Health Canada posts Diane-35 Safety Review Summary and works with
partners on a prescriber checklist as first step
OTTAWA, April 8, 2014 /CNW/ - The Honourable Rona Ambrose, Minister of
Health, today delivered on a commitment to begin transparently
publishing drug safety reviews. The Minister committed to providing
Canadians with access to Health Canada drug safety reviews with the
posting of a summary of the safety review of the acne treatment Diane-35. This is the first
summary safety review to be made public.
Once a drug is on the Canadian market, Health Canada continues to
monitor the safety of health products to identify and assess potential
harms. As a result, departmental safety reviews are conducted when a
safety issue is identified for a product on the Canadian market. The
posting of summary safety reviews will provide Canadians with
plain-language descriptions of Health Canada's findings and decisions,
so patients can make informed decisions and continue to have confidence
in the health products they use. The full reports will be made
available through a link on Health Canada's website; however they are
subject to redactions of personal and confidential information.
The posting of summary safety reviews is the first in a series of
measures that Health Canada is taking to be more transparent and open
with Canadians about regulatory decisions. As part of Health Canada's Regulatory Transparency and Openness Framework, the department has committed to providing Canadians with credible and
timely information. This easy to understand information will allow them
to make well-informed decisions concerning their health and that of
their families. Canadians will also have the chance to provide Health
Canada with feedback on the Framework.
Health Canada has also made available today a practical new tool to
assist in the safe prescribing of Diane-35 and to better inform
healthcare professionals and patients of its risks. In consultation
with the Canadian Pharmacists Association, the Canadian Dermatology
Association, and the Institute for Safe Medication Practices, Health
Canada has developed a checklist to guide healthcare professionals
through the decision to prescribe Diane-35. The checklist will
reinforce existing warnings and precautions for this drug.
Today's announcements build on the Government's Patient Safety agenda,
including Legislation that was introduced in December 2013, known as
the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law).
Health Canada's safety review of Diane-35 concluded that the drug's
benefits continue to outweigh the risks when the product is used
according to the conditions on the label. The results of the review
were communicated to Canadians on May 17, 2013.
With the posting of summary safety reviews, Health Canada is a leader in
making post-market drug safety information publicly available.
Canadians will now have access to more drug safety information than
ever before. The Diane-35 safety review is just the first summary to be
made public. Health Canada will be posting additional summary safety
reviews, beginning with those of highest interest to Canadians.
The Regulatory Transparency and Openness Framework lays out solid principles and commits Health Canada to a set of
concrete initiatives that will make regulatory health and safety
information more available to Canadians this year and in the years to
Vanessa's Law aims to protect Canadians and children from unsafe
medicine and will give the Government new tools to recall unsafe
products, require mandatory reporting of adverse reaction, impose tough
new penalties for unsafe products, including jail time and compel drug
companies to do further testing on a product, including when issues are
identified with certain at-risk populations such as children.
"Patient safety is a priority to our Government. Greater access to easy
to understand and credible information about the potential risks and
appropriate use of health products is one of the most valuable safety
tools we can provide Canadians and healthcare professionals."
Minister of Health
"With the posting of summary safety reviews, Health Canada is going
beyond what other regulatory agencies are doing in terms of sharing
this type of post-market drug safety information. This positive step is
the first of many measures the Department is taking to improve the
openness and transparency of its work."
Member of Parliament for Oakville
"We were pleased to partner with Health Canada on the prescriber
checklist for Diane-35, which will promote safe use of the drug. We
commend the Government of Canada's efforts to increase transparency by
making the findings of Health Canada's drug safety reviews publicly
available. This information will help front-line healthcare
professionals educate patients and ultimately protect the health of
Perry Eisenschmid, CEO
Canadian Pharmacists Association
"We are supportive of measures that increase safety for patients and
promote safe practices. The checklist for Diane-35 and its generics is
a good first step to assisting healthcare professionals in responsible
prescribing and highlighting important safety information for patients
and it is our hope this entire class of OCPs will be examined."
Dr Richard Langley, President
Canadian Dermatology Association
"Health Canada's release of the drug safety review summary for Diane-35
demonstrates commitment to transparency. The checklist developed for
Diane-35 can provide an aid when prescribing this medication and
communicating its risks to patients."
David U, CEO and President
Institute for Safe Medication Practices
Diane-35 Summary Safety Review
Regulatory Transparency and Openness Framework
Vanessa's Law - Information
Diane-35 Information Update (May 2013)
SOURCE: Health Canada
For further information:
Office of the Honourable Rona Ambrose
Federal Minister of Health
Health Canada news releases are available on the Internet at: www.healthcanada.gc.ca/media