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August 18
Join the Conversation:  Cybersecurity Challenges to Health Care

Implementing effective strategies and safeguards to address cybersecurity threats is a challenge for any industry, but the size and scope of attacks on health care information systems have grown rapidly in the past two years. Health care data can be used for to commit fraud or identity theft. It can also be used to disrupt of hospital systems. Connected medical devices with cybersecurity vulnerabilities left unaddressed could pose a risk to patient safety. Security of health care data and medical devices is essential to protecting patients and providing them with the highest level of care.

The Health Care Industry Cybersecurity Task Force is looking for your input to help improve cybersecurity across the industry. The Task Force is working to help identify risks, gaps, challenges, and best practices related to cybersecurity issues in the health care sector.

If you have an interest and expertise in health information technology, please help us better understand how you evaluate and mitigate risks related to cybersecurity in the health care sector and what gaps you think still remain.

Please take a few minutes to answer any or all of the following questions in comment to this blog. We are working to stimulate discussion and share the best ideas, so your responses may be made public. Please do not include any propriety, personal/private, sensitive, or confidential information.

  • What are the top cybersecurity risks and concerns unique to the health care sector?
  • What best practices are currently being employed by other sectors that might help us improve the security of the health care sector?
  • What are the biggest gaps and challenges for the development and deployment of medical devices and electronic health records?
  • How can the health care sector be better educated with regard to cybersecurity?
  • What challenges do health care sector organizations have to overcome in order to share cyber related incidents with a consortium?

Enhancing cybersecurity in the health care sector can help reduce risks for the industry and give patients peace of mind. The Task Force will use these inputs to augment its work and to support the broader goals of gathering information to disseminate to health care industry stakeholders; creating a single system for the Federal Government to share actionable cyber threat information; and developing the final report to Congress.

The Health Care Industry Cybersecurity Task Force was established by the U.S. Department of Health and Human Services in March 2016 per the Cybersecurity Information Sharing Act of 2015. The Secretary of Health & Human Services, in coordination with the Department of Homeland Security and the National Institutes of Standards and Technology, selected a broad array of expert representatives from the Federal Government, private sector health care organizations, other public and private sector experts on information technology and cybersecurity.

The Task Force holds monthly meetings to review its progress and identify concerns and practices both internal and external to the health care sector. The Task Force opens its meetings to the public on a quarterly basis. During the April and July meetings the Task Force received briefings from Federal leadership about the importance of cybersecurity for the health care sector, gained insight about the processes and best practices of other sectors, and reviewed the results of cybersecurity exercises and medical device workshops.

As Acting Assistant Secretary Mary K. Wakefield has indicated when she announced the formation of the Task Force, we need to protect the data that is at the foundation of our health care system. With your input, we hope to do that more effectively and find more efficient ways for the industry as a whole to protect health care information.

July 29
Pikachu in the PICU:  Pokémon Go Away!

By now you’ve heard of the new augmented reality game, Pokémon GO, which brings a beloved set of cartoon characters from the 1990s into your environment through an app on your cell phone.  Pokémon can appear anywhere on a map, so the game encourages you to walk around your neighbourhood to locations where the Pokémon can be found—generally known as  Pokéstops or Gyms.  You too can hunt, train, and capture Pokémon in your own backyard, your neighbourhood park, or… your local hospital…

That last location causes some challenges for maintaining safety and security at health care facilities.

When virtual Pokémon appear on their phone’s map, dozens of gamers can flock to that location.  Sometimes, that location can be near or even inside a health care facility, which can create anything from a nuisance for security guards to a patient safety issue. 

For example, the Utah Valley Hospital Exit Icon in Provo, Utah, found that it had four Pokéstops inside the hospital atrium, near a fountain, another display area, and even the hospitals helipad!  A dozen gamers standing around looking like they’re taking pictures in an atrium can made guards nervous.  A dozen gamers on a helipad trying to capture a difficult Pokémon can get in the way of patient care.

Guards have no way of telling the difference between a gamer and someone with nefarious intent casing the hospital’s vulnerabilities. 

