An Overview of Non-Medical Use of Prescription Drugs and Criminal Justice Issues in Canada

6. What are the societal implications of the increase in non-medical use of prescription drugs?

6.1. Introduction

There are two main areas through which the presence of, or increases in, psychoactive substance use impact most strongly on the societal level: health or burden of disease (e.g., premature mortality, morbidity and disability) as well as use-related crime. Drug-related crime, in turn, can either be behaviorally related to the use of the respective substance or be associated with its use, e.g., in the form of procurement crime (see below). These two areas, together with workplace or productivity costs, are most important also since they constitute the primary factors determining ‘social cost’ impacts of substance use. To concretely illustrate: Birnbaum and colleagues (2006) conducted a societal cost assessment of PO abuse in the US in 2001. Total costs were estimated to be $8.6 billion, comprised of $2.6 billion for healthcare costs, $1.4 billion for criminal justice costs and $4.6 billion for workplace costs (their particular methodology of cost analysis did not include the social costs of crime-related victimization) (Birnbaum et al., 2006). Given that these costs were estimated for 2001 based on conservative methodology, and that NMUPO levels are higher today, it can be assumed that these costs are substantially higher today. Given the scarcity or absence of relevant specific and/or systematic epidemiological, health services or crime data related to non-medical prescription drug use data in Canada, no empirical calculations or estimations could be provided for these potential impacts. This situation persists today from the gaps reflected in the most recent Economic Costs of Substance Abuse in Canada study (Rehm et al., 2006) which did not present any data on non-medical use of prescription drugs given that relevant data indicators did not exist, and the economic cost picture which it presented would likely look considerably different if prescription drugs had been included. The best that can be offered at this point is some ‘informed speculation’ about the issues of social consequences of non-medical use of prescription drugs under examination informed by of existing limited data from Canada or other jurisdictions (e.g., the US).

6.2. Health

6.2.1. Morbidity

There are several key categories of health impacts related to NMUPO for which over-time data have been documented, namely PO-related admissions to substance treatment programs and PO-related emergency room admissions. Both indicators – in the context of rising medical PO and NMUPO levels in the US - have substantively increased since the 1990s (Fischer et al., 2008b). For example, in the period 1997 – 2002, Emergency Room episodes involving POs in the US rose by 120%, and on that basis rose at a much higher rate than ER episodes related to alcohol or illegal drugs (Gilson et al., 2004). Further increases are documented for the period 2004 - 2006, when PO-related ER-admissions rose from 172,726 to 247,669, i.e. 43% within a two year period (figures are based on different methodology than previous reporting period and hence not fully comparable (Substance Abuse and Mental Health Administration (SAMHSA), 2008a)). In Canada, no data are available on ER-admissions, as such data are not routinely or systematically collected. Some data have recently emerged regarding PO-related treatment admissions. In Ontario, Canada’s most populous province, the DATIS collects data from virtually all publicly funded substance use treatment agencies, services and programs across the province. Most recent data indicate that PO-related admissions to publicly funded treatment agencies in Ontario approximately doubled in the period 2004/05 – 2008/09 (fiscal years), i.e. within a 5-year period, alone. Specifically, PO-related treatment admissions rose by a total volume of 60%; the proportion of PO-related admissions of all treatment admissions rose from 9.4% to 15.7% in the reporting period ((Fischer et al., 2009c) submitted, CMAJ). These data follow even more pronounced trends in the US, where PO-related admissions to substance use treatment – as documented by the national Treatment Episode Data Set database – have risen from 16,605 in 1997 to 74,750 in 2007, i.e. quadrupled in about a decade (Department of Health and Human Services, 2009). The increases in PO-related treatment admissions documented for Ontario are likely an underestimation, since DATIS does not cover admissions to or initiations of opioid (e.g., methadone or buprenorphine) maintenance treatment, which are a standard form of treatment for any form of opioid dependence ((Fischer et al., 2009c) submitted, CMAJ). In fact, both local methadone maintenance treatment as well as opioid detoxification programs in Ontario have reported substantial increases in admissions related to PO-problems in recent years. For example, in a sample of 178 admissions to the methadone treatment program at CAMH (Toronto) between 1997 – 1999, 83% either reported use of POs by themselves or in conjunction with heroin (Brands et al., 2004). Among 571 cases admitted to the opioid detoxification program between 2000 and 2004 at CAMH, the annual proportion of reported OxyContin use rose from 3.8% in 2000 to 55.4% in 2004 (Sproule et al., 2009). Evidently, any form of morbidity (e.g., dependence) related to the non-medical use of prescription drugs may lead to loss in social or economic productivity (e.g., by way of short- or long-term disability, inability to work) and hence – akin to other problematic substance use – may lead to negative social impact in this way (see (Birnbaum et al., 2006; Wall et al., 2000; Rehm et al., 2006). However, no data are available for Canada to even remotely estimate such potential impact on a comprehensive level are currently available.

