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COMMENTS/RESPONSES MISUSE OF BEERS CRITERIA To the Editor: It has recently come to my attention that a Medicare Part D insurance plan is misapplying the 2012 Beers criteria that the American Geriatrics Society (AGS) developed1 to deny payment for necessary medications. The specifics are that CIGNA, under Medicare Part D, has decided arbitrarily to deny medication insurance coverage for some prescribed medications under the policy that the insurance company will not pay for a “potentially unsafe drug.” We denied this request because: The American Geriatrics Society 2012 BEERS criteria suggest that the requested drug is potentially unsafe in people over the age of 65 years. Since the safety of the drug requested has not been proven in people over the age of 65 years, we have not approved this request.

The AGS should strongly protest to CIGNA, and other applicable parties involved in Medicare Part D, the misuse of the criteria and should oppose further efforts to apply the BEERS clinical criteria administratively where they are not appropriate. CIGNA appears to have created a computer edit that automatically denies any drug on the Beers list in any patient aged 65 and older. This does not appear to be a pharmacological judgment; it does not take into account many other clinical factors, such as previous use of the medication, other coadministered medications, degree of frailty of the patient, specific indications, alternative medications, or the opinion of the prescriber. There does not appear to be any pharmacist review of this automatic decision; it is not based on any patient-specific factors. They have created a dangerous standard wherein any drug on the Beers list has to be “proven” safe for people aged 65 and older. Very few older or generic drugs have been proven safe in elderly adults because of lack of specific clinical trials, expense, and previous Food and Drug Administration approval policy; most will never be proven safe. Although there may be specific safety risks for frail elderly adults, this is a clinical judgment that only the clinician who is treating the individual can make; a pharmacist cannot and should not make that decision, and a computer program certainly should not. CIGNA has not taken into account the quantitative risks involved. Only the treating physician can weigh the risks against the benefits, and for many of these medications, the potential risks may be minimal compared with the probable benefit. Factors such as dose, comorbid conditions, polypharmacy, physiological age, patient preference, cost, and formulary availability are important factors that should be considered when using the criteria, as was properly pointed out in the discussion of the 2012 Beers criteria. The risks to individuals of having medication denied, especially one that they had been previously taken, is significant. It appears that the insurance company, through their letters to beneficiaries, is implying that the physician is prescribing a dangerous drug to them. In addition, by declining to cover it, it creates a potentially dangerous situation whereby a beneficiary cannot get a prescription filled in a timely fashion.

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Obtaining approval after an administrative denial creates a major delay through the burdensome and expensive appeals process. These drugs do not require prior authorization. Please protest loudly to Medicare Part D insurers, the Centers for Medicare and Medicaid Services, and the medical and geriatric communities (AARP, for example) that a private corporation is misusing a clinical guideline to deny care. While other insurers make suggestions and provide information to physicians, second-guessing their choice of medications, usually under a pharmacist’s supervision, this particular insurer has preemptively overruled a clinical choice that the individual’s treating physician has made without knowledge of any of the clinical details. CIGNA has clearly misapplied the Beers criteria in a potentially harmful fashion, and as the developer of the criteria, the AGS should not allow this. Marc S. Berger, MD, CM, FAAFP Blue Ridge Integrative Health Care, Blue Ridge, Georgia

ACKNOWLEDGMENTS Conflict of Interest: The editor in chief has reviewed the conflict of interest checklist provided by the author and has determined that the author has no financial or any other kind of personal conflicts with this paper. Author Contributions: Marc Berger is responsible for the entire content of this paper. Sponsor’s Role: None.

REFERENCE 1. American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American Geriatrics Society updated Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc 2012;60:616– 631.

PSEUDODELUSIONS IN INDIVIDUALS WITH DEMENTIA To the Editor: Delusions have long been recognized as central to the notion of psychosis. As such, what constitutes a delusion lies at the heart of psychiatric practice and thought.1,2 Apart from particular significance for the diagnosis of psychotic disorders, delusions may be present in a number of other mental disorders and somatic illness.3

WHAT IS DELUSION? Several overlapping definitions of delusions have been reported. Emil Kraeplin, widely considered to be the founder of modern psychiatry, defined delusional ideas as pathologically derived errors not amenable to correction by logical proof to the contrary.4 The psychiatrist and philosopher Karl Jaspers defined delusions as false judgments that share the following external characteristics to a marked, although undefined degree. They are held with an extraordinary conviction, there is an imperviousness to other experiences and to compelling counterargument,

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and their content is impossible.1,5 Delusions are often described in textbooks as false, subculturally atypical beliefs, strongly maintained in the face of counterargument.4

