Published: 7 June 2019

Publications

The fantastic four of adverse drug reaction reporting

Prescriber Update 40(2): 34-35
June 2019

Key Messages

  • There are only four requirements for a valid adverse drug reaction report: patient identifier, medicine, reaction, reporter details.
  • You don’t need to be certain – just suspicious!

Background

All medicines can cause adverse drug reactions. These reactions can range from minor discomfort to serious harm. A recent study of medication-related harm in New Zealand hospital settings estimated that 28% of patients experienced one or more medicine-related harms1. This study suggests medicine-related harms, including adverse drug reactions, are common.

Reporting suspected adverse drug reactions enables Medsafe to quickly identify and respond to emerging medicine safety issues.

Reporting adverse drug reactions

You don’t have to be certain that a medicine caused a reaction. A suspicion of an adverse drug reaction is all that is required to prompt a report.

There are only four requirements for a valid adverse drug reaction report:

  1. one patient identifier (eg, name, initials, gender, date of birth, age)
  2. suspect medicine(s)
  3. suspected reaction(s)
  4. reporter details.

The patient can remain anonymous – only the age and/or sex are needed. Inclusion of the patient’s name, date of birth, and NHI in the report is optional.

Anyone can report an adverse drug reaction, including all healthcare professionals and patients/consumers (Figure 1).

The four requirements listed above are the minimum requirements. However, including more information in your report will help Medsafe to investigate the reaction more quickly.

Reporting is easiest online.

Figure 1: Screenshot of the Centre for Adverse Reactions Monitoring (CARM) online reporting page

Screenshot of the Centre for Adverse Reactions Monitoring online reporting page

Want to know more?

Complete the eLearning module and earn continuing professional development (CPD) points.

Each year, the March edition of Prescriber Update includes a summary of adverse drug reactions reporting in New Zealand. Read about adverse reaction reporting in 2018.

Search for suspected adverse drug reactions reported in New Zealand using the Suspected Medicine Adverse Reaction Search (SMARS).

References
  1. Robb G, Loe E, Maharaj A, et al. 2017. Medication-related patient harm in New Zealand hospitals. New Zealand Medical Journal 130: 21–32. URL: https://www.nzma.org.nz/journal/read-the-journal/all-issues/2010-2019/2017/vol-130-no-1460-11-august-2017/7328 (accessed 15 April 2019).
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