6.2.2. Mortality

Several studies from the US have indicated that accidental poisoning deaths (i.e., overdose deaths) related to POs have substantially risen in recent years. A seminal study by Paulozzi et al. documented that PO-related accidental poisoning deaths in the US increased by a rate of 91.2% between 1999 and 2002, i.e. doubled in a 3-year period alone to a total of 5,528 of PO-related deaths in 2002 (Paulozzi et al., 2006). Moreover, in the year 2002 documented PO-related accidental deaths outnumbered accidental deaths related to heroin or cocaine, i.e. the two major illicit drugs associated with mortality consequences (Paulozzi et al., 2006). Several studies in the US have furthermore documented strong increases in PO-related deaths on local or regional (e.g., state) levels (e.g., West Virginia, see (Paulozzi et al., 2009)). In Canada, much less is known about developments in regards to PO-related mortality. These data deficiencies in part relate to the fact that Canada has no centrally collected database on psychoactive drug related accidental deaths, and thus no relevant national data repository exists, since these data fall into the jurisdiction of provincial coroners’ services. Further methodological and practical problems are that provincial coroners’ services operate with highly divergent classification and analysis standards as well as data management procedures (e.g., electronic versus paper record keeping), and in many instances do not automatically separate PO-related deaths from other substance use related deaths cases. While no systematic data are available on PO-related mortality in Canada, some local and sporadic or preliminary information pieces are available which at least seem to suggest that PO-related deaths play a non-negligible and likely increasing role in psychoactive substance use related mortality. A recent analysis by Dhalla and colleagues suggested that PO-related mortality rates in the Ontario population have approximately doubled from 14 per million residents in 1991 to 27 per million residents in 2004 (Dhalla et al., 2009). Also in Ontario, OxyContin was reportedly involved in a total of 464 drug-related deaths in the period 2004 – 2008 – representing an approximate proportion of 20% - 25% of all drug-related deaths documented by the provincial coroner’s office in that period – and constituting a total death toll approximately 10-times higher than the number of deaths related to heroin (Silversides, 2009). A preliminary assessment of limited recent drug-related overdose data from select provinces (e.g., BC and Quebec) suggests that POs may even be involved in 30% to 40% of all drug-related mortality in these jurisdictions. A study by Martin et al. examined 112 cases of fentanyl-related overdose mortality cases which occurred in the province of Ontario between 2002 and 2004; these cases alone represented a proportion of ~8% of all drug-related overdose mortality that occurred in Ontario in that study period (Martin et al., 2006).

6.3. Crime

A further key consideration regarding the societal impact of non-medical use of prescription drugs is its possible impact on crime and subsequent burden to the criminal justice system. Especially when concerned with social costs related to substance use, crime and criminal justice impacts are highly relevant, since they typically account for the lion’s share – i.e., up to 80% - of social costs related to substance use, primarily because potential victimization and criminal justice system resources (e.g., law enforcement or correctional system resources) are extremely expensive compared to other potential cost sources (Wall et al., 2000; Fischer, 2003).

While there are at this point no empirical specific assessments of the crime and criminal impacts of non-medical use of prescription drugs in Canada, a number of key considerations for the potential nature and extent of such crime and criminal justice impact will be offered and illustrated with related empirical data where possible. First of all, following Paul Goldstein’s tripartite model of fundamental categories of drug-related crime, there are three basic categories of substance use related forms of crime: 1)pharmacological/behavioral crime (e.g., crime that is a result of behavioral effects of the pharmacology of the substances consumed, e.g., inter-personal violence); 2) acquisition crime (e.g., crime committed in the processes of obtaining drugs, i.e. either illegal purchasing or trafficking or crimes committed to obtain funds or resources needed to obtain the drugs; 3) systemic violence (e.g., crimes related to illegal distribution and markets of drugs; (Goldstein, 1985)). Given that both POs and BDs are narcotic/sedative kinds of drugs, and do not result in stimulant/aggressive effects, the potential pharmacological/behavioral crime effects, e.g., in the form of violence– in contrast to such well-documented effects for alcohol or cocaine/crack - are likely negligible and will not be further discussed here (Brands et al., 1998).

