This blog delves into:
- The definition and importance of “Sources of ICSR Cases”
- The various types of sources and their generation methods.
Table of Contents:
- Introduction
- What are Sources?
- Pre-Marketing Sources
- Post-Marketing Sources
- Conclusion
- Abbreviations
- FAQ
Introduction
You are exploring in to the generation of sources for ICSR cases. It is an integral part of understanding the fundamentals of this process.
It is important to delve into the origins of these sources and their types.
The goal of pharmacovigilance is to document the safety profile of a drug throughout its entire lifecycle.
Starting from the pre-marketing phase of approval all the way to post-marketing.
What are sources?
The sources are the collective information obtained from:
- The consume(s)/patient(s)/ subject(s)
- Physicians
- Investigators
- Legal persons
- Other HCPs
These sources contain the safety information i.e, effect/ reaction of drug the patient experienced.
Sources are classified in two major categories:
- Pre-Marketing sources
- Post-Marketing sources
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Pre-Marketing sources
This reports derived from:
- Clinical trial studies sponsored, conducted and supported by pharmaceutical companies or sponsors.
It is a regulated obligation for sponsors to monitor the safety profiles of the development molecule(s). And report the safety profile to the authorities and local bodies with in stipulated timelines.
it is further classified in to two sub categories are:
1. International clinical studies:
These are the studies which is covering from phase I to phase III.
The participants are:
- Patients
- Healthy volunteers
2. Compassionate used programs:
It is a unique approved program for a single patient (or) group of patients who unsatisfied with existing therapy and ready for test drug. For instances this trial may give them of good deeds.
Here the involving drug is unauthorized and unapproved to market.
Post-Marketing sources
The drug involves here is authorized and marketed.
It is the responsibility of Market Authorization Holder (MAH) to watch the safety to wide range of population.
To make sure the benefit risk profile collected from pre-marketing data.
The following are the potential sources under this category:
1. Literature sources
This is a reports published as an article(s). Ranges from well established global medical database to local non-indexed literature journals.
In this type of cases, the reporters are Health care professional or researchers.
2. Legal
- This safety information reported by legal person who is responsible to the single patient or group of patients who involved in this study. Eg: Legal lawyer.
- Legal cases are those filed under the law, subject to judicial review, and facing legal actions.
- Product liability issue
- Legal compliant on a product
- Reporter might be a legal person of the particular study
- Lawsuit actions
3. Post-Marketing study
These are the studies, registries or programs. It is a part of pharmacovigilance activity.
Most of the cases usually we receive for PMS. It is a properly well maintained and monitoring stduy.
MAH is obliged to conduct this study in regular basis to measure the risk-benefit profile of the marketed drug.
4. Spontaneous reports
It is a wide range of reporting source, it is an unorganised report. We receive information abut the report in any way spontaneously.
For eg: Direct report from the consumer, Media reports, lay press reports and even HCP.
I recommend checking out how social media has huge impact and influencing adverse event reports in pharmacovigilance.
This source type further classified in to two types:
1. Voluntary/ Passive reporting:
Direct report to HA from HCP or any consumer through telephone or Email communications or any contact information available.
2. Mandatory/ Active reporting:
This report could directly reported to manufacturers safety department directly from consumer or HCP through any kind of available contact information.
Conclusion
The above write-up provides detailed insights into the sources of ICSR reports. However, as new technologies emerge, reporting methods and sources may also evolve.
This is well-written overview that can help in understanding the nuances between the reports.
Feel free to mention any new methods not covered in the sources mentioned above.
Abbreviations:
- ICSR – Individual Case Safety Reports
- HCP – Health Care Professional
- HA – Health Authority
- MAH – Marketing Authorisation Holder
FAQ:
What do mean by “Sources of ICSR cases”?
What are the kind of sources of ICSR cases?
1. Pre-Marketing sources
2. Post-Marketing sources
What are pre-marketing sources of ICSR cases?
2. Compassionate used programs
What are post-marketing sources of ICSR cases?
2. Social media sources
3. Legal
4. Post-Marketing studies
5. Spontaneous reports
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