Small phase 1 and phase 2 multi-center, open label studies of melflufen toxicity and efficacy in combination with dexamethasone showed significant benefits in overall response rate in patients with relapsed/refractory multiple myeloma. A report on these studies was published in Lancet Hematology.

Nephron/Wikimedia Commons

In phase 2, patients treated with combination therapy achieved an overall response rate of 31% (14/45 patients) and a clinical benefit rate of 49% (22/45 patients). In the phase 2 single-agent cohort, the overall response rate was 8% (1/13 patients) and the clinical benefit rate was 23% (3/13 patients) before this aspect of the study was discontinued.

In terms of adverse events, among the 45 phase 2 combination–treatment patients, the most common grade 3-4 adverse events were clinically manageable thrombocytopenia (62% of patients) and neutropenia (58%) In addition, 24 serious adverse events were reported in 38% patients, most commonly pneumonia (11%).

Because of the benefits seen and the need for relapsed/refractory MM treatments, further studies on melflufen in combination therapies are ongoing, according to the researchers “with encouraging early results to date”: NCT03151811, NCT02963493, and NCT03481556.

“Melflufen represents a novel treatment concept with a unique mechanism of action that might find future use in combinations with key partners, such as proteasome inhibitors and monoclonal antibodies,” the researchers concluded.

The study was sponsored by Oncopeptides AB. The authors received funding from a variety of pharmaceutical companies.

mlesney@mdedge.com

SOURCE: Richardson PG et al. Lancet Hematol. 2020; doi.org/10.1016/S2352-3026(20)30044-2.

Small phase 1 and phase 2 multi-center, open label studies of melflufen toxicity and efficacy in combination with dexamethasone showed significant benefits in overall response rate in patients with relapsed/refractory multiple myeloma. A report on these studies was published in Lancet Hematology.

Nephron/Wikimedia Commons

In phase 2, patients treated with combination therapy achieved an overall response rate of 31% (14/45 patients) and a clinical benefit rate of 49% (22/45 patients). In the phase 2 single-agent cohort, the overall response rate was 8% (1/13 patients) and the clinical benefit rate was 23% (3/13 patients) before this aspect of the study was discontinued.

In terms of adverse events, among the 45 phase 2 combination–treatment patients, the most common grade 3-4 adverse events were clinically manageable thrombocytopenia (62% of patients) and neutropenia (58%) In addition, 24 serious adverse events were reported in 38% patients, most commonly pneumonia (11%).

Because of the benefits seen and the need for relapsed/refractory MM treatments, further studies on melflufen in combination therapies are ongoing, according to the researchers “with encouraging early results to date”: NCT03151811, NCT02963493, and NCT03481556.

“Melflufen represents a novel treatment concept with a unique mechanism of action that might find future use in combinations with key partners, such as proteasome inhibitors and monoclonal antibodies,” the researchers concluded.

The study was sponsored by Oncopeptides AB. The authors received funding from a variety of pharmaceutical companies.

mlesney@mdedge.com

SOURCE: Richardson PG et al. Lancet Hematol. 2020; doi.org/10.1016/S2352-3026(20)30044-2.

Small phase 1 and phase 2 multi-center, open label studies of melflufen toxicity and efficacy in combination with dexamethasone showed significant benefits in overall response rate in patients with relapsed/refractory multiple myeloma. A report on these studies was published in Lancet Hematology.

Nephron/Wikimedia Commons

In phase 2, patients treated with combination therapy achieved an overall response rate of 31% (14/45 patients) and a clinical benefit rate of 49% (22/45 patients). In the phase 2 single-agent cohort, the overall response rate was 8% (1/13 patients) and the clinical benefit rate was 23% (3/13 patients) before this aspect of the study was discontinued.

In terms of adverse events, among the 45 phase 2 combination–treatment patients, the most common grade 3-4 adverse events were clinically manageable thrombocytopenia (62% of patients) and neutropenia (58%) In addition, 24 serious adverse events were reported in 38% patients, most commonly pneumonia (11%).

Because of the benefits seen and the need for relapsed/refractory MM treatments, further studies on melflufen in combination therapies are ongoing, according to the researchers “with encouraging early results to date”: NCT03151811, NCT02963493, and NCT03481556.

“Melflufen represents a novel treatment concept with a unique mechanism of action that might find future use in combinations with key partners, such as proteasome inhibitors and monoclonal antibodies,” the researchers concluded.

The study was sponsored by Oncopeptides AB. The authors received funding from a variety of pharmaceutical companies.

mlesney@mdedge.com

SOURCE: Richardson PG et al. Lancet Hematol. 2020; doi.org/10.1016/S2352-3026(20)30044-2.

The adoption of the infused biosimilar infliximab therapies Inflectra and Renflexis was slower at an academic medical center than at a neighboring Veterans Affairs Medical Center (VAMC) during the same time period in 2015-2019, according to an analysis published in Arthritis and Rheumatology.

The use of the biosimilars also was associated with cost savings at the VAMC, but not at the academic medical center, which illustrates that insufficient financial incentives can delay the adoption of biosimilars and the health care system’s realization of cost savings, according to the authors.

Medicare, which is not allowed to negotiate drug prices, is one of the largest payers for infused therapies. Medicare reimbursement for infused therapies is based on the latter’s average selling price (ASP) during the previous quarter. Institutions may negotiate purchase prices with drug manufacturers and receive Medicare reimbursement. Biosimilars generally have lower ASPs than their corresponding reference therapies, and biosimilar manufacturers may have less room to negotiate prices than reference therapy manufacturers. Consequently, a given institution might have a greater incentive to use reference products than to use biosimilars.
 

An examination of pharmacy data

The VA negotiates drug prices for all of its medical centers and has mandated that clinicians prefer biosimilars to their corresponding reference therapies, so Joshua F. Baker, MD, of the University of Pennsylvania and the Corporal Michael J. Crescenz VAMC, both in Philadelphia, and his colleagues hypothesized that the adoption of biosimilars had proceeded more quickly at a VAMC than at a nearby academic medical center.

The investigators examined pharmacy data from the University of Pennsylvania Health System (UPHS) electronic medical record and the Corporal Michael J. Crescenz VAMC to compare the frequency of prescribing biosimilars at these sites between Jan. 1, 2015, and May 31, 2019. Dr. Baker and his associates focused specifically on reference infliximab (Remicade) and the reference noninfusion therapies filgrastim (Neupogen) and pegfilgrastim (Neulasta) and on biosimilars of these therapies (infliximab-dyyb [Inflectra], infliximab-abda [Renflexis], filgrastim-sndz [Zarxio], and pegfilgrastim-jmdb [Fulphila]).

Because Medicare was the predominant payer, the researchers estimated reimbursement for reference and biosimilar infliximabs according to the Medicare Part B reimbursement policy. They defined an institution’s incentive to use a given therapy as the difference between the reimbursement and acquisition cost for that therapy. Dr. Baker and colleagues compared the incentives for UPHS with those for the VAMC.
 

VAMC saved 81% of reference product cost

The researchers identified 15,761 infusions of infliximab at UPHS and 446 at the VAMC during the study period. The proportion of infusions that used the reference product was 99% at UPHS and 62% at the VAMC. ASPs for biosimilar infliximab have been consistently lower than those for the reference product since July 2017. In December 2017, the VAMC switched to the biosimilar infliximab.

Institutional incentives based on Medicare Part B reimbursement and acquisitions costs for reference and biosimilar infliximab have been similar since 2018. In 2019, the institutional incentive favored the reference product by $49-$64 per 100-mg vial. But at the VAMC, the cost per 100-mg vial was $623.48 for the reference product and $115.58 for the biosimilar Renflexis. Purchasing the biosimilar thus yielded a savings of 81%. The current costs for the therapies are $546 and $116, respectively.

In addition, Dr. Baker and colleagues identified 46,683 orders for filgrastim or pegfilgrastim at UPHS. Approximately 90% of the orders were for either of the two reference products despite the ASP of biosimilar filgrastim being approximately 40% lower than that of its reference product. At the VAMC, about 88% of orders were for the reference products. Biosimilars became available in 2016. UPHS began using them at a modest rate, but their adoption was greater at the VAMC, which designated them as preferred products.

Tendering and a nationwide policy mandating use of biosimilars have resulted in financial savings for the VAMC, wrote Dr. Baker and colleagues. “These data suggest that, with current Medicare Part B reimbursement policy, the absence of financial incentives to encourage use of infliximab biosimilars has resulted in slower uptake of biosimilar use at institutions outside of the VA system. The implications of this are a slower reduction in costs to the health care system, since decreases in ASP over time are predicated on negotiations at the institutional level, which have been gradual and stepwise. ...

“Although some of our results may not be applicable to other geographical regions of the U.S., the comparison of two affiliated institutions in geographical proximity and with shared health care providers is a strength,” they continued. “Our findings should be replicated using national VAMC data or data from other health care systems.”

The researchers said that their findings may not apply to noninfused therapies, which are not covered under Medicare Part B, and they did not directly study the impact of pharmacy benefit managers. However, they noted that their data on filgrastim and pegfilgrastim support the hypothesis that pharmacy benefit managers receive “incentives that continue to promote the use of reference products that have higher manufacturer’s list prices, which likely will limit the uptake of both infused and injectable biosimilar therapies over time.” They said that “this finding has important implications for when noninfused biosimilars (e.g. etanercept and adalimumab) are eventually introduced to the U.S. market.”

European governments incentivize use of biosimilars

Government and institutional incentives have increased the adoption of biosimilars in Europe, wrote Guro Lovik Goll, MD, and Tore Kristian Kvien, MD, of the department of rheumatology at Diakonhjemmet Hospital in Oslo, in an accompanying editorial. Norway and Denmark have annual national tender systems in which biosimilars and reference products compete. The price of infliximab biosimilar was 39% lower than the reference product in 2014 and 69% lower in 2015. “Competition has caused dramatically lower prices both for biosimilars and also for the originator drugs competing with them,” wrote the authors.

In 2015, the government of Denmark mandated that patients on infliximab be switched to a biosimilar, and patients in Norway also have been switched to biosimilars. The use of etanercept in Norway increased by 40% from 2016 to 2019, and the use of infliximab has increased by more than threefold since 2015. “In Norway, the consequence of competition, national tenders, and availability of biosimilars have led to better access to therapy for more people in need of biologic drugs, while at the same time showing a total cost reduction of biologics for use in rheumatology, gastroenterology, and dermatology,” wrote the authors.

Health care costs $10,000 per capita in the United States, compared with $5,300 for other wealthy countries in the Organization for Economic Cooperation and Development. Low life expectancy and high infant mortality in the U.S. indicate that high costs are not associated with better outcomes. “As Americans seem to lose out on the cost-cutting potential of biosimilars, this missed opportunity is set to get even more expensive,” the authors concluded.

The U.S. Department of Veterans Affairs, the National Institutes of Health, and the American Diabetes Association contributed funding for the study. Dr. Baker reported receiving consulting fees from Bristol-Myers Squibb and Gilead, and another author reported receiving research support paid to his institution by Pfizer and UCB, as well as receiving consulting fees from nine pharmaceutical companies. Dr. Goll and Dr. Kvien both reported receiving fees for speaking and/or consulting from numerous pharmaceutical companies, including Pfizer.

