The Novel Psychoactive Substances in the UK Project: empirical and conceptual review work to produce research recommendations

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Chapter 1 Introduction and background

This report presents the findings from a National Institute for Health Research (NIHR) Public Health Research (PHR)-funded programme of work to inform the development of public health intervention research on novel psychoactive substances (NPS) through systematically reviewing existing data on their use in the UK and the problems associated with, and the potential responses to, such use.

This chapter provides the background and rationale for conducting this research and describes the research objectives. This chapter also provides content as it existed at the outset of this research (i.e. prior to the implementation of the Psychoactive Substances Act in 2016). 1 The remainder of the report is divided into the following chapters, which represent the phases of the study:

• Chapter 2 – scoping review with a narrative synthesis of selected bodies of evidence on what is known about NPS use and the related harms of, and responses to, such use

• Chapter 3 – what might an evidence-informed public health approach to NPS use in the UK look like? A conceptual framework

• Chapter 4 – public involvement (PI)

• Chapter 5 – research recommendations.

Chapter 2 Scoping review with a narrative synthesis of selected bodies of evidence on what is known about novel psychoactive substance use, related harms and responses

Results

Evidence map

Literature searches

A total of 13,772 records were identified through electronic databases searches. A further 3260 were obtained through other sources, including contacting key researchers and policy experts (Figure 1). Of the 19 key researchers contacted, six responded, with four providing further records of published literature and one stating that the full results of one study had not yet been published. Policy experts provided four further records. A total of 995 articles were eligible for inclusion in the review after removing duplicates and screening titles, abstracts and, where necessary, full texts. 3,5,7,10,11,15,16,25–1008

FIGURE 1.

Flow of articles for the evidence mapping.

Of the 542 records excluded after reviewing the full texts, the main reasons for exclusion were not being specific to NPS (e.g. recreational drug use, club drug use, substance use/abuse, psychoactive substance use without presenting data on NPS use separately) (n = 211); being on drugs that are not included as NPS in the review [e.g. specific to illicit drug use, alcohol, tobacco, ketamine, khat, gamma-hydroxybutyrate (GHB) or gamma-butyrolactone (GBL)] (n = 107); being on the detection, identification and quantification of NPS, including methods validation (n = 69); being comments, editorials or letters to an editor within new primary or secondary data (n = 65); or being in a language other than English (n = 56). Most of the remaining 34 records were either Acts, regulations or drug schedules, or descriptions of surveillance and pharmacovigilance systems.

Characteristics of included articles

General characteristics of the 995 included articles in terms of the principal focus, setting, NPS type, study design and publication type are briefly summarised in Table 1. The majority of articles reported on problems or harms attributable to the use of NPS. Many of the articles focused on multiple issues, as represented in Figure 2. Synthetic cannabinoids and synthetic cathinones were the NPS that were most reported on, with case report/series being the most popular study design, followed by non-systematic literature reviews. Most articles reported on general hospital settings, followed by specialist settings. Within hospital settings, most articles were for emergency departments (EDs) (n = 236 reports), while within specialist settings, most articles were for poison centres (n = 65 reports). A total of 252 of the included reports were not specific to a particular setting.

TABLE 1 - General characteristics of included articles

A&E, accident and emergency; ED, emergency department; RCT, randomised controlled trial.

Characteristics	Distribution (n)
Principal focus
Use	385
Problems/harms	773
Responses	148
NPS type
All NPS	259
Synthetic cannabinoids	310
Synthetic cathinones	271
Phenethylamines	69
Piperazines	29
Other	114
Setting
Specialist settings (addiction treatment, psychiatric treatment, forensic and rehabilitation, poison centres, needle exchanges, other similar settings)	134
General hospital (inpatient, A&E/ED, outpatient settings)	294
Primary care setting	3
Educational setting (school, higher educational institutions such as university/college)	32
Criminal justice	9
Police	27
Defence forces (Air Force, Army, Navy)	9
Community setting	64
Home	27
Club/disco/dance scene	14
Internet	59
Data registry	13
EWSs	9
Research setting	22
Other	21
Not applicable	252
Not reported	24
Study design
Systematic review	10
Literature review	243
RCT	13
Survey	130
Laboratory sample analysis	58
Secondary quantitative data analysis	99
Prospective cohort studies	6
Case–control	1
Qualitative study	47
Case series/reports	367
Other	64
Publication type
Peer-reviewed journal article	654
Peer-reviewed report	1
Non-peer-reviewed article/report	119
Conference abstracts	205
Book	4
Dissertation	1
Online discussion forum	4

FIGURE 2.

Principal focus.

Most of the categories above are not mutually exclusive. For example, some articles use multiple study designs. Another example is presented in Figure 2 for principal focus.

Principal focus

The majority of reports were on problems/harms to individual NPS users. It is, however, important to note that many articles had more than one focus, as demonstrated in Figure 2.

Use

Of the 385 reports on NPS use, 117 presented survey data. The remaining 268 articles presenting NPS use data were case reports/series (n = 20); laboratory sample analyses (n = 39); qualitative studies (n = 39); randomised controlled trials (RCTs) (n = 1); reviews (n = 124); secondary qualitative data analyses (n = 49); systematic reviews (n = 1); prospective cohort studies (n = 2);215,976 or other designs (n = 21).

The 117 NPS use articles based on survey data comprise 13 national surveys and 104 surveys of subpopulations or convenience samples. Of the 13 national surveys, seven were conducted among adults, of which three were conducted in the UK, two in the USA, and one each in Canada and New Zealand. Two were conducted among young people (one covering Europe and the other covering Poland), and four were in schools (two in the UK, and one each in the USA and Romania). In terms of NPS type, of the 117 surveys presenting NPS use data, 54 provided data on all NPS, 28 provided data on synthetic cathinones, 25 provided data on synthetic cannabinoids, 4 provided data on piperazines, 1 provided data on phenethylamines and 19 provided data on other NPS.

UK survey data are presented in detail below (see UK survey data).

Problems

The 773 articles on problems attributable to NPS comprised at least 566 primary studies or secondary quantitative data analysis and 211 evidence syntheses; among these, four included both a primary study and evidence synthesis (Table 2).

