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The Anti-Antipsychotics Crusade Appears to Have Flopped — Could They Be Coming After You?

      For over half a century, medication management of behavior and psychiatric conditions (BPCs) in nursing home residents has been controversial. Over a decade ago, the Centers for Medicare & Medicaid Services launched a “National Partnership to Improve Dementia Care in Nursing Homes” (http://bit.ly/3ADBCwm) that included efforts to reduce the prescribing of antipsychotics.
      The latest salvos in this endless battle have come from the Office of the Inspector General (OIG) and CMS. An OIG report released in mid-November (“Long-Term Trends of Psychotropic Drug Use in Nursing Homes,” Nov. 14, 2022, bit.ly/3PN5ehj) appears to confirm that the net result of the intensive, lengthy, and costly focus on reducing antipsychotics has achieved little more than a shift to other categories of medications. Specifically, while the use of antipsychotics among nursing home residents decreased from 31% in 2011 to 22% in 2019 the use of antiepileptics (valproic acid, gabapentin, etc.) increased from 28% to 40% from 2011 to 2019.
      The serious flaws in the popular use of antiepileptics as an alternative to managing BPCs have now been flushed out into the open. A 2009 Cochrane review found that valproate did not improve agitation in adults with dementia, and actually increased adverse events (Cochrane Database Syst Rev 2009;[3]:CD003945). The National Institute for Health and Care Excellence in the United Kingdom has confirmed that valproate should not be used to manage agitation or behavioral disturbances in those with dementia (NICE Guideline NG97, June 20, 2018, https://bit.ly/3Wgzinb).
      The OIG report’s results are not surprising, given that this campaign was overly focused on one class of medications. The real underlying issues never were about any one class of medications (see my Caring OBRA Regulations columns from March through May 2020). Instead, the issues concern how licensed health care professionals and nursing home staff and management think about complex issues and about highly variable — and often inadequate — problem-solving efforts. As Abhilash Desai, MD, and I have written elsewhere, “One key reason why problems persist is because most efforts to ‘reform’ and ‘correct’ the situation have failed to explore or address root causes and instead have promoted inadequate piecemeal ‘solutions’” (J Am Med Dir Assoc 2017;18:284–289) — based excessively on the flawed narrative of greedy owners, “ageism,” and inadequate staffing. What is needed is a balanced effort to effectively address a complex medical, neurological, and psychosocial problem.
      CMS has tended to downplay the importance of judicious pharmacotherapy and has largely failed to offer nursing homes meaningful examples of the appropriate medication use in individuals with substantial BPCs who don’t respond well to alternative interventions. The usual problem-solving examples related to BPCs in surveyor guidance have been for nonpharmacological interventions, which are sometimes relevant and helpful but often inadequate. These cognitive biases have caused many to never learn about how or when to use medications properly. Unfortunately, there is the potential for every medical treatment of BPCs to come under increasing assault (not just scrutiny).
      In the most recent (October 2022) update of the Omnibus Budget and Reconciliation Act of 1987 (OBRA) survey-related State Operations Manual (SOM), CMS added considerable details about diagnoses of schizophrenia and advised surveyors and facilities to consider reporting physicians to licensing boards if they suspect misdiagnosis to facilitate ordering antipsychotics. If the current trends continue, it is just a matter of time before criminal prosecution is used, per consumer recommendations (“Examining Inappropriate Use of Antipsychotic Drugs, Part Three: Recommendations,” Center for Medicare Advocacy, Oct. 24, 2013, http://bit.ly/3VjTCEm).

      The Medical Practitioner’s Essential Role

      Given all this, the remainder of this month’s column is a detailed warning to physicians and advanced practice providers (APPs) to shape up and take charge or face the risk of disproportionate blame and serious legal and regulatory consequences.
      Sadly, despite the competent and commendable efforts by many individual medical practitioners, this aspect of care has been badly neglected and misunderstood by many practitioners, including physicians. Valid concerns persist about medication management of BPCs across all settings, including in post-acute and long-term care. Government agencies and advocates increasingly doubt whether nursing homes and medical practitioners (e.g., physicians and APPs) are able or willing to address these issues forthrightly. But, as with antipsychotics themselves, no single discipline, profession, or cause is primarily responsible for perpetuating the issue. Instead, everyone has played a role.
      Traditionally, physicians have often avoided these difficult and challenging patients with BPCs; instead, they have deferred to other members of the interdisciplinary team (IDT) and to psychiatric consultants to tell them what to do, and then have dutifully signed the orders. Nurses and physicians often disclaim responsibility for a patient’s treatments or complications, insisting that “we just did what the consultant told us.”
      Attending physicians rarely have the time or inclination to review a patient’s complex behavior history and are not usually present to witness actual episodes to gauge the nature and severity of the issues. It is reasonable to rely on other IDT members to gather and organize the important information about patients that is needed to understand and manage them. However, physicians and APPs need to do enough over time to validate others’ conclusions and requests for orders — they must not just assume these requests are reliable and pertinent.
      Regardless of who obtains the information, whatever has been gathered needs appropriate interpretation, precise problem definition, and accurate cause identification. It is not enough to just have staff report “agitation” or “restlessness” or “cognitive impairment.” Commonly, there are a mix of medical, psychosocial, environmental, and other causes.
      Furthermore, physicians and APPs should realize the substantial limitations of the OBRA-related Resident Assessment Instrument (including the Minimum Data Set [MDS]) as a clinical decision-making tool. The MDS instrument collects many details about a resident’s cognition, mood, behavior, and function. Unfortunately, it offers minimal guidance to help determine the meaning of that information and the relationships between and causes of symptoms. The Care Area Assessments and Care Area Triggers are inadequate in more complex cases for determining causes and contributing factors.
      Meaningful physician and APP participation can help ensure that there is an adequate appraisal of all relevant causes. This includes having a detailed discussion with the IDT about the patient in order to identify and document the basis for diagnostic conclusions. Without some sort of attempted verification or validation, it is imprudent to merely assume that the information and conclusions are complete and correct or to just copy others’ conclusions into the record.

