Did You Know?

Did you know that the FDA Plans to Implement its Medication Safe Use Initiative in Conjunction with an Industry Stakeholder?

The Food and Drug Administration (FDA) launched its Safe Use Initiative in November 2009 to take a more proactive role in reducing the risk of patients suffering unnecessary injuries due to medication use. Following an in-depth analysis of both unavoidable and manageable medication risks, the agency concluded that steps needed to be taken to establish a formal, coordinated system to protect the public from preventable harm caused by medication use. FDA's report, FDA's Safe Use Initiative: Collaborating to Reduce Preventable Harm from Medications, delineates the program the agency intends to implement to achieve its goals.

The chief mission of the agency's Safe Use Initiative is to build and facilitate public and private collaborations within the healthcare community through working closely with all of its stakeholders - patients, consumers, caretakers, healthcare practitioners, pharmacists, healthcare systems, health insurers, drug manufacturers and other federal agencies. The fundamental plan involves working with these stakeholders to identify specific, preventable medication risks through reviewing candidate cases - drugs, drug classes, and/or therapeutic situations - that are associated with significant and measurable amounts of preventable harm. The cases will be analyzed and cross-sector interventions will subsequently be developed, implemented and evaluated.1 FDA has already launched or is in the planning phase of introducing several risk reduction projects including:

  • modifying the current consumer medication information system;
  • increasing public awareness and instituting manufacturer requirements to ensure the correct use of medication dosing devices;
  • improving communication about the risk of inadvertent overexposure to acetaminophen;
  • implementing safeguards against surgery fires caused by alcohol-based surgical preps; and
  • avoiding contamination of multiple use medication vials.2

FDA-Biovista Collaboration

As part of FDA's primary mission to collaborate with the healthcare community to carry out the Safe Use Initiative program, the agency has partnered this month with one of its industry stakeholders, Biovista, Inc. Biovista specializes in building strategic global alliances with the pharmaceutical and biotechnology industry, academic institutions and research and government organizations by supplying information technology products that target basic and clinical drug research.3 FDA has agreed to license Biovista's Adverse Event Analysis (AEA) technology platform to facilitate the agency's goal of analyzing, identifying and fully comprehending the mechanism by which selected drugs can result in harmful side effects.

Biovista's AEA technology forms part of the company's Clinical Outcomes Search Space platform which focuses on the mechanism of action-based correlations between drugs, disease efficacy and adverse events. The AEA technology cross-correlates over 8,000 diseases and 12,000 adverse events known to medicine against any target, drug or combination.4 FDA's Office of Clinical Pharmacology within the Center for Drug Evaluation and Research will work closely with Biovista's scientists to study the serious side effects of several drugs or classes of drugs using the AEA technology. The goal of this collaborative research is to improve the ability to predict which patients may be most likely to experience adverse reactions to the selected medications and to reduce any associated risks. This, in turn, will enable healthcare providers to prescribe drugs more knowledgeably and safely and to be better prepared to protect their patients from harmful drug side effects. The agency views its new licensing arrangement with Biovista as exemplary of the direction it seeks to progress in terms of working with leading-edge technologies and stakeholders to achieve the goals of its Safe Use Initiative.

References

1. FDA's Safe Use Initiative: Collaborating to Reduce Preventable Harm from Medications, p.3.
2. Ibid, pp.21-22
3. Biovista Inc. - About website
4. Biovista Inc. and FDA to Collaborate on a Medication Safety Initiative

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This content was originally published in DRW Monthly. To learn more visit the DRW website or contact Diane R. Whitworth at drwresearch@comcast.net or by phone at 301.916.9669.






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