By now, you might be wondering a couple of things:

  • Are there Pokéstops or Gyms in my hospital or healthcare facility? If you don’t already know if your facility has Pokéstops, you can find out by looking for your facility through the Pokémon GO mobile interface or by searching for your address on the Ingress website.Exit Icon   If you find a green or blue dot at your address, you may be part of the game. 
  • If I find a Pokéstop or Gym in my facility, can I get rid of it? You can request that the Gym or PokéStop at your facility be removed from the game.Exit Icon You may have the best luck by identifying your location through latitude and longitude which can be found by using one of many apps on your phone or by using Google Maps.Exit Icon
  • Will this keep all the Pokémon out of my hospital?  Probably not.  Getting rid of Pokéstops and Gyms will decrease the number of Pokémon running through your hospital – but it won’t catch them all.  Pokémon run around. Some of them may run into your hospital.  Even if there isn’t a Pokéstop or Gym in your facility, there is probably one in your area.

There are also examples of hospitals using the game as therapyExit Icon for some of their young patients.  If Pokémon is providing a benefit to your patients – say, by giving kids in your cancer ward something that makes them happy and gets them out of bed – you may want to keep your facility’s Pokéstops and Gyms. 

If you do that, make sure that your security staff knows that they may attract people who aren’t supposed to be in your facility.  If you do decide to keep the Pokéstops, you need a plan.  Be sure that your facility has a policy for dealing with problems and ensuring patient safety.  Security guards can’t just give people a pass in the spirit of the game.

Whether or not you get rid of our hospital’s Pokéstops, it is critical for healthcare facilities to maintain awareness of individuals trying to access or photograph your facilities.  People wandering around a hospital or healthcare facility who aren’t supposed to be there and they create additional risk for your facility. Your security staff needs to recognize that they are a problem and deal with them appropriately.

There are a wide range of reasons that people should not be roaming the halls, potentially interfering with patient care or breeching sterile locations to find a cartoon character.  As your hospital plans for cyber-threats, remember that not all of them look scary on the outside.

July 25
An Opportunity for Sharing Information about Cyber Attacks

As recent news reports show, security breaches and ransomware attacks in the Healthcare and Public Health sector are on the rise.  Criminal cyber attacks against health care organizations are up 125 percent compared to five years ago, replacing employee negligence and lost or stolen laptops as the top cause of health care data breaches. The average consolidated total cost of a data breach was $3.8 million, a 23 percent increase from 2013 to 2015.

To better prevent attacks on health information technology, organizations need better visibility into what to expect and how to respond. Timely information on the nature of attacks is critical to that ability. To enable better dissemination of threat information, the U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology (ONC) and the Assistant Secretary for Preparedness and Response (ASPR) released two Funding Opportunity Announcements (FOAs) to build the capacity of an Information Sharing and Analysis Organization (ISAO). This organization is being asked to:

  • Issue warnings about potential cyber threats;
  • Provide outreach and education that improves cyber security awareness;
  • Equip Healthcare and Public Health sector stakeholders to take rapid actions in response to cyber threat information shared by the ISAO, and
  • Facilitate cyber threat information sharing widely within the HPH sector, regardless of the size of the organization.

In short, the ISAO will create a more robust cyber information sharing environment, especially for smaller entities that may not have the resources to access such information on their own, by leveraging existing relationships. Through the resulting streamlined cyber threat information sharing process, HHS will be able to send cyber threat information to a single entity, which will be able to share that information widely to support stakeholders.

This is just the latest step in our cybersecurity efforts.  As part of Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap version 1.0, ONC identified the need to “coordinate with ASPR on priority issues related to cybersecurity for critical public health infrastructure.” For the past three years, ONC has worked closely with ASPR and other HHS offices and agencies and offices to facilitate cyber threat information sharing across the Healthcare and Public Health sector. They include:

  • The Office of the Assistant Secretary for Administration (ASA),
  • The Office of the Chief Information Officer’s (OCIO) Office of Information Security (OIS), and
  • The Office of Security and Strategic Information’s (OSSI) Cyber Threat Intelligence Program (CTIP).

This work builds on two Executive Orders related to cybersecurity. Executive Order 13636, Improving Critical Infrastructure Cybersecurity, designates HHS as the agency responsible for sharing cyber threat information with private sector organizations in the Healthcare and Public Health sector. Executive Order 13691, Promoting Private Sector Cybersecurity Information Sharing, encourages the development of ISAOs to serve as focal points for cybersecurity collaboration within the private sector and between the private sector and government.  