AGA is taking the lead in educating health care providers and patients about biosimilars and how they can be used for IBD patient care. Learn more at www.gastro.org/biosimilars.

egreb@mdedge.com

SOURCES: Baker JF et al. Arthritis Rheumatol. 2020 Apr 6. doi: 10.1002/art.41277.

The adoption of the infused biosimilar infliximab therapies Inflectra and Renflexis was slower at an academic medical center than at a neighboring Veterans Affairs Medical Center (VAMC) during the same time period in 2015-2019, according to an analysis published in Arthritis and Rheumatology.

The use of the biosimilars also was associated with cost savings at the VAMC, but not at the academic medical center, which illustrates that insufficient financial incentives can delay the adoption of biosimilars and the health care system’s realization of cost savings, according to the authors.

Medicare, which is not allowed to negotiate drug prices, is one of the largest payers for infused therapies. Medicare reimbursement for infused therapies is based on the latter’s average selling price (ASP) during the previous quarter. Institutions may negotiate purchase prices with drug manufacturers and receive Medicare reimbursement. Biosimilars generally have lower ASPs than their corresponding reference therapies, and biosimilar manufacturers may have less room to negotiate prices than reference therapy manufacturers. Consequently, a given institution might have a greater incentive to use reference products than to use biosimilars.
 

An examination of pharmacy data

The VA negotiates drug prices for all of its medical centers and has mandated that clinicians prefer biosimilars to their corresponding reference therapies, so Joshua F. Baker, MD, of the University of Pennsylvania and the Corporal Michael J. Crescenz VAMC, both in Philadelphia, and his colleagues hypothesized that the adoption of biosimilars had proceeded more quickly at a VAMC than at a nearby academic medical center.

The investigators examined pharmacy data from the University of Pennsylvania Health System (UPHS) electronic medical record and the Corporal Michael J. Crescenz VAMC to compare the frequency of prescribing biosimilars at these sites between Jan. 1, 2015, and May 31, 2019. Dr. Baker and his associates focused specifically on reference infliximab (Remicade) and the reference noninfusion therapies filgrastim (Neupogen) and pegfilgrastim (Neulasta) and on biosimilars of these therapies (infliximab-dyyb [Inflectra], infliximab-abda [Renflexis], filgrastim-sndz [Zarxio], and pegfilgrastim-jmdb [Fulphila]).

Because Medicare was the predominant payer, the researchers estimated reimbursement for reference and biosimilar infliximabs according to the Medicare Part B reimbursement policy. They defined an institution’s incentive to use a given therapy as the difference between the reimbursement and acquisition cost for that therapy. Dr. Baker and colleagues compared the incentives for UPHS with those for the VAMC.
 

VAMC saved 81% of reference product cost

The researchers identified 15,761 infusions of infliximab at UPHS and 446 at the VAMC during the study period. The proportion of infusions that used the reference product was 99% at UPHS and 62% at the VAMC. ASPs for biosimilar infliximab have been consistently lower than those for the reference product since July 2017. In December 2017, the VAMC switched to the biosimilar infliximab.

Institutional incentives based on Medicare Part B reimbursement and acquisitions costs for reference and biosimilar infliximab have been similar since 2018. In 2019, the institutional incentive favored the reference product by $49-$64 per 100-mg vial. But at the VAMC, the cost per 100-mg vial was $623.48 for the reference product and $115.58 for the biosimilar Renflexis. Purchasing the biosimilar thus yielded a savings of 81%. The current costs for the therapies are $546 and $116, respectively.

In addition, Dr. Baker and colleagues identified 46,683 orders for filgrastim or pegfilgrastim at UPHS. Approximately 90% of the orders were for either of the two reference products despite the ASP of biosimilar filgrastim being approximately 40% lower than that of its reference product. At the VAMC, about 88% of orders were for the reference products. Biosimilars became available in 2016. UPHS began using them at a modest rate, but their adoption was greater at the VAMC, which designated them as preferred products.

Tendering and a nationwide policy mandating use of biosimilars have resulted in financial savings for the VAMC, wrote Dr. Baker and colleagues. “These data suggest that, with current Medicare Part B reimbursement policy, the absence of financial incentives to encourage use of infliximab biosimilars has resulted in slower uptake of biosimilar use at institutions outside of the VA system. The implications of this are a slower reduction in costs to the health care system, since decreases in ASP over time are predicated on negotiations at the institutional level, which have been gradual and stepwise. ...

“Although some of our results may not be applicable to other geographical regions of the U.S., the comparison of two affiliated institutions in geographical proximity and with shared health care providers is a strength,” they continued. “Our findings should be replicated using national VAMC data or data from other health care systems.”

The researchers said that their findings may not apply to noninfused therapies, which are not covered under Medicare Part B, and they did not directly study the impact of pharmacy benefit managers. However, they noted that their data on filgrastim and pegfilgrastim support the hypothesis that pharmacy benefit managers receive “incentives that continue to promote the use of reference products that have higher manufacturer’s list prices, which likely will limit the uptake of both infused and injectable biosimilar therapies over time.” They said that “this finding has important implications for when noninfused biosimilars (e.g. etanercept and adalimumab) are eventually introduced to the U.S. market.”

European governments incentivize use of biosimilars

Government and institutional incentives have increased the adoption of biosimilars in Europe, wrote Guro Lovik Goll, MD, and Tore Kristian Kvien, MD, of the department of rheumatology at Diakonhjemmet Hospital in Oslo, in an accompanying editorial. Norway and Denmark have annual national tender systems in which biosimilars and reference products compete. The price of infliximab biosimilar was 39% lower than the reference product in 2014 and 69% lower in 2015. “Competition has caused dramatically lower prices both for biosimilars and also for the originator drugs competing with them,” wrote the authors.

In 2015, the government of Denmark mandated that patients on infliximab be switched to a biosimilar, and patients in Norway also have been switched to biosimilars. The use of etanercept in Norway increased by 40% from 2016 to 2019, and the use of infliximab has increased by more than threefold since 2015. “In Norway, the consequence of competition, national tenders, and availability of biosimilars have led to better access to therapy for more people in need of biologic drugs, while at the same time showing a total cost reduction of biologics for use in rheumatology, gastroenterology, and dermatology,” wrote the authors.

Health care costs $10,000 per capita in the United States, compared with $5,300 for other wealthy countries in the Organization for Economic Cooperation and Development. Low life expectancy and high infant mortality in the U.S. indicate that high costs are not associated with better outcomes. “As Americans seem to lose out on the cost-cutting potential of biosimilars, this missed opportunity is set to get even more expensive,” the authors concluded.

The U.S. Department of Veterans Affairs, the National Institutes of Health, and the American Diabetes Association contributed funding for the study. Dr. Baker reported receiving consulting fees from Bristol-Myers Squibb and Gilead, and another author reported receiving research support paid to his institution by Pfizer and UCB, as well as receiving consulting fees from nine pharmaceutical companies. Dr. Goll and Dr. Kvien both reported receiving fees for speaking and/or consulting from numerous pharmaceutical companies, including Pfizer.

AGA is taking the lead in educating health care providers and patients about biosimilars and how they can be used for IBD patient care. Learn more at www.gastro.org/biosimilars.

egreb@mdedge.com

SOURCES: Baker JF et al. Arthritis Rheumatol. 2020 Apr 6. doi: 10.1002/art.41277.

The adoption of the infused biosimilar infliximab therapies Inflectra and Renflexis was slower at an academic medical center than at a neighboring Veterans Affairs Medical Center (VAMC) during the same time period in 2015-2019, according to an analysis published in Arthritis and Rheumatology.

The use of the biosimilars also was associated with cost savings at the VAMC, but not at the academic medical center, which illustrates that insufficient financial incentives can delay the adoption of biosimilars and the health care system’s realization of cost savings, according to the authors.

Medicare, which is not allowed to negotiate drug prices, is one of the largest payers for infused therapies. Medicare reimbursement for infused therapies is based on the latter’s average selling price (ASP) during the previous quarter. Institutions may negotiate purchase prices with drug manufacturers and receive Medicare reimbursement. Biosimilars generally have lower ASPs than their corresponding reference therapies, and biosimilar manufacturers may have less room to negotiate prices than reference therapy manufacturers. Consequently, a given institution might have a greater incentive to use reference products than to use biosimilars.
 

An examination of pharmacy data

The VA negotiates drug prices for all of its medical centers and has mandated that clinicians prefer biosimilars to their corresponding reference therapies, so Joshua F. Baker, MD, of the University of Pennsylvania and the Corporal Michael J. Crescenz VAMC, both in Philadelphia, and his colleagues hypothesized that the adoption of biosimilars had proceeded more quickly at a VAMC than at a nearby academic medical center.

The investigators examined pharmacy data from the University of Pennsylvania Health System (UPHS) electronic medical record and the Corporal Michael J. Crescenz VAMC to compare the frequency of prescribing biosimilars at these sites between Jan. 1, 2015, and May 31, 2019. Dr. Baker and his associates focused specifically on reference infliximab (Remicade) and the reference noninfusion therapies filgrastim (Neupogen) and pegfilgrastim (Neulasta) and on biosimilars of these therapies (infliximab-dyyb [Inflectra], infliximab-abda [Renflexis], filgrastim-sndz [Zarxio], and pegfilgrastim-jmdb [Fulphila]).

Because Medicare was the predominant payer, the researchers estimated reimbursement for reference and biosimilar infliximabs according to the Medicare Part B reimbursement policy. They defined an institution’s incentive to use a given therapy as the difference between the reimbursement and acquisition cost for that therapy. Dr. Baker and colleagues compared the incentives for UPHS with those for the VAMC.
 

VAMC saved 81% of reference product cost

The researchers identified 15,761 infusions of infliximab at UPHS and 446 at the VAMC during the study period. The proportion of infusions that used the reference product was 99% at UPHS and 62% at the VAMC. ASPs for biosimilar infliximab have been consistently lower than those for the reference product since July 2017. In December 2017, the VAMC switched to the biosimilar infliximab.

Institutional incentives based on Medicare Part B reimbursement and acquisitions costs for reference and biosimilar infliximab have been similar since 2018. In 2019, the institutional incentive favored the reference product by $49-$64 per 100-mg vial. But at the VAMC, the cost per 100-mg vial was $623.48 for the reference product and $115.58 for the biosimilar Renflexis. Purchasing the biosimilar thus yielded a savings of 81%. The current costs for the therapies are $546 and $116, respectively.

In addition, Dr. Baker and colleagues identified 46,683 orders for filgrastim or pegfilgrastim at UPHS. Approximately 90% of the orders were for either of the two reference products despite the ASP of biosimilar filgrastim being approximately 40% lower than that of its reference product. At the VAMC, about 88% of orders were for the reference products. Biosimilars became available in 2016. UPHS began using them at a modest rate, but their adoption was greater at the VAMC, which designated them as preferred products.

Tendering and a nationwide policy mandating use of biosimilars have resulted in financial savings for the VAMC, wrote Dr. Baker and colleagues. “These data suggest that, with current Medicare Part B reimbursement policy, the absence of financial incentives to encourage use of infliximab biosimilars has resulted in slower uptake of biosimilar use at institutions outside of the VA system. The implications of this are a slower reduction in costs to the health care system, since decreases in ASP over time are predicated on negotiations at the institutional level, which have been gradual and stepwise. ...

