Clinical Ethics in Anesthesiology. A Case-Based Textbook

3. Pain management

26. Opioid therapy in addicted patients: background and perspective from the US

Jane C. Ballantyne and Joseph Klein

The three cases

Please refer to the previous chapter’s cases for discussion.

Opium addiction as a social problem

Although opium derivatives have been used since antiquity for medicinal and recreational purposes, recognition of opioid addiction as a significant social problem emerged only relatively recently. The opium eaters of the eighteenth and nineteenth centuries consumed fairly low doses of active drug. Intoxication and addiction certainly existed, but the lack of widespread availability prevented broad societal ramifications. Nonetheless, a stigma was attached to opium consumption by a largely religious society that valued suffering as a moral good. The Quakers, for example, likened the soul to a physical entity; intoxicating substances impaired self-restraint, leading to lapses in moral judgment and consequent damage to the soul. Despite these views, few restrictions on opium existed.

With the emergence of purified morphine and later heroin, the deleterious effects of opioids on individuals and society came into focus. In the US, the number of narcotic addicts exploded, crime rose, and worker productivity declined. Legislation soon followed. The Harrison Act of 1914 restricted opioid and cocaine distribution to registered physicians and pharmacies. By the 1920s, authorities jailed physicians for distributing opioids outside their professional “course of conduct,” thus setting a precedent that would affect opioid prescribing for decades. Britain soon followed with its own legislation, the Dangerous Drugs Act, in 1920.

Regulatory influence

In the US, after Webb versus the United States1 and provisions of the 1914 Harrison Narcotic Drug Act made it illegal for physicians to prescribe opioids for the treatment of opioid addiction, opioid treatment of pain practically ceased. Not knowing which of their patients might be addicted, doctors in the US were intimidated lest they lose their medical license, or worse still, suffer criminal prosecution. The laws in other Western countries were less constraining. In the UK, guided by the Rolleston Committee (1924–1965), physicians were allowed to give their addicted patients diamorphine (heroin), syringes, and needles. At the time, heroin proliferation was less of a problem in the UK than in the US: in 1958 there were only 62 known heroin users in the UK, a number that would soon increase several-fold. In The (London) Times in 1955 it was argued:

Heroin addiction in Great Britain is practically unknown and it is difficult to see why administrative action … should be allowed to hinder the relief of suffering.”2

“Do not let us follow along the path of prohibition – a bad and dangerous way’.3

In a description of the London drug scene in the 1960s, the preacher Kenneth Leech wrote:

To cut off the supply by prescription would be easy; it has been done in the United States where doctors are not allowed to prescribe for addicts, with the result that the provision of drugs has become a flourishing industry and drug addiction increases there yearly.’4

The differences between the US and other Western countries persisted into the late 1960s when US President Richard Nixon’s “War on Drugs” led to even stricter regulations. The effect on the medical use of opioids in the US was disastrous. By the second half of the twentieth century, both addiction and pain were undertreated, with baleful consequences. When the iniquities of undertreatment were recognized, opioid advocacy was born. In the US, addiction advocacy brought about the re-establishment of opioid (methadone) treatment for addiction in 1974 (Narcotic Addict Treatment Act); pain advocacy during the 1970s and 1980s brought about the re-establishment of opioids for the treatment of acute and cancer pain, principles that were later extended to chronic pain.

Prevalence of prescription opioid abuse

Historically, under-treatment of pain as a consequence of draconian anti-drug laws occurred mainly in the US. The swing of the pendulum towards over-use, or at least careless use, of opioids for pain seems also a uniquely American problem,5 reflected in alarming statistics that demonstrate precipitous increases in prescription opioid abuse over the past decade, to the extent that prescription opioid abuse is now more prevalent in the US than is illicit heroin abuse.6 (Figure 26.1) Successful marketing of “designer” opioids increased prescribing of opioids for chronic pain.7 Increased prescribing for pain resulted in increased opioid analgesics in homes, pharmacies, and on the streets, and has likely contributed to the disturbing increases in prescription drug abuse and related deaths seen in the US.8 Surveys such as the National Household Survey do not exist in the UK, and it may be that, without an effective early warning system, the extent of the problem of prescription opioid abuse is unknown in UK.9 Whatever the benefits of the UK’s relatively forgiving approach to controlling addiction in terms of not having inhibited opioid prescribing for pain to the same extent as in the US, UK policies seem to be failing to control problematic illicit drug use when compared to other European countries. The UK now has the worst illicit drug problem in Europe, a situation that is bound to impact UK general practitioners at the intersection of pain and addiction. Effective confinement of prescription opioid use to medical use, as appears to have been achieved in the UK, seems ideal, yet the balance between prescription and illicit opioid abuse will always be precarious.

