Living Better with Chemistry:
Regulating with Drugs
Joel Lexchin MD
School of Health Policy and Management, York
University
Emergency Department, University Health Network
Living Better With Chemistry
• An exploration of the use of antipsychotic
medications for residents of long-term care
facilities
Regulation?
• What is regulation for?
– Ensure that antipsychotic medications are being used
in the best interests of residents
• Who is doing the regulation?
– Government, provincial colleges of physicians, longterm care residences
• Who is being regulated?
– People doing the prescribing (mostly doctors)
• Regulation & privatization
– Quality of prescribing and ownership
Number and Percent of Residents in
LTC Homes With Cognitive Impairment
2006: 275,000 LTC residents x 60% = 165,000 with moderate to severe cognitive
impairment
Percent of Residents Using
Antipsychotics
• Across Canada about 30% receive these drugs
– Wide variation among LTC homes from about 20 –
45%
– Recent estimate from BC – 50.3% of residents
(unknown how long medication is being used for)
– Within 100 days of admission 17% of residents who
had never used an antipsychotic received Rx for one
(24% by one year)
– Amongst those with dementia 52% of those in LTC
homes receive antipsychotics versus 21.3% of those
living in community
Cross National Survey (2003)
Reasons for Using Antipsychotics
• Cognitive impairment leading to disruptive
behavioural symptoms of dementia
– Aggression, problems with sleep, wandering
• Use of antipsychotics for these reasons is offlabel, i.e., hasn’t been approved by Health
Canada
– In US 83% of use of these drugs is off-label
Sleep Disorders
• 12 nursing homes in Massachusetts
• Reduction in the use of antipsychotics had no
effect on the percent of residents
experiencing sleep disorders
Behavioural Problems
• Database study in Netherlands
– 556 residents started on antipsychotics, at 3 months:
•
•
•
•
101 (18.2%) improved
260 (46.8%) deteriorated
195 (35%) stable
Those with severe challenging behaviour showed more
improvement
– 520 residents discontinued antipsychotics, at 3
months
• 155 patients (30%) improved
• 168 (32%) worsened
• 197 (38%) stable
Clinical Antipsychotic Trials of Intervention
Effectiveness–Alzheimer’s Disease
• Olanzapine, quetiapine and risperidone
• Cognitive benefits
– Over the course of 36 weeks, “atypical antipsychotics
were associated with worsening cognitive function at
a magnitude consistent with 1 year’s deterioration
compared with placebo”
• Psychosis, aggression or agitation
– “improvement was observed in 32% of patients
assigned to olanzapine, 26% of patients assigned to
quetiapine, 29% of patients assigned to risperidone,
and 21% of patients assigned to placebo”
Elderly With Dementia and Psychosis,
Mood Alterations and Aggression
• 3 meta-analyses
– Not all trials involved patients in LTC residences
– Overall some evidence of benefit but also
significant harms
Adverse Events Associated With
Beginning Antipsychotic Therapy
US - Omnibus Budget Reconciliation
ACT 1987 (OBRA 87)
• Each resident’s drug regimen must be free from
unnecessary drugs
• Resident has the right to be free from any
psychoactive drug administered for purposes of
discipline or convenience and not required to treat
the resident’s medical symptoms
• Facility must ensure that residents who have not
used antipsychotic drugs before are not given these
drugs unless such drug therapy is necessary to treat
a specific condition
Despite OBRA 87
• 22% of atypical antipsychotic drugs were not administered in
accordance with standards set by the Centers for Medicare &
Medicaid Services
• Between 23 to 32% of those prescribed this group of drugs
had no indication for these drugs
• Antipsychotic use increased 7.4 percentage points from 1999
to 2006
– Reflects both increasing proportions of residents diagnosed
with schizophrenia, bipolar disorder, dementia,
depression, or anxiety disorder and an increase in
antipsychotic treatment rates within each diagnostic
category
Canada and OBRA 87
• Unlikely to be feasible
• LTC homes are not covered under the provisions of
Medicare & therefore federal government does not
contribute any money for them and therefore lacks any
method of enforcing legislation
• Care in LTC homes is part of the delivery of health care and
is therefore a provincial responsibility
• No province has enacted any similar legislation &
Saskatchewan specifically rejected a legislated approach
• Only exception would be if antipsychotics were used as