“Although some of our results may not be applicable to other geographical regions of the U.S., the comparison of two affiliated institutions in geographical proximity and with shared health care providers is a strength,” they continued. “Our findings should be replicated using national VAMC data or data from other health care systems.”

The researchers said that their findings may not apply to noninfused therapies, which are not covered under Medicare Part B, and they did not directly study the impact of pharmacy benefit managers. However, they noted that their data on filgrastim and pegfilgrastim support the hypothesis that pharmacy benefit managers receive “incentives that continue to promote the use of reference products that have higher manufacturer’s list prices, which likely will limit the uptake of both infused and injectable biosimilar therapies over time.” They said that “this finding has important implications for when noninfused biosimilars (e.g. etanercept and adalimumab) are eventually introduced to the U.S. market.”

European governments incentivize use of biosimilars

Government and institutional incentives have increased the adoption of biosimilars in Europe, wrote Guro Lovik Goll, MD, and Tore Kristian Kvien, MD, of the department of rheumatology at Diakonhjemmet Hospital in Oslo, in an accompanying editorial. Norway and Denmark have annual national tender systems in which biosimilars and reference products compete. The price of infliximab biosimilar was 39% lower than the reference product in 2014 and 69% lower in 2015. “Competition has caused dramatically lower prices both for biosimilars and also for the originator drugs competing with them,” wrote the authors.

In 2015, the government of Denmark mandated that patients on infliximab be switched to a biosimilar, and patients in Norway also have been switched to biosimilars. The use of etanercept in Norway increased by 40% from 2016 to 2019, and the use of infliximab has increased by more than threefold since 2015. “In Norway, the consequence of competition, national tenders, and availability of biosimilars have led to better access to therapy for more people in need of biologic drugs, while at the same time showing a total cost reduction of biologics for use in rheumatology, gastroenterology, and dermatology,” wrote the authors.

Health care costs $10,000 per capita in the United States, compared with $5,300 for other wealthy countries in the Organization for Economic Cooperation and Development. Low life expectancy and high infant mortality in the U.S. indicate that high costs are not associated with better outcomes. “As Americans seem to lose out on the cost-cutting potential of biosimilars, this missed opportunity is set to get even more expensive,” the authors concluded.

The U.S. Department of Veterans Affairs, the National Institutes of Health, and the American Diabetes Association contributed funding for the study. Dr. Baker reported receiving consulting fees from Bristol-Myers Squibb and Gilead, and another author reported receiving research support paid to his institution by Pfizer and UCB, as well as receiving consulting fees from nine pharmaceutical companies. Dr. Goll and Dr. Kvien both reported receiving fees for speaking and/or consulting from numerous pharmaceutical companies, including Pfizer.

AGA is taking the lead in educating health care providers and patients about biosimilars and how they can be used for IBD patient care. Learn more at www.gastro.org/biosimilars.

egreb@mdedge.com

SOURCES: Baker JF et al. Arthritis Rheumatol. 2020 Apr 6. doi: 10.1002/art.41277.

A “strikingly high number” of women have bone marrow edema on MRI of the sacroiliac joints postpartum, according to a prospective study of 35 patients published in Annals of the Rheumatic Diseases. Postpartum sacroiliac bone marrow edema decreases over time. Its occurrence may be associated with a shorter duration of labor and a lack of epidural anesthesia, the researchers wrote.

Sacroiliac bone marrow edema in postpartum women “persists mainly in subjects older than 30 years,” noted Thomas Renson, MD, of Ghent (Belgium) University Hospital and colleagues. “When suspecting AxSpA [axial spondyloarthritis], our data indicate the need to wait at least 6 months to perform an MRI [of the sacroiliac joints] in postpartum women and, if positive, repeat the MRI after 12 months.”

Sacroiliac bone marrow edema is a hallmark of axSpA. However, recent studies of young, active people without the disease have found a high prevalence of bone marrow edema meeting the Assessment of SpondyloArthritis International Society (ASAS) definition of a positive MRI for sacroiliitis. Researchers have reported sacroiliac bone marrow edema in women during pregnancy and after childbirth, but prior studies have not assessed the trajectory of sacroiliac bone marrow edema after delivery, Dr. Renson and his colleagues said.

To study this question, the researchers recruited 35 subjects from the department of obstetrics at Ghent University Hospital. All participants were aged 18-45 years and had an uncomplicated, vaginal childbirth. The investigators excluded patients with a diagnosis of spondyloarthritis, inflammatory bowel disease, severe scoliosis, treatment with anti–tumor necrosis factor-alpha agents, any contraindication for MRI, childbirth through cesarean section, or pregnancy with more than one fetus.

Researchers performed a baseline MRI within 10 days of when patients gave birth and another MRI after 6 months. If the second MRI fulfilled the ASAS definition of a positive MRI for sacroiliitis, another MRI was performed at 12 months. Bone marrow edema was scored using the Spondyloarthritis Research Consortium of Canada (SPARCC) method.

In all, 77% of the patients had sacroiliac bone marrow edema on MRI an average of 5 days postpartum, and 60% fulfilled the ASAS definition of a positive MRI. After 6 months, 46% had bone marrow edema on MRI, and 15% had a positive MRI according to the ASAS definition. After 12 months, MRI was positive in 12% of the subjects. There was a high prevalence of bone marrow edema “even in subjects without back pain,” the researchers said.

“Four subjects would have fulfilled the ASAS classification criteria if there was a suspicion of axSpA: Three fulfilled the ASAS definition of a positive MRI for sacroiliitis and had inflammatory back pain, [and] one had chronic back pain, a positive MRI, and skin psoriasis,” the researchers wrote.

Misdiagnosis of axSpA based on MRI findings entails risks, the authors noted. NSAIDs may be less effective in patients who do not have axSpA, and patients may be “subsequently more likely to receive ineffective biological therapy, which has significant potential side effects and encompasses high socioeconomic costs,” the investigators said.

The study was supported by an ASAS research grant. The authors declared having no competing interests.

jremaly@mdedge.com

SOURCE: Renson T et al. Ann Rheum Dis. 2020 Apr 16. doi: 10.1136/annrheumdis-2020-217095.

A “strikingly high number” of women have bone marrow edema on MRI of the sacroiliac joints postpartum, according to a prospective study of 35 patients published in Annals of the Rheumatic Diseases. Postpartum sacroiliac bone marrow edema decreases over time. Its occurrence may be associated with a shorter duration of labor and a lack of epidural anesthesia, the researchers wrote.

Sacroiliac bone marrow edema in postpartum women “persists mainly in subjects older than 30 years,” noted Thomas Renson, MD, of Ghent (Belgium) University Hospital and colleagues. “When suspecting AxSpA [axial spondyloarthritis], our data indicate the need to wait at least 6 months to perform an MRI [of the sacroiliac joints] in postpartum women and, if positive, repeat the MRI after 12 months.”

Sacroiliac bone marrow edema is a hallmark of axSpA. However, recent studies of young, active people without the disease have found a high prevalence of bone marrow edema meeting the Assessment of SpondyloArthritis International Society (ASAS) definition of a positive MRI for sacroiliitis. Researchers have reported sacroiliac bone marrow edema in women during pregnancy and after childbirth, but prior studies have not assessed the trajectory of sacroiliac bone marrow edema after delivery, Dr. Renson and his colleagues said.

To study this question, the researchers recruited 35 subjects from the department of obstetrics at Ghent University Hospital. All participants were aged 18-45 years and had an uncomplicated, vaginal childbirth. The investigators excluded patients with a diagnosis of spondyloarthritis, inflammatory bowel disease, severe scoliosis, treatment with anti–tumor necrosis factor-alpha agents, any contraindication for MRI, childbirth through cesarean section, or pregnancy with more than one fetus.

Researchers performed a baseline MRI within 10 days of when patients gave birth and another MRI after 6 months. If the second MRI fulfilled the ASAS definition of a positive MRI for sacroiliitis, another MRI was performed at 12 months. Bone marrow edema was scored using the Spondyloarthritis Research Consortium of Canada (SPARCC) method.

In all, 77% of the patients had sacroiliac bone marrow edema on MRI an average of 5 days postpartum, and 60% fulfilled the ASAS definition of a positive MRI. After 6 months, 46% had bone marrow edema on MRI, and 15% had a positive MRI according to the ASAS definition. After 12 months, MRI was positive in 12% of the subjects. There was a high prevalence of bone marrow edema “even in subjects without back pain,” the researchers said.

“Four subjects would have fulfilled the ASAS classification criteria if there was a suspicion of axSpA: Three fulfilled the ASAS definition of a positive MRI for sacroiliitis and had inflammatory back pain, [and] one had chronic back pain, a positive MRI, and skin psoriasis,” the researchers wrote.

Misdiagnosis of axSpA based on MRI findings entails risks, the authors noted. NSAIDs may be less effective in patients who do not have axSpA, and patients may be “subsequently more likely to receive ineffective biological therapy, which has significant potential side effects and encompasses high socioeconomic costs,” the investigators said.

The study was supported by an ASAS research grant. The authors declared having no competing interests.

jremaly@mdedge.com

SOURCE: Renson T et al. Ann Rheum Dis. 2020 Apr 16. doi: 10.1136/annrheumdis-2020-217095.

A “strikingly high number” of women have bone marrow edema on MRI of the sacroiliac joints postpartum, according to a prospective study of 35 patients published in Annals of the Rheumatic Diseases. Postpartum sacroiliac bone marrow edema decreases over time. Its occurrence may be associated with a shorter duration of labor and a lack of epidural anesthesia, the researchers wrote.

Sacroiliac bone marrow edema in postpartum women “persists mainly in subjects older than 30 years,” noted Thomas Renson, MD, of Ghent (Belgium) University Hospital and colleagues. “When suspecting AxSpA [axial spondyloarthritis], our data indicate the need to wait at least 6 months to perform an MRI [of the sacroiliac joints] in postpartum women and, if positive, repeat the MRI after 12 months.”

Sacroiliac bone marrow edema is a hallmark of axSpA. However, recent studies of young, active people without the disease have found a high prevalence of bone marrow edema meeting the Assessment of SpondyloArthritis International Society (ASAS) definition of a positive MRI for sacroiliitis. Researchers have reported sacroiliac bone marrow edema in women during pregnancy and after childbirth, but prior studies have not assessed the trajectory of sacroiliac bone marrow edema after delivery, Dr. Renson and his colleagues said.

To study this question, the researchers recruited 35 subjects from the department of obstetrics at Ghent University Hospital. All participants were aged 18-45 years and had an uncomplicated, vaginal childbirth. The investigators excluded patients with a diagnosis of spondyloarthritis, inflammatory bowel disease, severe scoliosis, treatment with anti–tumor necrosis factor-alpha agents, any contraindication for MRI, childbirth through cesarean section, or pregnancy with more than one fetus.

Researchers performed a baseline MRI within 10 days of when patients gave birth and another MRI after 6 months. If the second MRI fulfilled the ASAS definition of a positive MRI for sacroiliitis, another MRI was performed at 12 months. Bone marrow edema was scored using the Spondyloarthritis Research Consortium of Canada (SPARCC) method.

