Social and Health Outcomes Research and Evaluation (SHORE), SHORE and Whariki Research Centre, School of Public Health, Massey University, Auckland, New Zealand.
Addiction. 2014 Oct;109(10):1580-6. doi: 10.1111/add.12484. Epub 2014 Feb 16.
New Zealand has recently attempted to address the underlying drivers of the escalating new psychoactive substances (NPS) ('legal highs') problem by establishing the world's first pre-market approval regulatory regime for NPS. NPS products which can be shown with clinical trial data to pose a 'low risk' of harm will be approved for legal manufacture and sale.
This paper critically assesses the new regime, drawing on experience of the pharmaceutical sector and legal BZP market.
A number of characteristics of the recreational use of NPS may not be well addressed by standard medical clinical trials, including binge use, polydrug use, use by vulnerable groups and high-risk modes of administration. The overt advertising and covert promotion of approved NPS products on the internet may make them fairly visible to young people. The black market for unapproved NPS may be difficult to suppress given that unapproved NPS will be physically identical to approved NPS. If the legal market for NPS encourages the use of NPS, alcohol and other drugs there may be an increase in drug-related harm. Alternatively, if the legal NPS market reduces the use of more harmful drugs, there may be a considerable public health benefit.
The clinical trials required for NPS products should address the characteristics of recreational NPS use. Enforcement resources and technical solutions are required to clearly distinguish legal NPS products. The impact the new NPS regime has on other drug use is a key issue and demands further study.
新西兰最近试图通过建立世界上第一个新精神活性物质（NPS）（“合法兴奋剂”）上市前批准监管制度来解决 NPS 问题不断升级的根本原因。可以通过临床试验数据证明对人体危害“低风险”的 NPS 产品将被批准合法制造和销售。
本文借鉴制药行业和合法 BZP 市场的经验，对新制度进行了批判性评估。
NPS 消遣性使用的一些特征可能无法通过标准的医学临床试验来很好地解决，包括狂欢使用、多药使用、弱势群体使用和高风险的给药方式。经批准的 NPS 产品在互联网上的公开广告和秘密促销可能会使它们在年轻人中相当显眼。未经批准的 NPS 黑市可能难以抑制，因为未经批准的 NPS 将与经批准的 NPS 在物理上完全相同。如果 NPS 的合法市场鼓励 NPS、酒精和其他药物的使用，可能会增加与药物相关的伤害。或者，如果合法的 NPS 市场减少了更有害药物的使用，可能会带来相当大的公共卫生效益。
NPS 产品所需的临床试验应解决 NPS 消遣性使用的特点。需要执法资源和技术解决方案来明确区分合法的 NPS 产品。新的 NPS 制度对其他药物使用的影响是一个关键问题，需要进一步研究。
