New psychoactive substances are easily available on the market; they are legal in spite of their danger. What can legislation do to keep up? In order to protect the health of individuals who use NPS, New Zealand has decided to regulate the market. It is now possible to sell these drugs legally in New Zealand – if you prove that they pose no more than a low risk of harm to individuals who use it. A global overview and a Swedish perspective will also be presented.

  • Mike Sabin, Member of parliament, New Zealand
  • Martin Raithelhuber, Illicit Synthetic Drugs Expert, United Nations Office on Drugs and Crime (UNODC)
  • Peter Hultén, General Secretary of the European Association of Poisons Centres and Clinical Toxicologists at Swedish Poisons Information Centre
Moderator: Jonas Hartelius, Special advisor, Carnegie Institute, Sweden

Jonas Hartelius opened the panel setting the stage for a discussion of one of the newest but growing challenges of the modern drug epidemic, the tsunami of new psychoactive substances.

Currently, there are scientific and forensic problems related to monitoring the market, analyzing the substances and assessing the hazards of the substances. Once the knowledge is collected about a substance, steps can be taken to schedule it.

Only 10 opiates of an estimated 4,000 have been scheduled in Sweden. There is a magnificent task ahead in terms of the number of new psychoactive drugs, identifying what they do and how to control them.

Mike Sabin provided an overview of the problem of psychoactive substances in New Zealand and the recent legislative changes made to address this problem. New psychoactive substances (NPS), or so-called “legal highs” are new chemical compounds that are intended to mimic the effects of scheduled drugs.

There is an endlessly long list of chemicals that can be changed to become an NPS.

Since the early 1990s, there has been an increase in drug use and harms from that use in New Zealand, driven by cannabis and pure methamphetamine use. The drug culture is different in New Zealand than in Europe. Binge use is common. As a result of this reality, the nation is working to spearhead drug policy solutions.

The country had a drug policy based on harm minimization since the mid-1990s. Mr. Sabin stressed that rather than harm reduction or minimization, harm prevention should be the goal of policy. Why is it with narcotic drugs that we wait until problem use before intervening? The direction of policy should be centered around prevention.

Tobacco policy has been very successful. Tobacco use is no longer acceptable in same way that it was 20 years ago.

Alcohol laws were liberalized in 1999 in New Zealand in which the purchase age from age 21 to age 18. Alcohol was then sold in the supermarket. As a result, binge drinking increased dramatically.

New Zealand has experienced an increase in the availability of high-potency cannabis (up to 35% THC) and pure methamphetamine. From 2000-2005, New Zealand had the highest population prevalence of methamphetamine in the world and in 2007 had the highest prevalence of marijuana use. New Zealand conducts good research on substance use.

NPS first became a problem in New Zealand in 2000. The term “legal high” implies acceptance as does “recreational” drug use. NPs are referred to as legal highs because the substances are not themselves illegal. The law is silent about NPS until they are used in a manner that would constitute as harmful. But the legal status of a substance will never alter its chemical components.

In New Zealand a BZP-based drug was advertised as a “safe legal alternative to methamphetamine. The country has seen an increase in methamphetamine use where getting high is normal part of growing up. Many people shifted from using new psychoactive substances to methamphetamine.

Presently, the youth in New Zealand are growing up with higher potency cannabis and are using at a greater prevalence. An increase of NPS have been sold on liquor stores, among others. Between 2008-2012, 300 products emerged, predominantly synthetic marijuana. A significant problem is that NPS are continually changing. Scheduling NPS is a cumbersome process of identifying a new product, determining the harms it causes, implementing temporary class status, legislation to schedule the drug and then between 6 and 12 months to pass the law.

In 2011, New Zealand instituted temporary bans on NPS to enable scheduling harmful products. By 2012 over 40 products had been banned using this “cat and mouse” system where the manufacturers of these substances tweaked their formula and the substance was no longer scheduled.

In July 2013, new legislation was introduced aimed at addressing manufacturers’ ability to beat legislation, entitled the Psychoactive Substances Bill. This bill treats NPS like any other food product where the manufacturer of a NPS has to demonstrate that the substance will be safe, and that there is either no harm or “low risk” of harm from its use. To do that a manufacturer will spend millions of dollars, conduct clinical trials and show that a drug is “low risk” meaning won’t produce addiction. Ultimately, a drug that is acceptable should not produce a high.

New Zealand established an expert advisory group and regulatory authority to asses products and regulate sales. The regime of clinical testing implemented including animal trials for the substances and sales were restricted to persons age 18 and older with other limitations on advertising, product labeling and location of sales.

At the time, 200-300 products were banned, and a total of 47 products were granted interim approval to remain on the market because at time there was no evidence of harm. Approximately 3000-4000 outlets were closed for retail sales and 150 retailers were given interim licenses.

There was tremendous public backlash against the law, including protest marches related to the animal testing provisions. By December 2013 the movement gained momentum and there was concern from the public that the government was endorsing drug use. Although the public wanted the NPS gone, the public didn’t understand that the government could not keep up with the regulation process.

In early 2014, a media campaign began showing lines of users waiting to buy NPS. By March 2014 there were marches and protests calling for blanket bans.

In response, on May 5, 2014 the government passed urgent legislation introduced to remove 47 products removed pending approval through the clinical trial process. The criteria for animal testing were removed and thus, products go through for human clinical trials. The legislation raises the bar for manufacturers in that they must come up with cause for conducting human trials.

