In pharmacovigilance, case processing is the fundamental activity that 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. The precision and quality of safety data processing, also from the medical point of view, is crucial for ensuring correct analysis and undertaking corrective actions in timely manner, which in turn helps to safeguard the health of the patients and allows safe use of the drug.
On June 23, seQure hosted a complimentary webinar on importance of quality case processing in pharmacovigilance operations. During this webinar we described the best practices in case processing and common sources of bias and presented case studies. The webinar was followed by a Q&A session.
The webinar was conducted by Stefania De Santis, Director of Pharmacovigilance of seQure. Stefania has been working in pharmacovigilance since 1985. Prior to joining seQure she held a position of Head of Corporate Drug Safety and qualified Deputy EU QPPV in a large pharmaceutical company where she managed Pharmacovigilance Department ensuring timely and quality delivery of projects. Stefania is a qualified EU-QPPV and certified by EMA for the use of EudraVigilance and XEVMPD.
Continue reading to discover the questions from the Q&A session from the webinar.
Is the use of a safety database mandatory for a sponsor or for a marketing authorisation holder?
Although the use of a validated safety database is not a legal requirement, it is strongly advised both for expedite reporting and for increased reliability of safety data queries and analysis.
What would be the minimum random sample for quality check in case of absence of quality issues?
As the argument is quite complex, I can suggest a very interesting papers that can help you in addressing this important question correctly:
- Committee on Review of Test Protocols Used by the DoD to Test Combat Helmets; Board on Army Science and Technology; Division on Engineering and Physical Sciences; National Research Council. Review of Department of Defense Test Protocols for Combat Helmets. Washington (DC): National Academies Press (US); 2014 Mar 31. 8, Lot Acceptance Testing.
In order to define precisely the minimum random sample for QC, careful consideration of all the details is necessary. If you have any doubts, we advise you to seek external expert support.
Would you recommend reporting 2 different SAEs in case of acute liver failure with liver obstruction?
Yes. Since the good practice of coding is to reflect as much as possible what has been described by the reporter, in this case you can choose the LLTs “Acute hepatic failure” and “Jaundice cholestatic”.
At which step of case processing should we perform quality check?
Generally, the QC step is performed after data entry, before Medical Assessment. After Medical Assessment the personnel in charge for reporting/distribution should check the Medical comment in order to be sure there are no inconsistencies or other kinds of errors.
What kind of person should carry out the quality check? Does it have to be a more senior person than the person who performed the data entry?
This is not mandatory but strongly advisable in order to comply with the quality standards. It also depends on the training and skills of the staff.
During an MRP Surveys, lots of companies are using Visual Analog Scale to collect HCP opinions on the likelihood of receiving lack of efficacy cases. What is the RA expectation to perform follow up? I.e. If HCP has given high score for likelihood of receiving lack of efficacy for MAH product, are we required to do follow ups in this situation?
If the survey is aimed to explore HCPs perception rather than addressing them a direct question if they have ever received such reports, then you might consider not performing follow-up requests. However, in case of doubts in similar situations we advise you to seek external expert support.
What suggestions do you have for a young professional that is approaching the world of case processing?
I suggest to read carefully GVP Module VI and to keep it on hand for consultation in case of doubt, to attend a MedDRA coding training course (it is free if the Company has a subscription), to request a feedback from colleagues performing QC in order to avoid repeating the same errors.
Which criteria could be used to identify a duplicate report?
Duplicate searches are generally performed based on similarities in patient, adverse reaction and medicinal product data. For cases originating from clinical trials which are usually well-documented duplicate detection can include other criteria which will be more reliable, e.g. Research Centre ID and study details (protocol number, study ID).
What is the role of the physician in the case processing?
The role of PV physician is:
- to provide medical advice to PV team for MedDRA coding of complex clinical pictures,
- to provide medical support in literature screening in order to select articles and to identify the treatment emergent adverse reactions to be reported in the ICSR
- to assess causality, confirm the listedness and write the Company Comment in the narrative.
In order to monitor the quality of case processing, how often and on how many cases the QPPV or PV compliance should randomly check the database?
If you have started working with a new service provider, then at least for the first 2 months, the checks should be weekly and on a greater number of cases. Then, when a satisfactory level has been reached, the frequency can be reduced to once a month, and on fewer number of cases.