Primary relevance in the discussion of the crime impact related to non-medical use of prescription drugs likely applies to the second possible crime category, namely drug acquisition crime. Several careful and distinct considerations are necessary here. First of all, with view on possible increases in non-medical use of prescription drugs in the general population (i.e., non-marginalized populations), it is fundamentally possible that increases in non-medical use of prescription drugs may lead to considerable increases in related acquisition crime, since these drugs are used non-medically and hence need to be obtained illegally. To illustrate: The equivalent of the population rate of NMUPO users in the US general population (5.0%) would translate into approximately >1 million Canadian NMUPO users, which could entail a substantial amount of PO-related crime. While most users of other illegal drugs which cannot be domestically or self-produced (as is, for example, possible with cannabis) are commonly involved in regular acquisition crimes primarily related to the act of obtaining drug supplies, a key issue is that supply and sourcing routes for non-medical use of prescription drugs are distinct from those of other illegal drugs and heterogeneously diverse, even though these are not assessed in necessary detail for Canada (Fischer et al., 2008b; Inciardi et al., 2007; Fischer et al., 2009a). As shown in Part 3, a majority of non-medical prescription drug users in the US report that they mainly obtain their drugs informally through family or friends, and hence do not involve drug-related crime in the conventional sense (see e.g. (McCabe & Boyd, 2005; Inciardi et al., 2007; Gilson et al., 2004)). There are data from the US and elsewhere which document that a substantial proportion of non-medically used prescription drugs are obtained through so-called ‘double doctoring’ (i.e., the presentation of real or feigned health systems to multiple medical care providers or pharmacies) to obtain/fill multiple prescriptions; prescription forgeries or fraud; pharmacy robberies; thefts of pharmaceutical products; break-ins/robberies in homes where prescription drugs are kept by legitimate patients (Inciardi et al., 2007; Hurwitz, 2005; Martyres et al., 2004; Inciardi et al., 2009). In the Canadian OPICAN study of regular illicit opioid users, respondents indicated that they obtained their drugs both from dealers and physicians, with primary PO users indicating a higher proportion of ‘having a regular doctor’ and thus suggesting potentially higher access to PO drugs by way of the medical supply (Fischer et al., 2009a). In an older Canadian survey of prescription drug abusers attending treatment, 39% of respondents reported that they had obtained their drugs from more than one doctor, i.e. had engaged in double doctoring (Goldman, 2002). In addition, a substantial proportion of prescription drugs – whether medically or non-medically used – can be obtained via Internet sales which also do not constitute acts of drug-related crime in the conventional sense (Forman, 2006; Inciardi et al., 2007). At the same time, there is evidence from both the US and locally limited research in Canada that prescription drugs are offered on black markets in Canada, and illegal drug trade activity involving prescription drug products clearly exists. Over a decade ago, Sajan and colleagues demonstrated in a study of street drug markets that prescription drugs, including POs and BDs, were amply available on Vancouver street drug markets (Sajan et al., 1998). In a recent two-site exploratory study conducted in Toronto and Victoria, Fischer et al. found that POs were available on street drug markets, yet that they were commonly available from dealers other than those offering other illicit drugs and traded through different selling or trading mechanisms (Fischer et al., 2009a). While recent RCMP ‘Drug Situation Reports’ address the national availability and trading activity of the prescription drug covered here on black markets only in briefest passing (i.e., subsumed under ‘other drugs’; (RCMP Criminal Intelligence, 2008)), the extent of prescription drug-related crime especially related to such use in general populations is not anywhere nearly sufficiently assessed to allow for any form of quantifiable statements, yet ought to be considered a high research priority.

Besides possible non-medical use of prescription drugs in general populations, some specific considerations need to be directed to street drug user populations, in which non-medical prescription drug use levels have been documented to be increasing and high. The Canadian multi-site OPICAN study assessed a sample of n=671 regular illicit opioid users of heroin and POs (and other drugs; (Fischer et al., 2005; Fischer et al., 2006b)). While the majority of the sample was involved in (mainly property) crime for income generation, an analysis of determinants of property crime involvement in the study sample assessed at baseline did not find an involvement in NMUPO to be a significant predictor of distinct levels of property crime involvement, although it is important to note that this analysis did not examine cleanly delineated sub-samples by specific drug use yet included mainly respondents with co-occurring/overlapping use patterns (Manzoni et al., 2006). A more recent and detailed analysis of the follow-up sample of the Canadian OPICAN study cohort, distinguishing between heroin-only, PO-only, and combined heroin and PO users, found that PO-only users indicated a substantially higher prevalence of income from legal paid work than the two other user categories (although it did not more specifically investigate drug-use related crime involvement; (Fischer et al., 2008a)). These findings may allude to what several US studies involving PO users have recently documented, namely that predominant prescription drug – e.g., PO – users in street drug use populations appear to be more socially integrated (e.g., e.g., less likely to be homeless or more likely to draw income from legal employment) and less crime-involved (e.g., as referring to property crime or sex work for income generation, or drug dealing) than – for example – predominantly heroin or cocaine/crack involved street drug users (Rosenblum et al., 2007; Davis & Johnson, 2008; Sigmon, 2006; Surratt et al., 2006; Miller et al., 2004). These observations may point to the fact that street involved predominantly prescription drug users constitute a somewhat distinct – i.e., more socially integrated and less criminogenic – population of illicit opioid drug users to begin with, in which patterns of predominant prescription drug use may reduce the likelihood of or necessity for criminal involvement. Specifically, it is quite possible that the distinctly available routes for obtaining or sourcing prescription drugs (e.g., double-doctoring, prescription drug exchanges) may decrease the extent of the involvement in property crime related to the acquisition of drugs (Fischer et al., 2009a). Again, none of these details are systematically empirically assessed in Canada, yet must be considered an urgent research priority.

