This blog covers:
- Definition of Expedited Reports in Pharmacovigilance
- Guidelines and Standards for Expedited Reporting
Table of Contents:
- Introduction
- Exploring the Concept of Expedited Reports in Pharmacovigilance
- Standards of Expedited Reporting in Pharmacovigilance
- Conclusion
- FAQ
Introduction
This article aims to provide insights into expedited safety reports and its significance.
By expediting this process, the goal is to enhance efficiency and prompt action. Ensuring the timely assessment and management of potential safety concerns.
Safety Submission
When a new drug approved and available to market to the public, it is crucial to continue monitoring. It is definitely need an investigate its safety profile.
To identify any previously unrecognized adverse reactions or side effects.
Expedited reporting plays a crucial role in focusing important adverse events.
Expedited reports meant in pharmacovigilance
Expedited safety reports do not need a specialized reporting process or a unique domain. But needs an attention.
It is simply a process, much like any other.
The term “expedited” implies that special attention required due to the urgent need for submission.
The term “expedited” indicates that these reports prioritised and require immediate attention._
Awareness, identifying, and submission urgency according to regulatory timelines is a task.
That requires specific attention to categories, products, events, and also country specific.
Expedited safety reports, also known as expedited adverse event reports or expedited case reports.
“Expedited reporting is the unwavering commitment to prioritize patient safety above all else, swiftly capturing and sharing vital safety information. In this race against time, every moment matters, and every report can make a difference in safeguarding lives and shaping a healthier tomorrow.”
Standards of Expedited Reporting
In this section we are going to discuss on the topics are:
- Minimum criteria for reporting
- What should be reported?
- How to expedite the report
- Reporting time frames
- Follow-up information
1. Minimum criteria for reporting
Recommended as much as possible to collect at the time initial report.
For ICSR case submission, a minimum set of criteria required to proceed. The case should not be invalid; yet, it considered incomplete.
To learn more in detail with what are those minimum criteria to define an ICSR a valid. Please check out this blog.
Check out our blog, If you wish to explore more on what are the minimum criteria of reporting.
2. What should be reported?
- Cases of all adverse event reports that need submission to regulatory authority. Yet:
- Both serious and unexpected (SUSAR)
- Serious with death and life-threatening
- Other serious than death and life-threatening
- Non-serious
- From the above list, should aware which is expedited, i.e need urgency in submission in terms of regulatory advice.
- Evidence of lack of efficacy should not normally expedited, but should discuss in the relevant periodic safety update report. Click here, To learn more the importance and handling LOE cases.
- If overdose as an event, Cases associated with serious adverse reactions are considered subject to expedited reporting, unless otherwise specified by local regulation.
3. How to expedite the Report?
In a single case report, any safety information that could change the risk-benefit evaluation. So submission is mandatory.
Expediting reports is based solely on regulatory requirements
“Expedited” does not mean that a case approaching a deadline due to delays internally.
Expedited processing should always begin with the allocation of cases. It based on regulatory timelines.
SUSAR cases take priority in expedited processing, followed by other serious cases. Additionally, some countries may have specific requirements for expedited handling.
For example: To Canada, all LOE cases needed expedition within 15 days.
4. Reporting time-frames
For all the regulatory it requires serious case expedited. In general exodition as follows:
- SUSAR (Death and life-threatening)
- Serious cases (Death and life-threatening)
- SUSAR and other serious cases
- Non-Serious
- FDA
- Others
| Case Category | Event Category | Timeline | Country |
|---|---|---|---|
| SUSAR | |||
| Death | 7 Calendar days | ||
| Life-Threatening | 7 Calendar days | ||
| Others | 15 Calendar days | ||
| Serious | |||
| Death | 7 Calendar days | ||
| Life-Threatening | 7 Calendar days | ||
| Others | 15 Calendar days | ||
| Non-serious (Event specific excluded) | |||
| 60 Calendar days | US | ||
| 90 Calendar days | Others |
The time-frame above is calculated based on the concept of day zero (0).
SUSAR vs Other reports:
- SUSAR reports generated from pre-marketing sources.
- Reports other than SUSAR are typically generated from post-marketing sources.
5. Follow-up information
The information from SUSAR cases when first received is possibly incomplete. Ideally, additional information would be available on efforts should be made to seek on selected reports, including second –hand reports.
Adverse event reports typically include details such as the patient’s demographics, the drug(s) involved, the dose and duration of treatment, Patient medical history and Adverse Events|the adverse event(s) experienced.
Conclusion
In summary, expedited safety reports are important in pharmacovigilance. To check and test the safety profile of medical products.
They monitor most notorious events and help ensure the ongoing safety of patients.
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