In this blog post, we explore:
- The definition of a valid ICSR
- The minimum criteria required to consider a case as a valid ICSR
- What those are invalid ICSR’s
Table of Contents:
- Introduction
- What is Valid ICSR?
- Minimum required data to validate ICSR
- The AE reports does not qualify for valid ICSR
- Conclusion
- References
Introduction
In the context of pharmacovigilance and drug safety, ICSR stands for Individual Case Safety Report.
Now we are look deep in to the significance and criteria to consider ICSR as valid to proceed. ICSR is a fundamental component of all the drug safety monitoring and reporting systems.
What is valid ICSR?
A valid ICSR is mean by a completed report to fullfill the minimum value required. To confirm an adverse drug reaction (ADR) once that occurred after the administration of a medication.
There are some specific criteria have established to evaluate and determine the validity of an ICSR. These predefined guidelines help to differ the reports from valid and those that do not.
📢 Many of us may not be aware of the process within ICSR, including handling invalid cases. However, you may wonder what these cases entail and why they are processed. Check out our blog where we discuss the processing of invalid composite cases.
Minimum required data to validate ICSR
“In accordance to ICH E2D guideline, validation of all the adverse event reports is necessary before submitting them to the authorities.“
Four minimum criteria are required for ICSR validation:
- One or more identifiable reporter.
- One single identifiable patient.
- One or more suspected substance/medicinal product.
- One or more suspected adverse reaction(s)/ event(s).
“In the realm of healthcare and pharmacovigilance, ICSR – Individual Case Safety Reports – become the guardian angels, quietly safeguarding patient well-being, guiding us towards safer horizons with every reported concern.”
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1. One or more identifiable reporter
“According to ICH E2D, the term ‘identifiable’ indicates the coder/ processor notified that the case has sufficient evidence of the person exist.“
Multiple identifiable reporters are characterised by some parameters such as qualifications (e.g. physician, pharmacist, other healthcare professional, lawyer, consumer or other non-healthcare professional) and name, initials, or address (e.g. reporter’s organisation, department, street, city, state or province, postcode, country, email, phone number).
“In accordance with ICH E2B, an ICSR is not valid for submission unless information concerning the qualification and the country is available for at least one reporter.“
2. One single identifiable patient
It is characterised by at least one of the following qualifying descriptors are:
- Patient initials
- Medical record number (from general practitioner, specialist, hospital, or investigation)
- Date of birth
- Age group
- Gestation period
- Gender
“In line with ICH E2D, the term ‘identifiable’ refers to to the possibility of verification of the existence of a patient based on the available information.“
3. One or more suspected substance/medicinal product
In numerous instances, it is important to consider the substances or multiple medicinal products that interact with each other as potential suspects. A careful evaluation of reports is conducted to examine the suspected drug(s) in question thoroughly.
4. One or more suspected adverse reaction(s)/ event(s)
The AE reports qualify for Valid ICSR:
- Specially notified events:
- Pregnancy
- Overdose
- Drug abuse
- Accidental administration
- Exacerbation of current condition
- Missing dose of drugs
- An intermittent events
- Medication use error(s)
- Non-prescribed drug intake
- Any undetermined events such as fall, getting wound, Mosquito bite
- Any identified suspected external medical devices associated events such as medical devices associated with events.
- The event led to associated outcome(s):
- Death
- Permanent impairment of body function or organs
- Life threatening situation
- Hospitalization
- Serious illness
Few examples of AE reports does not qualify for valid ICSR:
Below are some example scenarios, each either singular or combined with any of the following, also missing of the four minimum valid criteria of ICSR:
- When it reported that unspecified adverse event.
- When only outcome reported, since no further information about the clinical circumstances is provided to consider it as a suspected adverse reaction.
- The primary source has not indicated a possible causal relationship with the suspected medicinal product.
- If the primary source does not provide explicit statement about Causal relationship b/w drugs and event(s), when the MAH is even agreed.
- If the reported event occurred or ongoing without any changes since before the drug administered.
- Planned surgery.
- Reported event occurred prior to the administration of suspected drug. (Pregnancy is only condition excluded in this case even it occurred prior, should monitor until the baby born and it is normal).
- Any rehabilitation therapy.
- Event same as indication unless or until any progression.
- Hospitalization occur due to no symptoms or existing events or by ongoing pre-existing condition.
- Treatment non-compliance.
- Product inquiries.
- A report referring to indefinite or group of patients/ subjects, until the above four minimum criteria met.
- Medical inquiries with no patient/subject involved.
- Non-human subject (Animal/ veterinary pharmacovigilance/ Device Pharmacovigilance).
- Unidentified reporter.
Conclusion
We’ve aimed to explain the valid criteria of ICSR cases in a simple manner for your understanding. While you may already be familiar with most of these points, if any new insights it provided you as takeaways would be great.
If there’s anything we’ve overlooked or omitted, feel free to mention it in a comment.
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