Safety Aggregate Reporting

As the name suggests it is an aggregate (collection) of safety data of a particular drug, compiled and submitted periodically to the regulatory agencies to evaluate the risk- benefit balance of drug use. In comparison with single case studies, aggregate reporting is stronger evidence with respect to drug safety.

Adverse drug reactions are one of the leading causes of morbidity and mortality worldwide. Safety aggregate reporting paves way to mitigate the risk of ADR caused by drugs, medical devices or biologicals. It focuses on encapsulating the safety data during both pre and post marketing phase. More importantly during the Post marketing phase as the incidence of time related side effects can be keenly monitored.

In early 1990s the Council for the Organization of Medical Sciences established a safety aggregate reporting techniques as follows:

PSUR - Periodic Safety Update Report

DSUR - Development Safety Update Report, that has been accepted and implemented widely in many countries under different names.

In the EU, PSUR has been adapted as Periodic Benefit Risk Evaluation Report (PBRER) since January 2013 under the influence of European Medicines Association (EMA) and guidance of Good Pharmacovigilance Practices. In India, PSUR is submitted to the CDSCO.

PSUR includes drugs in the post marketing phase and DSUR includes drugs that are still under development.

PSUR should be submitted at defined time points after the Authorization of a new drug. Marketing Authorization holders are required to submit PSUR for the newly emerging drug every 6 months for the first two years, once a year for next two years followed by once in three years there on. All the PSUR submitted will be critically analyzed by experts in the field.

Aggregate reporting in the Post marketing phase helps in better demonstration of efficacy and stratification of risk associated with drug use which precisely marks the deviations in the Benefit Risk balance. Few examples of drugs withdrawn from market in India are Rosiglitazone, Phenformin and Cisapride due to adverse side effects.

Challenges and Opportunities in Safety Aggregate Reporting

  • Compilation of data is a tiresome process with regards to the extensive amount of data collected to analyze. Electronic conversation of processes and the data reduces the burden to some extent.

  • The main challenge faced is that it is a labor- intensive manual process. Right from data collection from sources, updating in the reports, communication with the stakeholders and the regulatory agencies is labor driven hence it requires proper orchestration.

  • Time management and meeting timelines is of prime importance in aggregate reporting

Author: Venkatesh. N

ClinoSol Student ID : 020/0222

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