THE PROPOSED DESIGN OF INDIVIDUAL CASE SAFETY REPORTS PROCESSING IN THE PHARMACOVIGILANCE DEPARTMENT IN BIO FARMA
The condition of COVID-19 pandemic affects the implementation of pharmacovigilance activities in the pharmaceutical industry. There was a disruption in processing reports of Adverse Events Following Immunization (AEFI) cases, where AEFI cases reported from external stakeholders increased multiple ti...
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| Format: | Theses |
| Language: | Indonesia |
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| Online Access: | https://digilib.itb.ac.id/gdl/view/71791 |
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| Institution: | Institut Teknologi Bandung |
| Language: | Indonesia |
| Summary: | The condition of COVID-19 pandemic affects the implementation of pharmacovigilance activities in the pharmaceutical industry. There was a disruption in processing reports of Adverse Events Following Immunization (AEFI) cases, where AEFI cases reported from external stakeholders increased multiple times in a short time. In 2021 performance reporting, the Pharmacovigilance Department did not achieve the expected performance of 90% of case reports being processed and analyzed within 30 days and experienced a decline to 80.70%.
The framework starts with analyzing the current state (input) using the POPIT model for internal factor analysis and business situation analysis (SWOT analysis) to identify external and internal factors. Initiation of business process changes is carried out with the steps listed in Business Process Management with the path of Process Identification to finding the root cause of the problem, Process Modeling using Business Process Modeling and Notation (BPMN), Process Analysis by measuring performance, Process Remodeling or Improvement, Process Implementation, and Monitoring and Control. The expected output is a problemsolving solution based on the results of the systematic business analysis so that it can be scientifically accounted for.
The results obtained from this study are problem-solving by increasing the number of staff, using artificial intelligence (AI) technology in processing AEFI case reports to avoid errors and manual input, and approaching external stakeholders to be able to report safety data more efficiently and with more structured data. With the addition of human resources to process the AEFI reporting data by one person, there will be an increase in performance value to 165% from the previous performance of 80.70%. If process efficiency is added using AI technology, the performance value of processing case reports increases to 219%. This value will increase if improvements are also made to the reporting process from external stakeholders.
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