More busy work for the bureaucracy. The buzz on the street is...we'll
believe it when we see results, not just press releases and
announcements.   Zee

S00879402 - Scrip
Canada to revamp drug safety and transparency

Canada is planning a number of measures to improve
drug safety and
transparency, including a new public drug database and
possibly mandatory
adverse drug reaction reporting.
Health Canada is setting up a new online database that
will provide drug
information to the public in the form of "notices of
compliance" (NOCs) on
all drugs marketed in the country since 1994. All
information will be easily
searchable and updated daily and will include
information on the drug's
therapeutic class and the way it is administered.
Currently Canada's ADR voluntary reporting system is
only mandatory for
children, but Health Canada is considering extending
this to other
"vulnerable" groups, such as elderly,
immunocompromised patients, and those
on products that appear to pose the highest risk,
Health Minister Ujjal
Dosanjh told the second Canadian Therapeutics Congress
last week.
Health Canada has just opened a new office of
paediatrics initiatives, which
will focus of children's health issues, including
product safety.
Two new regional ADR centres, in Alberta and Manitoba,
have been opened,
bringing the total number to seven. Each regional unit
assesses ADRs before
submitting them to the National Adverse Reaction
Centre in Ottawa.
Other measures announced include the setting up of a
scientific advisory
panel on the selective COX-2 inhibitors, which will
allow contributions from
the public. Its hearings are expected next month.
In terms of improving transparency, the health
minister has asked the chair
of the House of Commons standing committee on health
to consider how Health
Canada can open the drug review process to greater
public scrutiny, without
running foul of the law on privacy and commercial
confidentiality. The
committee is expected to make recommendations on the
public's input into the
drug review process and the public availability of
post-market drug
information.
The health minister has also asked the committee how
Health Canada might
better inform the public about safety concerns that
"crop up" once a drug is
already on market. But Mr Dosanjh maintains that much
"spadework" has
already been done on the post-market drug surveillance
system, with Can$170
million (over five years) having been promised in the
last federal budget to
strengthen this.
Mr Dosanjh is also consulting on how to make more
information on clinical
trials outcomes available to the public. Furthermore,
a new office of the
public ombudsman will be set up to hear concerns and
resolve complaints
about Health Canada. Its work will start in the
summer.

Full Title: SCRIP - World Pharmaceutical News -
FILED 20 April 2005

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