Improving Prescription Drug

Safety for Canadian Seniors irpp.org

Institute for Research on Public Policy

June 9, 2017
Improving Prescription Drug
Safety for Canadian Seniors irpp.org

Nicole F. Bernier, Ph.D., Former Research Director at IRPP

June 9, 2017
 Seniors are at risk
Heaviest users: 7.4 drugs
Half of the medication taken incorrectly or
prescribed excessively
5 times more hospitalizations due to an
adverse drug reaction
1 in 200 seniors hospitalized
27,000 older adults every year

3
 Why are seniors at risk?
Underrepresented in clinical trials
Seniors respond differently to drugs
Drugs not adequately studied on seniors
Off-label prescriptions
Limited evidence of safety and effectiveness
Even drugs known to present a risk are
prescribed to seniors

4
 Drug interactions
2/3 of seniors take five or more medications
take 10 or more medications
More likely to experience an adverse drug
reaction
12% of seniors on multiple medications
require medical attention or go to the
emergency department as a result

5
 Current initiatives
Doctors, pharmacists, advocacy groups and
health authorities collaborate
Better information on drug optimization
Professional training
Reallocation of roles and responsibilities

6
What more can be done?

Improving drug safety

for seniors
requires systemic change

7
 Unique role for governments
Heavy reliance on voluntary efforts
Neglecting their own steering powers
Legislation and financial instruments can be
used to a much greater effect

8
 Provincial/territorial
governments
Cover nondrug therapies
Require medication reviews
Incentives to consult with other professionals
Better clinical decision-making tools
Access to patients full medical records
Electronic prescribing systems with records of
dispensed medicines

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 Federal Government
Detailed examination of the rise of unsafe
medication use among seniors
Health Canadas leadership
Drug approval process
Monitoring drugs on the market
Reporting on ADR
Independent research on off-label use
Work with P/T govts and health authorities

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 Conclusion

Governments can do much more and better

to address this serious health issue.

11
Improving Prescription Drug Safety
for Canadian Seniors irpp.org

Isobel Mackenzie, Seniors Advocate British Columbia

June 9, 2017
 Legislative Mandate & Scope
Monitors the provision of
seniors services 5 mandated areas
Analyzes systemic issues
Health care
Provides information and
referral to seniors and their Housing
family members
Income support
Reports to Minister and to
the public on issues Personal Support
affecting seniors, and
provides recommendations Transportation
to the Minister and other
service providers

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 What the OSA Has Been Monitoring
Annual Monitoring Report and Residential Care Quick
Facts Directory
Use of antipsychotics without a diagnosis of psychosis
Use of antidepressants
Medication errors with adverse events
Home Support Survey
Clients understanding of what medications they are taking,
why they are taking them, and their side effects
Prevalence of use of blister packs
Residential Care Survey (in progress)
Residents understanding of what medications they are taking
Whether resident is consulted before taking new medications
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 Areas of Concern
Antipsychotic Use in Residential Care
Antipsychotic use is trending down in BC (but is still
higher than Alberta and Ontario)

However, further analysis showed:

32% of people with no history of antipsychotic use received
an antipsychotic within 6 months of admission to
residential care
70% of these began taking within 7 days of admission

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 Areas of Concern
Antidepressant use in Residential Care
29% of people with no history of antidepressant
use received an antidepressant within 6 months
of admission
52% of these began taking within 7 days of
admission

16
 Areas of Concern
Benzodiazepine Use
37% of people with no history of benzodiazepine
use received a benzodiazepine within 6 months of
admission
66% of these began taking within 7 days of
admission

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 Areas of Concern
Opioid poisoning
Seniors have the highest rate of opioid poisoning of all age
groups in Canada
Hospitalizations per 100,000 people
Age group (years) 20142015
<15 1.8
1524 10.4
2544 13.1
4564 18.3
65+ 20.1

Unlike other age groups, vast majority of events occur

during therapeutic (routine) use due to allergy or drug
interaction

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 Medications in Home Support
OSA conducted a survey of all publicly-subsidized
home support clients and their caregivers in
2015. Over 10,000 responses received
Findings
12% of clients dont know how many medications
theyre taking
Less than 60% know why theyre taking all
medications
Less than 20% know the side effects of all of their
medications

