Weitere ähnliche Inhalte Ähnlich wie Hart13 ppt ch12 (20) Hart13 ppt ch121. Chapter 12
Dietary Supplements
and Over-the-Counter
Drugs
© 2011 McGraw-Hill Higher Education. All rights reserved.
2. Dietary Supplements vs.
Drugs
Drugs and food share certain
characteristics
They contain chemicals that interact
with the body’s physiology
Drugs and food are not regulated
in the same ways
Supplements may be thought of
as drugs by consumers but are
legally classified as food products
© 2011 McGraw-Hill Higher Education. All rights reserved.
3. Dietary Supplements vs.
Drugs
Pills, capsules, liquids, and powders classified
as dietary supplements may be thought of as
drugs by consumers BUT
They are legally classified as food products
They are treated very differently by the Food and
Drug Administration (FDA)
Example of Saint John’s wort
Many people take it for its suggested ability to
improve mood, reduce anxiety, and induce sleep
Classified as a dietary supplement, it is regulated
more like a food than a drug
© 2011 McGraw-Hill Higher Education. All rights reserved.
4. Food, Drug, and Cosmetic Act
A drug is a product intended for use in the
diagnosis, cure, mitigation, treatment, or
prevention of disease
Before marketing, drugs must be shown to be
Safe when used as directed
Effective for their intended use
Food products and ingredients must be
Safe
Pure (unadulterated)
They are not required to show that they are
effective or provide any benefit
© 2011 McGraw-Hill Higher Education. All rights reserved.
5. Dietary Supplements:
Regulation
Dietary Supplement Health and
Education Act (DSHEA) of 1994
Passed in part due to pressure on
Congress from the supplement industry in
response to indications that the FDA was
planning to expand regulation of dietary
supplements
Defined supplements and set
regulations for safety and labeling
© 2011 McGraw-Hill Higher Education. All rights reserved.
6. DSHEA: Supplement Labeling
Same label format as those for packaged foods
Not as accurate or precise as drug labels
Testing has found that potency varies from bottle to
bottle and even capsule to capsule
Amounts listed on label are for a plant substance and not
the presumed active ingredient
Ingredients listed on the label may not be the actual
active ingredients in a plant or herb
Dosage guidelines are not well-established for many
supplements
There is no requirement for proof of effectiveness
© 2011 McGraw-Hill Higher Education. All rights reserved.
7. DSHEA: Defining Dietary
Supplements
DSHEA expanded the definition of supplements
to include a variety of substances:
Vitamins and minerals
Herbs and concentrates and extracts of herbs
Amino acids
Many forms:
Tablets
Capsules
Liquids
Powders
© 2011 McGraw-Hill Higher Education. All rights reserved.
8. DSHEA: Defining Supplement
Safety
FDA can declare a product to be adulterated
(unsafe) only if it presents a significant or
unreasonable risk of illness or injury
Ingredients already on the market at the time
of the Act:
Considered safe enough to be sold unless the FDA
can demonstrate a risk
New ingredients:
Need some evidence that they would not present a
significant or unreasonable risk
BUT much less evidence is required than for drugs
© 2011 McGraw-Hill Higher Education. All rights reserved.
9. Supplement Labeling:
Health Claims
FDA authorizes a small number of
health claims that food and supplement
manufacturers can use if their products
meet certain requirements
Based on available scientific research
Examples:
Adequate calcium intake and reduced risk of
osteoporosis
Soluble fiber intake and reduced risk of heart
disease
© 2011 McGraw-Hill Higher Education. All rights reserved.
10. Supplement Labeling:
Structure/Function Claims
Unapproved health claims are not
allowed, BUT
Supplement labels can make so-called
structure/function claims
Relate to the structure or functioning of the
body or to overall well-being
Examples:
Maintains cell integrity
Supports the immune system
© 2011 McGraw-Hill Higher Education. All rights reserved.
