Support : Publications : Chronolog Archives : January/February 2004

Major New Drug Adverse Events Database Launched on Dialog

DIOGENES®: Adverse Drug Events Database (File 181), a new database produced by FOI Services, is an essential research tool for all researchers with an interest in the safety of pharmaceuticals and related products. This resource file is available as a single, integrated database on Dialog only.

The database contains data about the experiences of individual patients with a commercially available drug or combination of drugs as reported to the U.S. Food and Drug Administration (FDA). The adverse event may be reported by a drug manufacturer, an individual, a health professional or a drug distributor. Note that reports regarding investigational drugs (i.e., drugs in clinical studies and not yet launched commercially) are not included.

Adverse Drug Events Database covers adverse events reported from 1969, when the report regulation was set up by the FDA, to the present. Because of changes in reporting requirements, the database contains two periods of records: 1969 to October 1997 and from 1997 onward.

Since 1969, the FDA has legally mandated adverse drug reaction reports from pharmaceutical manufacturers and maintained them in their Adverse Drug Reactions (ADR) system. The ADR reports vary greatly in detail, some providing only minimal information.

In November 1997 the ADR database was replaced by the Adverse Event Reporting System (AERS). AERS is maintained by MedWatch, the FDA's Safety Information and Adverse Events Reporting Program, and collects submitted reports dealing with serious adverse events, potential and actual product errors, and product quality associated with the use of FDA-regulated drugs. AERS provides many more details than the earlier ADR records; reports submitted through AERS are evaluated by clinical reviewers in FDA's Center for Drug Evaluation. Vaccines are reported in a separate system and are not included in this database.

Who Should Use Diogenes: Adverse Drug Events Database?

The database will be an invaluable source for regulatory affairs professionals, competitive intelligence researchers, quality control and quality assurance specialists, as well as drug safety officers and auditors. File181 will be of interest to:

• Pharmaceutical companies interested in adverse events reported for their own as well as their competitors' drugs. It is worth noting that File 181 provides the ISR number that a pharmaceutical company needs to request a copy of the original adverse event submission to the FDA.
  
  
• Health professionals who want to investigate reported adverse events in specific patient situations such as age and concurrent drugs.
  
  
• Investment firms and management consultants for awareness of adverse event exposure for certain products and companies.
  
  
• Litigation firms for any business they may have taken on that necessitates looking at products and the companies that produce them.

In summary, DIOGENES: Adverse Drug Events Database provides customers with a single integrated source of information on adverse events of commercially available drug products reported to the FDA.

Searching Diogenes: Adverse Drug Events Database

• Search for drugs in the Basic Index using /NA or in the Additional Indexes using NA=. The NA index includes drugs that may either be the primary named suspect drug or a concomitant drug.
  
  
• To isolate only the main named suspect drugs, search the NS= index.
  
  
• Use RE= for reactions.
  
  
• Search the OT= prefix for outcomes.
  
  

See the online version of Chronolog for a list of outcomes and a sample record.

Outcomes can be searched using the OT= prefix. Outcomes include:

OT=CONGENITAL ANOMALY
OT=DEATH
OT=DIED
OT=DISABILITY
OT=DISABLED
OT=HOSPITALIZ?
OT=LIFE-THREATENING
OT=NONE
OT=OTHER
OT=RECOVERED
OT=REQUIRED INTERVENTION?
OT=TREATED WITH RX DRUG

To search entries that are similar such as DEATH or DIED, use S OT=(DEATH OR DIED).

View a sample record from File 181.

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