TABLE 2 - Study design of reports on problems/harms attributable to NPS

Study design	Frequency
Primary studies and secondary quantitative data analyses (N = 566)
RCTs	12
Surveys	44
Prospective cohort studies	4
Case–control	1
Secondary quantitative data analyses	78
Laboratory analysis	27
Qualitative studies	33
Case reports/series	367
Evidence syntheses (N = 211)
Systematic reviews	10
Reviews	201

Of the 10 systematic reviews, one was on all NPS, five were on synthetic cannabinoids, two were on synthetic cathinones and two were on phenethylamines. More details of these 10 systematic reviews are provided within the narrative synthesis results section (see Systematic reviews).

Responses

Of the 148 reports on responses to NPS use, 17 were quantitative policy evaluation reports mainly evaluating legislative policy responses utilising before-and-after comparisons. Six reports were qualitative studies of legislative policy responses, 84 were policy discussion papers, 34 reports were on the clinical management of NPS users, 13 were on interventions to increase awareness and understanding of NPS among clinicians and members of the public and 5 were on harm reduction. Two reports were quantitative surveys of opinions on policy responses and another two classified under ‘other’ were on forensic science and research responses.

The quantitative policy evaluation studies are presented in more detail below (see Responses to novel psychoactive substance use and problems/harms).

Year of publication

The number of records by year of publication is shown in Figure 3.

FIGURE 3.

Number of records by year of publication for 2006–15.

There has been a year-on-year increase in the number of publications on NPS between 2009 and 2014. Although there is a slight dip in 2015, this may reflect the fact that, at the time of searching, not all studies published in 2015 had yet been added to the bibliographic databases. Therefore, we cannot yet confirm whether or not this trend continued into 2015. This general trend is also observed for principal focus (Figure 4), for NPS type, except for synthetic cathinones and piperazines (Figure 5), and for peer-reviewed journal articles and non-peer-reviewed journal articles and reports (Figure 6). Our search also identified 198 records from 2016 and nine records that did not have a publication date.

FIGURE 4.

Number of records by year of publication and principal focus for 2006–15.

FIGURE 5.

Number of records by year of publication and NPS type for 2006–15.

FIGURE 6.

Number of records by year of publication and publication type for 2006–15.

There were 85 records on use, 143 on problems/harms and 26 on responses also identified from 2016, and six records on use, eight on problems/harms and two on responses that did not have a publication year.

Of the records identified for 2016 (up to 29 June 2016), 71 were for synthetic cannabinoids, 34 were for synthetic cathinones, 6 each were for phenethylamines and piperazines, 24 were for other NPS and 72 were on all NPS. Of the nine records with no publication year, one was on synthetic cathinones, one was on other NPS and seven were on all NPS types.

For 2016, 114 peer-reviewed journal articles, 13 non-peer-reviewed journal articles/reports and 63 conference abstracts were identified. Peer-reviewed reports, books, dissertations and online discussion forums have not been included in the graph as the numbers are too low.

Figure 7 shows the number of records by year of publication and study design. The general trend for case reports/series, reviews, systematic reviews, surveys and qualitative studies was an increase up to 2013/14 and then a decrease. However, there is a general increase in the number of qualitative studies, RCTs and other research designs. The nine records with no publication year include qualitative studies (two records), reviews (two records), a survey, a case report and four records in the ‘other’ category. There was also a prospective cohort study for both 2013 and 2015, and a case–control study in 2015. Of the identified 2016 records, 2 were systematic reviews, 40 were reviews, 34 were surveys, 53 were case reports/series, 20 were laboratory sample analyses, 12 were qualitative studies, 5 were RCTs, 26 were secondary qualitative data analyses and 4 were prospective cohort studies. A total of 15 fell into the ‘other’ category and there were no case–control studies identified for 2016.

FIGURE 7.

Number of records by year of publication and study design for 2006–15.

Geographical location

Table 3 shows the number of articles included by geographic region where the study was conducted. A total of 19 of the 185 articles reporting on the UK also reported on at least one other country in Europe (this figure is also included in the 200 under the ‘Rest of Europe’ category but excluded from the ‘Multiregional’ category). The ‘not applicable’ category comprises reviews and systematic reviews that are international in nature, summarising data from different regions.

TABLE 3 - Number of studies by geographic region

Region	Distribution (n)
UK	185
Rest of Europe	200
North America	294
Australia/New Zealand	58
Africa	0
Asia	29
Middle East	7
Multiregional	22
Not applicable	216

Novel psychoactive substance type

The figures below show percentage of records by NPS type and study design (Figure 8), region (Figure 9), setting (Figure 10) and publication type (Figure 11).

FIGURE 8.

Percentage of records by NPS type and study design.

FIGURE 9.

Percentage of records by NPS type and study region.

FIGURE 10.

Percentage of records by NPS type and study setting. N/A, not applicable; NR, not reported.

FIGURE 11.

The percentage of records by publication type for each NPS category.

For most NPS types, the majority of studies were case reports/series, reviews or surveys. Prospective cohort and case–control studies are not represented here because of very low numbers.

The majority of studies on synthetic cannabinoids, synthetic cathinones and phenethylamines were conducted in North America, whereas the majority of studies on piperazines were conducted in Australia/New Zealand. Articles that looked at NPS in general were mostly from the UK and the rest of Europe.

The majority of studies on synthetic cannabinoids, synthetic cathinones and phenethylamines were conducted in general hospital settings. However, the majority of studies on piperazines were either conducted in research settings or not specific to any setting.

Most articles were peer-reviewed journal articles for each NPS category.

Study design

Figure 12 summarises the percentage of records by publication type for each study design category.

FIGURE 12.

The percentage of records by publication type for each study design category.

Most types of study designs were published as peer-reviewed journal articles. There were also three peer-reviewed articles and three conference abstracts on prospective cohort studies, one peer-reviewed article for a case–control study, four online drug forums and one dissertation that conducted secondary quantitative data analyses.

