CASE PROCESSING WORKFLOW
Introduction: In pharmacovigilance, case processing is a fundamental activity. It provides data for the analysis of adverse effects that allows to detection new safety concerns and to periodically assess the benefit-to-risk ratio associated with the use of a pharmaceutical product.
Definition of case processing work flow:
In pharmacovigilance, case processing is a fundamental activity. It provides data for the analysis of adverse effects that allows to detect new safety concerns and to periodically assess the benefit to risk ratio associated with the use of a pharmaceutical product.
Case processing is a vital activity in pharmacovigilance because it allows
different stakeholders like patients, healthcare professionals and competent
authorities, to exchange huge amounts of safety data.
Case processing includes the following steps:
Receipt of a Case Report
Registration of a Case Report
Validation of a Case Report
Triage
Duplicate Check
Data Entry
Quality Control of Data Entry
Medical Assessment
Transmission to Authorities or Partner.
Closure
11. Archiving
Ensuring the quality of data during case processing is vital. Correct performance of case processing activities is the basis of successful data analysis, scientific assessment and decision-making which in turn allows to effective protect public health.
The good quality of data is key to:
Optimal communication between Competent Authorities, Sponsors,
Marketing Authorisation Holders regarding the safety of medicinal
products
Regulatory compliance.
Effective analysis of safety data that is used for benefit/risk assessment and signal detection activities in order to safeguard patients’ health in an effective manner.
Common Errors in Case Processing and How to Avoid Them
There are several quality issues that pharmacovigilance personnel performing
case processing activities encounter.
The most frequent issues are:
Incomplete reports
Discordant data
Coding errors
Narrative: incomplete information, spelling errors and typos
Missing or inconsistent medical assessment
How to Achieve Quality Case Processing
Case processing is a vital activity that serves as a base for decision-making in pharmacovigilance.
If it is performed with precision, it allows the pharmacovigilance team to analyse the safety data correctly and take corrective actions in a timely manner, making sure that the drug benefits the patients in the best possible way.
There are several strategies that can help to increase the quality of case processing:
Clear written Standard Operating Procedures
Additional training for personnel who may receive or process safety reports (e.g., clinical development, sales, medical information, legal, quality control).
Clear and well-designed safety data collection forms.
Case Management Process Steps
1. Screening The first step in a case management process flow is to determine if the case needs the process at all.
2. Assessing In this step, a case manager will analyse the same information in the previous step, but to a greater depth.
3. Evaluating risks
4. Planning
5. Implementing
Conclusion:
A Case Management Workflow is the logic, process or method our business uses for resolving issues. Issues can have many sources. For instance, they can be raised by customers, partners or internal staff.
References:
Case Processing in Pharmacovigilance: Common Errors & How to Avoid Them (sequrelifesciences.com)
Case Processing in Pharmacovigilance Operations (arithmostech.com)
N. Neeraja Reddy.
Qualification: B pharmacy.
Student ID: 203/1222
Email id: neerajanoundla5@gmail.com.
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