Chapter 14
Prescription Drugs,
Over-the-Counter Drugs,
and Dietary Supplements
Categories of
Medicinal Products
Three categories of medicinal substances are
available for purchase:
• prescription drugs
• over-the-counter (OTC) drugs
• dietary supplements
Categories of
Medicinal Products
The U.S. Food and Drug Administration (FDA) sets
standards of safety, effectiveness, and honesty in
labeling for prescription drugs and OTC drugs.
Dietary supplements are not regulated as drugs.
Cosmetics are also regulated by the FDA.
“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"
What is a drug?
Drug: A chemical substance which, when taken into
the body, alters the structure or functioning of the
body in some way.
Problems with this definition?
…excluding those nutrients considered to be related
to normal functioning.
(whether the substance in question has been
intended to be used primarily as a way of inducing a
bodily or psychological change; p. 5)
Is toothpaste a drug?
Is deodorant a drug?
Is shampoo a drug?
Is skin moisturizer a drug?
Scents—Drugs or Not?
(does it make sense?)
Perfumes?
Room deodorizers?
Aromatherapy?
How the Regulation of Prescription and
OTC Drugs Began
No regulation prior to 1906; “snake oil” salesmen abounded
1906 Pure Food and Drug Act
ensured purity and consistency of drugs
active ingredients must be identified on label
1938 Food Drug and Cosmetic Act
ingredients in drugs and cosmetics must be proven safe
basis of modern food and drug regulations
1962 Kefauver-Harris Amendment
drug must be proven safe and effective
_________is the basis for all present-day U.S. food and
drug laws.
A. The Pure Food and Drug Act of 1906
B. The Dietary Health and Education Act of 1994
C. The Federal Food, Drug, and Cosmetic Act of 1938
D. The Kefauver-Harris Amendment of 1962
E. The Dietary Supplement Health and Education Act
of 1994
Procedures for Approving
Prescription and OTC Drugs
1. animal studies
determine safety limits and relative toxicity
2. clinical trials
a. healthy human volunteers
Phase 1: establish drug safety
b. patients
Phase 2: establish effectiveness for
therapeutic use
Phase 3: identify optimal doses and dosing
regimen; identify side effects
Marketing of drug
Patent clock begins to run
safety
therapeutic
effectiveness
LD 50,
birth defects
dosing regimen,
side effects,
usage—final tweaking
long-term toxicity
(or more)
A serious problem in the development and testing of many drugs is that interactions
with other drugs are not tested and may be unpredictable.
There may also be unanticipated long-term effects.
In Phase 1 clinical trials, __________.
A. certain pharmacological questions are answered
B. clinical samples are not involved
C. safe dosage levels are determined
D. drug effectiveness is not considered
E. all of the above
Procedures for Approving
Prescription Drugs
Very few new compounds are eventually approved by the
FDA for marketing as new prescription drugs.
The process often takes several years.
Patent clock (20 years) begins to run when Phase 1 clinical
trials begin.
drug companies must recover research costs
may introduce “new” drugs with minor differences to
obtain a new patent (e.g. time-release version)
may obtain approval to market drug OTC (e.g. Tylenol,
Benadryl, Claritin)
Table 14.2
Procedures for Approving
OTC Drugs
Since 1962, all OTC drugs have been required by
the FDA to be Generally Recognized As
Safe (GRAS)
Effective (GRAE)
Honestly Labeled (GRAHL)
Approval of OTC drugs must follow the NDA
process or, more commonly, conform to existing
drug monographs.
Table 14.3
Are FDA-Approved
Drugs Safe?
Prescription and OTC drugs are FDA-approved for
use when taken in the recommended dosages and
under the recommended circumstances, their
misuse can result in medical emergencies and
fatalities.
Prescription drug misuse, whether intentional or
unintentional (prescription errors), is a growing
public health problem as the number of available
medications increases.
There have been several recent instances of drugs
with similar names being incorrectly dispensed
Are FDA-Approved
Drugs Safe?
ER visits involving prescription drugs far fewer than
those involving illegal drugs
Prescription drugs are often the choice for suicide
attempts
Most ER visits involving prescription drugs are for
polydrug use, usually alcohol (e.g. benzodiazepines
and other depressants; OxyContin and other
opiates)
Doctor-shopping, lax medical oversight of multipleprescription users (often the elderly)
Which of the following best characterizes the FDA’s
approach to approving drugs for the market?
A. speed
B. empathy
C. caution (safety)
D. need for the drug
E. likely profitability of the drug
Major OTC Analgesic Drugs
OTC analgesic drugs
acetylsalicylic acid (aspirin),
acetaminophen (e.g. Tylenol)
ibuprofen (e.g. Advil, Motrin)
naproxen (e.g. Aleve)
Major OTC Analgesic Drugs
aspirin, ibuprofen and naproxen are antiinflammatory (non-steroidal anti-inflammatory
drugs; NSAIDs)
acetaminophen is not anti-inflammatory
aspirin and acetaminophen are both anti-pyretic
(fever-reducing)
long duration of effect makes naproxen effect for
relief of menstrual cramps
NSAIDs may interact with, and reduce the
effectiveness of, SSRI antidepressants.
