New PsychoactIve Substances - Evidence Review

6 Responses

Key Findings

• Countries are responding to the growth in demand and supply of NPS in three main ways: enforcement; prevention; and treatment.
• A range of different actions can be taken to place NPS under legal control. These include: adding new substances to the 1961 or 1971 UN Conventions; using the European Early Warning System (EWS) to identify NPS and place them under control; and various national measures which involve using consumer safety or medicines legislation, extending and adapting existing laws and processes, or devising new legislation for new substances.
• Although these measures may have worked to some degree in individual countries, they leave loopholes in the global control system which can be exploited by drug dealers.
• Efforts are also now being made to reduce the demand for NPS by educating young people and implementing targeted prevention initiatives. For example, in Scotland information on NPS is provided on the Know the Score website and to school children through the Choices for Life initiative.
• To date treatment for NPS users who seek formal help is primarily supportive and there is limited information on what constitutes appropriate psychosocial treatment for this group.

6.1 Countries are responding to the growth in demand and supply of NPS, and associated harms, in three main ways: enforcement (i.e. through legal controls); prevention (i.e. trying to stop people taking them in the first place); and treatment (for those experiencing problems from taking NPS). A brief summary of these types of response is given below.

Enforcement

6.2 NPS fall outside the global drug control system, but some governments have adopted either regional or national responses to the issue to protect public health.

International drug control system

6.3 A notification can be made to the UN Secretary General to add a new substance to any of the schedules of the 1961 or 1971 Conventions. An assessment is then made by the World Health Organisation (WHO) which may result in the Commission on Narcotic Drugs deciding to add, transfer or remove the substance from any of the schedules. This has not happened for any NPS yet, but the WHO are looking at a number of substances for risk assessment to take to the Commission on Narcotic Drugs (CND) in March 2015 (Hallam et al, 2014).

Regional responses

6.4 So far, the only regional response to the emergence of NPS is the European Early Warning System (EWS) of the EU. Established in 1997, and extended in 2005 (Council Decision 2005/387/JHA^[10]), the EWS enables the rapid exchange of information on NPS, the assessment of risk and the application of existing control measures to NPS. Each Member State shares information on the manufacture of, trafficking in, use of, and of preparations containing NPS through its Europol National Unit and its representative in the Reitox Network. This information is then shared with Member States, the EC and the European Agency for the Evaluation of Medicinal Products (EMEA). A report is prepared and submitted to the Council of the EU and if necessary, a risk assessment carried out by the EMCDDA. Within 6 weeks of the EC receiving the risk assessment report, the EC must present an initiative to the EU to place the substance under control, or if the EC doesn't find that necessary, then one or more of the EU member states can present an initiative. Then, if the EU decides to place control measures on the new substance, it should do so no later than one year from the date of the decision. By mid-2014, seventeen risk-assessments had been completed, as follows: 25I-NBOMe, AH-7921, MDPV, Methoxetamine, MBDB, 4-MTA, GHB, Ketamine, PMMA, 2C-I, 2C-T-2, 2C-T-7, TMA-2, BZP, Mephedrone, 4-methylamphetamine (4-MA) and 5-(2-aminopropyl)indole (5-IT). Of these, 11 have so far been placed under EU control.

National responses

6.5 Outside of Europe, several countries have taken action to control NPS at the local level, including Japan, New Zealand, Republic of Korea and the USA.

6.6 In Japan, at the Tokyo level in 2005, then at the national level in 2007, new legislative powers were granted to allow control over NPS, prohibiting their advertising, supply and production (with penalties of up to 5 years in prison, or fines of up to 5 million Japanese Yen). Possession for personal use does not constitute an offence. As at November 2012, 90 NPS were controlled under the 2007 law.

6.7 In New Zealand, the 2005 Misuse of Drugs Amendment Act created a new schedule to control the manufacture and sale of new 'restricted substances' for which there was not yet enough evidence of potential harm to prohibit them completely. BZP was placed on the schedule, but in 2008, on the basis of new evidence, it was placed in Schedule 3 (Controlled Drugs). In New Zealand a new Act came into force on 18 July 2013 which places the onus onto manufacturers to prove that their products pose a low risk of harm, prior to receiving approval which allows the products to be legally manufactured and sold (Wilkins et al, 2013). While the regulatory system was being developed, a number of interim retail and product licences had been granted for untested NPS. However, in May 2014, the NZ Government amended the Act to remove all interim approved psychoactive products from the market until further testing confirms they present a low risk of harm to users. A critical assessment of the new regime by Wilkins (2014) concluded that the clinical trials required to test NPS would need to address the characteristics of recreational drug use including binge use, polydrug use, use by vulnerable populations and high risk modes of administration.

6.8 In the Republic of Korea, drugs are controlled under the 'Act on the Control of Narcotics'. Several NPS have been controlled under the Act since the mid 2000s, and it was strengthened further in 2011 by the addition of a new 'temporary scheduling system' which allows the Korean Food and Drug Administration to temporarily schedule NPS for a year (UNODC, 2013a).

6.9 In the USA, the Controlled Substances Act (CSA) provides regulations for the manufacture, importation, possession, use and distribution of certain substances. Temporary scheduling of NPS to avoid imminent hazard to public safety is also possible under the CSA. As well as the CSA, the USA has the 'Federal Analogue Act' which was set up to control substances not specifically listed in the CSA. An 'analogue' drug is defined as a substance which is intended for human consumption and is structurally or pharmacologically substantially similar to, or is represented as being similar to, a Schedule I or Schedule II substance and is not an approved medication in the United States. Although other countries have adopted similar systems, it is acknowledged that the analogue system is not perfect, owing to (a) difficulties defining analogue drugs and (b) what to do with plant based substances that don't meet condition (i) above (UNODC, 2013a).