Summary of the evidence mapping

We identified a very large number of relevant reports (n = 995). However, despite the large volume of literature in this area, large gaps in the evidence base still remain, presumably owing to its recent development. It is, therefore, challenging to both summarise this literature and prioritise areas of the evidence base that require more detailed evidence synthesis.

In order to structure this summary and make decisions about further synthesis, we return to the a priori research questions on NPS use, NPS-related problems/harms and responses introduced at the beginning of this chapter. We briefly summarise the data available in relation to each initial question as the basis for an assessment of whether or not there were sufficient data to conduct more detailed syntheses.

Novel psychoactive substance use

1. What are the prevalence and patterns of NPS use in the UK general population and do they differ in particular subgroups of the population?

   We identified studies on prevalence and patterns of NPS use in the UK (see Table 4). These comprised nationally representative surveys in adults [such as the Crime Survey for England and Wales (CSEW)963 and the Scottish Crime and Justice Survey (SCJS)1009] and school children (such as the Smoking, Drinking, and Drug Use Among Young People in England in 2014 survey925) which indicate that NPS use is relatively rare at the population level (between 1% and 2%). Population prevalence rates for mephedrone use are declining; however, it is not yet possible to assess trends over time for NPS use as a whole. Surveys in targeted subgroups thought to be more likely to engage in NPS use have been conducted. Most data relate to attendees of gay-friendly nightclubs, where a similar pattern of a decline in mephedrone use has been identified. Therefore, the prevalence and patterns of NPS use in the UK is a promising area of research, which suggests that a more detailed synthesis of these data will be informative.

2. How do existing patterns of both legal and illegal drug use and social and other risk factors influence NPS use?

   There is limited preliminary evidence, as this research question does not appear to have been investigated in a dedicated manner. It would be challenging to provide even basic information on this subject. Therefore, there does not appear to be sufficient data available to conduct a more detailed synthesis.

3. Which other population-level risk factors influence NPS use?

   There are nationally representative survey data suggesting that males rather than females and younger adults rather than adults as a whole are more likely to engage in NPS use. However, we identified very few data on other population-level risk factors that influence NPS use. Given the limited exploration of these risk factors, we concluded that there were insufficient data to conduct further evidence syntheses. However, we decided that data on age and sex should be considered in the context of the national survey data on prevalence (see Narrative synthesis).

Novel psychoactive substance-related problems/harms

1. Which acute intoxication problems are associated with NPS use?

   There were a large number of case reports and case series on intoxication problems associated with NPS [e.g. attending accident and emergency (A&E) services after NPS use]. However, there were little or no population-level data other than registries of drug-related deaths. These data have begun to be synthesised and we identified 10 published systematic reviews (see Table 5). Given the size of the literature and the limited quality of the primary studies, the priority for synthesis appears to be summarising the findings of systematic reviews in this area, including an assessment of the extent to which this large volume of literature on case reports and registry data has been covered by these reviews.

2. What problems are associated with long-term regular NPS use?

   We identified very limited epidemiological data on problems associated with regular NPS use (such as symptoms of dependence, physical health problems and enduring mental health problems). However, this has begun to be explored in qualitative studies in NPS using populations. We identified seven qualitative studies in nine papers and, therefore, we synthesise these studies in more detail in subsequent sections of the report.

3. In addition to intoxication, long-term regular use and dependence problems, are there other types of NPS-specific problems or other problems associated with NPS use?

   Social and health harms associated with NPS use other than the types described above do not appear to have been investigated. Therefore, we concluded that it would be premature to conduct further syntheses, and, indeed, it may be better to pursue such questions in future research in the first instance in relation to specific NPS drugs or drug types rather than for NPS as a whole.

Responses

1. Are there dedicated primary or secondary prevention interventions in the UK and, if so, what is known about their outcomes?

   We did not identify evidence on primary or secondary prevention interventions in the UK; therefore, further syntheses are not currently possible.

2. Which generic interventions (early in life and early in drug-using careers) target NPS?

   We did identify some treatment audit data that show the proportions of people who use NPS receiving drug treatment services. However, no specific data exist on the content of these interventions and, therefore, there are very limited opportunities to conduct further syntheses.

3. How extensively does current generic UK drug prevention practice cover NPS?

   We did not find any data to inform a response to this question; therefore, no further evidence synthesis was conducted. Although there are policies such as the Psychoactive Substances Act 20161 and publicly available educational resources such as Talk to Frank (see www.talktofrank.com) that incorporate NPS, there were no data available for inclusion.

4. How good are treatment outcomes for NPS?

   We did not find any studies to inform a response to this question; therefore, no further synthesis was conducted.

5. What promising approaches are currently available, or can be made available, in the UK for intervening with NPS use?

   Although limited, there are data on NPS responses that indicate the need for further exploration. For example, key policy responses at present in many countries around the world involve the prohibition of NPS possession or supply. We have identified studies that have begun to evaluate the effectiveness of such responses, which we shall therefore further examine in the narrative synthesis (see Table 6).

6. What are the population-level or social structural factors limiting the effects of individual-level interventions?

   We did not find any data to inform a response to this question. Therefore, we did not conduct further evidence syntheses.

There were also three methodological questions as follows:

1. What is the nature of the current EWS provision?

2. Are there sentinel populations capable of being monitored to provide early warnings of new trends?

3. What are the issues raised by uncertainties about the identities of substances being used?

We did identify some data that were relevant to all three questions, although this related to the substantive areas such as descriptions of EWSs, sentinel population studies and detection, identification and quantification of substances (including waste water analysis, use of the world wide web and validation of analytical methods). Such topics are already covered elsewhere in the evidence mapping, and as the studies are not methodological in nature, it would be impractical to identify methodological issues across the literature as a whole. We therefore have no basis for any further methodological syntheses within this study.

Interim conclusions

We have identified a number of areas of the NPS evidence base in which there has been very limited research. For example, there are very limited data on epidemiological studies of the long-term harms of NPS, outcomes associated with current UK prevention provision for NPS use, and outcomes associated with the effectiveness of psychosocial interventions for NPS use.