Major OTC Analgesic Drugs
Hazards include:
aspirin: gastrointestinal irritation, bleeding
acetaminophen: bleeding, liver and kidney damage
especially troublesome with alcohol consumption
potentially lethal
ibuprofen: kidney damage or failure
naproxen: gastrointestinal irritation
Analgesic
Acetylsalicylic Acid
(aspirin)
Acetaminophen
(Tylenol)
Ibuprofen
(Advil, Motren)
Naproxen Sodium
(Aleve)
AntiInflammatory
Anti-pyretic
Other Major Classes
of OTC Drugs
OTC sleep aids and cough-and-cold remedies are
notable for their popularity and their potential for
misuse.
sleep aids with an active ingredient of either
diphenhydramine (e.g. Benadryl) or doxylamine
succinate (e.g. Unisom).
these antihistamines are depressants that are
typically components of “P.M.” versions of cold
medications
Other Major Classes
of OTC Drugs
OTC sleep aids and cough-and-cold remedies are notable
for their popularity and their potential for misuse.
antihistamines + alcohol additive
alcohol content increases abuse potential
pseudoephedrine used to make crystal methamphetamine
although still OTC, sales are now monitored
dextromethorphan is a continuing drug abuse
problem (so-called “robo-tripping,” after “Robitussin”)
The Pharmaceutical
Industry Today
Highly competitive market
advertising in mass media
diversification of products
protection from generics
The Pharmaceutical
Industry Today
Pressure to reduce prices
high cost of drug research
uninsured and underinsured patients
maintaining adequate supplies
problems regulating internet trafficking of prescription
medications
copycats masquerade as brand-name drug
often of foreign origin
manufacturing unsupervised
problems of accuracy and purity
What is a Dietary Supplement?
1994 Dietary Supplement Health and Education Act (DSHEA)
A dietary supplement is “a product taken by mouth that
contains a ‘dietary ingredient’ intended to supplement the
diet.
a vitamin
a mineral
an herb or other botanical
an amino acid
a dietary substance for use by man to supplement the
diet by increasing the total dietary intake (e.g., enzymes
or tissues from organs or glands)
a concentrate, metabolite, constituent or extract.
Dietary Supplements
A large number of dietary supplements are available to
the public.
Unlike OTC preparations, dietary supplements are not
evaluated by the FDA for safety or efficacy.
This lack of regulation should not be construed to tacit
approval of either their use or safety. They may or may
not be safe or effective and may interact with other
drugs.
Therefore, considerable caution should be exercised
when using them.
Which of the following is a dietary supplement?
A. an analgesic
B. a weight-loss aid
C. an herbal formula to boost testosterone
D. a cough and cold remedy
Dietary Supplements
Dietary supplements are considered foods, not drugs.
Under DSHEA, a firm is responsible for determining that
the dietary supplements it manufactures or distributes are
safe and that any representations or claims made about
them are substantiated by adequate evidence to show that
they are not false or misleading.
Pre-market review for safety data and other information is
required.
Manufacturers need to register with the FDA pursuant to
the Bioterrorism Act
Dietary Supplements
What must appear on a label of a dietary
supplement?
a descriptive name of the product stating that it is a
"supplement"
the name and place of business of the manufacturer,
packer, or distributor
a complete list of ingredients (active and inactive)
the net contents of the product
Dietary Supplements
Claims of medical benefits for supplements are often
exaggerated and are difficult to verify because wellcontrolled scientific studies of their effectiveness are
either nonexistent or incomplete.
Clearly, more scientific studies should be conducted to
evaluate these supplements.
(Why AREN’T there more studies?)
Dietary Supplements
The FDA
monitors the marketplace for illegal products (products
that may be unsafe or make false or misleading claims)
and obtains information from
inspections of dietary supplement manufacturers and
distributors
the Internet
consumer and trade complaints
occasional laboratory analyses of selected products
adverse events associated with the use of
supplements that are reported to the agency.
Dietary Supplements
A product cannot make claims to be a treatment,
prevention or cure for a specific disease or condition (only
substances classified and regulated as drugs may do that).
Manufacturers MAY make
health claims
(links between a food substance and disease or a
health-related condition)
structure/function claims
(intended benefits of using the product)
nutrient content claims
(amount of a nutrient or dietary substance in a
product)
Dietary Supplements
Disclaimers are often provided to qualify claims
“This statement has not been evaluated by the FDA. This
product is not intended to diagnose, treat, cure, or
prevent any disease”
Claims of medical benefits for supplements are often
exaggerated and are difficult to verify because wellcontrolled scientific studies of their effectiveness are
either nonexistent or incomplete.
Clearly, more scientific studies should be conducted to
evaluate these supplements.
(Why AREN’T there more studies?)
Dietary Supplements
Cautionary notes:
active chemical constituents of dietary supplements
need not be specifically identified
doses of active chemicals may vary by lot; actual dose
will therefore vary
those taking supplements may fall victim to the “more
must be better” thinking; e.g. pyridoxine (vitamin B6)
potential side effects need not be listed on the label
potential drug interactions need not be listed
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