A further important aspect of ‘social harms’ related to non-medical use of prescription drugs are possible costs to the medical system as well as private (insurances) or public drug benefit plans. In 2007, total prescription drug expenditures in Canada for POs amounted to $485 million and $247 million for BDs (Morgan et al., 2008). While the expenditures for BDs had remained relatively stable since 1998, the expenditures for POs approximately doubled in this period (Morgan et al., 2008). It is completely unclear at this point which extent of these drugs was dispensed or ended being consumed for non-medical purposes. Even if only 1% - likely an underestimation - of the total drug volume reported was dispensed or obtained to facilitate non-medical purposes, the economic harm for public and/or private drug plans would already be in the multi-million dollar range.

Little, if any, evidence is currently available in Canada to assess whether prescription drugs play a role in organized crime (‘gangs’) activity related to drugs and related violence (e.g., shootings) and other harms in Canada, as documented for heroin, cocaine or cannabis.

7. What are the criminal justice policy issues for addressing the non-medical use of prescription drugs?

There are several key issues to be considered for criminal justice policy regarding non-medical use of prescription drugs, which are especially important and crucial in this current climate where the area of non-medical use of prescription drug use in Canada finds itself in the early stages of a policy development or formation stage, in which best possible policy should be developed and bad policy should be avoided. The points are discussed in a non-specific order below.

First, either on the basis of adjustments to the applicable drug control laws (e.g., CDSA/FDA) or a respective targeting or re-orientation of existing (drug) law enforcement resources and practice, attempts could be made to tackle the currently emerging and growing problem of non-medical use of prescription drugs by way of active and expanded law enforcement. From available statistics, it appears that relatively few incidents of non-medical use of prescription drugs are enforced under current drug law statutes. Among the total of 100,675 drug offenses reported in Canada by police in 2007, only about 15% concerned ‘other drugs’, with about half of these for possession offenses, although this omnibus category, besides possibly including POs, involved drugs like metamphetamine, LSD, ecstacy etc. (specific details on enforcement of POs are not provided in these data; (Dauvergne, 2009)). Notably, it ought to be considered that given current prevalence estimates of non-medical use of prescription drugs, a large number of members of the Canadian general population, and many more actual incidents of non-medical use could – in theory – be subject to criminal drug law enforcement under the Controlled Drugs and Substances Act CDSA for drug possession related to prescription drug abuse involving drugs that are either not theirs or not used for the purposes as medically prescribed. To be specific, if US general population rates are applied, some >1 million of Canadian adults, and some one in five high-school students based on survey data, would be estimated to be active NMUPO users and thus could be subject to criminal enforcement for illegal possession. At the same time, there are numerous incidents of prescription drug sourcing or obtaining - outside of formal criminal acts like robberies, thefts, prescription forgeries, etc. - committed for the purpose of non-medical use which could be perceived and construed under current drug control legislation as illegal drug trading or trafficking from the perspective of law enforcement, and hence followed by strict criminal law enforcement and punishment.

None of these appear to be advisable as sensible policy measures or priorities on the basis of consideration of several kinds of evidence and information. First of all, most non-medical use of prescription drugs, as well as the predominant forms of sourcing or supply that appears to be occurring among most non-medical users in the form of informal sourcing from friends, family, the use of leftover medical supplies etc. (see above), is likely – except for marginalized populations, e.g. street-based populations or use/sourcing incidents occurring in public places – not realistically, equitably or effectively enforceable. Second, at this point, there is little or no comprehensive data available – especially for Canada – to assess how much of the so-called ‘non-medical’ use of prescription drugs actually occurs that is not in some form related to medical conditions or health problems (e.g., in the form of self-medication in the context of inadequate, terminated, unaffordable or inaccessible medical care for pain, etc. (Fischer et al., 2008b)) and thus in reality would reliably pass the fundamental test for ‘criminal’ drug misuse. For example, Novak et al. found in a nationally representative US population survey that both regular and incidental NMUPO was significantly associated with the presence of physical pain and psychiatric disorder symptoms (Novak et al., 2009). In a sample of dependent adolescent NMUPO users assessed at a treatment center in Baltimore, more than 75% had an Axis 1 disorder, with half having 2 or more disorders and 68% presenting a psychiatric treatment history (Subramaniam & Stitzer, 2009). This dynamic – i.e., the questionable nature of invoking criminal enforcement of illicit drug use as a crime against people who are severely ill, i.e. who are likely to use illicit drugs due to state of dependence and/or needs for self-medication (see also (Fischer et al., 2005; Fischer et al., 2008b; Khantzian, 1997)– is of course present in debates over current illicit drug control and thus not new when applied to the issue of appropriate measures and approaches to prescription drug control.

