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How to Reduce Medication Risk for You and Your Patients

When minimizing risks for patients, one concern psychiatrists regularly face is the potential side effects of medications, such as metabolic changes or weight gain that could lead to increased mortality or cardiovascular risk.

What precautions should prescribers take to minimize medication risk to patients and also our own liability?

Dr. Appelbaum: There are three key matters psychiatrists need to attend to when prescribing medications that have some risk of adverse consequences for their patients. You need to develop a rationale and document it, get the patient’s informed consent, and monitor the patient and intervene appropriately.

Can you elaborate on these three steps?

Dr. Appelbaum: The first is to develop and document a clear rationale for why you want to use a medication or combination of medications given the risks that it may present. Think through the risks, identify the potential benefits, and demonstrate why the benefits outweigh the risks. Then record that in the medical record so your reasoning process is clear to anyone who may review it in the future. Step two is engaging the patient in an informed discussion about your recommendation and the alternative options for treatment. Many physicians think informed consent just means getting the patient to sign a consent form—that is not what I am suggesting at all. I suggest a clear discussion between doctor and patient outlining the reasons for your recommendation. Discuss the likely benefits and then review the risks with the patient—whether they are metabolic syndrome, tardive dyskinesia, serotonin syndrome, or suicidality. Ultimately, it is the patient’s and not the physician’s choice what treatment the patient accepts. Third, after prescribing these medications with a patient’s consent, the physician has an obligation to monitor the patient closely enough to ascertain whether problematic side effects are occurring, and if they are, to step in. That could mean lowering the dosage, stopping the medication, or continuing for another week to see if the problematic side effects begin to fade.

To what extent should we involve other professionals in the patient’s care? For instance, if you are concerned about metabolic side effects should you share that with the patient’s primary care doctor who is managing the patient’s blood pressure and cholesterol?

Dr. Appelbaum: My bias is that more coordination is always preferable to less. It helps when a psychiatrist can touch base with the patient’s primary care clinician, cardiologist, or endocrinologist about such issues and document that interaction in the patient’s record. It shows that the psychiatrist is concerned and has acted appropriately to alert other caregivers to the potential issue.

Is it appropriate for a psychiatrist to manage side effects of a medication by giving additional medications that he or she might not be familiar with? Could that be construed as malpractice?

Dr. Appelbaum: Psychiatrists are physicians and all physicians can prescribe appropriate medications within the scope of their licensure. But a psychiatrist should clearly not go beyond his or her comfort zone. So if you are familiar with the treatment of metabolic syndrome, for example, and feel comfortable, there is certainly no reason not to undertake that treatment. If you lack that knowledge and aren’t comfortable, it is important to listen to your inner voice and to refer these patients to someone who can monitor them and make appropriate treatment recommendations.

What are your thoughts about the quality of informed consent as it is conducted in a typical treatment setting?

Dr. Appelbaum: Most evidence suggests that across the medical field—by no means just in psychiatry—informed consent is done rather poorly these days. Many physicians ignore the consent transaction entirely and simply say to their patient, “Well, this is a prescription that I am writing for you because I think this will help.” They don’t explore the rationale, the risks, the likely benefits, and the alternatives, which is what is required by the law of informed consent. In many settings, consent has become a formalistic, form-oriented process where clinics or hospital-based facilities prepare standard forms for classes of medications and give them to patients in place of having a discussion. These forms are often written in complex language that is well beyond the ability of most patients to understand. As a consequence, consent becomes a mere formality as opposed to an opportunity to teach patients about their medications and help them make informed choices.

The flip side of that argument is that the more we explain in the patient’s own language the potential risks of drugs, the less likely they may agree to treatment, and their psychiatric illness may go untreated.

Dr. Appelbaum: That is a common assumption. However, we have no data indicating that well-informed patients are less likely to accept treatment. Indeed, there are reasons to suspect that it might not be true—that patients who believe their physicians are being completely open with them might in the end be more trusting of their physicians’ recommendations. The point of informed consent, both as a legal doctrine and as an ethical principle, is precisely to allow the patient to make the choice.

We are all very familiar with the numerous class action lawsuits brought mostly against drug companies for medications that may increase suicidality or cause tardive dyskinesia. What liability might an individual doctor have?