In all, 77% of the patients had sacroiliac bone marrow edema on MRI an average of 5 days postpartum, and 60% fulfilled the ASAS definition of a positive MRI. After 6 months, 46% had bone marrow edema on MRI, and 15% had a positive MRI according to the ASAS definition. After 12 months, MRI was positive in 12% of the subjects. There was a high prevalence of bone marrow edema “even in subjects without back pain,” the researchers said.

“Four subjects would have fulfilled the ASAS classification criteria if there was a suspicion of axSpA: Three fulfilled the ASAS definition of a positive MRI for sacroiliitis and had inflammatory back pain, [and] one had chronic back pain, a positive MRI, and skin psoriasis,” the researchers wrote.

Misdiagnosis of axSpA based on MRI findings entails risks, the authors noted. NSAIDs may be less effective in patients who do not have axSpA, and patients may be “subsequently more likely to receive ineffective biological therapy, which has significant potential side effects and encompasses high socioeconomic costs,” the investigators said.

The study was supported by an ASAS research grant. The authors declared having no competing interests.

jremaly@mdedge.com

SOURCE: Renson T et al. Ann Rheum Dis. 2020 Apr 16. doi: 10.1136/annrheumdis-2020-217095.

MAUI, HAWAII – Results of a carefully conducted real-world study of adherence to oral methotrexate in patients with RA were “kind of scary,” Arthur Kavanaugh, MD, said at the 2020 Rheumatology Winter Clinical Symposium.

“At 24 weeks, adherence was only 75%. And these were people who knew they were being monitored, so this is the best of the best. And yet less than 20% took the drug perfectly, meaning they took every dose as it was supposed to be,” noted Dr. Kavanaugh, professor of medicine at the University of California, San Diego, and RWCS program director.

“Adherence to methotrexate is really not very good. This is our cornerstone drug – methotrexate – and I think it certainly applies to other medications that we’re using,” he added.

He and his fellow panelist John J. Cush, MD, discussed the implications of this recent study, led by Kaleb Michaud, PhD, of the University of Nebraska Medical Center, Omaha.

The methotrexate adherence study included 60 patients with RA whose use of the disease-modifying antirheumatic drug (DMARD) over 24 weeks was monitored via the electronic Medication Event Monitoring System. These were motivated patients seen in routine clinical practice: They were participants in Forward, the National Databank for Rheumatic Diseases, and they understood that their use of methotrexate was being monitored.

Among the key findings: Patients on average took their weekly dose as directed for a total of 18 of the 24 weeks, although adherence decreased over time. Overall, 13% of participants missed 1 week, and 68% skipped 2 or more weeks. There was no significant difference in methotrexate adherence between biologic-naive and -experienced patients, nor between those on methotrexate monotherapy versus those on additional medication. Patient demographics and RA severity were similar between patients who missed taking their methotrexate for 2 weeks or more and those who missed fewer or no doses.

Higher Patient Global Assessment of Disease Activity scores were associated with correct dosing. So was being unemployed, having no prior conventional DMARD experience, and having less disability. A higher baseline score on the Beliefs about Medicines Questionnaire Specific-Necessity subscale, which indicates stronger belief in the necessity of the medication, were associated with greater likelihood of appropriate dosing, while lower scores were linked with more weeks of early dosing. However, the other elements of the Beliefs about Medicines Questionnaire weren’t significantly associated with adherence.

“This is a big problem. A lot of factors go into medication nonadherence. The solution has to begin with your relationship with the patient. If you want people to trust you, you’re going to have to work at that,” observed Dr. Cush, who is professor of medicine and rheumatology at Baylor University Medical Center, Dallas, and director of clinical rheumatology at the Baylor Research Institute.

Roy Fleischmann, MD, a rheumatologist and medical director of the Metroplex Clinical Research Center, Dallas, said that widespread suboptimal adherence to oral methotrexate has important implications for clinical trials. Often the placebo response rate in a randomized trial where the control group is on background methotrexate is so unexpectedly high that the potential efficacy of the active drug is masked; in such situations, it’s quite possible that patients who previously weren’t taking their methotrexate consistently start doing so when they join a closely supervised study, with a resultant inflated placebo response rate, he said.

One audience member who sees lots of medication adherence issues in his practice suggested that it might be time to become more aggressive in using intravenous infusion therapy instead of subcutaneously administered agents in patients with active RA and adherence problems.

“Maybe that’s why rituximab does so well in the clinical trials,” he said.

Dr. Cush and Dr. Kavanaugh reported receiving research funding from and/or serving as consultants to numerous pharmaceutical companies.

bjancin@mdedge.com

MAUI, HAWAII – Results of a carefully conducted real-world study of adherence to oral methotrexate in patients with RA were “kind of scary,” Arthur Kavanaugh, MD, said at the 2020 Rheumatology Winter Clinical Symposium.

“At 24 weeks, adherence was only 75%. And these were people who knew they were being monitored, so this is the best of the best. And yet less than 20% took the drug perfectly, meaning they took every dose as it was supposed to be,” noted Dr. Kavanaugh, professor of medicine at the University of California, San Diego, and RWCS program director.

“Adherence to methotrexate is really not very good. This is our cornerstone drug – methotrexate – and I think it certainly applies to other medications that we’re using,” he added.

He and his fellow panelist John J. Cush, MD, discussed the implications of this recent study, led by Kaleb Michaud, PhD, of the University of Nebraska Medical Center, Omaha.

The methotrexate adherence study included 60 patients with RA whose use of the disease-modifying antirheumatic drug (DMARD) over 24 weeks was monitored via the electronic Medication Event Monitoring System. These were motivated patients seen in routine clinical practice: They were participants in Forward, the National Databank for Rheumatic Diseases, and they understood that their use of methotrexate was being monitored.

Among the key findings: Patients on average took their weekly dose as directed for a total of 18 of the 24 weeks, although adherence decreased over time. Overall, 13% of participants missed 1 week, and 68% skipped 2 or more weeks. There was no significant difference in methotrexate adherence between biologic-naive and -experienced patients, nor between those on methotrexate monotherapy versus those on additional medication. Patient demographics and RA severity were similar between patients who missed taking their methotrexate for 2 weeks or more and those who missed fewer or no doses.

Higher Patient Global Assessment of Disease Activity scores were associated with correct dosing. So was being unemployed, having no prior conventional DMARD experience, and having less disability. A higher baseline score on the Beliefs about Medicines Questionnaire Specific-Necessity subscale, which indicates stronger belief in the necessity of the medication, were associated with greater likelihood of appropriate dosing, while lower scores were linked with more weeks of early dosing. However, the other elements of the Beliefs about Medicines Questionnaire weren’t significantly associated with adherence.

“This is a big problem. A lot of factors go into medication nonadherence. The solution has to begin with your relationship with the patient. If you want people to trust you, you’re going to have to work at that,” observed Dr. Cush, who is professor of medicine and rheumatology at Baylor University Medical Center, Dallas, and director of clinical rheumatology at the Baylor Research Institute.

Roy Fleischmann, MD, a rheumatologist and medical director of the Metroplex Clinical Research Center, Dallas, said that widespread suboptimal adherence to oral methotrexate has important implications for clinical trials. Often the placebo response rate in a randomized trial where the control group is on background methotrexate is so unexpectedly high that the potential efficacy of the active drug is masked; in such situations, it’s quite possible that patients who previously weren’t taking their methotrexate consistently start doing so when they join a closely supervised study, with a resultant inflated placebo response rate, he said.

One audience member who sees lots of medication adherence issues in his practice suggested that it might be time to become more aggressive in using intravenous infusion therapy instead of subcutaneously administered agents in patients with active RA and adherence problems.

“Maybe that’s why rituximab does so well in the clinical trials,” he said.

Dr. Cush and Dr. Kavanaugh reported receiving research funding from and/or serving as consultants to numerous pharmaceutical companies.

bjancin@mdedge.com

MAUI, HAWAII – Results of a carefully conducted real-world study of adherence to oral methotrexate in patients with RA were “kind of scary,” Arthur Kavanaugh, MD, said at the 2020 Rheumatology Winter Clinical Symposium.

“At 24 weeks, adherence was only 75%. And these were people who knew they were being monitored, so this is the best of the best. And yet less than 20% took the drug perfectly, meaning they took every dose as it was supposed to be,” noted Dr. Kavanaugh, professor of medicine at the University of California, San Diego, and RWCS program director.

“Adherence to methotrexate is really not very good. This is our cornerstone drug – methotrexate – and I think it certainly applies to other medications that we’re using,” he added.

He and his fellow panelist John J. Cush, MD, discussed the implications of this recent study, led by Kaleb Michaud, PhD, of the University of Nebraska Medical Center, Omaha.

The methotrexate adherence study included 60 patients with RA whose use of the disease-modifying antirheumatic drug (DMARD) over 24 weeks was monitored via the electronic Medication Event Monitoring System. These were motivated patients seen in routine clinical practice: They were participants in Forward, the National Databank for Rheumatic Diseases, and they understood that their use of methotrexate was being monitored.

Among the key findings: Patients on average took their weekly dose as directed for a total of 18 of the 24 weeks, although adherence decreased over time. Overall, 13% of participants missed 1 week, and 68% skipped 2 or more weeks. There was no significant difference in methotrexate adherence between biologic-naive and -experienced patients, nor between those on methotrexate monotherapy versus those on additional medication. Patient demographics and RA severity were similar between patients who missed taking their methotrexate for 2 weeks or more and those who missed fewer or no doses.

Higher Patient Global Assessment of Disease Activity scores were associated with correct dosing. So was being unemployed, having no prior conventional DMARD experience, and having less disability. A higher baseline score on the Beliefs about Medicines Questionnaire Specific-Necessity subscale, which indicates stronger belief in the necessity of the medication, were associated with greater likelihood of appropriate dosing, while lower scores were linked with more weeks of early dosing. However, the other elements of the Beliefs about Medicines Questionnaire weren’t significantly associated with adherence.

“This is a big problem. A lot of factors go into medication nonadherence. The solution has to begin with your relationship with the patient. If you want people to trust you, you’re going to have to work at that,” observed Dr. Cush, who is professor of medicine and rheumatology at Baylor University Medical Center, Dallas, and director of clinical rheumatology at the Baylor Research Institute.

Roy Fleischmann, MD, a rheumatologist and medical director of the Metroplex Clinical Research Center, Dallas, said that widespread suboptimal adherence to oral methotrexate has important implications for clinical trials. Often the placebo response rate in a randomized trial where the control group is on background methotrexate is so unexpectedly high that the potential efficacy of the active drug is masked; in such situations, it’s quite possible that patients who previously weren’t taking their methotrexate consistently start doing so when they join a closely supervised study, with a resultant inflated placebo response rate, he said.

One audience member who sees lots of medication adherence issues in his practice suggested that it might be time to become more aggressive in using intravenous infusion therapy instead of subcutaneously administered agents in patients with active RA and adherence problems.

“Maybe that’s why rituximab does so well in the clinical trials,” he said.

