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Patient Safety Tip of the Week

August 24, 2021

More Home Infusion Safety Issues

More and more medication infusions are being done in the home, due to both convenience and economic reasons. Often these are for chemotherapy drugs. But there have been problems with home infusion of other drugs as well. Our August 2016 What's New in the Patient Safety World column “Home Infusion Therapy Pitfalls” highlighted a case related to home infusion of vancomycin. And, increasingly, we are seeing home infusion of biologic drugs used for treating immune-mediated disorders.

Baker et al. (Baker 2021) recently analyzed data on over 750,000 biologic infusions in over 57,000 patients, 4.5% of which were administered at home vs. 95.5% administered in facilities. They found that home infusions were associated with 25% increased odds of ED or hospital admission on the same or next day after the infusion (odds ratio 1.25) and 28% increased odds of discontinuation of the biologic after the ED or hospital admission (OR, 1.28). There was no difference in mortality rates between the two sites.

68% of patients were female, likely reflecting the increased incidence of immune-mediated disorders in women, and mean age of patients receiving infusions was 50.1 years. However, those receiving biologic infusions at home were younger, more likely to be male, and had lower Charlson Comorbidity scores than those receiving infusions in facilities.

The top 3 biologics administered at home were infliximab (60.6%), natalizumab (19.6%), and vedolizumab (7.9%), and the top 3 biologics administered at a facility were infliximab (52.1%), abatacept (15.4%), and natalizumab (13.3%).

Note that 25.5% of home infusion patients actually received their first infusion at a facility, followed by subsequent infusions of the same biologic at home.

The raw data showed that 4.4% of the home infusions were associated with ED or hospital admission on the same or next day, compared to 3.5% of those receiving facility infusions. This disparity occurred despite the home infusion patients being younger and having fewer comorbidities. After adjustment for multiple factors, infusions administered at home were associated with 25% increased odds of ED or hospital admission on the same or next day after the infusion compared with infusions administered at a facility (OR 1.25). Home infusions were also associated with 28% increased odds of discontinuation of the biologic after an ED or hospital admission (OR 1.28).

Infusion reactions most commonly occur after the first infusion of a biologic. In this study, the highest proportion of ED or hospital admissions occurred after the first infusion of a given biologic when administered at home, with 4.9% occurring after the first infusion, 4.3% after the second infusion, and 3.9% after the third infusion of the same biologic. Corresponding rates for facility infusions were 3.7%, 3.7%, and 3.9%. Remember that 25% of home infusion patients had received their first dose in a facility, so the relative risks of an adverse event after home infusion might even be greater.

Baker et al. hypothesize that administration of biologics at home involves less intensive monitoring, less physician oversight, and lack of immediate access to urgent medical treatment in the event of an acute infusion reaction and that this can result in delayed care and a more frequent need for escalation of care.

Although permanent discontinuation of a biologic after ED or hospital admission was a rare outcome, it occurred more also frequently after home infusions compared with facility infusions.

In the editorial accompanying the Baker study, Calip et al. (Calip 2021) point out numerous methodological problems and biases inherent in the Baker study. They caution that one cannot conclude causal attribution in such a study. But they acknowledge the evidence provided in the Baker study is highly relevant to understanding the risks and benefits of these disease-altering biologic therapies in different treatment settings.

It is probably no accident that the American College of Rheumatology recently released a position statement on patient safety and site of service for biologics (ACR 2021). It contains the following 3 position statements pertinent to infusion of biologics:

• Intravenous biologic agents should be administered in a monitored health care setting with onsite supervision by a provider with appropriate training in biologic infusions, ideally one who is actively involved with the patient’s care with access to their medical record.

• The ACR opposes policies that force patients to receive biologic infusions at home because such policies, designed for the sole purpose of cutting costs, undermine patient safety. Recognizing the convenience of home infusion for some patients, the ACR supports shared decision-making by the patient and their provider on the best course of treatment and safest option on a case-by-case basis.

