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.
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 a timely manner, which in turn helps to safeguard the health of the patients and allows safe use of the drug.
Why it is important to ensure the highest quality in case processing?
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
- Duplicate Check
- Data Entry
- Quality Control of Data Entry
- Medical Assessment
- Transmission to Authorities or Partner
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 effectively protect public health.
The good quality of data is a key to:
- optimal communication between Competent Authorities, Sponsors, Marketing Authorisation Holders regarding 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
In our experience, there are three main types of Incomplete Report errors:
- missing adverse events/special situations.
- Missing co-suspect drugs, medical history, lab data.
- Missing medical review and assessment.
One of the most effective ways to avoid the problem of data incompleteness is to conduct regular training. Trainings should involve not only the pharmacovigilance staff who may receive reports from patients/HCPs, but also other company departments (e.g. marketing, legal, QA), investigators, and clinical research assistants.
Moreover, it is important to ensure the quality of AE/SAE report forms in order to capture as much important information as possible.
Finally, it is helpful to request the missing data directly from the reporter, especially for serious unexpected ADRs. We advise using checklists to collect missing follow-up information in order to ease the daily work of the pharmacovigilance team.
Another common error regards the inconsistency of data.
One of the most common examples is the error in the gender of the patient. In this case, the structured field can feature “female” as gender, while the narrative has a reference to a male patient or vice versa.
In order to avoid such mistakes, we advise configuring automatic data checks in the security database. In this way, all inconsistencies are automatically detected and reported. It is possible to set automatic control to prevent the user from continuing the work until the inconsistency is resolved.
Medical coding is essential for preventing spelling errors, incorrect abbreviations or non-standardised terms, but its most relevant function is to standardise and organise scattered terms into a standard parent category, which is essential for effective safety data analysis.
An appropriate and clear source of data allows avoiding coding errors. However, pharmacovigilance professionals can sometimes receive inaccurate or unclear information and abbreviations:
- congestion – the type of congestion is not clear (nasal, liver, sinus, pulmonary…).
- Pain – the type of pain is not clear.
- MI – it is not clear whether MI stands for myocardial infarction or mitral incompetence.
In such cases, we advise requesting clarifications directly from the reporter. If the clarifications are not exhaustive, it is advised to consult the “MedDRA Points to Consider” document, as it contains many useful examples grouped by type coding errors.
Another common error type in the narrative is an inconsistency between key information present in the case narrative but missing from the structured database fields.
It is crucial that all information in the narrative is correctly captured and coded in the relevant structured fields. This approach allows pharmacovigilance professionals to assess the cases quickly and facilitate consistent data retrieval.
A way to avoid inconsistencies is to use the auto-narrative function of the safety database.
Moreover, personnel who works on case narrative should have a good knowledge of the English language and should also turn on spell check in their text editor while they are writing the case narrative.
Finally, it is important to involve a second person to perform Quality Control.
Missing or inconsistent medical assessment
Clinical medical assessment of cases is a vital integrated process that is performed in order to identify a diagnosis, ensure that diagnostic procedures have been carried out, identify suspect drugs and consider alternative causes of adverse events.
Therefore, clinical medical assessment should always be consistent and complete.
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 trainings 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.
- Quality Control performed by a second person of all data entered in the database.
- Periodic checks on random samples of cases entered in the database. This can be either a complete check or a check of the selected critical fields.
- KPIs monitoring and CAPAs in case of deviations.
How can we support your pharmacovigilance operations?
As Arithmos, we offer both Business Services for Pharmacovigilance and Safety domain and Pharmacovigilance Technology Solutions.
seQure is the business unit of Arithmos, related to Regulatory Compliance and Consulting Services.
We provide Pharmacovigilance services to our customers to support their Pharmacovigilance processes and ensure business continuity.
With seQure Pharmacovigilance services, we provide a complete portfolio of drug safety and risk management services ranging from case processing and reporting of Individual Case Safety Reports (ICSRs) and Serious Adverse Events (SAEs) to the collection, monitoring, assessment, and analysis of drug safety information and the detection of new safety concerns.
We support pharmaceutical companies and biotech’s with a full suite of services, including acting QPPV and deputy QPPV for pharmacovigilance in the EU.
Our professionals are well qualified to cover the role of Local Safety Officer/ Local Contact Person for Pharmacovigilance and to liaise with local authorities on behalf of our customers.
The right safety database offers solutions to multiple challenges that a pharmacovigilance team faces. We have a proven track record in defining user requirements and choosing a fit-for-purpose pharmacovigilance system, database and reporting system within a compliance strategy.
Are you looking for support with your pharmacovigilance operations? Discover our services and contact us here below!