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One unintended consequence of current medicines legislation is to leave distributors of ‘legal highs’ unable to disclose the true purpose of their product. General commonsense precautions that apply to any psychoactive drug cannot be given without risking prosecution. The dilemma is what to do between the appearance of a problem, risk assessment and the inevitable but uncertain legislative response.

Typically, when a new psychoactive substance is identified in the drugs market, scientific advisory bodies such as the Advisory Council on the Misuse of Drugs (ACMD) or European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) are requested by legislators to conduct a risk assessment [1]. If a certain level of harm is identified the substance is legislated against, typically under the Misuse of Drugs Act, which sets out drug controls in the United Kingdom. The situation may arise where a risk assessment concludes that there is no or minimal risk—what should we do then?

Substances have been produced and marketed with the explicit aim of circumventing legislative restrictions for several decades. What has changed is an increase in their range, potency, profile and availability. The development of global web-based marketing and distribution networks, as distinct from illegal street markets, has emerged concurrently, challenging further the utility of existing supply reduction strategies.

In 2009 the ACMD recommended the scheduling of 1-benzylpiperazine (BZP) and other piperazine derivatives, the gamma-hydroxybutyrate (GHB) pro-drugs gamma-butyrolactone (GBL) and 1,4 butanediol (Class C) and dozens of cannabinoid receptor agonists (Class B) [2–4], which came into force on 23 December 2009. Collectively, these and other synthetic compounds [e.g. mephedrone, Meow, M-cat (4-methylmethcathionine) and dipheny-2-pyrrolidinemethanol (D2PM)], traditional plant-based products such as herbs (e.g. Salvia divinorum), seeds (e.g. baby Hawaiian woodrose) and fungi (e.g. fly agaric) are known as ‘legal highs’.

To date the impact and consequences of legislation aimed at reducing the use of legal highs have varied between substance and country. In the United States, sanctions against GHB may have contributed to a reduction in use and emergency room presentations [5]. However, no such effect has been seen in Australia [6]. The effect of legal restrictions on the sale of GHB in the United Kingdom in 2003 did not appear to lead to significant reduction in associated mortality and morbidity but may, as was the case in Switzerland, have led to a rise in the use of its pro-drug GBL [7,8], which carries similar risks in overdose and withdrawal [3]. Legislation against GBL (if effective in cutting supply) might result in users presenting to specialist treatment services seeking withdrawal management and aftercare. It is also probable that users will seek alternative substances to substitute for GBL, several of which are readily available.

GHB is not the only example of where legislation against a molecule has led to the rebranding or development of an unsanctioned alternative. In 2002 BZP, a compound with a brief history of use in the United States in the 1990s, was promoted as a legal alternative to methylamphetamine in New Zealand. It rapidly became popular locally and was exported widely, often blended with 1-[3-(trifluoromethyl)phenyl] piperazine (TFMPP), the combination allegedly producing effects similar to ecstasy (3,4-methylenedioxymethamphetamine, MDMA). Adverse effects became apparent [9] and New Zealand introduced legal controls which resulted in the removal of BZP-containing products from the isolated New Zealand drug market. However ‘BZP-free’ products emerged promptly, containing compounds never used as drugs before, such as D2PM and mephedrone with unknown toxicity. Other less obvious consequences are also apparent. Follow-up studies of New Zealand users suggested that the ban on BZP led users to move towards the illicit market [10]. In the United Kingdom we have noted that the migration of similar compounds to ‘ecstasy’ tablets sold on the illicit market are now found to contain piperazines, often m-chlorophenylpiperazine (mCPP) instead of MDMA [11]. Thus, when a substance is removed from the drug market, it is likely to be replaced immediately.

In considering the consequences of legislation and approaches to reducing associated harm, the attraction for users needs to be considered. Factors such as price, availability, value for money, sought-after effect and perceived legal and physiological harms are all-important. Legal highs are priced competitively compared to their illicit counterparts [2] and are obtainable easily through shop fronts or from the internet. Some are marketed as ‘herbal highs’ to capitalize on the perception that they may be ‘safe’ and ‘natural’. Whether or not these substances are attracting a group of otherwise naive drug users is uncertain, but the possibility that they may act as a gateway to illicit drug use cannot be discounted.

Users may also escape detection through work-place or roadside drug testing. The fact that many of these drugs enjoy a window of relative invisibility while forensic science plays catch-up means that, for some, their attractiveness may remain despite legal sanctions [12].

Surprisingly many synthetic ‘legal highs’ may not be legal. Even if they have no history of previous use as drugs, substances called ‘Instantly Smashed’, ‘X4 Ecstasy’ and ‘Part E Pills’ may be liable to control under the Medicines Act (which governs the manufacture and supply of medicines in the United Kingdom) [13]. However claims that they are ‘plant feeders’, ‘bath salts’ and ‘not for human consumption’ may frustrate prosecution and while other legislative responses could be considered there is no precedent. Potential risks may be increased as a direct consequence of such obfuscation, with poor consumer information and people using high doses [14] (suspecting they are not as potent as illicit substances) or mixing with alcohol or other drugs [15].

Therefore, should a risk assessment determine that a compound was relatively harmless (aside from short-term behavioural risks associated with any form of intoxication), approaches other than the Misuse of Drugs Act could be considered. The application of the Medicines Act, for example, would require manufacturers to provide evidence of the safety of their products [16]. Web sales and distribution could be banned and availability restricted though licensing of vendors, the establishment of legal requirements of sale (as with alcohol and tobacco products) and restricted advertising [17]. Accurate information about product composition, standardization, quality control, dose recommendations [15] and contraindications could be enforced under existing consumer protection legislation. Products could be taxed accordingly.

While in no way does ‘legal’ confer relative safety, it does mean that a broader repertoire of responses is available. When a drug is made illegal, controls are limited to supply reduction and harm minimization.

The capacity to detect and respond effectively to harm early can occur only when data from diverse sources are collected routinely, collated and acted upon. Longitudinal integrated monitoring systems incorporating international data from emergency departments, treatment services, toxicology services, police, sentinel groups and the internet are required. Such systems would also allow for the impact of legislation on the global burden of drug-related harm to be assessed, including the impact upon the appeal, price and purity of existing illicit markets.

The medical ethic of ‘first do no harm’ needs to be applied when determining the most effective strategies in keeping users and the community safe from drug-related harms.

Acknowledgements

  1. Top of page
  2. Declarations of interest
  3. Acknowledgements
  4. References

The authors thank Les King and Kyle Dyer for the helpful comments on the paper and Katherine Berry for invaluable editorial assistance.

References

  1. Top of page
  2. Declarations of interest
  3. Acknowledgements
  4. References