Other regulatory frameworks

6.10 Several countries have introduced generic or analogue systems to control groups of similar substances to those individually listed, without the need to resort to legislative reform (e.g. UK, Hungary, Luxembourg, Italy, Ireland, Norway, USA). Many governments have also used 'emergency scheduling' to introduce temporary bans on NPS whilst the legislative process is being completed (e.g the UK, Denmark, Germany, Netherlands, Australia, USA). Finally, other regulatory frameworks, such as medicine legislation and consumer safety regulations have been used, primarily to control the sale of NPS (UNODC, 2013a).

6.11 In the UK, the government has control of substances under the Misuse of Drugs Act 1971. If a drug is causing sufficient concern, the UK Government (following consultation with the Advisory Council on the Misuse of Drugs (ACMD) can issue a Temporary Class Drugs Order for up to 12 months. This bans the import and supply of a substance but does not make possession a criminal offence. The ACMD then has 12 months to investigate and recommend classification if they consider there is sufficient evidence. In 2013, new categories of synthetic cannabinoids, methoxetamine and other compounds related to ketamine and phencyclidine were all made Class B drugs. 'NBOMe' and 'Benzofury' became subject to a Temporary Class Drug Order (TCDO) in June 2013 for a period of up to 12 months (Public Health England, 2013c). As of 10 June 2014, they became fully controlled as Class A and Class B drugs respectively (Home Office, 2014).

6.12 The UNODC's review of approaches recommended a global Early Warning System in order to inform Member States about the emergence of NPS on the market. This is now in place, entitled the 'Early Warning Advisory' and provides: a selected bibliography on NPS aimed to inform Member States, the scientific community and other users on recent available sources on methods for the analysis and identification of NPS; selected articles on the toxicology/pharmacology of NPS, use and treatment; as well as identified legislative responses to counteract the challenge of NPS (UNODC, 2014b). Alternative approaches to scheduling an ever larger number of substances have had some success in lowering NPS prevalence rates. However, the potential for supply and demand to simply shift to new substances must be kept in mind. In the long run, some form of common approach to NPS at the international level would be desirable. Although various approaches may have worked to some degree in individual countries, there are now multiple separate control regimes, leaving loopholes in the control system at the global level which drug manufacturers can exploit (UNODC, 2013b).

Prevention

6.13 To date, measures to reduce the demand for, and supply of, NPS have largely focussed on control measures, with countries using a mixture of market regulations, existing drug control legislation and new laws (see above). In addition, providing warnings on the adverse health effects of NPS is one of the activities of the Early Warning System that provides added value to the Member States. In 2012, the EMCDDA issued health alerts for seven NPS and one 'legal high' product (see report for more details) (EMCDDA, 2013b).

6.14 Interest is now growing in addressing the wider issues surrounding NPS, especially the need to understand the potential health and social impact of these drugs and to identify appropriate demand reduction strategies. A key recommendation from the ACMD report on NPS (2011) was that strategies are implemented to reduce the demand for NPS by including NPS in substance misuse education in schools and developing targeted prevention initiatives (ACMD, 2011). Among new approaches being studied are innovative internet-based prevention programmes and the delivery of targeted school based prevention messages (EMCDDA, 2012).

6.15 In the UK, 'legal high' facts, emergency help and drug treatment information are provided by 'talk to Frank''. In Ireland prevention and harm-reduction information on new drugs has been in circulation since 2010. In Poland, 3 prevention campaigns were launched in 2008: a web-based information campaign; meeting between parents and schools; and a universal prevention programme targeting the school population aged 15-18. The Recreational Drugs European Network Project (ReDNet) was a multi-site project funded by the EU's Health Programme to improve the level of information available to young people and professionals about the health risks associated with the use of NPS. An evaluation of the project concluded that web-monitoring activities are essential for mapping the spread of NPS and that technological tools can be used successfully in specific prevention programmes. The involvement of multi-disciplinary international partnerships was, and continues to be, fundamental for responding to the challenges posed by NPS (Corazza et al, 2013).

6.16 In Scotland work has been done to update the prevention messages on NPS, including updating the information available on the Know the Score website, and the development of an information resource, by Police Scotland, on NPS for high school children through the Choices for Life initiative.

6.17 In recognition of the growing problem in Wales, the Advisory Panel on Substance Misuse (APoSM) established a Psychoactive Substances Sub Group, which consisted of a range of stakeholders, to advise how to respond to this issue. The Sub Group recommended a number of preventative and harm reduction approaches which has resulted in the following:

• Working closely with partners to develop a range of education and prevention materials in addition to carrying out a national campaign in conjunction with the national helpline DAN 24/7, Real Radio and the Welsh Rugby Union.
• Developing a warning system whereby any alerts received from across the UK are distributed via the Chief Medical Officer. The purpose of these alerts is to circulate appropriate information to relevant clinical services, and to ask if any services - including Emergency Departments and ambulance teams - are aware of related cases or additional intelligence (Welsh government, 2013).

Treatment

6.18 A key recommendation from the ACMD report on NPS 2011 was for treatment to be provided for those with acute problems (eg within A&E) and dependency (ACMD, 2011). However, to date treatment for NPS users who seek formal help is primarily supportive and there is limited information on what constitutes appropriate psychosocial treatment for this group. In the UK, a multidisciplinary specialist clinic for users of club drugs has been piloted, offering a range of responses including: brief interventions; pharmacological therapies; and planned care support, demonstrating good retention and outcomes (EMCDDA, 2012). The National Treatment Agency states that, with new substances emerging all the time, treatment services must remain vigilant and adaptable (National Treatment Agency, 2012).