The CARM database provides New Zealand-specific information on adverse reactions to medicines and vaccines. CARM monitors and analyses the database for the identification of new signals, or important patterns, clusters or unusual events or practices that could have significance for medicine safety and prescribing practices in New Zealand. These findings are considered by Medsafe and/or the Medicines Adverse Reactions Committee (MARC). This may result in further investigation and/or formal review which can lead to emphasising or changing relevant prescribing advice or other regulatory actions aimed at ensuring the safety of medicines registered in NZ
The CARM-Medsafe database support NZ Pharmacovigilance through:
CARM provides expert clinical input to the MARC about serious or fatal adverse drug or vaccine reaction reports. There is a particular focus on events involving children, the elderly, Maori and Pacific peoples.
The MARC is a committee whose membership is appointed by the Ministry of Health and includes healthcare professionals from a diverse range of clinical disciplines and which provides advice to Medsafe. The MARC meets four times a year to review local and international issues of medicines safety of potential relevance to New Zealand. Individual or clusters of submitted reports that highlight an issue of concern are reviewed at this quarterly meeting.
The MARC may recommend that Medsafe alert prescribers to an adverse reaction through an article in Prescriber Update or a ‘Dear Doctor’ letter. The MARC may also recommend that the pharmaceutical company update the data sheet with advice to improve the safe use of a medicine.
CARM collaborates weekly with Medsafe via teleconference, to discuss issues of pharmacovigilance relevant to New Zealand. CARM often generates reports to support the ongoing monitoring in special situations and in the early phases of the use of new products such as the seasonal influenza immunisation programme or the introduction of a new vaccine.
- Research – The database supports ongoing medicine safety monitoring activities and plays an important role in signal generation, topics of interest and clinical research.
- WHO Programme of International Drug Monitoring Database
CARM in collaboration with Medsafe pools anonymised data, together with other national monitoring centres, into the WHO database based in Uppsala, Sweden. Through this network, New Zealand contributes to international pharmacovigilance knowledge and is able to keep abreast of the latest concerns around drug safety as they emerge. Access to the WHO database serves to complement the local experience of adverse reactions to medicines for the various national monitoring centres that submit reports to it.
Prescriber Update is a regular publication from Medsafe which focusses on current pharmacovigilance issues of relevance to New Zealand prescribers. It includes signals and prescribing advice generated from CARM reports. It is available at http://www.medsafe.govt.nz/profs/PUarticles.asp
CARM–Medsafe Adverse Drug Reactions Database↑
Any therapeutic product (medicine, complementary medicine, vaccine) may produce unwanted or unexpected adverse reactions. Rapid detection and recording of Adverse Drug Reactions (ADRs) is of vital importance so that unrecognised hazards are identified promptly and appropriate regulatory action is taken to ensure that medicines are used safely. ADR report reviews are an important component of New Zealand’s pharmacovigilance activities.
CARM evaluates and analyses spontaneous reports of adverse reactions to medicines, vaccines, herbal products and dietary supplements used in New Zealand. Currently the CARM database holds over 150000 reports received from health professionals, patients and pharmaceutical companies. In global ranking, New Zealand has a history of high rates of reporting. This high rate does not reflect a bigger problem in New Zealand; rather that we are more diligent about reporting these events.
Serious and significant events are evaluated by a medical assessor to determine the extent of a pharmacovigilance association between the adverse reaction(s) described and the medicine/therapeutic product(s) involved. These evaluations are based on and are limited by the information provided by the reporter at the time of reporting, although further follow-up information may be requested for clarification. For this reason, the CARM team is not able to provide clinical advice and assessments for individual patients.
The database also serves to support enquiries from health professionals regarding clinical decision making when unusual symptoms are thought to be therapy related.
Reports received by the CARM-Medsafe teams are submitted voluntarily and therefore the use or interpretation of these data holdings is subject to significant limitations such as incomplete or biased reporting of adverse events and the extent to which the clinical details provided in reports are complete. All data that is extracted for external use is provided in the context of a Caveat document explaining the limitations of the CARM dataset.
As of October 2023, there have been changes in the handling and processing of submitted reports. More information on the change is on the Medsafe website.
All patient and reporter details will remain confidential. CARM and Medsafe maintains confidentiality of data received from other parts of the health sector in accordance with the Privacy Act 2020. CARM and Medsafe have received advice from the Privacy Commissioner as part of this change.
Medical Warning System↑
Reporting to CARM can contribute to individual patient safety through the Medical Warning System module in the Health Statistic Collection of the Ministry of Health’s Information Group which enables the recording of an electronic alert. For severe and life threatening reactions CARM records Warning or Danger alerts for medicines for individual patients against their unique National Health Index number which is accessible to health care facilities in New Zealand. This means that when the patient is next seen and the system is accessed (usually at a hospital), the information is displayed. Medical Warnings are usually entered for medicines that have caused serious or potentially serious allergic reactions or other reactions likely to lead to serious illness or distress if re-administered. Medical Dangers are entered for medicines that are likely to cause life-threatening or fatal reactions if re-administered