1. Prescription Drugs, Over-the-Counter Drugs, and Dietary Supplements
Chapter 14
Prescription Drugs, Over-the-Counter Drugs, and Dietary Supplements

2. Categories of Medicinal Products
Three categories of medicinal substances are available for purchase:
prescription drugs
over-the-counter (OTC) drugs
dietary supplements

3. 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"

4. 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)

5. Is toothpaste a drug?
Is deodorant a drug?
Is shampoo a drug?
Is skin moisturizer a drug?

6. Scents—Drugs or Not? (does it make sense?) Perfumes? Room deodorizers?
Aromatherapy?

7. 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

9. _________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

10. 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

11. Patent clock begins to run Marketing of drug
safety
therapeutic
effectiveness
dosing regimen,
side effects,
usage—final tweaking
LD 50,
birth defects
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.

12. 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

13. 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)

14. Table 14.2

15. 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.

16. Table 14.3

17. 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

18. 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 multiple- prescription users (often the elderly)

19. 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

20. Major OTC Analgesic Drugs
acetylsalicylic acid (aspirin),
acetaminophen (e.g. Tylenol)
ibuprofen (e.g. Advil, Motrin)
naproxen (e.g. Aleve)

21. Major OTC Analgesic Drugs
aspirin, ibuprofen and naproxen are anti- inflammatory (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.

22. 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

23. Analgesic
Anti-Inflammatory
Anti-pyretic
Acetylsalicylic Acid
(aspirin)
Acetaminophen
(Tylenol)
Ibuprofen
(Advil, Motren)
Naproxen Sodium
(Aleve)

24. 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

25. 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”)

26. The Pharmaceutical Industry Today
Highly competitive market
advertising in mass media
diversification of products
protection from generics

27. 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

28. 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.

29. 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.

30. 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

31. 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

32. 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

33. Dietary Supplements
Claims of medical benefits for supplements are often exaggerated and are difficult to verify because well- controlled 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?)

34. Dietary Supplements The FDA and obtains information from
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.

35. 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)

36. 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 well- controlled 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?)

38. 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

39. http://www. forcefactor. com/