The pharmacovigilance sector has a great role to play in the healthcare patient protection and safety of medical products and devices. And regulatory reporting is one such vital key of pharmacovigilance that enhances the patient and drug safety. There are many types of regulatory reporting such as Individual Case Safety Report (ICMR), Periodic Safety Update Report (PSUR), Development Safety Update Report (DSUR), etc.
This comprehensive guide provides a deep insight into regulatory reporting of Individual Case Safety Reporting (ICSR)
What Is Individual Case Safety Report (ICSR)?
ICSR is a regulatory reporting document that includes in it all the details of individual suspected adverse events. ICSR should be prepared according to the requirements of ICH E2 (R3) guidelines. ICRS’s include all the information about the patient history, suspected drug details, adverse effect details, all relevant data of the drug, patient characteristics, etc.
ICSR Importance In Pharmacovigilance:
ICSR serves as an essential tool in collecting and reporting adverse effects related to drug, enhancing patient safety.
ICSR are used to identify new identify new safety issues and potential signals in terms of safety profile of drugs.
It helps to identify some important safety parameters which need to be instructed on the drug product label.
It also helps in post-marketing surveillance.
Transparency is maintained in the relationship between the manufacturer and the patient in terms of drug safety.
Detection of new side effects is possible with the help of ICMR.
A better understanding of patient demographics is achieved.
Safety standards are met as per the requirements.
Standards And Guidelines For Reporting ICSR Globally:
There are a certain set of standards and guidelines that the ICSR must follow for its preparation and submission. They are as follows:
The ICSR should be prepared according to the ICH E2 (R2/R3) and ISO HL-7 guidelines.
ICSR should be submitted in electronic format.
It should be submitted to the department concerned where the adverse event occurred.
Clinical trials ICSR should be submitted within 7 days for fatal adverse event and for serious adverse effects it should be submitted within 15 days.
For post market drug product ICSR should be submitted within 15 days for serious adverse effect and for non-serious it should be submitted within 90 days.
ICSR Submission Key Elements:
Steps Of ICSR Process:
ICSR is a six-step process, and their steps are as follows:
Case Intake: After the occurrence of an adverse event the case is registered.
Categorize: The adverse reaction observed is categorized according to its level of seriousness.
Data Entry: Now all the studied data of the adverse event is entered into the system as a document.
Quality Reiew: The quality of the data is checked by checking the accuracy and correctness of the data.
Medical Review: In this step the relationship between the adverse reaction and drug which caused so is studied.
Regulatory Submission: After successful completion of all the above steps, ICSR is submitted to the regulatory authority.
Challenges In Managing ICSRs:
There are a wide range of challenges faced while documenting an ICSR. They are as follows:
It becomes difficult to manage ICSR for every single adverse effect due to large number of population and use of drugs on a large scale.
Limited number of pharmacovigilance staff may affect the ICSR process.
Submission timelines make the whole process to get completed a bit difficult.
Lack of complete detailed information about the adverse reaction that occurred creates a barrier in the completion of ICMR.
Outdated software may hinder the whole process.
Sometimes it gets difficult to categorize the process as serious or non-serious.
It becomes difficult to prepare ICSR in compliance with patient confidentiality.
Sometimes regional and language barriers are also faced.
Lack of follow up by the pharmacovigilance team may lead to inaccurate data availability.
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How ICSRs Align With Regulatory Frameworks:
ICSR aligns with the regulatory framework in the following aspects:
1. Meeting Regulatory Aspects: ICSR is prepared in accordance with all the regulatory requirements as per ICH E2 (R2/R3) and ISO.
2. Following Good Pharmacovigilance Practices: All the steps in ICSR preparation such as collection, recording and storage follow good pharmacovigilance practice in terms of quality and assessment.
3. By Global Collaboration: ICSR collaborates with global collaboration by such as WHO, FDA, etc. to promote safety monitoring.
4. Preparing ICSR for Post market Approval: ICSR for post market approval drug products supports patient safety and adverse effect monitoring.
5. Conducting Frequent Audits and Inspection: Regular auditing and inspection process helps in meeting the regulatory compliance.
6. Continuously Updating According To Regulatory Requirements: A continuous update is required in accordance with the new requirements and compliance with the regulations.
FAQS:
What is the full form of ICSR?
The full form of ICSR is the Individual Case Safety Report which is a critical component of pharmacovigilance in terms of drug product safety.
Why is ICSR compliance crucial?
The ICSR compliance ensures that all the safety data is accurate and reported on time hence it is crucial.
What happens in late ICSR submissions?
When an ICSR is submitted late it results in penalties, delayed evaluations, etc.
Do ICSR management have automated tools?
Yes, ICSR has automated tools such as Veeva vault, MedDRA, PV, etc.
How is ICSR validation done before submission?
ICSR validation is done by checking the accuracy, completeness and regulatory compliance.
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