11. Supplement Labeling:
Structure/Function Claims
Not a claim to prevent or treat a disease
Not reviewed by the FDA
Must carry a disclaimer:
This statement has not been evaluated
by the Food and Drug Administration.
This product is not intended to diagnose,
treat, cure, or prevent any disease.
© 2011 McGraw-Hill Higher Education. All rights reserved.
13. Pros and Cons of Current
Supplement Regulations
Pro: Many more supplements on the market
Consumers have more options
Con: Much less research available about safety and
effectiveness of supplements
Con: Supplements remain on the market unless or
until the FDA presents clear evidence of risk
Example: Ephedra, a stimulant taken by people
wanting to lose weight
First evidence of safety concerns published by the FDA in
1994
With the burden of proof now with the FDA, it took 10
additional years for the FDA to compile evidence to get
ephedra off the market
© 2011 McGraw-Hill Higher Education. All rights reserved.
14. Supplements to Avoid
Definitely hazardous Likely hazardous
Aristolochic acid Bitter orange
Very likely Organ/glandular extracts
hazardous Lobelia
Comfrey
Pennyroyal oil
Androstenedione
Scullcap
Chaparral
Yohimbe
Germander
Kava
Cesium
Colloidial Siver
Graviola
© 2011 McGraw-Hill Higher Education. All rights reserved.
15. Dietary Supplement Act
Introduced by Senator John McCain in
February 2010.
Would have required all manufacturers to
register with the FDA and provide a complete
list of ingredients.
The FDA could also recall any ingredient they
found to be unsafe.
The dietary supplement industry mounted a
campaign against the regulation and McCain
withdrew the bill
© 2011 McGraw-Hill Higher Education. All rights reserved.
16. Examples of Psychoactive
Dietary Supplements
Saint John’s wort (Hypericum perforatum)
Was originally thought to prevent possession by
demons
Currently used as a potential treatment for both
anxiety and depression
Research results have been
mixed, but there is some
evidence supporting its use for
depression
It may interact with prescription
drugs, so users should notify their
physicians
© 2011 McGraw-Hill Higher Education. All rights reserved.
17. Examples of Psychoactive
Dietary Supplements
S-adenosyl-L-methionine (SAMe)
A naturally occurring substance, the active
form of amino acid methionine
Researched as a possible antidepressant
Not yet any solid evidence it is more
effective than placebo
© 2011 McGraw-Hill Higher Education. All rights reserved.
18. Examples of Psychoactive
Dietary Supplements
Ginkgo biloba
Long history of medical use in China
Active ingredients and mechanisms of action
haven’t yet been identified
Reduces blood clotting; thins blood to improve
circulation
Potentially risky if used with aspirin or other drugs
that reduce clotting
Research suggests a slight
ability to improve memory
© 2011 McGraw-Hill Higher Education. All rights reserved.
19. Dietary Supplements vs.
Drugs: Review
Supplements: no requirement for proof
of effectiveness
Disclaimer for any structure/function
claim:
“This statement has not been evaluated by
the Food and Drug Administration. This
product is not intended to diagnose, treat,
cure, or prevent any disease.”
© 2011 McGraw-Hill Higher Education. All rights reserved.
20. Over-the-Counter (OTC)
Drugs
A drug is a product intended for use in the
diagnosis, cure, mitigation, treatment, or
prevention of disease
Usage by Americans
Americans self-treat four
times as many health
problems as doctors treat,
often with OTC drugs
Americans spend over
$18 billion per year
on OTC drugs
© 2011 McGraw-Hill Higher Education. All rights reserved.
21. OTC Regulation
1962 Kefauver-Harris amendment required that all
drugs be evaluated for safety and efficacy
Active ingredients reviewed individually; three
standards considered:
1. GRAS (generally recognized as safe) means that,
given currently available information, the ingredient is
considered safe
Nothing is entirely safe
Safe = a “low incidence of adverse reactions or significant
side effects under adequate directions for use and warnings
against unsafe use as well as low potential for harm which
may result from abuse”
© 2011 McGraw-Hill Higher Education. All rights reserved.
