Initiatives to Track Adverse Event Reports
spite of the very low risk, both individual manufacturers and industry
trade associations have taken steps to track adverse events of dietary
supplements. Most manufacturers have in-house policies and procedures
for tracking and publishing adverse events. Many carry product liability
insurance that requires immediate reporting of any complaint that
could turn into a lawsuit.
developed several years ago about use of chaparral, which was reported
to have an adverse effect on patients suffering from liver disease
and hepatitis. A toll-free phone number for reporting adverse events
associated with chaparral was set up and maintained by the American
Herbal Products Association (AHPA).
Adverse event reports (AERs) were recorded and tracked for several
years until the rate of reports dropped to a low level.
control centers are now taking steps to address dietary supplements.
They are beginning to track and forward AERs to appropriate concerned
parties -- such as manufacturers and trade associations.
that is disseminated by poison control centers to callers is improving.
The National Nutritional Foods Association (NNFA)
is now helping to provide them with information such as antidotes
that can be used to counteract an overdose.
industry-wide good manufacturing practices (GMPs) standards require
tracking of customer complaints. One was issued by the FDA (originally
developed by the trade associations CRN,
NNFA, AHPA, and CHPA)
for all manufacturers of dietary supplements. A new GMP standard
is being released by the NNFA in 1999. The NNFA will require its
supplier members to track customer complaints per this standard.
FDA also monitors AERs for dietary supplements as part of the Special
Nutritionals Adverse Event Monitoring System (SN/AEMS) program.
However, these reports are completely unscreened. This results in
inaccuracies -- such as multiple reports of the same incident, and
uncertainty about the authenticity of reports. Such an unregulated
system is highly vulnerable to fraud and error and is therefore
dietary supplement industry continues to develop effective means
for adverse event reporting. To provide a basis for determining
how to go about reporting adverse events that is consistent and
accurate, the American Botanical Council (ABC) is now surveying
manufacturers to find out what procedures are currently in use.
following questions are yet to be answered:
types of reports constitute a valid complaint?
consistently such policies are applied across the industry?
survey feedback is expected to shed some light on these questions,
thus setting the stage for industry-standard policies and procedures.
more data is gathered and compiled, knowledge of the dangers associated
with dietary supplements will be further refined. Meanwhile, consumers
can rest assured that the risk of side effects is extremely low
when dietary supplements are taken as recommended.
learn more about the safety of specific dietary supplements, check
out these links to research information.