A day in the life of a pharma CPO

Pharmacovigilance (PV) has grown significantly in India in the last couple of decades. The etymological roots for the word “pharmacovigilance” are “Pharmakon”(Greek for drug) and “Vigilare”(Latin for to keep watch). It relies on information gathered from the collection of individual case safety reports and other pharmacoepidemiological data. The PV data processing cycle starts with data collection in computerized systems followed by complete data entry which includes adverse event coding, drug coding, causality and expectedness assessment, narrative writing, quality control, and report submissions followed by data storage and maintenance. A case processor plays an important role in conducting these various tasks. The case processor should also manage drug safety information, possess updated knowledge about global drug safety regulations, summarize clinical safety data, participate in meetings, write narratives with medical input from a physician, report serious adverse events to the regulatory authorities, participate in the training of operational staff on drug safety issues, quality control work of other staff in the department, and take on any other task as assigned by the manager or medical director within the capabilities of the drug safety associate.

The tasks undertaken by a case processor are given below:

  1. Case receipt
    The first thing a case processor will do is to check the email after logging in to the system. This allows the case processor to check the number of cases that have been assigned and also allows the associate to go through any feedback or other communication from the stakeholders.Once the assigned cases are identified, the case processor starts working on them.
  2. Data verification and validity check
    After receiving the source document (via email, fax, or phone), the case processor will look for the minimum information which is required for a valid safety report, i.e., an identifiable patient, an identifiable reporter, an adverse event/reaction, and a suspect or interacting drug.
  3. Case-book in and registration
    Once the case processor has completed duplicate search for a case in database there are two ways of processing a case. They are as follows:

    • Upon positive duplicate search, i.e., when the processor finds a case in the database, the processor can add a follow-up to the existing case and process the information.
    • Upon negative duplicate search, i.e., when the processor does not find any case in the database, the case processor will create a new case to process the information.
  4. Data entry
    Once the case has been triaged, the case processor will perform the complete data entry. The case processor will enter all the details from the source documents into the database, which include reporter information, patient information, patient medical history, laboratory details, family and surgical history, clinical course, and treatment details of the patient.
  5. Coding of adverse events and drugs
    This step involves coding of the adverse events in the Medical Dictionary for Regulatory Activities (MedDRA). MedDRA is a single standardized international medical dictionary which can be used for regulatory communication and evaluation of data pertaining to medicinal products for human use.
  6. Causality assessment
    A causality assessment is the relationship between the drug treatment and the occurrence of an adverse event. The case processor enters the reporter’s causality assessment (whether event is related to the drug: yes/no/not reported) in this section.

  7. Expectedness assessment
    The case processor goes through the reference safety documents to check whether the ADR which is reported is listed/expected in the reference safety information (RSI) document or not. The RSI is a list of medical terms detailing the Serious Adverse Reactions (SARs) that are expected for the investigational medicinal products (IMP) and is used by investigators as a reference point when assessing a SAR to determine whether it is a SUSAR. Various sections of the RSI need to be carefully checked, especially the undesirable effect section. An “unexpected” adverse reaction is one, the nature/severity/specificity/outcome of which is not consistent with the information in the relevant source documents.
  8. Case narrative
    The case processor describes the story of the entire case in this section. The case processor can use predefined templates for writing narratives as per the customer’s requirements. The associate provides a summary of the events to the readers, ensures completeness, chronology, and sufficient detail in a narrative so that the reader can come to a conclusion. The inputs given by the medical reviewers can also be incorporated in the safety narrative of the case.
  9. Self-quality check
    The associate does a self-quality check for the case before the case is pushed to the next workflow. The associate ensures the completeness and accuracy of the information entered into the database for all the cases. This is a very crucial step, especially when the associate is working on Suspected Unexpected Serious Adverse Reaction or fatal cases.

The significance of case processing:

For the case processor, every case is different, even within the same study. In fatal cases, the case processor will have to check many things such as the cause of death and autopsy details, whereas in other scenarios, the processor will have to check adverse events of special interests and important medical events and report the same to the stakeholders. The case processor should ensure that there are no grammatical/spelling errors in the case, while routing it to the next workflow. The case processor shares the best practices, which help other associates to do their job efficiently.

 

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