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UNIVERSITY OF KENTUCKY COLLEGE OF NURSING
NUR 866
Over-the-Counter Drugs and Herbal Remedies:
What Nurses Should Know
(Required Independent Reading)
OBJECTIVES:
At the end of this content the student will be able to:
1. Compare and contrast prescription, over-the-counter (OTC), and herbal
medications.
2. Explain the differences in federal legislation that govern the promotion and sale of
prescription versus OTC and herbal medications.
3. Provide valuable patient education on the potential benefits and limitations of
herbal supplements and OTC medications.
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Content Outline: OTC Drugs and Herbal Remedies
Legally, American consumers have 3 routes of access to therapeutic drugs:
1. prescription (physician, nurse practitioner, physician assistant, dentist)
2. OTC (over-the-counter)
3. Herbals (available as OTC)
Medications: Comparisons
Over-the-Counter (OTC)
Clients can conveniently,
effectively self-treat minor
ailments; enables doctor to
spend more time caring for
patients with more serious
health problems; overall cost
to client is less; may mask
seriousness of clinical
condition; possible delay in
professional diagnosis/
possible inaccurate selfdiagnosis
Prescription
Client is more likely to seek
medical attention to obtain
prescription (M.D.
maintains more control);
Possibly taken ‘more
seriously’ by consumers
than OTC
Herbal
Earliest form of medicine;
patients interested in
“natural health”; less
expensive; gives client
more control; unregulated;
not guaranteed
bioequivalence; Germany
 most doctors prescribe
herbs; government health
insurance reimburses
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All 3 types are an important part of client’s medical record!
With OTC medicines…client teaching is a MUST! Include:
 choosing an appropriate product
generic vs. trade name?
 correct dosing
extra-strength vs. regular strength?
 common side effects
 drug interactions with other medications
Examples of OTC:
Vitamins, cold/cough meds, analgesics, antacids, laxatives,
antihistamines, sleep aids, nasal sprays, weight-control meds
Recently, new FDA guidelines  more detailed labeling for OTC; better
information & describes benefits/risks
HISTORICALLY…
1972 – FDA assembled “OTC Drug Review” - Twofold purpose:
A. “Are the ingredients safe and effective for consumers to self-medicate,
and are the labeling, indications, dosage instruction, and warning
sufficient?” (Over 500 products). If they were found lacking, appropriate
recommendations had to be developed.
1983  Study completed; found:
*1/3 ingredients reviewed were safe/effective
*1/3 ingredients found to be ineffective
*1/3 ingredients found to be particularly or potentially dangerous
were either:
a. transferred to prescription status only
b. removed entirely from the market
(eg, aphrodisiacs, hairgrowers)
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B. Reclassification from prescription  OTC status of more than 40 primary
product ingredients.
Indications for use:
3 Criteria for OTC Status:
Safety Profile
Consumer must be able to easily:
1. diagnose condition
2. monitor effectiveness
Practical for OTC
Drug should have:
Drug should be:
1. favorable adverse-event 1. easy to use
profile ( incidence
of severe adverse effects)
2. limited drug-interaction 2. easy to monitor
profile
3. low potential for abuse
Herbal medicine - past and present:
Herbal & botanical medicine is not a new phenomenon.
*Prior to 1900’s, herbs sole source of medications
*Example:morphine, digoxin, theophylline, cocaine derived from plants
1920: Herbs began to be replaced with pharmaceutical drugs 2° more
pharmacologically dramatic & economically profitable
*However, sharp  in herbal remedies since 1990’s
*Approx. 1/3  1/2 people use herbs and don’t reveal to physician
*Tens of billions of $$ annually
Top-selling herbs:
1. Milk Thistle
2. Gingko
3. Echinacea
4. Soy
5. Saw palmetto
6. Ginseng
7. St. John’s wort
8. Cranberry
9. Black cohosh
10. Garlic
Other frequently used herbs
Chromium
Green tea extract
Glucosamine
Fish Oil
SAM-e
Coenzyme 10 (CoQ-10)
Possible Indications for Use:
*liver damage, hepatitis
* lower cholesterol
* improves immune system
* menopause sx, cardiovascular dx, cancer,
* benign prostatic hypertrophy (BPH)
* tonic, stress, energy booster
*depression, anxiety, insomnia
* urinary tract infection
* symptoms r/t menopause & PMS
*antioxidant, antibacterial, antiviral, antifungal
Possible Indications for Use
*weight loss
*weight loss
*early osteoarthritis
*to decrease platelet “stickiness”
* depression, hepatic cirrhosis
*many disorders
(heart disease, immume enhancement,
cancer)
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Why an increase in popularity in herbs?
*Less expensive
eg, St. John’s Wort vs. prescription antidepressant  Zoloft
*Client control
*Perception of being less harmful
*Dissatisfaction with traditional medical therapies
Food and Drug Administration (FDA) & Herbal Therapy: Key Points
*FDA  In order for a drug to be sold, product must undergo clinical trials/meet
strict FDA requirements for safety/efficacy.