Establishing robust threat information sharing infrastructure and capability within the Healthcare and Public Health Sector is the foundation for the privacy and security of health information, which in turn builds trust in the digital health system. By continuing to lead, coordinate, and fund cyber threat information sharing capability for the Healthcare and Public Health sector, together we can continue to strengthen the security of the health care system data and ensure it is available when and where it is needed to help improve individuals’ health.

Find more information about both the ONC and ASPR Funding Opportunity Announcements on www.Grants.gov.

July 15
Securing health at our nation’s most symbolic events

Two weeks ago, hundreds of thousands of Americans gathered in Washington, D.C., to celebrate our nation's birthday. The celebration brings to mind the battles that were fought to gain our nation’s independence, and the might we maintain to preserve it. Many of those gathered in our nation’s capital to celebrate might not have realized that there was a force working behind-the-scenes to protect their health during the event, just as we do during similar significant events.

The work that goes into protecting the health of those attending and working at these events is extensive, and we take many variables into consideration, such as estimated crowd size, demographics, weather conditions, the type of event, and potential man-made threats.

When we are asked to support an event, we coordinate with all other entities that have a supporting role, including federal, state and local governments as well as private entities, to ensure we have the resources on-hand to address the issues public health might face. This collective effort ensures that all issues are addressed and all necessary resources are provided to support the event and possible threats.

Our planning also takes into consideration various areas of public health, such as disease surveillance as well as addressing how we would get people who need medical treatment to medical facilities where they could receive care.

Take, for instance, Pope Francis’ visit to Washington, D.C., this past September. We had to consider the expected very large crowds, demographics, historical data from around the world, threats such as weather, transportation and security constraints, and the multiple venues that the Pope visited during the three days he was in Washington, D.C.

We also had to consider that people with more significant health issues might be more prone to join crowds gathered to celebrate Pope Francis’ visit in hopes they might receive a blessing. These factors helped us determine how best to protect the health of the attendees and support the needs of the agencies requesting our assistance.

While event attendees are one group we help support, we support those behind the scenes as well. For example, at some special events ASPR provides veterinarian support through HHS’ National Disaster Medical System to ensure that animals involved in law enforcement receive veterinary medical care if needed.

ASPR supports special events throughout the nation, but the Washington, D.C., area tends to support more special events than most other regions in the country combined. As the Regional Administrator/Regional Emergency Coordinator for the National Capital Region since 2007, I’ve been involved with dozens of events and have seen significant improvements in the way interagency partners collaborate in preparing for and responding to the various events. ASPR was created just six months before I joined, and I started two weeks before the agency supported its biggest event at that time – the 2007 Independence Day Celebration in Washington, D.C. A year-and-a-half later, we were requested to support the event that remains the largest event that this agency, and this region, has supported to date – the 2009 Presidential Inauguration of President Barack Obama.

President Obama’s 2009 inauguration was attended by approximately five times the number of people who attended the previous Independence Day Celebration event. Given its sheer size and scope, it presented the biggest planning and interagency coordination challenges we had faced.

Through supporting this event and a number of subsequent events — to include for example the 2010 & 2016 Nuclear Security Summit, 2012 African Leaders Summit, the 2013 Presidential Inauguration, and the yearly State of the Union Address — we have continually strengthened the collaboration and trust among our partner agencies at the federal and local levels.

After serving nine years in this role, I’ve seen that thorough planning, preparation and coordination is vital to protecting the safety and health of those gathering for special events no matter where they take place.

Do you have experiences or plans to share that would help other health agencies plan special events in your state or community? Share them securely through TRACIE!

July 14
Tome precauciones para evitar infectarse con el virus del Zika cuando viaja al extranjero

Por la Dra. Nicole Lurie, Subsecretaria para la Oficina de Preparativos y Respuesta, Departamento de Salud y Servicios Humanos de los Estados Unidos

Tome precauciones para evitar infectarse con el virus del Zika cuando viaja al extranjero

El virus del Zika está causando devastadores defectos de nacimiento en países que tienen brotes del mismo. Provoca malos resultados en los embarazos, como el aborto y el mortinato, y también puede causar problemas neurológicos serios. El Zika es un virus que se transmite principalmente por la picadura del mosquito, pero a diferencia de otros virus transmitidos por los mosquitos como el dengue, este también es de transmisión sexual.

