Use of Dietary Supplements by Military Personnel (2008) / Chapter Skim
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6 Monitoring Adverse Health Effects Associated with Dietary Supplement Use by Military Personnel
6 Monitoring Adverse Health Effects Associated with Dietary Supplement Use by Military Personnel
Pages 336-367
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From page 336... ...
Once on the market, there is no established system to monitor adverse events from foods; however, if a new ingredient is introduced to a previously available food product, the FDA might informally ask the manufacturer to conduct postmarket monitoring of adverse events. Receipt of a sufficient number of complaints from consumers or consumer organizations might also prompt the FDA to investigate the safety of an ingredient.
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From page 337... ...
Because there are no premarket assessments required for dietary supplements, there is a paucity of laboratory safety studies; hence, postmarket monitoring of adverse events becomes even more significant for ensuring public health. DSHEA provided the FDA with the authority to develop monitoring systems and to take necessary actions when it has sufficient evidence that a product is unsafe (Dietary Supplement Health and Education Act of 1994, Public Law 103-417, 108 Stat 4325, 103rd Congress, October 25, 1994)
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From page 338... ...
. Based on the heightened risks and the absence of an internal military process to report adverse events, this chapter discusses the need for the military to add dietary supplements to its current adverse-event monitoring system for medications so that this system responds to the unique risks and demands of military service.
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From page 339... ...
The proposed approach will alert the military of potential concerns derived from using specific dietary supplements, particularly when performance might be compromised, and will serve as a signal to initiate appropriate actions by military leadership, as described in Chapter 5. THE FDA'S PROCESS TO MONITOR ADVERSE EVENTS FROM DIETARY SUPPLEMENTS To make recommendations about approaches to monitoring military personnel for adverse health events that might indicate a concern associated with consumption of dietary supplements, the committee reviewed the FDA's systems for both medications and dietary supplements.
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From page 340... ...
To strengthen this system, the Dietary Supplement and Nonprescription Drug Consumer Protection Act mandates that after December 2007, serious adverse events voluntarily reported to dietary supplement manufacturers by consumers and others must be submitted by the manufacturer to the FDA via the MedWatch 3500A form (see Appendix D)
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From page 341... ...
. Given the low reporting rate for dietary supplement-related adverse events, and the absence of a well-established system to monitor adverse events, it seems essential for organizations and manufacturers to collaborate to understand the limitations and uses of the current systems for reporting adverse events associated with dietary supplements.
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From page 342... ...
Unfortunately, under the current voluntary system, the report rate is low -- the OIG estimated in 2001 that less than 1 percent of all adverse events are reported to the FDA -- for any of the following possible reasons. First, there is generally little consumer awareness of the importance of reporting adverse events from dietary supplements or even about the availability of a reporting system; if an individual is aware of the system, lack of familiarity with the form or lack of clarity in questions might deter submission.
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From page 343... ...
The report found that in 1999, the FDA recorded only 400 adverse events from dietary supplements via submission of MedWatch 3500 forms. Of those, medical records were unavailable in 58 percent of the cases, ingredients could not be determined in 32 percent, and there was no patient follow-up information available for 27 percent (OIG, 2001)
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From page 344... ...
and low "numerator" data (i.e., number of adverse events reported for a particular dietary supplement)
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From page 345... ...
With these serious limitations in the data quality and quantity and with reviews often conducted on a case-by-case basis, the extensive experience and appropriate expertise of the reviewers become critical when identifying signals. THE MILITARY'S SYSTEM TO MONITOR ADVERSE EVENTS The monitoring of adverse events related to dietary supplement use as a signal detection system within the military is integral to maintaining the health and optimal performance of military personnel.
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From page 346... ...
. All adverse events potentially associated with the use of medications by Army personnel are reported using MEDMARX, a subscription-based, adverse drug reaction database.
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From page 347... ...
. In 2000, the Army's Office of the Surgeon General implemented policy specific to dietary supplements with a memorandum directing health care providers to document in the patient's medical record adverse events believed to be associated with dietary supplements.
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From page 348... ...
. The Navy and Marine Corps Public Health Center website provides, as part of their ShipShape weight management program, information on dietary supplements and links to the NIH Office of Dietary Supplements (ODS)
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From page 349... ...
Challenges and opportunities discussed below relate to the collection of data and analysis by using the electronic health records system. Data Collection Process Low reporting rate in the military Factors contributing to a low reporting rate in the general civilian population are also encountered by the military: inconsistent definitions of the term adverse event, a voluntary monitoring system, poor communication with health care providers (e.g., reluctance to report dietary supplement use and adverse events as well as lack of discussions about dietary supplement use during medical visits)
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From page 350... ...
about dietary supplements of specific interest to the military would contribute to the infrequency of reporting adverse events associated with dietary supplement use. An already low rate of reporting within the U.S.
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From page 351... ...
For instance, such a system might be used to create computer-generated signals as a tool for identifying (and possibly preventing) likely specific adverse events or high-risk interactions of dietary supplements with medications or other dietary supplements, as an additional strategy to detect adverse events (Gardner and Evans, 2004)
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From page 352... ...
