Case processing in pharmacovigilance is a fundamental activity to support safety surveillance in clinical trials. Along with an anticipated therapeutic effect, medicinal products may also carry certain risks for adverse reactions. Some of these adverse reactions may be classified as ‘serious’ or have a causal relationship to the product. Because of this safety risk, drug monitoring is done continuously throughout the product life cycle during the trial and on a post approval basis. Pharmaceutical companies are mandated by regional health authorities in the US, EU and other countries, to collect data related to adverse events occurring with use of their medicinal products on an ongoing basis. It is the responsibility of the pharmacovigilance (PV) personnel to be involved in the continuous monitoring of the product under investigation. The PV Case Processor collects this information (Individual Case Safety Reports or ICSR) from various sources and processes the reports for timely submission to the regulatory authorities and/or Sponsor so that required actions can be taken. The following provides an overview of information for non-pharmacovigilance-oriented readers to better understand this critical safety surveillance process.
Individual Case Safety Report (ICSR)
ICSR is defined as an individual case study report which contains information regarding suspected adverse drug reaction related to the administration of one or more medicinal products to an individual patient at a specific point of time. According to WHO criteria, there is a set of basic information required before a case report becomes acceptable. Those criteria are:
- An identifiable reporter (HCP/non-HCP)
- An identifiable patient
- A description of suspected reaction(s)
- Name(s) of the suspected products(s)
A report is considered valid if it meets these four criteria. The patient and reporter identification are needed to verify the existence of each, avoid case duplication and facilitate follow-up. A description of the reaction, in sufficient detail, and suspected product associated with the reaction is also needed.
Sources of ICSR
There are two different kinds of sources for Adverse Event Safety data:
- Solicited – where Adverse Events are specifically requested in a clinical study, and
- Unsolicited – where safety information is provided outside of a study by a health care provider, consumer, or other organization.
Systemic pattern of case processing in PV
The following diagrams the steps needed to process Adverse Event information by the PV Case Processor. From receipt of the safety report to the final archival of the case report, the process is meant to ensure quality data for the data analysis, scientific assessments and decision making that is based on this data.
Safety reporting forms
The reporting of Adverse Events (AEs) during a clinical trial is an important activity accomplished by study personnel. However, once medical products get marketing approval, there is still a need to keep track of AEs and to report them to the appropriate Regulatory Authority (RA). Reporting to RAs is accomplished using both Voluntary and Mandatory forms. Voluntary forms or spontaneous reports of AEs can be made by healthcare professionals or consumers, with reports going to RAs and pharmaceutical companies. Once these reports are received, assessments are made by PV personnel and can lead to actions such as labelling changes and/or risk management plans. Mandatory forms (such as CIOMS or MedWatch) have been developed for the pharmaceutical sponsor (or marketing authorization holder) to submit ICSRs to RAs for both pre-approval and post-approval reporting periods.
Regulatory timeline for submitting an ICSR
The timeline for submitting an ICSR depends on country-specific regulatory requirements as well as the type of adverse reaction being reported. Serious AEs must be reported promptly while non-serious AEs have a larger window of time in which to be reported. Timelines for both the US and EU have been presented below.
US and EU reporting timeline & regulations
We hope you have found this article useful in understanding some of the basics of pharmacovigilance and ICSR reporting. Veranex is an experienced partner in pharmacovigilance services. We are here to help. Learn more here.