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 Raising Further Questions
Need to better understand
Role of hospitals in prescribing medications to
seniors prior to entry to residential care
Drivers of medication prescription for those who
are in residential care (staffing, behaviour
management, sleep aids, family pressure)

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 What Can We Do?
Highlight issues through public reporting
Share facility-level and provider-level data with
health authorities, facilities and care providers
More analysis of drivers of prescribing behaviour
Identify and promote non-medication
interventions in residential care and training for
staff
Better education of seniors about medication use
across the health care continuum

21
 OSA Future Work
Advisory member Health Care Consent, Aging
and Dementia Project (Canadian Centre for Elder
Law)

Work is wrapping up on a province-wide survey

of all publicly-subsidized residential care clients in
B.C.
Survey asked about many quality of life aspects for
residents, including medications (knowing why theyre
taking, being consulted about new medications, etc.)
Public release of results

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Improving Prescription Drug Safety
for Canadian Seniors irpp.org

Joel Lexchin, School of Health Policy and Management, York University

June 9, 2017
Health Canada, Drug Safety and
the Elderly

Joel Lexchin MD
Professor Emeritus, School of Health Policy
and Management, York University
Staff Physician, Emergency Department,
University Health Network

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 Conflicts of Interest
No financial conflicts of interest to declare

25
 Points to Cover
Premarket clinical trials
Priority approvals
Resource distribution: approvals vs safety
Postmarket clinical trials
Drug withdrawals
Health Canada communications

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 Efficacy Trials
Trials undertaken to get a new
drug onto the market
Exclusions:
Elderly
Those on multiple medications
Those with multiple co-
morbidities
Women

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 Short-Term Testing & Small
Patient Numbers
16 new active substances launched in Canada
1990-2000
Small numbers of patients, e.g., when risperidone
marketed 2 published trials with 1-49 patients and one
with 49-99 patients
Out of 129 published trials
34% <4 weeks
9% >26 weeks
E.g., no olanzapine trial longer than 26 weeks

Lexchin. Can Fam Physician 2002;48:1487-92

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Safety Differences Between Standard
& Priority Review Times
Standard review =
300 days
Priority review =
180 days

Difference does not

seem to be due to
mechanism of action
of drug or condition
it is approved to
treat

1995-2015 25% of
new drugs had a
priority review

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Resource Distribution & Drug Safety

Approves new drugs

Approves new drugs

Monitors safety of drugs

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 Postmarket Clinical Trial Fulfillment
Conditions Fulfilled (years) Conditions Not Fulfilled (years) NOC/c
revoked,
0-2 2-4 4-6 >6 0-2 2-4 4-6 >6 suspended,
not fulfilled,
removed,
product
removed
from market
No. of 12 18 9 7 14 4 2 9 (3 8
indicato more
ins than 10
years)

83 NOC/c for new products or new indications (63 separate products):

46 conditions fulfilled
29 conditions not fulfilled
8 revoked, suspended, not fulfilled, conditions removed, product
removed
from market before fulfilling conditions 31
*As of April 27, 2017
 Withdrawals and Questions
Valdecoxib and Sitaxentam
20 days from approval to first safety warning
Cerivastatin, Lumiracoxib, Efalizumab
23 to 62 days from safety warning to withdrawal
Calcitonin, Ceftobiprole, Drotrecogin alpha,
Grepafloxacin, Idebenone, Pergolide,
Remoxipride, Tegaserod, Tolcapone, Troglitazone,
Trovafloxacin,
All withdrawn without any prior safety warning
Were there prior concerns about safety

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Safety Warnings May Not Help
Atypical Antipsychotics

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 Conclusions
Premarket information about drug safety is
very limited
Postmarket pharmacosurveillance system is
not adequately resourced
Drug safety withdrawals raise questions
about how Health Canada evaluates
information
Health Canada communications about drug
safety may not be effective

34
Improving Prescription Drug
Safety for Canadian Seniors irpp.org

Institute for Research on Public Policy

June 9, 2017