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
How to identify non-serious reportable case? Thank you
Hi Anee,
Like mentioned in the article, all types of AESI events (serious and non serious) will be provided in protocol.
Hi Ramya, can we have instructions in the protocol (on reporting) but refer to the IB for the AESI List? This would circumvent an amendment if the List needs to be updated?
Thanks!
Rayma I have a question about special situation events. At multiple companies I have seen different approaches in how to assess causal relationship to suspect drugs. Some have them all as unrelated, others have certain events such as Lack of efficacy as always related from a data entry convention perspective. Can you provide some background and reference to some regulations on how these events are or should be assessed.
Hi Carol
Cioms V has labelling assessment guidelines, may be you can refer to that document for better understanding.
User error is considered as which type of special situation. In which the bottle of medicine is fall in the floor by mother.
Hi..
Because of this issue if the patient is not able to take the medication then we will consider it as valid report with missed dose
Hi Ramya,
In regards to the special situation topic, would you be able to direct to Regulatory or industry guidance documents that can referred to understand how to assess and report special situation events?
Hi Ramya, could you please help me with literature cases? In a case report, there is a patient who takes 20 mg of x drug. But I know, that the maximum recommended dose of this drug is 10 mg. NO ADR is experienced. This means, that overdose is reported in this case (so it has to be registered), or it is just my opinion, but not reported? Thank you.
Hi Melinda, yes the case can be created for overdose.
Hi Ramya is underdose also considered as special situation as there is no mention of it in GVP module vi
What is causality for special situation
? Can we consider it possible as it can occur with any drug
Hi Ramya, Which SSR would you put the following scenario into – Eyedrop solution accidentally gets into nose or mouth?
It will be a medication error scenario. Accidental exposure or occupational exposure depending on the scenario