Muchas personas viajan durante el verano, ya sea a visitar familiares y amigos, para tomar unas vacaciones o de negocios. Este verano, alentamos a las personas a considerar los riesgos que viajar puede tener  por la creciente propagación del virus del Zika, especialmente si usted o su pareja está embarazada o si están tratando de embarazarse. Si planea viajar a un lugar donde el virus del Zika se está esparciendo, estos son unos pasos importantes que debe tomar durante su viaje y a su regreso.

Si va a viajar al extranjero, primero revise la página de salud del viajero de  los Centros para el Control y Prevención de Enfermedades (CDC por sus siglas en inglés) (http://espanol.cdc.gov/es/travel/page/zika-travel-information) para ver si el virus del Zika se está propagando en su destino planeado. El virus del Zika se está propagando en México, Centro y Suramérica, las islas del Pacífico y partes de África.

Ya que el virus puede causar severos defectos de nacimiento, los CDC recomiendan que las mujeres embarazadas no viajen a áreas donde hay Zika. Si una mujer embarazada debe viajar a un área donde hay Zika, debe hablar con su médico y seguir de manera estricta los pasos para prevenir las picaduras de mosquitos. Las mujeres embarazadas también deben hacerse la prueba de diagnóstico a su regreso a los Estados Unidos. Los hombres que son parejas de mujeres embarazadas deben considerar la posibilidad de que ellos puedan infectar a sus parejas a través de relaciones sexuales. Los hombres que viajen a zonas donde se está propagando el virus del Zika deben tomar los pasos apropiados para prevenir las picaduras de los mosquitos o usar condones de forma correcta cada vez que tengan relaciones sexuales durante el embarazo.

Todos deben tomar precauciones para prevenir las picaduras de los mosquitos, evitar las infecciones con el virus del Zika y prevenir que se siga progando. Para prevenir las picaduras de los mosquitos, tome las siguientes precauciones durante al menos tres semanas después de que regrese de su viaje:

Los síntomas del virus del Zika incluyen fiebre, salpullido, dolor en las coyunturas y ojos rojos. Sin embargo, la mayoría de las personas infectadas por el  Zika nunca tienen síntomas, así que no asuma que no está infectado si no se siente enfermo. Instamos a todos para que tomen precauciones y prevenir las picaduras de los mosquitos, también para prevenir la propagación del virus del Zika a través de las relaciones sexuales.

Los CDC recomiendan que las mujeres, que hayan viajado a un país en el que haya transmisión del Zika, esperen al menos ocho semanas, después de su regreso a casa, antes de tratar de embarazarse, ya sea que tengan o no tengan síntomas. Los hombres que hayan viajado a áreas donde hay propagación activa del virus del Zika y que no hayan desarrollado síntomas de infección del mismo deben utilizar un condón o abstenerse de tener relaciones sexuales durante al menos ocho semanas después de regresar de su viaje. Los hombres que hayan viajado a un país con transmisión del Zika y que tengan síntomas deben considerar el uso de condón, o no tener relaciones sexuales, durante al menos seis meses después de que iniciaron los síntomas.

Las mujeres que no quieran o no planeen embarazarse deben hablar con sus médicos sobre los diferentes métodos anticonceptivos disponibles para prevenir embarazos no planeados. Como madre y abuela, yo tomo los efectos del Zika en la salud de una forma muy, muy seria. Los efectos de la infección por virus del Zika pueden ser devastadores. Saber qué hacer para protegerse del Zika le ayudará a disfrutar su viaje al extranjero de forma segura y puede ayudar a prevenir la propagación del virus en los  Estados Unidos.

Para mantenerse actualizado con la información del Zika y lo que significa para la salud de su familia visite http://espanol.cdc.gov/enes/zika/.   

July 06
Take precautions to avoid Zika virus infection during trips abroad

The Zika virus is causing devastating birth defects in countries with outbreaks of the virus. It also causes bad pregnancy outcomes, like miscarriage and stillbirth, and can cause serious neurologic problems as well. Zika is a virus primarily spread through mosquito bites, but unlike other mosquito-borne viruses such as dengue, it can also be spread through sex.

