Home Infusion Therapy: What Pharmacists Should Know

Connie Sullivan, Rph

Binh Ngo, PharmD

Pharmacist-led home infusion centers are making it easier for patients to access long-term therapy without enduring protracted hospital stays. Not only does it enable patients to more quickly resume their normal activities, but home infusion can be more cost effective than a long hospital stay and reduce the risk of hospital-acquired infections.

“The push is to get patients home and not be in the hospital so someone has to provide a service for them when they are home,” said Ryan McFerrin, PharmD and co-owner of Druid City Vital Care, Northport, Alabama. “What happens on the other days that you used to be in the hospital? Keeping people out of the hospital is our main goal. We want you to get therapy, but if you ask me, I’d rather get therapy at home on my couch than in a hospital bed.”

The National Home Infusion Association (NHIA) estimates that there are currently 1500 US pharmacies offering infusion therapies. “The industry has experienced rapid growth in the last decade,” said Connie Sullivan, RPh, NHIA president and chief executive officer. “We think that the growth is going to continue.”

According to the Department of Health and Human Services, home infusion is one of the fastest growing sectors of home health care. One reason for projecting growth is that the numberof patients estimated to need such therapy is expected to increase. The American Hospital Association estimates that approximately 133 million Americans currently have at least 1 chronic illness. That figure is forecasted to reach 170 million by 2030, with many of those patients requiring medication that needs to be infused or injected, including the growing number of biologics.

Unlike retail or independent pharmacies, infusion centers are basically closed-door pharmacies that not only compound prescriptions for patients but can administer therapy-via needle or catheter-and monitor a patient’s treatment.

“We don’t have customers walking in to fill a prescription,” said Sullivan. “An infusion center operates essentially in collaboration with home health care agencies and companies, such as durable medical equipment companies, to provide acute and chronic clinical oversight and sterile products to patients who need extended infusion therapy. They’re facilities that offer sterile compounding services, primarily to make IV solutions, and provide the clinical oversight of these patients, which can be quite acute.”

Infusion centers provide ongoing therapy for conditions such as congestive heart failure, cancer, multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease, psoriasis, and pain treatment, as well as nutrition and hydration problems.

“Anti-infectivesarethemostcommon therapies for home infusion, such as van-comycin, cefazolin, ceftriaxone, ertape- nem, [and] micafungin,” said Binh Ngo, PharmD, pharmacy manager at University of California San Diego Pharmacy Infusion Services. “Other therapies that are often provided in the home are total parenteral nutrition, inotrope for CHF, chemotherapy, hydration, and factor replacement for hemophilia.”

Although very few retail pharmacies currently offer infusion therapy, Sullivan said it’s possible for a retail pharmacy to expand and diversify into home infusion if they understand the care model and the facility requirements for the sterile compounding component.

“We are creating a hospital level environment in a home setting for those patients [who] want to or need to continue their IV treatments after they are dis- charged from the hospital,” said Sullivan.

A home infusion center setup requires an office area for staff and patient care management, as well as sufficient space for equipment and inventory. Some centers have an on-site, ambulatory infusion suite for specialty infusion therapy. An essential requirement of any home infusion center is a sterile compounding facility.

“A sterile compounding facility that is compliant with USP 797 and 800 is a must for home infusion services,” said Ngo. “There must be training and competencies on aseptic technique, process validation for the pharmacists and technicians, handhygiene, and garbing. Equipment for sterile compounding such as automated compounding devices will be needed for TPN and compounding.”

A home infusion center generally dispenses a 7-to-14 day supply of compounded sterile medication to the patient with laboratory tests typically done at least weekly. Pharmacists need to coordinate the blood draw and track laboratory test results before the next shipment is due, so the results can be reviewed before the drug is shipped out. This can be challenging if a patient does not keep appointments.

“Certain drugs require more clinical oversight, such as those that require PK monitoring, TPN, inotrope, or chemotherapy,” said Ngo.