Enactment of laws and their effect on opioid prescribing for pain

In the US, the Controlled Substances Act of 1970 unified many previous laws under a single framework regulating the manufacture, distribution, prescription, and dispensing of opioids and other substances with abuse potential. Controlled substances were assigned to one of five schedules based on their medical utility and abuse potential. The Controlled Substance Act defines neither legitimate medical purpose nor standards of professional practice: this falls to the state medical boards, professional societies, the Department of Justice, or even lay juries in criminal trials. Criminal charges against physicians generally arise only when both bad practice and bad intention by the practitioner are established.

Because of legal constraints placed on opioid prescribing in the US, gross negligence (bad practice) may lead to criminal prosecution even when there is good intention. For example, a physician is more likely to be accused of involuntary manslaughter if the drug chosen for overdose by a suicidal patient is an opioid rather than a noncontrolled drug such as a tricyclic antidepressant. In People v Schade, a physician was convicted of involuntary manslaughter when a patient with known addiction and suicidal ideation killed himself with an opioid that had been prescribed within days of a previous suicide attempt. The jury deemed this to be reckless facilitation of a suicide. Had the medication not been a controlled substance, the physician more likely would

Figure 26.1.

Figure 26.1. Dependence or Abuse of Specific Illicit Drugs among Persons Aged 12 or Older: 2003

have faced malpractice (a civil action not subject to incarceration), rather than criminal charges.10

The perception of risk of even being investigated, let alone being tried and convicted on criminal charges, has deterred many physicians from aggressively treating pain with controlled substances. In the US there is a risk also of being charged with undertreatment of pain. In 2001 a California physician was convicted of elder abuse for underprescribing pain medications in a malpractice suit. The jury awarded the family $1.5 million.11 Cases such as these have raised significant societal debate on the role of the courts in dictating what constitutes a “legitimate medical purpose,” a role historically the purview of state medical boards and professional societies. Contradictory legal precedent places physicians in a quandary: prescribe liberally and risk possible criminal investigation or prescribe sparingly and risk civil proceedings for the undertreatment of pain. The war on drugs collides with another American phenomenon, patient advocacy for the right to pain control. Physicians are left caught in the middle.

Because UK drug regulations are less restrictive than those in the US, criminal prosecution of physicians on charges related to opioids were virtually unheard of until the notorious case of Harold Shipman in 1998. Harold Shipman was a general practitioner who was tried and convicted of the murders of 15 elderly patients. He had administered diamorphine (a legal drug in the UK for clinical use). After his trial, a special inquiry (the Shipman Inquiry) found evidence to suggest that he had, in fact, killed as many as 250 people. The press coverage of the case was such that Harold Shipman’s activities became well known in the UK. Unlike the US, where criminal prosecution of physicians had occurred relatively frequently with an insidious effect on opioid prescribing for pain, the Shipman case had an immediate and profound effect on opioid prescribing in the UK. The Shipman Inquiry was damning in its criticism of the General Medical Council (the body that accredits British doctors) saying that the body had protected doctors at the expense of protecting patients.12 The inquiry suggested two ways in which risk might be reduced, which had been recognized in earlier legislation but never implemented: they found that doctors should not be allowed to prescribe controlled substances: (1) for their own use; or (2) when not in “actual practice” (with an active medical license). Another provision that had been suggested in earlier regulations, but never implemented, was that all private prescriptions should be written on special forms. In 2006, the Misuse of Drugs Regulations were changed, and new arrangements made for prescribing controlled substances on special forms.13

Demanding opioids: the impact of cultural and healthcare system differences

At the end of the twentieth century, doctors stopped worrying that opioid treatment of chronic pain was neither effective nor safe, and caution turned to confidence. It was believed that treatment could relieve people of the burden of chronic pain and improve their lives. This philosophical shift was important for persuading the medical community that opioids should be widely used for the treatment of chronic pain. But what if, after all, opioids are not so effective for relieving pain and improving lives, as has been suggested by several recently published epidemiological studies?14 Is patient desire for opioid treatment of their pain enough?

Studies are beginning to show that pain treatment, any pain treatment, can produce positive patient satisfaction ratings even if that treatment fails to produce the results treating clinicians want to see (improvement in pain, function, and quality of life).15 Simply validating a pain complaint by continuing treatment may be enough to satisfy patients. But if that treatment is an opioid, then there are several reasons why the treatment could produce good satisfaction ratings despite failing to achieve the primary goals of treatment. Only a few patients will develop true addiction, but many if not all patients receiving continuous opioid treatment will develop dependence (physical and psychological).16 They may therefore give up opioids only with difficulty, even when such drugs are not working well. By the definition of addiction, those patients that do develop iatrogenic addiction will desire opioids beyond their ability to improve quality of life. Many patients will rely on opioids to treat symptoms other than pain (“chemical copers”). The addictive properties of opioids introduce complications such as deliberate or careless diversion. There is also a sense that there is nowhere to go beyond opioid treatment – that there is nothing better, so it must be good.

