a status report on
The National Pharmaceuticals Strategy:
A Prescription Unfilled
January 2009
contents
01 Foreword from the Chair
03 Why pharmaceutical reform matters
04 Safety and appropriate use
09 Financial burden of prescription drugs
13
14
16
16
17
18
18
21
21
25
25
26
A closer look at The National Pharmaceuticals Strategy
Key developments, 2003 to 2008
What was promised and what has happened
Catastrophic drug coverage
Expensive drugs for rare diseases
Breakthrough drugs
Pricing and purchasing
Analyzing costs
Influencing prescribing
E-prescribing
Common national drug formulary
Real-world drug safety and effectiveness
29 In summary
30 References
31 Figures
32 Acknowledgements
33 About the Health Council of Canada
Production of this report has been made possible through a
financial contribution from Health Canada. The views expressed
herein represent the views of the Health Council of Canada
acting within its sole authority and not under the control or
supervision of Health Canada. This publication does not
necessarily represent the views of Health Canada or any provincial
or territorial government.
To reach the Health Council of Canada:
Suite 900, 90 Eglinton Avenue East
Toronto, ON M4P 2Y3
Telephone: 416.481.7397
Fax: 416.481.1381
[email protected]
www.healthcouncilcanada.ca
A Status Report on The National Pharmaceuticals Strategy:
A Prescription Unfilled
January 2009
ISBN 978-1-897463-46-8
How to cite this publication:
Health Council of Canada. (2009). A Status Report on The National
Pharmaceuticals Strategy: A Prescription Unfilled. Toronto: Health Council.
www.healthcouncilcanada.ca.
Contents of this publication may be reproduced in whole or in
part provided the intended use is for non-commercial purposes
and full acknowledgement is given to the Health Council
of Canada.
© 2009 Health Council of Canada
Cette publication est aussi disponsible en français.
F O R EWO R D F RO M T H E C H A I R
The National Pharmaceuticals Strategy was established in 2004 to develop
nationwide solutions to some of the concerns about the safety and affordability
of prescription medications in Canada. Individual governments have various
programs to improve the accessibility, safety, and affordability of prescription
medications, but there are limits to what they can do on their own. This
patchwork of different initiatives across the country also means that not all
Canadians have the same advantages.
The strategy was part of the 2004 health accord, the First Ministers’
10-Year Plan to Strengthen Health Care, in which participating* governments
agreed to make a variety of improvements to their health care systems,
accompanied by additional annual payments from the federal government.
* Quebec has its own pharmacare program and is not part of the development of the National Pharmaceuticals Strategy,
but the province shares information and best practices.
H e a lth C ounc il of Canada
In the accord, the prime minister and premiers
(First Ministers) gave the federal, provincial, and
territorial ministers of health the job of collectively addressing a number of priority areas in
pharmaceutical reform (see The nine elements of
the National Pharmaceuticals Strategy, page 14).
In lay terms, the strategy was intended to:
> develop options for catastrophic drug coverage to
ensure that Canadians don’t face undue financial
hardship to pay for prescription medications
they need, regardless of where they live (catastrophic refers to the impact on a person’s
finances, not to his or her medical condition);
> find ways to reduce the costs of prescription
medications to governments and individual
Canadians;
> improve patient safety by helping health care
professionals provide the most appropriate and
safest prescriptions for their patients, and by
implementing electronic prescribing to reduce
medication errors;
> improve the way medications are monitored after
they are released onto the Canadian market to
protect patients from unanticipated side effects;
> ensure that all Canadians have access to the
same prescription drugs through their
government drug plans, based on a common
national drug formulary; and
> provide faster access to new emerging drugs for
unmet health needs.
In this report, we look more closely at some of
the problems the National Pharmaceuticals
Strategy was intended to solve, and its progress
more than four years later. Our commentary
on these findings can be found in a companion
document, A Commentary on the National
Pharmaceuticals Strategy: A Prescription Unfilled,
available at www.healthcouncilcanada.ca.
We have also used this report as an opportunity
to educate Canadians about the importance
and complexity of pharmaceutical reform. This
area has not received the same level of public
interest as changes to other areas of the health
care system, perhaps because the concerns about
prescription medications are not well known
or understood. In the following section, Why
pharmaceutical reform matters, we provide
compelling data and a snapshot of some of the
significant challenges related to the use of
prescription drugs in Canada. It’s important to
note that the National Pharmaceuticals Strategy
was designed to address some, but not all, of
these concerns.
When we began this report, the economic
climate was much more favourable. Now, as
more Canadians lose their jobs and associated
health benefits, more people are likely to
need help with the costs of their medications.
The work of the National Pharmaceuticals
Strategy is more important than ever. It has
become even more critical to find ways to
reduce the costs of prescription drugs, and to
ensure that Canadians continue to have
access to safe and appropriate medications.
JEANNE F. BESNER, RN, PHD
CHAIR, HEALTH COUNCIL OF CANADA
2
Why pharmaceutical
reform matters
H e a lth C ounc il of Canada
Safety and appropriate use
Canadians take a lot of prescription medications.
In two independent 2007 surveys of Canadian
adults, half (51-53%) said they take at least one
prescription drug, while approximately 15%
said they take four or more. (See Figure 1.) The
numbers climb much higher for those with
chronic diseases (37% take four or more prescriptions) and seniors (40% take four or more). 1, 2
Canadians may assume they are receiving
safe and effective medication for their
conditions, but this isn’t always the case.
While most Canadians take their medications
without incident, too many people receive
an inappropriate prescription. The medication
may not be right for them or their condition,
may be the wrong dose, or may react with other
prescription drugs and treatments in ways
that cause unforeseen complications and health
problems. Sometimes people are not given a
prescription when they need one, which can also
have negative effects on their health.
In addition, the use of prescription drugs
has soared in the last decade: The number of
prescriptions filled each year in Canadian pharmacies nearly doubled over a recent 10-year
period, from approximately 234 million in 1996
to more than 422 million in 2006.3
The main causes of problems have been shown
to be inappropriate prescribing, the underuse
or incorrect use of medications by patients, and
the lack of continuous and adequate tracking
of problems.4,5,6
In most respects, these are positive developments.
Prescription medications are often the best and
most cost-effective treatment for many diseases,
and are increasingly used in place of other
interventions. But as the use and price of pharmaceuticals have increased, so have issues
and concerns – particularly about the safe and
appropriate use of medications, and the
challenge of the increasing financial burden
to Canadians and governments.
100
FIGURE 1
90
15
15
13
18
11
18
23
38
40
33
39
35
34
36
47
45
54
42
53
45
40
80
70
60
50
40
30
% of adults
20
Half of all Canadian adults take at
least one prescription medication
In an international survey of seven
countries, 53% of Canadian respondents
said they take at least one prescription
medication: more than one third (38%)
take between one and three prescriptions, and one in seven (15%) takes four
or more. The percentage of adults in
other countries who take at least one
prescription medication ranges between
46% and 59%.
4 or more
10
1 to 3
0
Canada
Australia
Germany
Netherlands
New
Zealand
United
Kingdom
United
States
Question: “How many different prescription medications are you currently taking?”
Note: Percentages may not add up to 100% due to missing, refusal, and “don’t know” responses.
Source: The Commonwealth Fund 2007 International Health Policy Survey of the General Public’s
Views of their Health Care System’s Performance in Seven Countries.
4
None
Who can prescribe?
Although the majority of prescriptions are issued
by medical doctors, other health professionals
can prescribe medications in a more limited way.
All dentists, for example, can prescribe medications for pain relief. And in some provinces and
territories, health professionals such as pharmacists, nurse practitioners/extended practice
nurses, midwives, podiatrists, and optometrists
can prescribe certain medications.7 The trend
to extend prescribing authority to more health
professionals means that more prescribers need
accurate, current, and comprehensive information
on medications and patients’ histories.
H e a lth C ounc il of Canada
> A 2007 study showed that between 8-12% of
M E D I C AT I O N E R R O R S A R E F A R
TOO COMMON
seniors in four provinces (Alberta, Saskatchewan,
Manitoba, and New Brunswick) had a long-term
prescription for a high-risk drug on the Beers
List, an internationally recognized list of drugs
that are identified as potentially inappropriate to
prescribe to seniors due to an elevated risk of
adverse effects.9
In the years since the National Pharmaceuticals
Strategy was established, research has begun
to highlight the extent of medication errors in
Canada:
> A 2008 study of a busy Vancouver hospital
showed that 12% of emergency department
visits by adults were related to problems
with medications.8
> A 2005 study at a Moncton hospital showed that
40% of patients had inconsistencies or omissions
in their prescription medication treatment
plan at the time they were discharged from the
hospital.10
> In a 2007 international survey, 6% of Canadian
respondents said that they had either been given
a wrong medication or wrong dose in the past
two years. This survey also showed that 10% of
Canadians who have two or more chronic health
conditions reported experiencing a medication
error.2 (See Figure 2.)
> A 2004 study by an Ottawa hospital showed
that 72% of the adverse events reported by
patients in the 14 weeks after leaving the hospital
were caused by medication errors.11
> In another 2007 survey, 4% of Canadian
> A 2004 study showed that 7.5% of adult patients
respondents said they had been given a wrong
prescription at a pharmacy and 18% of those
said it caused a very serious health problem.1
50
45
in Canada experience some kind of adverse event
in the hospital, and the second most common
cause is medications.12
All adults who experienced medication error
FIGURE 2
Adults with 2 or more chronic conditions who experienced medication error
Six percent of Canadians report
medication errors
In an international survey of seven
countries, 6% of Canadian adults
said they were given the wrong
medication or wrong dose when filling
a prescription or while hospitalized in
the past two years. Ten percent of
those who have two or more chronic
health conditions said they experienced this type of medication error.
