Published: 7 March 2019
Revised: 29 August 2023
Publications
Adverse reaction reporting in New Zealand – 2018
Prescriber Update 40(1): 10–11
March 2019
Thank you to everyone who submitted reports of suspected adverse reactions during 2018. You are making an important contribution to the safety monitoring of medicines in New Zealand.
What is being reported?
In 2018, the Centre for Adverse Reactions Monitoring (CARM) received a total of 4,373 reports of suspected adverse reactions. These included 2,843 reports associated with medicines, 1,473 reports associated with vaccines and 57 reports associated with complementary or alternative medicines (CAMs). This year there was a significant increase in reports for CAMs, partly accounted for by reports of adverse reactions to Arthrem1. A significant increase in the number of reports from consumers was also observed this year, this may in part be due to the publication of a consumer reporting portal on the CARM website in November 2017.
Of all reports received in 2018, 20.1% were considered serious. Serious reports accounted for 28.6% of medicine reports, 3.5% of vaccine reports and 24.6% of CAM reports. According to internationally agreed criteria, a serious adverse reaction is defined as any reaction that results in death or is life-threatening, causes or prolongs hospitalisation, results in persistent or significant disability/incapacity, is a congenital abnormality or is a medically important event.
You can search for suspected adverse reactions reported in New Zealand on the Medsafe website using the Suspected Medicine Adverse Reaction Search (SMARS) (www.medsafe.govt.nz/projects/B1/ADRSearch.asp).
Who is reporting?
Anyone can submit a report. Figure 1 shows the number of reports received from healthcare professionals and consumers during the last five years. Nurses continue to submit the most reports, and the number of reports from consumers is increasing.
Please continue to report any suspected adverse reactions to medicines, vaccines or CAMs to CARM.
How do I report?
Reporting is easiest online: https://nzphvc.otago.ac.nz/reporting/
Other ways of reporting include:
| Online |
Submit a CARM report Prescribers can also submit a report using the online reporting tool available in patient management software. |
| Paper |
Download a consumer reporting form (Word Document, 61KB,
1 page) Download a healthcare professional reporting form (PDF, 292 KB, 2 pages) Submit completed forms by emailing CARMreport@health.govt.nz or mail (Medsafe, Ministry of Health, 133 Molesworth Street, Thorndon, Wellington, 6011). |
| CARMreport@health.govt.nz |
Where can I learn more about reporting?
Complete the eLearning module and earn continuing professional development (CPD) points (www.medsafe.govt.nz/profs/ADR-training/story_html5.html).
Figure 1: Number of reports received from healthcare professionals and consumers, by year, 2014–2018
Reference
- Medsafe. 2018. Artemisia annua (Sweet wormwood, Sweet Annie, Qing hao) extract marketed as Arthrem: risk of harm to the liver – statement under section 98 of the Medicines Act 1981 27 November 2018. URL: www.medsafe.govt.nz/safety/EWS/2018/ArthremNov2018.asp (accessed 5 February 2019).
