Adverse Reaction Reporting Guide for New Zealand

New Zealand maintains one of the highest global reporting rates for adverse reactions to medicines. The Centre for Adverse Reactions Monitoring (CARM) in Dunedin serves as the national repository for these reports, supporting international pharmacovigilance activities. The data collected plays a vital role in ensuring the continued safety and effective use of medicines within the country.

Contribution of Individual Reporting to Global Pharmacovigilance

Despite New Zealand’s world‑leading reporting rate—measured both per 1,000 doctors and per million people—it is estimated that only about 5% of adverse reactions are reported. CARM, contracted by Medsafe, collects voluntary reports on adverse reactions involving medicines, vaccines, herbal products, dietary supplements, and blood products. The database contains more than 48,000 reports, providing valuable insight into local patterns of medicine‑related adverse effects.

Identification of Potential Safety Issues and their Patterns in NZ

Medical assessors are assigned with the duty to evaluate each report submitted to CARM. It helps them in deciphering the linkage between the reaction and the medicine. The database is also used to support enquiries from health professionals regarding the possibility of adverse reactions as the cause of a diagnostic dilemma.

Enhancing Patient Safety

When a serious adverse reaction is identified, CARM records a “danger” (where re‑administration may be life‑threatening) or “warning” (where re‑administration may cause a clinically significant reaction) flag in the National Health Index (NHI) database. Hospitals routinely access this database when patients seek care. 

• The Medicines Adverse Reactions Committee (MARC) also reviews published data during quarterly meetings. Based on its assessments, MARC may recommend updates to pharmaceutical data sheets to strengthen safe medicine use.
• Reporting Guidelines :- Anyone may submit an adverse reaction report to CARM. While reports from healthcare professionals are preferred, 65% of CARM’s reports come from community doctors (mainly general practitioners), while hospital doctors contribute 17%. Pharmacists submit approximately 2.3% of reports. Consumer reports are accepted but must involve the patient’s practitioner, who may not otherwise be aware of the issue.
• Yellow Reporting Form :- In June 2001, CARM reinstated the pale yellow version of its adverse reaction reporting form. A survey of trainee interns at Dunedin Hospital identified difficulty accessing the form as a barrier to reporting. Returning to the yellow colour was intended to make it easier for healthcare providers to locate the form. The updated form was included in the June 2001 issue of *Prescriber Update*.
• How to Report in Three Steps
  • Patient Information :- Patient details—including name, address, date of birth, sex, and ethnicity—are required when a danger or warning must be placed on the NHI database. CARM safeguards this information and uses it to identify duplicate reports.
  • Medicine or Suspected Product :- Provide the name of the suspected medicine (including brand name, if known), dosage, and the dates the medicine was started and stopped. This information helps assess causality.
  • Adverse Reaction Description :- Include the date the reaction began, along with detailed descriptions of symptoms, signs, laboratory results, and relevant medical history. It is also important to describe follow‑up events—such as recovery after stopping the medicine (dechallenge), recurrence after re‑exposure (rechallenge), and severity of the outcome.
• Reporting IMMP Events :- Adverse events involving medicines listed in the Intensive Medicines Monitoring Program me (IMMP) may also be reported using the CARM form. The list of IMMP medicines is available in *Prescriber Update*, the CARM and Medsafe websites, and the New Ethicals Catalogue.

MARC maintains a list of medicines associated with adverse reactions of current concern. Hen can be found in each issue of Prescriber Update and on the Medsafe web site