Dr. Cush and Dr. Kavanaugh reported receiving research funding from and/or serving as consultants to numerous pharmaceutical companies.

bjancin@mdedge.com

Chronic conditions such as lung disease, diabetes, and heart disease frequently receive attention for increasing the risk of complications for people who contract the coronavirus. Meanwhile, many members of the epilepsy community continue to wonder how the virus affects them. To address these concerns, the Epilepsy Foundation has released information that answers many common questions that people with epilepsy have about how COVID-19 can impact their health.

Perhaps the most pressing of these questions is: Does epilepsy increase the risk or severity of the coronavirus? According to the Epilepsy Foundation’s website, having epilepsy poses no additional risk for contracting COVID-19 or worsening the severity of the virus.

“The most common thing we’re hearing from patients in my practice is their proactive concern for being at increased risk for getting the coronavirus,” confirmed Selim Benbadis, MD, division director, epilepsy, EEG, and sleep medicine at the University of South Florida in Tampa. “Epilepsy patients are not at increased risk for complications from the coronavirus because epilepsy does not affect the immune system.”

In other words, people who have epilepsy face the same health challenges as people who do not have the condition and are otherwise healthy. For this reason, people who have epilepsy should exercise the same habits and preventative measures that healthy people would typically take, such as social distancing; avoiding contact with sick people; washing hands regularly; disinfecting surfaces regularly; and avoiding touching hands, eyes, nose and mouth.

However, as Dr. Benbadis explained, the high fever associated with coronavirus can trigger seizures. The increased risk is another reason people who have epilepsy should do their best to avoid getting sick.
 

Seizure medications do not increase COVID-19 risk but other conditions can

Similarly, epilepsy medications do not increase the risk of contracting the disease.

“The medications patients take to treat their epilepsy do not affect their immune system,” said Andrew Wilner, MD, associate professor of neurology at the University of Tennessee Health Science Center, Memphis. There are a few exceptions – such as adrenocorticotropic hormone and everolimus – but doctors rarely use these drugs to treat epilepsy.

However, there are some situations and conditions that may pose a risk for people who contact the coronavirus. For instance, people who have problems swallowing their food and tend to suck food down their windpipes are more likely to develop pneumonia. Also, much like the general population, having diabetes, heart disease, or lung problems increase the chances of developing complications from the virus.
 

The best ways to avoid additional risks in epilepsy

Because of the pandemic, people who have epilepsy may have found that many of their doctors’ appointments have been canceled. Many clinics and medical practices have done this in order minimize exposing people who have acute illnesses to the virus. By focusing more on patients with acute conditions, doctors and nurses can better tend to patients with acute problems. As a result, practices have shifted to providing patient care using telemedicine as much as possible.

“Telemedicine services have surged, and I’ve been saying for years that telemedicine was going to grow,” Dr. Benbadis said. “It’s more convenient, and I believe that we’re going to see increased use of telemedicine long after the coronavirus pandemic is over.”

Aside from communicating with their doctors, the Epilepsy Foundation and Dr. Wilner stress that the best way for people who have epilepsy to stay healthy is by taking their medications on a regular basis exactly as prescribed.

“Taking mediation correctly and regularly is the best strategy for epilepsy patients to avoid unnecessary hospitalizations,” Dr. Wilner said. “If they have breakthrough seizures and get sent to the emergency room, then they risk being exposed to the virus in the ER.”

Also, because ERs are more crowded than usual, the Epilepsy Foundation encourages people who suspect they have the coronavirus to call their doctor’s office first. The goal is to try to make sure that people who have severe or life-threatening symptoms have access to treatment in the ER.

As with the general population, the first thing that epilepsy patients who suspect they have the coronavirus should do is call his or her doctor’s office. The health care professional taking the call will ask the patient a series of questions to determine whether the patient has COVID-19 or another condition or needs to seek emergency medical attention.

Fever, cough, and trouble breathing fall among the most commonly reported symptoms of the coronavirus. In many cases, health care providers recommend that people with mild versions of these symptoms stay at home.
 

Helpful tips

The Epilepsy Foundation offers tips on signs to look for when trying to figure out when a seizure requires an ER visit. These are:

• Seizures in which awareness is lost for more than 5 minutes and no reversal medications are available.
• Seizures with an unusual pattern or duration.
• Seizures that cannot be treated safely at home or are not responding to rescue medication even after the medication has had enough time to work.
• Seizures that occur after a severe blow to the head.

Additionally, while COVID-19 can cause death and sudden death in patients, the virus does not cause sudden unexpected death in epilepsy (SUDEP). Because SUDEP is extremely rare, Dr. Benbadis said that there is no information to suggest that contracting the coronavirus will increase the risk,

Finally, no shortages of seizures medications have been reported as a result of COVID-19. However, there were shortages of generic levetiracetam immediate-release and levetiracetam extended-release medications prior to and during COVID-19. Experts expect the shortage to continue.

Overall, people who have epilepsy should be able to stay healthy – provided they exercise healthy and preventative habits.

“The majority of epilepsy patients should be reassured that if they continue their usual care, take their meds as directed, get adequate sleep, nutritious diet, they’re not at any increased risk compared to the general population,” said Dr. Wilner.

Dr. Benbadis reported the following disclosures: consultant for Bioserenity (DigiTrace), Brain Sentinel, Cavion, Ceribell, Eisai, Greenwich, LivaNova, Neuropace, SK biopharmaceuticals, Sunovion; speakers bureau for Eisai, Greenwich, LivaNova, Sunovion; Florida Medical Director of Stratus/Alliance; Member: Epilepsy Study Consortium; grant support from Cavion, LivaNova, Greenwich, SK biopharmaceuticals, Sunovion, Takeda, UCB, Xenon; royalties as an author or editor for Emedicine-Medscape-WebMD, UpToDate; editorial board for the Epilepsy.com (Epilepsy Foundation) controversy section, Emedicine-Medscape-WebMD, Epileptic Disorders, Epilepsy and Behavior, and Expert Review of Neurotherapeutics. Dr. Wilner reports Medical Advisory Board of Accordant Health Services, Greensboro, S.C., and book royalties: “The Locum Life: A Physician’s Guide to Locum Tenens,” Lulu Press.
 

Chronic conditions such as lung disease, diabetes, and heart disease frequently receive attention for increasing the risk of complications for people who contract the coronavirus. Meanwhile, many members of the epilepsy community continue to wonder how the virus affects them. To address these concerns, the Epilepsy Foundation has released information that answers many common questions that people with epilepsy have about how COVID-19 can impact their health.

Perhaps the most pressing of these questions is: Does epilepsy increase the risk or severity of the coronavirus? According to the Epilepsy Foundation’s website, having epilepsy poses no additional risk for contracting COVID-19 or worsening the severity of the virus.

“The most common thing we’re hearing from patients in my practice is their proactive concern for being at increased risk for getting the coronavirus,” confirmed Selim Benbadis, MD, division director, epilepsy, EEG, and sleep medicine at the University of South Florida in Tampa. “Epilepsy patients are not at increased risk for complications from the coronavirus because epilepsy does not affect the immune system.”

In other words, people who have epilepsy face the same health challenges as people who do not have the condition and are otherwise healthy. For this reason, people who have epilepsy should exercise the same habits and preventative measures that healthy people would typically take, such as social distancing; avoiding contact with sick people; washing hands regularly; disinfecting surfaces regularly; and avoiding touching hands, eyes, nose and mouth.

However, as Dr. Benbadis explained, the high fever associated with coronavirus can trigger seizures. The increased risk is another reason people who have epilepsy should do their best to avoid getting sick.
 

Seizure medications do not increase COVID-19 risk but other conditions can

Similarly, epilepsy medications do not increase the risk of contracting the disease.

“The medications patients take to treat their epilepsy do not affect their immune system,” said Andrew Wilner, MD, associate professor of neurology at the University of Tennessee Health Science Center, Memphis. There are a few exceptions – such as adrenocorticotropic hormone and everolimus – but doctors rarely use these drugs to treat epilepsy.

However, there are some situations and conditions that may pose a risk for people who contact the coronavirus. For instance, people who have problems swallowing their food and tend to suck food down their windpipes are more likely to develop pneumonia. Also, much like the general population, having diabetes, heart disease, or lung problems increase the chances of developing complications from the virus.
 

The best ways to avoid additional risks in epilepsy

Because of the pandemic, people who have epilepsy may have found that many of their doctors’ appointments have been canceled. Many clinics and medical practices have done this in order minimize exposing people who have acute illnesses to the virus. By focusing more on patients with acute conditions, doctors and nurses can better tend to patients with acute problems. As a result, practices have shifted to providing patient care using telemedicine as much as possible.

“Telemedicine services have surged, and I’ve been saying for years that telemedicine was going to grow,” Dr. Benbadis said. “It’s more convenient, and I believe that we’re going to see increased use of telemedicine long after the coronavirus pandemic is over.”

Aside from communicating with their doctors, the Epilepsy Foundation and Dr. Wilner stress that the best way for people who have epilepsy to stay healthy is by taking their medications on a regular basis exactly as prescribed.

“Taking mediation correctly and regularly is the best strategy for epilepsy patients to avoid unnecessary hospitalizations,” Dr. Wilner said. “If they have breakthrough seizures and get sent to the emergency room, then they risk being exposed to the virus in the ER.”

Also, because ERs are more crowded than usual, the Epilepsy Foundation encourages people who suspect they have the coronavirus to call their doctor’s office first. The goal is to try to make sure that people who have severe or life-threatening symptoms have access to treatment in the ER.

As with the general population, the first thing that epilepsy patients who suspect they have the coronavirus should do is call his or her doctor’s office. The health care professional taking the call will ask the patient a series of questions to determine whether the patient has COVID-19 or another condition or needs to seek emergency medical attention.

Fever, cough, and trouble breathing fall among the most commonly reported symptoms of the coronavirus. In many cases, health care providers recommend that people with mild versions of these symptoms stay at home.
 

Helpful tips

The Epilepsy Foundation offers tips on signs to look for when trying to figure out when a seizure requires an ER visit. These are:

• Seizures in which awareness is lost for more than 5 minutes and no reversal medications are available.
• Seizures with an unusual pattern or duration.
• Seizures that cannot be treated safely at home or are not responding to rescue medication even after the medication has had enough time to work.
• Seizures that occur after a severe blow to the head.

Additionally, while COVID-19 can cause death and sudden death in patients, the virus does not cause sudden unexpected death in epilepsy (SUDEP). Because SUDEP is extremely rare, Dr. Benbadis said that there is no information to suggest that contracting the coronavirus will increase the risk,

Finally, no shortages of seizures medications have been reported as a result of COVID-19. However, there were shortages of generic levetiracetam immediate-release and levetiracetam extended-release medications prior to and during COVID-19. Experts expect the shortage to continue.

Overall, people who have epilepsy should be able to stay healthy – provided they exercise healthy and preventative habits.

“The majority of epilepsy patients should be reassured that if they continue their usual care, take their meds as directed, get adequate sleep, nutritious diet, they’re not at any increased risk compared to the general population,” said Dr. Wilner.