Canada is not alone in struggling with
this issue; the results were similar
in other countries.
40
35
30
25
20
15
10
% of adults
13
13
13
12
10
8
6
7
5
5
8
6
6
6
New
Zealand
United
Kingdom
7
0
Canada
Australia
Germany
Netherlands
United
States
Question: “In the past 2 years, have you ever been given the wrong medication or
wrong dose by a doctor, nurse, hospital or pharmacist when filling/collecting a prescription
at a pharmacy or while hospitalized?”
Source: Morgan S, Kennedy J, Boothe K, McMahon M, Roughead E and Watson D. (2008). Toward high
performing ‘Pharmacare’ systems: A review of experiences in seven countries. (Under review).
6
A Status Report on The National Pharmac eu t ic als S t r at eg y
Many unexpected and often preventable incidents involving medication are severe enough to
require hospitalization. Others happen to
patients who are already in the hospital. Patients
are also at risk for experiencing medicationrelated problems during transitions of care, such
as when they are discharged from a hospital,
as noted in the 2005 Moncton hospital study
cited earlier.10 In the 2004 Ottawa hospital study,
the medication errors reported after discharge
were related to a lack of ongoing monitoring.11
These findings indicate that too many Canadians
are at risk for problems with their medications.
Many medication-related problems and deaths
internationally are preventable. In a review of
studies conducted worldwide, health problems
related to medication accounted for an estimated
3-9% of hospital admissions. Of all these, 50%
were judged to be preventable.5,13 This helps to
illustrate the significant impact of medicationrelated incidents on people’s health, as well as
the strain on health care systems everywhere.
Seniors are a particularly vulnerable population,
as they are often on multiple prescriptions and
may be more sensitive to medications and their
interactions. A review of international studies
found that up to 88% of medication-related
hospitalizations of seniors are preventable.14
A study in one Canadian hospital showed that
41% of admissions among seniors involved
problems with medication, 97% of these were
potentially preventable, and most involved
frequently prescribed medications.15 Although
there is little research on the costs of all medication-related problems in Canada, one study
estimates that preventable medication-related
incidents and deaths in seniors alone cost
approximately $11 billion annually.16
7
P AT I E N T S L A C K G O O D I N F O R M AT I O N
Many Canadians don’t use their medications
correctly, which can lead to health problems
or missed health benefits. Although there are no
comprehensive data on the scope of this problem, the 2008 Vancouver hospital study cited
earlier provides some insight: more than onequarter (28%) of the medication-related visits
by adults to the emergency department were
because patients had not taken their prescribed
medication, or had taken it incorrectly.8
A lack of appropriate and clear information for
patients – about side effects, drug interactions,
and how to take a medication – can have
very serious consequences. Yet two 2007 surveys
indicate that Canadians are not getting the
information they need about their medications.
In the 2007 Canadian Survey of Experiences
with Primary Health Care, 39% of Canadian
adult respondents said that their doctor or
pharmacist had rarely or never reviewed and
discussed all their different medications in
the last 12 months.1 And in the Commonwealth
Fund 2007 survey, 15% of Canadian adult
respondents who were hospitalized in the past
two years said they did not receive counselling
about their prescription medications before
they were discharged.2
Steps and stages of safe and
effective medication use
In an ideal situation:
> the patient receives a timely and correct diagnosis;
> the health professional has full knowledge of
the patient’s condition (e.g. co-morbidities, allergies,
competency to properly use the medication),
prescribes appropriately, and has a measurable
objective for the patient’s health for each prescription;
> the medication is effective and has an acceptable
safety profile;
> the patient can afford the prescribed medication
or is covered by insurance (if he can’t, he may not
fill the prescription);
> the pharmacist dispenses the medication correctly
and the patient receives appropriate advice on how to
take the medication;
> the patient takes it as prescribed or has someone who
can assist to see that it is taken properly;
> the patient’s condition is monitored appropriately,
and his medication use is reviewed regularly;
> there is access to full patient information;
> the health professionals responsible for the patient’s
care communicate regularly with each other; and
> public and private payers look for trends in medication
use and prescribing.
Research shows that at least one of these steps is
missing for most patients.17
A Status Report on The National Pharmac eu t ic als S t r at eg y
Health professionals play a vital role in educating patients about their prescriptions. Patients
don’t always know what they should be asking
about medication. A US study showed that
91% of patients attending a guided counselling
session asked about the potential side effects
of a new medication, but only 21% asked about
medication interactions and 19% asked how
to take the medication.18
Although there is a great deal of written
information for patients about diseases and
treatments, including medications, much
of this information is conflicting, inaccurate,
or poorly written.19,20 Research shows that
patients want more information about the side
effects of medications than they currently
receive.21
M E D I C AT I O N S C A N C R E AT E
UNEXPECTED HAZARDS
Before medications can be approved for
distribution on the Canadian market,
drug manufacturers must show the effectiveness
and potential side effects through clinical
trials. But these studies often examine a limited
number of patients under very defined
conditions over a limited amount of time and
generally only for the intended use of the
medication. Still, clinical trials are considered
a “gold standard” in scientific research.
When a medication enters the market and is
prescribed for a large number of patients
in “real-world” settings, unforeseen, serious side
effects sometimes arise for some patients or
in certain circumstances.
Canadians may remember the worldwide
withdrawal of the widely used pain medication
rofecoxib (VIOXX®) in 2004, which was found
to be associated with an unacceptable increased
risk of heart attack and stroke.22, 23
Financial burden
of prescription drugs
Prescription medications can be prohibitively
expensive for both Canadians and their insurers,
particularly governments and employers. Many
Canadians struggle to pay for their medications,
an added stress when they may already be
vulnerable because of illness or unemployment.
The rising cost of prescription drugs is significantly straining government health budgets,
raising serious questions about sustainability.
Governments say that drug plan expenditure
growth squeezes out other health department
priorities, and that overall health budget
growth crowds out other government priorities
including education and public infrastructure.24
C A N A D I A N S P AY T O O M U C H
F O R M E D I C AT I O N S
In a 2007 international study, 6% of Canadian
adults said that their families spent more than
$1,000 in the past year out of their own pockets
(not covered by insurance), a higher percentage
of respondents than the other seven countries
in the survey, except for the US.2
In a 2008 international survey of adults
described as “sicker” (those who experienced
some specific health challenges – see below),
11% of respondents said that their families spent
more than $1,000 in the past year out of their
own pockets (not covered by insurance). Many
more Canadians with chronic conditions such
as diabetes or arthritis had high drug costs:
17% of Canadian adults who have one chronic
health condition and 21% who have two
or more said they paid more than $1,000 a
year out-of-pocket.25
Note: The 2008 Commonwealth Fund survey identified sicker adults as
those “who met at least one of four criteria: rated their health as fair
or poor; reported that in the past two years they had a serious illness, injury,
or disability requiring intensive medical care; had major surgery; or had
been hospitalized”.
9
H e a lth C ounc il of Canada
Each province and territory, as well as the
federal government, offers prescription medication benefit plans to cover the costs borne by
Canadians. In fact, there are often many different benefit plans within one jurisdiction,
offering coverage based on criteria such as age
(e.g. for seniors), income (e.g. for people on
social assistance), type of health condition,
or other factors. Many jurisdictions also offer
coverage for the high prescription costs of
people who fall between the cracks of other
plans. But not all jurisdictions choose – or can
afford – to offer the same kinds of benefit
plans, and the criteria vary widely. As a result,
not all Canadians have the same access
to affordable medications; someone may be
eligible for a government drug plan in one
province, but have to pay out-of-pocket if he
or she moves to another. 26,27
Between 60% and 75% of Canadians have
private insurance coverage for prescription
drugs, and on average about 25% (ranging from
9% to 43%) qualify for government reimbursement. 27, 28 But even those with private coverage
can struggle to pay when their medication
costs are high. When insurance companies are
faced with the increasing costs of prescriptions,
eventually they look to their beneficiaries to
contribute more to the total cost through higher
premiums, larger deductibles, and co-payments.
Insurance companies might also opt to drop
coverage of some medications. In some cases,
private plans will pay for prescription costs only
to a yearly or lifetime maximum, or will not
cover certain medications at all. And the loss of
a job that includes private insurance coverage
can catapult someone with high prescription
costs into a financial crisis, placing undue stress
on patients and their families.