We identified UK prevalence data on NPS use both at a general population level and in potential sentinel populations. Initial scoping suggests that this is an area that requires more detailed synthesis to assess current findings and future research needs. Similarly, given the importance of legislation and other policy initiatives on NPS use, synthesising studies evaluating the effectiveness of these types of responses should be useful. There is also a need to explore further the qualitative studies that we identified on long-term harms and other subjects to inform future research. Finally, there is a relatively large body of literature on harms and problems associated with NPS use, although this mainly consists of case reports and case series. In addition, we identified systematic reviews of harms and problems that seek to synthesise some of this literature. We judged that a detailed synthesis of the primary literature may be useful, although a review of existing systematic reviews should be considered before any synthesis of the primary literature. Therefore, we made a pragmatic decision to summarise these reviews, judging this to be of greater priority given the size and scope of our project.

Conclusions

Main findings

The main finding is that the literature on NPS use, problems and responses is currently at a very early stage of development in terms of being capable of informing public health decision-making. Nationally representative surveys on prevalence are available for the UK. However, the most comprehensive data are on mephedrone, with data on NPS use as a whole, and on particular NPS other than mephedrone being much less developed, and comparisons across years are not yet possible. Data on reasons for, and patterns of, use are largely limited to a small number of qualitative studies.

For problems or harms attributable to NPS use, we identified a large number of case reports/case series of acute intoxication, toxicity, emergency presentation or similar data. There were also 10 systematic reviews of this literature, which mostly reported psychiatric and other neurological manifestations and cardiovascular, renal and gastrointestinal adverse effects, the treatment of which was mostly observation and supportive care. There are also limited data on subjective adverse effects of NPS use from few qualitative studies. Literature on acute health harms in a population context is also limited, as is literature on adverse effects attributable to long-term regular NPS use and chronic health or social harms in a longitudinal context.

We identified studies evaluating the effectiveness of regulation or prohibition of NPS possession or supply. Seventeen of these studies were quantitative evaluation studies, 16 of which evaluated the effects of legislative prohibitions of NPS use or supply, and one of which evaluated a multicomponent intervention comprising surveillance, reporting, law enforcement partnership and legislative changes. Overall, the studies reported generally favourable effects on a number of outcome including access, use, health-care utilisation and self-reported exposure and toxicity. However, most outcomes were simple counts of routinely collected data (poison centre/hospital admissions data) and all studies were before-and-after comparisons without any controls, which makes rigorous attribution of changes to intervention effects challenging.

Strengths and limitations of the study

Strengths

This study utilised a multistaged, multipronged analytical approach, as summarised in Figure 13. This involved the development of a conceptual framework hypothesising an evidence-informed public health approach to NPS use in the UK (see Chapter 3) and systematic review work that comprised a scoping review evidence mapping stage, evidence gap analysis in relation to a priori research questions and a narrative presentation/synthesis of four selected bodies of literature. Two researchers independently selected articles and extracted data in order to minimise selection bias and errors in data extraction. The findings of the scoping review were interpreted in light of the conceptual framework. Together, these strands of conceptual and empirical research were used as the basis of a set of research recommendations. Although the review and conceptual framework findings were quite distinct, the analytical approach afforded high-level integration of findings, with the main observation being that the existing literature does not resemble what we think may be needed for an evidence-informed public health strategic approach, and there is a reasonable level of support for our view in the research recommendations made in the existing studies themselves. In addition to what is presented in Figure 13, the findings of the review work, conceptual framework and the draft research recommendations derived from these were shared and discussed with one NPS user, five user carers (who attended a group discussion at a face-to-face user carer forum), four policy-makers and five researchers (who constituted the project steering group; see Chapter 4). The feedback from these three groups was utilised to refine and finalise the research recommendations (see Chapter 5). It is intended that this analytical approach, and the transparency with which it is presented, has enhanced the validity and rigour of the research recommendations drawn from this work, as well as their relevance to the UK context.

FIGURE 13.

Overarching analytical approach. 1 = Interpretation of scoping review and narrative synthesis findings in light of conceptual framework; 2 = planned revision of conceptual framework in light of the systematic review findings.

Limitations

A risk-of-bias assessment was not conducted because of the large number of articles identified. In addition to the size of this body of literature, however, the areas covered by this review that were not already covered by systematic reviews were judged not to have adequate study numbers and/or study quality and/or study findings sufficient to warrant a systematic review. In most cases the study designs were such that it is difficult to establish the nature of relationships between NPS use and problems/harms, or responses to NPS use and outcomes. This was also a pragmatic decision, made while mindful of time pressures and in light of the need to undertake this work quickly in order for it to be as useful as possible.

Possible implications for research recommendations

There are a number of evidence gaps identified in the scoping review and narrative synthesis. First, there are a number of areas in which literature is scarce (a priori research questions 2, 3, 5–10 and 12). Second, even in those areas in which some literature was identified, at a high level of generality, existing studies are not sufficiently well advanced to be able to meaningfully inform public health approaches to NPS use. For example, there is need for epidemiological research on acute health harms (i.e. undertaken in a population-at-risk context), as well as on chronic health and other health and social harms attributable to regular NPS use. There is an obvious need for more rigorous study designs capable of assessing major policy changes. In addition, there is a need to examine the utility of routinely collected NPS data in different settings, as well as pharmacovigilance data, including sources of information bias.

