Wang Siri, Giannuzzi Viviana
Norwegian Medical Products Agency, Oslo, Norway.
Fondazione per la Ricerca Farmacologica Gianni Benzi onlus, Research Department, Valenzano, Italy.
Front Med (Lausanne). 2024 Sep 16;11:1456247. doi: 10.3389/fmed.2024.1456247. eCollection 2024.
The lack of available appropriate paediatric formulations is a significant challenge for optimal treatment in children. The resulting manipulation of adult medicines implies risk of medication errors, inaccurate dosing, and unacceptable dosage forms resulting in non-compliance. This represents significant unmet needs for a large and vulnerable patient group. Currently, the repurposing discussions seems only to a limited degree to cover the aspects of paediatric off-label use of adult medicines, including reformulation strategies to cover unmet needs for suitable formulations in the youngest age groups. Similarly, limited focus seems to be put on incentives in this specific area of repurposing. This paper will discuss the role of reformulation for paediatric needs as part of the repurposing concept, and potential factors contributing to barriers to incentivise the development of new formulations for children.
缺乏合适的儿科制剂是儿童最佳治疗面临的重大挑战。对成人药物进行调整意味着存在用药错误、剂量不准确以及剂型不可接受导致不依从的风险。这表明一个庞大且易受伤害的患者群体存在重大未满足需求。目前，药物重新利用的讨论似乎仅在有限程度上涉及成人药物儿科超说明书使用的方面，包括重新配方策略以满足最年幼儿童群体对合适制剂的未满足需求。同样，在这个特定的药物重新利用领域，对激励措施的关注似乎也很有限。本文将讨论重新配方在满足儿科需求方面作为药物重新利用概念一部分的作用，以及导致激励儿童新制剂开发障碍的潜在因素。