• Nurse practitioners and physician assistants who supervise infusion centers, or free-standing infusion sites, should have specialized training in the use and administration of biologic therapies and work in the context of a collaborative or supervised relationship with a physician as regulated by state law. The recent development of free-standing infusion centers without clinicians properly versed in the arena of biologic medications, poses an increased risk to patients.

The ACR position statement notes that adverse drug reactions associated with biologics occur in up to 30% of patients in clinical trials and, although injection site reactions caused by subcutaneous biologics are generally easily managed, infusion reactions associated with IV biologics are often more serious. These reactions range in severity from a mild rash and myalgia to hypertension, shortness of breath, headaches, and even life-threatening anaphylaxis, and can occur during or after the infusion. It points out the importance of monitoring for infusion reactions because some must be promptly evaluated and treated. It notes that, for a mild reaction, the infusion rate can often be slowed potentially allowing the patient to complete the infusion. But moderate reactions require cessation of the infusion and either oral or IV medications to prevent clinical decline. And severe reactions can involve multiple organ systems and lead to respiratory and cardiovascular collapse, so these are medical emergencies requiring immediate therapy with medications such as epinephrine and IV glucocorticoids. It warns that such interventions are often beyond the scope of home health providers and delays waiting for emergency services further jeopardize patients’ lives. Experienced providers, available on site, are most capable of deciding whether it is safe to continue therapy in the setting of mild reactions and providing prompt treatment for moderate or severe reactions.

Other considerations pointed out by the ACR are that home infusions do not allow for rigorous maintenance of conditions such as recommended temperature, storage away from sunlight, and proper reconstitution or dosing.

It further cautions that financial considerations related to potential cost savings of home infusions should not override patient safety and standards of care. The position of the ACR is that “proper administration of biologics should take place under the close supervision of a physician in a provider’s office, infusion center or hospital rather than in a patient’s home, unless the patient and provider decide that home infusion is in the patient’s best interest.“ It also suggests that forcing patients to receive infusions at home or in facilities not supervised by a trained provider may reduce access to these critical therapies.

The ACR opposes policies that require home infusion of biologics. “In the absence of an
agreement between the provider and the patient that home infusion is the best option due to extenuating circumstances (i.e., lack of transportation or medical comorbidities) and that the risks of home infusion are outweighed by the benefits, required home infusion is an unnecessary risk to patients and violates current clinical standards of practice.”

It is important that we balance reasons for recommending home infusion therapies against the patient safety issues related to home infusions. While there are likely legitimate reasons for doing such infusions in the home, it is important to recognize what can go wrong and take steps to ensure that any adverse reactions will be recognized promptly and appropriately managed.

Some of our prior columns on patient safety issues in the home:

• April 12, 2011 “Medication Issues in the Ambulatory Setting”
• May 7, 2013 “Drug Errors in the Home”
• August 13, 2013 “Adverse Events in Home Care”
• September 16, 2014 “Focus on Home Care”
• August 2016 “Home Infusion Therapy Pitfalls”
• August 2018 “IHI on Safety of Care in the Home”
• June 16, 2020 “Tracking Technologies”

References:

Baker MC, Weng Y, Fairchild R, Ahuja N, Rohatgi N. Comparison of Adverse Events Among Home- vs Facility-Administered Biologic Infusions, 2007-2017. JAMA Netw Open 2021; 4(6): e2110268

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2780573?utm_source=silverchair&utm_medium=email&utm_campaign=article_alert-jamanetworkopen&utm_content=mthlyforyou&utm_term=070421

Calip GS, Yerram P, Ascha MS. Nonrandomized Comparison of Adverse Events Following Facility- and Home-Infused Biologics Using Real-World Data. JAMA Netw Open 2021; 4(6): e2111156

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2780575?utm_source=silverchair&utm_medium=email&utm_campaign=article_alert-jamanetworkopen&utm_content=mthlyforyou&utm_term=070421

ACR (American College of Rheumatology). Position Statement. Patient Safety and Site of Service for Biologics. American College of Rheumatology 2021; June 2021

https://www.rheumatology.org/Portals/0/Files/Biologics-Patient-Safety-and-site-of-Service.pdf

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