The Food and Drug Administration Safety and Innovation Act (Senate Bill 3187) was signed into law by President Barack Obama on July 9. This mammoth bill is designed to ensure both the safety and adequacy of the nation’s drug supply. Three parts of the law that will affect EMS are Title IX: drug approval and patient access, Title X: drug shortages and Title XI: Subtitle D–synthetic drugs.
Nearly half of the drugs on the FDA’s shortage list are administered on ambulances. Many of those drugs are used to treat seizures, cardiac arrests and other life-threatening conditions. Hampered by shortages, EMS providers have used expired or alternative medications, and have been forced to follow modified treatment protocols that don’t represent best practices in patient care.
Title X of the new law is designed to reduce drug shortages and improve information sharing regarding certain drugs, including those used in emergency medical care. Manufacturers will be required in most cases to provide at least six months notice to the government of the discontinuance of the production of a drug or interruption in its manufacture. And Health and Human Services (HHS) will now be required to disclose both the discontinuation and manufacturing interruption of critical drugs to all appropriate healthcare providers, including EMS agencies.
Also, if HHS determines that there’s likely to be a shortage of any critical drug, it must expedite the review of new drug applications for which doing so would mitigate or prevent the drug shortage. Moreover, if HHS determines that an enforcement action against a manufacturer–who has notified HHS of a discontinuance or interruption in drug production–could reasonably cause or exacerbate a shortage of the drug, HHS is to evaluate the risks associated with such shortage on patients before determining what enforcement measures, if any, to impose.
Additionally, the new law calls for a federal task force to develop and implement a strategic plan to enhance HHS’s response to preventing and mitigating drug shortages. A component of the strategic plan will include an evaluation of whether to establish a manufacturing partnership program through which a qualified manufacturer would have the capacity and capability to supply, within a rapid time frame, drugs determined or anticipated to be in short supply. Further, within 18 months after the bill’s enactment, the Comptroller General of the U.S. will be required to conduct a study to examine the cause of drug shortages and make recommendations on how to prevent and alleviate such shortages.
Title IX addresses the need for expedited drug approval while maintaining safety and effectiveness standards. EMS providers will be primarily concerned with “fast-track products” (i.e., a drug that is intended for the treatment of a serious or life-threatening disease or condition) and accelerated approval for such drugs.
It remains to be seen how effective this legislation will be in addressing the drug shortage dilemma. The problems can’t be resolved overnight, and implementation of some of the provisions in Title X may need to await the adoption of regulations, which the law requires within 18 months (although many federal agencies often don’t complete the task of issuing new regulations within the time frames established by Congress). Regardless, there’s no “quick fix” for drug shortages that limit treatment options and threaten patient care, but the enactment of this bill is a move in the right direction.
Bath salts have had serious implications for EMS. Patients under the influence of bath salts can present with altered mental status, auditory and visual hallucinations, agitation and violence.
Subtitle D of Title XI is the Synthetic Drug Abuse Prevention Act of 2012. It expands the list of Schedule I controlled substances. Schedule I drugs include substances with high potential for abuse, no currently accepted medical use in the U.S., and a lack of accepted safety for use of the drug or other substance under medical supervision. Unless specifically authorized, the manufacturing, distribution, dispensing, possession or the intent to engage in such conduct is illegal. The Synthetic Drug Abuse Prevention Act adds bath salts as a Schedule I controlled substance. This means the possession of bath salts will be a violation of federal law. Of course, EMS providers encounter patients under the influence of all sorts of drugs, both legal and illegal, and merely classifying bath salts as illegal drugs will not stop their use. Hopefully, the act will reduce the frequency with which they’re encountered in the field.
Like any new massive federal legislation, the new federal drug law will have its share of bureaucratic tangles. However, several provisions of this law promise a new beginning in addressing drug supply problems that have plagued EMS agencies across the U.S.
Supreme Court Ruling
Affordable Care Act intact
On June 28, the Supreme Court issued its historic ruling on the constitutionality of the Affordable Care Act (ACA). This ruling moves the country one step closer to the full implementation of the healthcare reform that passed Congress and was signed into law by President Obama more than two years ago. Personal opinions aside, this ruling will have broad implications for everyone in the healthcare industry.
