Experimental efforts are now underway to attempt postmarketing surveillance
of drugs using EHR data.
A postmarketing surveillance
program to monitor Ultram (tramadol hydrochloride) abuse in the United States.
Although all 28 people appeared to have clinically experienced an immediate hypersensitivity to an allergen, our postmarketing surveillance
could not demonstrate that the Cry9c protein was actually in the product consumed prior to the adverse health event.
The legislation also mandates that FDA require postmarketing surveillance
for devices that may cause serious injury or death or that are life-supporting.
Though the experts eventually and unanimously bought into the FDA's logic, they also advised the agency to follow up with beefed-up postmarketing surveillance
to make certain that the extrapolated indications do not put patients at risk.
In response to this need, over the last several years there has been a steady increase in the number of regulatory requests/requirements for postmarketing surveillance
studies for new medications likely to be used by women of reproductive age or by pregnant women.
But it took 5 years of postmarketing surveillance
before that benefit was recognized.
At the meeting, speakers summarized postmarketing surveillance
data from Mexico, Brazil, Australia, and the United States for Merck's Rotateq and Glaxo-SmithKline's Rotarix.
provide an early examination of postmarketing surveillance
data from Brazil, one of the first countries to implement routine childhood immunization with Rotarix vaccine (I).
Although anyone can report an adverse drug event (ADR) to MedWatch, the authors indicated that the most common bias in this database is underreporting, as only 1%-10% of adverse events are reported to this postmarketing surveillance
Mandatory postmarketing surveillance
is needed to address off-label prescribing that is unsupported by evidence, authors of an Agency for Healthcare Research & Quality-funded study say, The Pink Sheet reports.
In September 2003, CDC initiated postmarketing surveillance
in 14 state and local health departments to monitor the performance of the OraQuick[R] test.