However, the field of prescription drug control – especially from a criminal justice end – is in a state of early formation and hence a realm where errors or counterproductive directions in this respect can still largely be avoided at this point. Second, given that many current non-medical users of prescription drugs in Canada are young people, the possible criminalization of non-medical users might do more harm than good, i.e. by way of criminal labeling and stigma effects, secondary deviance, foreclosing social, professional and educational opportunities, etc., which may be far more severe than the actual benefits accomplished through such user enforcement (Fischer et al., 1998; Lenton & Heale, 2000; Lenton et al., 2000). These effects have been quite well documented for other groups of psychoactive substance users (e.g., cannabis users) who are currently subject to law enforcement and for whom – in the interest in sensible, good and public health oriented public policy – the non-enforcement or elimination of active user criminalization has been repeatedly and authoritatively recommended (see e.g., (Room et al., 2008)).

Further related considerations are that of a possibly intensified focus of enforcement on sourcing or supply routes of prescription drugs consumed non-medically may possible intensify black market dynamics and related un-intended consequences. Specifically, if the current low levels of focus of drugs enforcement on prescription drugs (see recent ‘RCMP Drug Situation Reports’; (RCMP Criminal Intelligence, 2008)) is intensified, relevant substances may more actively be sold/dealt with in the context of black markets (i.e., by professional dealers, possibly increasing the involvement of organized crime) at increasing black market prices, and – in the context of demand or non-medical use levels remaining constant – thus potentially leading the increasing levels or severities of acquisition crime by non-medical users or supply related crimes by traffickers, dealers etc. These speculative effects within the described scenarios are dynamics that are well-documented for other areas of psychoactive substance use, including more recently in varying forms contexts for alcohol, tobacco, cannabis and khat (MacCoun & Reuter, 2001; Babor et al., 2003; Room et al., 2008; Joossens & Raw, 2000; Beare, 2002).

A final consideration refers to the current realities and profiles of sources of prescription drugs – whether for medical or non-medical use – in a globalized Canada in the 21st century. While specific estimates vary, unquestionably a substantial extent of current prescription drug supply – with the specific drug categories discussed in this paper being at the top of the list – are currently bought/obtained via the Internet (Inciardi et al., 2007; Joranson & Gilson, 2006; Fischer et al., 2008b; Nielsen & Barratt, 2009; Compton & Volkow, 2006). For example, Foreman et al. (2006) found that Vicodin was available without a prescription on about half of the top 100 Internet sites offer prescription drug sales (see also (Forman, 2006)). Littlejohn & colleagues found that prescription drugs were readily available for sale on the internet, yet pointed out that such access still privileges individuals in higher socio-economic strata, with higher access levels to the Internet (Littlejohn et al., 2005). In a CASA study conducted in 2007, a total of 210 hours was devoted to documenting the number of Internet sites dispensing selected prescription drugs. Using Internet search engines and e-mail advertisements, researchers discovered that of the 187 Internet sites found to be selling controlled prescription drugs during this period, 157 (84%) did not require any prescription. Of these sites, 52 (33%) clearly stated that no prescription was needed, 83 (53%) offered an “online consultation” and 22 (14%) made no mention of a prescription (Beau Dietl & Associates, 2006). At the same time, a couple of studies in the US which asked NMUPO users about their sourcing found that Internet sales still played a relatively minor/secondary role as a sourcing pathway (Cicero et al., 2008b; Inciardi et al., 2007). This share is likely to consistently increase, rather than decrease, in the coming years. While the problematic and challenges of governing and enforcing laws in respect to the Internet are well discussed elsewhere (e.g., (Jerian, 2006)), it suffices to say here that the Internet as a supply route for the sourcing of prescription drugs for the purpose of non-medical use will be and remain extremely difficult at best with available means of criminal law and enforcement. There are important efforts underway to control or curtail this form of ‘virtual’ drug trade, yet it is unlikely that these will significantly change the availability of prescription drugs through these pathways for those who have access to a computer/the internet and a credit card (i.e., the majority of Canadians).

A key component in the wider policy debate regarding possible legal and regulatory control mechanisms towards non-medical prescription drug use concerns tighter control of medical care and drug providers (i.e., physicians and pharmacists), e.g., by way of more intensive scrutiny or auditing regarding compliance with drug control, prescribing, dispensing and reporting requirements, as well as different models or variations of ‘prescription monitoring programs’ (PMPs). PMPs are mechanisms in which – either by way of hard-copy prescription and dispensing records or electronic data entry/monitoring programs, data are collected regarding the prescription and dispensing activities of select prescription drugs by physicians and pharmacists, and the time and amounts of respective drugs prescribed or dispensed to individual patients. By way of PMPs – in theory – irregular prescribing or dispensing by medical professionals (e.g., overprescribing) or deviant patient behavior (e.g., multiple doctor-shopping) can be prevented or detected and enforced. In Canada, PMPs or so-called ‘triplicate prescription programs’ are in place in some provincial jurisdictions, yet – based on the primary and relatively independent responsibility of the provinces in the delivery of health care – are designed and operate quite inconsistently (El-Aneed et al., 2009; College of Physicians and Surgeons of Alberta: 2004).

