Published on 17/12/2025
How to Handle Serious and Unexpected ADRs (SUSARs)
In the landscape of pharmacovigilance, timely and accurate reporting of serious and unexpected adverse drug reactions (SUSARs) is paramount for patient safety and regulatory compliance. This article outlines a step-by-step approach for regulatory affairs consulting firms and related services aiming to manage SUSARs efficiently. By adhering to guidelines set by the FDA, EMA, MHRA, ICH, and other regulatory agencies, organizations can ensure compliance and maintain robust pharmacovigilance systems.
How to Identify Serious and Unexpected ADRs (SUSARs)
The first step in handling SUSARs is to recognize which adverse drug reactions qualify as serious and unexpected. The term ‘serious’ refers to any adverse drug reaction that results in any of the following outcomes:
- Death
- Life-threatening
- Inpatient hospitalization or prolongation of existing hospitalization
- Persistent or significant disability/incapacity
- Congenital anomaly/birth defect
On the other hand, an adverse event is considered ‘unexpected’ when its nature, severity, or outcome does not align with the information provided in the product’s summary of product characteristics (SmPC) or the Investigator’s Brochure (IB). For example,
It is crucial for regulatory affairs consulting firms to train their teams on these definitions and to ensure all personnel involved in pharmacovigilance are adept at recognizing SUSARs during clinical trials and post-marketing surveillance.
How to Report SUSARs to Regulatory Authorities
Once a SUSAR is identified, the next critical step is reporting it to the relevant regulatory authorities. Each region has specific reporting timelines and requirements:
United States (FDA)
According to the FDA regulations, SUSARs must be reported within 7 calendar days of the sponsor’s knowledge of the information. The following details should be included:
- Patient identifiers (anonymized)
- Drug exposure details (dosage, route, etc.)
- Adverse event description
- Outcomes of the event
- Relatedness assessment
European Union (EMA)
The EMA mandates that a similar report should be submitted within 15 days for serious adverse reactions that are also unexpected. The EHR (European Harmonised Report) should be utilized, which requires the following data:
- Event categorization
- Timezone of the event occurrence
- Detailed narrative of the event
It is recommended for regulatory affairs consulting firms to utilize pharmacovigilance databases and systems to streamline the reporting process and maintain compliance with reporting obligations.
How to Document and Assess SUSARs in Clinical Trials
Documentation and assessment of SUSARs must be meticulous. After identifying and reporting a SUSAR, the next step involves a thorough investigation to assess its potential causal relationship with the investigational product. This includes:
- Collecting all relevant data surrounding the SUSAR from clinical trial sites
- Performing a medical review to assess the temporal relationship between drug administration and the event
- Evaluating the severity and details of the adverse event
- Assuring adherence to ICH-GCP principles for data integrity and subject safety
Assessments may also involve consultation with a pharmacovigilance expert to interpret complex cases and to provide insights based on clinical experience. Additionally, the documentation of these assessments must be kept in line with applicable guidelines and be easily retrievable for audits.
How to Communicate with Stakeholders Regarding SUSARs
Effective communication with stakeholders regarding SUSARs is essential for transparency and safety. This involves:
- Notifying clinical trial investigators promptly
- Updating study protocols or informational bulletins to reflect relevant changes
- Offering training or informational sessions on the new findings or changes to address concerns
For example, if a SUSAR indicates potential issues with drug safety, a regulatory affairs consulting firm should ensure that the risk communicate to all involved parties—investigators, ethics committees, and potentially affected patients. This facilitates an informed understanding of potential risks and adds value to the decision-making process from the perspective of the clinical teams.
How to Utilize KPIs for Effective Management of SUSAR Reports
Key Performance Indicators (KPIs) are vital for assessing the efficiency of the SUSAR management process. Establishing KPIs may include:
- Cycle time for SUSAR reporting
- Rate of serious adverse events reported
- Proportion of SUSARs adequately documented and assessed within set timelines
For instance, if the KPI indicates that the cycle time for SUSAR reporting exceeds the regulatory timeline, a regulatory affairs consulting firm must analyze the process to identify bottlenecks. This may involve reviewing internal workflows, identifying training gaps, or improving electronic reporting systems. Regularly reviewing KPIs will enhance the overall pharmacovigilance performance and ensure regulatory compliance.
How to Ensure Compliance with Global Standards and Guidelines
Given the diverse regulatory landscape across regions, ensuring compliance involves a comprehensive understanding of all applicable guidelines and frameworks, including:
- The FDA’s {‘FDA‘} reporting guidelines in the United States
- The EMA’s {‘EMA‘} pharmacovigilance regulations in Europe
- ICH guidelines governing international pharmacovigilance best practices
Regulatory affairs consulting firms must ensure that their processes not only adhere to local regulations but also align with international guidelines to facilitate future trials across multiple jurisdictions. This can be achieved through:
- Participating in industry group discussions and training sessions on regulatory changes
- Utilizing automated tools for compliance tracking
- Engaging with external regulatory experts to audit compliance protocols
By developing a proactive compliance strategy that encompasses local and global regulations, organizations can mitigate risks while enhancing the safety profiles of the products they manage.
How to Leverage Technology for Improved SUSAR Management
Technology plays a pivotal role in managing SUSARs efficiently. Regulatory affairs consulting firms can adopt various technological solutions to streamline processes such as:
- Utilizing electronic data capture (EDC) systems that facilitate rapid SUSAR identification and reporting
- Implementing pharmacovigilance software that automates data collection and reporting processes
- Employing artificial intelligence (AI) algorithms to analyze adverse event data and identify patterns
For example, AI technology can analyze large datasets from clinical trials to highlight potential safety signals that might indicate SUSAR trends, enabling organizations to act promptly. Incorporating such technologies into pharmacovigilance practices not only improves compliance but also enhances operational efficiency.
Conclusion: The Importance of Effective SUSAR Management
Handling Serious and Unexpected Adverse Drug Reactions (SUSARs) is a complex yet vital aspect of pharmacovigilance. By following structured processes for identification, reporting, assessment, communication, and compliance, regulatory affairs consulting firms can ensure safety and regulatory adherence. The integration of strong KPIs and technology further strengthens these efforts, driving continuous improvement in pharmacovigilance practices. Ultimately, maintaining a proactive approach to SUSAR management fosters better safety outcomes for patients and upholds the integrity of the clinical research process.