Non-life-threatening adverse events are to be recorded by the manufacturer, and records retained for 6 years in case the FDA needs to inspect the information. This act defines the term adverse event very broadly as any health-related event associated with the use of a dietary supplement that is adverse.
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From page 353... ...
In addition, sales data provided to the committee indicate high use of some multi-ingredient dietary supplements; the effects of ingredient interactions are mostly unknown and present concerns. Based on the heightened risks, frequency of use among military service members, the lack of consistent policies, and the absence of a military process to report adverse events, a separate system for use by the military to monitor and evaluate adverse effects from dietary supplements is warranted.
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From page 354... ...
Army Center for Health Promotion and Preventive Medicine recommends various educational tools, but also urges that reports of adverse events associated with dietary supplements be reported through the Army Reportable Medical
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From page 355... ...
(As the military continues to move toward a single electronic health record for each service member, provisions will be needed to ensure entry of data on dietary supplement use and adverse events when service members receive health care from providers not located in the MTFs.) Implementation of a centralized system will have to address difficulties such as the need for additional staff time and training efforts to collect, identify, and code dietary supplements being used.
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From page 356... ...
Recommendation 8: The military should designate a committee or military entity to be responsible for the oversight and coordination of dietary supplement-related activities, such as overseeing the adverse event surveillance system and parallel educational components. Based on the heightened risks, the frequency of use among military service members, the lack of consistent policies, the suspected associations between adverse events in the field and the use of dietary supplements, the absence of a military system to report these adverse events, and the potential consequences of the unguided use of dietary supplements for an individual's health or mission success, a military entity or committee (hereafter referred to as the designated oversight committee)
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From page 357... ...
to identify, in col laboration with the FDA, adverse events and their association, when possible, with particular dietary supplements and other self-care products used by the U.S. population; (2)
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From page 358... ...
These data should be provided to the MTF P&T Committee in a timely manner to be evaluated along with other adverse events reported from health care providers. The designated oversight committee will clearly define the systems intended to submit the adverse event reports, including the forms to be used (e.g., MedWatch, MEDMARX ADR)
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From page 359... ...
cDesignated oversight committee members, registered dietitians from each military service, USARIEM, pharmacist from the DoD Pharmacoeconomic Center and services, medical representative from each service, FDA's Center for Food Safety and Applied Nutrition, Federal Trade Commission, NIH's Office of Dietary Supplements, AAFEX/NEX (Army and Air Force Exchange Service/Navy Exchange Service) , and other sales outlets located on military installations; industry trade association; Health and Wellness and 359 Health Promotion Centers from the services, fitness centers or units trainers from the services.
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From page 360... ...
. Recommendation 9: The responsibility of the local Medical Treatment Facilities' Pharmacy and Therapeutics Committees should be extended to reviewing and summarizing the adverse event reports as submitted by health care providers or service members, and preparing and provid ing summaries via a process recommended by the designated oversight committee.
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From page 361... ...
The MTF P&T Committees should develop summaries of these adverse event reports highlighting dietary supplements of concern and associated adverse events, and particularly emphasizing those concerns related to military performance and environments of specific military groups (e.g., Special Forces, Rangers)
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From page 362... ...
• NIH Office of Dietary Supplements • Army and Air Force Exchange Service/Navy Exchange Service (AAFES/NEX)
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From page 363... ...
Army, and U.S. Navy • Other representatives To support the goal of the partnership, the collaboration might include sharing information and fostering discussion on the following topics: • Sales outlet reports from AAFES/NEX, Defense Commissary Agency, and/or other sources at military installations to compare sales of d ietary supplements from year to year and identify new products introduced to the market • Reports from industry trade associations on changes in products and sales trends • Summary of adverse events from specific military installations to identify regional differences, active surveillance data on adverse events at sentinel installations, and overall trends • Summary of FDA adverse event reports as available, including relevant data from the PCCs; in addition, data on health claims of efficacy for dietary supplements would also be shared as appropriate • Summary of FTC evaluation of dietary supplement products • Summary of clinical trials registered by the NIH Center for Alternative Medicine evaluating dietary supplements • Reports about dietary supplement use from in-depth surveys on sentinel installations -- sentinel sites would be selected based on the mission of forces stationed at the installation (e.g., Rangers, Army Special Forces, Air Force Special Operations Command, B-1B long-range bomber crew, Navy Seals)
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From page 364... ...
This hotline service would serve two purposes, education of the service member and data collection of adverse events. The following are recommendations for educational activities: Develop educational materials on dietary supplements and balanced nutrition, tailored to military members The proposed designated oversight committee should oversee the development of educational materials to be disseminated through a variety of methods (e.g., posters, websites, or point-of-sale brochures)
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From page 365... ...
should improve their abilities to evaluate dietary supplement use, to inform military members, and to appropriately report adverse events. Education should be included in existing programs (e.g., Uniformed Services University of Health Sciences, internships and residencies, aerospace medicine training, independent duty medical technician training, and mandatory continuing education at medical staff meetings)
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From page 366... ...
Dietary supplement adverse events: Report of a one-year poison control center surveillance project. J Med Toxicol.
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From page 367... ...
2006. Safety evaluation and adverse events monitoring by poison control centers: A framework for herbs and dietary supplements.
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