**1.1 Concern about associations of antipsychotic medication and mortality in older people**

The research that follows evolved from participation by the lead author in unpublished work in the late 1990s commissioned by the Canadian Institute for Health Information (CIHI). The purpose was to analyze early Canadian data on version two of the Minimum Data Set (MDS 2.0), which is the former name of the RAI 2.0. In 1996, this tool became mandated for use in all chronic care hospitals, now known as complex community care (CCC) facilities in the Canadian Province of Ontario. The residents of these facilities are mainly older people in receipt of continuing care and/or rehabilitation associated with disabling chronic illness.

The findings from that work that was most troubling included high frequencies of physical restraint and chemical management in Canadian facilities compared to findings with the same tool in other countries. Although Canadian physical restraint levels lessened in frequency since that time, such is not the case for chemical management. Hence the enduring interest in chemical management by these authors.

The purpose of chemical management is to address symptoms that fall under the umbrella of behavioral and psychological symptoms of dementia (BPSD). The definition of the latter at a 1996 Consensus Conference of the International Psychogeriatric Association (IPA) is as follows: "symptoms of disturbed perception, thought content, mood or behavior that frequently occur in patients with dementia" [1]. The behavioral symptoms include physical aggression, loud vocalization, restlessness, agitation, and wandering. The psychological symptoms include anxiety, depressive mood, hallucinations, and delusions.

Current estimates suggest that over half the patients with dementia are at risk to such symptoms, which typically arise during the middle or later stages of the disease. Chemical management may include analgesics to lessen pain and discomfort, along with antidepressants, anti-anxiety medication and antipsychotics, all of which address behavioral and psychological symptoms [2]. The most frequent concerns about chemical management relate to antipsychotic medication. These are drugs first developed for the treatment of psychosis [3]. Presently, antipsychotic drugs fall within two categories. Typical antipsychotics include those initially developed to treat psychosis, while atypical antipsychotics were developed later to reduce adverse side effects of the former.

Concerns about harmful effects of antipsychotics in dementia patients are legitimate. The adverse effects of these drugs include high rates of cardiovascular events, cardiac arrhythmias, cerebrovascular events, cognitive decline, extrapyramidal symptoms, pneumonia, falls and fractures, and others [4]. However, the most serious concern is an elevated risk of mortality. Notice of such concerns began early this millennium with evidence that these adverse effects were over and above those associated with old age, an underlying dementia, and behavioral and psychological symptoms that might precipitate the use of antipsychotics [5].

In 2002, the manufacturer of a typical antipsychotic medication warned of an increased risk of adverse cardiovascular events [5]. Subsequently, the US Federal Food and Drug Administration (FDA) required "black box" warnings about the use of atypical antipsychotics (in 2005) and typical antipsychotics (in 2008). The warning states: "WARNING: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death." Health authorities in other countries subsequently expressed similar concerns.

Conclusions from the most recent and most extensive meta-analysis of studies that relate the use antipsychotic medication to the mortality of elderly people [6] are as follows. Mortality risk with antipsychotic medication (1) is twice that of people without such prescription, (2) comparable between typical and

**3**

*Psychotropic Medication Use and Mortality in Long-Term Care Residents*

atypical antipsychotics, (3) highest during the initial half-year of use, (4) higher at higher dosage, and (5) comparable between people with or without diagnosed dementia. One interpretation of these five points is that people with more severe dementia-related psychosis are at greater risk of mortality, with that risk lessening 6 months after they begin that course of medication. However, findings from placebo-controlled trials indicate antipsychotic use is associated with an increase in mortality above and beyond the baseline dementia symptoms. The authors of this meta-analysis also recommended a restricted use of antipsychotic medication with

older people and encouraged the deployment of de-prescribing practices.

Final thoughts by those authors concur with comments made earlier by authors of this chapter [7]. Ralph and Espinet [6] anticipate greater cultural disapproval about the sedation of older people through antipsychotic, anxiolytic, and hypnotic medications. They envision attitudinal changes within the health and legal professions to consider such practices examples of systemic elder abuse that requires legal reform. A current drive toward the de-prescribing of antipsychotic medication to

**1.2 Preliminary study of antipsychotic medication and mortality in older people**

relationships between antipsychotic medication and mortality in older people, after control for a wide range of variables we describe subsequently, faculty members Michael Stones and Peter Brink were happy to oblige. These researchers had a working familiarity with the RAI 2.0. They hoped to obtain census level data, with linkages to other mortality relevant datasets, to provide Sarah with the means to conduct her research. Peter Brink

successfully submitted a proposal to CIHI for access to access these data.