Dr. Benbadis reported the following disclosures: consultant for Bioserenity (DigiTrace), Brain Sentinel, Cavion, Ceribell, Eisai, Greenwich, LivaNova, Neuropace, SK biopharmaceuticals, Sunovion; speakers bureau for Eisai, Greenwich, LivaNova, Sunovion; Florida Medical Director of Stratus/Alliance; Member: Epilepsy Study Consortium; grant support from Cavion, LivaNova, Greenwich, SK biopharmaceuticals, Sunovion, Takeda, UCB, Xenon; royalties as an author or editor for Emedicine-Medscape-WebMD, UpToDate; editorial board for the Epilepsy.com (Epilepsy Foundation) controversy section, Emedicine-Medscape-WebMD, Epileptic Disorders, Epilepsy and Behavior, and Expert Review of Neurotherapeutics. Dr. Wilner reports Medical Advisory Board of Accordant Health Services, Greensboro, S.C., and book royalties: “The Locum Life: A Physician’s Guide to Locum Tenens,” Lulu Press.
 

Chronic conditions such as lung disease, diabetes, and heart disease frequently receive attention for increasing the risk of complications for people who contract the coronavirus. Meanwhile, many members of the epilepsy community continue to wonder how the virus affects them. To address these concerns, the Epilepsy Foundation has released information that answers many common questions that people with epilepsy have about how COVID-19 can impact their health.

Perhaps the most pressing of these questions is: Does epilepsy increase the risk or severity of the coronavirus? According to the Epilepsy Foundation’s website, having epilepsy poses no additional risk for contracting COVID-19 or worsening the severity of the virus.

“The most common thing we’re hearing from patients in my practice is their proactive concern for being at increased risk for getting the coronavirus,” confirmed Selim Benbadis, MD, division director, epilepsy, EEG, and sleep medicine at the University of South Florida in Tampa. “Epilepsy patients are not at increased risk for complications from the coronavirus because epilepsy does not affect the immune system.”

In other words, people who have epilepsy face the same health challenges as people who do not have the condition and are otherwise healthy. For this reason, people who have epilepsy should exercise the same habits and preventative measures that healthy people would typically take, such as social distancing; avoiding contact with sick people; washing hands regularly; disinfecting surfaces regularly; and avoiding touching hands, eyes, nose and mouth.

However, as Dr. Benbadis explained, the high fever associated with coronavirus can trigger seizures. The increased risk is another reason people who have epilepsy should do their best to avoid getting sick.
 

Seizure medications do not increase COVID-19 risk but other conditions can

Similarly, epilepsy medications do not increase the risk of contracting the disease.

“The medications patients take to treat their epilepsy do not affect their immune system,” said Andrew Wilner, MD, associate professor of neurology at the University of Tennessee Health Science Center, Memphis. There are a few exceptions – such as adrenocorticotropic hormone and everolimus – but doctors rarely use these drugs to treat epilepsy.

However, there are some situations and conditions that may pose a risk for people who contact the coronavirus. For instance, people who have problems swallowing their food and tend to suck food down their windpipes are more likely to develop pneumonia. Also, much like the general population, having diabetes, heart disease, or lung problems increase the chances of developing complications from the virus.
 

The best ways to avoid additional risks in epilepsy

Because of the pandemic, people who have epilepsy may have found that many of their doctors’ appointments have been canceled. Many clinics and medical practices have done this in order minimize exposing people who have acute illnesses to the virus. By focusing more on patients with acute conditions, doctors and nurses can better tend to patients with acute problems. As a result, practices have shifted to providing patient care using telemedicine as much as possible.

“Telemedicine services have surged, and I’ve been saying for years that telemedicine was going to grow,” Dr. Benbadis said. “It’s more convenient, and I believe that we’re going to see increased use of telemedicine long after the coronavirus pandemic is over.”

Aside from communicating with their doctors, the Epilepsy Foundation and Dr. Wilner stress that the best way for people who have epilepsy to stay healthy is by taking their medications on a regular basis exactly as prescribed.

“Taking mediation correctly and regularly is the best strategy for epilepsy patients to avoid unnecessary hospitalizations,” Dr. Wilner said. “If they have breakthrough seizures and get sent to the emergency room, then they risk being exposed to the virus in the ER.”

Also, because ERs are more crowded than usual, the Epilepsy Foundation encourages people who suspect they have the coronavirus to call their doctor’s office first. The goal is to try to make sure that people who have severe or life-threatening symptoms have access to treatment in the ER.

As with the general population, the first thing that epilepsy patients who suspect they have the coronavirus should do is call his or her doctor’s office. The health care professional taking the call will ask the patient a series of questions to determine whether the patient has COVID-19 or another condition or needs to seek emergency medical attention.

Fever, cough, and trouble breathing fall among the most commonly reported symptoms of the coronavirus. In many cases, health care providers recommend that people with mild versions of these symptoms stay at home.
 

Helpful tips

The Epilepsy Foundation offers tips on signs to look for when trying to figure out when a seizure requires an ER visit. These are:

• Seizures in which awareness is lost for more than 5 minutes and no reversal medications are available.
• Seizures with an unusual pattern or duration.
• Seizures that cannot be treated safely at home or are not responding to rescue medication even after the medication has had enough time to work.
• Seizures that occur after a severe blow to the head.

Additionally, while COVID-19 can cause death and sudden death in patients, the virus does not cause sudden unexpected death in epilepsy (SUDEP). Because SUDEP is extremely rare, Dr. Benbadis said that there is no information to suggest that contracting the coronavirus will increase the risk,

Finally, no shortages of seizures medications have been reported as a result of COVID-19. However, there were shortages of generic levetiracetam immediate-release and levetiracetam extended-release medications prior to and during COVID-19. Experts expect the shortage to continue.

Overall, people who have epilepsy should be able to stay healthy – provided they exercise healthy and preventative habits.

“The majority of epilepsy patients should be reassured that if they continue their usual care, take their meds as directed, get adequate sleep, nutritious diet, they’re not at any increased risk compared to the general population,” said Dr. Wilner.

Dr. Benbadis reported the following disclosures: consultant for Bioserenity (DigiTrace), Brain Sentinel, Cavion, Ceribell, Eisai, Greenwich, LivaNova, Neuropace, SK biopharmaceuticals, Sunovion; speakers bureau for Eisai, Greenwich, LivaNova, Sunovion; Florida Medical Director of Stratus/Alliance; Member: Epilepsy Study Consortium; grant support from Cavion, LivaNova, Greenwich, SK biopharmaceuticals, Sunovion, Takeda, UCB, Xenon; royalties as an author or editor for Emedicine-Medscape-WebMD, UpToDate; editorial board for the Epilepsy.com (Epilepsy Foundation) controversy section, Emedicine-Medscape-WebMD, Epileptic Disorders, Epilepsy and Behavior, and Expert Review of Neurotherapeutics. Dr. Wilner reports Medical Advisory Board of Accordant Health Services, Greensboro, S.C., and book royalties: “The Locum Life: A Physician’s Guide to Locum Tenens,” Lulu Press.
 

Emerging studies on coronavirus disease 2019 (COVID-19) confirm high rates of infection among healthcare workers (HCWs).¹ As widespread community transmission increases, frontline HCWs, such as hospitalists, are at particularly high risk of exposure to people with undiagnosed COVID-19. Although there is no known effective treatment for COVID-19, early detection is vital to decreasing ongoing transmission through contact tracing and quarantine. However, lack of adequate testing capacity prevented basic public health interventions from curbing the pandemic at an earlier stage. As a result, given high rates of presumed community transmission of COVID-19 and evidence for asymptomatic transmission, there have been moves toward the use of universal personal protective equipment (PPE). This strategy is challenging to implement because of the acute PPE shortage, which has resulted in an urgent need to embrace innovation in infection prevention.

The current pandemic has resulted in an unprecedented volume of data being generated and disseminated, with the potential to impact real-time responses in geographically disparate regions. Here, we focus on the potential for innovation and knowledge sharing from an infection prevention perspective, which could enhance frontline HCW safety in the current COVID-19 pandemic.

Every outbreak begins and ends with a diagnostic test. Widespread population testing coupled with intensive contact tracing had the potential to curb national epidemics if it had been implemented in time. In the United States, which now has the highest number of COVID-19 cases worldwide, there were technical difficulties with the first diagnostic test developed by the Centers for Disease Control and Prevention (CDC) and subsequent delays in scaling up access to COVID-19 diagnostic testing.² The strategy of initially reserving testing only for those who were critically ill meant that by the time patients with COVID-19 were being diagnosed, widespread community spread had occurred because of the lack of detection of individuals with less severe or asymptomatic infections.

In contrast, scaled-up testing in South Korea has helped limit the spread and consequences of COVID-19. The use of drive-through testing centers enabled safe and efficient testing, while minimizing the risk to HCWs and eliminating the possibility of cross infection among people being tested.³ Although outdoor testing is not feasible in all settings, this approach avoids resources and time typically needed for ventilation (typically a negative pressure room with 12 air changes per hour would be used) and cleaning of specimen collection rooms.

The other major diagnostic gap is the ability to identify individuals who have recovered from COVID-19 and are immune. There is an urgent need to develop and scale up a rapid serological test that avoids cross-reactivity with other coronaviruses. Ideally, this test would permit testing of HCWs to determine who is likely immune and can therefore return safely to work.

There has been a massive and rapid increase in the need for PPE globally because of overwhelmed health systems having to care for large numbers of patients with suspected or confirmed COVID-19. This has been exacerbated by public fear, which has led to panic buying of medical face masks (primarily used to protect others from infections with a droplet mode of transmission) and filtering facepiece half-mask respirators, which include N95 respirators (used to protect the wearer from infections with an airborne mode of transmission).

COVID-19 is thought to be predominantly spread by transmission of respiratory droplets (>5 and <10 μm in diameter), which occurs when people are in close contact (within 1 meter) with others who typically (but not always) have respiratory symptoms such as cough or sneeze or with fomites that have come into contact with an infected person. This is in contrast to infectious diseases such as tuberculosis (TB) or measles, which are spread by airborne transmission of virus suspended in droplet nuclei (<5 μm in diameter), which can remain in the air for prolonged periods of time and can be transmitted over distances greater than 1 meter.⁴

While World Health Organization (WHO) and CDC infection prevention guidance have cited droplet transmission as the primary mode of transmission for COVID-19, current CDC guidelines state that respirators are preferred for the care of patients with known or suspected COVID-19, given the potential for opportunistic airborne transmission.⁵ However, in the setting of respirator shortages, it is recommended that these should be prioritized for HCWs caring for patients with COVID-19 in the context of aerosol-generating procedures or other patients with infections spread by airborne transmission such as TB or varicella until the supply chain is restored. Of note, optimal use of respirators requires fit testing, which is often lacking in nursing homes and outpatient facilities, as well as more widely in resource-limited countries.

Universal masking (use of surgical mask) for HCWs caring for any patient irrespective of symptoms or presenting complaint has also been implemented by many large hospital systems in recent days. Although universal masking adds to the burden of the PPE shortage, in settings with widespread community transmission and given increasing evidence⁶ demonstrating transmission from people with asymptomatic and presymptomatic infection, universal masking may be useful to decrease transmission. However, particularly in the setting of PPE shortages, it is important to understand that surgical masks are designed to be single use and that dampness and frequent adjustment of the mask affects their effectiveness.

