Pain policy and abuse of prescription opioids in the USA: a cautionary tale for Europe

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The last two decades have seen a profound cultural shift in institutional and provider attitudes towards pain management in America. Pain and its under-treatment are widely reported in the medical literature and media to be an international health crisis. The Joint Commission, a major hospital regulatory body in the USA, states that 76 million Americans suffer from chronic, acute, or post-surgical pain [1]. The Institute of Medicine (IOM), a non-governmental USA advisory organisation, reported this number to be as high as 100 million adults [2], or nearly one in three Americans. The financial cost of pain, according to IOM's 2011 report Relieving Pain in America, ranged between $560 billion and $635 billion (£367–416 billion; €422–478 billion) in 2010 [2]. Brennan and colleagues describe a recent ‘inflection point’ in the international medical, legal, and ethical worlds, in which the treatment of pain, once long-ignored, became a fundamental human right [3]. In 2001, the International Association for the Study of Pain (IASP) and the European Federation of IASP Chapters (EFIC) declared to the European Parliament that chronic pain is a major healthcare problem, a disease in itself, and could affect 50% of people at any point in time [4]. The World Health Organization, long a proponent of treatment of acute and cancer pain, backed a global day against pain in 2004, emphasizing the importance of treating chronic pain as well [5].

In this editorial, we will explore both the historical basis of the evolution of pain policy in the USA in the last two decades and the development of an American public health crisis surrounding the widespread use and misuse of opioids. We suggest that the American experience in pain policy is a cautionary tale for Europe.

Pain becomes a ‘vital sign’ in the USA

The 1990s saw a proliferation of consensus statements and regulatory mandates calling attention to the problem of pain in all healthcare settings in the USA. In 1992, the Agency for Healthcare Quality Research (AHQR), a USA Government quality-improvement agency, issued a two-part guideline declaring that half of surgical patients, over 10 million Americans, do not receive adequate post-surgical analgesia, and that fears of addiction to opioids are largely unfounded [6, 7]. The concept that addiction is rare in opioid-naïve patients treated for acute pain was supported exclusively by a brief New England Journal of Medicine letter in 1980 that described only four instances of iatrogenic drug abuse in approximately 12 000 patients treated with narcotics [8]. The AHQR guidelines were widely disseminated in the media, even trumpeted by the widely-read New York Times as the birth of guideline-driven healthcare [9]. The AHQR document made clear that pain management ‘is a right’. In 1995, the American Pain Society (APS), a leading multidisciplinary organisation that exists to advance pain-related research, education, treatment and professional practice (see www.americanpainsociety.org), developed a landmark consensus statement with guidelines for a quality-improvement approach towards the treatment of acute and cancer pain [10], expanding upon its 1989 guidelines [11] for the treatment of pain in the hospital setting. The consensus stated that pain intensity should be recorded as a part of the patient's permanent medical record, “such as on the vital sign sheet”. The focus on analgesic drugs is clear, though the statement recognises the existence of non-pharmacological measures to treat pain [10]. However, no consensus statement, practice guideline, or committee report had the cultural and practical impact on the treatment of pain in the USA that the Joint Commission on Accreditation of Health Care Organizations (JCAHO) did in 2001, with its release of pain management standards for the accreditation of healthcare organisations [1]. What were previously labelled clinical guidelines and parameters effectively became practice mandates that drove provider and hospital behaviours. The reach of JCAHO, now known as the Joint Commission, cannot be underestimated, as it is responsible for accrediting and certifying 20 000 American healthcare organisations to ensure the ‘safest, highest-quality care’ [12]. The Veteran's Health Administration (VHA), the USA's largest integrated health system, serving 8.3 million military veterans (see www.va.gov/health/), became among the first major health organisations to join the anti-pain movement. Continuously documenting pain in the hope of heightening the awareness of pain was the cornerstone of the movement. The VHA adopted the ‘fifth vital sign’ term and in 1998 enacted a national strategy to ensure that pain is routinely assessed at all patient encounters, including in the ambulatory setting, using a 0–10 numeric rating scale [13]. Governmental, non-governmental, and pharmaceutical organisations [14] campaigned vigorously for more aggressive pain treatment on all fronts. Despite the noble intention to reduce pain-related suffering, these cultural and regulatory shifts have led to unintended consequences, especially when the ‘fifth vital sign’ concept is rolled out to settings where the presentation is not acute. Finally, it is difficult to ignore the influence, even if subtle and when openly declared, of potential financial conflicts of interest, with sponsorship and/or compensation by the pharmaceutical industry of leading societies, clinicians and regulatory bodies involved with pain advocacy [14, 15].

The influence of American pain policies on opioid prescriptions

Social policy, carried out in the form of a pain-centered mandate for accreditation of American healthcare facilities, with influence from a variety of consensus and guidelines [6, 10, 16], was successful in increasing the quantity of opioids prescribed and consumed by Americans. These pro-opioid policies were likely to have been fuelled by the American health system's payment procedures that link ‘patient experience’ to reimbursement, a mechanism that has been demonstrated to drive overprescribing and morbidity [17].

