The PSUR Process

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Chapter: Pharmacovigilance: Periodic Safety Update Reports

The PSUR process comprises the following steps: • intake of ADR information; • case processing; • data retrieval; • data analysis and • medical review and risk assessment.


THE PSUR PROCESS

The PSUR process comprises the following steps:

intake of ADR information;

case processing;

data retrieval;

data analysis and

medical review and risk assessment.

Once an ADR has been reported (usually sponta-neously to a company representative), the case is entered into a safety database, a narrative is prepared and a MedDRA term assigned to ADRs described in the case. Seriousness and labelledness are assigned, and these determine whether or not the event needs to be processed as an expedited report. Data retrieval from the DLP and generation of line listings and summary tabulations are typically the most time-consuming parts of the PSUR process but are the key to a thorough medical review and risk assessment. The sections of the PSUR which lend it its value as a pharmacovigilance tool, the presentation of individ-ual case histories and the overall safety evaluation, depend critically on the data retrieval step. Data anal-ysis is based on the traditional method of medical review carried out by trained healthcare professionals and increasingly supplemented by data mining meth-ods which are emerging as useful tools in signal detec-tion. Finally, the medical review and risk assessment steps force the MAH to take a critical look at its data to determine whether the risk for the marketed product has changed and whether changes to the product label have to be made or other risk management initiatives need to be implemented.

The PSUR process can be illustrated by the stan-dard operating procedure (SOP) of H. Lundbeck A/S in this context. There are five stages to Lundbeck’s procedure:

data collection;

PSUR writing;

approval;

archiving and

distribution.

The data is collected from the following sources:

Access to safety data: a tool for searching, report-ing and extracting data from the pharmacovigilance database;

Regulatory Affairs Division and Regulatory Central Archive of Lundbeck;

International Clinical Research – Psychiatry and/or International Clinical Research – Neurology and Mood Disorders divisions of Lundbeck;

Financial services of Lundbeck and

Literature.

The data is then analysed and a first draft of the PSUR written. That draft is reviewed by relevant parties internal to Lundbeck and corrected to produce a second draft. Following a review by the safety board, the document is approved, archived, distributed to Lundbeck subsidiaries and finally submitted to the competent authorities. Lundbeck usually prepares 6-month PSUR during the first 5 years after the IBD. For products older than 5 years, the company prepares yearly PSURs.

Events concerning population often not studied during the phase II and III studies (pregnant women, elderly and children) are discussed separately in the PSUR and the data are collected in our Lundbeck database with standard phrases [especially for preg-nancies (trimester of exposure, retro or prospective case report etc.) to allow a quick overview on the course and outcomes of these pregnancies].

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