Who is responsible for pharmacovigilance in Aotearoa New Zealand?
Reporting and assessment of suspected adverse reactions before October 2023
Reporting and assessment of suspected adverse reactions since 1 October 2023
Who can report a suspected adverse reaction?
How to report a suspected adverse reaction
Information to include in a report of a suspected adverse reaction
What happens after reports of suspected adverse reactions are assessed?
What is pharmacovigilance?
As well as their desired benefits, medicines and vaccines can sometimes produce adverse effects (adverse reactions). Although the efficacy and safety of these products are tested in clinical trials before they are approved for use, the trials generally involve relatively small numbers of selected individuals who are followed up for limited periods of time. This means that some adverse effects are only identified once the medicine or vaccine has been used by large numbers of people (including people who have other health conditions, are taking several other medicines, or are pregnant) and they have been followed up for substantial periods of time. It is therefore essential to have an organised system that promptly detects adverse reactions to medicines, vaccines, and other therapeutic products, and when required, takes action to ensure patient safety. These activities are known as pharmacovigilance.
Who is responsible for pharmacovigilance in Aotearoa New Zealand?
Overall responsibility for pharmacovigilance in Aotearoa New Zealand lies with Medsafe, which contracts the Centre for Adverse Reactions Monitoring (CARM) to undertake various national pharmacovigilance activities.
Medsafe
Medsafe is the New Zealand Medicines and Medical Devices Safety Authority. It is a business unit of the Ministry of Health and is the statutory authority responsible for the regulation of therapeutic products in Aotearoa New Zealand.
The Centre for Adverse Reactions Monitoring
CARM was established at the University of Otago in 1965 following the thalidomide disaster and a call from the 16th World Health Assembly in 1963 for “a systematic collection of information on serious adverse drug reactions during the development and particularly after medicines have been made available for public use.” CARM subsequently became one of ten founding members of the World Health Organization (WHO) Programme for International Drug Monitoring when it was established in 1968.
The New Zealand Pharmacovigilance Centre
CARM is located within the New Zealand Pharmacovigilance Centre (NZPhvC), at the University of Otago. In addition to contracted CARM activities, the NZPhvC undertakes other work that contributes to the safer use of therapeutic products.
Reporting and assessment of suspected adverse reactions before October 2023
In October 2023, in the context of a need to develop a more modern adverse reactions database, changes were made to the process of submitting reports of suspected adverse reactions to medicines, vaccines, and other therapeutic products.
Before October 2023, prescribers and other healthcare professionals, as well as patients or their whānau or carers, reported suspected adverse reactions to therapeutic products directly to CARM in Dunedin. Medically-trained assessors (Medical Assessors) at CARM reviewed the information provided in the report, as well as information from various other sources when necessary for the assessment of the suspected adverse reaction. Sources included medicine datasheets and other prescribing information, published scientific and medical literature, and information about similar cases reported nationally to CARM or internationally to the global database of the WHO Programme for International Drug Monitoring (Vigibase). Medical Assessors also requested additional information from reporters if required. A pharmacovigilance assessment procedure employed across the WHO Drug Monitoring Programme was then used to assign standardised event terms to the reaction. This standardised approach ensured consistency over time and enabled Medsafe to identify events or patterns of events which required regulatory action. In addition, it facilitated the inclusion of anonymised data in Vigibase.
In the early years of CARM, a paper-based system was used for reporting and documenting assessments of suspected adverse reactions. Subsequently, advances in information technology facilitated the adoption of electronic reporting and the development of a digital database held securely within CARM. Under both systems (paper and electronic), feedback letters were sent to all prescribers and healthcare professionals who had provided contact details in their reports. In more recent years, for severe and life-threatening reactions, Medical Assessors also entered electronic alerts for individuals against their unique National Health Index number (NHI) in the national Medical Warning System. This meant that when the person was next seen in a public hospital, the healthcare professionals treating that person were aware of the reaction when making treatment decisions.
Reporting and assessment of suspected adverse reactions since 1 October 2023
Reports of suspected adverse reactions to therapeutic products should now be submitted directly to a new national pharmacovigilance database commissioned and maintained by Medsafe, or emailed to Medsafe (see How to Report below). Medsafe undertakes an initial assessment and triage of the reports, and all reporters are sent a formal acknowledgement to confirm that their report has been received.
Reports that meet certain criteria are forwarded, within the secure environment of the new pharmacovigilance database, to CARM for assessment; these include reports of fatal events and non-fatal events classified as serious (events that were life-threatening; caused or prolonged a hospital admission; were disabling, incapacitating, or another medically important condition; or were a congenital anomaly). Any other reports containing information suggesting that it would be appropriate to enter an alert in the national Medical Warning System are also forwarded. The processes employed by the Medical Assessors at CARM to review these reports and enter alerts into the national Medical Warning System are the same as those used before October 2023. Similarly, a response is still provided to prescribers and other healthcare professionals following assessment of their reports. Collectively, the current CARM Medical Assessor team has expertise in Pharmacology, Hauora Māori, General Practice, Rural Medicine, Vaccinology, Public Health, and Epidemiology.