physical “restraints” – in BC would have to be consistent
with provincial legislation (no consent required)
Other Regulation
• No provincial college has set out formal
requirements for the use of these medications
Guidelines
• BC Medical Association & BC Ministry of Health:
Clinical Practice Guideline on Cognitive Impairment in
the Elderly: Recognition, Diagnosis and Management
• National Guidelines for Seniors’ Mental Health: The
Assessment and Treatment of Mental Health Issues in
Long Term Care Homes
• Canadian National Consensus Guidelines for Dementia
• Alzheimer Society of Canada: Guidelines for Care:
Person-centred care of people with dementia living in
care homes
• Guidelines have no regulatory force
Educational Efforts - International
• US
– Outreach program for doctors, nurses and nursing assistants
that emphasized alternatives to these drugs
– Decrease use of 27% in the experimental homes versus 8% in
the control homes
– No difference between the two groups in disruptive behaviour
• UK
– Emphasized issues such as environmental, care practice, and
attitudinal factors through didactic training, skills modelling, and
supervision of groups and individual staff
– After 12 months, there were significantly fewer residents taking
neuroleptics in the intervention homes (23.0%) compared to the
control homes (42.1%)
– No differences in the levels of agitated or disruptive behaviour
Educational Efforts - Canadian
• Montreal
– Consciousness-raising, educational sessions, and clinical
follow-up for administrators, physicians, pharmacists,
nursing staff, and personal care attendants
– Over 6 months among 81 residents there were 40 (49.4%)
discontinuations of antipsychotics and 11 (13.6%) dose
reductions and the frequency of disruptive behaviors
decreased significantly
• Alberta
– Two-month series of educational sessions for physicians,
facility pharmacists, nursing staff and family members
– No significant decline in the use of antipsychotics in the
intervention facilities versus controls
Prescribing Behaviour
• Saskatchewan
– 17 – 47% of prescriptions depending on drug were
for higher than recommended doses
• Alberta
– Dose reduction attempted in only 16% of cases at
6 months
Physician Characteristics Associated
With Prescribing Antipsychotics
• Interview with 9 doctors in the Montreal area
who prescribed antipsychotics to communitydwelling seniors
• “All of the physicians interviewed perceived the
aging process as a negative experience and stated
that the long-term use of psychotropic
medication is justified by the distress of their
aging patients and the few negative side effects
that are noticed.”
• Skeptical about nonpharmacological approaches
Lack of Appropriate Training for
Doctors
• Canadian Patient Safety Institute
– “Physicians may not always have the best practice
knowledge in terms of what medications are
appropriate, let’s say use of psychotropics as an
example, for many people, psychotropics is totally
inappropriate.”
Doctors’ Acquisition of Knowledge
Antipsychotic Prescribing by Type of
Ownership
• Manitoba
– Odds of being dispensed antipsychotic medications were
1.7 times greater for residents of for-profit homes in the
Winnipeg Regional Health Authority versus not-for-profit
and public homes in Manitoba
• Minnesota
– Medicare and Medicaid certified for-profit facilities had
higher antipsychotic use rates than did not-for-profit
facilities
• United States
– All 14,631 Medicare and Medicaid certified homes
– Antipsychotic use was higher in those operated on a forprofit basis versus those on a not-for-profit basis
Quality of Care and Type of Ownership
• BC for-profit versus not-for-profit facilities
– Higher adjusted hospitalization rates for pneumonia, anemia, and
dehydration
– No difference for falls, urinary tract infections, or decubitus
ulcers/gangrene
– No difference in mortality rates
• Two meta-analyses (American data)
– “systematic differences exist between for-profit and not-for-profit
nursing homes. For profit nursing homes appear to provide lower
quality of care in many important areas of process and outcome”
– Not-for-profit facilities delivered higher quality care than did for-profit
facilities for two of the four most frequently reported quality
measures” and for the two others there were non-significant results
favouring not-for-profit homes
Conclusions
• Lack of regulation
– Government and regulatory body about
prescribing
– About privatization
• Best interests of LTC residents are not being
protected
– More harms than benefits from prescribing