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Improving the speed and ease of collecting pharmacovigilance data

Posted on June 12th, 2019 by in Pharma R&D

Learn how the staff of biotechnology company 4P-Pharma uses Elsevier’s Embase to address challenges in conducting clinical trials.

Challenge

To conduct clinical trials with their stimulant abuse deterrent (a drug that induces undesirable side effects such as headaches only when stimulants are abused), 4P-Pharma must provide regulatory agencies documentation of all the adverse events that have occurred as a result of stimulant misuse and abuse. Performing a clinical trial with a fixed-dose combination stimulant/abuse deterrent both with different potential side effects is a daunting task requiring the clinical trial staff to be able to distinguish the drug responsible for the observed side effect. Knowledge of these adverse events is essential for keeping a clinical trial safe and interpreting drug safety and efficacy.

Solution

4P-Pharma staff use the PV Wizard tool of Elsevier’s Embase to search for literature that reports on stimulant abuse and misuse. This new application enables 4P-Pharma to build an optimized search query designed to filter and find all relevant adverse events for a medicinal substance. They also utilize Emtree in these queries to refine their search results to the most pertinent articles. “Embase is more powerful than PubMed to access relevant safety data” says 4P-Pharma Scientific and Clinical Operations Manager Keren Bismuth. Embase enables staff to use their time more efficiently so that they are not searching through articles for pharmacovigilance data only to later find them irrelevant. 4P-Pharma also values the email alert option to stay up to date on these pharmacovigilance reports.

Impact

The ease of collecting pharmacovigilance data through Embase has helped 4P-Pharma establish — and continuously enrich — a table on stimulant abuse they created. It tabulates not only the associated adverse events, but also other valuable information, such as which populations are abusing stimulants, what doses are being used and how the drug is being administered.

With this table, 4P-Pharma has been better able to communicate the extent of the medical emergency attributable to drug abuse. “The numbers that we extract from our Embasesearches are helping us convince potential partners or investors that the need for a solution [such as a stimulant abuse deterrent] is real and urgent,” Keren says.

Author

Marnix Wieffer  
Drug Safety Information Specialist 

As drug safety information specialist, I support pharmaceutical companies in identifying potential drug toxicity concerns and adverse effects. During my first 3 years at Elsevier, I have been working with both academic and corporate customers in northern Europe. As senior marketing manager, I am currently responsible for Elsevier’s drug safety messaging, internal training and market engagement.

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Drug Safety Information Specialist