Also in the context of the critical fact that the prescription drugs under discussion here are first and foremost medical or pharmaceutical products developed for and employed in key areas of medical (e.g., pain, mental health, sleep disorder) care, there are some important theoretical considerations and empirically documented experiences with the above mentioned control mechanisms which are relevant for sensible policy development. Very specifically, a key challenge is to select, devise and design control mechanisms (e.g., PMPs – see also below) that are effective in preventing non-medical use of prescription drugs or related harms, while avoiding possible forms of ‘collateral harms’ in the areas of medical care where the prescription drugs under discussion are needed and employed in the interest of patient care, individual and public health (Joranson et al., 2002; Joranson & Gilson, 2006; Simoni-Wastila, 2001; Simoni-Wastila et al., 2004a; Brushwood, 2003; Fischer et al., 2008c; Fishman, 2006; Hurwitz, 2005).

Relevant empirical experiences in this respect come mainly from the US. In general – even though the US today by far report the highest medical PO consumption rate in the world – it is widely accepted that the phenomenon of ‘opiophobia’ has for decades hindered and compromised sufficiently effective, available and accessible pain care in the US (and continued to do so elsewhere in the world, also accepting the overwhelming evidence that most regions of the world are catastrophically and inhumanely underserved with respect to pain care). ‘Opiophobia’ has been hindering adequate pain care in the US and elsewhere since the early parts of the 20th century, when original forms of opioid (e.g., morphine) addiction became more widely prevalent and led to initial restrictive – and punitive - legal monitoring and controls over opioid drugs (which are different than for most other forms of pharmaceutical drugs (Morgan, 1985; Bennett & Carr, 2001; Rhodin, 2006). Reports on the addictive properties of opioids in conjunction with the tight and punitive legal controls over opioid-based prescription medicines created a mythology or culture of fear (‘phobia’) regarding the potential use of these drugs in medical care among medical providers until the present, thus hindering and limiting adequate, accessible and effective health and medical care involving these substances (ibid). It has been recognized that ‘opiophobia’ needs to be recognized and prevented, i.e. in physician training & education, as well as a critical component in potential interventions aiming to address non-medical use of prescription drugs and diversion.

One of the main tools implemented in the US to control the non-medical use of psychoactive pharmaceuticals are so-called prescription monitoring programs (PMPs). The first PMP was established in New York State in the 1910s, and PMPs now exist in about two thirds of the US states (Office of Diversion Control, 2008). The central objective behind PMPs essentially is to centrally monitor and control the prescription and dispensation of certain controlled drugs by a central authority in order to prevent or enforce ‘doctor-shopping’, prescription forgeries, counterfeits, diversion etc. (i.e., drug abuse on the demand side) as well as over-prescribing or –dispensation (e.g., physician or pharmacist misconduct). Earlier PMPs relied on the use of duplicate or triplicate prescription copies, one of which would be sent to a designated agency for data collection and monitoring of the prescribed/dispensed drug. Current or modern versions of PMPs rely on electronic data entry, monitoring and analysis, much of which in advanced systems can happen in real-time (or close to real time). All PMPs in the US are state-based, and there is no federal-level PMP or central database, although the PMP databases are regularly accessed by federal control authorities and there are incentives from the federal level for states to establish modern (i.e., electronic) PMPs (Fishman et al., 2004; Brushwood, 2003; Office of Diversion Control, 2008).

While there is wide-spread belief and promotion by government and enforcement authorities that PMPs are effective tools in preventing the non-medical use and diversion of controlled drugs, the available empirical evidence suggests a much more complex and mixed picture which is nonetheless critical for evidence-based and sensible policy development in this area (Brushwood, 2003; Office of Diversion Control, 2008). The first piece of critical evidence is that overall, PMPs appear to be associated with lower levels of prescription of controlled substances, or that they lead to decreases in prescriptions when established. In Idaho, New York, Rhode Island, and Texas, the prescribing levels of Schedule II drugs decreased by rates of between 50% and 64% after the introduction of PMPs (Fishman, 2006). In 1989, US states with PMPs had 1.8% of all prescriptions written for Schedule II substances, while in states without PMPs the percentage was 4.7% (Wastila & Bishop, 1996). Curtis et al. examined levels of opioid prescriptions in US states, based on prescription drug insurance claims in a large nation-wide database in 2000. Claim rates by states varied widely, from <20 claims to >100 claims for POs per 1,000 total claims. The authors concluded that the “presence of a statewide [PMP] is associated with lower claim rates” (Curtis et al., 2006). While PMPs appear to be associated with overall lower or decreased levels of prescriptions of controlled drugs, there is at this point “little evidence to demonstrate that [PMPs] actually prevent drug misuse and diversion” (Joranson and Gilson in (Brushwood, 2003; Fishman, 2006). In other words, while overall prescriptions for controlled drugs in PMP jurisdictions tend to be lower, there is little or no concrete evidence that these reductions occur by eliminating diversion, misuse or abuse of controlled drugs.