The rise in the number of prescriptions written for opioids in America over the last decade has been nothing short of astounding. The estimated number of prescriptions filled for opioid substances increased from 174 million in 2000 to 257 million in 2009 [18]. Compared with 1997, retail sales of opioid medications in 2007 increased by 75.8 million grams, an increase of 149% [19]. This increase in retail sales corresponded to an increase in the therapeutic use of opioids by 296 mg per American, a change of 402% [19]. Americans, constituting less than 5% of the world's population, now consume 80% of the world's opioids and 99% of the world's hydrocodone [20]. In grams per person, this is the highest consumption of opioids in the world [21]. In 2010, enough opioids were sold to medicate every American adult with a typical dose of 5 mg hydrocodone every 4 hours for one month [22].

Data on the economic impact of the increasing use of opioids are limited; however, there is a suggestion that prescriptions for controlled substances represent a significant proportion of the rising costs for health insurers, reflecting an increase in the therapeutic use of opioids to manage chronic pain [23]. According to market research firm Frost and Sullivan, the US opioid pain management market generated revenues of $11 billion (£7.1; €8.3 billion) in 2009 and is expected to reach $15 billion (£9.7 billion; €11.3 billion) in 2016 [24].

A new American public health crisis emerges

Increased medical use of opioids is directly correlated with increased abuse as well as subsequent morbidity and mortality [25, 26]. Emergency department visits related to opioids increased significantly in the USA in the time that opioid prescriptions increased [27, 28]. In some instances, the increases were equivalent and parallel; in others, such as in the case of fentanyl, emergency department attendances increased 50-fold from 1994 to 2002, while prescriptions increased by 7.2 times [20]. The Centers for Disease Control (CDC) reported in the Morbidity and Mortality Weekly Report that visits to emergency departments for non-medical use of opioids increased 111% between 2004 and 2008, and 29% between 2007 and 2008 [28]. The highest number of visits involved methadone, oxycodone and hydrocodone [28]. Despite the controversy around whether data surrounding emergency room visits and opioid use has a causal relationship, this increase is striking [29, 30].

Several national surveys work to estimate the illicit use of opioids in the USA, including the National Survey of Drug Use and Health, the Monitoring the Future survey funded by the National Institutes of Health, and the Drug Abuse Warning Network [30]. Misuse of OxyContin® alone increased from 221 000 persons in 1997 to 3 176 800 in 2004 [31]. According to the National Center on Addiction and Substance Abuse at Columbia University (CASA) in 2005, 15.1 million people abused prescription drugs, more than those who admit abusing cocaine, hallucinogens, inhalants and heroin combined [32]. Indeed, CASA strongly links the increase in prescriptions to increase in abuse, noting that during a time when the population of the USA increased by 13%, the number of controlled drug prescriptions increased by 154% [32].

The gravity of the American epidemic cannot be overemphasised. The USA Government declared abuse of prescription opioid analgesic drugs an epidemic, and the nation's fastest-growing drug problem [18]. In 2011, the CDC reported that American deaths from opioids exceeded those from cocaine and heroin combined between 1999 and 2008 [22]. In 2008, 36 450 people died from drug overdose overall, a rate of 11.9 per 100 000, a number approaching deaths from motor vehicle accidents [22]. The death rate from opioid overdose in 2008 was four times higher than in 1999, paralleling the quadrupling in sales of opioids. Mortality is one aspect of opioid harm; the CDC notes that for every one death from oral analgesics, there are 10 treatment admissions for abuse, 32 emergency room visits for misuse or abuse, 130 people who are dependent, and 825 who use the drugs recreationally [33]. The financial burden of misuse is difficult to quantify; a lower estimate was $8.6 billion (£5.6 billion; €6.5 billion) in the USA in 2001, consisting of healthcare, criminal justice and workplace costs [34].

Has widespread opioid use improved patient outcomes in America?

Whether the negative health implications of pain on a public health level have actually been reduced since the array of consensus statements and practice mandates is questionable. Despite the increase in opioid therapy for non-cancer pain, neither compelling nor consistent evidence for the long-term efficacy of this therapy exists [35-37]. In fact, scant data are available to support the claim that on a large scale, pain management has improved since the era of mandates and the explosion of opioid prescriptions. A comprehensive review exploring the effectiveness of long-term therapy for chronic, non-cancer pain highlights the extraordinary paucity of compelling data on long-term opioid therapy [38]. In particular, there is limited evidence to support significant improvements in functional status and quality of life among opioid users [39].

What can Europeans learn from the American experience?

The literature on prescription opioid abuse in the European Union is notably scarce; however, isolated reports of alarming incidences of prescription drug abuse within individual European Union countries are emerging [40]. The United Nation's International Narcotics Control Board highlights the worldwide misuse of prescription drugs and predicts that it will exceed illicit drug use [41]. In 2011, the United Nations published a World Drug Report outlining a declining world market for illicit drugs but a worldwide increase in demand for prescription opioids [42]. A report by the European Monitoring Centre for Drugs and Drug Addiction presents similar concerns about the misuse of synthetic opioids [43]. It is our opinion that America is an epicenter of a potentially emerging worldwide epidemic. The vertically integrated healthcare systems of the UK and much of Europe are in unique positions to advocate for effective and safe prescribing of opioids. Given that the evidence-based benefits of opioid therapy are quite limited, best-practice approaches and formulary recommendations should focus on short-term and limited use for acute and non-palliative pain. Additionally, the NHS should mature its support for the utilisation of non-opioid pain therapies such as acupuncture, for which there is a growing evidence base and public interest [44]. We sincerely hope that the UK and other European countries are able to learn from the American experience and avoid the same pitfalls. There is still time.

Competing interests

MKK and BDS are supported by an ASA Committee on Professional Diversity Mentorship Grant. No competing interests declared.

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