reduce absorption. Cimetidine
inhibits hepatic microsomal drug-metabolizing enzymes.
3.
Misuse or abuse of OTC products may actually
produce significant medical complications
Note:
Many of the more potent OTC ingredients are
hidden in products where their presence
would not ordinarily be expected:
Examples:
1.
Alcohol (% ethanol) in cough syrups, cold
preparations, and mouthwashes
2.
Antihistamines in analgesics, menstrual
products, sleep aids,
3.
Aspirin & other salicylates: in antidiarrheals,
cough/allregy preparations
4.
Caffeine in analgesics, menstrual products and
stimulants
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Cont’d
5. Benzocaine in antitussives/lozenges,
dermatologic preparations, hemorrhoidal
products, toothache, cold sore and teething
products
6. Sodium in analgesics, antacids and laxatives
7. Sympathomimetics in analgesics, asthma
products, cough, cold and allergy preparations,
hemorrhoidal products and sore throat products
Homework
Drug interactions with OTC (Table 13, page 12)
 Adverse effects of some inactive
ingredients (Table 1-4, page 13)
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