Chapter 3 What might an evidence-informed public health approach to novel psychoactive substance use in the UK look like? A conceptual framework

Results

The changing context of developments in drug policies

Legal prohibition of drug possession has been the cornerstone of the societal response to illicit drugs for a century. 1027 Although a public health approach to drugs is often counterpoised to that of law enforcement, this can be regarded as a false dichotomy, as the illegality of drugs can in certain circumstances raise prices and restrict availability (both generally effective approaches for addictive behaviours), and reduce use and associated harms. 1024 In addition, treatments such as opioid substitution treatment can reduce crime. 1024 While initially introducing TCDOs to rapidly bring individual NPS under legal control, the UK government has decided to follow Ireland by making all psychoactive substances illegal to produce and supply, without prohibiting possession or considering potential harm. 705

Decriminalisation of drug use and other recent global policy innovations, including the quasi-legalisation of cannabis production and supply in some US states and in Uruguay,1028,1029 provide another context for thinking about NPS. Data are beginning to emerge on the effects of these policy changes,1030 although rigorous evaluation studies are needed. The use of drugs remains a controversial and difficult issue for society, although seemingly not as difficult as it once was. 1031–1035 The goals of drug policy are now less contested, as there is greater recognition of the limitations of sole reliance on prohibition, and more willingness to address tobacco, alcohol and drugs together. 1035 Use reduction is now more widely accepted as a vehicle for harm reduction, reducing problems among users, and those directly and indirectly affected by drug use, as well as reducing the overall societal burden. 1026,1033

Contemporary evidence-informed public health

The history of public health has been strongly influenced by the growth of scientific knowledge, the rise of the welfare state and an increased focus on lifestyle risk factors in recent decades. 1036–1038 The evidence required to inform any public health approach is to some extent determined by how public health itself is defined. Contemporary definitions highlight the improvement of population health and wellbeing. 1039,1040 The underpinning rationale for strategic public health approaches that move the entire population distribution of risk in a more healthy direction was based on data showing that a large number of people at lower risk can often result in greater health burden than a smaller group at higher risk (the prevention paradox). 1041,1042 In addition, individual or group behaviour is usually socially influenced and thus contextually dependent, so modifying population factors underlying the risk distribution may be more effective than seeking to encourage high-risk individuals to act against social norms, both for those at high risk and for the rest of the population. 1041,1042

Many contemporary public health challenges have been conceptualised as requiring complex adaptive system changes. 1036,1038 Mehta et al. 1043 provide a useful example of how contemporary thinking on public mental health can draw on well-established ideas, such as the biopsychosocial model of health, and about levels of prevention in addressing such complex challenges. Complex challenges often require that careful attention is given to future risks, which are somewhat unpredictable in scale and are likely to impact differently on different groups,1044 rather than to current harms. For example, frameworks for responding to the health impacts of climate change highlight the importance of building the evidence-base through surveillance of morbidity, mortality and health system indicators, and modelling trend data for future risks including contextual factors impacting on risk of harm. 1045,1046

The social ecological framework offers one way of thinking about complex public health issues. 1047 This also encourages multilevel conceptualisations of problems and invites multilevel strategic responses. 1048 For example, risk behaviours and intervention targets can be understood as being shaped by interactions between the micro- (e.g. family, school, neighbourhood), meso- (interactions between the different micro-systems), exo- (systems that impact on the micro-system such as worksite policies) and macro- (cultural values, norms and laws) levels. 1049

Obesity is another example of a socially structured public health challenge where risk differs substantially between groups in a given population, which may also be facing a malnutrition problem. 1050 Relevant unhealthy behaviours cluster, particularly among more socioeconomically deprived populations. The World Health Organization Commission on childhood obesity uses a multilevel social-ecological approach to identify the need for interventions targeted at contextual factors such as political (e.g. fiscal policy), built (e.g. urban planning and design), social (e.g. norms in different groups) and family (e.g. parental knowledge, norms, behaviour) environments. In addition, they recommended a life-course approach, arguing that the key contextual risk factors that impact on obesity differ through the life course. 1051 Targets for prevention thus need to be conceptualised at environmental levels, and in long-term individual developmental perspectives.

Towards a hypothetical prevention systems approach to novel psychoactive substances

We make a number of assumptions here, which we shall revisit to interrogate their validity. We hypothesise that the challenges posed by NPS have many of the features of the complex problems previously discussed. Hypotheses on NPS can also take advantage of the conceptual frameworks already developed for other drugs. 1022,1026 Figure 14 provides a conceptual map of key individual-level risks and harms attributable to NPS adapted from those developed for other forms of drug use, and incorporating an overarching biopsychosocial perspective. Apart from the acute effects, most forms of harm develop over time. Beyond potency and toxicity, harms to individuals, whether they are health-specific or wider harms, will be strongly shaped by environmental and contextual influences dynamically interacting with life-course stages. Prevention therefore has the potential to interrupt the evolution of harm over time, and this is insufficiently recognised. 1052 Intervention targets for prevention extend far away from those that are proximal to acts of drug use, as attention is warranted to social structural influences that shape individual risk. Other drug use, both licit and illicit, should be expected to be implicated in the production of harm where other drugs are being used, and it will be rare that none are.

FIGURE 14.

A model of risks and harms attributable to NPS use.

Problems also manifest themselves at levels beyond the individual user, for example involving family members and local communities. 1053,1054 Harms to society, for example, include the costs of health care, crime and law enforcement. 1055 Health impacts incurred by NPS users can be aggregated with measures of physical and/or mental health, quality-adjusted life-years (QALYs) lost, and by applying a monetary value to QALYs lost. Impacts on education among young people can lead to adult employment and economic productivity harms, to which an economic cost can be attributed.

Box 1 provides a thought experiment. There are no obvious problems with NPS use, and one possibility is that there is no role for public health responses and that the Smith family just get on with their lives. Alternatively, we suggest that a prevention orientation, informed by appreciation of risk generation over time, offers the most appropriate long-term public health response. This suggests the need to intervene environmentally, and early, in order to prevent harms, which may develop to become more widespread and more intractable in the absence of prevention.

BOX 1 - A portrait of NPS use in the ‘Smith family’

The Smiths (father Peter, mother Jane, 18-year-old son Tom, 16-year-old daughter Karen, and 14-year-old son Jack) are an unremarkable family. Both parents work locally and receive family credits to supplement their incomes. The children are doing OK at school, and the school itself is not bad. Tom does not know what he will do after leaving school next summer and Karen is thinking about going to college. Outside school they do the same things as their friends: Tom plays football, Karen plays computer games and spends a lot of time online, and Tom and Jack are into music. They are comfortable in their home, which they part-own, and live in an area that used to have a problem with burglaries.

There are no big health problems in the family. They are not into sports or exercise, apart from Tom. Peter drinks more alcohol than is good for his health, although he definitely would not consider himself an alcoholic or feel comfortable talking to his general practitioner about his drinking. He misses work occasionally on Mondays. Jane has times when she is depressed, for which she takes medication. She drinks occasionally and gave up smoking 5 years ago.