Reports that do not meet the criteria for referral to CARM, and reports from pharmaceutical companies, are handled by Medsafe.
What to report
Pharmacovigilance in Aotearoa New Zealand is a surveillance system that relies on prescribers and other healthcare professionals, as well as patients and their whānau or carers to spontaneously (voluntarily) report adverse events that they suspect might be caused by a therapeutic product (both prescription and non-prescription products), including:
- Medicines
- Medicine-associated therapeutic devices (such as inhalers, insulin pens, and contraceptive implants)
- Medicinal cannabis products
- Vaccines
- Complementary and alternative medicines, including herbal medicines
- Dietary supplements
Newly introduced therapeutic products
For newly introduced therapeutic products, or those being used for new indications or being delivered by a different route, reporting of all suspected reactions (including minor reactions) is strongly encouraged as this contributes to the rapid recognition of possible new concerns or hazards (sometimes referred to as signal detection).
Established therapeutic products
Reporting of all fatal and non-fatal serious (see definition above) suspected reactions, and other reactions of clinical concern, to established therapeutic products is also strongly encouraged; reactions should be reported even if a relationship between the product and reaction is well-known. Examples of important reactions include, but are not limited to, anaphylaxis, blood disorders, endocrine disturbances, haemorrhage from any site, renal impairment, jaundice, ophthalmic disorders, severe central nervous system effects, rhabdomyolysis, severe skin reactions, drug interactions, effects on fertility, reactions in pregnant women, and congenital anomalies.
For life-threatening and other severe reactions, reporting is particularly important for patient safety as it enables CARM to enter an electronic alert for individuals against their unique National Health Index number (NHI) in the National Medical Warning System, as discussed above. Medical Warnings (cautions) 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 (contraindications) are entered for medicines that are likely to cause life-threatening or fatal reactions if re-administered.
Who can report a suspected adverse reaction?
Although healthcare professionals have traditionally submitted the majority of reports, patients or their whānau or carers are strongly encouraged to report any suspected adverse reactions.
How to report a suspected adverse reaction
There are several options for submitting a report:
- Online (preferred)
- Complete the web form
- Prescribers and other healthcare professionals in primary care can also submit a report using the online reporting tool (e.g. ERMS, bpacnz) available in their patient management software.
- Other
- Download a reporting form
- Download a healthcare professional reporting form (PDF, 292 KB, 2 pages)
- Download a consumer reporting form (Word Document, 61KB, 1 page)
- Send the completed form to Medsafe by either:
- Email to CARMreport@health.govt.nz, or
- Post to Medsafe, Ministry of Health, 133 Molesworth Street, Thorndon, Wellington, 6011
- Download a reporting form
Information to include in a report of a suspected adverse reaction
Please complete each section of the web form or downloadable reporting form in as much detail as possible. Copies of hospital discharge letters or other letters from specialists are also very helpful. Detailed information contributes to better decisions about whether a therapeutic product is likely to have contributed to an individual’s adverse event.
What happens after individual reports of suspected adverse reactions are assessed?
Weekly teleconferences
CARM and Medsafe have weekly teleconferences to discuss recent adverse reaction reports that might require further action.
The Medicines Adverse Reactions Committee
CARM also discusses anonymised summary information about suspected adverse reaction reports reviewed by its Medical Assessors at the quarterly meeting of the Medicines Adverse Reactions Committee (MARC, a technical advisory committee established to provide expert advice to the Minister and Ministry of Health about the safety of approved medicines and vaccines) and highlights individual, or clusters of, adverse reactions of concern. These findings are considered by Medsafe and MARC, and they may result in various actions to reinforce or change relevant prescribing advice and/or other regulatory actions aimed at ensuring the safety of medicines and vaccines, as well as other therapeutic products used in Aotearoa New Zealand.
Prescriber Update
CARM reports provide the basis for the Gathering Knowledge section of the Medsafe publication Prescriber Update. Other articles are often prompted by CARM reports which indicate a need for more information on a particular safety topic.
Publications and other dissemination
To raise awareness and contribute to safer use of medicines in Aotearoa New Zealand, CARM may publish anonymised information, arising from reported reactions, in medical journals and other publications. CARM Medical Assessors also undertake continuing professional education activities with healthcare professional groups.
The World Health Organization Programme for International Drug Monitoring
Aotearoa New Zealand contributes to international efforts to detect potential safety issues with therapeutic products by submitting anonymised summary information about suspected adverse reactions to Vigibase.
Data privacy and security
CARM is bound by the Privacy Act 2020 and the Health Information Privacy Code 2020 in its ongoing work with reports of suspected adverse reactions and related health information, and in the secure storage of reports received before October 2023 (it is essential that this information continues to be held for ongoing pharmacovigilance purposes). The identity of reporters and patients is kept strictly confidential, and all CARM (and Medsafe) staff who view original reports have signed confidentiality agreements.
Contact us
Postal Address:
CARM
New Zealand Pharmacovigilance Centre
Division of Health Sciences
PO Box 913
Dunedin 9054
NEW ZEALAND
Email for general enquiries: nzphvc@otago.ac.nz
For report submissions, please see the How to Report section above.
Phone: +64 3 479 7185
© 2024, University of Otago