WHAT OVERLOOKED CRITERION BECOMES IMPORTANT WHEN WE EVALUATE DELUSIONS IN ELDERLY ADULTS? Few articles that discuss delusions in elderly adults discuss diagnosing delusions but rather focus on epidemiology, risk factors, classification, and neurobiology of delusions,6–10 but before the definition of delusion is applied to older adults, the specific features of old age that may be misleading when evaluating delusions should be considered. The common denominator of definitions of delusions is the contrast between the strong conviction in the delusional belief and superior evidence to the contrary that are ignored. Evidently, a person should have the capacity to process the relevant evidences; that is, the person who has a delusional belief should have the cognitive capacity to understand the relevant counterarguments, but that criterion is not explicitly mentioned in the standard definitions of delusions, which, taking into account that most people have relatively intact cognition, may not be viewed as a serious issue, but what we do not use, we may lose; in this case, we may neglect the question of intellectual capacity when it does matter. In an elderly population, specifically individuals with dementia, the condition of appropriate intellectual ability becomes important. Nevertheless, the role of adequate intellectual capacity in delusions has not been debated, neither generally nor in individuals with dementia. There is also the problem that the subtle loss of cognitive function may easily be overlooked.

THE SEQUELAE OF NEGLECTING COGNITIVE IMPAIRMENT WHEN DIAGNOSING DELUSION The danger of not taking cognitive deficits into account lies in misdiagnosing delusions. Someone’s strange new belief delusion-like belief

no

cognitive deficit

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could predominantly be the result of his or her diminished cognitive capacities. The impairment of a person’s memory, visuospatial skills, reasoning, learning, and attention, among other things, distorts the process of reality interpretation. That should prompt one to adjust their expectations when evaluating the view of reality of a person with dementia. As Jaspers expressed it—delusion is ultimately not understandable; that is, even putting oneself in a person’s position and seeing the world from his or her point of view, one is still unable to understand how they could hold that belief with delusional intensity.1 A belief that seems strange may lose its strangeness if we try to see it from the point of view of the person with dementia. To declare a belief of a person with dementia a delusion, when cognitive impairment could explain it, is like declaring a green rosebud of a red–green color-blind person an illusion. Similarly, a confabulation is not a lie. What loss of cognitive function could explain should not be mistaken for delusion. Beliefs, thoughts, or judgments that superficially seem delusional but miss the essence of delusions after accounting for cognitive component could be called pseudodelusions (Figure 1). Recognizing whether delusion-like belief is a symptom of cognitive impairment or has a psychotic background may have important social and clinical implications. Declaring someone psychotic affects our attitude toward them and may have legal consequences. Misdiagnosing cognitive impairment as delusion may lead to focusing on antipsychotic treatment, instead of on treatment of dementia. Moreover, introducing antipsychotics in individuals with dementia requires additional caution; apart from possible side effects, it has been shown that antipsychotics increase the risk of stroke and death in this vulnerable population. In conclusion, before declaring someone delusional, we should try to estimate whether their cognitive capacities are preserved enough to form the “right” belief and whether those capacities could be restored—whether we should treat the cause before focusing on consequences. Marija Eterovic, MD Dragica Kozaric-Kovacic, MD, PhD Department of Psychiatry, Referral Centre of the Ministry of Health for Stress-Related Disorders, University Hospital Dubrava, Zagreb, Croatia

yes

ACKNOWLEDGMENTS

true delusion

yes

capacity to process specific (counter)arguments

no

Conflict of Interest: The editor in chief has reviewed the conflict of interest checklist provided by the authors and has determined that the authors have no financial or any other kind of personal conflicts with this paper. Author Contributions: Both authors contributed significantly to this letter. Sponsor’s Role: None.

pseudodelusion

REFERENCES treatment of psychotic feature

treatment of dementia

Figure 1. Differentiating true delusions from pseudodelusions.

1. Jaspers K. General Psychopathology. (Hoenig J, Hamilton MW, trans.) Manchester: Manchester University Press, 1963. 2. Mullen R. Delusions: The continuum versus category debate. Aust N Z J Psychiatry 2003;37:505–511.

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3. Kiran C, Chaudhury S. Understanding delusions. Ind Psychiatry J 2009; 18:3–18. 4. Gipps RGT, Fulford KWM. Delusions. In: Weiner IB, Craighead WE, eds. The Corsini Encyclopedia of Psychology, 4th Ed. New York: Wiley, 2010, pp 470–472. 5. Butler RW, Braff DL. Delusions: A review and integration. Schizophr Bull 1991;17:633–647. 6. Flynn FG, Cummings JL, Gornbein J. Delusions in dementia syndromes: Investigation of behavioral and neuropsychological correlates. J Neuropsychiatry Clin Neurosci 1991;3:364–370. 7. Ballard C, Oyebode F. Psychotic symptoms in patients with dementia. Int J Geriatr Psychiatry 1995;10:743–752. 8. Harvey RJ. Review: Delusions in dementia. Age Ageing 1996;25:405–408. 9. Bassiony MM, Steinberg MS, Warren A et al. Delusions and hallucinations in Alzheimer’s disease: Prevalence and clinical correlates. Int J Geriatr Psychiatry 2000;15:99–107. 10. Holt AE, Albert ML. Cognitive neuroscience of delusions in aging. Neuropsychiatr Dis Treat 2006;2:181–189.

