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.
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.