title: Issues with monitoring the safety of psychoactive products under a legal regulated market for new psychoactive substances ('legal highs') in New Zealand.
abstract: New Zealand's Psychoactive Substances Act (2013) established the world's first regulated market for 'low risk' psychoactive products ('legal highs'). Under an interim PSA regime, 47 existing products were permitted to be continued to be sold.
  
  
  
  To explore issues with the implementation of regulatory systems to monitor the safety of products on the legal market under the interim Psychoactive Substances Act regime.
  
  
  
  Semi-structured interviews with 30 key stakeholders, including industry, government agency, health and drug service professionals were conducted, transcribed and analysed thematically.
  
  
  
  In retrospect stakeholders questioned the decision to approve strong synthetic cannabinoid smoking products, noting their health risks because of product formulation, inconsistent manufacturing practices and smoking as the means of administration. Industry actors claimed the decision to approve synthetic cannabinoid smokeable products prevented potentially safer products from gaining market share. The system for withdrawing approved products which were subsequently found to be harmful was criticised for the poor quality of data available, limited engagement with health professionals and the slowness of product withdrawal. Many of the problems with the regime were attributed to the urgency under which the legal market under the interim Psychoactive Substances Act was established and implemented.
  
  
  
  The selection of 'safer' products, implementation of the product monitoring system, and engagement with health professionals may have benefited from more time and resources. An incremental approach to establishing the new market may have made the regulatory management of the new regime more workable. [Rychert M, Wilkins C, Witten K. Issues with monitoring the safety of psychoactive products under a legal regulated market for new psychoactive substances ('legal highs') in New Zealand. Drug Alcohol Rev 2017;00:000-000].
authors.affiliation: SHORE & Whariki Research Centre, Massey University, Auckland, New Zealand.
authors.forename: Marta
authors.initials: M
authors.lastname: Rychert
authors.affiliation: SHORE & Whariki Research Centre, Massey University, Auckland, New Zealand.
authors.forename: Chris
authors.initials: C
authors.lastname: Wilkins
authors.affiliation: SHORE & Whariki Research Centre, Massey University, Auckland, New Zealand.
authors.forename: Karen
authors.initials: K
authors.lastname: Witten
mesh_terms: D003132:Commerce / Q000331:legislation & jurisprudence*; D006801:Humans; D013287:Illicit Drugs / Q000009:adverse effects* / Q000331:legislation & jurisprudence*; D007880:Legislation, Drug; D009520:New Zealand; D012449:Safety / Q000331:legislation & jurisprudence; D000073597:Stakeholder Participation
chemical_list: D013287:Illicit Drugs
keywords: commercial drug market; legal highs; new psychoactive substances (NPS); pharmacovigilance; regulation