22. OTC Regulation
2. GRAE (generally recognized as
effective) = a reasonable expectation
that the pharmacological effect of the
drug will provide clinically significant
relief of the type claimed in a
significant proportion of the target
population
© 2011 McGraw-Hill Higher Education. All rights reserved.
23. OTC Labeling
3. GRAHL (generally recognized as
honestly labeled)
More than 300,000 OTC products on the
market contain fewer than 1,000 total
active ingredients now reviewed in over
80 therapeutic classes.
Those that the FDA has classified as safe and
effective
© 2011 McGraw-Hill Higher Education. All rights reserved.
24. OTC Labeling
Uniform labeling standards were adopted in 1997 to
reduce consumer confusion
Layout, headings, and
topics are consistent,
and language has been
made clearer and more
concise, with less
medical terminology
Consistent labels make
it easier for consumers
to compare products
© 2011 McGraw-Hill Higher Education. All rights reserved.
26. OTC vs. Prescription Drugs
1938 Food, Drug, and Cosmetic Act
established a classification of drugs that can
be sold only by prescription
Possible differences between OTC and
prescription drugs
Dosage: An OTC version of a drug may come in
smaller doses
Chemicals: A prescription drug may contain a
chemical not allowed for OTC sale due to
potential toxicity
© 2011 McGraw-Hill Higher Education. All rights reserved.
27. OTC vs. Prescription Drugs
FDA panels review products and may switch
drugs to OTC status
Examples of drugs switched to OTC status
include ibuprofen (analgesic), orlistat (weight-
loss), and cetirizine (antihistamine)
Should there be a class
of drugs between OTC
and prescription?
Pharmacist
recommended?
© 2011 McGraw-Hill Higher Education. All rights reserved.
28. Examples of Psychoactive
OTC Drugs
Stimulants
FDA allows stimulants to be sold to “help
restore mental alertness or wakefulness
when experiencing fatigue or drowsiness”
Only ingredient allowed by FDA in OTC
stimulants is caffeine
Combinations of caffeine and other
stimulants (e.g., ephedrine) are not allowed
© 2011 McGraw-Hill Higher Education. All rights reserved.
29. Examples of Psychoactive
OTC Drugs
Weight-control products
Phenylpropanolamine (PPA) was sold over
the counter by the late 1970s
Combinations of PPA and caffeine sold for
a brief period before being banned in 1983
Concerns over effectiveness of PPA and
the safety of recommended dosage due to
its effects on blood pressure
2000: FDA requested all companies to stop
marketing products containing PPA
© 2011 McGraw-Hill Higher Education. All rights reserved.
30. Examples of Psychoactive
OTC Drugs
Weight-control products
Additional products banned due to lack of
safety or effectiveness
Ephedrine
Benzocaine-containing candies and gums
Starch blockers
Cholecystokinin (CCK)
Currently, one FDA-approved weight-
control OTC drug: Orlistat (alli)
© 2011 McGraw-Hill Higher Education. All rights reserved.
31. Examples of Psychoactive
OTC Drugs
Sedatives and sleep aids
Early OTC sedatives and sleep aids
acetylcholine receptor blocker scopolamine +
antihistamine methapyrilene
FDA review panel eventually rejected scopolamine but
accepted methapyrilene
Later methapyrilene was found to cause cancer in rats, so
it was no longer classified as GRAS
Different antihistamines were then marketed, and
brands changed active ingredients frequently
Currently, there are no approved OTC sedatives;
OTC sleep aids contain antihistamines
© 2011 McGraw-Hill Higher Education. All rights reserved.
32. OTC Analgesics: Pain and
People
Anesthetics (“without sensibility”) reduce all types of
sensation or block consciousness completely
Analgesics (“without pain”) reduce pain selectively
without causing a loss of other sensations
Types of pain, based on place of origin
Visceral pain from nonskeletal portions of the body
Relieved by opioids
Somatic pain from muscle or bone
Relieved by aspirin and related products
About 35 percent of patients obtain pain relief from a
placebo
© 2011 McGraw-Hill Higher Education. All rights reserved.
