Part 6 of 7 parts.
Doctors and patients can report adverse
events, product use errors, and product quality problems associated
with dietary supplements through an FDA voluntary online reporting
system known as MedWatch. MedWatch is the FDA Safety Information and
Adverse Event Reporting Program for reporting serious reactions,
product quality problems, therapeutic inequivalence/failure, and
product use errors with human medical products, including drugs,
biologic products, medical devices, dietary supplements, infant
formula, and cosmetics.
If a doctor has a patient that suffered
a serious harmful effect or illness after taking a dietary
supplement, a healthcare provider can report this by calling FDA's
MedWatch hotline at 1-800-FDA-1088 or online at the Medwatch
Website. The identity of the patient is kept
confidential.
Consumers
also can report an adverse event or illness they believe to be
related to the use of a dietary supplement. Health professionals and
consumers also can check for dietary supplement alerts and safety
information at
http://www.fda.gov/Food/DietarySupplements/Alerts/default.htm
or by contacting the FDA Center for Food Safety and Applied Nutrition
Outreach and Information Center at 1-888-SAFEFOOD. Clinician
resources can be found online or in software packages for computers
and mobile devices, usually as part of an electronic health records
package.
With an estimated 50% of the US
population using dietary supplements, it is imperative that the
clinician always ask about dietary supplements during the clinical
encounter. This is particularly important during early encounters
when the patient care dyad is being established. The clinician
should clearly ask about vitamins, minerals, and botanicals and
encourage patients to bring their dietary supplements to clinic
visits. The US Preventive Services Task Force recommends including
questions about supplement use in the patient education and
counseling for prevention section of the clinical encounter.
Clinicians who have regular interaction
with patients need to be up to date on current dietary supplement
usage patterns in the clinician's patient pool and in the United
States in general. NHANES collects the most comprehensive data on
supplement use, and studies using NHANES data are likely to provide
the most accurate, representative information. A search on PubMed or
Google will produce several articles and journals on dietary
supplement use patterns among various populations and subgroups in
the United States and elsewhere.
The FDA regulates dietary supplements
far less stringently than it regulates pharmaceutical drugs. Because
of this disparity in regulation, patients could be taking supplements
that have unreliable amounts of the active ingredient or those that
are adulterated with impurities. Certain geographic areas of the
world may be associated with specific patterns of contamination. It
is essential, therefore, to understand not only the epidemiology of
supplement use patterns but also the sources of the supplements used
by the population in order to identify possible side effects or
contaminants.
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