As urgent attempts to coordinate and increase PPE manufacture are being made by health systems, in conjunction with private partnerships, there has also been a burst of public campaigns to sew cloth masks to mitigate the real-time shortages. Although it is likely that cloth masks provide inadequate protection in comparison with surgical masks,⁷ evidence does suggest that cloth masks provide some degree of protection from the spread of respiratory viruses,⁸ particularly if these are replaced promptly when damp or damaged and if combined with other interventions such as hand hygiene. This has led to recommendations for the general public in various countries to wear cloth face coverings in public settings, particularly where social distancing may be harder to maintain, but these are not recommended for use by HCWs in healthcare settings.

Strategies to navigate the PPE shortage in the era of COVID-19 include importing, reclaiming, reusing, and repurposing PPE; generating and extending supply; eliminating nonessential services; reducing patient contact; and using nonhuman services such as drones to deliver equipment and undertake tasks such as decontamination.^9,10 Multidisciplinary teams are working on creative ways to use existing resources to make effective PPE, including alternatives to N95 respirators. An outbreak simulation study at Emory University in Atlanta, Georgia, and the University of Texas Health Science Center at Houston in Texas demonstrated that HCWs could be rapidly trained and fit tested to use elastomeric half-mask respirators, which are reusable.¹¹ A multidisciplinary team at Boston Children’s Hospital in Massachusetts has developed and completed a small pilot study of a reusable elastomeric respirator made using an anesthesia facemask, antimicrobial filter, and elastic straps.¹²

Given evidence that suggests that COVID-19 involves a component of airborne transmission,¹³ in addition to droplet spread and surface (fomite) contamination,¹⁴ using known infection prevention techniques that work to decrease airborne transmission of other respiratory infectious diseases should also be considered. Germicidal ultraviolet (GUV) air disinfection rapidly disinfects upper room air, which is then continually exchanged with contaminated lower-room air. GUV air disinfection has been demonstrated to be a safe and cost-effective intervention, with an efficacy of approximately 80% for decreasing TB transmission.¹⁵ GUV air disinfection is also effective against airborne influenza and measles and may play a role in surface decontamination by accelerating viral inactivation. Enabling GUV in high-risk areas such as the emergency department or intensive care unit could be a high-yield intervention to decrease transmission of COVID-19.

HCWs exposed to other respiratory infections such as influenza or TB may receive preventive therapy to reduce the risk of developing disease. High rates of COVID-19 in HCWs have prompted several initiatives to evaluate innovative approaches to decreasing this risk. Multiple studies are underway to determine whether hydroxychloroquine could be used for pre- or postexposure prophylaxis to prevent COVID-19. Another multisite trial will evaluate whether the BCG vaccine, primarily used to reduce the risk of TB, provides protection against COVID-19 in HCWs, driven by data suggesting a correlation between universal BCG vaccination policy and reduced morbidity and mortality for COVID-19.¹⁶

Infection prevention efforts can benefit from the unprecedented amount of data on COVID-19 that is being generated and shared. Successful examples of the rapid intensification of infection prevention measures to decrease transmission in healthcare facilities should be emulated. The hospital authority of Hong Kong implemented a bundle of measures focused on early recognition, isolation, notification, and molecular diagnostics for people being evaluated for COVID-19.¹⁷ They subsequently broadened the clinical and epidemiological criteria of surveillance as the outbreak evolved and intensified PPE recommendations to all HCWs (face masks for all and N95 respirators for those performing aerosol-generating procedures), which appears to have resulted in no cases of HCW infection or nosocomial transmission.

Data characterizing the extent of occupational infections in HCWs during acute and chronic epidemics is often lacking and subject to wide variability in reporting, which limits its impact. For example, HCWs in high TB incidence countries have at least twice the risk of developing TB, compared with the general population. Although there are still major gaps in national data collection regarding the incidence of occupational TB, recent attempts by WHO to systematically record this data have resulted in increasing prioritization of this group as an at-risk population who may benefit from TB preventive therapy. We strongly advocate that health systems systematically record and share longitudinal data on numbers of HCWs infected with COVID-19. This transparency will facilitate urgent action to replenish and sustain resources such as PPE and enable institutions to share and adapt successful infection prevention strategies. Examples such as the prevention of central line- associated bloodstream infections demonstrate the potential impact of national collaborative efforts to strengthen infection prevention, although further effort is needed to optimize knowledge sharing in the context of outbreaks.

The cost of not investing in public health pandemic preparedness including measures to protect HCWs is now widely apparent. HCWs have a right to safety in their workplaces as they fulfil their duty of care to patients.¹⁸ Rapid scale-up of diagnostic testing capacity, and bundles of infection prevention interventions including universal masking and drive-through testing, can safeguard HCWs and the patients they serve in the current COVID-19 pandemic. Re-establishing immediate access to quality-assured PPE is imperative to reduce the individual and workforce consequences of HCWs developing COVID-19 or other infectious diseases like TB that are continuously a threat to the workforce. Meanwhile, innovative approaches such as repurposing resources to develop PPE and use of GUV air disinfection may help to mitigate PPE shortages, and use of preventive therapies may also decrease COVID-19 risk in HCWs. Reliable surveillance data on HCW infection rates can help identify and track gaps in infection prevention, as well as identify strategies that impact this outcome. Ultimately greater top-down political commitment is urgently needed to ensure that frontline HCWs have the necessary resources to address the current pandemic and to sustain these interventions to protect HCWs in the future.

Emerging studies on coronavirus disease 2019 (COVID-19) confirm high rates of infection among healthcare workers (HCWs).¹ As widespread community transmission increases, frontline HCWs, such as hospitalists, are at particularly high risk of exposure to people with undiagnosed COVID-19. Although there is no known effective treatment for COVID-19, early detection is vital to decreasing ongoing transmission through contact tracing and quarantine. However, lack of adequate testing capacity prevented basic public health interventions from curbing the pandemic at an earlier stage. As a result, given high rates of presumed community transmission of COVID-19 and evidence for asymptomatic transmission, there have been moves toward the use of universal personal protective equipment (PPE). This strategy is challenging to implement because of the acute PPE shortage, which has resulted in an urgent need to embrace innovation in infection prevention.

The current pandemic has resulted in an unprecedented volume of data being generated and disseminated, with the potential to impact real-time responses in geographically disparate regions. Here, we focus on the potential for innovation and knowledge sharing from an infection prevention perspective, which could enhance frontline HCW safety in the current COVID-19 pandemic.

Every outbreak begins and ends with a diagnostic test. Widespread population testing coupled with intensive contact tracing had the potential to curb national epidemics if it had been implemented in time. In the United States, which now has the highest number of COVID-19 cases worldwide, there were technical difficulties with the first diagnostic test developed by the Centers for Disease Control and Prevention (CDC) and subsequent delays in scaling up access to COVID-19 diagnostic testing.² The strategy of initially reserving testing only for those who were critically ill meant that by the time patients with COVID-19 were being diagnosed, widespread community spread had occurred because of the lack of detection of individuals with less severe or asymptomatic infections.

In contrast, scaled-up testing in South Korea has helped limit the spread and consequences of COVID-19. The use of drive-through testing centers enabled safe and efficient testing, while minimizing the risk to HCWs and eliminating the possibility of cross infection among people being tested.³ Although outdoor testing is not feasible in all settings, this approach avoids resources and time typically needed for ventilation (typically a negative pressure room with 12 air changes per hour would be used) and cleaning of specimen collection rooms.

The other major diagnostic gap is the ability to identify individuals who have recovered from COVID-19 and are immune. There is an urgent need to develop and scale up a rapid serological test that avoids cross-reactivity with other coronaviruses. Ideally, this test would permit testing of HCWs to determine who is likely immune and can therefore return safely to work.

There has been a massive and rapid increase in the need for PPE globally because of overwhelmed health systems having to care for large numbers of patients with suspected or confirmed COVID-19. This has been exacerbated by public fear, which has led to panic buying of medical face masks (primarily used to protect others from infections with a droplet mode of transmission) and filtering facepiece half-mask respirators, which include N95 respirators (used to protect the wearer from infections with an airborne mode of transmission).

COVID-19 is thought to be predominantly spread by transmission of respiratory droplets (>5 and <10 μm in diameter), which occurs when people are in close contact (within 1 meter) with others who typically (but not always) have respiratory symptoms such as cough or sneeze or with fomites that have come into contact with an infected person. This is in contrast to infectious diseases such as tuberculosis (TB) or measles, which are spread by airborne transmission of virus suspended in droplet nuclei (<5 μm in diameter), which can remain in the air for prolonged periods of time and can be transmitted over distances greater than 1 meter.⁴

While World Health Organization (WHO) and CDC infection prevention guidance have cited droplet transmission as the primary mode of transmission for COVID-19, current CDC guidelines state that respirators are preferred for the care of patients with known or suspected COVID-19, given the potential for opportunistic airborne transmission.⁵ However, in the setting of respirator shortages, it is recommended that these should be prioritized for HCWs caring for patients with COVID-19 in the context of aerosol-generating procedures or other patients with infections spread by airborne transmission such as TB or varicella until the supply chain is restored. Of note, optimal use of respirators requires fit testing, which is often lacking in nursing homes and outpatient facilities, as well as more widely in resource-limited countries.

Universal masking (use of surgical mask) for HCWs caring for any patient irrespective of symptoms or presenting complaint has also been implemented by many large hospital systems in recent days. Although universal masking adds to the burden of the PPE shortage, in settings with widespread community transmission and given increasing evidence⁶ demonstrating transmission from people with asymptomatic and presymptomatic infection, universal masking may be useful to decrease transmission. However, particularly in the setting of PPE shortages, it is important to understand that surgical masks are designed to be single use and that dampness and frequent adjustment of the mask affects their effectiveness.

As urgent attempts to coordinate and increase PPE manufacture are being made by health systems, in conjunction with private partnerships, there has also been a burst of public campaigns to sew cloth masks to mitigate the real-time shortages. Although it is likely that cloth masks provide inadequate protection in comparison with surgical masks,⁷ evidence does suggest that cloth masks provide some degree of protection from the spread of respiratory viruses,⁸ particularly if these are replaced promptly when damp or damaged and if combined with other interventions such as hand hygiene. This has led to recommendations for the general public in various countries to wear cloth face coverings in public settings, particularly where social distancing may be harder to maintain, but these are not recommended for use by HCWs in healthcare settings.

Strategies to navigate the PPE shortage in the era of COVID-19 include importing, reclaiming, reusing, and repurposing PPE; generating and extending supply; eliminating nonessential services; reducing patient contact; and using nonhuman services such as drones to deliver equipment and undertake tasks such as decontamination.^9,10 Multidisciplinary teams are working on creative ways to use existing resources to make effective PPE, including alternatives to N95 respirators. An outbreak simulation study at Emory University in Atlanta, Georgia, and the University of Texas Health Science Center at Houston in Texas demonstrated that HCWs could be rapidly trained and fit tested to use elastomeric half-mask respirators, which are reusable.¹¹ A multidisciplinary team at Boston Children’s Hospital in Massachusetts has developed and completed a small pilot study of a reusable elastomeric respirator made using an anesthesia facemask, antimicrobial filter, and elastic straps.¹²

Given evidence that suggests that COVID-19 involves a component of airborne transmission,¹³ in addition to droplet spread and surface (fomite) contamination,¹⁴ using known infection prevention techniques that work to decrease airborne transmission of other respiratory infectious diseases should also be considered. Germicidal ultraviolet (GUV) air disinfection rapidly disinfects upper room air, which is then continually exchanged with contaminated lower-room air. GUV air disinfection has been demonstrated to be a safe and cost-effective intervention, with an efficacy of approximately 80% for decreasing TB transmission.¹⁵ GUV air disinfection is also effective against airborne influenza and measles and may play a role in surface decontamination by accelerating viral inactivation. Enabling GUV in high-risk areas such as the emergency department or intensive care unit could be a high-yield intervention to decrease transmission of COVID-19.