33. OTC Analgesics:
Acetylsalicylic Acid (Aspirin)
Development
Long historical use of teas and extracts of willow
and poplar bark for pain relief
Active ingredient—salicylic acid—was identified,
synthesized, and mass-produced in the nineteenth
century
Related compound—acetylsalicylic acid—was
synthesized in 1898 by a Bayer Laboratories’
chemist; had fewer side effects
1899: Patented and released for prescription sale in the
form of a white powder
1915: Sold over the counter in tablet form
© 2011 McGraw-Hill Higher Education. All rights reserved.
34. OTC Analgesics:
Acetylsalicylic Acid (Aspirin)
Therapeutic use
1. Analgesic—effectively blocks mild-to-moderate
somatic pain
Maximum pain relief occurs in about one hour; effect
lasts for up to four hours
Especially effective for headache and musculoskeletal
pain
1. Antipyretic—reduces fever
Does not lower body temperature in someone with
normal body temperature
Causes vasodilation of peripheral blood vessels and
increased perspiration
© 2011 McGraw-Hill Higher Education. All rights reserved.
35. OTC Analgesics:
Acetylsalicylic Acid (Aspirin)
Therapeutic use
3. Anti-inflammatory—reduces swelling,
inflammation and soreness
Relatively low toxicity
Absorbed from the stomach and intestines
© 2011 McGraw-Hill Higher Education. All rights reserved.
36. OTC Analgesics:
Acetylsalicylic Acid (Aspirin)
Effects/Risks
Increases bleeding time by inhibiting blood platelet
aggregation
Can cause bleeding problems for surgical patients
May prevent heart attacks and strokes by preventing clots in
high-risk patients
Induces gastrointestinal bleeding
Reye’s syndrome—rare but serious disease
Effects can include disorientation, personality changes, lethargy,
coma, and death
CDC recommends that aspirin should not be given to anyone
under age 20 who has a suspected viral illness such as cold,
influenza, or chicken pox
Accidental poisonings and suicide attempts
© 2011 McGraw-Hill Higher Education. All rights reserved.
37. OTC Analgesics:
Acetylsalicylic Acid (Aspirin)
Mechanism of action
Prostaglandins are local-acting hormones
Released when cell membranes are injured
Mediate pain in injured areas by sensitizing
neurons to stimulation
Aspirin inhibits two forms of the
cyclooxygenase (COX) enzyme
Blocks the synthesis of pain-causing
prostaglandins
Aspirin also acts on prostaglandins involved
in heat regulation
© 2011 McGraw-Hill Higher Education. All rights reserved.
38. OTC Analgesics:
Acetaminophen
Acetaminophen is closely related to
phenacetin, a now banned pain reliever
Compared to aspirin:
As effective in analgesic and antipyretic effects
Less useful as an anti-inflammatory drug
Causes less gastric bleeding
Overuse of acetaminophen can cause serious
liver disorders
Not safer than aspirin if recommended dose is
exceeded
As of 2009, the FDA limited the maximum single
adult dose to 650 mg for OTC products
© 2011 McGraw-Hill Higher Education. All rights reserved.
39. OTC Analgesics: Ibuprofen
and Other NSAIDs
Ibuprofen is an aspirin-like analgesic and
anti-inflammatory; it also inhibits COX
enzymes
Potential side effects
Nausea and stomach pain
Liver damage (if taken in large amounts)
Class of drugs is known as nonsteroidal
anti-inflammatory drugs (NSAIDs)
Originally available by prescription, but now
also available over the counter
© 2011 McGraw-Hill Higher Education. All rights reserved.
40. OTC Cold and Allergy
Remedies
All-too-common cold
Colds are viral infections, caused by
viruses in the rhinovirus or
coronavirus families
Viruses damage or kill the cells they
attack
In the case of colds, the affected cells are
on the upper respiratory tract
Symptoms include coughing, sneezing,
and production of fluid by the mucous
membranes
© 2011 McGraw-Hill Higher Education. All rights reserved.