10
TOO MANY CANADIANS CAN’T AFFORD
THEIR PRESCRIPTIONS
When out-of-pocket medication costs become
too high to manage, some people cut corners
in ways that can compromise their health.29,30 In
the Commonwealth Fund 2007 survey, 8% of
Canadian respondents said they had not filled a
prescription or had skipped a dose in the past
year because of the cost.2
Other research confirms that patients who can’t
afford medications often fail to get their prescriptions filled, cut back on the dosage without
telling their doctor or pharmacist,29 or share the
medications of family or friends.31
High prescription costs now pose a similar
financial threat to some Canadians that hospital
care and doctors’ fees once posed in the days
before these services were funded by governments. This isn’t acceptable to Canadians: In
a 2006 public opinion survey, 83% of Canadians
said that governments should ensure there is a
limit to how much individuals should personally
pay for the costs of their prescription medication. Even more respondents (90%) said that if a
medication is covered by one province, it should
automatically be covered by other provinces.32
A Status Report on The National Pharmac eu t ic als S t r at eg y
SOARING COSTS STRAIN THE
BUDGETS OFINDIVIDUALS, INSURERS,
AND GOVERNMENTS
The money spent on pharmaceuticals is
consuming an increasing size and proportion
of health care dollars, and the costs are escalating
faster than the rate of inflation. Spending on
prescription medication in Canada grew at an
average annual rate of 10.6% between 1985
and 2005, compared with total health spending
which grew at an average annual rate of 6.5%.33
In 2006, total drug expenditures were $25.3
billion. (This includes both prescription
and non-prescription medications, but not drugs
used in hospitals.) This amount was expected
to reach $29.8 billion in 2008. Governments
pay approximately 40% of these costs through
government drug plans, while individual
Canadians and private insurers pay the remaining
60%. They also feel the impact of rising drug
costs.34
The annual growth in spending largely represents
increases in price and use, rather than inflation or
changes in population size.
Governments have said that they are increasingly
stretched to pay for pharmaceuticals and are
diverting resources from other areas of
their budgets. Governments also struggle with
complicated issues of ethics and funding
that surround new, exceedingly expensive drugs
to treat rare genetic diseases.24
M E D I C AT I O N S A R E T O O E X P E N S I V E
One of the major issues is that prescription
medications in Canada could be – and should
be – less expensive.
Canadians and their governments pay more for
medications than many other Western countries.
We pay more for generic prescription medications compared to 11 other countries. We
also pay more for patented and non-patented
branded prescription medications(see below)
than most other countries studied (except for
Switzerland and the US).35 (See Figure 3, page 12.)
While generic prescription drug prices dropped
in all countries studied in 2005, Canada’s
prices dropped by only 0.3% compared to drops
of between 1.2% (France) and 32.4% (UK).
Similarly, for non-patented branded prescription drugs, Canada’s prices rose by 3.4%
whereas most other countries saw a drop in
their prices.
These data come from Canada’s Patented
Medicine Prices Review Board (PMPRB),
which monitors the international prices of
patented medications and regulates prices
that companies can charge for these drugs
based on international comparisons.35
Note: As defined by the PMPRB, a patented drug is a drug that is subject
to PMPRB price review; a generic drug is sold under the name of its principal
ingredients; and a branded drug is sold under a particular trade name.
11
H e a lth C ounc il of Canada
If Canadian prices had been kept in check and
not exceeded international median prices
in 2005, spending on non-patented prescription
drugs could have been reduced by an estimated
$1.47 billion in that year alone.36
SUMMARY
This is by no means a full picture of the
concerns and complexities surrounding the use
of pharmaceuticals. But the information presented clearly shows that Canadians face a high
risk of preventable problems with their medications. And both Canadians and their insurers
(governments and employers) pay a great deal
more for prescription drugs than in other
countries, straining personal budgets, business
competitiveness, and a sustainable approach
to financing our health care system.
In addition, a recent report from the Competition
Bureau states that Canadians could save up to
$800 million a year if changes are made to the way
private plans and provinces pay for generic drugs.37
The National Pharmaceuticals Strategy,
established in 2004, was intended to be the
vehicle for provinces, territories, and the
federal government to collectively address
some of these issues. In the next section we will
look at what governments agreed to do
through the national strategy and the result
of their efforts more than four years later.
Patented – a drug that is subject to PMPRB price review
FIGURE 3
Generic – sold under the name of its principal ingredient(s)
Canadians pay more than they
should for prescription medications
Canadians pay more for patented,
generic, and non-patent branded
prescription medications than people
in many Western nations studied
(six of these countries are shown).
2.46
3.00
Non-patented branded – sold under a particular trade name
2.50
1.69
2.00
0.65
0.87
0.90
0.80
0.64
0.23
0.50
0.79
0.72
0.85
0.80
0.91
0.96
0.84
0.85
1.00
0.81
0.78
Foreign-to-Canadian price ratio
1.50
0.00
Australia
Germany
Netherlands
New Zealand
United Kingdom
United States
Source: Patented Medicine Prices Review Board ( PMPRB ). (June 2006). Non-Patented Prescription Drug
Prices Reporting. Canadian and Foreign Price Trends.
12
The foreign-to-Canadian price ratios
shown in this figure indicate how
much less (or more) people pay for
their medications in other countries.
A foreign-to-Canadian price ratio
of 1.0 means that average prices in
that country are on a par with Canada;
less than 1.0 means the medications
have a lower average price than in
Canada, and higher than 1.0 means
that the average price is higher.
A closer look at the
National Pharmaceuticals
Strategy
H e a lth C ounc il of Canada
The National
Pharmaceuticals Strategy
Key developments, 2003 to 2008
“No Canadian should suffer undue financial
hardship for needed drug therapy.”
2003 First Ministers’ Accord on Health Care Renewal
T H E N I N E E L E M E N T S O F T H E N AT I O N A L
P H A R M A C E U T I C A L S S T R AT E G Y
The First Ministers directed their health ministers to
establish a ministerial task force that would develop and
implement a National Pharmaceuticals Strategy with
the following nine action items:
1) Develop, assess, and cost options for catastrophic
pharmaceutical coverage;
GROUNDWORK IN 2003
The prime minister and premiers (First Ministers) signed
2) Establish a common National Drug Formulary
a health accord to increase access to many health
for participating jurisdictions based on safety and cost
care services, including necessary prescription medication.
effectiveness;
Governments all agreed that no one should suffer undue
financial hardship to pay for prescription medications.
This 2003 First Ministers’ Accord on Health Care Renewal
committed governments to ensure that Canadians,
wherever they live, have reasonable access to catastrophic
3) Accelerate access to breakthrough drugs for
unmet health needs through improvements to the
drug approval process;
4) Strengthen evaluation of real-world drug safety
and effectiveness;
drug coverage by the end of 2005/06. (Catastrophic
refers to the effect on a patient’s finances, not the nature
5) Pursue purchasing strategies to obtain best prices for
of his or her health condition.)
Canadians for drugs and vaccines;
The First Ministers also agreed that one of their priorities
6) Enhance action to influence the prescribing behaviour
would be to collaboratively promote use of the best
of health care professionals so that drugs are used
practices in prescribing medications. They also pledged to
only when needed and the right drug is used for the
better manage the costs of all prescription medications,
right problem;
including generic medications, and to ensure that
medications are safe, effective, and accessible in a timely
and cost-effective fashion.38
“Affordable access to drugs is fundamental
to equitable health outcomes for all our
citizens.”
10-Year Plan to Strengthen Health Care
S T R AT E G Y L A U N C H E S I N 2 0 0 4
The First Ministers recommended a National
Pharmaceuticals Strategy as part of their 10-Year Plan
to Strengthen Health Care. The accord stated that
“no Canadian should suffer undue financial hardship
in accessing needed drug therapies. Affordable
7) Broaden the practice of e-prescribing through
accelerated development and deployment of the
Electronic Health Record;
8) Accelerate access to non-patented drugs and achieve
international parity on prices of non-patented drugs; and
9) Enhance analysis of cost drivers and cost-effectiveness,
including best practices in drug plan policies.39
DEVELOPMENTS IN 2005
Ministers of health met and reaffirmed their commitment
to the National Pharmaceuticals Strategy. At that time,
they asked their officials to:
> accelerate work on catastrophic drug coverage;
access to drugs is fundamental to equitable health
outcomes for all our citizens”.39
> expand the scope of the Common Drug Review (CDR) to
consider all medications, not just the new ones considered after the CDR began its work in 2003. (The CDR is a
process that involves evaluating the cost-effectiveness
of drugs and making recommendations to governments
about whether medications should be funded through
their drug plans.);
> work towards a common national formulary (a listing of
medications approved as benefits under the various
government-funded drug plans) so that all Canadians
have access to public funding for the same drugs;
14
A Status Report on The National Pharmac eu t ic als S t r at eg y
> give the Patented Medicine Prices Review Board the
Work has continued on various elements by both the
additional responsibility to monitor and report on the
federal government and provincial/territorial
prices of non-patented prescription medications; and
governments, although not necessarily collectively
> undertake time-limited research programs on
treatments for the rare conditions Fabry disease and
MPS1-Hurler Schie syndrome on a risk-shared basis
with manufacturers .
40
under the auspices of the National Pharmaceuticals
Strategy ministerial task force.
No further public information was available about the
strategy until September 2008. The provinces and
territories had developed a list of decision points that
CHANGES IN 2006
they made public following their annual meeting
The premiers directed the ministerial task force to
that month. This signalled the provincial and territorial
release a progress report on the National Pharmaceuticals
ministers’ intent to raise the profile of the National
Strategy and to “continue to work on key elements …
Pharmaceuticals Strategy and to negotiate some elements
with a special focus on the catastrophic drug program”.
of it with the federal government:
In a progress report later that year, the ministerial
> Establishing a national standard of pharmacare coverage
task force stated that the following items of the National
for all Canadians. The proposed funding agreement
Pharmaceuticals Strategy would be given “short to
would protect the flexibility and autonomy of provinces
medium term focus”:
and territories to define programs for their populations,
ensure that prescription drug costs will not exceed 5%
> catastrophic drug coverage;
of the net income base for their respective populations,
and recognize shared responsibility by allocating the cost
> expensive drugs for rare diseases;
of catastrophic drug coverage 50/ 50 between the federal
> common national formulary;
government and the provinces or territories;
> pricing and purchasing strategies; and
> real world drug safety and effectiveness.
