Optimizing PSUR Literature Section Preparation with DrugCard

Crafting periodic safety update reports (PSURs) in pharmacovigilance is as much an art as a science. Although these reports have standardized templates, they must be tailored to the unique characteristics of each molecule studied. The complexity of PSUR writing mirrors the pharmaceutical landscape’s complexity, which is more evident in the literature section. Here, we delve into the intricate process of PSUR preparation, focusing mainly on the Literature section. We also explore how the Article card feature on the DrugCard platform serves to navigate this complexity with precision and professionalism.

Understanding the uniqueness of PSUR composition

PSURs can never be a “one-size-fits-all” endeavor. Each report is tailored to the specific characteristics of the molecule, reflecting the diverse array of factors that influence its safety and efficacy profile. Whether it’s the nature of adverse events, the complexity of drug interactions, or the nuances of patient populations, the composition of PSURs is as individualized as the molecules themselves. Yet, amidst this diversity, a common thread binds them together—the adherence to unwavering rules of pharmacovigilance practice.

Navigating the Literature section

The Literature section within a PSUR plays a vital role in detecting emerging safety issues associated with the drug. It offers a thorough examination of pertinent scientific publications during the reporting timeframe. Regulatory bodies like the EMA mandate meticulous scrutiny of scientific literature in PSURs. It’s crucial to emphasize that adherence to current pharmacovigilance guidelines and regulations is imperative for constructing the Literature section. Consequently, Marketing Authorization Holders (MAHs) must establish a robust procedure for identifying relevant scientific literature. They should also assess its pertinence to the drug’s safety and efficacy and promptly notify regulatory entities of any newfound safety concerns.

Harnessing the power of the Article Card

In their quest for efficiency and effectiveness, pharmacovigilance professionals embrace innovative tools to streamline their processes. Writing reports like PSURs is no different, and in this realm, the DrugCard platform’s functionality proves invaluable. Within the PSUR preparation context, the Article card on the DrugCard platform emerges as a strategic asset. Pharmacovigilance specialists can annotate articles with concise notes detailing their relevance to PSURs, thus ensuring that pertinent information is readily accessible during report compilation. Whether highlighting valid adverse drug reactions or flagging insights crucial for upcoming PSURs, the Article card facilitates efficient knowledge dissemination within the team. Beyond its role as a simple annotation tool, the Article card serves as a knowledge repository, seamlessly integrating annotation, archival, and reporting functions into a single cohesive platform.

Streamlining PSUR preparation

How does creating notes in the Article Card facilitate writing the Literature section? It’s straightforward! During literature monitoring, when you encounter an article fitting the criteria for inclusion in the Literature section, you save its key information in a note. This way, the article and its notes are archived in the Knowledge Base. Then, when preparing the PSUR, you select a reporting period in the Knowledge Base to retrieve all articles discovered during that time frame. With just a click, you generate a report for the period, obtaining a ready-to-use Excel document for incorporation into the PSUR.

Four easy steps for crafting the PSUR Literature section with DrugCard

Article Selection: When you find an article that meets the criteria for inclusion in the Literature section, categorize it in Safety Information.

Note Creation: Save the primary information from the article in the note.

Storage in Knowledge Base: The annotated article and its notes are stored in the Knowledge Base for future reference.

Report Generation: When preparing the PSUR, access the Knowledge Base and select the desired reporting period. With a mouse click, generate a report for the period chosen. This will provide a ready-to-use Excel document containing the necessary articles for incorporation into the PSUR.

Efficiency Today, Time Saved Tomorrow

In conclusion, crafting the Literature section of PSURs requires meticulous attention to detail and adherence to regulatory standards. The Literature section is critical for detecting emerging safety concerns associated with medicinal products. Pharmacovigilance professionals can streamline the literature review and annotation by utilizing innovative tools like the Article Card feature on the DrugCard platform. This ensures that pertinent information is readily accessible during report compilation, ultimately enhancing efficiency and precision in PSUR preparation. Professionals can improve efficiency and accuracy in PSUR writing by following four simple steps. With these tools and methodologies, pharmacovigilance specialists can navigate the complexities of PSUR preparation with ease and confidence.