BETHESDA, MD 14 December 2009—FDA in November announced the launch of the Safe Use Initiative, an undertaking intended to avert unnecessary adverse events arising from the inappropriate use of medications.
"I feel strongly that reducing preventable harm from medication misuse should be a top priority for the FDA," said Commissioner Margaret A. Hamburg during a November 4 media briefing.
FDA is focusing on what Hamburg called "avoidable harm," such as unintentional overdoses, dosing errors, and medication abuse. In a report announcing the initiative, FDA cited research indicating that at least 1.5 million avoidable adverse drug events occur in health care settings each year.
Hamburg said that a majority of medication-related injuries "could be prevented using currently available knowledge." The report set that figure at 11–50%.
FDA officials acknowledged that a true measure of the extent of preventable medication harm in the United States does not exist, because data on the subject are not routinely collected. But FDA plans to work with the Centers for Disease Control and Prevention to develop population-based estimates of preventable harm from medications.
According to the report, this data will be categorized by drug, drug class, and therapeutic situation.
Engaging stakeholders. The report states that FDA`s goal over the next year is to identify and implement "a small number of interventions" to improve the safety of medication use, focusing on drugs that "are associated with significant and measureable amounts of preventable harm." To do this, FDA plans to work with a variety of interested groups to decide which specific harm-prevention strategies to undertake first.
"This effort will involve patients, consumers, health care practitioners, pharmacists, insurers, drug manufacturers, and our colleagues in other federal agencies," Hamburg said. "It will also include specific measures of success that will be used to track the impact of each project."
She said the initiative will le led by Janet Woodcock, director of FDA`s Center for Drug Evaluation and Research.
Bona Benjamin, director of medication-use quality improvement at ASHP, said the Society "has already engaged with FDA in efforts related to the initiative and plans to continue working closely with the agency to identify important medication use safety issues."
FDA`s website lists several Safe Use target areas in which the agency is already working with collaborators or seeking their input. These efforts include improving consumer medication information leaflets; preventing medication errors related to the improper use of dosing devices that are supplied with nonprescription medications, especially liquid formulations for pediatric patients; and protecting patients from infections resulting from improperly handled injectable medications.
FDA also plans to hold public meetings and solicit suggestions online to help the agency develop its list of interventions.
A new direction. FDA officials said that the Safe Use Initiative transcends the agency`s long-standing mission to ensure that medications are safe and effective, of good quality, properly labeled, and promoted responsibly and accurately.
"This is a paradigm shift for FDA, and we recognize this. We`re going beyond our traditional role as regulators of the industry and reaching out to make sure we`re impacting on the real problems out there in the real world," Woodcock said.
She noted that regulatory muscle granted to FDA by the Food and Drug Administration Amendments Act of 2007 gave the agency new ways to ensure that medications are used safely and a directive to do so.
For example, she explained, the agency can require manufacturers to develop a risk evaluation and mitigation strategy, or REMS, for already-marketed drugs on the basis of new data indicating a safety problem.
REMS have included elements such as the creation of medication guides, special training for prescribers and dispensers, patient registries, and restricted distribution systems to control access to medications.
But Woodcock said regulatory approaches need to be supplemented by other actions throughout the health care system.
"Simply putting in restricted distribution systems, for example, is not the entire answer," she said. "We need health care to be able to operate in a way that keeps patients safe, and we need to work together."
Hamburg likewise noted that adding new risk warnings to product labeling "does not ensure that that information necessarily translates into the safe and effective use of that medication."
Building blocks. Woodcock said the Safe Use Initiative is the second of a two-part program launched by FDA in 2008.
The first element, dubbed Safety First, was announced in February of that year as a plan to improve and modernize FDA`s internal procedures for managing critical drug safety issues, particularly postmarketing safety. A July 2009 FDA report to Congress calls Safety First a response to recommendations in the seminal 1999 Institute of Medicine report, "To Err Is Human: Building a Safer Health Care System."
According to the July report, Safety First has led to improved communication within FDA and with outside experts in drug safety. Woodcock said Safety First has also led the agency to improve its postmarketing surveillance activities for drugs.
The July report explained that Safe Use was still in development but was intended to create partnerships with stakeholders "to ensure that drugs are used safely and appropriately" and to use electronic health data to develop a "cutting-edge pharmacovigilance system."
"This has been an evolving process," Hamburg said. "We have tried to really emphasize and underscore the public health mission of this agency...and to recognize that we have an overarching responsibility to assure that medicines are used safely and that safe use supports the benefits that those medicines hold."
