On January 13th and 14th, 2005, the National
Institutes of Health (NIH) held a conference on dietary supplements,
coagulation, and antithrombotic therapies in Masur Auditorium, NIH in Bethesda,
Maryland. The broad interest in this subject was reflected by the number of
co-sponsors and the scope of their collective missions: the National Heart,
Lung, and Blood Institute (NHLBI), the Office of Dietary Supplements (ODS), the
NIH Clinical Center (CC), the National Center for Complementary and Alternative
Medicine (NCCAM), the National Institute for Neurological Disorders and Stroke
(NINDS), the Office of Rare Diseases (ORD), and the Foundation for the National
Institutes of Health (FNIH).
Approximately 4 billion people around the world
use some form of dietary supplement to enhance their nutritional intake and/or
treat disease in conjunction with medical therapies, such as antithrombotic
agents, without their healthcare providers knowledge. Greater acceptance
and informed management of these complicating factors, better knowledge about
the likelihood for dietary supplement-drug interactions, and better methods for
obtaining and disseminating this information could only lead to improved
patient safety and management.
The goal of the two-day meeting was to gain
greater understanding of the complex issues of dietary-supplement use by
patients undergoing antithrombotic therapies. To achieve this, the organizers
brought scientific and medical expertise together with interested parties from
academia, industry, patient-advocacy groups, and government regulatory
agencies.
The conference organizers and attendees took a
critical scientific look at how dietary supplements affect the human body's
normal clotting response and the antithrombotic therapies (anticoagulant and
antiplatelet agents) commonly used to treat and prevent thrombosis. Additional
objectives included the development of strategies to raise awareness among
patients and practitioners about the use of dietary supplements, to formulate a
framework for future clinical guidelines on dietary-supplement use in patients
on antithrombotic therapies, and to integrate new knowledge into various media
outlets, including internet resources and web-based home-monitoring systems for
antithrombotic therapies. The conference addressed existing gaps in the current
knowledge about dietary supplements, their use, and their potential
interactions with prescription drugs, as well as the need to formulate a
forward-looking research agenda to address such gaps.
The meeting comprised seven sessions, which
encompassed: 1) dietary supplements known to affect hemostasis and thrombosis;
2) what those effects on hemostasis are; 3) clinical data on dietary
supplements affecting hemostasis and antithrombotic therapies; 4) new tools and
methodologies for research and clinical practice in this area; 5) opinions and
research priorities from a panel of experts; 6) public-health concerns from
academia, industry, and regulatory bodies; and 7) dialogue with patient-care
organizations.
The conference revealed six areas for action to
develop an improved understanding of how dietary supplements may be used safely
and effectively in conjunction with antithrombotic therapies.
- An Inventory of Dietary Supplements
for Distribution to Emergency Rooms and Poison-Control Centers
Currently, there is no comprehensive listing of manufacturers, product names,
and product ingredients for the 30,000-plus dietary supplements on the market.
Such a database would address a major public health need and would greatly
assist the poison-control centers and emergency rooms, which respond to most of
the cases of dietary supplementdrug interactions. The conference
organizers and participants felt that this action should be a high priority to
help manage interactions and risk in acute, emergency cases. Such information
would also be useful for future compiling and analyzing case reports covering
supplement interactions with antithrombotic drugs.
- A Research Agenda Aimed at Short-
and Long-Term Patient Care and Safety
The conference organizers
and participants recognized the need for real-world data on dietary-supplement
use and interactions with anticoagulant and antiplatelet therapies in special
populations, such as the elderly, women (especially during pregnancy and
lactation), minorities, patients with comorbid conditions (hepatic or renal
impairment), and children. It was recommended that cases from poison centers
and emergency rooms throughout the country should be entered in a national
registry, and that research utilizing case-control studies in anticoagulation
clinics, as well as outcome studies on those patients taking and those patients
not taking concomitant herbal medicines or ingredients, should be conducted.
These types of data would substantially raise the level of public health
awareness and enhance patient care and safety in the United States. Potential
sources of funding were discussed.
- Improved Case Reporting and History
Taking on Patients with Likely DrugDietary Supplement
Interactions
Improvements in case reporting on patients with
likely drug-dietary supplement interactions should ultimately result in
improved background data for research in and monitoring of interactions between
dietary supplements and antithrombotic therapies. This recommendation also
includes the development of an accessible, internet repository for researchers
and healthcare providers who need to report incidents and refer to relevant
case reports. For this purpose, a properly implemented Web site, hosted either
by the Food and Drug Administration (FDA) or the NIH, as well as simplified
case reporting form and process, could be utilized. The web-based reporting
system would be designed to prompt reporters to enter all pertinent
information, and would filter or prioritize the case reports based on the
amount of relevant information provided. Expert systems could also be used to
assess data trends which demand immediate attention. The Web site would also
give users a printout or an electronic version of the report (for publishing
purposes) and, perhaps most importantly, it would automatically upload the
report to the FDA or NIH database. These actions should allow more timely,
accurate, and scientifically based conclusions to be drawn about interactions
between dietary supplements and prescribed therapies.
- Improved Communication
Understanding which dietary supplements are being used by patients
and their effects has lagged because inadequate information has flowed to
researchers and healthcare providers. Efforts need to be made to improve the
way medical professionals and the healthcare community collect information on
supplement use. The conference organizers recommend the involvement of NIH in
these efforts. Organizers hope to begin this process with new educational
programs at some of the larger society meetings, such as those for the American
Society of Hematology (ASH) and the American Heart Association (AHA). The
organizers will also seek to collaborate with the American College of Chest
Physicians (ACCP) in rewriting the next version of its consensus guidelines for
antithrombotic therapy to include a section on the use of dietary supplements.
With regard to public outreach, the National Consumers League, which was
represented at the conference, is seen as an excellent potential collaborator
and as an excellent source of consumer information. Lastly, the NIH Web sites
should consider having an area dedicated to dietary supplements, their use, and
interactions with antiplatelet and anticoagulant therapies.
- Regulatory Improvements: Incident
Reporting, Quality Data Collection, and Warning Labels
Increased
information on product names, better data on the contents of dietary
supplements, and a change in the warning labels indicating known and potential
interactions are needed. In light of the difficulty in changing the labeling on
dietary supplements, the conference organizers recommend that the FDA consider
requiring better labeling on prescription drugs with respect to potential
interactions with dietary supplements. For example, current warnings on
important drugs, such as warfarin, are inadequate, and more detailed warnings
on prescription-drug labels would be a first step at better informing the
public of known and uncertain hazards. Labeling changes would be based on what
is already known and updated as more scientific data accumulates.
- Wider Collaboration and Information
Sharing
Progress can be achieved by formalizing input from and
collaborating with experts who exist nationally, in Europe, and elsewhere
an activity the conference organizers recommend strongly as follow-up to
these sessions. Moreover, educational seminars at scientific and medical
conferences, such as those held by ASH and AHA, are recommended as annual
training opportunities for fellows, physicians, and other healthcare providers.
The organizers hope that the sponsors of this conference would also become
involved in such efforts.
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