Control of the release of antimicrobials into the environment

AMR stands for “antimicrobial resistance,” that is, resistance to antimicrobials (antibiotics and synthetic antimicrobials). While AMR is believed to be principally caused by inappropriate or excessive administration of antimicrobials, release from manufacturing plants is also considered another factor in the emergence of bacteria resistant to antimicrobials. Therefore, it is essential to devise countermeasures from various aspects to control AMR. Having been engaged in the development, manufacture and sale of antimicrobials for many years, Shionogi has always strictly controlled the release of antimicrobials into the environment.

In September 2016, Shionogi signed the “AMR Industry Roadmap” with 13 global pharmaceutical companies and organizations at the World Economic Forum in Davos, to take the lead in combatting AMR. The signatory companies and organizations commit themselves to the strict management of antimicrobial release by themselves and throughout their supply chains, specifying their release management techniques in the form of a roadmap to be offered to all antimicrobial manufacturers so that they will also join in this worldwide effort to combat AMR.

As part of AMR Industry Alliance activities, Shionogi regularly inspects its antimicrobial release control and management. We have already completed the inspection of all of our antimicrobial-manufacturing plants, as well as all of our suppliers in Japan, in compliance with the guidelines for antimicrobial release control published by the AMR Industry Alliance.

Table 1: Criteria for release into the environment for active pharmaceutical ingredients (API) of antimicrobials handled by Shionogi and audited items (those in yellow were audited in FY 2018)

Companies E‒H: Overseas suppliers (to be audited)

Table 2: Supplier auditing results (FY 2018)

Supplier	Management system	Waste water management	Solid waste material management	Conformity to criteria for release
Company A	〇	〇	〇	〇
Company B	〇	〇	〇	〇
Company C	〇	〇	〇	〇
Company D	△	〇	〇	△

○：Conforming to the AMR Industry Alliance guidelines

△：Not fully conforming to the AMR Industry Alliance guidelines; remedial measures being implemented

As part of Shionogi’s antimicrobial release control and management at its antimicrobial-manufacturing plants, waste water is released into in-house treatment facilities after antimicrobials contained in the waste water are deactivated. Laboratory tests have confirmed the efficacy of this process in rendering waste water harmless when released into the natural environment. In preparation for the present EHS report, the concentration of antimicrobials in actual waste water from Shionogi’s plants was once again analyzed in compliance with the AMR Industry Alliance guidelines. We have confirmed that waste water from three out of the five antimicrobial products manufactured at the Kanegasaki Plant, Shionogi’s principal manufacturing establishment, conform to the criteria for harmless antimicrobial release into the environment. Regarding the two other products, we are continuing the monitoring and analysis of their antimicrobial concentrations.

As for solid waste materials generated in the process of antimicrobial manufacturing at the Kanegasaki Plant, they are entirely entrusted to an external service provider (Ecosystem Akita) for disposal by incineration. We have confirmed that there is no antimicrobial release into the environment via solid waste materials.

We have also confirmed that three of the four antimicrobials whose manufacturing is commissioned to suppliers in Japan conform to the criteria for harmless release into the environment. We are continuing surveillance and taking necessary remedial measures with regard to products whose conformity with the criteria has not been confirmed. In the near future, we intend to audit the status of conformity to the criteria on the part of our overseas suppliers related to antimicrobial manufacturing.