The EudraVigilance Expert Working Group (EV-EWG) has coordinated the development of an Important Medical Event Terms (IME) list. This IME list aims to facilitate the classification of suspected adverse reactions as well as aggregated data analysis and case assessment in the frame of the day-to-day pharmacovigilance activities of stakeholders in the European Union.
Below are the updates from the recent version:
- Terms that represent modes of infection transmission (e.g., PT Indirect infection transmission) are excluded, as these are not events but a disease mechanism. However, PT Transmission of an infectious agent via product and PT Suspected transmission of an infectious agent via product are exceptions to this criterion and are included because these are important concepts requiring expedited reporting.
- Unqualified (e.g., PT Cystitis, PT Rhinitis) and nonspecific inflammations (e.g., PT Connective tissue inflammation of non-vital organs and tissues, are excluded.
- Cysts and polyps (unless qualified as malignant), benign and unspecified neoplasms and neoplasms in remission (e.g., PT Acute leukaemia in remission), are excluded.
- Nonspecific “complication” terms (e.g., PT Vascular access complication) are excluded, unless they imply that a vital organ or structure is threatened.
- Terms referring to trauma or clearly implying a traumatic aetiology are generally excluded. However, trauma terms related to pregnancy, e.g., PT Birth trauma are included as well as trauma terms referring to bleeding because of the relevance in patients taking anticoagulants, e.g., PT Traumatic intracranial haemorrhage.
- Congenital anomaly or birth defect – EMA recommended that reconsideration of this criterion be made relative to inclusion of terms on the IME list. Not all congenital anomalies have clinical consequence and can be considered even normal variants. Furthermore, not all genetic conditions have a drug related aetiology.
- Trivial conditions and normal variants are excluded (e.g., PT Birth mark, PTAccessory spleen, PT Persistent left superior vena cava). Gene carrier states (e.g., PT Cystic fibrosis carrier) in which the affected patient is disease free are also excluded.
- Isolated genetic mutations (e.g., PT BRCA1 gene mutation) and other genetic conditions that can have spontaneous or de-novo occurrences (non-familial inheritance) and which do not have significant clinical manifestations are excluded.
- Congenital conditions for which the aetiology is not known, and which have significant clinical manifestations are included.
- Genetic conditions that do not have a drug-related aetiology are excluded:
- Heritable genetic disorders, e.g., haemophilia, thalassaemia, Huntington’s disease
- Chromosomal abnormalities, e.g., Trisomy 21, Turner’s syndrome
- Mitochondrial diseases, e.g., MELAS syndrome, Kearns-Sayre syndrome.
- 7. Isolated findings of an increased or decreased measured parameter (e.g., PT Blood magnesium increased) and unqualified test terms (e.g., PT Angioscopy) are excluded
- 8. Surgical and medical procedures terms that imply that an IME has occurred are excluded
- 9. “Elective abortion” terms are excluded
- 10. Nonspecific “disorders” and “anomalies”, and other categorisations referring broadly to an organ system (e.g. PT Skin disorder) are excluded
- 11. Exposures and poisonings to external agents, e.g., PT Gas poisoning, are excluded
- 12. “Lesion” terms are excluded, unless the finding automatically implies an IME, such as for PT Precancerous mucosal lesion and certain nervous system lesions
- 13. “Mass” terms are excluded because they are nonspecific
- 14. Signs and symptoms (such as pain and discomfort) are excluded as they generally do not fulfil the definition of an IME
- 15. Medication error, accidental exposures, and product quality concepts are generally excluded. Administration site and other “site” concepts are generally excluded except for the following: site ischaemia, site joint infection, site necrosis, site thrombosis and other site conditions that have the potential to spread systematically and result in immediate clinical consequences with the loss or compromise of arteriovenous fistula/arteriovenous graft function (e.g. PT Arteriovenous fistula site infection, PT Arteriovenous graft site abscess and PT Arteriovenous graft site infection).
