Regulatory Focus™ > News Articles > FDA Seeks to Broaden Collection of Prescribing Data in Bid to Track Use, Safety of Drugs

FDA Seeks to Broaden Collection of Prescribing Data in Bid to Track Use, Safety of Drugs

Posted 10 March 2014 | By Alexander Gaffney, RAC

US regulators are laying the groundwork to potentially monitor the use of drugs by patients discharged by healthcare facilities, mirroring and expanding upon other planned activities.


In June 2013, the US Food and Drug Administration (FDA) announced that it was seeking access to data on adult and pediatric utilization of drugs used in inpatient and emergency settings.

The intent, FDA said, was to better conduct postmarket surveillance on the safety of pharmaceutical and biopharmaceutical products.

The proposal, first posted on 3 June 2013 and since updated with additional information, is a response to what the US Food and Drug Administration (FDA) identified as two primary factors: A 2005 report by the Institute of Medicine (IOM) that called for a modernized drug safety system built upon new databases, and the 2007 passage of the FDA Amendments Act (FDAAA), which permitted the agency to access disparate data sources to identify drug use trends on a national level.

FDA said it wanted more ways to identify and respond to the "increasing number of post-marketing issues" it comes across.

And for FDA, one of the best sources of information would be hospital settings, where patients are admitted to address either planned or emergency procedures. The contract notice said FDA wanted to use this data to provide context for adverse event reports, model drug risk based on use patterns, and to calculate reported use rates for various drugs.

This could also be used to determine how drugs are actually being used by practitioners versus how they were intended to be used per their FDA-approved indication.

FDA also said it was interested in seeing which drugs were being used in children, which would allow it to better request studies from manufacturers if use of the drug was not supported by pediatric-specific data.

From Inpatient to Outpatient

Now regulators appear to be broadening their scope of interest.

In a 7 March 2014 contract pre-solicitation notice-essentially a notice to gauge the interest and abilities of contractors-FDA said it wished to access outpatient prescription and patient level drug utilization data.

The contractor, as envisioned by FDA, would provide "continuous automated access to nationally-based, prescription-level outpatient information." In addition, the contractor would provide FDA with trend analyses and historical data.

But perhaps most importantly, the contractor would need to provide FDA with the ability to
analyze "patient-level data," including "unique patients utilizing drug products in an outpatient setting, with the capability of stratifying by patient age and sex, as well as new and continuing users."

FDA said it is also interested in longitudinal data, allowing it to track the health of a patient over a longer period of time.

"The longitudinal data shall include information at the medical claim and prescription claim levels with the ability of characterizing concomitant drug use, and duration of drug use.  The medical claims data shall provide immediate automated access with the ability of providing counts of current and historical aggregate national and sub-national drug utilization prescription information."

Such information would be useful in uncovering difficult-to-detect long-term health effects associated with a product.

Responses are due to FDA by 14 March 2014.


Access to Outpatient Prescription and Patient Level Drug Utilization Data

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