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Congress Passes Bill Addressing Drug Shortage; Awaiting Presidential Approval

In the past five years, fire departments and EMS agencies across the country have experienced a tripling in shortages of the drugs needed to save the lives of their patients. Many drugs, including Diazepam and Fentanyl, that are used to treat life-threatening medical emergencies, such as seizures or for pain management, are all experiencing shortages. In fact, many fire and EMS departments are completely running out of the drugs.

When the prices of these drugs go up, EMS agencies can't keep as many of the drugs in stock. Unlike hospitals, EMS agencies don't have the ability to pass along the price increase to patients due to the current reimbursement models of Medicare and Medicaid. For this reason, EMS responders have to wait 15 minutes or more, traveling to the emergency room, before crucial drugs can be administered to a patient—minutes that could spell the difference between life and death.

According to Chief Gary Ludwig, chair of the IAFC's EMS Section, "We all know that rapid intervention is essential in these situations," and due to the drug shortages, rapid intervention is no longer guaranteed. This lack of appropriate drugs available to the EMS system creates a public-safety issue that needs to be addressed.

In the final week of June, the U.S. Congress passed legislation addressing the rising occurrence of drug shortages; this bill is currently awaiting presidential approval. The Food and Drug Administration Safety and Innovation Act (S. 3187) would create a warning system for possible or eventual shortages of drugs that are "life-supporting, life-sustaining or intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or surgery."

One of the most critical pieces of the bill will require manufacturing companies to notify the secretary of Health and Human Services (HHS) six months before a possible discontinuance or disruption of any life-saving drug.

The bill will also create a task force to develop and implement a strategic plan to support the secretary in responding to a notification of a possible shortage. The response to the notification could include the secretary's request to the attorney general to increase the drug quota if the drug is included in the Controlled Substances Act, expedite a review of a new drug application or expedite the inspection or reinspection of a factory to mitigate or prevent the drug shortage.

The distribution of the emergency drugs throughout the EMS system will help alleviate or completely avoid the consequences of the original drug shortage, saving countless lives.

In addition, both the secretary of HHS and the comptroller general will have the authority to conduct third-party studies to determine the possible causes or trends of the shortages and make recommendations on their prevention.

The House and Senate passed this legislation on June 20 and 26, respectively, and President Obama is expected to sign it into law.

Emily Whitmarsh is a member of the IAFC's Government Relations and Policy Department.

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