> Creating a Canadian Access Program for Drugs for Rare
Diseases. The proposed program would involve a
centralized, transparent decision-making model with
A comment in the report stated that this was done to
public involvement, a 50/50 split of the cost of these
“facilitate timely and concrete results for Canadians”.
medications between the federal government and
Several elements of the original 2004 strategy were not
provinces or territories, and would require participation
given any particular focus and were therefore essentially
in research and monitoring; and
marginalized:
> Supporting a federally funded program to enhance
> accelerate access to breakthrough drugs for unmet
health needs through improvements to the drug
approval process;
the degree to which drugs are monitored and ensure
real-world safety and effectiveness.
The provincial and territorial ministers of health also
> enhance action to influence the prescribing behaviour
of health care professionals so that drugs are used
only when needed and the right drug is used for the
right problem; and
> broaden the practice of e-prescribing through
accelerated development and deployment of the
electronic health record.36
indicated that from their perspective:
> the intent of a common national formulary has been
met through the Common Drug Review process; and
> a nationwide approach to savings in pricing and
purchasing is not realistic at this time, but interprovincial
collaborations should be separately pursued.24
As of January 2009, there had not been any further
2 0 0 9 : W H E R E T H E N AT I O N A L
P H A R M A C E U T I C A L S S T R AT E G Y S TA N D S N O W
public information on the status of these discussions
The first few years of the National Pharmaceuticals
Pharmaceuticals Strategy.
Strategy involved “unprecedented”
41
collaboration
between federal and provincial/territorial governments.
But then governments changed, and progress slowed.
15
with the federal government, or on the National
H e a lth C ounc il of Canada
What was promised and what
has happened
In 2008, the Health Council of Canada conducted a review of the National Pharmaceuticals
Strategy to monitor how it had progressed in the
four years since it was launched.
We compiled a review of its stated progress
as of January 2009 through the use of publicly
available documents, information from representatives in the jurisdictions, and discussions
with experts and academics who work in health
policy and pharmaceuticals management.
C ATA S T R O P H I C D R U G C O V E R A G E
“Develop, assess and cost options for
catastrophic pharmaceutical coverage”
The high cost of medications can be financially
devastating – catastrophic – for Canadians
who don’t meet the criteria for existing public
drug plans and who lack health insurance.
Contrary to public perception, it isn’t only
people with illnesses such as HIV or cancer who
need help with high costs; someone with chronic
health conditions and multiple prescriptions
could also have difficulty making ends meet.
Governments have agreed – especially in the 2004
health accord – that no one should suffer
financial hardship to pay for medication that
they need to care for their health.39
Some jurisdictions have programs that
specifically address catastrophic drug expenses.
Others have drug benefit programs that their
residents can access depending on income and
whether they have access to private plans to
cover their high drug costs.26 Eligible First
Nations and Inuit people who are not insured
elsewhere may be covered for drug expenses
under Health Canada’s Non-Insured Health
Benefits program.42
16
Plans vary in their criteria and in the out-ofpocket costs that residents must pay. In addition,
each jurisdiction has a drug formulary or
a list of drugs that are covered and the lists
in each jurisdiction differ. An expensive
drug might be covered in one province, but not
another. Atlantic Canada in particular has
struggled with the affordability of catastrophic
drug coverage.26,43
One element of the National Pharmaceuticals
Strategy was to reach common criteria for
catastrophic drug coverage – and to determine
how much it would cost.39
In the 2006 progress report from the National
Pharmaceuticals Strategy ministerial task force,
governments said they were looking at consistent
nationwide criteria – such as a percentage of
income – that Canadians would need to pay for
their medications before they would be eligible
for catastrophic drug coverage.36
No further public information was released for
more than two years. Then, in September 2008
at their annual meeting, the provincial and
territorial ministers of health issued a public
statement about the National Pharmaceuticals
Strategy, saying they held a “common view
that Catastrophic Drug Coverage is as essential
to Canadians as physician and hospital coverage”
and that the “federal government has a funding
responsibility to establish a minimum standard
of drug coverage for all Canadians”.24 They
indicated their intent to pursue this issue with
the federal government.
A Status Report on The National Pharmac eu t ic als S t r at eg y
The provincial and territorial governments
indicated that they want to establish a mutually
agreeable funding formula with the federal
government to support a “national standard of
pharmacare coverage for all Canadians”.
Provinces and territories hope to introduce
and/or maintain a program designed to best
meet the needs of their residents where, on
average, prescription drug costs will not exceed
5% of the net income base for their respective
populations. They propose that the federal
government share responsibility for catastrophic
drug coverage 50/50 with the provinces and
territories.24
As of January 2009, no further public
statements had been made about catastrophic
drug coverage.
OF NOTE
Some jurisdictions have made prescription
medications more accessible and affordable for
their residents in the last few years or have
announced their intention to do so: Alberta,44
Newfoundland and Labrador,45 Nova Scotia,46
Prince Edward Island,47 and Saskatchewan.48
EXPENSIVE DRUGS FOR RARE DISEASES
“Undertake research on expensive
medications for rare diseases”
In 2005, the ministers of health added another
area of focus to the National Pharmaceuticals
Strategy: the issue of funding costly medications
for patients with rare diseases. Governments
are facing increasing public pressure to pay
for these medications – often without sufficient
scientific evidence to support the decision.40
With rare diseases, it’s often very difficult to
identify enough patients to conduct an appropriately sized scientific clinical trial that will
determine whether new medications help or
harm patients – or whether they are sufficiently
effective to warrant funding. Governments
agreed to undertake time-limited research
17
programs on treatments for Fabry disease and
MPS1-Hurler Schie syndrome on a risk-shared
basis with manufacturers.36, 40 The Canadian
Fabry Disease Initiative study was launched in
2006, a three-year research study to gather
information on the real-world effectiveness of
two forms of enzyme replacement therapy
for Fabry disease. The study is being funded by
federal and provincial governments and two
drug companies that developed the enzymes.49,50
Governments identified that this issue
needed a collaborative approach under the
National Pharmaceuticals Strategy because of
the extremely high cost of these therapies
(e.g. $263,000 - $290,000 per year to treat Fabry
disease 51) and the domino effect that can
occur if one jurisdiction decides to fund these
medications. Other governments are immediately under public pressure to follow suit, and
patients from other parts of Canada might
understandably want to move to the jurisdiction
that funds the drug.
In September 2008, the provincial/territorial
health ministers indicated their intent to
approach the federal government to establish
a Canadian Access Program for Drugs for
Rare Diseases. The program would involve
centralized, transparent decision-making with
public involvement, with the cost of these
medications split 50/50 between the federal
government and the provinces or territories.24
As of January 2009, no further information
was available about this proposal.
OF NOTE
In December 2008, Alberta announced
its intention to fund expensive medications
for people with rare genetic conditions
if they have lived in the province for at least
five years.44
H e a lth C ounc il of Canada
BREAKTHROUGH DRUGS
“Accelerate access to breakthrough drugs for
unmet health needs through improvements
to the drug approval process”
All new prescription medications must be
approved as safe and effective by Health
Canada before they can be offered to Canadians.
But new “breakthrough” medications can be
temporarily distributed (with restrictions) for
compassionate reasons, such as new medications
for conditions such as HIV and cancer.
The goal of the National Pharmaceuticals
Strategy in this area was to speed access
to breakthrough drugs through improvements
to policies and regulations that influence
the drug approval process. However, this item
was not on the list of priorities in the 2006
progress report on the National Pharmaceuticals
Strategy. Even basic elements such as establishing
a clear definition for the term “breakthrough
drug” have not been completed.
OF NOTE
There have been efforts in some jurisdictions
such as Ontario (see Bill 102 – Bold legislation
in Ontario aims to reduce costs and improve
access, page 19) to monitor Health Canada’s
review process for promising new therapies
so that when a medication is approved, the
province does not then need to take additional
time to decide whether or not to fund it.
This enables patients to receive the medication
more quickly.
18
PRICING AND PURCHASING
“Pursue purchasing strategies to obtain best
prices for Canadians for drugs and vaccines”
“Accelerate access to non-patented drugs
and achieve international parity on prices of
non-patented drugs”
Governments spend a significant amount of
money on medications prescribed in hospitals
and through public drug plans. They will
spend even more when they extend catastrophic
drug coverage nationwide or provide access to
highly expensive drugs for rare diseases, making
it increasingly important for them to find
savings from within their budgets for prescription
medications. As noted earlier, Canadians
and their governments pay more for medications
than many other Western countries.35
In 2005, as part of their work on the National
Pharmaceuticals Strategy, health ministers asked
the Patented Medicine Prices Review Board
(PMPRB) to track domestic and international
prices of non-patented medications.35 The
PMPRB now does this – but it doesn’t regulate
the prices as it does with patented drugs.
Bill 102 – Bold legislation in
Ontario aims to reduce costs and
improve access
drugs for life-threatening diseases. And if a drug
is not approved, the government will tell patients
and manufacturers the reasons;
In June 2006, the Ontario legislature passed Bill
102, the Transparent Drug System for Patients Act.