The second key piece of evidence is that PMPs may in fact lead to considerable unintended negative consequences with respect to access to or the quality of clinical care. Concretely, this refers to the so-called ‘chilling effect’ of PMPs, by way of which physicians are less likely to prescribed stringently controlled drugs at all, or prescribe them later in the course of symptoms or in lower doses or concentrations, which could be triggered by fear of monitoring, potential problems or the inconvenience of regulatory procedures (e.g., (Brushwood, 2003)). This ‘chilling effect’ – which is of course crucially problematic for an area like pain care which has fought hard in recent years to increase quality care by increasing access and dosing in most cases - has been documented in practice by comparing relevant prescription or care practices (e.g., for pain care) as well as physician attitude surveys (e.g., (Wastila & Bishop, 1996). For example, a study of opioid prescribing practices for acute lower back pain in US states found significant inter-state variation for early opioid prescriptions which was “almost fully explained by state level contextual factors” ((Webster et al., 2009):162), i.e. the presence or non-presence of PMPs. Furthermore, there is evidence for compromised clinical care associated with the introduction or operation of PMPs, largely due to the so-called ‘substitution effect ’ which Fishman describes as follows: “It is well established that when physicians are faced with barriers to prescribing a certain type of medication they will often prescribe around that barrier, turning to drugs that are less scrutinized, even if they are less efficacious and/or more harmful” ((Fishman, 2006), see also (Fishman et al., 2004)). Specifically, after BDs were added to the scope of PMP requirements in New York State in 1989, the BD-prescription rate decreased, but “increases were seen in alternative drugs that were often therapeutically less optimal, held a greater chance of toxicity, and carried equal or greater abuse potential” (Fishman, 2006; Weintraub et al., 1991). While BD-related overdoses slightly decreased, there was a 30% increase in non-benzodiazepine sedative-hypnotic overdoses in the year following the introduction of the PMP requirement (ibid.). More recently (2004) in California it was discovered that the state’s triplicate PMP clearly had resulted in comparably lower levels of OxyContin prescribing, California had a disproportionately high rate of Schedule III opioid prescribing (e.g., hydrocodone (Vicodine) (Fishman, 2006)). These patterns are notable since hydrocodone was noted to be more prevalent in PO-related emergency room visits in the US in 2002 than OxyContin (Paulozzi et al., 2006).

8. Issues not addressed/ Conclusions

The non-medical use of prescription drugs, and related harms, is a substantial – and at least in the case of POs a growing – problem in Canada which has only recently begun to be noticed and attended to by researchers and policy makers (see (Fischer et al., 2008c)). In many ways, Canada thus finds itself on the verge of a very important policy formation or development phase, in which the right choices for policy development have to be made and errors and mistakes should be avoided. What makes the area of non-medical use of prescription drugs complex and challenging for policy development is that this phenomenon does not represent a form of drug use that is exclusively limited to or defined as ‘illegal’ (as more conventional forms of illegal drug use, like cannabis or cocaine use, are defined), yet that it involves the form of drugs which are important pharmaceutical substances which play an important role in key areas of medical care (e.g., pain, psychiatric, sleep disorder care). In that context, policy development must include and consider aspects and considerations from many different angles and fields, yet policy decisions or measures aiming to tackle the problem of non-medical use of any of these prescription drugs can easily do considerable harm or undermine the availability, accessibility or quality of care in these related medical areas, which cannot and should not be the outcome of policy making (see also (Joranson & Gilson, 2006; Hurwitz, 2005; Fishman, 2006). Especially with an eye on criminal law or criminal justice oriented measures or policy development aiming at the problem of non-medical use of prescription drugs, we want to explicitly urge for extreme caution and restraint, and an employment of available tools only after consideration of best possible available evidence and with a principle preparedness to retract any possible measures employed if these demonstrate to lead to negative or undesired effects in the population or any relevant realm of policy action.

We want to offer or repeat key reasons for that. First of all, policy and control to psychoactive substances use – especially in regards to so-called ‘illegal drugs’ – has traditionally been dominated by criminal law and justice mechanisms in Canada, even though these have generally not been in the interest of the individual health of users or public health, and in many key ways caused or amplified problems towards these (see (Fischer, 1999; Giffen et al., 1991)). With the exception of specific targeted measures in which deterrence is proven to work (e.g., in the prevention of impaired driving) and punishment seems normatively and socially desired (e.g., drug-selling for profit by non-addicts), the powers of the criminal law enforcement and punishment and criminal justice should be used and applied with utter caution. This point is made especially with regards to the – at least theoretical – possibility of a more active or intensified ‘criminalization’ approach to the – large and growing – populations of non-medical prescription drug users in Canada. Such users include many young people, and individuals from all socio-economic, cultural and regional parts of Canadian society.