41. OTC Cold and Allergy
Remedies
All-too-common cold
Most cold viruses enter the body through
the nose or eyes; they are usually
transmitted via an infected person’s hands
Frequent handwashing is a good strategy
to reduce the risk of contracting a cold
© 2011 McGraw-Hill Higher Education. All rights reserved.
42. OTC Cold and Allergy
Remedies
Treatment of cold symptoms—no cure
Modern cold remedies contain three
common types of ingredients
Antihistamines for temporary relief of runny
nose and sneezing
– Of questionable benefit for cold symptoms
Nasal decongestants for temporary relief of
swollen nasal membranes
Analgesic-antipyretics for temporary relief of
aches and pains and fever reduction
© 2011 McGraw-Hill Higher Education. All rights reserved.
43. OTC Cold and Allergy
Remedies
Allergy and sinus medications
Rely mainly on antihistamines
May also include an analgesic
© 2011 McGraw-Hill Higher Education. All rights reserved.
44. Choosing an OTC Product
Most products contain one or more of only a
small number of ingredients, in different
combinations
An informed consumer can understand a large
proportion of these products by being familiar with
only a few drugs
Single ingredient medications may be
preferable to combination products
Avoid medication interactions and side effects of
drugs that are designed to treat symptoms you may
not have
© 2011 McGraw-Hill Higher Education. All rights reserved.
45. Chapter 12
Dietary Supplements
and Over-the-Counter
Drugs
© 2011 McGraw-Hill Higher Education. All rights reserved.
Hinweis der Redaktion Image source (pills): Brand X Pictures/Punchstock (Ch12_01PillsCart) Image source (ginkgo): Mitch Hrdlicka/Getty Images (Ch12_10Ginkgo) Image source: (border pills/capsules): Photodisc Collection/Getty Images (Image Ch12_04PillsCapsules2) Image source (acetaminophen): The McGraw-Hill Companies, Inc./Photo by Eric Misko, Elite Images Photography (Image Ch12_16Acetaminophen) Image source (supplement): see Chapter 3 image bank (Image Ch03_12DietarySupplement) Image source: Nancy R. Cohen/Getty Images (Image Ch12_06HerbalMedicine2) Image source: Insel/Roth, Core Concepts in Health, 10th ed. New York: McGraw-Hill (Image Ch12_07SupplementLabel) Source: Classifications/list from “Dietary Supplements,” May 2005 posting of ConsumerReports.org Image source: Spike Mafford/Getty Images (Image Ch12_08StJohnsWort1) Image source: Mitch Hrdlicka/Getty Images (Ch12_10Ginkgo) Image source: Royalty-Free/CORBIS (Image Ch12_11Drugstore) Image source: The McGraw-Hill Companies, Inc./Suzie Ross, photographer (Image Ch12_12ReadingLabel) Image source: Insel/Roth, Core Concepts in Health, 10th ed. New York: McGraw-Hill (Image Ch12_13OTCLabel) Image source: Royalty-Free/CORBIS (Image Ch12_14Pharmacist) Image source: The McGraw-Hill Companies, Inc./Elite Images (Image Ch12_15Aspirin) Image source: The McGraw-Hill Companies, Inc./Photo by Eric Misko, Elite Images Photography (Image Ch12_15Acetaminophen) Image source: The McGraw-Hill Companies, Inc./Photo by Eric Misko, Elite Images Photography (Image Ch12_17Advil) Image source: Photodisc Collection/Getty Images (Image Ch12_18Cold) Image source: McGraw-Hill Companies, Inc./Christopher Kerrigan, photographer (Image Ch12_19Handwashing) Image source: Getty Images (Image Ch12_03PillsCapsules1) Image source (pills): Brand X Pictures/Punchstock (Ch12_01PillsCart) Image source (ginkgo): Mitch Hrdlicka/Getty Images (Ch12_09Ginkgo)