Home' Australian Pharmacist : Australian Pharmacist February 2014 Contents Australian Pharmacist February 2014 I ©Pharmaceutical Society of Australia Ltd.
CONTINUING PROFESSIONAL DEVELOPMENT
5. Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants
of Under-Reporting of Adverse Drug Reactions: A
Systematic Review. Drug Safety 2009;32(1):19–31.
6. Robertson J, Newby DA. Low awareness of adverse drug
reaction reporting systems: a consumer survey. MJA
7. Edwards IR, Aronson JK. Adverse drug reactions:
definitions, diagnosis, and management. Lancet
8. Mackay K and the Adverse Drug Reactions Unit. Showing
the blue card: reporting adverse reactions. Aust Prescr
9. Therapeutic Goods Administration. Why hasn’t the TGA
taken Stilnox off the market? 2012. At: www.tga.gov.au/
10. Therapeutic Goods Administration. Pan Pharmaceuticals
Limited: Regulatory action and product recall information.
2013. At: www.tga.gov.au/safety/recalls-medicine-
• Pharmacists can contribute to the
better understanding of possible
adverse effects to medicines through
the reporting of ADEs.
• To report an adverse medicine event:
TGA: phone on 1800 044 114
Send completed Blue cards to the
By mail to: Office of Product Review,
Reply Paid 100, Woden ACT 2606
By fax to: 02 6232 8392
By email to: email@example.com
• You can access the DAEN to find
information about ADEs reported to
• There is low consumer awareness of
ADE reporting schemes; pharmacists
can raise awareness of these schemes.
1. World Health Organisation. The importance of
pharmacovigilance: Safety monitoring of medicinal
products. Geneva: WHO; 2002. p. 44 . At: http://apps.who.
2. Therapeutics Goods Administration. Advisory Committee
on the Safety of Medicines (ACSOM). 2013. At: www.tga.
3. Therapeutics Goods Administration. Reporting medicine
and vaccine adverse events. 2013. At: http://tga.gov.au/
4. Therapeutics Goods Administration. Australian statistics
on medicines and vaccines 2012. 2013. At: www.tga.gov.
Paul should be advised that rasagiline
is a new medicine and that some
potential adverse effects may not be
detected during clinical trials. You take
a brief history and determine that there
is a temporal association between
the commencement of rasagiline and
the development of his symptoms.
As the symptoms are disturbing for
Paul, you obtain consent to call his
specialist. His specialist requests that
Paul makes an appointment to see him
The TGA values reports of ADE to new
medicines. You advise Paul of the
benefits of reporting his suspected ADE
to the government and he consents to
the process. He explains his symptoms
to you in greater detail and you take a
comprehensive medical and medication
history and cross check against your
dispensing history. You lodge the
report online through the link on the
Finally, you invite Paul to update you
on the outcomes of his specialist
appointment and if his symptoms
resolve. If there are any changes, you will
update the TGA report using the unique
identifying number for Paul’s case.
1. Which of the following statements
is MOST APPROPRIATE regarding
reporting a suspected ADE to the
a) Submitting a report should be delayed
until all the information of the case is
known as additions cannot be added
once it is submitted to the TGA.
b) The causative drug must be identified
with certainty prior to submitting and
c) It would unwise to submit a suspected
ADE report if the symptoms are not
listed in the product information as all
adverse effects of drugs are known.
d) A suspected ADE to a complementary
medicine may be reported through the
TGA reporting system.
2. The DAEN can be accessed to:
a) Find a list of recall actions to medicines
b) Search for reports of adverse effects
submitted to the TGA.
c) Download a blue card to allow
reporting of a suspected adverse drug
d) Access information to provide advice to
consumers on reporting schemes.
3. Which of the following information is
NOT required to be submitted when
reporting a suspected ADE?
a) A patient identifier.
b) A description of reaction.
c) The contact details of the reporter.
d) Evidence from primary literature to
support your case report.
4. Where is a blue card UNABLE to be
a) Within the ‘Report a Problem’ area of the
b) Within selected issues of Australian
c) Within the current Australian Medicines
d) Ordered from the TGA Office of Product
THE COMPLEMENTARY APPROACH
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