Be a pharmacovigilance superhero

In recent years, pharmaceutical companies and government bodies have placed increasing emphasis on safety and pharmacovigilance risk management. This is largely driven by a number of high profile drug withdrawals in addition to growing consumer expectation regarding drug safety. Compounding these pressures to pharmacovigilance is the deluge of adverse event information from sources ranging from social media sites, published literature, conferences, pre-clinical and clinical trials, patient healthcare reports, etc. Given the high cost of failure, companies remain focused on comprehensive tracking of drug adverse events, while being cautious of false information.

Pharmacovigilance also requires the tracking and reporting of drug safety issues from multiple geographies to multiple regulatory agencies, which all involve different procedures and require different types of information. For example, in the European Union, there are different rules in different member countries for labeling standards and reports. Reports need to be made to individual member countries, duplicating effort for pharmacovigilance teams and Information managers that are already under pressure. The consequence is that pharmacovigilance groups must maintain a repository of adverse drug reactions (ADR) data, while also keeping up with changing global regulatory safety requirements.

Track peer-reviewed, validated adverse events reported in the literature

The needs are clear. Pharmacovigilance requires up-to-date, accurate and comprehensive information, containing all data that the regulatory bodies might require, while avoiding both false information and duplicate records that can lead to over-reporting. ProQuest Dialog with its comprehensive collection of biomedical and pharmaceutical databases provides the answer to pharmacovigilance needs.

Three important databases on ProQuest Dialog for tracking adverse events are Embase^®, MEDLINE^® and Adis Reactions Database.

Embase serves pharmacovigilance reporting needs by broadly tracking adverse events from comprehensive high-quality sources. Embase tracks products not only post-market but also in preclinical and clinical trials. The database comprises 24 million records from over 7,500 authoritative, peer-reviewed biomedical journals, which come from over 70 countries. It is updated daily with approximately 4,000 new records going live each day and more than one million records each year. To ensure currency, Embase also includes indexed Articles in Press for over 25 percent of the records. In addition to literature coverage, Embase covers more than 2,000 conferences and more than 700,000 conference abstracts from journals and journal supplements published since 2009, which Embase and users have identified as critical content to monitor.

Embase records are deeply indexed using the Emtree thesaurus to make searching faster, more accurate and more specific. Emtree lists more than 60,000 preferred terms and over 260,000 synonyms, including generic and trade names of drugs. Indexing is focused toward pharmaceutical use. Teams at Embase index all 7,500 journals a year, checking through the full text and identifying drug and trade names, CAS^® registry numbers, molecular sequence numbers, medical device and manufacturer names, as well as other indexing. Additionally, MEDLINE indexing is mapped to Embase index terminology for about 2,000 journals licensed from the National Library of Medicine.

MEDLINE is an outstanding resource with approximately 5,500 journals in more than 70 countries with a focus primarily on biomedicine. Although MEDLINE does not include conferences, it is among the main sources of information used to detect whether a drug may be responsible for adverse drug reactions cases. MEDLINE is indexed using NLM's controlled vocabulary, MeSH ^® and is focused towards clinical use.

From more than 2,000 major international medical and biomedical journals, Adis Reactions Database, updated daily, provides comprehensive reporting of all adverse reaction case reports, drug safety studies and regulatory news identified in international biomedical literature.

Pharmacovigilance groups today face heightened challenges due to evolving and increasingly complex global regulations, public demand for safer products and faster response times—all within a landscape of ever more data. As pharmacovigilance groups look to meet highly exacting regulatory requirements in drug monitoring, there is a need for expansive coverage of ADR data to ensure that important signals are not missed. This ProQuest Dialog terrific trio of databases—Embase, MEDLINE, and Adis Reactions Database—when searched together provide comprehensive international coverage, the ability to remove duplicate records from the search and the currency needed.

MAY 2013

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