Case Processing
Receiving information, case entry, duplicate check, reporting the case, triage, data entry & narrative writing, medical review, case closure, and reporting ICSRs and aggregate are all steps in the systematic process known as case processing.
List of Activities in a PV Database
Day 0
Medical coding
Labelling
Seriousness criteria
Dechallenge – Rechallenge
Narrative writing
Causality assessment
Submission – 7/15/30/60/90 days
AEs received from a variety of sources via a wide range of methods like Telephones calls, Fax, Mail, and electronic media.
After receiving the source document, the case process will look for the minimum criteria which are required for a valid safety report-
- an identifiable patient
- an identifiable reporter
- an adverse event/reaction
- and a suspected product
Day “0”/initial receipt date/regulatory clock start date
The date of initial awareness/receipt date of a valid ICSR by a company/company’s representative (Irrespective of weekend/Holiday) is considered “Day 0”. It is the start date of the regulatory timeline for a case
1-Case receipt
Case number
Initial report or follow-up report
Companies the drug belongs to
Seriousness about the case
The date of receipt by the company becomes the regulatory clock start date
Drug details
The reported suspects that one of the drugs is the cause, it is called d suspected drug
The other associated drugs are called concomitant drugs, along with the names of drugs, dose, frequency, regimen, and indication are recorded where ever possible.
Patient’s details
Patients’ age, country, ethnicity, medical histories, etc.
Case reporter details
About the person who reported the case
when the case is reported when the drug is in a clinical trial, it is called clinical trial reporting.
When the case is reported when the drug is in the market, it is called spontaneous reporting.
When the case is reported through publication it is called literature reporting.
Sources of Cases
Cases are gathered from a variety of sources, including clinical trials, investigator-initiated trials, post-authorization safety studies, spontaneous cases, observational studies, literature, patient orientation programs, regulatory agencies, and social media websites.
2-Triaging
Under this step, the case processor prioritizes all the incoming reports as per the receipt date, seriousness, causality, and expectedness assessment in the triage step. Once the cases are triaged, they can be processed as per the priority assigned to each case. This is done to ensure that cases that need expedited reporting can be processed and submitted to the regulatory authorities within timelines.
3-Duplicate search
Every safety database has a facility to identify and delete duplicates.
The case processor performs a duplicate search for every document received with certain characteristics of a case (gender, age or date of birth, reaction, clinical trial protocol, country, reference number, etc.) to identify whether the same report has been data-based previously or not.
This action is of significance for further processing of the case. The duplicate could actually be follow-up information that could alter the seriousness and hence reporting timeline of the case. Missed duplicates could send misleading information to the signal detection system.
4-Data entry
The four components of a strong case must be properly described in detail. The HIPPA code of confidentiality must be respected with regard to patient information.
In order to be able to reach the reporter, if necessary, the information must be precise and detailed.
The accurate capturing of drug identifiers such as name, formulation, and dose is required. The event report needs to be comprehensive enough for the assessor to determine what caused the unfavorable incident. This would include a description of the occurrence or events in chronological order, its type, localization, severity, characteristics, the findings of any investigations or tests, the start date, course, and conclusion, any concurrent medications, and any other risk factors.
5-Medical Coding
Medical coding is the process of transforming descriptions of ADRs into universal medical terms with the help of drug dictionaries such as MedDRA, WHO-ART, WHO-DDE, CONSTART, and ICD10 CM
6-Causality Assessment
Non-Spontaneous case reports usually indicate whether an adverse drug reaction is suspected due to the administered drug.
In these circumstances and even otherwise, a causality assessment is required to be conducted.
Various approaches have been developed for the structural determination of the likelihood of a causal relationship between the drug exposure and adverse event
7 -Case Review
All cases should be reviewed after processing to ensure regulatory, scientific, and medical standards are met.
A case review is a 2-step process-
Quality review
Safety Assessment
8-Narrative Writing
Narrative writing is defined as a medical report containing all known relevant clinical and related information, including –
Patient characteristics
Therapy details
Medical history
Clinical course of the event(s)
Diagnosis
Adverse reactions including the outcome
Relevant laboratory evidence (including normal ranges).
9-Medical Review
Adverse event captured-Appropriateness of the AE terms selected.
Sequencing of the AE
Confirmation of coding
Confirmation of the seriousness classification of the AE terms
Confirmation of Listedness/expectedness classification of Ae terms
Reviews concurrent conditions, medical history
Identification of any specific additional information needed for medical assessment
Company causality assessment, wherever appropriate
Identification of potential safety signals.
10-Case Completion
The case is considered ready for completion when it has gone through triage, processing, review, and approval.
The case completion process includes:
- Any updates to the case as required by the review cycle
- Incorporation of additional information request to standard follow up requests.
- Generation of final and distribution of the final report to appropriate external and internal parties, including regulatory submission
- Archiving the report and accompanying source document (both paper and electronic).
11-Follow up Information
Recommendation to prioritize case reports by importance-
Serious and unexpected
Serious and expected
Non-Serious and unexpected
Case of special interest like pregnancy
Follow-up can be obtained by-
Telephone, Site visit, Written request
Written confirmation should be obtained wherever possible for the data supplied
Conclusion
Each case is unique from the perspective of the case processor. In fatal cases, the case processor will need to look into a number of things, including the cause of death and the results of the autopsy, whereas in other cases, they will need to look into adverse events involving special interests and significant medical occurrences and report those to the relevant parties. Before moving on to the next workflow, the case processor should make sure there are no grammatical or typographical mistakes in the case. The case processor imparts best practices, assisting other employees in performing their duties effectively.
It could appear that a case processor's job would become routine after a few months, but every day and every case is new to them. Every case that has new information results in ongoing learning, which steepens the learning curve. The CPU will benefit from this experience in additional instances.
References
1-World Health Organization. Essential Medicines and Health Products, Pharmacovigilance Available at http://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/
2- Latest Trends on Case Processing in Pharmacovigilance: Review Article. Available at: https://iosrjournals.org/iosr-jpbs/papers/Vol15-issue5/Series-7/E1505073646.pdf
3- Pharmacovigilance process work flow available at: https://www.slideshare.net/KatalystHLS/pharmacovigilance-process-work-flow-katalyst-hls
4- A study on pharmacovigilance case processing, Available at https://saap.org.in/journals/index.php/jiaps/article/view/338
Written by: Mohd Suhail Ansari
Student Id-CSRPL_INT_OFL_WKD_142/0822
Mohdsuhail05012000@gmail.com
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