According to the Ontario Ministry of Health and
Long-Term Care, the government expects to save up
to $277 million per year as a result of the new
legislation.52
> listening to the views of Ontarians through a new
The Act includes:
> recognizing the valuable role of pharmacists in patient
> achieving significant savings by striking the
best possible deals when purchasing medications
for the government’s Ontario Drug Benefit
Program, which currently spends $3.4 billion on
medications each year;
> closing loopholes that lead to unacceptable price
increases for drugs;
> improving patient access to drugs. The government
will permit rapid funding decisions for breakthrough
Citizens’ Council that will advise the Ministry on the
social aspects of drug policies and priorities;
> strengthening transparency by giving patients
a role in drug listing decisions of the Committee to
Evaluate Drugs;
care by paying them for enhanced patient counselling
and other professional services;
> using the expertise of Ontario’s pharmacists through
a new Pharmacy Council to advise the Ministry and
the Executive Officer of the public drug programs; and
> freeing doctors of the burden of paperwork
associated with Exceptional Access drugs (drugs
that require special authorization/approval by
physicians in order for the prescription to be eligible
for government reimbursement).52,53
National Prescription Drug
Utilization Information System
( NPDUIS)
This valuable database can be used to track
and analyze prescription medications provided
through publicly funded drug benefit plans in
participating jurisdictions. It was established with
the support of all ministers of health in 2001,
as a collaborative effort between the Canadian
Institute for Health Information (CIHI) and the
Patented Medicine Prices Review Board (PMPRB).
The objective was to provide analysis of price,
utilization, and cost trends so that Canada’s health
system has more comprehensive and accurate
information on how prescription drugs are being
used, as well as the sources of cost increases.
In addition, doctors and pharmacists have better
information from which to provide care to
patients.54,55
In 2004, Health Canada awarded CIHI additional
funding to explore opportunities to include
data about the prescription drugs funded by the
private sector (i.e. insurance companies and
out-of-pocket payers).
Over time, analysis of data in the NPDUIS database is expected to help drug plan managers to:
1) access standardized drug product information
and comparable data on publicly funded
drug formularies across the country; 2) measure
and analyze drug utilization; and 3) better
understand the difference between drug plans
and the impact on drug utilization. The NPDUIS
database should enable managers to monitor
their cost management strategies and to identify
best practices based on comparisons between
jurisdictions.
As of November 2008, 11 jurisdictions (federal,
provincial, and territorial) were participating
in varying degrees. Six are providing claims data,
10 are providing drug plan coverage data,
and all jurisdictions are providing information on
program policies. Data sharing agreements for
claims data are under discussion in three jurisdictions. For NPDUIS to reach its goal of tracking
and analyzing prescription medication use
through publicly funded drug plans, it needs
comprehensive data to be submitted from all
participating jurisdictions.56 For more information,
visit www.cihi.ca/drugs.
A Status Report on The National Pharmac eut ic als S t r at eg y
In 2006, the ministerial task force said that
options for a comprehensive national
pricing and purchasing framework were being
considered. They also recommended that
Canada take a “business-management approach”
regarding the pricing of medications, with
a priority on generic medications because of
their high cost to Canadians.36
In September 2008, the provincial and territorial
ministers of health said that, in their view,
a “national approach to achieving pricing and
purchasing savings is not realistic at this
time, given the economic development and
legislative/policy considerations within individual
jurisdictions”. However, they recommended
that “interprovincial collaborations should be
separately pursued and evaluated outside of a
National Pharmaceuticals Strategy”. Essentially
they have recommended that this commitment be undertaken by jurisdictions alone or
through interprovincial collaborations.24
A N A LY Z I N G C O S T S
“Enhance analysis of cost drivers and
cost-effectiveness, including best practices
in drug plan policies”
Governments can save money on their drug
plans through strategies such as tighter management, more cooperation among jurisdictions,
and improved prescribing behaviour on the part
of health professionals. A key part of reducing
costs involves looking closely at the reasons
costs are rising, such as: prescribing trends and
the intensification of drug use in medicine
overall; rising prices for drugs; inappropriate
prescribing; and demographic trends. It also
involves looking at successful strategies in other
jurisdictions and countries.
The National Pharmaceuticals Strategy has
not taken direct action in this area, but has noted
that work is partially underway through the
National Prescription Drug Utilization Information System (NPDUIS).
OF NOTE
Ontario,53 Quebec,57 and Newfoundland and
Labrador 58 have used legislation to create major
shifts in their approach to pricing and
purchasing. Some jurisdictions, such as British
Columbia and Alberta, have joined forces
to look at purchasing medications together.59
INFLUENCING PRESCRIBING
“Enhance action to influence the prescribing
behaviour of health care professionals so
that drugs are used only when needed and
the right drug is used for the right problem”
With thousands of prescription medications
on the market and more being added all the
time, it’s a challenge for health care professionals
to be well informed about all the options and
potential side effects of new drugs, as well as
the interaction risks of each and every treatment
choice. With patients often receiving prescriptions
from more than one health care professional,
the challenge increases.
Yet current and consistent information is critical
to helping a patient receive a safe and effective
prescription, tailored to his or her specific needs.
For example, an elderly patient may need a
lower dose or a different medication than would
be prescribed for a younger adult.
21
H e a lth C ounc il of Canada
Physicians frequently learn about medications
from drug company representatives. The
pharmaceutical industry has been criticized for
over-emphasizing the positive elements of
studies and downplaying the adverse effects of
drugs.60 Health professionals who prescribe and
dispense prescription medicines benefit from
easily accessible, evidence-based information
about the proper use and risks of each medication, as well as from education about the most
cost-effective options for patients.
In 2006, the ministerial task force assured
Canadians that two efforts were under way to
help influence prescribing behaviour, but
neither is under the umbrella of the National
Pharmaceuticals Strategy. The two initiatives
were the National Prescription Drug Utilization
Information System (NPDUIS), and the
Canadian Optimal Medication Prescribing and
Utilization Service (COMPUS), which produces
tools and strategies to help physicians prescribe
the most appropriate medications. COMPUS
was established in 2004 by the deputy ministers
of health and is funded by Health Canada to support all jurisdictions.36
Like the electronic health record, both COMPUS
and NPDUIS have long-term potential to help
influence prescribing behaviour, but they need
the committed participation of all jurisdictions.
This commitment to influence prescribing
behaviours was not slated as a priority in
the National Pharmaceuticals Strategy 2006
progress report. The ministerial task force stated
that progress would be monitored and links
would be formed where appropriate to influence
prescribing.36
22
The Health Council of Canada has been concerned about this gap, and in response hosted
a 2007 policy symposium called Safe and Sound:
Optimizing Prescribing Behaviours. A summary
report on the main themes and insights is
available at www.healthcouncilcanada.ca.
Experts recommended a number of other efforts
that would help with appropriate prescribing,
such as providing more one-on-one educational
sessions to physicians (see Academic detailing:
Getting the right information to prescribers,
page 23).
Academic detailing: Getting the
right information to prescribers
One initiative under way in several provinces
is called academic detailing, in which physicians
and other prescribers are provided with the
latest academic evidence on medications and
recommended prescribing practices.
The academic detailer is most commonly a
pharmacist who provides doctors with evidencebased information about specific medications
or classes of medications in order to promote
optimal prescribing.60 These efforts are intended
to counterbalance information from the
representatives of pharmaceutical companies,
a common way that physicians receive
information about medications.
There is considerable evidence that academic
detailing programs are effective at changing
physicians’ prescribing patterns.61,62,63 In 2008,
only four provinces had these programs
(British Columbia, Nova Scotia, Saskatchewan
and Manitoba). British Columbia’s academic
detailing program was recently expanded from
one academic detailer to 10 full-time pharmacists, aimed at supporting up to 2,000 physicians
and other health care professionals in the
province.64 Alberta’s provincial-level program
has been discontinued, but academic detailing
initiatives in the province continue at the
regional level.60
The total academic detailing workforce in
Canada is estimated to be small. In contrast, the
pharmaceutical industry employs 5,500-6,000
detailers in Canada.60
E-health and medication safety
Millions of dollars are being invested across the
country in the infrastructure to support electronic
health records and drug information databases.
These tools are essential for many aspects of the
medication-use system, from improving the way
medications are prescribed and safely used to tracking
and analyzing data that can help to shape policy.
While Canada Health Infoway does not specifically
fund e-prescribing initiatives, the electronic health
record infostructure designed and funded by Infoway
will support e-prescribing activities throughout
Canada. Infoway has allocated $250 million in funding
towards the development of drug information
systems across the country that allow prescriptions to
be sent, viewed and confirmed electronically. When in
place, these systems will identify drug-to-drug interactions automatically, adding this information to the
patient’s drug profile to warn of potential danger.65
Implementation targets are to “electronically capture
and store approximately 75% of dispensed medication
information by 2010 and 95% by 2016 and provide
approximately 50% of retail pharmacies with access to
patients’ medication profiles by 2010 and 100% by
2016”.66 As of March 2008, drug information systems
had been deployed for 50% of the population in
British Columbia, Manitoba, and Ontario, and are in
the adoption phase for 100% of the population
in Alberta, Prince Edward Island, and Saskatchewan.
With the exception of the Northwest Territories,
which has yet to initiate a plan towards implementing
a drug information system, the remaining provinces
and territories are in the planning and implementation phases.66 In addition, family physicians must be
linked to these systems; many of them must pay
to provide the computer infrastructure that links them
to electronic health records and databases.
