Informed Consent Standards – A House of Cards

I recently submitted a recommendation to Oregon’s mental health officials as they consider revising their clinical standards. My recommendation for these clinical practice standards has to do with providing true informed consent for prescribing psychotropic medications. If it were adopted, it would threaten to bring down a kind of “house of cards” that is the centerpiece of the mental health system.

The state is asking for feedback on what they call administrative rules for behavioral health. These rules provide the practice standards required of service providers.

The current rules provide only a very superficial section on how patients are to be informed about the medications. I think that if persons who were about to be prescribed psychiatric drugs had complete and accurate information, they would be very cautious about which ones they take, in what dosages and for how long they would take them.

As most anyone who is likely to be reading this knows, people who come to community mental health programs are told that their treatment with medications is critical to their stability, that they will likely need to be taken for a long time if not the rest of their lives, and that it’s all based on their having a chemical imbalance. This imbalance will be corrected with maybe only a few side effects here and there–minor inconveniences like dry mouth and restless legs, but worth the discomfort.

However, those who are about to be prescribed antidepressants, for example, are not told about their well-documented lack of effectiveness nor about the increased risk of suicide and withdrawal syndromes that they can expect if they want to go off the drugs. Similarly, with antipsychotics, they are not likely to be told much about the possibility of tardive dyskinesia—a serious and often debilitating effect of taking the drugs.

As an illustration of this, a May 2019 article from the on-line version of Psychiatric Times points out that “few persons know about the condition and many do not recognize it.” This admission comes after over 60 years of prescribing the drugs that cause it.

By the same token, they are extremely unlikely to be informed that the antipsychotics “are engineered to occupy 70% or more of D2 receptors” as documented by the data-based Institute for Safe Medication Practices (ISMP) 2016 QuarterWatch report).

The same source of information goes on to say, “The problem is that these receptors are widely distributed throughout the brain and central nervous system and mediate a long list of important body functions, including mood, sleep, memory, impulse control, decision-making, muscle movement, appetite, blood pressure, and sexual development.”

It would be surprising if any more than a few prescribers have available the kind of information outlined in the ISMP article referenced above that quotes from a National Institutes of Health (NIH) study of five antipsychotics: “66.7% [of these drugs] showed moderate to severe harms over approximately 18 months of treatment. The drugs may also cause cognitive impairment, sexual dysfunction, and diabetes.”

Adding to the problem of fully informing a patient is that there are significant gaps in side effect and adverse reaction information that actually exist for prescribers. A December 4, 2019 STAT article points out that “It’s no secret that the many side effects caused by medicines do not get reported to the Food and Drug Administration, but a new report suggests the magnitude of underreporting is far greater than imagined.” It goes on to say that just 1% of an estimated 276,000 serious adverse events had been reported to the FDA in 2017.

Undoubtedly, most prescribers, including the many primary care physicians who prescribe the full range of psychiatric medications, think that they are providing excellent “informed consent.” They believe they learned how to do this in medical school and their residencies. They further absorbed this belief through a combination of osmosis and the rather minimal practice standards and regulations to which they are expected to adhere.

To operationalize these practice standards, most publicly funded programs do require an informed consent form and a progress note to put it all in a bow. That usually does it. I think it is fair to say that most of them are lacking the kind of complete information outlined above so they do not have anything to challenge them as to whether or not they are doing a good job. Their existing clinical standards don’t speak to this in more detail than they deliver.

The basic question then is this: Are conversations with people who are being prescribed psychiatric medications fully informing them about psychiatric drugs? The answer to this question was clear in the Mad in America Continuing Education webinar series “What Would Real Informed Consent on Psychiatric Drugs Look Like?”

We started and ended the series with a panel of people who had been prescribed them to hear what they had experienced. Not surprisingly, none of them had received anywhere near true and complete informed consent.

So what would a former state bureaucrat turned advocate like me want to do about it now? The answer is in the draft I submitted for a change in practice requirements.

Here are my proposed revisions in bold:
(f) Give full and evidence-based informed consent in writing prior to the start of services, except in a medical emergency or as otherwise permitted by law. Full and informed consent for the prescription of psychiatric medications means information provided both verbally and in writing which explains possible side effects, both short- and long-term as well as information based on unbiased, well-constructed research regarding likely short-term, mid-term and longer-term outcomes and what can be expected in terms of withdrawal from the prescribed medications. Information must be provided about alternatives to psychiatric medications. Informed consent must also include information about the benefits and risks of prescribing more than one psychiatric medication.

You can see from the current wording (unbolded) that there’s been a lot left out in the current rule. The substantial additions will not go over well. Once consideration of the proposal starts, the objections will be fast and furious.

The first will likely be that this kind of information is already provided. If that is the case, then there should be no problem at all in placing the additional requirements into the standards so that there is never a doubt about the scope and importance of providing true informed consent.

Another objection will be that psychiatric patients have “anosognosia”—a term borrowed inappropriately from neurology–so they can’t be expected to understand the information. My response is twofold—first, this is a condescending and inappropriate view of patients which disrespects the cognitive capacity of almost every person who is prescribed the drugs. Second, it is the responsibility of the prescriber to make the information understandable, not the patient’s responsibility to ask all the right questions.

Finally, there will be the quite realistic observation that because of the way in which services are structured, there isn’t enough time to do a good job of delivering full and complete informed consent. They will point out that there is very limited time for treatment assessments and the follow up 15 minute med checks are additional serious limitations.

It is also true that the alternatives available to avoid overuse of medications are in extremely short supply. But changing these realities is the responsibility of program designers and funding to make the resources an integral part of every program.

The changes in wording I have proposed will require not only major reconstruction of services but also will demand a great improvement in continuing education regarding the actions, effectiveness, and risks of prescribing medications.

Being a realist, I think it is extremely unlikely that Oregon or any other state will have the courage to adopt the proposed revisions and then, just as importantly, follow through with the education and enforcement that will become necessary.

However, at the least, this proposal will open the door to a much wider recognition of the role that poorly conducted informed consent plays in the excessive use of psychiatric medications.

The house of cards built with existing informed consent practices and the systems it reflects will then be in peril, as advocates expose the lack of true informed consent and the disrespect it shows to persons who are confronting decisions about whether to take these powerful drugs or not. Of course, I would happily be wrong and see major changes begin sooner rather than later.

bnikkel_miaceRobert Nikkel, MSW, is a Clinical Assistant Professor in the Public Psychiatry Training Program at Oregon Health and Science University. He was the State of Oregon’s commissioner for both mental health and addictions from 2003-2008. He is the director of the Mad in America Continuing Education project and Board President of Dual Diagnosis Anonymous of Oregon.

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