Dr. Appelbaum: The drug companies themselves are attractive targets. But as physicians, we all know we can be sued at some point by any of our patients. The question is: are we likely to lose such a suit? To put it in a more positive way: how can we best prepare for that possibility and defend ourselves against such claims? That is where the three steps that I described earlier can play a critical role. We have a clear rationale for why we are doing what we did, we have obtained the patient’s informed consent to that particular treatment, and we have followed and monitored the patient appropriately. The courts have been very clear that physicians are not guarantors—to use the language that the courts would use—of a good outcome. Sometimes things go wrong. Physicians are responsible for doing what a reasonable physician in a similar situation would do, which is essentially the definition of the standard of care. So as long as we live up to that standard and can prove that we did, we ought not to be overly concerned about lawsuits.

There have been some high profile cases recently where patients have been prescribed medications and then used them inappropriately or in combination with other medications or with alcohol or drugs, resulting in a lethal outcome. What steps should psychiatrists take in protecting themselves and their patients from this sort of abuse?

Dr. Appelbaum: We begin by acknowledging that we can’t control what the patient does outside the office. A patient who is intent on engaging in risky behavior is going to do it despite our best efforts. However, a physician who has concerns about such misuse would want to discuss the risks with the patient in advance.

One of the advantages of an electronic record system is that we have ready access to the medications a patient might be taking. However, often times it is not accurate; something hasn’t been reported correctly or it hasn’t been eliminated from a person’s medication list. Can a doctor be held responsible for an imperfection in the electronic record?

Dr. Appelbaum: Only if that physician was responsible for causing the imperfection in the first place. So if you make an error in entering a patient’s medications into the record that leads to a mistake in judgment by another physician down the road, you could potentially be held responsible for that mistake. If you are concerned about the accuracy of a record, check with the patient and make sure the list in the chart is correct. Keep in mind that many medications are prescribed for patients that they never put in their mouths. We have reason to believe that more than a sixth of patients never take the prescription that they are given, with nonadherence rates even higher for psychiatric disorders (Osterberg L and Blaschke T, N Engl J Med2005;353:487–497).

Could you talk about some of the risks of doctors using social media?

Dr. Appelbaum: When you enter into the world of social media, whether via YouTube, Twitter, Facebook, or something else, you need to keep in mind that what you post is potentially available to the world—privacy settings notwithstanding—for an indefinite period of time. Physicians would be well advised not to post anything that they do not want the world at large to see and do not want to become a part of their permanent digital footprint. You take a risk posting anything that shows a lack of professionalism in your behavior. An example is a picture of you being drunk at a party or posting derogatory information about patients or the facility where you work. You risk discouraging patients from seeking care by holding up parts of the medical care system as inadequate or simply unprofessional. If you post information about a specific patient, you also risk violating that patient’s privacy rights in a way that is both legally and ethically objectionable.

What about using the Internet to find potentially valuable information about a patient that might be very pertinent to his or her care? Is that taboo?

Dr. Appelbaum: I think that psychiatrists and other physicians are still working out what the proper dimensions are when seeking information about their patients online. Some respected psychiatrists believe that anything that is on the Internet is public and there is no reason why they shouldn’t access it. Others have concerns about intruding into patients’ lives in ways that transcend what goes on in the office and perhaps strip patients of control over what they choose to tell or withhold from the psychiatrist. I think psychiatrists would do well to follow a few simple rules. First, make sure if you seek information about a patient online that it is for legitimate medical purposes as opposed to merely satisfying prurient interests. Searching for information such as real estate transactions and political contributions that have nothing to do with a patient’s therapy are not warranted. On the other hand, if a patient has been in the public eye as a result of behavior that is directly relevant to the treatment, there may be a stronger rationale for seeking that information. Second, seriously consider obtaining the patient’s consent prior to searching for such information because the alternative is not a very appealing one. The psychiatrist who knows things about his or her patient that the patient isn’t aware that the psychiatrist knows is in an awkward position and it inevitably will put a strain on the therapeutic alliance.

Thank you, Dr. Appelbaum.

Source: We thank The Carlat Psychiatry Report for allowing us to re-post this article. Luminello subscribers get a discount on The Carlat Report newsletters, books, CME credit opportunities, and ABPN Maintenance of Certification courses. Learn more

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