Environmental monitoring of the sterile room is mandatory, including temperature and humidity monitoring. The room needs to receive clean room certification every 6 months. The frequency of end-product testing may differ from state to state, depending on what the board of pharmacy requires.

Not only should staff be knowledgeable about how to use home infusion equipment, but the office will require a staff member who knows how to bill such services since insurance considerations can differ from those encountered by a retail pharmacy. Infusion pharmacies must comply with licensing and other regulatory requirements imposed by state pharmacy boards, as well as accreditation standards required by third-party payers.

Some pharmacists, such as McFerrin, opt to franchise their home infusion center, because the company provides contracts and deals with billing.

“They provide a lot of clinical support and billing support, but mainly it’s the access,” said McFerrin. “If I don’t have access to insurance contracts or products, it’s very difficult for me to be successful.”

Staffing requirements at infusion centers differ from those of a retail pharmacy. An infusion center requires a team of health care professionals that is likely to include a pharmacist who is well-rounded in managing various disease states and therapies; a care transition nurse; an infusion nurse; and, for patients receiving clinical nutrition, a dietitian.

“The home-infusion practice is a multidisciplinary practice and requires someone [who] is team oriented and enjoys speaking to internal and external customers,”saidNgo.“Thepharmacist would be working with an RN [registered nurse], RD [registered dietician], intake [department representative], billing [department representative], pharmacy technicians, [and] physicians. There is quite a bit of coordination of care that takes place when a patient is on board to be discharged. Once a referral is confirmed for the start of care, the intake specialist will inform the pharmacist. Nursing may be staffed by your own nurses, or it can be outsourced to a home health agency, depending on the insurance and whether there are other needs required, such as PT [physical therapy], OT [occupational therapy], ST [speech therapy], or wound care.”

At a home infusion center, the pharmacist reviews and processes the order, including infusion supplies, then consults with the patient and arranges a delivery time. As part of the consultation, the pharmacist determines how the drug is going to be administered- IV push, elastomeric device, gravity, or mechanical pump-and assesses whether the patient or caregiver is able to learn to self-administer, the type of IV access, and home environment before deciding on the setup.

The nurse or home health agency should be informed when the medica- tion and supplies will be delivered, as well as when the first set of laboratory tests should be done.

“The pharmacist speaks with the patient periodically to assess [adverse] effects of the medication and to make recommendations for changing the therapy, should a patient need the change,” said Sullivan. “If the patient is not responding or developing some sort of adverse effect, that needs to be assessed.”

One important consideration before starting any home infusion center is that it will not be a Monday to Friday workweek.

“It’s a very demanding profession in the sense that when a patient needs a drug, they need a drug, and you need to do what’s required to make sure the patient doesn’t miss a dose, so there’s no interruption in therapy,” said Sullivan.

McFerrin agrees that the schedule can be demanding; however, he enjoys visiting patients at home and getting to know them. Interacting with patients was what he liked most about his previous retail pharmacy job, but offering infusion services provides new challenges and a chance to deliver an essential service to his community.

“You’re basically on call 24/7, 365 days a year. That’s the biggest word of caution I would offer to someone considering this. But at the same time, the biggest reward I get is seeing sick people get better. You see people that have a festering wound and they’re not able to walk around and then 6 weeks later- because you coached them through with IV antibiotics and fielded calls in the middle of the night-they’re back to their normal life and they stayed at home through the entire process.”

References:

1. National Home Infusion Association. www.nhia.org/faqs.cfm. Accessed March 3, 2020.
2. Department of Health and Human Services, Office of Inspector General. Medicare Home Infusion Therapy. https://oig.hhs.gov/oei/reports/oei-02-92-00420.pdf. Published September 1993. Accessed March 3, 2020.
3. American Hospital Association. Health for Life. www.aha.org/system/files/content/00-10/071204_H4L_FocusonWellness.pdf. Accessed February 21, 2020.