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Pharmacists’ Investigational Drug Services Aid Ebola Response

Dec 03, 2014
Janet Mighty

Janet Mighty

THE HANDFUL OF  U.S. CASES OF EBOLA  VIRUS DISEASE (EVD) have cast investigational drug therapy into the national spotlight and brought attention to this area of pharmacy practice.

“We are currently in discussions and working to facilitate agreements in order to obtain access to investigational new drugs” for patients with EVD, said Janet Mighty, assistant director of the investigational drug service at Johns Hopkins Hospital in Baltimore.

Johns Hopkins is one of three state-designated EVD treatment hospitals in Maryland but, at presstime, had not admitted any patients diagnosed with the disease.

Mighty said the selection process for the state designation required a site visit by Centers for Disease Control and Prevention (CDC) officials, and pharmacists assisted with the review of the hospital’s readiness.

She said pharmacists have also participated in administrative meetings and conference calls convened by Johns Hopkins Medicine to discuss the clinical care of patients with EVD and networked with colleagues elsewhere to obtain information about the best practices for patient care.

Mighty couldn’t comment on specific investigational drugs that Johns Hopkins may use to treat patients with EVD. But only a few such products appear to be currently available.

Durham, North Carolina–based Chimerix Inc. on October 6 announced that brincidofovir, an investigational oral nucleotide analog whose efficacy against several viruses is being tested, was being made available under an emergency use protocol for the treatment of patients with EVD.

Other investigational drugs that have been used in patients with EVD include TKM-Ebola, from Vancouver, British Columbia–based Tekmira Pharmaceuticals Corp., and ZMapp, made by Mapp Biopharmaceutical Inc. of San Diego.

Johns Hopkins Medicine's Investigational drug services may have an important role to play in the current Ebola virus public health issue.

Investigational drug services may have an important role to play in the treatment of patients with the Ebola virus.

The supply of ZMapp has been temporarily exhausted, according to the manufacturer. But at least one U.S. hospital—the Nebraska Medical Center in Omaha—has experience with procuring and using the other two investigational drugs in patients with EVD.

According to the hospital, Ebola victim Richard Sacra’s treatment regimen included TKM-Ebola. Ashoka Mukpo, the second Ebola virus–infected patient to receive care at the hospital’s biocontainment unit, received brincidofovir during his hospital stay.

Both patients also received blood components from patients who had recovered from EVD, as well as supportive care, and both were ultimately cured of the infection and released from the hospital.

Three Nebraska Medical Center pharmacists—Katharine Reisbig, medication safety manager; Melissa Welch, operations manager; and Jonathan Beck, investigational drug service coordinator—said in a written statement that the pharmacy department is an integral component of the safe and effective care provided to patients in the biocontainment unit.

According to the statement, the acquisition and management of investigational therapy may require coordination among pharmacy and medical staffs and drug manufacturers, outside agencies such as FDA, CDC, and state and local health departments. Pharmacy staff may also need to work with specialized courier services to bring investigational therapy onsite for emergency use outside of normal business hours.

For investigational drugs and other therapies used in the biocontainment unit, getting the medicines from the pharmacy to the patient requires “a review of every touch point within the medication delivery model,” according to the statement.

That means meticulous attention to details, like using disposable medication containers that can be incinerated and ensuring that no staples or other sharp objects are present in packaging that is sent to the unit.

Vivian Johnson, vice president of pharmacy services at Parkland Health & Hospital System in Dallas, said her department recently spent two days examining the medication-use process, from procurement to administration, and making changes needed to safely care for patients with EVD.

Dallas was home to the first three cases of EVD diagnosed or transmitted in the United States.

Parkland hasn’t treated any patients infected with the virus. But the hospital is providing pharmacy services for a biocontainment unit at nearby Methodist Richardson Medical Center that can be activated if needed.

The University of Texas Southwestern Medical Center is also contributing staff and expertise to the biocontainment unit, which is part of an emergency response project announced October 21 by Texas Governor Rick Perry.

Johnson said Parkland’s critical care pharmacists have volunteered to be on call to provide both clinical care and distributive services to the unit. The pharmacists are working with colleagues at Methodist to set up a satellite pharmacy near the isolation unit that would house any patients infected with the virus.

“We have prepared that area so that we can communicate with the nursing and medical staff; we can receive orders, we can prepare i.v.’s and store the drugs that would be available for the patients,” Johnson said.

She said the group has developed a formulary for the biocontainment unit and reviewed the processes for prescribing and pharmacy review of medication orders.

In addition, the staff has conducted simulations to ensure that medications are dispensed in such a way that nurses can manipulate any packaging and administer the drugs while wearing personal protective equipment (PPE).

“We wanted to make sure that there would be no problems with opening medications in this [biocontainment] area,” Johnson said.

Pharmacy staff members have been trained in the use of PPE, but they will not enter what Johnson called the “hot zone” inside the unit. But pharmacists will be able to communicate with staff in the unit by phone.

Johnson said Parkland has a longstanding investigational drug service that works closely with Parkland’s medical staff to procure experimental drugs for clinical trials and emergency or compassionate use.

She said the critical care pharmacists who have volunteered to work at the biocontainment facility don’t normally work with investigational drugs for emergency use and have received special training in this area to prepare them if the unit is activated.

Johnson said the investigational drug service has already completed some initial preparation for obtaining experimental therapies for EVD.

“We were able to actually do a lot of the work in advance, sitting down with the infectious disease team and the intensivist just to talk about the types of treatments available and which would be the priorities,” Johnson said.

She said the pharmacists have already communicated with manufacturers about potentially acquiring investigational anti-EVD drugs and correctly administering them to patients.

“This is definitely an opportunity where pharmacists can support the team,” Johnson said.

By Kate Traynor, reprinted with permission from AJHP (Dec. 1, 2014; volume 71, pages 2000, 2004, 2006)


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