Healio
Healio
June 02, 2008
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FDA to implement a national electronic system to efficiently monitor product safety

The new system enables the FDA to query several existing data sources at remote locations.

The FDA recently launched the Sentinel Initiative, which will eventually create the national electronic Sentinel System for the monitoring of drug and medical product safety.

“This initiative will tremendously increase the FDA’s capacity to monitor the use of medical products on the market,” Mike Leavitt, Secretary of the Department of Health and Human Services, said in a press release. “We are moving from a reactive dependence on voluntary reporting of safety concerns to a proactive surveillance of medical products on the market. In addition, Medicare data on prescription drug use will be available to help government agencies and researchers improve the safety, quality and efficiency of health care services.”

Creation, implementation of the system

To address Congress’s mandate in the FDA’s Amendments Act of 2007, the new system is expected to increase post-market surveillance of medical products.

By building on existing systems and data, the Sentinel System will follow the scientific principles of surveillance, use health information technology standards coordinated with the Healthcare Information Technology Standards Panel and ensure that the privacy and security of personal health information is not compromised. Furthermore, the system will support research and epidemiological studies as well as the FDA’s existing risk identification and analysis processes.

The FDA will be able to query several existing data sources at remote locations for information about medical products, ultimately allowing the FDA to monitor a product from the time it goes on the market throughout the product’s entire lifecycle.

“The Sentinel System will not only revolutionize how we protect the health of the patient and the patient’s family, but it also holds vast potential for the FDA to learn more about the conditions that affect the benefit and the risk of medical products,” Andrew C. Eschenbach, MD, Commissioner of Food and Drugs, said in a press release. “This will enable us to make wiser regulatory decisions about drugs and devices and help physicians and patients make better decisions regarding appropriate use of these products.”

Organizational challenges and future strides

In the Sentinel Initiative’s National Strategy for Monitoring Medical Product Safety report, the FDA addressed the potential for administrative, organizational, procedural and methodological challenges that may arise with the establishment of the Sentinel Initiative and the Sentinel System.

The FDA proposed the following key principles:

  • Safeguards for protecting data and personal privacy information must be established prior to implementation of the Sentinel System.
  • Research must adhere to high standards for data integrity and protection of each individual. Potential conflicts of interest should be avoided.
  • Management structure and data analysis components of the system must be protected from unwarranted influence.
  • All public and private stakeholders have a specific role to play.
  • Stakeholders should have an opportunity to provide input on the standards and processes of the system.
  • Governance structure and process should provide for incorporation of a broad range of expertise and opinion and minimize both conflicts of interest and perceptions of conflicts of interest.
  • Protocols and data should be accessible for the public.
  • Standards, methodologies and source codes for software used by the system should be made available for end users.

The Sentinel Initiative will progress in stages and will be funded within the fiscal year 2008 appropriation and the fiscal year 2009 President’s budget request. In addition, a series of meetings have been scheduled between the FDA and potential partners to formalize both short- and long-term goals for implementing the Sentinel System.

“While the broad Sentinel Initiative is being created and implemented, the FDA will continue participating in ongoing pilot projects and when appropriate, initiate new projects with relevant stakeholders,” according to the FDA. “We will continue working nationally and internationally on standards development efforts to enhance existing risk management and communication processes at the FDA.” – by Jennifer Southall

PERSPECTIVE

It has become clear that clinical trials leading to FDA approval can miss important adverse effects of the drug under evaluation. For example, osteonecrosis of the jaw and severe bone pain were reported in patients treated with bisphosphonates only after the drugs were approved and marketed. However, the anecdotal nature of such reports makes it difficult to establish casual relationships between the drug and the adverse effects. And in some cases, the drug company has not been forthright in reporting the adverse events seen during clinical trials. The FDA's Sentinel Initiative will implement modern information technology to monitor in a scientifically meaningful manner the safety of medical products and to thus shield the public from adverse events. This benefit comes with the risk for invading patient privacy, so only time will tell if the benefit is worth the risk.

– L.J. Deftos, MD

Endocrine Today Editorial Board member

For more information:

  • Food and Drug Administration. The Sentinel Initiative National Strategy for Monitoring Medical Product Safety. Food and Drug Administration website. www.fda.gov/oc/initiatives/advance/reports/report0508.pdf. Published May 2008.
  • To read more from Dr. Eschenbach about the Sentinel Initiative, visit: www.fda.gov/oc/vonEschenbach/andys_take/default.html.
  • Additional information about the Sentinel System can be found at www.hhs.gov.