PAIN TREATMENT—BAD NEWS AND GOOD To the Editor: Recent changes in the understanding of evidence on pain treatment have cast doubt on the interpretation of much of the older evidence in this field, particularly on the treatment of chronic noncancer pain. We would like to highlight several different issues that we feel are likely to have significant implications for the treatment of older adults. It has become increasingly clear that there is considerable variation in the responses of individuals to medication used for analgesia.1 Some individuals (responders) gain good pain relief with a particular drug, but others receive little or no benefit (nonresponders); relatively few have an “average” response. Similar patterns of responses are seen in acute and chronic pain and with different drug classes. Clinical trial results are typically presented as mean change in pain score, without information about how many participants achieve the reductions in pain that actually matter to pain sufferers. Closer attention to individualcentered outcomes shows that individuals want large reductions in pain, or no worse than mild pain,2 although other outcomes are important and may be of particular relevance to older people (e.g., increased independence in activities of daily living). If a decision on including or excluding a drug in a formulary is based on information on mean efficacy, some individuals may lose the opportunity to receive a drug that is effective for them. This is especially likely to be true if the formulary is overly restrictive. Interpretation of data from clinical trials of treatment on chronic noncancer pain has been questioned for other reasons, too. Details of the methodology of clinical trials of pain treatments are unlikely to interest nonspecialists, but they are important because they can have a significant effect on the conclusions drawn from trials and meta-analyses. In particular, there are several commonly used techniques to analyze data from individuals who drop out or withdraw during a trial. This is especially relevant in studies of treatment of chronic noncancer pain because more than half of the individuals who start, say, a 12-week trial may not complete it. Very different

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conclusions can be reached, depending on which technique is used to analyze data from individuals who do not complete a trial.3,4 For opioids, use of individual-centered outcomes and handling dropout data in a way relevant to clinical practice leads to a conclusion that their benefit is probably no better than placebo for chronic noncancer pain. No opioid other than tapentadol has yet to show any benefit beyond placebo using these new higher standards of evidence.4 There have been long-standing concerns about the use of nonsteroidal anti-inflammatory drugs and opioids for chronic noncancer pain in older adults. Acetaminophen (paracetamol) is commonly recommended, particularly for osteoarthritis, but it is of questionable efficacy and not without potential harms, including gastrointestinal and cardiovascular events.5,6 A Cochrane review of acetaminophen for osteoarthritis found that, although there was a statistically significant reduction in pain with acetaminophen, the effect was small and “of questionable clinical significance.”7 Furthermore, most of the studies included in the analysis were of 6 weeks duration or less (which can overestimate treatment effects) and used high doses of acetaminophen (4 g/d). In a subsequent review, no significant reduction in pain in osteoarthritis of the knee and hip was found when analysis was restricted to high-quality trials.8 Recent draft UK guidelines on the treatment of osteoarthritis reflect this change of view on acetaminophen.9 Healthcare professionals working with older adults often have to make clinical decisions based on little evidence—and to communicate this to patients and their families. It is disconcerting to find that evidence that we have trusted may not be as good as we had believed, but better understanding of current uncertainties should lead to better treatment of pain. As an eminent geriatrician cautioned in 1995 “healthcare managers and triallists may be happy for treatments to work on average; patients expect their doctors to do better than that. Moreover, as clinicians we must not arrogate to ourselves decisions that properly belong to our patients.”10 Helen Gaskell, DPhil Department of Clinical Geratology, John Radcliffe Hospital, Oxford University Hospitals National Health Service Trust, Oxford, UK Pain Research and Nuffield Division of Anaesthetics, Churchill Hospital, University of Oxford, Oxford, UK Andrew Moore, DSc Pain Research and Nuffield Division of Anaesthetics, Churchill Hospital, University of Oxford, Oxford, UK

ACKNOWLEDGMENTS Conflict of Interest: Andrew Moore has consulted for various pharmaceutical companies and received lecture fees from pharmaceutical companies related to analgesics and other healthcare interventions, including (in the past 5 years) Astellas, AstraZeneca, Eli Lilly, Flynn Pharma, Furtura Medical, Gr€ unenthal, GSK, Horizon Pharma,

Pseudodelusions in individuals with dementia.

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