Anita Cicero

Expanding practitioner scopes of practice during public health emergencies: experiences from the 2009 H1N1 pandemic vaccination efforts.

In a public health emergency involving significant surges in patients and shortages of medical staff, supplies, and space, temporarily expanding scopes of practice of certain healthcare practitioners may help to address heightened population health needs. Scopes of practice, which are defined by state practice acts, set forth the range of services that licensed practitioners are authorized to perform. The U.S. has had limited experience with temporarily expanding scopes of practice during emergencies. However, during the 2009 H1N1 pandemic response, many states took some form of action to expand the practice scopes of certain categories of practitioners in order to authorize them to administer the pandemic vaccine. No standard legal approach for expanding scopes of practice during emergencies exists across states, and scope of practice expansions during routine, nonemergency times have been the subject of professional society debate and legal action. These issues raise the question of how states could effectively implement expansions for health services beyond administering vaccine and ensure consistency in expansions across states during catastrophic events that require a shift to crisis standards of care. This article provides an overview of scopes of practice, a summary of the range of legal and regulatory approaches used in the U.S. to expand practice scopes for vaccination during the 2009 H1N1 response, and recommendations for future research.

The Risk of Engineering a Highly Transmissible H5N1 Virus

Over the past 8 years, H5N1 avian influenza has sickened 571 people, killing 59% of them. To give some perspective, the fatality rate of the virus that caused the 1918 Great Pandemic was 2%, and that pandemic killed on the order of 50 million people. Like all influenza strains, H5N1 is constantly evolving in nature. But thankfully, this deadly virus does not now spread readily through the air from person to person. If it evolves to become as transmissible as normal flu and results in a pandemic, it could cause billions of illnesses and deaths around the world—the proportion of the global population affected by past pandemics. Scientists recently have announced that they genetically modified H5N1 in the laboratory and that this mutated strain spread through the air between ferrets that were physically separated from each other. This is ominous news. Since ferret influenza virus infection closely mirrors human infection and is similarly transmissible, these scientists appear to have created a bird flu strain with characteristics that indicate it would be readily transmissible by air between humans. In fact, the lead scientist on one of the experiments explicitly stated this. The question is this: Should we purposefully engineer avian flu strains to become highly transmissible in humans? In our view, no. We believe the benefits of this work do not outweigh the risks. Here’s why. There are no guarantees that such a deadly strain of avian flu would not escape accidentally from the laboratory. This particular experiment was performed by internationally respected scientists in biosafety conditions considered top of the line. They seem to have taken the expected and necessary precautions. The risk of a person accidentally becoming infected and starting an outbreak with this new strain is low. But it is not zero. The safety record of most labs working at high biocontainment levels is outstanding, and the historic number of accidents is very low. In almost all situations, even if a laboratory worker comes in contact with a dangerous pathogen and becomes sick, the risk of extensive wide community spread is negligible. This is because very few dangerous pathogens are as highly transmissible as influenza is. An accidental escape of an influenza strain from a lab in 1977 proves the possibility: That accident led to widespread flu epidemics. Given the potential global consequences of an accident with the newly modified strain of avian flu, we are playing with fire. We are not opposed to research in high-containment labs using dangerous pathogens, including H5N1. Over the past decade, the Center for Biosecurity has publicly argued for the importance of such research to develop diagnostics, medicines, and vaccines for the most threatening infectious diseases. But research and development for those purposes does not require engineering lethal viruses to make them more transmissible between humans. There is no virus disease today other than influenza that has exhibited the potential attributes of global transmission such as has been

Biosurveillance Where It Happens: State and Local Capabilities and Needs

In recent years, improved biosurveillance has become a bipartisan national security priority. As has been pointed out by the National Biosurveillance Advisory Subcommittee and others, building a national biosurveillance enterprise requires having strong biosurveillance systems at the state and local levels, and additional policies are needed to strengthen their biosurveillance capabilities. Because of the foundational role that state and local health departments play in biosurveillance, we sought to determine to what extent state and local health departments have the right capabilities in place to provide the information needed to detect and manage an epidemic or public health emergency-both for state and local outbreak management and for reporting to federal agencies during national public health crises. We also sought to identify those policies or actions that would improve state and local biosurveillance and make recommendations to federal policymakers who are interested in improving national biosurveillance capabilities.

Antimicrobial Resistance Is a Global Health Emergency

Leading experts have declared that the end of the age of antibiotics is imminent and that this development could undermine the foundation of much of modern medicine and public health.1,2 Since antibiotics were first introduced into clinical practice some 80 years ago, microbes have been evolving ways to resist these drugs, but in recent years this problem of antimicrobial resistance (AMR) has been rapidly getting worse.1 It is estimated that there are at least 2 million cases per year of AMR infection in the United States directly resulting in at least 23,000 deaths.2 In many nations around the world, the problem of AMR is worse than in the US. For example, rates of gram-negative resistance reach over 25% in parts of southern Europe, and all 6 regions of the World Health Organization (WHO) include countries that are reporting more than a 50% incidence of resistance of Klebsiella to third-generation cephalosporins.3,4 There are no reliable estimates of the number of cases globally, largely because surveillance is incomplete; however, fragmentary evidence suggests that the problem is much worse in many developing countries.1 These infections occur in nearly all medical settings. A substantial percentage of childhood ear infections, urinary tract infections, community-acquired pneumonias, sexually transmitted infections, and wound and skin infections are caused by pathogens that have evolved resistance to one or more antibiotics to which they were previously sensitive. For example, all WHO regions report countries with rates of resistance to penicillin exceeding 50% in community-acquired pneumococcal infections, and half of the WHO regions have countries wherein the rate of gonorrhea resistance to third-generation cephalosporins exceeds 50%.4

Travel Bans Will Increase the Damage Wrought by Ebola

Cases of Ebola that have turned up in Dallas and New York City have prompted calls for a travel ban to prohibit travelers from Sierra Leone, Liberia, and Guinea from entering the US during the ongoing Ebola outbreak. But travel bans have not worked in past epidemics and will not stop Ebola from spreading. Banning travel would slow the movement of people and goods to those countries, harm the international response to the outbreak in West Africa, and increase the prospect of ongoing global spread of Ebola. In addition, travel bans could lead to complete isolation of those 3 countries and would further worsen the economic and humanitarian toll of this crisis. US travel bans would also run counter to international agreements and could encourage other countries to impose their own bans against the United States and other countries in future outbreaks. The occurrence of secondary cases in 2 US nurses who treated the first Ebola patient in Dallas, and the corresponding lack of secondary cases occurring among members of the broader community, underscores the importance of focusing our Ebola control efforts on US hospitals and ensuring that clinicians in these settings have all of the training and protective equipment necessary to safely diagnose and treat Ebola patients.

Improving epidemic response: building bridges between the US and China.

I mproving Epidemic Response: Building Bridges Between the US and China was held in Washington, DC, on May 15, 2012. Hosted by the Center for Biosecurity of UPMC, this conference brought together leaders from China and the US who represent federal government, city and county governments, research organizations, industry, think tanks, and academia. The meeting provided a forum to increase mutual understanding of US and Chinese strategies for responding to major disease epidemics. It was also a venue for leaders, scientists, and officials from both countries to present their approaches to disease outbreak response and to consider effective practices and the potential for future collaborations in epidemic preparedness and response. Distinguished speakers and panelists explored a range of topics, from surveillance and sequencing, to medicine and vaccine development, to lessons from natural disasters, to partnerships between the respective federal agencies, to epidemic response in large cities.