Many people travel during the summer, whether to visit family and friends, to take a vacation, or for business. This summer, we urge people to consider the risks that travel may pose due to the growing spread of Zika, especially if you are or your partner is pregnant or trying to get pregnant. If you are planning to travel to a place where Zika is spreading, there are some important steps you should take during your trip and after you return.

If you are traveling abroad, first check the Centers for Disease Control and Prevention’s travel page to see if Zika is spreading in your planned destination. Zika virus is currently being spread in Mexico, Central and South America, the Caribbean, the Pacific Islands, and parts of Africa.

Because the virus can cause severe birth defects, CDC recommends that pregnant women do not travel to areas with Zika. If a pregnant woman must travel to an area with Zika, she should talk with her health care provider and strictly follow steps to prevent mosquito bites. Pregnant women also should be tested upon return to the United States. Male partners of pregnant women should consider the possibility that they could infect their partners via sex if they become infected. Men who travel to areas where Zika is spreading should take appropriate steps to prevent mosquito bites and either use condoms correctly every time they have sex during the pregnancy.

Everyone should take precautions to prevent mosquito bites to avoid infection with Zika virus, and to prevent further spread of the virus. To prevent mosquito bites, follow these precautions for at least three weeks after you return from travel::

The symptoms of Zika include a fever, rash, joint pain, and red eyes. However, most people infected with Zika never have any symptoms, so do not assume you are not infected if you do not feel sick. We urge everyone to take precautions to prevent mosquito bites and to prevent the spread of Zika virus via sex.

CDC recommends that women who have traveled to a country with Zika transmission wait at least eight weeks after returning home before trying to become pregnant, whether they have symptoms or not. Men who have traveled to areas where Zika is actively spreading and did not develop symptoms of Zika virus infection should use a condom or abstain from sex for at least eight weeks after returning from travel. Men who traveled to a country with Zika transmission and had Zika symptoms should consider using condoms or not having sex for at least six months after the symptoms began.

Women who do not want to or are not planning to become pregnant should talk with their healthcare providers about the many kinds of contraception available to prevent unintended pregnancy. As a mother and grandmother, I take the health effects of Zika very, very seriously. The effects of Zika virus infection can be devastating. Knowing what to do to protect yourself from Zika will help you safely enjoy your trip abroad, and can help prevent Zika from spreading in the continental United States.

To keep up with the latest information about Zika and what it means for your family’s health, visit the Center for Disease Control and Prevention's Zika Virus page.

July 05
Staying Safe in the Summer Heat

For most parts of the country, summer brings lots of heat. Over the last few weeks, just about everybody has been feeling the heat. Cities and towns from across the country have been coping with heat advisories and trying to find ways to stay cool.

Some people handle the heat pretty well. They just need to remember to take it slow, protect themselves from sun exposure, drink plenty of fluids, and do their best to stay cool. But other people – especially young children, older adults, athletes, people with low incomes, outdoor workers, and people with certain medical conditions – are at greater risk and need to be even more careful.

By knowing how to prevent heat-related illnesses, spot the warning signs, and being ready and willing to act, you could protect your own health or even help save someone’s life.

Prevention promotes summer fun

Preventing heat-related illnesses is the best way to protect yourself and those you care for. Here are some things you can do to stay healthy when temperatures rise:

  • Spend time in locations with air-conditioning when possible.
  • Drink plenty of fluids. Don’t wait until you are thirsty. Good choices are water and diluted sport electrolyte drinks (1 part sport drink to 2 parts water) unless told otherwise by a doctor.
  • Choose lightweight, light-colored, loose-fitting clothing.
  • Limit outdoor activity to morning and evening hours.
  • Never leave a child or a pet in a parked car - even if the windows are open.

Helping people with heat stroke and heat exhaustion

Heat stress and heat exhaustion are two serious heat-related illnesses. Although both illnesses are brought on by heat, but the signs and the treatment are a little different for each one.

Heat stroke is the most severe heat-related illness. Signs include a body temperature above 103 degrees Fahrenheit; hot, red, dry skin; rapid and strong pulse; dizziness; nausea; and altered mental status which can range from confusion and agitation to unconsciousness.