*Herbal therapy  Lacks testing
*No financial incentive to invest time/money
*Patents (“exclusive ownership”) not allowed on plant products
*1997 FDA issued warning:
“Just because a product is labeled ‘natural’ or from an herbal source,
it is not guaranteed to be safe.”
*Bioequivalence not required
*Variance between brands/between lots (“batches”) of same brand
*Active ingredient not always known
Dietary Supplement Health Education Act of 1994 (DSHEA)
 Created 2° congress acknowledging consumers’ desire for empowerment (to
have access to herbs)
 Extended definition of dietary supplements to include  herbals (herbs are
edible plants)
 Permitted sale of herbal remedies as dietary supplements as long as no
therapeutic claims
 Developed monographs to define identity & purity standards (1995  2002,
Developed 86 standard monographs on 25 herbs (some multi-herb
products)
 Not subjected to same rigorous testing/approval process by FDA as drugs are
 Declared botanical products cannot be removed from the market if they make
no health claims and are not proven unsafe
* Burden of proof of safety lies with FDA, not manufacturer (unlike prescription drugs)
 Determined herbal products cannot make any claim of efficacy, only
on body structure or function
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
Example of wording: (DSHEA requirements)
St. John’s Wort:
“Helps maintain a healthy emotional balance” 
NOT  “Treats depression” 
Saw Palmetto:
“Helps maintain urinary function in men” 
NOT “ Treats benign prostatic hypertrophy”
DSHEA…
*Requires product bearing nutritional support statements to prominently display the
disclaimer:
“This product has not been evaluated by the FDA. This product is not
intended to diagnose, treat, cure, or prevent disease.”
Problems with natural products
Not regulated by FDA
Only few herbs have met these requirements; now sold as OTC  senna,
cascara, psyllium
Marketed as dietary supplements and not drugs
Labeling may not be accurate
Appropriate dosing guidelines unknown
Most are not proven safe or effective
Potential for drug (OTC & prescription) /disease interactions
U.S. health care professionals possess little knowledge about herbal
supplements
Proceed with caution  Tips for herbal remedy users:
1. Educate yourself
Go with manufacturer with good reputation
Label should have:
*Scientific name/plant parts
*Manufacturer name/address
*Lot number
*Date of manufacture/expiration (however, expiration is often
arbitrary)
Herbs take longer to work than traditional pharmaceuticals
2. Tell your physician
<40% clients disclose their use to physician (concerned with dr. not
understanding or criticizing)
3. Prepare for surgery
D/C 2 weeks before any surgery
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4. Stop taking immediately if experience unusual reactions, notify
Physician
Further caution if:
*Chronically ill
*Liver or kidney disease
*Elderly
*Under age of 18
*Pregnant or breastfeeding
Potential Avoidable Problems with use of Supplements
 Patients and nurses/HCP not communicating
 Fear of being patronized
 Nurses/HCP not inquiring what supplements their patients are taking
 Patients using massive doses of a supplement
 Off label use of supplements
 Lack of education by health care professional on use of supplements
The Myth vs the Reality of Herbs and Supplements
THE MYTH
THE REALITY
Chemicals derived from common plants
couldn’t possible be useful as drugs
Patients only want to use therapies (drugs)
that are proven safe and effective and
approved by the FDA
We don’t know how herbs work. There’s
very little, well documented data on
mechanism of action
Greater that 30% of “conventional” drugs
used today come from plant sources
Supplements are not regulated by the FDA like
drugs- yet, supplement sales exceeded $16.8
billion in 2000 –and continue to grow!
The mechanism(s) of action for a good
many of the drugs listed in the PDR states:
“Unknown or not fully understood”
Who’s taking what?
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59% take supplements regularly
46% take multiple vitamin/minerals
35% take single vitamins
15% take herbs
8% take specialty supplements (SAM-e, CoQ10, glucosamine)
from: 2001 Harris Survey
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Expectations of People Using Supplements
Improved health and well being
 Feel better = 72%
 Prevent illness = 67%
 Treat illness = 51%
 Live longer = 50%
 Increase muscle mass = 37%
 Weight management = 12% (going UP)
Herbal Supplements: Websites of Interest
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National Center for Complementary and Alternative Medicine Clearinghouse:
www.nccam.nih.gov
One of 27 institutes that makes up the National Institute for Health (NIH); funded by congress; lots of
information regarding research development and dissemination (public and professional); really
interesting information on clinical trials.
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National Library of Medicine Fact Sheets on Supplements:
www.nlm.nih.gov/medlineplus/vitaminandmineralsupplements.html
A service of the U.S. National Library of Medicine (the world’s largest medical library) and the NIH;
has extensive information on over 600 diseases and conditions; on home page, click on “H” at the top
of page, then click on “Herbal Meds” and you will get to a wealth of knowledge from reliable sources.
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American Botanical Society:
www.herbalgram.org
A non-profit organization education/research organization whose mission is to disseminate sciencebased information related to the safe, effective use of medicinal plants. Has a “Latest News” section.
Presented by the American Botanical Council.