Of note
Many jurisdictions have moved ahead with
implementing drug information systems. In British
Columbia, the government has operated a
computerized pharmacy database called PharmaNet
since 1995. PharmaNet links all pharmacies in the
province to the database. It is key to reducing the
risks of medication-related problems: pharmacists and
other authorized health professionals at hospitals or
in the doctors’ offices can log on to PharmaNet for the
latest information about a person’s prescriptions.
Among its many features, the system helps health
professionals to flag potential side effects and dangerous drug-to-drug interactions.67
A Status Report on The National Pharmac eu t ic als S t r at eg y
E-PRESCRIBING
“Broaden the practice of e-prescribing
through accelerated development and
deployment of the Electronic Health Record”
Writing prescriptions on a computer and sending
them electronically to a pharmacy reduces the
odds of medication errors at the pharmacy from
misinterpreting bad handwriting,68 and speeds
the dispensing of a patient’s prescription.
In 2006, the progress report of the National
Pharmaceuticals Strategy ministerial task force
said that two steps had been made towards
this commitment:
1) Health Canada and Canada Health Infoway,
on behalf of participating provinces and territories, had collaborated to identify a technical
standard and protocol that could be used across
Canada to ensure the accuracy of electronic
prescriptions; and
2) During consultations in 2005, stakeholders
agreed upon the proposed standard and support
was given to amend any regulations needed
to enable electronic prescribing, which Health
Canada was pursuing.36
However, the National Pharmaceuticals Strategy
ministerial task force made no recommendations
for the future related to this commitment;
the 2006 progress report commented generally
on the integration of e-prescribing with other
existing and emerging electronic systems, and
with current modes of practice and promotion
of e-prescribing.36
C O M M O N N AT I O N A L D R U G F O R M U L A R Y
“Establish a common National Drug
Formulary for participating jurisdictions
based on safety and cost effectiveness”
The list of prescription drugs that a government
has decided to fund through its public drug
plans is called a formulary. Each province and
territory, as well as the federal government,
currently has its own formulary. The purpose of
establishing a common national drug formulary
is to ensure that the same prescription medicines are funded by each jurisdiction.
Prior to 2003, provincial governments conducted
their own assessments of the clinical effectiveness and costs of medications, which is partly
why the formularies were so different. But since
then, governments (except Quebec) have been
using one central drug review process – the
Common Drug Review – to make these assessments. Experts conduct objective, rigorous
analysis of medications, and then recommend
which prescription drugs governments should
provide through their public plans.
The final decision is still made independently
by each jurisdiction. But the Common
Drug Review has been viewed as a major step
forward in collaboration and cooperation
among governments, saving each jurisdiction
the expense and time of assessing medications
on its own.69,70 However, the Common Drug
Review has not been without growing pains,
as there have been some criticisms of both
process and effectiveness.71
In 2006, the National Pharmaceuticals Strategy
ministerial task force recommended a staged
expansion of the Common Drug Review to
increase the similarity of public plan formularies, and continued discussions on the design of
a common national formulary. The ministerial
task force also recommended expanding the
Common Drug Review to include medications
not in its original mandate, and to look at the
feasibility and benefits of a common review
process for cancer medications 36 (which began
in 2007).
25
H e a lth C ounc il of Canada
Although there are some inequities in the
coverage of prescription medications across the
country,27 provincial and territorial ministers
of health said in September 2008 that in their
view, a common national formulary is no longer
needed. They said there is greater than 90%
commonality between jurisdictional plans 24
(although some experts believe this number is
much lower 72). Still, this would mean that
10% of medications, which may include newer
and/or more expensive medications, are inconsistently offered across the country. Canadians
need to know what these medications are, as
well as the governments’ plans to work to close
that 10% gap.
REAL-WORLD DRUG SAFETY
AND EFFECTIVENESS
“Strengthen evaluation of real-world drug
safety and effectiveness”
The risks and benefits of medications are usually
identified in clinical trials (research involving
patients) before they are approved for market.
But sometimes new and potentially dangerous
side effects are identified once a product is put
on the market and used by many more people
in real-world conditions.
Information about the positive and negative
impact of prescribed medications changes over
time, as does knowledge about drug interactions.
In order to ensure patient safety, countries need
proactive strategies to collect and interpret
information about the real-world experiences of
people who take medications. Countries also
need policies and protocols so that they can take
appropriate action when it is warranted.
One of the challenges of real-world safety and
effectiveness is being able to learn about
unexpected hazards as quickly as possible, so
that steps can be taken to protect patients.
26
In July 2008, the federal government announced
an intention to invest $1 million to support the
establishment of the Drug Safety and
Effectiveness Network (DSEN) as a component
of the Food and Consumer Safety Action Plan.
The network will create the link between
research centres of excellence and coordinate a
common research agenda. The linked centres
will conduct research to address the agenda
developed by a national oversight body. This
will help to increase knowledge about the safety
and effectiveness of drugs based on their use
in the real world, outside the controlled
experimental environments of clinical trials.73
In January 2009, the federal minister of health
announced a commitment of a further
$31 million to the network over the next four
years, and $10 million per year after that.74
OF NOTE
The MedEffect program, launched in 2005
as part of Canada’s Therapeutic Access Strategy,
provides centralized access to health product
safety information as soon as it becomes available. MedEffect provides health professionals
and patients with information, and a simple,
fast way to obtain and file information about
adverse reactions to medications.75 (Visit
www.healthcanada.gc.ca/medeffect for more
information.)
Proposed new federal legislation could also make
a significant difference to the real-world safety
of medications (see Bills C-51 and C-52, page 27).
Bills C-51 and C-52
In April 2008, the federal government tabled Bill
C-51, An Act to Amend the Food and Drugs Act and
introduced Bill C-52, the Canada Consumer Product
Safety Act to the legislature.
If the acts are reintroduced and passed into law,
the government will be able to put new terms
and conditions on prescription drugs when they are
authorized to be marketed in Canada. As one
example, the government might require a drug
company to track and report on any health problems
that arise with the use of the drug. The government
will also have the power to require more stringent
product labels about potential health risks, and will
be able to disclose information to the public about
the risks and benefits that are associated with a
drug. The federal government would gain the power
to suspend or revoke a company’s authorization to
market the drug under specific conditions. In
addition, health care institutions such as hospitals
will be required to provide information about
adverse reactions from therapeutic products.76,77
Canadians may be surprised to learn that the federal
government does not already have these powers.
Although this proposed legislation is promising,
there are concerns that it does not go as far as it
could. While it indicates that no person shall
advertise a therapeutic product unless they are
authorized by the regulations to do so,76 it does not
call for a ban on all forms of direct-to-consumer
advertising of prescription drugs. There is reliable
evidence that this type of advertising does not
protect the interests of patients and in fact may
cause harm as physicians are more likely to
prescribe an unnecessary medication in response
to a patient’s request for an advertised brand.78
In 2004 and 2006, both the parliamentary Standing
Committee on Health79 and the Health Council
of Canada80 considered the evidence for and against
direct-to-consumer advertising and then called for
strengthening of legislation to ban all forms of it.
The proposed legislation also does not adequately
establish mechanisms to gather the types of
information needed by governments to execute its
new authorities. While it indicates that governments
will establish and maintain a publicly accessible
register to keep information about therapeutic
products,76 which is a good idea, it provides no
mechanism to require researchers or pharmaceutical
companies to disclose confidential business information, even if it were valuable information about
the safety of a prescription drug, or data collected
from people who agreed to be research subjects.
Bill C-51 introduces a definition of commercial
confidentiality into the Food and Drugs Act for the
first time. This definition broadly includes any
information that firms do not wish to disclose and
have not disclosed publicly, and that might affect
profitability if disclosed. Information indicating
inadequate effectiveness or a safety concern can
affect a company’s share price and sales.
While the legislation has great promise, it must
be noted that there are concerns in the health care
community about these and other flaws.81
In summary
A Status Report on The National Pharmac eu t ic als S t r at eg y
Making the necessary changes to our highly complex pharmaceutical
system is not easy. It requires exceptional cooperation among the provincial,
territorial, and federal governments to resolve complicated issues of
regulations, ethics, and financing.
Provinces, territories, and the federal government can move ahead with
pharmaceutical reforms on their own, and many have. But there are
interdependencies and limitations to what individual jurisdictions can
achieve on their own. That’s why the premiers and the prime minister decided
in 2004 that the National Pharmaceuticals Strategy is essential. It is through
this collective action, as well as through changes in each jurisdiction,
that all Canadians will benefit.
Additional perspective on the findings of this report is available in a
companion document, A Commentary on the National Pharmaceuticals
Strategy: A Prescription Unfilled, available at www.healthcouncilcanada.ca.
29
H e a lth C ounc il of Canada
REFERENCES
1 Statistics Canada. (2007). Canadian Survey of Experiences with Primary
Health Care, 2007.
2 The Commonwealth Fund. (2007). The Commonwealth Fund 2007
International Health Policy Survey in Seven Countries.
3 IMS Health. (2007 March 21). Canadian internet pharmacy
sales to the United States down 50% in 2006. [news release].
www.imshealthcanada.com.
4 McNeil BJ. (2001). Shattuck Lecture – Hidden barriers to
improvement in the quality of care. New England Journal of Medicine;
345(22): 1612-1620.
5 Hepler CD and Grainger-Rousseau TJ. (1995). Pharmaceutical
care versus traditional drug treatment. Is there a difference?
Drugs; 49(1): 1-10.
6 Segal R and Wang F. (1999). Influencing physician prescribing.
Pharmacy Practice Management Quarterly; 19(3): 30-50.
