Pharmacovigilance serves the critical role of ongoing monitoring of medicinal products’ potential adverse reactions and in understanding the benefit-risk balance of the product. The management and processing of Individual Case Safety Reports (ICSRs), which consist of detailed information on adverse events or other safety information reported by patients, healthcare professionals, or pharmaceutical companies, are critical procedures in pharmacovigilance operations.
Benefits of safety database
Quality and accuracy of ICSRs is essential for identifying new safety signals and making decisions on actions to improve the safety of medicinal products for users.
A fundamental component of a Pharmacovigilance system is a drug safety database, where a company has ICSRs and other safety information for their medicinal products collected from global solicited and unsolicited sources. A structured safety database provides tools for the analysis, visualisation, and reporting of safety data. This gives the company key information for safety signal management and means for the ongoing evaluation of the benefit-risk profile of the product.
Features of the safety database
Selection of the safety database is a long process with several points of view to be considered. There is need to have a diverse team involved in this process, where expertise and insight from several different functions can be utilised in decision making. Validation, quality, safety database technical structure, and safety reporting regulatory requirements are among these required expertise.
A validated safety database must comply with regulatory requirements and be structured according to the International Conference on Harmonisation ICH E2B(R3) standards. The system must also comply with the FDA’s CFR 21 Part 11 and EMA’s EudraLex Volume 4 Annex 11. A Safety database has properties to allow data traceability and integrity by having audit trails from triage to archiving with the justification of changes made. Clear workflows and user roles are needed. The company must have a quality management system to handle the initial validation and installation, and all changes made to the system so these can be managed and documented at the required level.
Automatic detection of missing data and duplicate reports checking are standard features of the safety database to ensure quality of ICSRs. Pre-existing report formats (e.g. CIOMs and MedWatch) in the safety database and automated functions for the submission of ICSRs to the Competent Authorities assist with ensuring submission is completed within required timelines. No additional manual work is needed as electronic Gateway submission would be used instead of manual entry, e.g. through EMA’s web portal. To ensure the security and confidentiality of data, strict control measures should be in place to provide access to documents and to databases only to authorised and trained personnel, and to ensure the database is a multitenant system.
User-friendliness
The safety database’s clear structure and workfloware important for the users so that case processing can be effectively performed at a high-quality level. A straightforward database reduces the need for IT experts or the system helpdesk’s involvement.
Software solution for case processing
There are different types of implementation models for the safety database. Choosing the right solution depends on several important factors such as the company’s own infrastructure and willingness to improve it, the need for the company’s own control over the safety database, the company’s special customisation needs, and available resources and expertise.
With an On-premises solution, the company is responsible for everything related to the software, including the management of physical servers with their backups, upgrades, and security, and the cost associated with buying the full software and its license. The benefit is that customisations and modifications can be made as necessary according to company needs, e.g., problems with slow or unreliable internet can be bypassed. However, there would the need for own infrastructure, specialised skills and resources, and the scalability could be complicated as if more bandwidth or users were needed, more servers would also be required.
With a Hosted solution, the company buys the software and the license but rents the infrastructure and hardware from a provider. This reduces the costs of maintaining physical infrastructure while still owning the software and the license; however, the company still needs to provide their own IT support for the software and is responsible for the maintenance, e.g. backups and updates.
With a Cloud solution, the server infrastructure, security, backups, and updates are managed by the provider, which will require less expense and expertise from the company. The availability and scalability are better as usually backups of data are spread over several servers at different physical locations, and if there is an increase in user demands, you can add more resources more easily. Software as a Service (SaaS) provides a multi-tenanted environment suited for keeping multiple client’s data separate and secure, and all software backups and updates are done by the provider, thus reducing the need for IT support. All required customisations will be provided by the SaaS Provider.
What about outsourcing the case processing and safety database?
It is valuable to consider outsourcing the case processing process to a pharmacovigilance service provider. With their experienced personnel, readily validated systems, and infrastructure, the company would save their own pharmacovigilance, quality, and IT resources, not forgetting the server costs. The company’s own employees’ time can be used on management, data analysis, and oversight of the system rather than setting up a database from scratch and learning to use it for everyday tasks.
See also:
- Outsourcing ICSR processing – benefits and considerations
- ICSR Project Leader responsible for case processing
Author: Satu Kujala, Head of Pharmacovigilance
Satu Kujala has worked at Medfiles since 1999 acting in various leadership positions. She is currently serving as Head of the Pharmacovigilance team consisting of 20 experts in Finland and Baltics.
Satu has a Licentiate’s degree in Philosophy (pharmacy), and she has specialised in pharmacology and industrial pharmacy. She graduated from the University of Helsinki. After a short career in the university and pharmacy, she has worked within the pharmaceutical industry for 30 years and has gained diverse experience through working on marketing, quality, wholesale, clinical trials, safety and regulatory tasks. She is familiar with Good Clinical, Pharmacovigilance and Distribution Practices (GCP, GVP and GDP). Acting as EU QPPV for sixteen years has given her deep knowledge and experience of pharmacovigilance systems.
