Initial Comments

 A. Themes and Approaches

 B. General Recommendations

 C. Structure and Process

 D. Specific Recommendations by Item

Structure, Process and Points of Clarification

  • The Action Plan would benefit from stating explicitly the overall goal which guides the objectives in each of the separate sections. The overarching goal of the Action Plan could appropriately be: to minimize the emergence and transmission of antibiotic resistance. Likewise, a general Action Plan objective which needs to be highlighted at the beginning could be: to minimize the unnecessary use of antibiotics in people, animals and plants so as to decrease the overall selective pressure leading to increased resistance.

  • The bulk of the plan focuses on antibacterial resistance. To enable concerted action, the stated focus throughout the Action Plan should be bacterial resistance rather than all antimicrobial resistance. Fungi and antivirals may require the attention of a different set of resources and approaches.

  • It would be helpful if the Action Plan includes a baseline assessment of all related activities and resources of each Federal agency working in this area, and of major private, academic, and non-profit organizations with related missions. Based on this assessment, recommendations could include the need for additional statutory authority and funding for both the Federal and non-Federal entities to conduct a sound program. And finally, to avoid duplication of effort, these findings and recommendations would delineate the interrelationship between the Federal government, state governments, non-profit organizations, academia and others, acknowledging appropriate additional roles each contributes to this important problem.

  • The Final Action Plan should include measurable objectives for assessing whether and when the goals are reached. We believe such accountability needs to be agency-neutral and vested in the highest level of government. We suggest this structure since it is our understanding that single agencies within any one department do not have authority over other agencies within the Federal government.

  • Because of the urgency of the problem, several known interventions and certain essential data collection should begin immediately rather than within the larger time frame suggested. For example, public health approaches such as the CDC "hand washing campaign" should be strengthened and emphasized as preventative programs. Also, there is a major need to mandate and collect adequate antibiotic use data in order to guide current FDA deliberations.

  • In order to improve readability and provide a more immediate understanding, we suggest a glossary and definitions section near the beginning of the Action Plan and a more thorough reference section at the end.

 

 

ALLIANCE FOR THE PRUDENT USE OF ANTIBIOTICS © 1999

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