Adverse event is any untoward change to medical condition affecting a patient receiving a medicine, although it is not known whether a causal relationship to treatment with this medicine exists.
Adverse event can therefore be:
- any adverse or unintended sign (for example, an abnormal laboratory finding)
- symptom
- disease temporarily associated with the use of a medicinal product, whether ornot a causal relationship with the treatment)”
SPECIAL SITUATIONS
Special Situations are non-standard medical conditions that provide valuable information (e.g. clinical, safety) about a medicinal product, even when they don’t occur in association with an adverse event or medical condition; therefore should be recorded/ reported/ monitored for:
- complying with regulatory guidelines (e.g. ICH, FDA, EMA)
- Meeting protocol specific requirements
- the continuous benefit-risk assessment of medicines
Examples for Adverse event reports of Special Situations:
- Pregnancy
- Lack of efficacy
- Overdose
- Misuse and abuse / overuse
- Medication and administration errors
- Occupational exposure
- Suspected transmission of infectious agents via a medicinal product (STIAMP)
- Counterfeits
- Reports from lawsuits
- Deaths
- Off-label use
- Disease progression related to the use of the product
- Drug interactions, drug addiction and withdrawal syndrome
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