An overview of herbal medicines and
From the August 26 , 1998 issue
The use of herbal medicines has become a part of the US
mainstream. Surveys suggest that about one-third of Americans
use herbal products as medications. Some use herbal products
with conventional medicine, others use them as a replacement.
For western-trained health practitioners, their use poses
a dilemma. Few practitioners have received herbal medicine
education during their training. A great deal of herbal medicine
information is written in foreign languages, but it is slowly
becoming available in English. Some of the information is
available as human clinical research reports, but most includes
practitioner observations and historic use records.
Conventional drugs, regulated by the Food and Drug Administration
(FDA), require quality assurance in manufacturing, labeling
accuracy, demonstrated safety and efficacy before marketing,
and post-marketing surveillance for adverse effects. They
are available only by prescription from a trained, licensed
prescriber. On the other hand, herbal medicines are regulated
as food supplements under the Dietary Supplement Health and
Education Act (DSHEA) of 1994. As such, there are no quality
assurance requirements for manufacturing and labeling. Claims
on the labels about efficacy or use are loosely regulated.
Yet, DSHEA requires a disclaimer on package labeling: "This
statement (about use of the product) has not been evaluated
by the FDA. This product is not intended to diagnose, treat,
cure, or prevent any disease."
While efforts continue to establish and regulate good manufacturing
practices for herbals, no standards or guidelines exist to
assure quality. There are no provisions for pre-marketing
approval to demonstrate safety and efficacy. Plant materials
may be misrepresented or substituted to manufacturers, or
may contain environmental or man-made contaminants. They may
contain little or none of the plant material(s) stated on
the label, or an entirely different plant material than is
listed on the label. Some products may have been adulterated
with conventional drugs. Since herbal medicines are freely
available for sale, without limitation or medical consultation,
a person with a significant health problem may, through self-guidance
or untrained advice, postpone seeking adequate medical care.
They may even abandon conventional drug therapy in favor of
herbal therapy alone.
Herbal medicines appear relatively safe, but there is limited
human research or prospective/retrospective data concerning
adverse events and herbal-drug interactions. They are generally
less potent than their pure drug relatives because they contain
a mixture of many chemicals in small quantities. Thus, they
often have a longer onset of action than conventional drugs.
Although they appear to have a lower risk of adverse effects,
herbal products are not free of risk.
Practitioners should learn about herbal medicines and other
alternative therapies. Keep rational, reliable herbal medicine
references on hand. Ask patients about their use of alternative
therapies, including herbal medicines. Record all findings
in the patient's medical record. Monitor patients carefully
and report observations of adverse/unusual events. Ask patients
to keep a daily diary of all therapies they use and bring
it in for review at each visit to a healthcare professional.
ISMP will be working with herbal expert Dr. Forrest Batz,
affiliated with the University of California San Francisco
School of Pharmacy, to bring you regular information on herbal
products. Our goal is to help practitioners identify and prevent
herbal-related adverse events. Upcoming: reporting adverse
events involving herbal products.