Diversion of Human Drugs Used for Dogs and Cats in Veterinary Drugs
Companion animals, primarily dogs and cats, mainly live in the same place as humans, making the distance between humans and animals the closest. Therefore, we can easily imagine that antimicrobial resistant bacteria in animals can spread to humans through animal’s feces, and such studies were reported. On the other hand, most antibiotics used for companion animals are human drugs, accordingly, off-label human drugs. Both the trend of antimicrobial resistant bacteria caused by companion animals and the amount of antibiotics used are unknown. The amount of antibiotics used is a “black box” when tackling strategies for antibiotics based on the One Health approach on a global scale. That is why the monitoring of antimicrobial resistance (AMR) related to companion animals is an element of the national action plan on AMR issued in 2016. The MAFF stated to start the AMR monitoring of companion animals, and is considering a survey of usage of human antibiotics. However, it is anticipated that the survey of label-off use of human antibiotics in pets might prove difficult.
To promote the proper use of antibiotics in pets, it seems important to use approved veterinary antibiotics based on the Pharmaceuticals and Medical Devices Law. However, developing new veterinary antibiotics in pharmaceutical companies is difficult owing to lower-priced human drugs. Therefore, in 2014, the MAFF made an exception on documents in clinical studies when pharmaceutical companies try to obtain manufacturing and marketing approval for human drugs which have already been widely used in veterinary medicine. As a reason of this exception, considerable clinical experiences and reports were accumulated so as to be regarded as public knowledge which human drugs were widely used in veterinary medicine, and which are effective and safe for pets. Unfortunately, no veterinary drugs have used this revolutionary system for approval yet, therefore, we would like to request the use of this system for antibiotics.
The contents of the system are the following; it is capable of substituting both the survey of actual usage based on domestic clinical experiences and papers based on domestic and international clinical experiences for essential attachments of clinical study in approval. However, biological preparations and new quinolone antibiotics are excluded. A veterinary drug which was approved by using this system is obligated to gather information about its efficacy and safety within two years after approval, and to submit their results to the director in the National Veterinary Assay Laboratory (NVAL). If verification is required after examination of submitted information, a post-marketing clinical study is conducted in more than one facility.
This system has advantages not only in that pharmaceutical companies can promote the development of new drugs at lower cost, but also the management and regulation based on the law such as understanding the amount of usage can be strengthened by usage of approval drugs for pets. We would like to request utilization of this system as one of AMR measures in companion animals.