Chapter 12    Dietary Supplements    and Over-the-Counter           Drugs© 2011 McGraw-Hill Higher Education. All rights r...
Dietary Supplements vs.                                                   Drugs               Drugs and food share certai...
Dietary Supplements vs.                                                   Drugs            Pills, capsules, liquids, and ...
Food, Drug, and Cosmetic Act            A drug is a product intended for use in the                   diagnosis, cure, mi...
Dietary Supplements:                                                      Regulation            Dietary Supplement Health...
DSHEA: Supplement Labeling         Same label format as those for packaged foods         Not as accurate or precise as d...
DSHEA: Defining Dietary                                             Supplements       DSHEA expanded the definition of su...
DSHEA: Defining Supplement                                      Safety            FDA can declare a product to be adulter...
Supplement Labeling:                                                  Health Claims            FDA authorizes a small num...
Supplement Labeling:                                      Structure/Function Claims            Unapproved health claims a...
Supplement Labeling:                                      Structure/Function Claims                      Not a claim to p...
Supplement Labeling© 2011 McGraw-Hill Higher Education. All rights reserved.
Pros and Cons of Current                                       Supplement Regulations            Pro: Many more supplemen...
Supplements to Avoid            Definitely hazardous                            Likely hazardous                      A...
Dietary Supplement Act            Introduced by Senator John McCain in                   February 2010.                 ...
Examples of Psychoactive                                        Dietary Supplements         Saint John’s wort (Hypericum ...
Examples of Psychoactive                                        Dietary Supplements            S-adenosyl-L-methionine (S...
Examples of Psychoactive                                        Dietary Supplements            Ginkgo biloba             ...
Dietary Supplements vs.                                               Drugs: Review            Supplements: no requiremen...
Over-the-Counter (OTC)                                                   Drugs            A drug is a product intended fo...
OTC Regulation            1962 Kefauver-Harris amendment required that all                     drugs be evaluated for saf...
OTC Regulation              2. GRAE (generally recognized as                            effective) = a reasonable expectat...
OTC Labeling           3. GRAHL (generally recognized as              honestly labeled)                      More than 30...
OTC Labeling               Uniform labeling standards were adopted in 1997 to                      reduce consumer confus...
OTC Labeling© 2011 McGraw-Hill Higher Education. All rights reserved.
OTC vs. Prescription Drugs               1938 Food, Drug, and Cosmetic Act                      established a classificat...
OTC vs. Prescription Drugs            FDA panels review products and may switch                   drugs to OTC status    ...
Examples of Psychoactive                                            OTC Drugs            Stimulants                     ...
Examples of Psychoactive                                            OTC Drugs            Weight-control products         ...
Examples of Psychoactive                                            OTC Drugs            Weight-control products         ...
Examples of Psychoactive                                            OTC Drugs            Sedatives and sleep aids        ...
OTC Analgesics: Pain and                                             People            Anesthetics (“without sensibility”...
OTC Analgesics:                                  Acetylsalicylic Acid (Aspirin)            Development                   ...
OTC Analgesics:                                  Acetylsalicylic Acid (Aspirin)         Therapeutic use                  ...
OTC Analgesics:                                  Acetylsalicylic Acid (Aspirin)         Therapeutic use                  ...
OTC Analgesics:                                  Acetylsalicylic Acid (Aspirin)            Effects/Risks                 ...
OTC Analgesics:                                  Acetylsalicylic Acid (Aspirin)            Mechanism of action           ...
OTC Analgesics:                                                            Acetaminophen              Acetaminophen is cl...
OTC Analgesics: Ibuprofen                                       and Other NSAIDs            Ibuprofen is an aspirin-like ...
OTC Cold and Allergy                                                    Remedies         All-too-common cold             ...
OTC Cold and Allergy                                                    Remedies            All-too-common cold          ...
OTC Cold and Allergy                                                    Remedies            Treatment of cold symptoms—no...
OTC Cold and Allergy                                                    Remedies            Allergy and sinus medications...
Choosing an OTC Product         Most products contain one or more of only a               small number of ingredients, in...
Chapter 12    Dietary Supplements    and Over-the-Counter           Drugs© 2011 McGraw-Hill Higher Education. All rights r...
Upcoming SlideShare
Loading in …5
×

Hart13 ppt ch12

992
-1

Published on

(c) McGraw-Hill 2011

0 Comments
3 Likes
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total Views
992
On Slideshare
0
From Embeds
0
Number of Embeds
1
Actions
Shares
0
Downloads
14
Comments
0
Likes
3
Embeds 0
No embeds

No notes for slide
  • 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)
  • Hart13 ppt ch12

    1. 1. Chapter 12 Dietary Supplements and Over-the-Counter Drugs© 2011 McGraw-Hill Higher Education. All rights reserved.
    2. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.
    12. 12. Supplement Labeling© 2011 McGraw-Hill Higher Education. All rights reserved.
    13. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.
    25. 25. OTC Labeling© 2011 McGraw-Hill Higher Education. All rights reserved.
    26. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 45. Chapter 12 Dietary Supplements and Over-the-Counter Drugs© 2011 McGraw-Hill Higher Education. All rights reserved.
    1. A particular slide catching your eye?

      Clipping is a handy way to collect important slides you want to go back to later.

    ×