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Chapter 12

Dietary Supplements and

Over-the-Counter Drugs

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Drugs and food are similar in some respects

For example, both contain chemicals that interact with the body’s physiology

Dietary supplements may be thought of as drugs by consumers

Example: St. John’s Wort to improve mood

But they are legally classified as food products

There are important differences in the ways drugs and food are regulated

Dietary Supplements: Food or Drug?

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Defines a drug as

A product intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease

According to the Act, drugs must be shown to be

Safe when used as directed

Effective for their intended use

According to the Act, food products must be

Safe

Pure (unadulterated)

Not required to show that they are effective or provide any benefit

Food, Drug and Cosmetic Act

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Dietary Supplement Health and Education Act (DSHEA) of 1994

Passed in part due to pressure on Congress from the supplement industry

Industry wanted to limit FDA regulation

DSHEA made several important changes including

Redefinition of which substances could be dietary supplements

Redefinition of presumed safety

Vague health claims without proof were allowed

Regulation of Dietary Supplements

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DSHEA expanded the definition of supplements to include a variety of substances:

Vitamins and minerals

Herbs (whole, concentrates, and extracts)

Amino acids

DSHEA: Defining Dietary Supplements

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FDA can declare a dietary supplement to be unsafe or adulterated

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

Recent rules have emphasized safety

Good Manufacturing Practices rules

“Adverse Events Reporting” process

But the rules for supplements are still more lenient than those for drugs

DSHEA: Defining Safety

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Dietary supplements cannot claim to be a treatment for a disorder

Statements can be made about:

Beneficial effects on a structure or function of the body or on “well-being” in general

Sellers do not have to prove these claims

Only have to provide evidence that the claims are not false or misleading

Label 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

DSHEA: Supplement Labeling

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Boon:

Many more supplements on the market

Thus, consumers have more options

Cons:

Much less research available about safety and effectiveness

Supplements remain on the market until the FDA presents clear evidence of risk

Case study: Ephedra

a stimulant for weight loss

1994: First evidence of safety concerns published by FDA

However, it took 10 more years for FDA to compile evidence to get ephedra off the market

DSHEA: Boon or Threat to Consumers?

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2010: Introduced by Senator John McCain

Key innovations:

All manufacturers would have to register with FDA

Manufacturers would have to provide a complete list of ingredients

FDA could recall any ingredient they found to be unsafe

Outcome:

Dietary supplement industry mounted a campaign against the regulation

McCain withdrew the bill

Dietary Supplement Act

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Saint John’s wort

Hypericum perforatum

Used for centuries

Once thought to prevent possession by demons

Currently used as a potential treatment for both anxiety and depression

Some evidence supporting its use for depression

May interact with prescription drugs

so users should notify their physicians

Psychoactive Dietary Supplements

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SAMe

S-adenosyl-L-methionine

A naturally occurring substance found in the body

The active form of amino acid methionine

A possible antidepressant

Several studies indicate it is as effective as approved antidepressants

But many of the studies have not been well controlled

Psychoactive Dietary Supplements

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Ginkgo biloba

Long history of medical use in China

Active ingredients are unclear

Reduces blood clotting

May improve circulation

Potentially risky if used with aspirin or other drugs that reduce clotting

Psychoactive Dietary Supplements

Research suggests slight improvements in memory in some people

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Image source: © Mitch Hrdlicka/Getty Images (Ch12_10Ginkgo)

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Weight control products

People hoping to lose weight are the biggest dietary supplement market

Many different products

Like other supplements, no evidence of effectiveness is required

Example: Herbalife

Before the FDA banned ephedra, many original products contained this drug

Now many products contain large doses of caffeine

Herbalife reported $3.5 billion in worldwide sales in 2011

Psychoactive Dietary Supplements

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OTC drugs

Self-prescribed for treatment of self-diagnosed illnesses

Americans spend over $18 billion per year on OTC drugs

Americans self-treat four times as many health problems as doctors treat

Often with OTC drugs

Over-the-Counter (OTC) Drugs

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1962 Kefauver-Harris amendment required that all drugs be evaluated for safety and efficacy

FDA was charged with reviewing all OTC drugs currently on the market

An impossible task?

