Information for Industry

Adverse reaction reporting for medicines – Guidance for industry

Sponsors have a responsibility to submit valid case reports of all serious adverse reactions to any of their medicines (including vaccines) occurring in a patient in New Zealand (ie, the medicine was dispensed, purchased or obtained in New Zealand).

Background
What to report
How to report
When to report
Specific situations
Clinical trials
Further information

Background

Information on this page is provided to help sponsors understand the reporting requirements for individual case safety reports (ICSRs) contained in the Pharmacovigilance Guideline.

What to report

Report valid ICSRs of all serious adverse reactions to the New Zealand Pharmacovigilance Database. This includes ICSRs where the company does not agree with the reporter's causality assessment.

Valid ICSRs must contain the following four mandatory items:

An identifiable reporter
An identifiable patient
A suspect medicine
A suspect reaction.

How to report

Choose one of the methods shown in Table 1 to report valid serious ICSRs.

**Table 1: How to report valid serious ICSRs to the New Zealand Pharmacovigilance Database**
Method of reporting	Directions
Online via the New Zealand Adverse Reaction Reporting Form with CIOMS attachment (Preferred)	New Zealand Adverse Reaction Reporting form: https://pophealth.my.site.com/carmreportnz/s/ Complete the following sections of the webform only: Reporter details A patient detail At least one medicine At least one reaction Attach CIOMS reporting form
Email	Email CIOMS form to carmreport@health.govt.nz
Electronic file transfer system (EFT)	Submit CIOMS form via Medsafe's electronic file transfer system (EFT). EFT information can be located on the Medsafe website.

When to report

Submit valid ICSRs of serious adverse reactions within 15 calendar days of receipt (Table 2). The clock for reporting starts (ie, Day 0) when the New Zealand sponsor or contracted vendor receives the information.

**Table 2: Timeframe for reporting valid serious ICSRs to the New Zealand Pharmacovigilance Database**
Adverse reaction report	Report as soon as possible and no later than
Initial reports of serious adverse reactions	15 calendar days
Follow-up reports when additional medically relevant information is received for a previously reported case. Note: Please indicate that it is a follow-up report and quote the original report number so they can be linked.	15 calendar days

Specific situations

Table 3 provides guidance on reporting valid ICSRs in certain situations.

**Table 3: Guidance on reporting valid ICSRs in certain situations to the New Zealand Pharmacovigilance Database**
Specific situation	Valid ICSRs requiring reporting
Lack of therapeutic effect^a	Medicine used for an approved indication resulting in a lack of therapeutic effect which was serious for the individual. Examples include vaccines, contraceptives, and antibiotics (with sensitivity in in vitro testing). Use clinical judgement when considering reporting other cases of lack of therapeutic effect.
Misuse or abuse	The misuse or abuse caused a serious adverse reaction.
Off-label use of an approved medicine	The off-label use resulted in a serious adverse reaction.
Unapproved medicines (Section 29)	There was an unexpected^b serious adverse reaction.
Unapproved medicinal cannabis products	There was a serious adverse reaction.
Medication error	The medication error caused a serious adverse reaction.
Overdose or occupational exposure	The overdose or occupational exposure caused a serious adverse reaction.
Quality defects	Serious adverse reactions after a quality defect has been investigated and is not confirmed. See guideline for more information on reporting quality defects.
Period after suspension, revocation of consent to distribute, or company-initiated removal from the market	Report unexpected^b serious adverse reactions up to the expiry date of the last distributed batch in New Zealand.
Post authorisation safety studies	There was a serious adverse reaction considered related by the principal investigator or sponsor.

Notes:

For vaccines, cases of a lack of prophylactic efficacy may highlight signals of reduced immunogenicity in a subgroup of vaccines, waning immunity, or strain replacement.
For antibiotics, a lack of therapeutic effect may indicate newly developing resistance, making further study necessary. Antibiotics used in life-threatening situations where the medicine was not appropriate for the infective agent do not require reporting to Medsafe.
A lack of therapeutic effect may also be related to, but not necessarily considered to be, a quality issue.
An unexpected adverse reaction is an adverse reaction that is not currently listed in the Company Core Data Sheet.