7 Health Council of Canada. (2007). Optimal Prescribing and Medication
Use in Canada: Challenges and Opportunities. Toronto: Health Council.
www.healthcouncilcanada.ca.
8 Zed PJ, Abu-Laban RB, Balen RM, et al. (2008). Incidence, severity and
preventability of medication-related visits to the emergency department:
A prospective study. CMAJ; 178(12): 1563-1569.
9 Canadian Institute for Health Information. (2007). Drug claims by
seniors: An analysis focusing on potentially inappropriate medication use,
2000 to 2006. Ottawa: CIHI. www.cihi.ca.
10 Nickerson A, MacKinnon NJ, Roberts N, et al. (2005). Drug-therapy
problems, inconsistencies and omissions identified during a medication
reconciliation and seamless care service. Healthcare Quarterly; 8(Special
issue October 2005): 65-72.
11 Forster AJ, Clark HD, Menard A, et al. (2004). Adverse events among
medical patients after discharge from hospital. CMAJ; 170(3): 345-349.
12 Baker GR, Norton PG, Flintoft V, et al. (2004). The Canadian Adverse
Events Study: The incidence of adverse events among hospital patients in
Canada. CMAJ; 170(11): 1678 -1686.
13 Winterstein AG, Sauer BC, Hepler CD, et al. (2002). Preventable
drug-related hospital admissions. The Annals of Pharmacotherapy;
36(July/August): 1238-1248.
14 Beijer HJM and de Blaey CJ. (2002). Hospitalisations caused by
adverse drug reactions (ADR): A meta-analysis of observational studies.
Pharmacy World & Science; 24(2): 46-54.
15 Courtman BJ and Stallings SB. (1995). Characterization of
drug-related problems in elderly patients on admission to a medical
ward. Canadian Journal of Hospital Pharmacy; 48(3): 161-166.
16 MacKinnon NJ. (2002). Early warning system: How vigilant
pharmacists can prevent drug-related morbidity in seniors. Pharmacy
Practice; 18(8): 40-44.
17 MacKinnon NJ. (2007). Introduction. Safe and Effective: The Eight
Essential Elements of an Optimal Medication-Use System. MacKinnon NJ
(editor). Ottawa: Canadian Pharmacists Association.
18 Barnett CW, Nykamp D, Ellington AM. (2000). Patient-guided
counseling in the community pharmacy setting. Journal of the American
Pharmaceutical Association; 40(6): 765-772.
22 Mamdani M. (2005). The changing landscape for COX-2 inhibitors:
A summary of recent events. Healthcare Quarterly; 8(2): 24-26.
23 Canadian Medical Association Journal. (2005). Vioxx: Lessons for
Health Canada and the FDA. [editorial]. CMAJ; 172(1): 5.
24 Canadian Intergovernmental Conference Secretariat. (2008
September 4). Annual Conference of Provincial-Territorial Ministers
of Health. National Pharmaceuticals Strategy decision points.
[backgrounder]. www.scics.gc.ca.
25 The Commonwealth Fund. (2008). The 2008 Commonwealth Fund
International Health Policy Survey of Sicker Adults.
26 Canadian Life and Health Insurance Association Inc. (2008). Provincial
and Territorial Drug Program Information. Toronto: CLHIA. www.clhia.ca.
27 Demers V, Melo M, Jackevicius C, et al. (2008). Comparison of
provincial prescription drug plans and the impact on patients’ annual
drug expenditures. CMAJ; 178(4): 405-409.
28 Kapur V and Basu K. (2005). Drug coverage in Canada: Who is at risk?
Health Policy; 71: 181-193.
29 Piette JD, Heisler M, Horne R, et al. (2005). A conceptually based
approach to understanding chronically ill patients’ responses to medication
cost pressures. Social Science & Medicine; 62(4): 846-857.
30 Wallston KA. (2007). Patient health care behaviours related to
medication use and adherence. Safe and Effective: The Eight Essential
Elements of an Optimal Medication-Use System. MacKinnon NJ (editor).
Ottawa: Canadian Pharmacists Association.
31 Goldsworthy RC, Schwartz NC, Mayhorn CB. (2008). Beyond abuse
and exposure: Framing the impact of prescription-medication sharing.
American Journal of Public Health; 98(6): 1115-1121.
32 Pollara Inc. (2006). Health Care in Canada Survey, 2006. Toronto:
Pollara. www.pollara.ca.
33 Canadian Institute for Health Information. (2008). Drug Expenditures
in Canada, 1985 to 2007. Ottawa: CIHI. www.cihi.ca.
34 Canadian Institute for Health Information. (2008). National Health
Expenditure Trends, 1975-2008. Ottawa: CIHI. www.cihi.ca.
35 Patented Medicine Prices Review Board. (2006). Non-patented
Prescription Drug Prices Reporting: Canadian and Foreign Price Trends
June 2006. Ottawa: PMPRB. www.pmprb-cepmb.gc.ca.
36 Federal/Provincial/Territorial Ministerial Task Force on the National
Pharmaceuticals Strategy. (2006). National Pharmaceuticals Strategy
Progress Report. Ottawa: Health Canada. www.hc-sc.gc.ca.
37 Competition Bureau. (2008). Benefiting from Generic Drug
Competition in Canada: The Way Forward. Ottawa: Competition Bureau.
www.competitionbureau.gc.ca.
38 Canada. First Ministers’ Meeting. (2003). First Ministers’ Accord on
Health Care Renewal. Ottawa: Health Canada. www.hc-sc.gc.ca.
39 Canada. First Ministers’ Meeting. (2004). A 10-Year Plan to
Strengthen Health Care. Ottawa: Health Canada. www.hc-sc.gc.ca.
40 Canadian Intergovernmental Conference Secretariat. (2005 October
22-23). Annual Conference of Federal-Provincial-Territorial Ministers of
Health. [news release]. www.scics.gc.ca.
41 National Pharmaceuticals Strategy. (2006 September 21). Progress
report outlines next steps to improve prescription drug access and cost.
[news release]. www.news.gov.bc.ca.
19 Kirkpatrick MAF and Mohler CP. (1999). Using the readability
assessment instrument to evaluate patient medication leaflets. Drug
Information Journal; 33: 557-563.
42 Health Canada. (2008). Non-Insured Health Benefits for First Nations
and Inuit [web page]. www.hc-sc.gc.ca/fniah-spnia/nihb-ssna/index-eng.php.
20 Buck ML. (1998). Providing patients with written medication
information. The Annals of Pharmacotherapy; 32(9): 962-969.
43 Plasmid Biocommunications Inc. (2007). Prescription drug coverage in
Canada [web page]. www.drugcoverage.ca.
21 Nair K, Dolovich L, Cassels A, et al. (2002). What patients want to
know about their medications: Focus group study of patient and clinician
perspectives. Canadian Family Physician; 48: 104-110.
44 Alberta Health and Wellness. (2008). Alberta Pharmaceutical Strategy.
Edmonton: Alberta Health and Wellness. www.health.alberta.ca.
30
A Status Report on The National Pharmac eu t ic als S t r at eg y
45 Newfoundland and Labrador. (2007 October 11). New prescription
drug plan provides assurance for residents with high drug costs. [news
release]. www.gov.nl.ca.
66 Canada Health Infoway. (2008). Paving the Way to
Collaborative Care. Corporate Business Plan 2008-09. Toronto:
CHI. www.infoway-inforoute.ca.
46 Nova Scotia. (2007 November 26). New Nova Scotia family
pharmacare program announced. [news release]. www.gov.ns.ca.
67 British Columbia Ministry of Health. PharmaNet [web page, no date].
www.health.gov.bc.ca/pharme/pharmanet/netindex.html.
47 Corpus Sanchez International Consultancy. (2008 October).
An Integrated Health System Review in PEI. A Call to Action: A Plan for
Change. Charlottetown: Corpus Sanchez International Consultancy.
www.gov.pe.ca.
68 Health Council of Canada. (2007). Safe and Sound:
Optimizing Prescribing Behaviours. Toronto: Health Council.
www.healthcouncilcanada.ca.
48 Saskatchewan. (2004 February 10). Saskatchewan drug plan
coverage expanded. [news release]. www.gov.sk.ca.
49 Health Canada. (2006 June 14). Federal government to participate in
study of Fabry disease. [news release]. www.hc-sc.gc.ca.
50 Dalhousie University Faculty of Medicine. (2007 September 5). Fabry
disease patients have chance at therapy: Canadian Fabry disease initiative
study underway. [news release]. www.communications.medicine.dal.ca.
51 Ghatak R and Ma J. (2004 July 21). Health Newsflash: Fabry Disease.
ESI Canada; 6(10): 1-2.
52 Ontario Ministry of Health and Long-Term Care. (2006). Transparent
Drug System for Patients Act, 2006. www.health.gov.on.ca/english/
public/legislation/drugs/hu_drugsact.html.
53 Ontario Ministry of Health and Long-Term Care. (2006 April 13).
Bill 102, Transparent Drug System for Patients Act, 2006: Introduction
of Legislation. www.health.gov.on.ca.
54 Canadian Institute for Health Information. (2006). National Prescription Drug Utilization Information System (NPDUIS): Revised Privacy Impact
Assessment. Ottawa: CIHI. www.cihi.ca.
55 Canadian Intergovernmental Conference Secretariat. (2001
September 26). Annual Conference of Federal-Provincial-Territorial
Ministers of Health. Health ministers move forward on improving
health care in Canada. [news release]. www.scics.gc.ca.
