6

Findings and Recommendations

In this chapter, the committee summarizes its major findings and recommendations. Throughout the report, however, especially in Chapter 5, the committee makes additional suggestions that, although not carrying the weight of final recommendations, it thinks would be useful.

FINDINGS

  1. Military personnel, especially when they are deployed, are exposed to a large number of drugs, biologics, and chemicals to which their civilian counterparts in the United States are not exposed. None of the information gathered on additional planned prophylactic-preventive agents had a substantial impact on the committee's deliberations.

  2. The published scientific literature on the interactions of militarily relevant drugs, biologics, and chemicals does not provide an adequate basis for assessing the degree of safety; the committee, however, did not find any basis for extraordinary concern.

  3. Discussions held with liaisons from the medical divisions of the Canadian and British militaries indicated the international need for increased information and research regarding interactions.

  4. The diversity and number of agents precludes not only the testing of all possible combinations for interactions but also the development of systems that could be used to identify and predict with confidence all possible interactions that could result in increased toxicity.



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Interactions of Drugs, Biologics, and Chemicals in U.S. Military Forces 6 Findings and Recommendations In this chapter, the committee summarizes its major findings and recommendations. Throughout the report, however, especially in Chapter 5, the committee makes additional suggestions that, although not carrying the weight of final recommendations, it thinks would be useful. FINDINGS Military personnel, especially when they are deployed, are exposed to a large number of drugs, biologics, and chemicals to which their civilian counterparts in the United States are not exposed. None of the information gathered on additional planned prophylactic-preventive agents had a substantial impact on the committee's deliberations. The published scientific literature on the interactions of militarily relevant drugs, biologics, and chemicals does not provide an adequate basis for assessing the degree of safety; the committee, however, did not find any basis for extraordinary concern. Discussions held with liaisons from the medical divisions of the Canadian and British militaries indicated the international need for increased information and research regarding interactions. The diversity and number of agents precludes not only the testing of all possible combinations for interactions but also the development of systems that could be used to identify and predict with confidence all possible interactions that could result in increased toxicity.

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Interactions of Drugs, Biologics, and Chemicals in U.S. Military Forces Operational requirements may necessitate the use of combinations of agents of known or potential toxicity. The committee understands that it is Department of Defense (DoD) policy to ensure that the benefits outweigh the risks when these combinations of agents are used. Many programs are under way within the military in the areas of drug and vaccine design and development, research on the effects of those agents that are administered to military personnel or to which military personnel are known to be exposed, and the development of surveillance systems and related databases that could be used in epidemiologic studies. However, many of the surveillance systems are incomplete, and databases that contain related, relevant information have not been linked to date. Most important, a coordinated effort among the services to link the relevant programs is lacking. RECOMMENDATIONS A focused strategy for evaluating and managing the effects of interactions needs to be developed. This strategy should also be suitable for new agents. The proposed approach involves the characterization of interactions into three broad categories: Known: those interactions for which there is documented evidence of risk in humans; Potential: those interactions that are known from animal studies or that can be anticipated or predicted on the basis of the individual properties of the agents in putative combinations; and Unknown: the interactions of combinations of agents that cannot be anticipated on the basis of current knowledge (this is the largest class). For agents with known interactions, if exposure cannot be avoided, surveillance measures should be implemented and focused studies should be undertaken to identify ways to minimize risk levels. Potential interactions might be predicted by use of a matrix based on target organ toxicity, pharmacokinetics, and pharmacodynamics. High-priority potential interactions should be investigated in a tiered process involving in vitro, animal, human volunteer, and epidemiologic studies. For agents with unknown interactions, three strategies are recommended. The first strategy is to develop, enhance, and implement surveillance systems to monitor both exposure combinations and health outcomes. Surveillance systems for exposures should include data regarding drugs, biologics, and other deployment-site-specific chemicals. Surveillance systems for health outcomes should be expanded to capture additional sentinel events (using notifiable conditions) and could be used to support focused

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Interactions of Drugs, Biologics, and Chemicals in U.S. Military Forces prospective studies, provided they are of sufficient sample size, to compare specific health measures before and after deployment. The second strategy is to conduct a battery of in vitro and in vivo experimental studies to investigate a core set of exposures anticipated for most deployed troops. When outcomes of interest are identified, they should be investigated with carefully designed epidemiologic studies of disease-exposure relationships. The committee recommends further that efforts be better coordinated within and among all those military units and branches involved with the development of these systems. Programs within the Army and DoD that involve product development, preventive medicine (including the development of surveillance systems and integrated databases), clinical medicine, and the medical defense against biological and chemical warfare weapons should be closely coordinated. An advisory committee should be established to help identify and use existing and future research tools for the purposes of anticipating, studying, and minimizing harmful interactions.

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