When Sarah Worobetz, a doctoral student at Lakehead University, wanted to research

The RAI 2.0 is a standardized assessment tool used routinely in LTCH and CCC facilities in Ontario and other settings across the world. The tool contains over 350 items relevant to medical diagnoses; physical, cognitive, social, and emotional functioning; and treatment categories that include medication use. It also indexes mortality within the relevant facilities. The trained health care professionals responsible for RAI 2.0 assessments obtain that information from multiple sources, such as direct observation, medical records, and communication with family members and other health care professionals. Objective scales on the RAI 2.0 consist of sets of items selected for relevance to a given construct. Evaluation of such scales may be against "gold standard" measures of the constructs (e.g., measures of activities of daily living, cognitive status, depression, aggression, and pain) or relevant outcomes (e.g., mortality risk). From a measurement perspective, previous findings on data quality and the reliability and validity of RAI 2.0 measures are positive [8–10]. The antipsychotic medication item on the RAI 2.0 falls within a psychotropic category that also contains items on antidepressant, analgesic, anxiolytic, and hypnotic medications. The wording of each of these items asks for the number of days during the past week that the resident received the medication. This form of measurement differs from that common to previous studies of psychotropic medication and mortality, which invariably report specific medications and dosages

The other databases provided by CIHI are the Discharge Abstract Database (DAD) and the National Ambulatory Care Reporting System (NACRS). The DAD contains demographic, administrative, and clinical data for hospital discharges (inpatient acute, chronic, and rehabilitation) and day surgeries. The NACRS contains data for hospital-based and community-based emergency and ambulatory care (e.g., day surgery and outpatient clinics). Both datasets contain mortality data pertaining to their respective contexts. CIHI encrypted the personal and facility identifiers across

*DOI: http://dx.doi.org/10.5772/intechopen.85971*

elderly people is consistent with these beliefs [8].

but not frequency of medication use.

### *Psychotropic Medication Use and Mortality in Long-Term Care Residents DOI: http://dx.doi.org/10.5772/intechopen.85971*

*Aging - Life Span and Life Expectancy*

**older people**

**1.1 Concern about associations of antipsychotic medication and mortality in** 

The research that follows evolved from participation by the lead author in unpublished work in the late 1990s commissioned by the Canadian Institute for Health Information (CIHI). The purpose was to analyze early Canadian data on version two of the Minimum Data Set (MDS 2.0), which is the former name of the RAI 2.0. In 1996, this tool became mandated for use in all chronic care hospitals, now known as complex community care (CCC) facilities in the Canadian Province of Ontario. The residents of these facilities are mainly older people in receipt of continuing care and/or rehabilitation associated with disabling chronic illness. The findings from that work that was most troubling included high frequencies of physical restraint and chemical management in Canadian facilities compared to findings with the same tool in other countries. Although Canadian physical restraint levels lessened in frequency since that time, such is not the case for chemical management. Hence the enduring interest in chemical management by these authors.

The purpose of chemical management is to address symptoms that fall under the

Psychogeriatric Association (IPA) is as follows: "symptoms of disturbed perception, thought content, mood or behavior that frequently occur in patients with dementia" [1]. The behavioral symptoms include physical aggression, loud vocalization, restlessness, agitation, and wandering. The psychological symptoms include anxiety,

Current estimates suggest that over half the patients with dementia are at risk to such symptoms, which typically arise during the middle or later stages of the disease. Chemical management may include analgesics to lessen pain and discomfort, along with antidepressants, anti-anxiety medication and antipsychotics, all of which address behavioral and psychological symptoms [2]. The most frequent concerns about chemical management relate to antipsychotic medication. These are drugs first developed for the treatment of psychosis [3]. Presently, antipsychotic drugs fall within two categories. Typical antipsychotics include those initially developed to treat psychosis, while atypical antipsychotics were developed later to

Concerns about harmful effects of antipsychotics in dementia patients are legitimate. The adverse effects of these drugs include high rates of cardiovascular events, cardiac arrhythmias, cerebrovascular events, cognitive decline, extrapyramidal symptoms, pneumonia, falls and fractures, and others [4]. However, the most serious concern is an elevated risk of mortality. Notice of such concerns began early this millennium with evidence that these adverse effects were over and above those associated with old age, an underlying dementia, and behavioral and psychological

In 2002, the manufacturer of a typical antipsychotic medication warned of an increased risk of adverse cardiovascular events [5]. Subsequently, the US Federal Food and Drug Administration (FDA) required "black box" warnings about the use of atypical antipsychotics (in 2005) and typical antipsychotics (in 2008). The warning states: "WARNING: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death." Health authorities in

Conclusions from the most recent and most extensive meta-analysis of studies that relate the use antipsychotic medication to the mortality of elderly people [6] are as follows. Mortality risk with antipsychotic medication (1) is twice that of people without such prescription, (2) comparable between typical and

symptoms that might precipitate the use of antipsychotics [5].

other countries subsequently expressed similar concerns.

umbrella of behavioral and psychological symptoms of dementia (BPSD). The definition of the latter at a 1996 Consensus Conference of the International

depressive mood, hallucinations, and delusions.

reduce adverse side effects of the former.

**2**

atypical antipsychotics, (3) highest during the initial half-year of use, (4) higher at higher dosage, and (5) comparable between people with or without diagnosed dementia. One interpretation of these five points is that people with more severe dementia-related psychosis are at greater risk of mortality, with that risk lessening 6 months after they begin that course of medication. However, findings from placebo-controlled trials indicate antipsychotic use is associated with an increase in mortality above and beyond the baseline dementia symptoms. The authors of this meta-analysis also recommended a restricted use of antipsychotic medication with older people and encouraged the deployment of de-prescribing practices.

Final thoughts by those authors concur with comments made earlier by authors of this chapter [7]. Ralph and Espinet [6] anticipate greater cultural disapproval about the sedation of older people through antipsychotic, anxiolytic, and hypnotic medications. They envision attitudinal changes within the health and legal professions to consider such practices examples of systemic elder abuse that requires legal reform. A current drive toward the de-prescribing of antipsychotic medication to elderly people is consistent with these beliefs [8].