Mr. Sabin noted that in spite of the reaction to New Zealand’s NPS system of regulation, a new lobby has emerged promoting the decriminalization/legislation of cannabis. He noted that if cannabis were subjected to the standards of NPS, it would not pass. More people are hospitalized in New Zealand for cannabis-related problems than any other drug.

Mr. Sabin concluded by emphasizing that laws should set the direction of civil society and that laws are for the populous to influence the majority of people who will obey them; and to have consequences for those who will not follow.

Martin Raithelhuber, PhD provided a global perspective on new psychoactive substances (NPS) from his work at the United Nations Office on Drugs and Crime (UNODC) in Vienna. The UNODC definition of NPS includes that it is a substance of abuse that is not covered in the UN Conventions, it may pose a public health threat and is recently available. There are different classes of NPS as they typically mimic other drugs. For example, synthetic cannabinoids (‘spice’) produce cannabis-like effects and synthetic cathinones (mephedrone) are stimulants that mimic amphetamines.

When using an NPS a user cannot rely on what is on the packaging. These substances are sold as other products, advertised for other uses, and their contents are not known. NPS are associated with serious health risks, though many risks are unknown. Many NPS are more intense and higher potency, at lower doses, and there are few studies on the impacts of these drugs.

In terms of health services, it is difficult to treat effects of drugs in emergency cases to determine the correct medical response. Adding to the complexity, laboratories may not be able to identify range of NPS available.

NPS have emerged in over 90 countries globally beyond Europe and North America to Latin America, Africa and Southeast Asia. By 2013, 348 substances were reported to UNODC globally and the number is increasing by the month.

To create an NPS, designers take the basic structure of a drug and identify areas where the compounds can be modified, replaced or otherwise changed. This is why there are so many new psychoactive substances.

Since 2008-2009 UNODC has been counting NPS not covered by international drug conventions. The number of NPS already exceeds number of controlled substances. To determine which NPS are successful on the market, UNODC is looking at the frequency of NPS reported within its global network of laboratories. Low frequency indicates that the NPS is less successful.

National legislative responses to NPS have included banning the sale of a specific substance, instituting temporary bans and rapid procedures for NPS and generic legislation to look at groups of NPS that cause harm.

New changes with regard to NPS include the establishment by UNODC of an Early Warning Advisory, and new high-tech technology is being developed for rapid NPS detection using portable devices.

UNODC is releasing its Global Synthetic Drugs Assessment 2014 (NOW AVAILABLE HERE)

Dr. Raithelhuber confirmed that UNODC is using the term NPS to try to eliminate terms like “designer drug” and “legal high” because of connotations that they are legal, chic, and acceptable.

Dr. Raithelhuber concluded his presentation by recognizing that the internet has played an important part of the development of NPS and their sales. The internet is an as acceptable tool to exchange information on chemistry worldwide, proving tools to allow financial transactions (e.g. paypal, bits which are difficult to trace), and its use as a communication channel. Chemists exchange their experiences on blogs, networks, etc. about what formulations of NPS worked and what failed. These elements are key factors in making the emergence of NPS a global phenomenon.

Peter Hultén, MSc began his presentation about new psychoactive substances (NPS) by reflecting on the fact that he began at the Swedish Poisons Information Centre as a one-person team and now he is part of a five-person team. This is a direct reflection of the increase in prevalence of NPS in Sweden.

His organization takes 82,000 calls each year, though not all are about NPS. They are interested in the clinical toxicology of the NPS, specifically acute poisonings and examining the effects and risks of these substances

To evaluate these effects and risks the office follows NPS through telephone inquiries; medical records from hospitals; journal articles internal monograph updates; participating in the NADiS (Network for the present drug situation in Scandinavia) advisory group; and STRIDA (national project for monitoring il(legal) internet drugs) which in 2010 started analyzing urine/blood samples for NPS. Presently it is rare to have data about living intoxications rather than lethal exposures to drugs which is why this data is so helpful. Internet surveillance on NPS is difficult.

From 2000 to 2013 Swedish Poisons Info Centre experienced a dramatic increase in the number of calls related to NPS whereas calls related to scheduled illicit drugs have remained steady over this time. Cathinoine-derivatives are the focus of most NPS calls.

In Sweden the NADiS Network monitors NPS providing expert guidance to responsible authorities to inform their role in controlling NPS.

There are two ways to address NPS in Sweden. Drugs are scheduled one-by-one which is a lot of work and it is difficult to keep up with the vast number of NPS. An alternative is to list a substance as “Goods Dangerous to Health”. There are presently 83 substances on a waiting list for investigation on how to go about controlling these drugs.

The Poisons information Centre looks at number of inquiries for NPS and the number of positive urine/blood samples from STRIDA to evaluate the status of an NPS.

The prevalence and impact of an NPS can be monitored in different ways. While MXE, a ketamine-like substance was first confirmed in a sample in 2010, calls about its use occurred in 2011 through early 2012. Along with those calls were more analytic confirmations. After it was scheduled, the use of MXE declined. There are no recent confirmation tests and inquiries. Similar patterns were seen for 4-OH-MET and 5-IT

MDPV entered the market in 2008 after methadrone. During 2010, there were calls and it was scheduled as a narcotic drug. In 2012 there was an increase in calls and confirmed cases (about 20 per month), and Sweden still has a problem with this NPS drug, receiving about 200 calls each year.

The Swedish city of Vasteras saw an increase in MDPV-inquires. During that time Google trends for “MDPV” searches increased and could be traced to that region in Sweden.

Jonas Hartelius added that after the criminal sanctions for MDPV were lowered, police investigators saw an increase in sales. There was subsequently a large increase in confirmations in STRIDA-samples for MDPV

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