Heat stroke is a medical emergency. If someone is suffering from heat stroke, call 911 immediately and take steps to cool the person. Don’t give the person fluids to drink. Instead, get them into cold water – you could put them under a cold shower or cool them off with a garden hose. When help arrives, be sure to let responders know what you have done to help.

People suffering from heat exhaustion may experience heavy sweating; weakness; cold, pale, and clammy skin; fast, weak pulse; and nausea or vomiting. Early signs include muscle cramps, heat rash, fainting or near-fainting spells, and a pulse or heart rate greater than 100.

If someone is suffering from heat exhaustion, help them rest and cool down. Apply cool, wet cloths to the body especially to head, neck, arm pits and upper legs near the groin area where combined 70 percent of body heat can be lost; and have the person sip water. They should remain in the cool location until recovered with a pulse heart rate is well under 100 beats per minute. If the symptoms persist, call a doctor.

Protecting your community

As air conditioning use increases, electrical grids can become overwhelmed causing power outages. In power outages, people who rely on electricity-dependent medical devices, like oxygen concentrators, may need assistance so check on family members, friends and neighbors who use this type of equipment.

Community organizations and businesses can help local emergency managers and health departments plan for the community’s health needs amid the summer heat – and other emergency situations that cause power outages – using the HHS emPOWER Map. The HHS emPOWER Map provides the monthly total number of Medicare beneficiaries’ claims for electricity-dependent equipment at the national, state, territory, county, and zip code levels.

Learn More

These tips can help you have a safer, healthier summer. To learn more about groups that are a risk for heat-related illnesses, check out the CDC Extreme Heat Prevention Guide.

June 14
When active shooters invade safe spaces, having a plan matters

Planning considerations for health care settings

This week, we saw the deadliest mass shooting in the United States. When many people in the community talk about Pulse, the gay night club that was the scene of the attack, they say the same thing: “this was a safe place.”

The same can be said for hospitals:  we think of them as safe places. Yet according to a study in the Annals of Emergency Medicine, there were 154 hospital-related shootings from 2000-2011.

The statistic is a tragic reminder of the need to be ready at all times.

At this time, there are no specific, credible threats to the U.S., including to the health care system. But this is a good time to think about ways that your hospital or health care facility can plan to protect patients and staff if an active shooter threatened your facility.

What would that response look like in your hospital? Your neonatal ICU? Your emergency department? Your infectious disease quarantine areas? How can you plan for a response that takes into account the special challenges throughout your hospital? And how can you make sure your staff knows what to do and is ready to act when seconds count?

Federal agencies and private sector partners have collaborated on planning guides to help you work through many of these issues.

2015 Healthcare and Public Health Sector Coordinating Council Guidance on Active Shooter Planning and Response in a Healthcare Setting contains specific guidance for healthcare providers. This guidance addresses many unique aspects of healthcare settings, including many of the issues outlined above.

Incorporating Active Shooter Incident Planning into Health Care Facility Emergency Operations Plans helps emergency planners, disaster committees, executive leadership, and others better prepare for an active shooter incident and integrate that planning into their emergency operations plans. Using this resource, your facility can work to improve information sharing, coordination with law enforcement, and implementation of psychological first aid strategies.

Both of these resources give you some great tools to get started. To learn more, check out the ASPR TRACIE topic collection on Explosives and Mass Shooting. ASPR TRACIE Technical Assistance Specialists can help you locate specific resources and connect you with subject matter experts.

If your health care facility is already planning for the effects of a mass casualty event, let us know. We want to highlight best practices and share them with the community so that we can all better protect health and save lives. 

The Healthcare and Public Health Critical Infrastructure Partnership Program connects public and private sector to enhance resilience of our health care system.  If you would like more information about the partnership, please visit the Critical Infrastructure Protection for the Healthcare and Public Health Sectors website.

June 07
Anticipating Threats, Investing in Solutions

Deadly new strain of bacteria? BARDA’s already working on it.

