Data Collection of Antimicrobial Use In Animals

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Concerns about the potential for antibiotic resistance started when they were first introduced as life-saving tools in human medicine.  Despite such concerns, the importance of these tools for public and animal health have been memoralized:

Since the discovery of penicillin in the late 1920s, hundreds of antimicrobial agents have been developed for anti-infective therapy.  Antimicrobials have become indispensable tools for decreasing morbidity and mortality associated with a host of infectious diseases and, since the introduction of antimicrobials into veterinary medicine, animal health and productivity have improved significantly.

P. Boerlin and D White, “Antimicrobial Resistance and Its Epidemiology,” Antimicrobial Therapy in Veterinary Medicine, Fourth Ed. C. 2006, p. 27.

Now, after significant regulatory controls have already been adopted to curtail the use of medically important antimicrobials in food animals, veterinarians, scientists and animal health regulators have started to collaborate in data collection from the actual use of animal treatment to inform future regulation.

A significant step toward that goal is the recently-approved AVMA policy “Support for the Collection of Antimicrobial Use Data for Antimicrobial Stewardship,” which “describes best practices for collecting this (antimicrobial use) data, what should be considered during its analysis, and how the data might be used to inform and advance veterinary clinical decision making.”

Of course, the collection of actual, unbiased, and validated data about what practices have resulted in antimicrobial resistance, should serve as the basis for regulatory controls implemented to effectuate a desired goal—decreased antimicrobial resistance.

Data collection of antimicrobial use is underway on swine herds in the US, where veterinary researchers are engaged in research on swine farms in collaboration with USDA.  As reported by the AVMA, according to USDA officials, “[t]his is the first time that the federal government, producers and veterinarians, and the swine industry have partnered on addressing antimicrobial resistance.”

At the same time, the Center for Veterinary Medicine at the FDA has started requesting information about antimicrobial use in companion animals from stakeholders, scientists, the regulated community and the public.  CVM has requested input on the following questions (subparts excluded), as set forth in the Federal Register (Antimicrobial Drug Use in Companion Animals; Request for Comments, February 16, 2022; 87 FR 8848).  Current deadline for responses to CVM is June 16, 2022.

  1. Please describe if antimicrobial use practices in companion animals have impacted the development of antimicrobial resistance in bacterial pathogens of companion animals. Please provide information, data, and/or references to support your response.

  2. Please describe if antimicrobial use practices in companion animals, including extralabel use, have impacted the development of antimicrobial resistance in human bacterial pathogens. If possible, please describe whether the impact was the result of direct or indirect contact between humans and the treated companion animals. Are there specific concerns about the development of antimicrobial resistance in human bacterial pathogens when particular antimicrobial drugs or drug classes are used in companion animals? Please provide information, data, and/or references to support your response.

  3. How should the human medical importance of particular antimicrobial drugs or drug classes be considered when deciding whether, or under what conditions, to use such drugs in companion animals?

  4. How can CVM best engage with our stakeholders on promoting antimicrobial stewardship for companion animals? Examples of stakeholders include other government agencies, the pharmaceutical industry, public health organizations (both public and private entities), veterinary professional organizations, veterinary schools, veterinarians, pet owners, and veterinary diagnostic laboratories.

  5. How can CVM encourage the development of antimicrobial drugs consistent with the principles of antimicrobial stewardship for the treatment of infectious diseases in companion animals for which there are no FDA-approved animal drugs?

           . . .

  1. Labeling:

  2. What information on currently approved animal drug labeling helps the veterinarian prescribe or use an antimicrobial drug in a manner consistent with the principles of antimicrobial stewardship?

  3. What additional information could be added to the approved animal drug labeling to improve the veterinarian’s ability to prescribe or use an antimicrobial drug in a manner consistent with the principles of antimicrobial stewardship?

  4. Is there a need for materials containing labeling information and/or information about antimicrobial stewardship that veterinarians could provide to the client when they prescribe an antimicrobial drug ( e.g., client information sheets or other educational handouts)?

  5. With respect to the use of antimicrobial drugs in companion animals, what other actions should CVM consider taking to foster greater antimicrobial stewardship?

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