The issue of patients desiring opioid treatment, even when the treatment fails to achieve conventional treatment goals, exposes some important differences between the US and the UK. Consider first the profound cultural differences that drive ethical and moral arguments in these two countries. Liberty and the right to pursue happiness were fundamental to the constitution of the New World – values that have remained central to the American character ever since. In the US, the rights of the individual are of primary importance. In healthcare, this means that patients dominate in healthcare decisions, provided they or their insurance can pay. Statutes are written to ensure that patients have a right to determine their own treatment, including Intractable Pain Statutes that establish the right of patients to receive opioids for the treatment of intractable pain.17 Physicians are supposed to help inform patients about the capability of a treatment to achieve its goals, and to steer the patient’s decision within a guidance-co-operation model, as distinct from the paternalistic model of care seen more often in government run healthcare systems. This forms the basis of the shared decision-making that is prevalent in US healthcare.

Medical ethics: the role of patient choice

The most difficult ethical arguments arise when there is this difference of opinion between the patient and physician, especially when the argument pitches the individual patient against the needs of society.18 In the US, there is cultural bias to allow patient choices, while in the UK healthcare system and culture, a more socialist approach is encouraged. This difference becomes important when considering the role of patient satisfaction as an “outcome” of opioid treatment. Addiction risk aside, if opioid treatment of chronic pain effectively achieves any of the conventional goals of treatment (e.g., sustained pain relief), most people would agree that there is a strong argument for providing it. If the treatment is desired but not effective, or even harmful, then differences in the value placed on patient satisfaction will be starkly exposed.

The US healthcare system is unique in that it is the only system in the world that relies on employers, through insurance agencies, to fund healthcare. Medicare and Medicaid fund healthcare for the elderly and the impoverished, respectively. The truly uninsured are a small minority of the population. Healthcare in the US is therefore driven by marketing – not by welfare – politics, and the model of American healthcare is a business model.

Attention to pain, and successful treatment of pain, have become important markers of quality of care. Measures of patient satisfaction are now included in most hospital outcome metrics, and are used for accreditation of US hospitals, as well as to assess the performance of individual clinics and clinicians. Failure to compete in terms of patient satisfaction could mean institutional failure, loss of institutional support, or loss of livelihood for clinicians. Patient satisfaction with opioid treatment without any other demonstrable benefit presents a dilemma for some clinicians, who may feel pressured to prescribe against their better judgment. The conflicts that can arise in discussing withdrawal of opioid treatment in patients who have not demonstrated traditional signs of clinical efficacy may deter many clinicians, since it is much easier to simply prescribe the opioids the patient is seeking. A business model of healthcare may thus promote a tendency to overprescribe.

Case resolutions

Case 1

The best way to keep Alesha’s addiction under control is to formalize her addiction treatment, ideally in recognition that she needs both pain and addiction treatment. Opioid maintenance or analgesic treatment alone will not be enough to control either her pain or her addiction, and counseling and other nonmedical interventions should be an integral part of treatment. In the US, a patient like this may fall through the cracks if she doesn’t have some sort of healthcare coverage (e.g. Medicaid). It is highly likely that this patient will suffer a relapse if she does not receive appropriate treatment. The ethical issues that arise here are: (1) that the stigma of addiction affects physicians’ prejudices and their willingness to treat pain with opioids; and (2) she may be denied appropriate medical care because of lack of, or limited, benefits – a reason some may argue at the broad political level that it is unethical to continue with the current healthcare system and its disparities.

Case 2

Ian is in a high-risk, low-benefit category for opioid pain treatment. He presents a high risk of misuse due to his alcoholism and chaotic lifestyle, and he has a pain condition that can be effectively treated using non-opioid approaches. Ideally, he should be offered both addiction and chronic pain treatment, the latter being with nonopioid approaches. The ethical issue here is whether physicians can and should withhold opioids if they believe that in prescribing, they could do harm. In the US, the physician risks losing DEA certification or medical license if prescribing to a patient who subsequently harms him/herself. Fear of liability thus becomes a significant factor in clinical decision making.