There were approximately 300,000 products

Solution: Only active ingredients were reviewed

The 300,000 individual products contain fewer than 1,000 total active ingredients

FDA Regulation of OTC Products

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GRAS (generally recognized as safe)

given currently available information, the ingredient is considered safe

Safe = a “low incidence of adverse reactions”

Note that no drug is entirely safe

GRAE (generally recognized as effective)

a reasonable expectation that the pharmacological effect of the drug will provide clinically significant relief

GRAHL (generally recognized as honestly labeled)

OTC Regulation: 3 Standards

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Consistent labels make it easier for consumers to compare products

Uniform labeling standards were adopted in 1997 to reduce consumer confusion

Layout, headings, and topics are consistent

Language has been made clearer and more concise

Less medical terminology

OTC Drug Labeling

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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

OTC vs. Prescription Drugs

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OTC Drug Review process:

FDA reviews products and may switch drugs to OTC status

Examples of drugs switched to OTC

ibuprofen (Advil: analgesic)

lansoprazole (Prevacid: heartburn)

fexofenadine (Allegra: antihistamine)

OTC vs. Prescription Drugs

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Stimulants

Only legal OTC ingredient is caffeine

Combinations of caffeine and other stimulants (e.g., ephedrine) are not allowed

Example: Vivarin

Sedatives and sleep aids

Early OTC sedatives and sleep aids

Combination of scopolamine (acetylcholine receptor blocker) and methapyrilene (antihistamine)

These were found to be unsafe

Brands changed active ingredients frequently

Current OTC drug is diphenhydramine (antihistamine)

Psychoactive OTC Drugs

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Weight-control products

1970s: phenylpropanolamine (PPA) was legal OTC

2000: FDA requested all companies to stop marketing products containing PPA

Concerns over safety and effectiveness of PPA

Currently, one FDA-approved weight-control OTC drug:

Orlistat (alli)

The weight-control market has shifted largely from OTC drugs to the less well regulated dietary supplements

Psychoactive OTC Drugs

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Two major classes of drugs to reduce pain:

Anesthetics reduce all types of sensation or block consciousness completely

Analgesics reduce pain selectively without causing a loss of other sensations

OTC analgesics include:

Aspirin

Acetaminophen

Ibuprofen

Experience of pain varies with:

personality, gender, time of day, and other factors

About 35 percent of patients obtain pain relief from placebo

People and Pain

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Chemical Name:

Acetylsalicylic Acid

Development:

Long historical use of teas and extracts of willow and poplar bark for pain relief

19th century: active ingredient (salicylic acid) identified, synthesized, and mass-produced

1898: Acetylsalicylic acid synthesized by Bayer

1915: Aspirin sold over the counter in tablet form

OTC Analgesics: Aspirin

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Analgesic

Effectively blocks mild-to-moderate somatic pain

Especially effective for headache and musculoskeletal pain

Antipyretic

Reduces fever

Causes vasodilation of peripheral blood vessels and increased perspiration

Anti-inflammatory

Reduces swelling, inflammation, and soreness

Used extensively for arthritis treatment

Aspirin: Therapeutic Use

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Inhibits 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

Symptoms include disorientation, personality changes, lethargy, coma, and death

Almost all case occurred in people under age 20 who have had a viral illness such as influenza, or chicken pox

Aspirin: Effects and Risks

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Analgesic action:

Aspirin inhibits the synthesis of prostaglandins

Prostaglandins are local-acting hormones

Released when cell membranes are injured

Mediate pain in injured areas by sensitizing neurons to stimulation

Aspirin: Mechanism of Action

Antipyretic action:

Aspirin acts on prostaglandins involved in heat regulation

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Compared to aspirin:

As effective in analgesic and antipyretic effects

Less useful as an anti-inflammatory drug

Risks:

Overuse can cause serious liver disorders

DAWN data: acetaminophen has far surpassed aspirin for ER visits and deaths

FDA has limited the maximum single capsule amount to 650 mg for OTC products

OTC Analgesics: Acetaminophen

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Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID)

Effective as an analgesic and anti-inflammatory

Like aspirin, inhibits COX enzymes

Potential side effects

Nausea and stomach pain

Liver damage (if taken in large amounts)

OTC Analgesics: Ibuprofen

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All-too-common cold

Colds are viral infections

More than 100 have been identified

Symptoms include coughing, sneezing, and production of fluid by the mucous membranes

OTC Cold and Allergy Products

Virus transmission

Most cold viruses enter the body through the nose or eyes

Usually transmitted via an infected person’s hands

Frequent handwashing is a good strategy to reduce the risk of contracting a cold

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Cold symptoms can be treated, not cured

Modern cold remedies contain three common types of ingredients

Antihistamines for temporary relief of runny nose and sneezing

Also used for relief of allergy symptoms

Nasal decongestants for temporary relief of swollen nasal membranes

Analgesic-antipyretics for temporary relief of aches and pains and fever reduction

OTC Cold and Allergy Products

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Most products contain one or more of only a small number of ingredients, in different combinations

Thus, 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

Avoid treating symptoms you may not have

Choosing an OTC Product

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