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COVID-19 Vaccine Adverse Reactions
Mpox Vaccine Adverse Reactions
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 at https://pophealth.my.site.com/carmreportnz/s/ • The electronic adverse reaction reporting tool available in Practice Management Software programmes in primary care
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 electronic form at https://pophealth.my.site.com/carmreportnz/s/.
All reports are reviewed in the same way and included into the CARM database
What to Report
Any serious 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. CARM, the New Zealand Pharmacovigilance Centre (NZPhvC) and Medsafe wishes to emphasise that ADR reporting in New Zealand continues to be a no-faults process.
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 concerns or 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.
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 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.
CARM, the New Zealand Pharmacovigilance Centre (NZPhvC) and Medsafe have a no faults policy and are fully compliant with the provisions of the Privacy Act Guidelines. 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 work.
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 indicate the suspected medicine if known. Also, wherever possible 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.
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.
Further information on this programme is available at https://www.medsafe.govt.nz/profs/m2medicinesmonitoring.asp
Confidentiality Information for Reporters
CARM as part of the NZ Pharmacovigilance Centre (NZPhvC) is an independent organisation operating within the University of Otago, providing national pharmacovigilance services on Contract to Medsafe in the Ministry of Health.
Since inception of the Adverse Reactions Monitoring centre in 1965, reports submitted have been received in confidence and managed according to the guidelines of the Privacy Act. Medsafe, who since 01 October 2023 operate the pharmacovigilance infrastructure and database operate under the same Privacy Act Information produced from the database is usually in a collated summary format and anonymised and where small case numbers or individual reports, may be involved, no information which can identify a patient or a reporter is disclosed. Reports in their original format are not accessible outside of the pharmacovigilance system.