Informed Consent in Addiction Treatment: An Ethical Obligation

Informed Consent in Opioid Addiction Treatment: An Ethical Obligation

This article was originally published in The Carlat Addiction Treatment Report, Volume 2, #3, May 2014

Source: 

 CATR, May 2014, Vol 2, Issue 3, Opioid Addiction

Mark Willenbring, MD

Founder and CEO, Alltyr Clinic, St. Paul, MN, Former Director, Division of Treatment and Recovery Research, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD

Dr. Willenbring has disclosed that he has no relevant financial or other interests in any commercial companies pertaining to this educational activity.

Informed consent—whether it be for psychotherapy, prescribing a medication, or performing a surgical procedure—is an ethical principle firmly established in law and medicine.

While there has been no formal research on this subject, my experience suggests that many addiction treatment programs fail to obtain valid informed consent. The starkest example occurs in the treatment of opioid addiction, where the practices and beliefs of clinicians often differ markedly from the evidence regarding effective treatments.

What is Informed Consent?

Informed consent refers to the collaborative process that a provider and patient go through to develop a treatment plan for the patient’s problems. This moral requirement is based on the principle of respecting a person’s autonomy, that is, their right “to hold views, to make choices, and to take actions based on their values and beliefs” (Beauchamp TL & Childress JF.Principles of Bio-medical Ethics, 7th ed. New York: Oxford University Press, 2013:122–123).

Valid consent fulfills three criteria (Grimm DA, N M Law Rev 2007;37(1):39–83). First, the patient needs to have decision-making capacity. Capacity, in a medical context, refers to patients’ ability to understand information, appreciate their situation, use reason to make a decision, and communicate their choices (Applebaum PS, N Engl J Med 2007;357(18):1834–1840). This is referred to as the “capacity” criterion.

Second, the provider needs to present the full range of available treatment options based on current scientific knowledge. During this discussion, he or she needs to outline the risks and benefits of these various options and what could be reasonably expected if the patient declines treatment altogether. This is called the “disclosure” criterion.

Finally, valid consent requires that patients are free from coercion—that is, they are in a position to voluntarily choose any treatment option that they feel is best for them. This is described as the “voluntariness” criterion.

A provider has failed to obtain valid informed consent if any of these elements are missing.

Legal Standards

Legal requirements for consent have evolved over centuries. Until relatively recently, courts used a physician-oriented point of view: the physician was required to provide information he or she felt was in the patient’s best interests. This resulted in practices such as informing a spouse, but not the patient, of a terminal disease. In other cases, providers deliberately omitted certain treatment options from their discussions with patients because of their personal beliefs or biases against them.

Through a series of court decisions, a new standard, the “reasonable person” or “prudent person” standard, emerged. Providers are now expected to present patients with information that a reasonable or prudent person would want to know in order to make healthcare decisions (Berg JW et al.Informed Consent: Legal Theory and Clinical Practice, 2d ed. New York: Oxford University Press, 2001:48).

In clinical practice, a provider is not allowed to withhold information from a patient based on his or her judgment that one treatment is better than another. The provider is thus required to present the scientific evidence supporting available treatment options, the expected outcomes of these various treatments, and the clinician’s recommendation for the patient and the rationale for it. This recommendation also needs to take into account any patient-specific features that factored into the provider’s decision-making.

This means that clinicians are legally obligated to provide information that they may prefer to withhold. The purpose of informed consent, however, is not to “conveniently promote a treatment plan; it requires informing patients with the recognition that they may disagree with a recommended treatment plan and retain the authority to do so” (Berg et al, op.cit).

There is also an important distinction between the actual process of obtaining autonomous authorization for a treatment or procedure and institutional requirements that patients sign informed consent documents. Patients frequently sign such documents in the absence of true informed consent (Beauchamp & Childress, op.cit).

Evidence-Based Treatment

Providers are obligated to summarize the scientific data concerning the effectiveness of various treatment options. The only treatment with consistent, strong evidence of effectiveness for opioid addiction is indefinite opioid maintenance therapy with either buprenorphine or methadone (Mattick RP et al, Cochrane Database Syst Rev 2014;2:CD002207).

Currently, the World Health Organization, US Centers for Disease Control and Prevention, US Department of Health and Human Services, and many other agencies and organizations recommend methadone and buprenorphine maintenance as first-line treatments.

In contrast, there is no evidence commending drug-free (or so-called abstinence-based) treatments (Mayet S et al, Cochrane Database Syst Rev2005;1:CD004330). Moreover, there is good evidence that psychosocial or intensive behavioral approaches fail to improve outcomes compared to minimal drug counseling in patients receiving opioid maintenance therapy (Amato L et al, Cochrane Database Syst Rev 2011;10:CD004147; Fiellin DA et al, Am J Med 2013;126(1):74.e11–17).

