van Puijenbroek E P, Hepburn P A, Herd T M, van Grootheest A C
Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH 's-Hertogenbosch, The Netherlands.
Regul Toxicol Pharmacol. 2007 Mar;47(2):213-20. doi: 10.1016/j.yrtph.2006.10.007. Epub 2007 Jan 3.
Post Launch Monitoring (PLM) is one of the new approaches that are used in assessing the safety of novel foods or ingredients. It shares a close resemblance with procedures applied in the field of medicines, where Post Marketing Surveillance (PMS) has been carried out since the beginning of the 1960s. For this reason, Unilever and the Netherlands Pharmacovigilance Centre Lareb, maintaining the national reporting scheme in the Netherlands for adverse drug reactions, have been working together to optimize the Unilever's Post Launch Monitoring service. As a result of this cooperation a practical model for conducting PLM for food products has been developed. This model is also applicable for consumer products in general. The system allows for coding and assessing reports and the early detection of 'signals' of unintended health reactions. The methodological issues surrounding reporting of possible health reactions and practical issues surrounding coding and assessment of the reports that were encountered in the first period of this partnership are discussed. In addition, similarities and differences concerning PMS and PLM are described.
上市后监测(PLM)是用于评估新型食品或成分安全性的新方法之一。它与药品领域应用的程序极为相似,自20世纪60年代初以来,药品领域一直在开展上市后监测(PMS)。因此,联合利华与荷兰药物警戒中心Lareb(该中心负责维护荷兰药品不良反应国家报告计划)一直在合作,以优化联合利华的上市后监测服务。通过此次合作,已开发出一种针对食品进行PLM的实用模型。该模型通常也适用于消费品。该系统允许对报告进行编码和评估,并能早期发现意外健康反应的“信号”。本文讨论了在该合作的第一阶段所遇到的围绕可能健康反应报告的方法学问题以及围绕报告编码和评估的实际问题。此外,还描述了PMS和PLM的异同。