Pharmacovigilance
Pharmacovigilance
Medsafe, part of the Ministry of Health, is
responsible for pharmacovigilance activities in New Zealand. The collection of
reports of suspected adverse reactions to medicines is contracted by the
Ministry of Health to the Centre for Adverse Reactions Monitoring (CARM) in
Dunedin. CARM analyses these reports and informs Medsafe of any potential
medicine safety issues arising from these reports. It is Medsafe's
responsibility to investigate and action safety issues arising from these
reports and other sources of information.
Sponsors Obligations under the
Medicines Act 1981
Medicine importers and manufacturers (sponsors) have a
statutory obligation (under section 41 of the Medicines Act 1981) to report
untoward effects of medicines to the Director-General of Health. In practice
this means that single case reports of suspected adverse reactions to approved
medicines should be reported to CARM and information on new potential safety
signals should be reported to Medsafe.
Suspected Adverse Reaction Reports
In general the ICH E2D guideline should be followed.
Cases meeting the following criteria should be sent to CARM:
- All serious cases occurring in New Zealand.
- All cases must be valid as specified in ICH E2D
- All serious literature reports of New Zealand cases where an identifiable patient is the subject of the report; the reference should be included with the report.
- Unblinded clinical trial reports for approved medicines included in studies conducted in New Zealand.
Do NOT report
- Cases occurring outside New Zealand
- Non-serious cases
- Clinical trial cases for unapproved medicines; the reporting requirements for these cases are specified in Part 11 of the Guideline of Therapeutic Products in New Zealand. (http://www.medsafe.govt.nz/regulatory/guidelines.asp)
- Blinded clinical trial cases for approved medicines; these may be reported once the medicine has been identified.
Follow-up Information
Where significant
additional information for a case has been received this should be forwarded
to CARM. Please quote the CARM reference number and the date of the original
report when sending further information.
Reports may be made on CIOMS or CARM forms and should be sent to
POST:
Freepost 112002
The Medical Assessor
CARM
PO
Box 913
Dunedin
FAX +64 (0)3 4797150
EMAIL carmnz@otago.ac.nz
New Potential Safety Issues
Sponsors should promptly inform Medsafe of
any significant safety concerns with their medicines. For example:
- Investigations of safety issues by another medicines regulator.
- When their review and analysis has concluded that a safety issue exists.
- Issues for which the sponsor is considering sending a Dear Health Care Professional Letter.
- Significant safety results from post marketing studies.
Dear Healthcare Professional Letters should be submitted to Medsafe for review and a final copy provided prior to distribution.
Periodic Safety Update Reports
and Risk Management Plans
Medsafe does not require routine submission of PSURs
or RMPs, but may request them for specific medicines.
Statutory Benefit
Risk Reviews
Section 36 of the Medicines Act 1981 allows for a review of
the benefits and risks of a medicine. If such a review is conducted the
sponsor will be informed in writing; the sponsor is allowed 60 days to
respond. As a result of this review action may be taken to prohibit the supply
of the medicine or impose conditions on the supply of the medicine. Sponsors
requiring more information in the event of such a review should contact
Medsafe (see below).
Correspondence
Correspondence should be addressed
to the Manager of Clinical Risk Management and sent to:
EMAIL Medsafeadrquery@moh.govt.nz
FAX +64 (0)4 8196806
POST
Medsafe
PO Box 5013
Wellington