Case 3

Evidence and expert opinion strongly suggests that open-ended dose escalation doesn’t work, and eventually leads to opioid refractoriness. Peter should be advised that, if the opioid is no longer working well, his choices include opioid holiday or opioid switch, but not dose increase. Peter’s concomitant marijuana issue is always tough. Since marijuana use is illegal in the US, the physician can either take the hard line of not prescribing opioids to patients who use marijuana (which may be revealed on the urine toxicology screen even if the patient doesn’t admit to use) or deal with it in a “don’t ask, don’t tell” manner. He would probably not be prescribed a synthetic cannabis analogue because it doesn’t work well for pain. This author would not be threatened by the patient’s statement about going back to buying on the street, since she cannot prevent that. Ethically, the physician is bound to treat pain to the best of their ability according to their knowledge. In this case, that would be with a rational and stable does of opioid, with the usual safeguards. Although for a patient who has already threatened to “buy on the street,” there will always be a risk of him selling his prescribed opioid, on balance this tendency may be better controlled if he is provided with a stable dose of opioid in a medical setting. Some American physicians may fear regulatory scrutiny in this situation, with appropriate documentation of this rationale for the treatment decision, they would be unlikely to be faulted by the authorities.

Key points

• Differences in history, culture, healthcare systems, laws, and attitudes have significantly affected perspectives on the ethical management of opioid use between the US and the UK.

• Use of illicit opioids in the US has lead to reactionary legislation with harsh penalties. The present state of affairs is that abuse of prescription opioids is more prevalent in the US than abuse of “street” heroin.

• Opioid treatment of pain has periodically come under intense scrutiny in the US, resulting in fluctuations between under- and overtreatment of pain. In the UK, opioid treatment has long been maintained as being humane, ethical, and necessary.

• Physician choices in the US are influenced by legal issues; US physicians can be held liable for both over-treatment and under-treatment of pain, while in the UK such cases are rare.

• Fears of civil or criminal prosecution may unduly influence physicians in the US, placing self-interest ahead of the traditional prioritization of beneficence and respect for patient autonomy.

• Differences between the US and UK in healthcare provision additionally influence opioid prescribing.

• Lack of universal healthcare coverage in the US means that, at one end of the spectrum, for the uninsured, it may not be possible to offer appropriate care for pain and addiction.

• At the other end of the spectrum, strong patient advocacy and the established rights of the insured, mean that patients dominate in healthcare decisions, including the right to receive opioids. The paternalistic approach more predominant in universal healthcare systems is not appropriate in the US. This produces ethical dilemmas for the US physician whose concept of risk versus benefit may differ from that of the patient, and who additionally may be driven to produce good patient satisfaction ratings in a market-driven healthcare system.

References

1 Webb et al. v United States, 249 US 96 (1919).

2 Horder, T.J. (1955). Manufacture of Heroin. The Times, London. 26th May;11e.

3 Webb-Johnson, A.E. House of Lords debates, 13th December 1955, vol 195, columns 45–6

4 Leech, K. (1991). The London Drug Scene in the 1960s. Policing and Prescribing, eds. Whynes D and Bean P. McMillan, London UK, pp. 43–4.

5* Zacny, J.Bigelow, G.Compton, P.et al. (2003). College on Problems of Drug Dependence taskforce on prescription opioid non-medical use and abuse: position statement. Drug Alcohol Depend,69(3), 215–32.

6 Office of Applied Studies (2008). Results from the 2007 National Survey on Drug Use and Health: National findings (DHHS Publication No. SMA 08–4343, NSDUH Series H-34. Rockville, MD: Substance Abuse and Mental Health Services Administration.

7* Van Zee A. (2009). The promotion and marketing of oxycontin: commercial triumph, public health tragedy. Am J Public Health99(2), 221–7.

8* Kuehn, B.M. (2007). Opioid prescriptions soar: increase in legitimate use as well as abuse. JAMA17(3), 249.

9* Spence, D. (2010) Bad medicine: pain. Br Med J340, b5683.

10 Romanow, K. (2003). Criminal law: physician convicted for recklessly prescribing OxyContin. J Law Med Ethics31(1), 154–5.

11 Bergman v. Eden Medical Center, No. H205732–1 (Cal. Super. Ct. Aug. 20, 2001).

12 The Shipman Inquiry. http://www.the-shipman-inquiry.org.uk/home.asp.

13 Department of Health (2006). Safer Management of Controlled Drugs (CDs): Private CD prescriptions and other changes to the prescribing and dispensing of controlled drugs (CDs). Guidance for Implementations. Gateway Reference: 6820.

14 Eriksen, J.Sjogren, P.Bruera, E.et al. (2006). Critical issues on opioids in chronic non-cancer pain. An epidemiological study. Pain125, 172–9.

15* Ballantyne, J.C. and Fleisher, L.A. (2010). Ethical issues in opioid prescribing for chronic pain. Pain148(3), 365–7.

16* Ballantyne, J.C. and LaForge, S.L. (2007). Opioid dependence and addiction in opioid treated pain patients. Pain129, 235–55.

17 Dubois, M.Y. (2005). The birth of an ethics charter for pain medicine. Pain Med6(3), 201–2.

18* Rubin, S.B. (2007). If we think it’s futile, can’t we just say no? HEC Forum19(1), 45–65.