Drug safety case processing: key issues and strategies to prevent them

Case processing is one of the most crucial aspects of drug safety. It provides data for the analysis of side effects, enabling us to identify newly emerging safety concerns and regularly assess the balance between the risks and benefits of using a pharmacological treatment.

Safety data processing must be exact and of a high standard from a medical and scientific perspective to give accurate analysis and prompt corrective action, which in turn serves to safeguard the health of the patients and make it possible for the safe use of the drug.

Why is it so important to ensure the highest degree of case processing quality?

Case processing, a crucial pharmacovigilance activity, enables the transmission of substantial volumes of safety data across numerous stakeholders, such as patients, physicians, and responsible authorities. Processing a case involves the following steps:

Case report presentation

• Prioritization of case reports: duplicate check validation
• Transmission of a medical evaluation to partners: quality assurance closure for data entry for archiving.
• When processing cases, it is crucial to ensure the quality of the data.
• Effective data analysis, scientific evaluation, and decision-making are dependent on the proper handling of case processing tasks, which in turn enables effective public health protection.
• Observing regulations: To effectively protect the health of patients, safety data must be properly analyzed and used for benefit/risk evaluation and signal detection activities.

Case processing common mistakes:

Numerous quality problems are encountered by pharmacovigilance staff members who handle case processing activities. The most typical problem is:

1. Insufficient reporting

Contradictory data and coding errors signify an incomplete or inconsistent medical assessment.

2. Incomplete report mistake 

The most efficient way to deal with the issue of incomplete data is through routine training. 

The quality assurance AE/SAE report is also included.

3. Incorrect coding

• The most important role of medical coding is to standardize and group disparate phrases into a standard parent category, which is necessary for efficient safety data analysis.
• Medical coding is crucial for preventing spelling errors, inaccurate abbreviations, or non-standardized terms.
• Coding mistakes can be avoided with a suitable and transparent source of data. Pharmacovigilance experts, however, occasionally get acronyms and information that are incorrect or unclear.
• Congestion, of which the type (pulmonary, nasal, hepatic, sinus, etc.) is unclear,
• Uncertainty about the sort of pain
• Myocardial infarction (MI) or mitral incompetence (MI) are the two terms that are not entirely clear.
• It is recommended to speak with the reporter personally to get clarification in such circumstances. The use of lower-level terminology might be permissible if the clarifications weren’t thorough.
• If the clarifications are not exhaustive, lower-level terminology (LLT) should be used. The “MedDRA Points to Consider” page is also beneficial to review because it has a wealth of examples organized by type of coding issue.

Narrative

When crucial details from the case narrative are missing from the structured fields, it is a common type of error for the narrative to be incorrect.

All information in the narrative must be accurately documented in the pertinent structured fields for pharmacovigilance professionals to promptly examine the cases and enable reliable data retrieval.

How to Process a Quality Case

Case processing is an essential task that forms the basis of pharmacovigilance decision-making. It enables the pharmacovigilance team to accurately analyze the safety data and take remedial actions promptly, ensuring that the drug benefits the patients in the best way possible.

There are many strategies that can help to raise the standard of case processing, including:

• Employees in clinical development, sales, medical information, legal, and quality control may require additional training.
• Safety data collection forms that are easy to read and well-designed.
• Random samples of patients are periodically examined.
• All data entered into the database is subjected to quality control by a second individual.
• Regular checking of a sample of instances taken randomly from the database. This can either be a thorough check or a check of the essential fields you’ve chosen.
• Checking for deviations in KPIs and CAPAs.

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