69 Canadian Agency for Drugs and Technologies in Health. (2008).
Common Drug Review [web page]. www.cadth.ca.
70 McMahon M, Morgan S, Mitton C. (2006). The Common Drug
Review: A NICE start for Canada? Health Policy; 77(3): 339-351.
71 Canada. House of Commons. Standing Committee on Health (2007).
Prescription Drugs, Part 1 – Common Drug Review: An F/P/T Process:
Report of the Standing Committee on Health. Chair was Joy Smith.
www.parl.gc.ca.
72 MacKinnon NJ. (2004). Provincial drug plans: Now there’s a minefield.
Data on provincial differences add important perspective. Canadian
Pharmacists Journal; 137(7): 14 -16.
73 Health Canada. (2008 July 14). Government of Canada announces
post-market drug safety and effectiveness network. [news release].
www.hc-sc.gc.ca.
74 Health Canada. (2009 January 14). Government of Canada works
to improve knowledge about the safety and effectiveness of drugs.
[news release]. www.hc-sc.gc.ca.
75 Health Canada. About MedEffect Canada [web page, no date].
www.hc-sc.gc.ca/dhp-mps/medeff/about-sujet-eng.php.
76 Canadian Health Food Association. Backgrounder: Bill C-52 [web
page, no date]. www.chfa.ca.
56 Michele Arthur, Program Lead, Pharmaceuticals, Canadian Institute
for Health Information, personal communication, November 28, 2008.
77 Canada. (2008 April 8). Bill C-51: An Act to Amend the Food and
Drugs Act and to Make Consequential Amendments to Other Acts.
First Reading in the House of Commons. 2nd session, 39th Parliament.
www.parl.gc.ca.
57 Revenu Quebec. (2007). Principal changes for 2007 [web page, no
date]. www.revenu.gouv.qc.ca/eng/travailleur_autonome/oblig_fiscales/
retenues/changements.asp.
78 Mintzes B. (2006). Direct-to-Consumer Advertising of Prescription
Drugs in Canada: What Are the Public Health Implications? Toronto:
Health Council of Canada. www.healthcouncilcanada.ca.
58 Newfoundland and Labrador. (2007 December 21). Regulation
125/07, The Interchangeability Drug Formulary Regulations, 2007.
Newfoundland and Labrador Gazette. www.gov.nf.ca.
79 Canada. House of Commons. Standing Committee on Health.
(2004). Opening the Medicine Cabinet: First Report on Health Aspects of
Prescription Drugs. Chair was Bonnie Brown. www.parl.gc.ca.
59 Alberta and British Columbia. (2007 May 18). Alberta-British
Columbia Memorandum of Understanding: Proposed Joint Procurement
of Pharmaceuticals and Medical Devices. www.gov.bc.ca/health/down/
mou_pharmaceuticals.pdf.
80 Health Council of Canada. (2006). Health Care Renewal: Clearing the
Road to Quality. Toronto: Health Council. www.healthcouncilcanada.ca.
81 Lexchin J. (2008). Progressive licensing of drugs: Music or noise?
Healthcare Policy; 3(4): 11-20.
60 Kondro W. (2007). Academic drug detailing: An evidence-based
alternative. CMAJ; 176(4): 429.
61 Davis DA, Thomson MA, Oxman AD, et al. (1995). Changing
physician performance. A systematic review of the effect of continuing
medical education strategies. JAMA; 274(9): 700 -705.
62 Grimshaw JM, Thomas RE, MacLennan G, et al. (2004). Effectiveness
and efficiency of guideline dissemination and implementation strategies.
Health Technology Assessment; 8(6): 1-72.
63 O’Brien TMA, Oxman AD, Davis DA, et al. (2008). Educational
outreach visits: Effects on professional practice and health care outcomes
(Review). Cochrane Database of Systematic Reviews; (2): CD000409.
www.cochrane.org.
64 British Columbia Ministry of Health. (2008 March 25).
Province promotes best practices for drug prescribing. [news release].
www.news.gov.bc.ca.
65 Jim McLean, Senior Vice-President, Clinical Adoption, Canada Health
Infoway, personal communication, November 3, 2008.
31
FIGURES
1 / Page 4
Half of all Canadian adults take at least one prescription medication
2 / Page 6
Six percent of Canadians report medication errors
3 / Page 12
Canadians pay more than they should for prescription medications
H e a lth C ounc il of Canada
ACKNOWLEDGEMENTS
The Health Council of Canada would like to acknowledge the significant
efforts of many people who collaborated in creating this report.
Development of the report was led by the Council’s National
Pharmaceuticals Strategy (NPS) Committee, which included Councillors
Dr. Alex Gillis (Chair), Dr. Nuala Kenny, and Mr. George Morfitt.
The Council thanks lead contributors Dr. Neil J. MacKinnon (Associate
Director for Research and Associate Professor, College of Pharmacy,
Dalhousie University) and Dr. Diane Watson (Faculty, Centre for Health
Services and Policy Research, University of British Columbia) for their
contributions to the research and development of this report.
The Council also thanks external NPS committee members Dr. Steve
Morgan (Associate Director, Centre for Health Services and Policy
Research, University of British Columbia) and Mr. Bob Nakagawa
(Assistant Deputy Minister, Pharmaceutical Services, British Columbia
Ministry of Health) for their contributions.
The Council acknowledges members of the Council secretariat for their
leadership and collective work in the creation of this report.
The analyses and conclusions of this report do not necessarily
reflect those of external contributors or the organizations with which
they are affiliated.
About The Commonwealth Fund
The 2007 International Health Policy Survey of the General Public’s
Views of their Health Care System’s Performance in Seven Countries was
sponsored by The Commonwealth Fund with Harris Interactive as the
surveyor. Co-funding of the Canadian sample was provided by the Health
Council of Canada; the Dutch sample by The Dutch Ministry of Health,
Welfare and Sport and The Centre for Quality of Care Research (WOK),
Radboud University Nijmegen; and the German sample by the German
Institute for Quality and Efficiency in Health Care.
The 2008 Commonwealth Fund International Health Policy Survey
of Sicker Adults, conducted by Harris Interactive, assessed health care
system performance and responsiveness from the perspective of
sicker adults. Conducted in Australia, Canada, Germany, the Netherlands,
New Zealand, the United Kingdom, the United States, and France, the
study explored the experiences and views of adults with health problems
with a focus on key aspects of access, quality, patient-centeredness,
and efficiency, including safety, waiting times, communication,
care coordination, administrative burden, and financial barriers. The
Commonwealth Fund provided core funding for the eight-country
international survey. In addition, co-funding of the country-specific sample
was provided by the Health Council of Canada, the Quebec Health
Commission, the Ontario Health Quality Council, the Health Foundation
(UK), the German Institute of Quality and Efficiency, and the Dutch
Ministry of Health, Welfare and Sport.
32
A B O U T T H E H E A LT H C O U N C I L O F C A N A D A
Councillors *
Canada’s First Ministers established the Health Council of Canada
G O V E R N M E N T R E P R E S E N TAT I V E S
in the 2003 Accord on Health Care Renewal and enhanced our
Mr. Albert Fogarty – Prince Edward Island
role in the 2004 10-Year Plan to Strengthen Health Care. We
Dr. Alex Gillis – Nova Scotia
report on the progress of health care renewal, on the health
Mr. Stuart Whitley – Yukon
status of Canadians, and on the health outcomes of our system.
Mr. Michel C. Leger – New Brunswick
Our goal is to provide a system-wide perspective on health
Ms. Lyn McLeod – Ontario
care reform for the Canadian public, with particular attention
Mr. David Richardson – Nunavut
to accountability and transparency.
Ms. Elizabeth Snider – Northwest Territories
The participating jurisdictions have named Councillors
Dr. Les Vertesi – British Columbia
representing each of their governments and also Councillors with
N O N - G O V E R N M E N T R E P R E S E N TAT I V E S
expertise and broad experience in areas such as community
Dr. Jeanne F. Besner – Chair
care, Aboriginal health, nursing, health education and
Dr. M. Ian Bowmer – Vice Chair
administration, finance, medicine and pharmacy. Participating
Mr. Jean-Guy Finn
jurisdictions include British Columbia, Saskatchewan, Manitoba,
Dr. Nuala Kenny
Ontario, Prince Edward Island, Nova Scotia, New Brunswick,
Dr. Danielle Martin
Newfoundland and Labrador, Yukon, the Northwest Territories,
Mr. George L. Morfitt
Nunavut and the federal government. Funded by Health
Ms. Verda Petry
Canada, the Health Council operates as an independent nonprofit agency, with members of the corporation being
the ministers of health of the participating jurisdictions.
The Council’s vision
An informed and healthy Canadian public, confident in the
effectiveness, sustainability and capacity of the Canadian health
care system to promote their health and meet their health
care needs.
The Council’s mission
The Health Council of Canada fosters accountability and
transparency by assessing progress in improving the quality,
effectiveness and sustainability of the health care system.
Through insightful monitoring, public reporting and facilitating
informed discussion, the Council shines a light on what helps
or hinders health care renewal and the well-being of Canadians.
Dr. Stanley Vollant
* as of January 2009
www.healthcouncilcanada.ca
To reach the Health Council of Canada:
Telephone: 416.481.7397
Facsimile: 416.481.1381
Suite 900, 90 Eglinton Avenue East
Toronto, ON M4P 2Y3