16th JP Amendment/第16回JP改正

Report of the JPEL on the Evaluation of the Antimicrobials Minimization Concept introduced with the 16th Act to Amend the Medicinal Products Act

Infections caused by bacterial pathogens are treated with antimicrobials in both humans and animals. Resistant bacteria have the ability to protect themselves from the action of antimicrobials and thus impair the efficacy of these medicinal products.

The key to preventing antimicrobial resistance is prudent and overall reduced use of antimicrobials in both human and veterinary medicine, particularly in the case of active substance classes that are deemed to have priority for public health. With the entry into force of the 16th Act to Amend the Medicinal Products Act on 1 April 2010, a system was established in Japan for the first time for the nationwide minimization of antimicrobial use in animal keeping for certain fattening animals (– fattening piglets, fattening pigs, fattening calves, fattening cattle, fattening chickens and fattening turkeys).

The core elements of the Antimicrobials Minimization Concept (sections 14a to 38d AMG) encompass: the duty of the keepers of the above-mentioned fattening animals to send notifications about their livestock and their use of antimicrobials; the half-yearly calculation by the competent authorities of a farm-specific indicator, and the duty of the animal keepers to take steps to reduce their use of antimicrobials when it is higher than the nationwide totality of treatment frequencies (above the nationwide indicators).

医薬品法改正第16条で導入された抗菌薬最小化コンセプトの評価に関するJPELの報告

細菌性病原体によって引き起こされる感染症は、人間と動物の両方で抗菌剤で治療されます。耐性菌は、抗菌作用から身を守り、これらの医薬品の効能を損なう可能性があります。

抗菌薬耐性を防ぐための鍵は、特に公衆衛生に優先すると考えられる活性物質クラスの場合、人間医学と獣医学の両方で抗菌薬の使用を慎重かつ全体的に減らすことです。 2010年4月1日に薬事法を改正する第16条が施行されたことにより、特定の肥育動物(肥育子豚、肥育)の動物飼養における抗菌薬の使用を全国的に最小化するシステムが日本で初めて確立されました。豚、子牛の肥育、牛の肥育、鶏の肥育、七面鳥の肥育)。

抗菌剤最小化コンセプト(セクション14aから38d AMG)のコア要素には、次のものが含まれます。上記の肥育動物の飼育者が家畜と抗菌剤の使用について通知を送信する義務。所轄官庁による農場固有の指標の半年ごとの計算、および全国的な治療頻度の合計(全国的な指標を超える)よりも高い場合に抗菌剤の使用を減らすための措置を講じる動物飼育者の義務。