{"id":25669,"date":"2022-07-26T13:52:56","date_gmt":"2022-07-26T13:52:56","guid":{"rendered":"https:\/\/www.rightsdirect.com\/?post_type=blog_post&p=25669"},"modified":"2023-02-16T13:50:45","modified_gmt":"2023-02-16T13:50:45","slug":"literaturrecherche-zur-pharmakovigilanz","status":"publish","type":"blog_post","link":"https:\/\/www.rightsdirect.com\/de\/blog\/literaturrecherche-zur-pharmakovigilanz\/","title":{"rendered":"Arzneimittel\u00fcberwachung: F\u00fcnf \u00dcberlegungen f\u00fcr optimierte Arbeitsabl\u00e4ufe bei der Literaturrecherche"},"content":{"rendered":"\n

Literaturrecherche ist eine Kernkomponente der Arzneimittel\u00fcberwachung. Die zunehmende Anzahl von Datenquellen und regulatorischen Anforderungen kann diesen Prozess jedoch zu einer entmutigenden Aufgabe machen. Da mehr Datenquellen verf\u00fcgbar sind als je zuvor und sich die globalen Vorschriften st\u00e4ndig \u00e4ndern, stehen Arzneimittel\u00fcberwachungs-Teams unter Druck, Strategien zu entwickeln, die sowohl umfassend als auch flexibel sind, um wesentliche Erkenntnisse schnell zu erfassen.<\/h2>\n\n\n\n

Nachfolgend lesen Sie f\u00fcnf konkrete \u00dcberlegungen dazu, wie den neuen Herausforderungen klug begegnet werden kann.<\/h2>\n\n\n\n

While literature review is a core component of pharmacovigilance, the increasing number of data sources and regulatory requirements can make the process a daunting task.  With more data sources available than ever before, and global regulations constantly shifting, pharmacovigilance teams are under stress to develop strategies that are both comprehensive and flexible.<\/p>\n\n\n\n

Scientific literature is one of the most significant sources of information to monitor the safety profile and the risk-benefit balance of medicinal products, particularly in relation to detecting new or emerging safety signals or issues.<\/p>\n\n\n\n

Monitoring this type of literature\u2014and in particular, case reports\u2013 is the most accurate, efficient, and effective warning system for initial detection of new adverse reactions, rare events, or at-risk patients, because the corresponding case reports are detailed, assessed for quality by reviewers (mostly independent from commercial incentives), and open to any interested parties.<\/p>\n\n\n\n

So, as you consider more efficient approaches for monitoring, searching, and distributing the results to the pharmacovigilance team, I would recommend the following:<\/p>\n\n\n\n

1. Review SOPs<\/h4>\n\n\n\n

If you\u2019re new to the library, get a copy of the pharmacovigilance SOP (standard operating procedures) from your quality assurance team.\u00a0 Review it carefully to see what role your team plays in the pharmacovigilance process.\u00a0 If the library is not part of the workflow for monitoring the literature, it likely should be.\u00a0 However, you also want to make sure that the library is not tasked with deliverables outside of your expertise.\u00a0 In a routine in-house audit during my first year on the job, I learned that the library \u2018owned\u2019 the SOP for the drug safety reporting process.\u00a0 This \u2018ownership\u2019 made us ultimately responsible for the performance of the entire drug safety team.\u00a0\u00a0 I felt strongly that this was the wrong chain of command, as the library team had no expertise in drug safety or adverse event reporting.\u00a0 Over the course of a 4-month collaboration with global drug safety, legal, and regulatory, we were able to revise the SOP and turn ownership over to the global drug safety team.\u00a0 We are now firmly ensconced in the workflow as the literature experts, but without overall responsibility for the process.<\/p>\n\n\n\n

Carefully review the role of the library throughout the PV workflow to decide whether your team has the expertise to fulfill the requirements of the SOP.  Remember that pharmacovigilance is a regulated process and all parties involved in the documented workflow are subject to FDA audit.<\/p>\n\n\n\n

2. Align Information & Pharmacovigilance Departments<\/h4>\n\n\n\n

Although the library no longer owns the SOP, we continue to be an important element in the overall process. Our role is to collaborate with the PV scientists to create the safety queries and make sure that the resulting alerts are delivered to the appropriate people in the appropriate time span.<\/p>\n\n\n\n

Libraries must also work with pharmacovigilance colleagues to assist in creating search strategies. This includes choosing the most relevant publication databases, keywords, date ranges, and filters for your literature review.<\/p>\n\n\n\n

Remember: They are the experts in drug safety.  We are the experts in documents and creating robust searches.  Work together to play on your strengths.<\/p>\n\n\n\n

3. Work with your database providers to create a pharmacovigilance tool that meets your needs<\/h4>\n\n\n\n

Work with your database and tool providers to make sure what you want can be delivered.  Do weekly check-ins with your data providers until the process you\u2019re building is perfect.<\/p>\n\n\n\n

When it comes to selecting a search and monitoring tool, I would recommend including your pharmacovigilance teams as you consider changes.<\/p>\n\n\n\n

Here was a list of the qualifications we were both looking for within a tool:<\/p>\n\n\n\n