      How Much Diagnostic Effort?

      Correctly diagnosing BPCs in nursing home residents is very challenging. Often, the origin and basis of psychiatric diagnoses and the rationale for related treatments are unknown, unclear, or inadequate. Discharge information from other settings may not help much. Many patients have accumulated multiple (sometimes a dozen or more) psychiatric diagnoses such as anxiety disorder, major depressive disorder, bipolar disorder, cognitive impairment, dementia, schizophrenia, and personality disorder.
      I recall a nursing home resident, admitted from the community, who was taking 50 mg a day of haloperidol for an alleged diagnosis of schizophrenia. Even with the input of a psychiatric consultant, the facility maintained the medication and dose because no one knew how to validate the diagnosis. Eventually, she was identified as not having symptoms of mental illness, and she was weaned off all medication with no adverse consequences.
      I helped the staff analyze the situation by using the care delivery process. As I wrote with my colleague Dr. Desai in the aforementioned 2017 JAMDA article, effective management of BPCs “requires faithful adherence to clinical reasoning based on patient-specific evidence. Key care delivery process steps include: (1) collecting and analyzing information; (2) detailed problem definition and cause identification; (3) selection of pertinent interventions; and (4) monitoring the results and adjusting interventions accordingly.” This is the essential basis for treatment decisions that have a clinically sound foundation.
      Physicians and APPs must lead the cause-identification effort for patients with BPCs. It should be — but too often is not — standard practice for medical practitioners and the IDT to review and attempt to validate any conclusions about causes (not just medical ones) and related factors.
      The routine first step in addressing all BPCs is for medical practitioners to help identify medical causes such as delirium and adverse medication consequences. For instance, the DSM-5 Handbook of Differential Diagnosis (American Psychiatric Association, 2014) states, “Virtually any presentation encountered in a mental health setting can be caused by substance use. Missing a substance etiology is probably the single most common diagnostic error made in clinical practice.” Correctly identifying and addressing adverse medication consequences can often resolve the problem or reduce the need for psychopharmacological medication interventions.
      Subsequently, attending physicians and APPs should be able to do at least some of the following, as written in my 2017 JAMDA article (from Table 2, “Sequence of Differential Diagnosis Thinking”):
      • Consider medical causes: (a) delirium, (b) medical conditions and medication-related adverse consequences.
      • Consider major psychiatric causes: (a) psychosis, (b) onset or exacerbation of chronic mental illness (e.g., bipolar mania, schizophrenia).
      • Consider mood and anxiety disorders: (a) minor mood disorders including demoralization syndrome, (b) depression, (c) anxiety disorders.
      • Consider other disorders: (a) other medical causes, (b) substance-abuse related, (c) personality disorders.
      • Consider dementia and other neurocognitive disorders.
      • Consider environmental and psychosocial causes or adjustment difficulty following a care transition.
      Physicians and APPs who do not follow these simple approaches may fail the patient and put themselves at risk for being accused of using unnecessary medications to chase the side effects of other medications that could’ve been either changed, eliminated, or reduced in dose. Improving diagnosis takes practice, reliable consultative support, and knowing one’s limits.

      The Medical Practitioner’s Role in Treatment

      Medical practitioners can learn to use psychopharmacological medications responsibly to tackle BPCs, despite the challenges. Given the many nonspecific symptoms, diverse causes, numerous medication options, and often substantial overall medication regimens in many patients, this is no small challenge even for experienced clinicians.
      Every medical practitioner has some significant role in identifying whether a specific individual with BPCs warrants an intervention, whether that intervention should include medications, and if so, which medication(s) and what doses, frequency, and duration. There isn’t any type or category of intervention that is consistently successful.
      Over the last several decades, a whole industry of psychiatric consultants has arisen, ostensibly to help nursing homes and medical practitioners. As discussed in a previous column (Caring for the Ages 2021;22[1]:8–9), these consultants must be used properly and prudently. Clinicians should not rely on psychiatric consultants as a substitute for adequate evaluation and discussion of patients with BPCs. Many facilities allow anyone to directly request psychiatric consultations. This is highly problematic because preliminary “homework” — such as defining issues precisely and considering medical and medication causes — is essential whether or not psychiatric consultations are used.

      Don’t Let It Happen to You

      Physicians and APPs are increasingly being held responsible for the conclusions on their patients, and they cannot escape scrutiny or potential problems by simply saying “I didn’t know” or “that’s what somebody else told me was true.”
      The care of BPCs involves sound clinical reasoning and effective diagnosis. Others can contribute information, but clinical reasoning and diagnosis are ultimately the responsibility of attending physicians, who must be involved even while working closely with other IDT members.
      The attending physicians and APPs who are doing this right are to be applauded and supported. Those who have not been performing adequately in this area will want to shape up without further delay — or risk harsh and avoidable consequences. Medical directors must vigorously help facilities strengthen their approaches.
      Dr. Levenson has spent 42 years working as a PALTC physician and medical director in Maryland. He has helped guide facilities throughout the country through his work in the educational, quality, and regulatory realms. The author’s views do not represent those of the Society or any other entity.