Tom does not smoke. He usually goes to nightclubs at the weekend, where he takes drugs that are sold to him and his friends such as ecstasy and mephedrone. He also usually drinks alcohol in bars before going on to clubs. Karen smokes a few cigarettes each day and has a joint most days. She smokes herbal cannabis and sometimes spice, a synthetic cannabinoid, with her 18-year-old boyfriend and his friends. She tends to smoke spice when they are out of cannabis or when they hear it is particularly good. Her mum worries about her. The group she smokes with have a reputation for getting into trouble. Jack has got really drunk twice, and drinks alcohol only at parties with his friends. Jack has not used any drugs because, he says, he does not like smoking and has heard bad things about pills and powders.

Table 8 offers a presentation of how a systems-based prevention approach may be applied in this situation. This presentation is illustrative, as it is also possible to conceptualise levels differently, for example separating family and peers, in such a system. Note that there is no compelling logic to any NPS-only response, as factors that impact on NPS use do not appear to differ from those that impact on the use of other drugs. Interventions may be designed to target a single level (e.g. family), and may be effective in so doing. Their effectiveness, however, will be limited by the influence of variables in other levels of this system, which is important to assess for intervention decision-making. This presentation calls attention to the adequacy of existing responses and their longer-term consequences, as decisions not to intervene, or to intervene weakly, will also have consequences that should be considered.

TABLE 8 - Examples of public health opportunities for responding to risk

Approach	National	Local	Family and peers	Individual
Health	Health services and public health policies; tobacco control policies	Local health service provisions and public health actions	Parental general practice and other NHS contacts; peer network intervention projects; health promotion campaigns	NHS contacts (e.g. general practice, sexual health services, A&E); online and telephone helplines; counselling services
Multisectoral	Housing, employment, education and welfare and economic policies; drug and alcohol policies	Policing, education, community development, licensing and other local authority policies and services	School drug education; youth services provisions; family support services; community groups	School mentoring and counselling; criminal justice system contacts

How well does this approach address health inequalities issues? This is important to consider explicitly, as whole-population approaches have been shown to alter the shape of the distribution of risk within a population as it moves to the left (i.e. less risk for the population as a whole but greater absolute or relative risk in subgroups), as has happened, for example, in relation to tobacco. 1056 This happens because those with more psychosocial resources for health gain greater health benefits than those with fewer resources, for whom such inequalities exert pervasive health effects. 1056 It is also well established that problematic drug use is more concentrated in deprived communities. 1057–1059 This consideration suggests the need for an integrated strategy of multilevel whole-population and vulnerable subpopulation interventions that address the environmental causes of the distribution of risk within populations. Capacity to incorporate attention to health inequalities and their associated social determinants at the local level may already exist owing to the devolved nature of the UK public health system. 1060

A priori data needs

Having considered hypothetical determinants of NPS use, risk and harm, and the breadth of possible responses, attention to the empirical data needed to inform public health decision-making is warranted. Acute health and wider problems will be experienced following particular episodes of use, most likely in relation to intoxication or direct poisoning (see Figure 14). 1024 Presentations to health services and community safety indicators may provide data on trends in the potency and toxicity of NPS, taking account of possible sources of information bias in existing routine monitoring systems. Chronic mental health, physical health and social problems may develop over the longer term as a consequence of regular use, with risk accumulating over time as involvement in drug use continues. Where drug use escalates, and consumption becomes heavier, risks will accumulate faster. 1022 Existing routine data sources are quite likely to be relatively insensitive to changes in patterning of risks, and prevalence and incidence of harms, unless they become severe. Dedicated research studies or highly sophisticated monitoring approaches may be more likely to be needed to provide more detailed investigations of these sorts of issues.

This discussion has largely avoided disaggregating the category of NPS, as the points made may be seen to apply with greater or lesser force to all NPS. Dedicated attention to individual NPS drug types is also needed, as the public health burden associated with each will vary according to the harms that are consequent on their use and to their use prevalence. Capacity to identify new NPS early, particularly those that are more potent or more toxic, and to track their spread, is foundational to appropriately calibrating the required responses. Indeed, distinctions between NPS and existing drugs may be expected to reduce over time, with particular NPS drug types considered alongside more established drugs if and when they become more prevalent.

Gradual deterioration of organ function as a result of toxicity may be a key biological mechanism involved in stable longer-term patterns of use and this will be difficult to detect early in all but the most severe instances. The development of dependence may occur at different rates for different drugs and patterns of use,1061 although it is largely driven by the extent of involvement in drug use. 1062 Dependence may occur in isolation from other psychosocial difficulties, although this is rare in addiction treatment populations. 1063 Dependence itself is also an important mediator of other harms. 1024 Scrutiny of routine health services data will be useful for the examination of trends in dependence and other presenting problems,1064 and will be quite likely to need to be supplemented by dedicated studies that capture population data on the prevalence of dependence and other problems.

There are two key issues revealed by this preliminary consideration of data needs. First, existing data sources are likely to be profoundly biased towards both severe and episodic problems and less likely to be directly informative about patterns of use, risk and harm in the general population over the longer term. Second, it is assumed that NPS use is identifiable, either as a result of self-presentation or toxicology, the provision for which will vary across settings. There may be many circumstances in which this is problematic, for example when episodic or regular use occurs alongside other drug use and/or when it is not clear what the cause of the problem may be or the contribution of NPS to it. NPS markets may be thought of as more complex drug markets, where products may be branded without any necessary correspondence to contents, and consumers may be more willing to accept unbranded and unknown content. As part of an effective pharmacovigilance system, simple case finding approaches may need to rely in the first instance on generic screening tools for drug use, which appear to be effective for other forms of drug use, prior to more in-depth drug use assessment. 1065 Again, data from health-care services and other sectors will identify NPS use where it is most obvious, and will be vulnerable to missing the contribution that NPS use makes to other presenting problems (e.g. mental health). Communicating the risks associated with particular NPS drug types poses challenges even when such data are in place.

