Safety surveillance databases

The FDA s Spontaneous Reporting System (SRS) was in operation from 1968 to October 1997. The reports were transitioned to the AERS, which has been used from October 1997 to the present. A publicly released version can be purchased on a quarterly basis. It is a passive surveillance system where direct volunteer reporting accounts for 10% of reports from healthcare professionals and consumers. Ninety percent of reports in the FDA s postmarketing safety surveillance databases come from pharmaceutical companies, as they are mandated by regulations to report AEs that they receive. The combined SRS + AERS database currently contains more than 2.7 million reports and is growing rapidly, at about 465, 000 reports on an annual basis. The number of reports has more than doubled in the last 10 years and because the FDA is interested in serious, unlabeled reports, that has grown as a percentage of the total number of reports submitted to the FDA. 

There are two key approaches to safety surveillance. First, the intraproduct signaling, which seeks to identify changes in the overall AE pattern for specific products over time. This monitors selected AEs for a specific product over time to determine changes in the frequency and severity of AE reports. The other type of approach is the interproduct signaling which compares a specific product with all products in the database. 

Thus, it is clear that the safety surveillance process is an iterative one. It looks at multiple data sources, whether screening large regulatory databases, looking at company databases or looking at manufacturing Lot related AEs for patential problems. The surveillance process screens the data using both the intraproduct and the interproduct methods. The object is to identify topics for further review to develop case definition, to compile a case series and then to characterize that case series. 

The data mining output is similar to the safety surveillance output in that hypotheses are generated and these may need to be evaluated with additional quantitative analyses as appropriate, using the company database, stimulated reporting, enhanced surveillance or they may require the conduct of epidemiological studies. 

Databases That Can Be Used for Signal Detection in Post-Authorization Drug Safety Surveillance... 

Death Data on the efficacy of buflomedil in intermittent claudication were retrieved from a Cochrane systematic review, and data on safety were obtained by comparing the number of reports of serious adverse events and deaths published in the literature with those reported in postmarketing surveillance databases The authors concluded that the evidence that buflomedil is beneficial is undermined by documented publication bias. They also concluded that there is bias in reporting adverse events to international safety databases, illustrated by the discrepancy between the number of published drug-related deaths (20), deaths recorded in the WHO database that were potentially drug related (20), and deaths that were attributed to buflomedil in the database of the international marketing authorization holder (11). 

The FDA s postmarketing surveillance of drug safety in FY 2003 includes a new database on prescribed drug use (with patient idenhhes removed). The agency uses this database of marketed drugs to "make risk assessments and decisions about the most appropriate way to manage any new risk or new perspective on a previously known... 

The FDA may mandate specific postmarketing surveillance programs when a concern about the safety or efficacy of a new medication is suggested by either the preclinical or clinical database used for marketing approval. 

A review of the prechnical studies, clinical studies, and postmarketing surveillance data has given no support to the proposed association between bambuterol and cardiac failure. The UK Committee on Safety of Medicines has received no spontaneous reports of cardiac failure due to bambuterol. Data from the WHO database, INTDIS, show no reports of cardiac failure with bambuterol, in contrast to ten reports for salmeterol. 

Critical document reviewis done by the PLL team for documents provided by the government, including reports of unusual occurrences or events, safety reviews (including near-miss advisories), reports of nonconformance or non-compliance, reports of test results, audit surveillance inspection reports, daily and weekly operating reports, and campaign reports. The purpose of these reviews is to identity lessons that will be added to the PLL database, update the database as needed, introduce appropriate topics tor discussion at workshops and, if needed, recommend direct actions to secure further information. 

Several inventory and tracking systems, often using bar code scanners and computer databases, are used throughout the complex. The databases typically include locations, amounts, uses, hazards, and custodians. Regardless of the inventory and tracking software used, it is important to integrate this software with other computerized environment, safety, and health systems, such as Hazard Communication, waste disposal, medical surveillance, and MSDS systems, at a particular site. 

National Institute for Occupational Safety and Health (NIOSH) Databases offer online chemical-specific safety, emergency response, and medical surveillance information http //www.cdc.gov/niosh/database.html... 

GACVS also discussed the association of IS and RV vaccination at their meeting in December 2013. They reviewed recently published data from Australia and the United States. IS cases in Australia were identified from Jxme 2007 to June 2010 using nahonal database resources and active hospital surveillance techniques, and both Rotateq and Rotarix were found to carry similar risk. The estimated relative risk for IS was 5.6 additional cases per 100,000 vaccinated infants. In the United States, data from three vaccine safety reporting systems were reviewed (VAERS, VSD and Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program). Between 2006 and 2012, 584 cases of IS... 

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