In one of the most watched cases in recent history, the court kept the law largely intact. The most controversial issue was regarding the constitutionality of the individual mandate provision that requires virtually everybody who can afford health insurance to buy it. In a 5 to 4 decision, the court ruled that the federal government has the authority to penalize individuals who choose not to purchase health insurance.*
One of the main goals of the ACA is to reduce the number of U.S. citizens without health insurance. It does so primarily through a combination of requiring people who can afford health insurance to buy it, requiring more businesses to provide health insurance to their employees and dramatically expanding Medicaid coverage. Medicaid is the joint state-federal health coverage for low-income and disabled individuals. Each state administers its Medicaid program within broad federal guidelines. Eligibility for the Medicaid recipients is largely left up to the individual states, with dramatic differences among them.
The ACA required states to standardize Medicaid eligibility to include everybody who has income less than 133% of the federal poverty level. For some states, this would represent a large increase in coverage, and costs. To ease the financial burden on the states, the federal government will cover all the costs of the Medicaid expansion for the first three years and 90% starting in 2020 and beyond.
The Supreme Court ruled that the federal government can’t withhold Medicaid funding from states that don’t expand their coverage. Effectively, this enables states to decide whether they’ll expand Medicaid, and some have already stated their reluctance to do so. Many experts believe that the Medicaid expansion is a good deal for the states and that state legislatures and governors will be under intense pressure from hospitals, healthcare providers and constituents to use the generous federal funds to cover more low-income people, but politics and ideology are sure to play a role as this plays out over the next few years.
Implications for EMS
Most experts feel that healthcare reform offers many opportunities for expanded roles for EMS in community healthcare. Reducing the uninsured will increase demand for health services, especially for primary and emergency care. Numerous innovative EMS agencies in the U.S. are learning from international experiences and working to deliver high-quality, cost-effective healthcare delivery models using EMS personnel in expanded roles and unique deployment strategies.
Despite the fact that the Supreme Court ruling affirms the constitutionality of the ACA, the federal and state elections in November are sure to play an important role in how healthcare is delivered in this country for decades to come. –Keith A. Monosky, PhD, MPM, EMT-P
Heat Wave Across the U.S.
As temperatures rise across the country, so does concern over the effect of this ongoing heat wave. The National Climatic Data Center reported more than 4,500 record daily highs nationwide in the past month. At least 30 heat-related deaths have been reported across the country, including 10 in Virginia, where many homes have been without power due to thunder storms.
Laura Stokes, MPAS, EMT-P, with Maryland’s Anne Arundel County Fire Department, says, “Since January, we’ve had 51 heat-related calls. [In] June we had 26. And just in the 10 days starting July, we’ve had 19. So we’re already way above what we would expect.” She advises her EMS colleagues to be aware that not all heat-related problems have obvious symptoms and that heat can exacerbate such existing conditions as chronic obstructive pulmonary disease and asthma.
David Miramontes, MD, FACEP, the EMS medical director and assistant chief of fire and EMS for the D.C. Office of Fire and EMS, also offered recommendations about dealing with hot temperatures and patient influx. He advises eating foods high in carbohydrates and drinking plenty of fluids throughout one’s shift, but avoiding caffeine. Dehydration due to such diuretics as caffeine and certain medications can be problematic for both EMS workers and patients alike. –Jackie Krah
Chicago Puts EMS Bus in Service
When Chicago Fire Commissioner Raymond Orozco saw an EMS bus at a conference in Washington, D.C. about four years ago, he knew it would be a helpful asset for the Chicago Fire Department (CFD). And thanks to a grant from the Department of Homeland Security and May’s North Atlantic Treaty Organization (NATO) Summit, it’s now part of the fleet in the Windy City, potentially freeing up some seven to 13 units for major events.
Leslee Stein-Spencer, manager of medical administration and regulatory compliance for CFD, wrote the Urban Area Security Initiative grant, which was approved because of (and rolled out for) the NATO Summit. It was officially unveiled to the public on June 15.
“We can transport up to 13 non-critical patients to different hospitals,” she says. “We staff it with four paramedics, and if someone took a turn for the worse, we can provide critical care.”
Reaction to the approximately $500,000 vehicle has been positive. “Hospitals that oversee our medical license love it. The Allied Department of Public Health, which is our regulatory agency, thinks it is great,” she adds.
Medical Director Eric Beck, DO, EMT-P, says, “The bus has advantages beyond transport and mass casualty events. It also has value at larger incidents where an air conditioned base would be desired or for rehab at a large fire.”
In the future, Beck says the department is working on obtaining a similar vehicle but with specific resources for burn patients and a large cache of burn supplies.