Basic epidemiological data on the prevalence and incidence of NPS use and problems may be difficult to obtain in a timely manner owing to rapidly changing trends, hence the prominence of toxicological surveillance and the development of EWSs in the existing first wave of responses to NPS. 909,982,1066 Qualitative and quantitative studies investigating patterns of use in potentially important subpopulations (such as homeless people, those with serious long-term mental health problems and prisoners), or derived from emergency health-care presentations, can be informative on issues such as constituents, doses and other drugs being used simultaneously. 757,761 The more such studies give rigorous attention to sampling, the more straightforward the consideration of generalisability will be.

Novel psychoactive substance data collection can be added to existing large population cohort studies. 1067 ‘Prevention systems’ approaches,1068 as hypothesised here to be relevant to NPS use, require strong health services research investment on both NPS use and drug use more broadly. Observational studies of the actual operation of prevention systems, with robust designs capable of identifying key characteristics associated with effectiveness are needed, as are evaluation studies of any innovations. 1064

A consideration of NPS data needs also calls attention to the scrutiny of the adequacy of the existing drug research infrastructure. The past year prevalence of ecstasy use declined among 16- to 24-year-olds from approximately 6.8% in 2001/2 to average approximately 3.8% over the past 5 years. 1020 It is not known to what extent, if any, this may be due to NPS use and/or whether other factors may be responsible for this fall. There have also been reductions in the prevalence of alcohol consumption among young people across the world,1069 and a similar question could be posed. We suggest that consideration of the need to build the NPS evidence base should examine such inter-relationships and pay attention to the research capacity for drug and alcohol research more generally.

Validity issues

We now offer a brief assessment of the validity of the underlying assumptions and discuss some study implications. We suggest that there are five key logical steps taken in building this framework for which counterfactual reasoning can be applied as follows.

1. NPS are not in fact like other drugs; there is something different about them.

2. The complex systems conceptualisation is not appropriate for NPS.

3. The life-course approach is inapplicable to NPS.

4. The prevention system cannot or will not operate in the way proposed; the multilevel contribution of system elements is unattainable, even if desirable.

5. A high-risk population approach may be preferable only as it is easier to implement.

Steps 1–3 are dealt with together because individually and collectively they are foundational to much thinking in contemporary public health. It is either implausible that they are true, or it is the case that existing public health evidence and ideas are much weaker than they seem. We prefer the former explanation. Although the production, distribution and retail of NPS may have features that distinguish them from other drugs, in other respects the user populations and drivers of demand and supply are similar, and in the future they may be even more so.

There are, of course, likely to be limits to the extent to which approaches to NPS can be informed by comparisons to addressing challenges such as public mental health, climate change or obesity. Perhaps this is less true of drawing on thinking about other forms of drug use, although a key weakness in this area is that arguably too much existing thinking about risk and harm occurs at the individual rather than the population level (reflecting the historical development of addiction sciences for alcohol and drugs in particular). Drawing together population-level data on risk and harm may be a sensible response to this conceptual weakness. Similarly, although the prospect of early (in the life course) interventions for prevention may be alluring, what are the clinical, public health and wider public policy responses to harms that are occurring now, and how extensively do they provide a firm foundation on which to build?

Step 4 is difficult to rebut. Although multisectoral contributions self-evidently have some part to play, it is highly aspirational that they can work in synergy to meaningfully form a system, as is proposed. This will require resources and high-level political commitments that may seem far-fetched in times of austerity in public sector finances. Although a counter argument in terms of the long-term costs and consequences may seem reasonable, this does not diminish the extent to which major efforts to initiate and maintain such systems are probably required. This is a serious objection.

Step 5 is valid in its own terms and is also particularly limited in respect of the neglect of action on upstream determinants. This ignores much that has been learnt in public health about the importance of prevention. High-risk subpopulations may be difficult to reliably identify, particularly where evidence is limited. It should be noted that we do not suggest avoiding the targeting of high-risk subpopulations but rather that this should be undertaken alongside whole-population interventions in line with the strategic approach developed by Rose. 1042

If the counterfactual reasoning to both steps 4 and 5 appears attractive, one might look more bleakly on the prospect of influencing, never mind exercising control over, future trends in drug use. One may also be sceptically inclined towards researchers calling for more research, although we suggest that there is a strong case that existing evidence is not adequate to inform public health strategic responses. This does not necessarily mean that new research is needed in all cases, as existing data collection efforts may be usefully extended, even though the need to build a more secure research platform is an overarching conclusion that we do draw. We may be wrong in our thinking and we invite readers to judge the adequacy of our approach and the conceptual findings themselves. A favourable assessment may lead the reader to be interested in the research recommendations presented in the next chapter. A more critical reader may like to test the assumptions that we have made here (and transparently reported), and/or the evidence gap analysis in the review, to produce a different research agenda.

Implications

Assessing the population impacts of the use of, and possible responses to, NPS thus requires the capture of routine data, the generation of scientific data and the modelling of these data. Modelling may be particularly important early on to help inform coherent policy strategies, for example on potential future impacts on health-care resources, as well as helping to identify epidemiological and other research priorities. The value of such early models is bounded by the assumptions used in the models themselves, which may need to be crude in the absence of high-quality empirical data. The nature of contemporary drug trends poses big challenges to conventional practices in research and in informing policy-making with research summed up as ‘how to speed up science, increase knowledge and get responsible regulatory policies enacted.’1070 The regulation of drugs arguably shares this problem with other cultural forces in which the internet is central, from organised crime to consumer protection, offering opportunities for knowledge transfer. 1071

As the NPS phenomenon is global in character, comparative studies of the diffusion of new drugs in other countries and continents should be valuable. The UK, and Europe as a whole, have so far avoided the epidemics of methamphetamines and prescription opioid use seen elsewhere. It is reasonable to suppose that future generations of NPS will have effects on users that are similar to those of existing drugs, and that a more extensive and complex range of drugs might be used. In the future, the most optimistic scenario possible is that the most harmful drugs are largely avoided because they are harmful, regardless of their attractiveness. In such a scenario, harmful drugs are still likely to be used by vulnerable or high-risk populations, complicating and making more intractable existing problems and probably deepening health inequalities. Cross-national studies using quasi-experimental designs may have capacity to be informative about the effectiveness of different policy measures and approaches.