For the first time, the bacterial gene mcr-1, which confers resistance to the “antibiotic of last resort,” colistin, was found in a bacterium isolated from a patient in the United StatesExit Icon. The bacterium bearing the gene, a member of the E. coli strain, was recently found in the urine sample of a woman in Pennsylvania. While this particular strain of bacteria is still sensitive to other antibiotics, there is concern that its appearance in the U.S. may signal the dreaded arrival of readily-transferrable colistin-resistance to the American healthcare system.

Resistance to colistin, a member of the polymyxin-class of antibiotics, is especially troubling because colistin is widely considered the drug of last resort for treating patients with multidrug-resistant infections. Amongst multidrug-resistant bacterial strains, one particularly dangerous family of bacteria is the carbapenem-resistant Enterobacteriaceae (CRE).

The medical community is particularly concerned about CRE given that nearly half of all hospital patients that contract CRE-based bloodstream infections do not survive.

Colistin, one of the few antibiotics left that still works against CRE, often serves as the last available treatment option for those fighting these deadly infections. Given the lack of alternatives, the rapid spread of resistance to this last line of defense is cause for alarm.

The mcr-1 gene is one that that confers colistin resistance to its bacterial carriers. While its appearance in the U.S. is certainly distressing, it is not altogether surprising. Scientists first identified the mcr-1 gene in China in 2015Exit Icon and since then have found it lurking in bacteria in other locations around the world. The gene itself is found on a small piece of DNA called a plasmid that is capable of moving from one bacterium to another.

As such, the mcr-1 containing plasmid can help spread of colistin resistance rapidly to other bacteria, including those already resistant to all other available antibiotics. As a result, a ‘post-antibiotic era’ of deadly bacterial strains that are not treatable with any available antibiotic is becoming a very real possibility – a potentially nightmarish scenario for healthcare providers.

Having recognized that drug-resistant bacteria are a serious health threat, and in particular, CRE strains that are resistant to the last remaining treatments (in other words, colistin), BARDA already has made investments to develop new antibiotics that will bolster the treatment options. One such candidate is plazomicin, a product under development in partnership with Achaogen, Inc.

Plazomicin is a novel member of the aminoglycoside class of antibiotics, a group that includes such well-known antibiotics as gentamicin and amikacin. However, unlike its predecessors, plazomicin has been engineered to overcome the resistance mechanisms that bacteria use to inactivate other aminoglycosides. Plazomicin is active against a broad spectrum of bacteria, including multidrug-resistant strains that are not susceptible to many other antibiotics.

Of note, plazomicin shows activity against bacterial isolates that exhibit both carbapenem- and colistin-resistance, making it a candidate for treating CRE infections or infections resulting from colistin-resistant strains. In one exciting set of preliminary laboratory tests, plazomicin demonstrated activity against colistin-resistant strains that use the same mechanism of resistance as that conferred by the mcr-1 gene.

Plazomicin currently is being tested in two Phase 3 clinical trials, one focusing on the treatment of patients with serious infections due to CRE, and the other focusing on the treatment of patients with complicated urinary tract infections (cUTI).

As a continuation of this project, BARDA recently awarded an option worth $20 million on its current contract with Achaogen to fund, in part, the cUTI Phase 3 clinical trial. This clinical trial is intended to support the FDA approval of plazomicin, thereby bringing it to the market for clinical use.

Other promising candidates are being developed through BARDA’s public-private partnership with GlaxoSmithKline, plc (GSK). This partnership enables BARDA and GSK to develop, jointly, a flexible collection of drug candidates identified from GSK’s own antibiotic portfolio.

One is gepotidacin (GSK2140944), the first in a new class of antibiotics that is currently in Phase 2 human clinical trials for the treatment of gonorrhea. Gepotidacin is a novel triazaacenapthylene antibacterial that selectively inhibits bacterial DNA gyrase and topoisomerase IV by a unique mechanism not utilized by any currently approved human therapeutic agent.

A second candidate is a compound called GSK3342830, a novel cephem antibiotic that is engineered to take advantage of bacterial iron-uptake pathways, thereby increasing its own uptake into (and therefore, activity against) otherwise drug-resistant bacteria.

Both candidates show broad-spectrum in vitro activity against a variety of multidrug resistant bacterial strains, including colistin-resistant E. coli strains specifically bearing the mcr-1 plasmid (limited set of data). Although more tests will be necessary to explore the potential of both drugs for treating colistin-resistant bacterial infections in the clinic, these preliminary results are very promising.

