Adverse event processing & causality assessment is the preferred way to identify a drug product related risk and its association with patient safety. An Individual Case Safety Reports (ICSRs) is an important source of information that contains crucial data on an adverse event that a patient is experiencing when taking a drug. The purpose of these reports is to monitor product safety and take the necessary actions to reduce patient harm. Moreover, they be used to exchange information on medication errors, off-label use, and complaints associated with a drug and ultimately help in determining the safety profile of the medicine. A valid case report must include an identifiable patient, an identifiable reported, a suspected adverse event, and a suspected drug product. The main steps of ICSR processing are:
Any adverse event may be received by a pharma company through HCP or regulator or reported directly by a consumer/patient either verbally or on phone of through email. Any such details about the AE received verbally or on phone are transcribed on a form so that they act as source document for the reported AE. Such report is checked for completeness and legibility. If required, clarifications are requested and duplicate search in ICSR databases are conducted to avoid duplicate entries of the same report. Cases are verified in terms of initial or follow up reports. Examples of reporting forms include CIOMS I, MedWatch Form 3500 and 3500A, Yellow Card
Preliminary assessment of safety reports is performed in terms of its reportability. The validity of the safety report is confirmed based on the ICH specifications for a valid case. The seriousness and causality of the report is determined.
Data Entry and Case Processing
Details such as patient details, medical history, adverse events, product information, country of incidence, case reference number, causality assessment etc are captured, coded using drug dictionaries such as MedDRA or WHO DD, and entered into safety databases.
Quality analysis includes solving any validation warnings as necessary and determining missing information in the reports for which follow-ups are required. The overall completeness and case consistency is checked against the source document. Coding and assessment are verified.
Healthcare physicians are responsible for reviewing signal detection, case assessment, source of data, and overall information consistency. Medical review is conducted for all serious cases and follow up activities for critical clinical information is requested.
Final checks are conducted where the completeness, consistency, content, coding, and evaluation of the cases are thoroughly checked. If additional information is required, then it must be followed up. No corrections can be made after this stage. Once all checks are complete, the cases are considered complete and submitted to the relevant competent authorities per the timelines.
ICSR processing capabilities at DDReg:
Our pharmacovigilance team receives medical information queries, product quality complaints, and adverse event reports from a variety of sources. We conduct case processing activities and have experience in handling various safety databases that are ICH E2B(R3) compliant and integrated with MedDRA and WHO DD. Our team conducts triage of initial and follow up ICSRs as well as SUSARs, and meticulous quality and medical checks. We are reputed for our timely submissions and reconciliation processes with our customers. Get in touch with us at email@example.com to know more about how our ICSR Processing Pharmacovigilance Services can be of assistance to you.