Reporting

Medsafe Statement on Enlafax

COVID-19 Adverse Events – Report Online
Report Online (Health Professional)
Report Online (Consumer/Patient)
Request Reporting Cards
Download Reporting Card (PDF)

How to Report

Although healthcare professionals have traditionally submitted the majority of reports, anyone may report a reaction and all are urged to report suspected ADRs directly to the Centre for Adverse Reactions Monitoring (CARM) within the New Zealand Pharmacovigilance Centre (NZPhvC) using the following options:
• Online reporting or using electronic forms at https://nzphvc.otago.ac.nz/report/
• The electronic adverse reaction reporting tool available in Practice Management Software programmes
• Freepost Yellow Cards available from the address below, and also found in the MIMS New Ethicals and inside the back cover of the Prescriber Update.
• CARM is available to discuss ADRs by telephone and also accepts reports by email or fax. Outside office hours a telephone-answering machine will take messages
• An iPhone/iPad iOS application is also available for download via the NZPhvC website https://nzphvc.otago.ac.nz/app

Send ADR Cards to:
Freepost No. 112002
The Medical Assessor
Centre for Adverse Reactions Monitoring
University of Otago Medical School
PO Box 913
DUNEDIN

Tel: 03 479 7247
Fax: 03 479 7150
Email: carmnz@otago.ac.nz
Web: www.otago.ac.nz/carm

Who can Report

Anyone may report a suspected adverse event to CARM.
Reports from health professionals are preferred. Doctors and other prescribers, pharmacists and nurses usually are able to provide more detailed information about the medications in use and other medical history from patient records that are helpful in evaluating the adverse reaction.
Self-reporting by patients/consumers
CARM accepts reports from consumers, patients or carers, but where possible an attempt is made to involve the patient’s practitioner who often may be unaware of the reaction. In recent years increasing numbers of consumers and patients have reported adverse events to CARM. Reports can be made to CARM through the ADR Reporting Card using the electronic form at https://nzphvc.otago.ac.nz/report/, by telephone on 03 479 7247, or by downloading the ADR Reporting Card form from https://nzphvc.otago.ac.nz/reporting-forms

All reports are reviewed in the same way and included into the CARM database

What to Report

Any suspected ADRs to any medicine, vaccine or complementary medicine should be reported. This should include those that are self-medicated as well as those prescribed. We also encourage reports to Psychoactive Substances

Established medicines and vaccines
Healthcare professionals and coroners are asked to report all serious suspected reactions and other reactions of clinical concern to established medicines (including over-the-counter, complementary and alternative products, and medicines used off-label) and vaccines. Serious reactions include those that are fatal, life-threatening, disabling, incapacitating, or which result in or prolong hospitalisation; they should be reported even if the effect is well recognised. Examples include anaphylaxis, blood disorders, endocrine disturbances, effects on fertility, haemorrhage from any site, renal impairment, jaundice, ophthalmic disorders, severe CNS effects, rhabdomyolysis, severe skin reactions, reactions in pregnant women, congenital abnormalities and any drug interactions.

Newly introduced medicines and vaccines
Spontaneous reporting is particularly valuable for recognising possible new hazards rapidly. For newly introduced medicines and vaccines, or those being used for new indications or being delivered by a different route CARM asks that all suspected reactions (including minor reactions) are reported.
An adverse reaction should be reported even if it is not certain that the drug has caused it, or if the reaction is well recognised, or if other drugs have been given at the same time.
Even if you only thought it could be an ADR, report it
If in you are in doubt, report!
In summary, please report:
– all adverse reactions of clinical concern
– all adverse reactions to new medicines
– all reactions for which a warning about future use would be appropriate especially serious allergic reactions (see Medical Warning System)
– drug interactions

What to Include

The reporting forms (Online, Yellow Card and Downloadable options) contain the data fields that will provide the most useful information to enable the best possible assessment of an ADR report. Your assistance in completing all or as much of the detail as possible will be of great value in evaluating the report. Even if you are unable to supply all the details, a copy of the patient’s discharge letter from the hospital or specialist is always helpful.

Patient and Reporter identification and Privacy
Throughout CARM’s history, patient identifying details (name, address, date of birth, sex, ethnicity and NHI) and reporter contact details have been provided. The patient details are of critical importance if the report is to result in an entry of a Medical Warning or Danger on the National Medical Warning System which are recorded against the patients NHI number. The contact detail of the reporter enables the Medical Assessor to write a letter of response back to the reporter, or there is a need to clarify details or obtain further information. They also help to identify duplicates if a report has already been received from another source.

Original reports are never released. Patient details held at CARM remain completely confidential. 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.

CARM and the NZPhvC operations are fully compliant with the provisions of the Privacy Act Guidelines.

The medicine(s) including OTC and alternative health products
The name of the medicine (and brand name if available) suspected of causing the reaction and dose is necessary. Ideally list all medicines including OTC and herbal or alternative remedies, and asterisk the suspected medicine if known. Also provide dates of starting and stopping the medicines as this information is particularly helpful when assessing causality.

The event
It is important to provide the date of onset of the adverse reaction as this is crucial for causality assessment. The more details, the better; list symptoms, signs, laboratory results, past medical history. Also describe what happened later: did the person fully recover after withdrawal of the medicine (dechallenge), did they have a similar reaction if the medicine was used again (rechallenge), and was the event severe or fatal? Give any alternative diagnoses that have been excluded. More evidence will provide the CARM medical assessor with more certainty when deciding whether the medicine caused the adverse reaction.

Reporting Forms

You can download or view the reporting forms from here. You can then print them out and fax or mail it back to us

COVID-19 Adverse Events – Report Online

NZ Pharmacovigilance Centre Reporting Form (PDF)

NZ Pharmacovigilance Centre Reporting Form (MS Word)

Blood Product Reporting Form

Reporting form for Adverse Events Following Immunisation [AEFIs]

Request forms be posted to you

CARM Fax +64-3-479-7150

M2 Monitoring

M2 is a monitoring scheme designed to stimulate the reporting of adverse reactions to specific medicines providing more information to help CARM and Medsafe investigate safety signals. Potential safety signals are identified from reports of suspected ADRs sent to CARM. A summary of criteria for placing a potential safety signal is available on the Medsafe website.

Medicines with signals currently being monitored are listed on the Medsafe website, and are published in Prescriber Update and MIMS New Ethicals. It is important to note that a medicine appearing on M2 does not mean that Medsafe and CARM have concluded that this medicine causes the reaction.

After a pre-determined period (usually six months) reports are reviewed and included in Medsafe’s investigation of the safety signal. Findings are published on the Medsafe website and in Prescriber Update. Other action may be taken such as changes to the data sheet(s) or direct communication with healthcare professionals to highlight a medicine related safety concern.
Reports stimulated via M2 should be submitted to CARM using the same methods as for other medicines.

About Reporting

Confidentiality Information for Reporters

Changes to accessing original reports submitted to CARM Nov 2012

Report COVID-19 Vaccine Adverse Events here.. Feature image


Centre for Adverse Reactions Monitoring
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