The individual case safety reports can be obtained from the spontaneous reports and observational post marketing surveillance studies. The unsolicited spontaneous reports are carried voluntarily by healthcare or non-healthcare professionals, medical journals, legal advisers, etc. It is not derived from any study or any organised data collection system. On the other hand, PMS (Post-Marketing Surveillance) studies are observational. They can be observed from serious adverse events (SAE) in the clinical trial. So MAH (Marketing Authorization Holder) would organize an appropriate causality assessment bt the health care professionals, medically qualified physicians or pharmacovigilance team. The ICH E2A has guidelines for the understanding, prevention and treatment of adverse reaction occurred to the patient during the clinical trial. These guidelines are followed by the pharmacovigilance team.
The adverse event (AE) derived clinical trial during any phase between I-IV includes, post marketing surveillance, the visit of medical representative to the doctors, company sponsored surveys and pamphlets, patient or survey programs and call centers contacting the health care and non-health care professionals. The contractual agreement which specify the processes for safety information exchange, including responsibilities for the maintenance of time lines and regulatory reporting. The agreement is formed between two or more companies which may market the same product in the same or different countries. There should be some restrictions to avoid duplicate reporting to Regulatory Authority (RA) by both the parties. However, MAH is ultimately responsible for this report. The individual serious unexpected AE reports originating from the foreign regulatory authorities are subject to expedited reporting to the other authorities by each MAH. Resubmission of the serious AE cases without new information is usually unnecessary.
ICH (International Conference on Harmonisation) has laid down some guidelines for reporting the adverse events during the trial. The criteria for reporting as per ICH guidelines are as follows-
i) Product name and serial numbers should be mentioned in the case of medical devices.
ii) The initials and the demographic data of the patient should be reported.
iii) The clinical descriptions of the patient like, doctors' prescription, laboratory results should be noted down.
iv) Confounding factors like concomitant medicines and medical history should be clearly reported.
v) The temporal information including the date of event onset or start and stop dates of medicine used should be specified.
vi) The dose of the drug taken and frequency of its use as per the prescription.
vii) The results of biopsy or autopsy in the case of death of the patient.
viii) The dechallenge or rechallenge information should be minutely detailed by the health care professionals.
ix) The result or outcome of the trial.
x) Causality assessment.
xi) Reporter's details should be mentioned clearly.
xii) Individual serious unexpected AE reports originating from the foreign regulatory authorities are subject to expedited reporting to the other authorities by each MAH.
While assessing the patient and reporter identity it is very significant to avoid case duplication, fraud cases and follow-up of the appropriate cases.
The identity of the patient should be proved by providing initials, name, gender, nature of study of the patient. These details are enough to prove the existence of the patient. The details of the reporter should also be documented. The initial, name, relationship with the patient, name of the institution, complete mailing address, professional qualification, etc should be mentioned correctly. These evidences prove the identity of the reporter. The evidences of the adverse events should also be registered. The specific symptoms, diagnosis, lab reports, lack of efficacy of the treatment, death, pregnancy, overdose, abuse, accidental administration, disease aggravation, etc are the important parameters to be mentioned while reporting the adverse event to the regulatory authority. The investigational product under suspect is identified by mentioning the generic formulation, license, SAE report, registration of the product.
The efficient handling of the adverse event's data is important so WHO has taken the initiative by designing VIGIBASE a vigilance database, used by the pharmaceutical companies and Contract Research Organisation (CROs) for claiming the safety of data while processing cases of adverse events. For handling the process flow of ICSRs (individual case safety reports ) four basic steps are followed:
• Case intake;
• Case processing;
• Case review;
• Case reporting.
The reported adverse event cases are reviewed under a set of standardized criteria:
• Seriousness-The seriousness of the adverse events described in the report as defined by the set of predefined ICH criteria. For e.g., cases of life-threatening and hospitalization).
• Expectedness- to judge that whether the reaction was within the expected range of side effects as defined in the investigator brochure or the product label.
• Causality-The degree to which a causal relationship between the product and the event is established or suspected.
Once the case is reviewed by the regulatory authority (FDA), it is locked by the authorized person.
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