A case report of a suspected adverse event or overdose may contain some of the following information:
• Where it is permitted by the country health information privacy code, and with appropriate confidentiality, there should be some form of identification of the consumer/patient in order to avoid duplications and facilitate follow-up.
• Age, sex, and brief medical history (when relevant). In some countries ethnicity may need to be specified.
• Details of suspected TM/CAM therapy if known. For herbal medicines: species name and/or brand or ingredient name(s) including Latin binomial and common name, part of plant used, preparation methods; manufacturer, country of origin, batch number, expiry date and provider.
• Administration details: dose and quantity supplied, dosage form, route, start/stop dates.
• Indication or reason for use.
• Adverse events: date of onset (or duration from first administration to onset of event), description with symptoms and signs, severity and seriousness, results of clinical investigations and tests, course and outcome; and, if appropriate, consider dechallenge/rechallenge with the same product.
• All other medicines used (including self-medication) with administration details.
• Risk factors (e.g. age, impaired renal function, previous exposure to the therapy, previous allergies, drug misuse or abuse, recreational use of drugs).
• Name and address of reporter (to be considered confidential and to be used only for data verification, completion and case follow-up).