There is a dose–response relationship between the prevalence of many forms of drug use and the consequent public health and societal harms and the shape of the risk functions vary for different drugs. 1022,1024 Public health approaches thus seek to find ways to manage demand and supply. The need to embrace the complexity and daunting scale of the challenge is widely recognised, so it is timely to develop public health approaches to drugs both new and old, and to promote the use of scientific evidence in shaping society’s evolving responses.

Chapter 4 Public involvement

Chapter 5 Research recommendations

This chapter provides a brief integrative overview of earlier chapters, by way of introducing the research recommendations. Chapter 2 found that there were many evidence gaps in relation to the original set of research questions that we identified a priori. We selected a number of areas that were judged to warrant fuller presentation and synthesis of data, without there being a substantial basis for a full systematic review. Following this, we concluded that this literature was at an early stage of development in its capacity to inform strategic public health responses. This conclusion was reached through the contextualisation of review findings within a conceptual framework developed for the purposes of this research. This sought to address what an evidence-informed public health approach to NPS use in the UK might look like. The framework was initially developed prior to the review, and the developmental process is described in detail in Chapter 3. We used this framework to interpret the data from the review, and we subsequently revised the conceptual material in minor ways in light of the review data, as there was no rationale for substantive change. Stakeholder contributions are described in Chapter 4. Together, the conceptual framework and review indicate a need for a major research effort to be directed at NPS, which should address NPS together with other forms of licit and illicit drug use.

Research recommendations were developed from two distinct data sources. First, research recommendations were made in studies included in the review. This data source offers the perspectives of the authors who have been involved in accumulating the existing research literature and assessing how it needs to be developed further. Second, we use the conceptual framework for NPS developed by the authors of this report to identify what may be missing from this literature.

Research recommendations made by the authors of primary studies in the four bodies of existing literature selected for narrative synthesis (UK prevalence surveys and qualitative studies, policy evaluation studies and systematic reviews) were extracted and coded independently by two reviewers. The resulting codes were similar and were integrated by means of paying attention to detailed content and frequency, as well as by discussion among the reviewers. This led to higher-level coding to produce recommendations in three broad thematic areas, namely research relating to pharmacology, epidemiology and intervention research. Many recommendations previously made were quite generic in nature, and the detailed content of the recommendations proposed adds substance to earlier recommendations based on the review work, thus involving the interpretation of the authors.

Work on the conceptual framework paid particular attention to possible research data needs, as part of the elaboration of a hypothesised evidence-informed public health approach to NPS. This involved the identification of material that is both present in and absent from the other data source. As the conceptual material has quite a different evidential status to previously identified research recommendations, we have sought to use a transparent approach in our handling of it.

The research recommendations are targeted at both researchers and commissioners of research, with a view to inform discussions between both parties about, and to enable decision-making on, future research needs and how they may be met. Research recommendations targeting researchers were primarily based on the synthesis of prior research recommendations. Recommendations for research commissioners were based on the conceptual framework and on conclusions drawn by the researchers across the project as a whole. It was intended that these different approaches would be complementary and that overlaps between material from both sources would be particularly informative. The key recommendations are thus those that are drawn from both data sources. It is noteworthy how far the conceptual framework based on evidence from other parts of the public health literature reflects and builds on the recommendations previously made by authors of the NPS literature.

Acknowledgements

We are grateful to Kath Wright (Centre for Reviews and Dissemination, University of York) for conducting the electronic database searches and assisting with the ordering of articles for the scoping review and narrative synthesis (Chapter 2). We are also grateful to Melody Hardcastle (Centre for Reviews and Dissemination, University of York) for their assistance with ordering articles for the scoping review.

We would like to thank Neil Hunt for his advice on the research proposal. We would also like to thank the following policy actors and researchers for their very useful comments on our research process and methods, findings and recommendations: Megan Jones, Owen Bowden Jones, Nick Sheron (all Public Health England) and Anna Richardson (Home Office).

We are grateful to our PI members: the five Newcastle User Carer Forum members who attended the forum meeting in October 2016 (including Cliff McKenna, Mark Argument, Terry Hatch and Thomas McDine), and the NPS user recruited from an online drug forum for providing very useful feedback and input to our project findings and recommendations. We would also like to thank Andy Hackett (Service User Involvement Officer, Public Health, Newcastle City Council) and Rachael Hope (Community Safety Specialist – Drugs Safe Newcastle/Public Health, Newcastle City Council) for their invaluable contribution to our public involvement strategy by facilitating and hosting a discussion of our project with Newcastle User Carer Forum members.

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Appendix 1 Novel psychoactive substances electronic database literature search (original search: 16 November 2015; updated search: 29 June 2016)

We searched the EMBASE, MEDLINE, PsycINFO and Science Citation Index databases and a total of 13,772 records were identified. These were imported into bibliographic software and deduplicated, leaving a total of 9165 records.

Appendix 2 Legal high brand/trade names included in the electronic searches

List of abbreviations

A&E

accident and emergency

ACMD

Advisory Council on the Misuse of Drugs

AIPS

All Ireland Prevalence Survey

BZP

benzylpiperazine

CSEW

Crime Survey for England and Wales

ED

emergency department

EMCDDA

European Monitoring Centre for Drugs and Drug Addiction

EWS

early warning system

GBL

gamma-butyrolactone

GHB

gamma-hydroxybutyrate

HIV

human immunodeficiency virus

HSCIC

Health and Social Care Information Centre

MDMA

3,4-methylenedioxymethamphetamine (ecstasy)

MDPV

methylenedioxypyrovalerone

MSM

men who have sex with men

NBOMe

N-methoxybenzyl

NEPTUNE

Novel Psychoactive Treatment: UK network

NPS

novel psychoactive substance

PI

public involvement

QALY

quality-adjusted life-year

RCT

randomised controlled trial

SALSUS

Scottish Schools Adolescent Lifestyle and Substance Use Survey

SCJS

Scottish Crime and Justice Survey

TCDO

Temporary Class Drug Order