Event Coding in Pharmacovigilance (PV)
Event coding in PV stands out as a critical process. A systematic and standardised approach to coding adverse events and medical terms is essential for efficient signal detection, risk management and regulatory reporting.
Please Note: It's very important to have a PV person residing in Australia, who can interpret adverse events in the Australian context and guide the Case Processing team (if they are residing outside Australia) to code the events correctly. This person can be your Qualified Person responsible for PV (QPPV) as long as they understand the extent of this task. Please see a true story below on why this is so important. This story is, of course, one of many.
What is Event Coding?
Event coding is the process of transforming clinical information from adverse event reports into standardised terminologies or codes. These codes, usually derived from standardised dictionaries like MedDRA (Medical Dictionary for Regulatory Activities) or WHO Drug Dictionary, represent specific medical concepts such as symptoms, diseases, procedures, and laboratory findings. By assigning these codes, pharmacovigilance professionals ensure that adverse events are uniformly documented and easily retrievable for analysis.
Importance of Event Coding in Pharmacovigilance:
Consistency and Standardisation: Event coding ensures uniformity in adverse event documentation across different databases and healthcare settings. Standardised coding facilitates effective communication between stakeholders, including healthcare professionals, regulatory agencies, and pharmaceutical companies. This is especially important for data migration from one Drug Safety database to another.
Signal Detection: By coding adverse events consistently, pharmacovigilance experts can identify patterns or clusters of events associated with a particular drug. This enables early detection of potential safety issues or emerging risks, prompting further investigation and risk mitigation strategies.
Data Analysis and Reporting: Coded adverse event data form the basis for various pharmacovigilance analyses, including periodic safety reports, signal evaluation, and risk management activities. Standardised coding enhances the efficiency and accuracy of data analysis, enabling informed decision-making regarding drug safety.
Regulatory Compliance: Regulatory authorities mandate the use of standardised terminologies for reporting adverse events in pharmacovigilance. Event coding ensures compliance with regulatory requirements, facilitating the timely submission of safety reports and regulatory notifications.
Post-Marketing Surveillance: Beyond clinical trials, pharmacovigilance relies on real-world data to monitor the safety of marketed drugs. Event coding enables systematic analysis of adverse event reports from post-marketing sources, such as spontaneous reporting systems, electronic health records, and literature databases.
Challenges in Event Coding:
Despite its importance, event coding in pharmacovigilance comes with several challenges:
Complexity of Clinical Data: Clinical narratives in adverse event reports may contain complex medical terminology, abbreviations, or misspellings, making coding challenging and prone to errors.
Coding Inconsistencies: Differences in coding practices among healthcare professionals (HCPs) or across healthcare systems can lead to inconsistencies in adverse event coding, affecting data quality and analysis. That's why it's so important for pharma companies and PV vendors to be consistent and accurate when coding events as per the HCPs' or patients' verbatim.
Note: A real story from one of our consultants: Nurse's verbatim was that the patient has experienced a burning sensation at the administration site ("left cheek") and knowing that the injection site for this medication is the gluteal muscle (as per the Product Information), the verbatim made sense for the Australian PV Team. However, the Global PV team residing outside of Australia, interpreted that the injection site was on the left cheek of the face, which lead to confusion and a slightly embarrassing explanation from the Australian PV Team.
3. Integration with Information Systems: Integrating event coding processes with pharmacovigilance information systems requires careful planning and coordination to ensure seamless data capture and retrieval.
It's so important to have a dedicated IT team to support the data migration from one PV database to another as it gets very technical.
4. Continuous Updates: With the evolving landscape of medical knowledge and regulatory requirements, maintaining up-to-date dictionaries and coding guidelines is essential to ensure the relevance and accuracy of event coding practices.
Future Directions:
To address the challenges and harness the full potential of event coding in pharmacovigilance, several initiatives are underway:
Advancements in Natural Language Processing (NLP): NLP technologies hold promise for automating parts of the event coding process by extracting and mapping relevant information from unstructured clinical narratives to standardised codes.
Enhanced Interoperability: Efforts to improve interoperability between pharmacovigilance databases and healthcare information systems aim to streamline data exchange and facilitate seamless event coding and reporting.
Standardisation and Harmonisation: Collaborative initiatives among regulatory agencies, industry stakeholders, and standards organisations seek to harmonise coding practices, enhance data quality, and promote consistency in adverse event reporting globally.
Incorporation of Real-World Evidence: Leveraging real-world data sources and advanced analytical techniques, such as data mining and machine learning, can enrich pharmacovigilance activities and strengthen signal detection capabilities.
Event coding is a fundamental process in pharmacovigilance, essential for systematically documenting, analysing, and reporting adverse events associated with drugs. By ensuring consistency, standardisation, and compliance with regulatory requirements, event coding plays a crucial role in safeguarding public health and promoting drug safety throughout the product lifecycle. As technology advances and collaborative efforts continue, the future of event coding holds promise for enhancing pharmacovigilance practices and enabling more proactive risk management strategies.
