Dear Dr. Mossman,
All the psychiatrists at our clinic agree: It is hard to remember when our patients who take an antipsychotic are due for metabolic monitoring, and it’s even harder to get many of them to follow through with timely blood tests. For many, stopping their medication would be a bad idea. If we keep a patient on an antipsychotic and a metabolic problem results, how serious is our malpractice liability risk?
Submitted by “Dr. V”
Antipsychotics, the mainstay of treatment for schizophrenia,1 put patients at risk of gaining weight and developing metabolic syndrome, including type 2 diabetes mellitus, hypertension, and dyslipidemia.2 Second-generation antipsychotics are the biggest offenders, but taking a first-generation antipsychotic also can lead to these adverse effects.3
Most psychiatrists are aware of these risks and prefer that their patients do not experience them. However, many psychiatrists neglect proper monitoring or, like Dr. V, find it hard to ensure it happens and thus worry about clinical deterioration if patients stop taking an antipsychotic.4 If you are in the same situation as Dr. V, what medicolegal risks are you facing?
To answer this question, we will:
- review the clinical guidelines and standards for monitoring metabolic effects of antipsychotics
- examine how well (or poorly) physicians adhere to these standards
- discuss what “standard of care” means and how a practice guideline affects the standard effects
- propose how psychiatrists can do better at policing the metabolic effects of antipsychotics.
I’ll be watching you: Following guidelines
Several medical specialty societies have published guidelines for monitoring the metabolic effects of antipsychotics.5-8 These guidelines instruct physicians to obtain a thorough personal and family history; consider metabolic risks when starting a medication; and monitor weight, waist circumference, blood pressure, glucose, hemoglobin A1c, and lipids at various intervals. They also advise referral for management of detected metabolic problems.
Although the recommendations seem clear, many physicians don’t follow them. A 2012 meta-analysis of 48 studies, covering >200,000 antipsychotic-treated patients, showed that baseline measurements of cholesterol, glucose, and weight occurred in <50% of cases.9 A more recent review found that, among adults with a serious mental illness, the rate of lipid testing varied from 6% to 85% and for glucose monitoring, between 18% and 75%.10 In the first years after antipsychotic monitoring guidelines were established, they had only a modest impact on practice,9,11 and some studies showed the guidelines made no difference at all.12-14
Monitoring compliance varies with the type of insurance coverage patients have but remains suboptimal among the commercially insured,11 Medicaid patients,14-16 and veterans.17,18 Studies on antipsychotic treatment in children, adolescents, patients with dementia, and patients with an intellectual disability show insufficient monitoring as well.9,14,17,19-21 The reasons for these gaps are manifold, but one commonly cited factor is uncertainty about whether the psychiatrist or primary care physician should handle monitoring.22
Every claim you stake: The ‘standard of care’
In a medical malpractice case, the party claiming injury must show that the accused physician failed to follow “the generally recognized practices and procedures which would be exercised by ordinary competent practitioners in a defendant doctor’s field of medicine under the same or similar circumstances.”23 In the studies mentioned above,9-14 a large fraction of psychiatrists—many of whom, we can presume, are “competent practitioners”—don’t follow the antipsychotic monitoring guidelines in actual practice. Could failing to follow those guidelines still be the basis for a successful lawsuit?
The answer seems to be ‘yes.’ Published legal decisions describe malpractice lawsuits alleging physicians’ failure to follow antipsychotic guidelines,24,25 and online advertisements show that attorneys believe such cases can generate a payout.26,27 This may seem odd, given what studies say about psychiatrists’ monitoring practices. But determining the “standard of care” in a malpractice case is not an empirical question; it is a legal matter that is decided based on the testimony of expert witnesses.28 Here, customary practice matters, but it’s not the whole story.
Although the standard of care against which courts measure a physician’s actions “is that of a reasonably prudent practitioner …, The degree of care actually practiced by members of the profession is only some evidence of what is reasonably prudent—it is not dispositive.”29 To support their opinion concerning the standard of care, testifying medical witnesses sometimes use practice guidelines. In this case, an explanation of why a particular guideline was chosen is crucial.30
Using guidelines to establish the standard is controversial. On one hand, using guidelines in malpractice litigation allows for some consistency about expectations of practitioners.31,32 Although guidelines are not identical to evidenced-based medicine, they generally reflect an evidence-based expert consensus about sound medical practice. If a hospital uses a guideline to train its employees, the guideline provides the courts with clear information on what should have happened.33,34 Laws in some states allow clinicians to invoke their adherence to a guideline in defense against malpractice claims.35