Analysis↑
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
Database extracts↑
The CARM database is the source for regular report outputs that support NZ Pharmacovigilance. These include:
- MARC – Routine summary extracts of reports to CARM are provided to the MARC. These extracts include summaries of reports in the last quarter of all deaths reported to CARM, serious reports in children, the elderly over 80 years, and Adverse Events Following Immunisation. Also any individual report or clusters of reports that highlights an issue of concern are also included. MARC is a government appointed committee of diverse clinical disciplines with an interest in Medicine Safety providing 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. 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.
- Medsafe – Regular reports are often generated 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 new vaccine. CARM also has a weekly teleconference with Medsafe which facilitates discussion around issues of pharmacovigilance relevance to New Zealand.
- Researchers – The Database at CARM is frequently used as a source of information to support New Zealand researchers in their investigations and projects. CARM provides data extracts that are tailored to the researchers’ requirements.
- WHO Database – CARM as New Zealand’s national monitoring centre, collaborates with and pools anonymised data, together with other national monitoring centres, into the database of the World Health Organisation’s International Drug Monitoring Programme based in Uppsala, Sweden. Through this network, New Zealand is able to keep abreast of the latest concerns around drug safety as they emerge, whilst access to the international database serves to complement the local experience of adverse reactions to medicines. These reports also contribute to international knowledge of pharmacovigilance. They are anonymised and pooled with other countries’ reports in the World Health Organisation’s International Monitoring Centre database in Uppsala, Sweden. Participating monitoring centres can use this database to complement their own reports
Feedback to Reporters↑
Letter of response are provided to each report received by CARM.
CARM data is the source of data in support of articles on pharmacovigilance directed to NZ Health Professionals. 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 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. Adverse reaction reporting is an important component of New Zealand’s pharmacovigilance activities. The Centre for Adverse Reactions Monitoring (CARM) in Dunedin is New Zealand’s national monitoring centre for adverse reactions. It collects, 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 110 000 reports received largely from health professionals, although there has been a small but increasing proportion from patients in recent years. Pharmaceutical companies are also important contributors to the CARM database.
New Zealand has had the highest rate of reporting adverse reactions to medicines per population in the world for at least the last two decades. However, since 2011 Singapore and in 2012 the USA now has a higher rate of reporting, but NZ is still the 3rd highest reporting country globally. This high rate does not reflect a bigger problem in New Zealand; rather that we are more diligent about reporting these events.
Each report received by CARM is evaluated by a medical assessor to determine the extent of an association between the adverse reaction(s) described and the medicine/therapeutic product(s) involved which are entered into the database along with all the relevant details in the report.
After each report has been assessed by one of CARM’s Medical Assessors, letters providing relevant information about the ADR are sent in response to each report. These written responses may include information about causality, similar reactions and prescribing advice to assist with risk:benefit assessment of future treatment for the patient involved.
The database also serves to support enquiries from health professionals regarding clinical decision making when unusual symptoms are thought to be therapy related.
Caveat↑
Reports received by CARM 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.
Data Privacy↑
Any data that is extracted from the Database is always anonymised both for the patient and reporter. Usually report data is provided in summary format, but where an individual report may be appropriate, special attention is devoted to ensuring that the identity of the patient is protected. Original reports are never released. Following Stakeholder consultation, from 01 November 2012 Medsafe has access to copies of original reports submitted to CARM (anonymised where possible) to facilitate the conduct of pharmacovigilance in New Zealand. This level of data access is limited to Medsafe only and is in keeping with international practice as Pharmacovigilance Centres are usually part of the Regulatory Agency.
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