Naltrexone is the only other medication that has been approved by the FDA for opioid addiction. Oral naltrexone (ReVia) is ineffective (Minozzi S et al,Cochrane Database Syst Rev 2011;4: CD001333) and the efficacy of extended-release, injectable naltrexone (Vivitrol) was established in just a single, industry-sponsored study conducted in Russia, where buprenorphine and methadone are not legally available (Krupitsky E et al, Lancet2011;377(9776):1506–1513).

Presently, evidence for Vivitrol’s effectiveness is limited and generalization of clinical trial data to other countries is questionable. (For more, see“Vivitrol: Another Option for Opioid Addiction?”)

Meeting the Capacity Criterion

In addiction treatment, patients who are experiencing severe withdrawal symptoms may not have capacity due to pain and emotional distress. Other confounders include co-occurring mental disorders and cognitive impairment associated with prescribed medications and substances of abuse. Although beyond the scope of this article, simple bedside instruments allow providers to evaluate and easily document a patient’s decision-making capacity (Tunzi M, Am Fam Physician 2001;64(2):299–306).

Meeting the Disclosure Criterion

Providers need to have a clear understanding of available treatment options and the scientific evidence supporting each one, so they can meet their obligation concerning disclosure.

This article’s brief summary may serve as a starting point. Standard textbooks are also a ready source of such information (eg, Strain EC & Stitzer ML eds. The Treatment of Opioid Dependence. Baltimore, MD: Johns Hopkins University Press, 2006). In addition, a number of plain language resources geared toward patients are available (eg,http://1.usa.gov/1ibCKou).

Providers need to present patients with more than their program’s philosophy or even the community standard of care. Remember, the standard for disclosure is what a reasonable or prudent patient would want to know, not a narrow presentation concerning usual care or the provider’s personal preferences. In the case of opioid addiction, this means summarizing the scientific data on the effectiveness of treatment options. This is a fiduciary duty that trumps the clinician’s personal preferences and their program’s philosophy of care.

Meeting the Voluntariness Criterion

Providers need to be very sensitive to overt, and more subtle covert, coercion when discussing treatment options with patients. Many people presenting for substance use treatment are subject to significant coercion from the legal system, employers, and families. Thus, we need to ensure that consent is truly voluntary and that we are not using coercion to impose our own views concerning treatment upon patients.

This ethical obligation may require advocating for a treatment option different than what a judge, probation officer, employer, or family prefers or recommends.

CATR’s Take: Addiction treatment has historically been very prescriptive and patients often had little choice about the care that they received. This article is a good reminder that providers have an affirmative duty to obtain informed consent and engage patients in shared decision-making.

Wacky Progressives and Scientific Illiteracy

In a disturbing article in the New York Times, Amy Harmon chronicles the tale of a brave county councilman on the island of Kona, Hawaii, who refused to be steamrolled by those who categorically believe that genetically modified organisms (GMOs) are dangerous and should be banned across the board. He actually took the time to look into the scientific research, to consult with scientists who know about this, and he attempted to draw a reasonable conclusion. He is faced, however, with a group of true believers, who keep repeating obscure claims based on long-discredited "research." They shout down their opponents and make outlandish claims that have no scientific basis or rationale. They demonize their opponents, and constantly shift the arguments when faced with scientific facts. Most disturbing of all was the refusal of his fellow council members to even allow scientists to testify, instead giving the floor repeatedly to unqualified zealots who continued to make broad, unsupportable statements. 

It turns out, then, that it's not only climate-change deniers and birthers who maintain passionately held beliefs that have no scientific basis. Worse, it shows how repeating false claims becomes a sort of echo chamber for those with similar beliefs. Finally it shows that such behavior is not limited to Tea Party fanatics or religious zealots, but applies equally to so-called progressives on the left side of the political spectrum. I write about this because it applies as well to too much in the fields of psychotherapy, behavior change and addiction treatment.

We tolerate too much of this type of thinking in our field. How many treatment centers offer "holistic" therapies such as yoga, energy field work, Reiki, or massage, or worse, "nutritional treatment" that is not only unsupported, but may well be harmful? Why are state agencies still allowing such centers to obtain licensure? Why are people paying for brain scans or quantitative EEGs or neurofeedback? And, of course, why do so many people cling to the fiction that 90x90 is effective for most people, or that 12-step approaches are 100% effective if you follow directions? (What treatments for human maladies, short of penicillin for strep throat, can claim 100% effectiveness?)