These three compounds – plazomicin, gepotidacin, and GSK3342830 – represent components of BARDA’s existing antibacterials portfolio that have the potential to address colistin-resistant strains, a critical gap in our current medical armamentarium.

As new forms of antibiotic resistance continue to spread globally, the possibility for nightmarish bacterial strains can no longer be ignored; the continued development of new options for treating drug-resistant bacteria will be essential to preserving our ability to effectively combat infections. BARDA and its industry partners will continue to lead the charge against these threats, both present and future.

May 27
Want a healthy, safe summer? Here are 3 tips to help you get started!

I love summer.  Love it! Every chance I get, I want to go outside, play with my daughter, hit the pool, and find lots of new ways to enjoy the sunshine.  There is so much to see, do – so much fun to experience – over the summer. To keep doing all of those things, you have to protect your health.  And you’ll probably want to help your friends, family and neighbors stay healthy this summer, too. 

Whether you love the sun or you can’t imagine why anybody would want to be outside when the temperature is above 70 degrees, here are three things that you can do to promote health and safety.

Tip 1:  Stay safe in extreme heat: 

What is extreme heat anyway? The answer depends on where you live, but in general, the Centers for Disease Control and Prevention (CDC), extreme heat or heat waves occur when the combination of heat and humidity causes the air to become oppressive.  When that happens, take precautions.  You might want to just go inside to an air conditioned place – especially if you are an older adult, have a young child or suffer from a chronic medical condition

If you can’t get inside to an air conditioned spot or you just don’t want to, there are still some precautions you can and should take to stay healthy.  Stay hydrated by drinking lots of water – and avoiding sugary beverages.  Wear light-weight, light colored, loose fitting clothes.  Protect yourself from sunburn. Sunburn can significantly slow the skin’s ability to release excess heat.  If you are an athlete, limit your outdoor activity. If you are going to work out outside, do it during the coolest parts of the day.

Extreme heat can cause heat stroke or heat exhaustion.  Learn the signs of both and how to help.

Tip 2:  Protect Yourself from Zika and Other Mosquito-Borne Illnesses

By now, you’ve probably heard a lot about the Zika virus and how it can affect your health or – if you are pregnant – the health of your baby.  You can get Zika by being bitten by an infected mosquito or by having sex with someone who is infected with Zika.

So far, there have not been cases of Zika caused by mosquitos in the United States, though there have been cases of Zika among people who have traveled to countries where mosquitos carry the virus.  There have also been cases of local mosquito-borne transmission of Zika virus in some U.S. territories, including Commonwealth of Puerto Rico, the U.S. Virgin Islands, and American Samoa. 

If you are pregnant, don’t travel to areas where there is local transmission of Zika. If your partner has traveled to an area where Zika is being spread by mosquitoes, take steps to avoid sexual transmission by either using condoms or refraining from sex for the duration of the pregnancy.

Although there have not been any domestic cases of Zika, there have been domestic cases of other mosquito-borne diseases like dengue and chikungunya viruses. Take steps to avoid getting bitten by mosquitoes by wearing long sleeves and long pants and using an EPA-registered insect repellent.

There’s a lot of information out there on Zika – and not all of it is accurate. As the situation on Zika evolves, learn about Zika from credible sources like the Centers for Disease Control and Prevention (CDC).

Tip 3:  Update Your Emergency Plans

Are you traveling this summer? Are your kids going to summer camp? Are you headed somewhere you don’t normally go? If so, be sure to update your emergency plan.

If you have children, as school lets out for the summer, think about your emergency communications plan to be sure you, your kids, and the people who can for them can get in touch with each other – whether that is a summer camp or just a family member babysitting. If disaster does strike, having a plan for reunification can reduce stress for the whole family.

If you are traveling, make sure that you know the common hazards of the places where you are going and how to stay safe. For example, if you’re headed to the beach, learn a little bit about hurricane preparedness and find the evacuation routes.   

Summer can be a great time to enjoy the outdoors, the sunshine and maybe even a bit of travel.  Make sure you include protecting your health and safety in your summer plans so that you can make the most of the season. 

Got other ideas on staying safe and healthy this summer? Share them in a comment on this blog!

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