consumer groups must also be engaged, as should those involved in the development and deployment of electronic medical records (EMRs).

It is the FDA’s job to propel this initiative forward, highlighting the issue of safe medication use because there are lives to be saved. Medication injuries can occur in two scenarios. In the first scenario, questions are raised about the benefit/risk balance for a particular drug. In the second scenario, medication-related injuries include cases where the benefit does exceed the risk, but unnecessary injuries still occur.

In the benefit/risk balance scenario, the FDA has the authority to pull the drug from the market or to put new safety restrictions on the use of the drug. Restrictions are deemed necessary for making the benefits exceed the risks. The FDA can restrict sales to a single pharmacy, or make sure doctors obtain training, and make sure patients are informed. Restrictions have been put in place for several medications because the FDA believes those drugs cannot be safely marketed without these restrictions.

The second scenario for medication injuries where benefit does exceed the risk has been overlooked historically, but there are lives that can be saved by reducing the risks of these medicines. Examples of this category include children who ingest adult medicines or patients who experience difficulties with warfarin or insulin. This second category has been overlooked historically, but we know that there are lives that can be saved by reducing the risks with these medications. If systems can be put in place to make medication use safer in practice, then regulation is less necessary.

The FDA prefers not to have to employ burdensome restrictions on use to keep medications safe. The Safe Use Initiative is about identifying areas where there are unnecessary, preventable medication adverse events, developing a coalition, setting clear goals, and accomplishing real things so people are not injured. The agency wants to be able to measure progress. One way to do this is to monitor what happens in emergency rooms in the United States before an action is taken and how those measured events change after the action.

Since launching the Safe Use Initiative in late 2009, the FDA has been holding listening sessions to obtain input from the public and professional groups about the kinds of issues the initiative should address. The FDA also wants to know about existing efforts and ongoing activities. Having FDA become part of the process may be just the extra push that is needed to move the activities forward. For example, professional societies, pharmacies, insurers, and many others have guidelines for making decisions based on evidence. How can such existing knowledge and energy be channeled to reduce medication harms?

Karen Weiss, director of the Safe Use Initiative, is here to participate

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