As elaborated on in Section 6, a variable of key importance is that it is empirically absolutely unclear for Canada at this point to which extent the various forms of non-medical use of prescription drugs in this country occurs for medical or health-related reasons, e.g., due to dependence, un-diagnosed or –treated co-morbidity, psychological distress, limited availability, accessibility or affordability of proper medical care involving prescription drugs, or a form of self-medication, etc.. As several studies cited above have documented, the presence of key co-morbidities (e.g., pain or psychiatric disorders) in prescription drug misusing populations is enormously high (e.g., (Novak et al., 2009; Subramaniam & Stitzer, 2009; Rosenblum et al., 2007). In addition, many incidents of prescription drug dependence or non-medical use may actually originate or be associated with a history of medical care involving these drugs, in which a course of medical drug use was not adequately terminated, dependence may have been arisen, etc. Any of these causes or dynamics – presumed to be highly prevalent and present in the current total of incidents of non-medical prescription drug use, even though specific data for Canada do not exist at the present moment – are first and foremost health problems, and ought to be remedied by health-based interventions or improvements to health care, rather than criminal law, enforcement or criminal justice measures. Much additional research on these issues is urgently needed to empirically underscore and illustrate the above arguments, yet on the basis of these broad-stroked considerations alone, the role and place for criminal justice based measured in an overall evolving strategy to address the phenomenon of non-medical prescription drug use will likely appropriately be (especially compared to health-based or –focused interventions or measures) rather secondary and targeting very specific and limited aspects of the problem.

A further additional point to be offered is that current assessments, interventions or calls for measures aiming at the problem of non-medical use of prescription drugs predominantly see and analyze the root of the problem on the individual level (e.g., in the form of deviant individuals seeking to ‘get high’, i.e. by trying to exploit the psychoactive effects of the prescription drugs under examination in this paper, or ‘addictive’ personalities or behaviors, etc.) and offer suggested mechanisms of remedies on how to recognize such individuals and keep them from accessing or ‘abusing’ relevant substances. These perspectives – to a large and problematic extent – limit or prevent possible views and explanations for the large/rising non-medical prescription drug use problem in Canada that relay or refer more to possible system (or systemic) determinants or dynamics. For example, the comparably high – i.e., as compared to other industrialized countries or global regions – levels of overall prescription drug use in Canada may document easy availability and accessibility of these drugs when needed for appropriate or best possible medical care, yet may also reflect overly generous usage – i.e., contributing to ‘prescription drug rich environments’ - when not critically important or indicated and/or prevent alternative interventions from being employed (Fischer et al., 2008b). In 2001, the INCB in a press release for its annual World Drug Report explicitly lamented the “widespread overuse and overconsumption” of narcotics and psychotropic medications (including POs and BDs) in the industrialized world, which – as critically facilitated by “aggressive marketing … improper or even unethical prescription practices … and easy availability” of relevant substance has lead to an extensive and growing problem of misuse, diversion and related problems (International Narcotics Control Board, 2001). Among other measures, the INCB called for a “more rational prescription culture” as one of the key steps needed to curtail these problems.

To concretely illustrate for the case study of Canada: The medical use levels of POs on a population level in Canada is about double that of Australia, 4-times that of the UK and 20-times that of Japan (International Narcotics Control Board, 2008a). Without examining specific data, it is most unlikely to assume that the overall prevalent levels of severe/chronic pain in Canada are double those of Australia, 4-times those of the UK and 20-times those of Japan. In Canada, as well as in many other industrialized countries, the overly generous prescription levels or the ‘overprescribing’ of BDs have been an issue of discussion for decades, yet have not really led to fundamental changes or restrictions (Rogers et al., 2007; Busto et al., 1996; Hamilton et al., 1990; Schiralli & McIntosh, 1987). It is an important health system reality that, even in the context of a system of public or socialized health care (meaning that care is predominantly paid for by public, i.e. tax-generated funds) physicians in the Canadian health care system are still financially rewarded, i.e. have a financial incentive, by writing/issuing a prescription, and are not paid for, i.e. do not have a financial incentive, to avoid writing a prescription for a prescription drug when seeing a patient. On the other end, within the Western, industrialized and distinct socio-cultural parameters of health, health care and doctor-patient relationships, a large proportion of patients – also as influenced by direct-to-consumer advertising by pharmaceutical companies - presenting with health problems or symptoms expect a quick and tangible cure to come in form of a pharmaceutical drug or ‘pill’, and often make specific requests which drug they would like to have prescribed (Mintzes et al., 2002; Gilbody et al., 2005; Stevenson et al., 2000; Maddox & Katsanis, 1997). Even before the currently observed spikes in non-medical use of prescription drugs, Canada used the be the country with the by far highest per capita consumption of codeine consumption in the world, largely reflecting the fact that ‘mass products’ of over-the-counter-pharmaceuticals (e.g., cough syrups or pain medications for non-severe pain) were available including codeine and therefore used in high quantities (see (International Narcotics Control Board, 2002; Romach et al., 1999). Canada is also a society with one of the lowest usage rates of alternative forms, e.g. homeopathic etc., of medicine among Western/industrialized countries (e.g., (Fernandez et al., 1998; Hollenberg, 2006).

All of the above mentioned systemic indicators may play an important role in facilitating or fuelling currently observed high/rising levels of non-medical use of prescription drugs in Canada, and respective revisions or interventions – beyond the primary focus on ‘deviant patients’ - thus ought to be considered as potentially important action points or targets for prevention or policy measures.

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