The Periodic Safety Update Report as a Pharmacovigilance Tool

Abstract

The periodic safety update report for marketed drugs (PSUR) was designed to be a stand-alone document that allows a periodic but comprehensive assessment of the worldwide safety data of a marketed drug or biological product. The PSUR can be an important source for the identification of new safety signals, a means of determining changes in the benefit-risk profile, an effective means of risk communication to regulatory authorities and an indicator for the need for risk management initiatives, as well as a tracking mechanism monitoring the effectiveness of such initiatives. For these reasons, the PSUR can be an important pharmacovigilance tool. Numerous steps are involved in the PSUR process including: intake of adverse drug reaction information, case processing, data retrieval, data analysis, and medical review and risk assessment. These processes are heavily reliant on the availability of adequate resources. An overarching principle throughout the PSUR process is the need for a proactive approach in order to identify the critical steps in the process and to have a clear understanding of the consequences of any critical 'mis-step'. With this information comes appropriate planning, building quality into each step of the PSUR process and monitoring performance will maximise the likelihood of generating a quality report. Any failure of a key PSUR process will have the opposite effect - a poor quality report that will give little insight into emerging safety signals or provide misleading information that can adversely affect public health. A pragmatic approach that will avoid or minimise these pitfalls includes the following: adequate resource planning, training, development of 'scripts' designed to maximise the capture of key information for medically important reactions, standardised and harmonised Medical Dictionary for Regulatory Activities (MedDRA) coding procedures, pre-specified search criteria for data retrieval, ongoing medical review, and metrics to evaluate the effectiveness and efficiencies of these processes. With these quality measures in place, the utility of the PSUR as an effective pharmacovigilance tool is enhanced.

Signal Detection and their Assessment in Pharmacovigilance

“…PSURs must be submitted for all registered products, regardless of their marketing status. A single report may cover all products containing the same active substance(s) licensed by one marketing authorisation (MA) holder [30].…”

Periodic Safety Update Reports

“…In a paper published in 2004, Michael J. Klepper of North Carolina based Integrated Safety Systems, Inc., a safety surveillance and consulting firm for pharmaceutical, biological, and medical device companies, outlined some of the ways that companies could maximize the efficiency of their procedures for producing PSURs, avoid potential pitfalls, and ensure full compliance (Klepper, 2004). Some of these elements have also been considered in a recent paper by Brian D. Edwards and Giovanni Furlan that describes how to apply the human factor to PSURs (Edwards and Furlan, 2010).…”

Pharmacovigilance Programme of India

“…Pharmacovigilance is defined as "the pharmacological science relating to the recognition, assessment, understanding and prevention of adverse effects, particularly long term and short term adverse effects of medicines." 2,3 After discovery and pre-clinical phases, a drug typically undergoes trials in human volunteers. Clinical trials are highly regulated and closely monitored by the investigators and the manufacturing company.…”