I'm not arguing that an absence of evidence of effectiveness is evidence of ineffectiveness. There is lots we all do that hasn't been studied well, simply because it is impossible to conduct a large randomized controlled trial on every possible therapy. However, in addiction treatment we have a very large and very strong evidence base from which to draw. It's actually far better than in many other areas of health care. In order to include an approach in a licensed program, at the least, we should require 1) a scientifically plausible rationale for a treatment, 2) that unsupported treatments should not be likely to cause significant harm or cost a significant amount of money, 3) that there is not significant evidence that the approach is not effective, and 4) that there is not a well-supported approach already available.

I'm also not suggesting that yoga, meditation, Reiki, energy field work, reflexology, acupuncture, massage, etc., may not be experienced as beneficial to some people. I recently underwent Rolfing, for example, which I found to be very helpful (if painful). But I didn't expect my health insurance to pay for it, and I reject any large claims concerning what it and similar approaches might accomplish. Such approaches might be made available to clients (at their own expense), but not as presented as a scientifically based health practice.

I have been surprised at how trendy the psychotherapy community is in general, not just in addiction treatment. One current example is the spread of dialectical behavior therapy (DBT) beyond its proven focus on borderline personality disorder. It seems that it's being applied to anyone and for every condition short of psychosis. Another trend is "trauma informed therapy" using eye-movement desensitization and reprocessing therapy (EMDR), DBT, prolonged exposure, or mindfulness. All of a sudden, everyone has "trauma" for which these are appropriate treatments, even though many do not meet criteria for post-traumatic stress disorder (PTSD.) What was psychoanalysis if not focused on trauma? For that matter, "mindfulness" is another trendy approach, with practitioners charging for something the Buddha gave away 2600 years ago and which can be had for free at your local Buddhist meditation center.

At the same time, I seldom encounter high quality cognitive-behavior therapy (CBT) being applied to co-existing anxiety or depressive disorders, in spite of a mountain of evidence supporting their effectiveness. And too many in our field still believe that "I don't believe in it" is an adequate reason to not support anti-relapse medications that also have a strong evidence base. When we have such well-supported therapies, why aren't we using them? Why are we instead embracing half-baked ideas and approaches? Why do we tolerate so much scientific ignorance? Why do we tolerate lack of informed consent, where clients are not given information about what the evidence supports and what it does not, but instead receive biased and incorrect information that deprives them of the opportunity to make an informed decision?

Restricted Access to SUD Meds and the Lack of Informed Consent

by Ian McLoone

A recent study by Abraham, et al., published in the March Journal of Studies on Alcohol and Drugs, finds that patients receiving treatment at publicly-funded programs have significantly less access to potentially life-saving substance use disorder (SUD) medications like buprenorphine, disfulfiram, acamprosate, and naltrexone. Buried in the report, however, is the shocking statistic that a full 56.4% of the programs (publicly- or privately-funded) prescribed no medications whatsoever. Clearly, there are a whole lot of consumers not being informed of their full array of choices when it comes to managing their treatment.

The study analyzed nearly 600 treatment programs throughout the country - data originally part of the National Treatment Center Study – and looked for differences in physician access and SUD medication access. The authors found that 10.9% offered access to one medication, while 32.7% offered more than one medication. Fewer than 5% of programs offered access to all of the above medications.

The authors note that nearly 2/3 of all specialty SUD treatment programs in the US are publicly funded, relying on government block grants and state contracts for the money needed to provide treatment, while private funding tends to come from private insurance and self-paying patients.

When divided into publicly-funded and privately-funded categories, private programs were almost 15% more likely to have a physician on-staff and nearly 10% more likely to employ master’s-level counselors. And while publicly-funded treatment programs were almost 14% less likely to prescribe buprenorphine, only 32.5% of all programs offered the medication. Only 20.6% of programs offered disulfiram, 27% offered tablet naltrexone, 27% offered acamprosate, and a slim 13.1% of programs offered injectable naltrexone.

Among other findings, programs with a more professional workforce were positively correlated with the number of SUD medications offered, and programs with a physician on staff were more likely to offer higher numbers of SUD medications than programs with no access to physicians.

These findings beg the question: why are evidence-based practices so rare and why is this tolerated in addiction treatment but not in other professional treatments? (What if over half of American cardiologists prescribed no medications to their patients?) Sure, public programs offer fewer scientifically-supported therapies – but even people who are spending a fortune of their own money are often getting poor care. When patients are not informed of the full array of treatment options, the lack of informed consent becomes an ethical – and likely legal – issue.