Ebola treatment in America

With few patients and no approved medications for the treatment of Ebola virus in the United States, caring for those who develop the disease may seem like uncharted territory to many. Pharmacists who have already worked with these patients can help provide a road map for others in the profession.

During a session at ASHP’s 2014 midyear meeting in Anaheim, Calif., pharmacists who treated patients with Ebola virus disease in hospitals across the United States shared their clinical insights, nutritional considerations, and experiences working with investigational medications.

Impact in the United States

While most confirmed cases of Ebola virus have been in West Africa, the United States also has played a role in the 2014 Ebola outbreak by conducting trials, caring for patients with the disease in America, and sending officers of the U.S. Public Health Service Commissioned Corps to lend a hand in Liberia. 

According to Robert DeChristoforo, RPh, MS, FASHP, chief of the National Institutes of Health (NIH) Clinical Center Pharmacy, the NIH is currently conducting two Ebola vaccine trials at its campus in Maryland. The first will assess the safety and immunogenicity of the NIH/GSK cAd3-EBO vaccine, while the second will seek to establish the maximum safe and tolerated dose of a two-dose prime boost IM VSV EBOV vaccine.

The United States also has begun to see cases of patients infected with the Ebola virus disease within its own borders, and healthcare teams across the country are preparing to treat this complicated and potentially deadly disease.

Clinical presentation

Clinical pharmacists can play a valuable role throughout the treatment of patients with Ebola virus disease. They can determine drug distribution, serve as coordinators of pharmaceutical care, and participate in daily patient meetings, although since pharmacists are not typically numbered among the personnel essential to the patient room, they may need to communicate by means of such alternative methods as short-wave radio or walkie-talkie.

Andrew Faust, PharmD, BCPS, is a critical care pharmacy specialist at the Texas Health Presbyterian Hospital, where two of the first Ebola cases to arise in the United States - both nurses at the hospital -were treated.

Experts agree that early detection of Ebola virus disease is critical to providing the best patient outcome; however, said Faust, the difficulty with the early stage of the disease is that it looks like many other viral illnesses. Early disease symptoms that occur between days one and four include fever, myalgias, malaise, and cramping.

“Really, what you need to do with these people is draw labs, and the hallmark labs here are going to be leukopenia, thrombocytopenia, and transaminitis,” he said. “If you see those in conjunction with the travel history and it all seems to fit, you need to start thinking ‘Ebola virus.’”

Faust recommends consideration of alternative infectious diseases, such as malaria or bacterial gastroenteritis, and the use of empiric antibiotics, if needed, until EVD is confirmed.

Fluid loss

The acute phase, which is said to begin about day five, consists of severe gastrointestinal symptoms, hypotension, coagulopathies, electrolyte derangements, and renal failure.

“The amount of GI output in these patients is profound - I mean eight to 10 liters of diarrhea a day. Even as an ICU clinical specialist, having seen people who are really, really sick, I’ve never seen diarrhea like that before,” Faust said.

Supportive care is an essential part of caring for these patients.

To compensate for the large volume of diarrhea patients can discharge, fluid resuscitation is particularly important. Faust said that when teams at Texas Health Presbyterian Hospital were treating patients, they tried to ensure that the amount of fluid going in matched the amount of fluid going out.

“Your rates on fluids may exceed things like 300 or 400 cc an hour, especially if your patients have GI loss of diarrhea and vomiting at the same time,” he said.

There’s no established best choice for fluid, but based upon what’s known about sepsis and septic shock, said Faust, crystalloids may be preferred over colloids.

“What we found was that when our patients developed liver failure or hypoalbuminema, we ended up using a combination of IV albumin and crystalloid,” he said.

Anticipate problems

As the Ebola virus runs its course, all electrolytes may be affected, creating the need for electrolyte management. It is best to anticipate problems early, Faust said, such as the need for saline if the patient is vomiting a lot or of bicarbonate if there is frequent diarrhea.

One of the biggest challenges with electrolyte management and provision of other types of treatment is that the healthcare team may not have the luxury of frequently running patient labs. According to Faust, most hospitals do not have biosafety level 4 facilities equipped for the safe handling of such virulent pathogens. Thus, labs should be preferentially run on point-of-care devices in the patient’s room; however, not all lab tests are available on such platforms.

Finally, those patients who reach the late stage of Ebola disease may experience immunosuppression, rapid deterioration with multiple organ failure, anuria, respiratory failure, or hemorrhage.

Limited data are available concerning critical care practices for Ebola patients; however, Faust believes, the most important aspect of any care plan is to plan ahead and be prepared for whatever may happen.

Nutritional considerations

Early aggressive nutrition support may also be beneficial for patients with Ebola virus disease. Most patients experience significant gastrointestinal symptoms as well as cytokine surges and releases of reactive oxygen species associated with the disease.

According to Nisha Dave, PharmD, BCNSP,a nutrition support clinical specialist at Emory University, it is important to monitor a patient’s nutrition intake and tolerance very carefully.

“If diarrhea is present, oral rehydration salts or solutions should be considered and used early on in the disease process,” she said. “Once the GI symptoms progress, however, the use of parenteral nutrition as well as enteral nutrition should be considered and started, earlier rather than later.”

Micronutrient supplements, such as vitamin A, vitamin B complex, or vitamin C, could also be used in an effort to replace nutritional losses and boost a patient’s immunity.

Investigational drugs

Investigational drugs can play an important role in the treatment of Ebola virus disease, but owing to their investigational status, they aren’t always easy to acquire, and obtaining them may require some additional preparation.

Jonathan Beck, PharmD, pharmacist coordinator of the Investigational Drug Service at Nebraska Medicine, the teaching hospital for the University of Nebraska Medical Center, said that once a hospital is notified of an incoming Ebola patient, one of the first places to start actually is with a drug manufacturer.

“They are at the point now where they have all gone through this procedure several times,” Beck said. “They have protocols. They have policies. They know shipping, they know how to get things across international borders, and they have INDs that can help,” he said, referring to Investigational New Drug applications.

Hospitals can apply for an IND as well, or for an exemption from the FDA to allow the transport of investigational medications; however, the application process is lengthy and time-consuming to complete.

An eIND bypasses the IND application and allows the FDA to authorize the use of an experimental drug in an emergency situation; however, Beck said, another option is contacting the manufacturer who may already have INDs available.

“So what you are doing is basically you are becoming a site in their protocol, so you are following their protocol, you’re working with them, you’re using the IND, and from that point forward it saves you a lot of time and you can work on all the other documentation,” he said, adding that drug plans will also have to be approved by a hospital’s institutional review board.

Jill Sederstrom is a freelance writer in Kansas City.