Edwards Brian, Olsen Axel K, Whalen Matthew D, Gold Marla J
Benefit Risk Management, Division of Janssen Cilag, UK.
Curr Drug Saf. 2007 May;2(2):135-9. doi: 10.2174/157488607780598331.
Despite the best efforts of industry and regulatory authorities, the trust of society in the process of medicine development and communication of pharmaceutical risk has ebbed away. In response the US government has called for a culture of compliance while the EU regulators talk of a 'culture of scientific excellence'. However, one of the fundamental problems hindering progress to rebuilding trust based on a pharmaceutical safety culture is the lack of agreement and transparency between all stakeholders as to what is meant by a 'Safety of Medicines'. For that reason, we propose 'Guiding Principles of Safety for Pharmaceuticals' are developed analogous to the way that Chemical Safety has been tackled. A logical starting point would be to examine the Principles outlined by the US Institute of Medicine although we acknowledge that these Principles require further extensive debate and definition. Nevertheless, the Principles should take centre stage in the reform of pharmaceutical development required to restore society's trust.
尽管制药行业和监管机构已竭尽全力，但社会对药物研发过程及药品风险信息沟通的信任还是逐渐流失。作为回应，美国政府呼吁营造合规文化，而欧盟监管机构则倡导“科学卓越文化”。然而，阻碍基于药品安全文化重建信任取得进展的一个根本问题是，所有利益相关者对于“药品安全”的含义缺乏共识和透明度。因此，我们建议制定“药品安全指导原则”，其方式类似于处理化学安全问题的方式。一个合乎逻辑的起点是审视美国医学研究所概述的原则，尽管我们承认这些原则需要进一步广泛的辩论和界定。尽管如此，这些原则应在恢复社会信任所需的药品研发改革中占据核心地位。