HCWs exposed to other respiratory infections such as influenza or TB may receive preventive therapy to reduce the risk of developing disease. High rates of COVID-19 in HCWs have prompted several initiatives to evaluate innovative approaches to decreasing this risk. Multiple studies are underway to determine whether hydroxychloroquine could be used for pre- or postexposure prophylaxis to prevent COVID-19. Another multisite trial will evaluate whether the BCG vaccine, primarily used to reduce the risk of TB, provides protection against COVID-19 in HCWs, driven by data suggesting a correlation between universal BCG vaccination policy and reduced morbidity and mortality for COVID-19.¹⁶

Infection prevention efforts can benefit from the unprecedented amount of data on COVID-19 that is being generated and shared. Successful examples of the rapid intensification of infection prevention measures to decrease transmission in healthcare facilities should be emulated. The hospital authority of Hong Kong implemented a bundle of measures focused on early recognition, isolation, notification, and molecular diagnostics for people being evaluated for COVID-19.¹⁷ They subsequently broadened the clinical and epidemiological criteria of surveillance as the outbreak evolved and intensified PPE recommendations to all HCWs (face masks for all and N95 respirators for those performing aerosol-generating procedures), which appears to have resulted in no cases of HCW infection or nosocomial transmission.

Data characterizing the extent of occupational infections in HCWs during acute and chronic epidemics is often lacking and subject to wide variability in reporting, which limits its impact. For example, HCWs in high TB incidence countries have at least twice the risk of developing TB, compared with the general population. Although there are still major gaps in national data collection regarding the incidence of occupational TB, recent attempts by WHO to systematically record this data have resulted in increasing prioritization of this group as an at-risk population who may benefit from TB preventive therapy. We strongly advocate that health systems systematically record and share longitudinal data on numbers of HCWs infected with COVID-19. This transparency will facilitate urgent action to replenish and sustain resources such as PPE and enable institutions to share and adapt successful infection prevention strategies. Examples such as the prevention of central line- associated bloodstream infections demonstrate the potential impact of national collaborative efforts to strengthen infection prevention, although further effort is needed to optimize knowledge sharing in the context of outbreaks.

The cost of not investing in public health pandemic preparedness including measures to protect HCWs is now widely apparent. HCWs have a right to safety in their workplaces as they fulfil their duty of care to patients.¹⁸ Rapid scale-up of diagnostic testing capacity, and bundles of infection prevention interventions including universal masking and drive-through testing, can safeguard HCWs and the patients they serve in the current COVID-19 pandemic. Re-establishing immediate access to quality-assured PPE is imperative to reduce the individual and workforce consequences of HCWs developing COVID-19 or other infectious diseases like TB that are continuously a threat to the workforce. Meanwhile, innovative approaches such as repurposing resources to develop PPE and use of GUV air disinfection may help to mitigate PPE shortages, and use of preventive therapies may also decrease COVID-19 risk in HCWs. Reliable surveillance data on HCW infection rates can help identify and track gaps in infection prevention, as well as identify strategies that impact this outcome. Ultimately greater top-down political commitment is urgently needed to ensure that frontline HCWs have the necessary resources to address the current pandemic and to sustain these interventions to protect HCWs in the future.

Emerging studies on coronavirus disease 2019 (COVID-19) confirm high rates of infection among healthcare workers (HCWs).¹ As widespread community transmission increases, frontline HCWs, such as hospitalists, are at particularly high risk of exposure to people with undiagnosed COVID-19. Although there is no known effective treatment for COVID-19, early detection is vital to decreasing ongoing transmission through contact tracing and quarantine. However, lack of adequate testing capacity prevented basic public health interventions from curbing the pandemic at an earlier stage. As a result, given high rates of presumed community transmission of COVID-19 and evidence for asymptomatic transmission, there have been moves toward the use of universal personal protective equipment (PPE). This strategy is challenging to implement because of the acute PPE shortage, which has resulted in an urgent need to embrace innovation in infection prevention.

The current pandemic has resulted in an unprecedented volume of data being generated and disseminated, with the potential to impact real-time responses in geographically disparate regions. Here, we focus on the potential for innovation and knowledge sharing from an infection prevention perspective, which could enhance frontline HCW safety in the current COVID-19 pandemic.

Every outbreak begins and ends with a diagnostic test. Widespread population testing coupled with intensive contact tracing had the potential to curb national epidemics if it had been implemented in time. In the United States, which now has the highest number of COVID-19 cases worldwide, there were technical difficulties with the first diagnostic test developed by the Centers for Disease Control and Prevention (CDC) and subsequent delays in scaling up access to COVID-19 diagnostic testing.² The strategy of initially reserving testing only for those who were critically ill meant that by the time patients with COVID-19 were being diagnosed, widespread community spread had occurred because of the lack of detection of individuals with less severe or asymptomatic infections.

In contrast, scaled-up testing in South Korea has helped limit the spread and consequences of COVID-19. The use of drive-through testing centers enabled safe and efficient testing, while minimizing the risk to HCWs and eliminating the possibility of cross infection among people being tested.³ Although outdoor testing is not feasible in all settings, this approach avoids resources and time typically needed for ventilation (typically a negative pressure room with 12 air changes per hour would be used) and cleaning of specimen collection rooms.

The other major diagnostic gap is the ability to identify individuals who have recovered from COVID-19 and are immune. There is an urgent need to develop and scale up a rapid serological test that avoids cross-reactivity with other coronaviruses. Ideally, this test would permit testing of HCWs to determine who is likely immune and can therefore return safely to work.

There has been a massive and rapid increase in the need for PPE globally because of overwhelmed health systems having to care for large numbers of patients with suspected or confirmed COVID-19. This has been exacerbated by public fear, which has led to panic buying of medical face masks (primarily used to protect others from infections with a droplet mode of transmission) and filtering facepiece half-mask respirators, which include N95 respirators (used to protect the wearer from infections with an airborne mode of transmission).

COVID-19 is thought to be predominantly spread by transmission of respiratory droplets (>5 and <10 μm in diameter), which occurs when people are in close contact (within 1 meter) with others who typically (but not always) have respiratory symptoms such as cough or sneeze or with fomites that have come into contact with an infected person. This is in contrast to infectious diseases such as tuberculosis (TB) or measles, which are spread by airborne transmission of virus suspended in droplet nuclei (<5 μm in diameter), which can remain in the air for prolonged periods of time and can be transmitted over distances greater than 1 meter.⁴

While World Health Organization (WHO) and CDC infection prevention guidance have cited droplet transmission as the primary mode of transmission for COVID-19, current CDC guidelines state that respirators are preferred for the care of patients with known or suspected COVID-19, given the potential for opportunistic airborne transmission.⁵ However, in the setting of respirator shortages, it is recommended that these should be prioritized for HCWs caring for patients with COVID-19 in the context of aerosol-generating procedures or other patients with infections spread by airborne transmission such as TB or varicella until the supply chain is restored. Of note, optimal use of respirators requires fit testing, which is often lacking in nursing homes and outpatient facilities, as well as more widely in resource-limited countries.

Universal masking (use of surgical mask) for HCWs caring for any patient irrespective of symptoms or presenting complaint has also been implemented by many large hospital systems in recent days. Although universal masking adds to the burden of the PPE shortage, in settings with widespread community transmission and given increasing evidence⁶ demonstrating transmission from people with asymptomatic and presymptomatic infection, universal masking may be useful to decrease transmission. However, particularly in the setting of PPE shortages, it is important to understand that surgical masks are designed to be single use and that dampness and frequent adjustment of the mask affects their effectiveness.

As urgent attempts to coordinate and increase PPE manufacture are being made by health systems, in conjunction with private partnerships, there has also been a burst of public campaigns to sew cloth masks to mitigate the real-time shortages. Although it is likely that cloth masks provide inadequate protection in comparison with surgical masks,⁷ evidence does suggest that cloth masks provide some degree of protection from the spread of respiratory viruses,⁸ particularly if these are replaced promptly when damp or damaged and if combined with other interventions such as hand hygiene. This has led to recommendations for the general public in various countries to wear cloth face coverings in public settings, particularly where social distancing may be harder to maintain, but these are not recommended for use by HCWs in healthcare settings.

Strategies to navigate the PPE shortage in the era of COVID-19 include importing, reclaiming, reusing, and repurposing PPE; generating and extending supply; eliminating nonessential services; reducing patient contact; and using nonhuman services such as drones to deliver equipment and undertake tasks such as decontamination.^9,10 Multidisciplinary teams are working on creative ways to use existing resources to make effective PPE, including alternatives to N95 respirators. An outbreak simulation study at Emory University in Atlanta, Georgia, and the University of Texas Health Science Center at Houston in Texas demonstrated that HCWs could be rapidly trained and fit tested to use elastomeric half-mask respirators, which are reusable.¹¹ A multidisciplinary team at Boston Children’s Hospital in Massachusetts has developed and completed a small pilot study of a reusable elastomeric respirator made using an anesthesia facemask, antimicrobial filter, and elastic straps.¹²

Given evidence that suggests that COVID-19 involves a component of airborne transmission,¹³ in addition to droplet spread and surface (fomite) contamination,¹⁴ using known infection prevention techniques that work to decrease airborne transmission of other respiratory infectious diseases should also be considered. Germicidal ultraviolet (GUV) air disinfection rapidly disinfects upper room air, which is then continually exchanged with contaminated lower-room air. GUV air disinfection has been demonstrated to be a safe and cost-effective intervention, with an efficacy of approximately 80% for decreasing TB transmission.¹⁵ GUV air disinfection is also effective against airborne influenza and measles and may play a role in surface decontamination by accelerating viral inactivation. Enabling GUV in high-risk areas such as the emergency department or intensive care unit could be a high-yield intervention to decrease transmission of COVID-19.

HCWs exposed to other respiratory infections such as influenza or TB may receive preventive therapy to reduce the risk of developing disease. High rates of COVID-19 in HCWs have prompted several initiatives to evaluate innovative approaches to decreasing this risk. Multiple studies are underway to determine whether hydroxychloroquine could be used for pre- or postexposure prophylaxis to prevent COVID-19. Another multisite trial will evaluate whether the BCG vaccine, primarily used to reduce the risk of TB, provides protection against COVID-19 in HCWs, driven by data suggesting a correlation between universal BCG vaccination policy and reduced morbidity and mortality for COVID-19.¹⁶

Infection prevention efforts can benefit from the unprecedented amount of data on COVID-19 that is being generated and shared. Successful examples of the rapid intensification of infection prevention measures to decrease transmission in healthcare facilities should be emulated. The hospital authority of Hong Kong implemented a bundle of measures focused on early recognition, isolation, notification, and molecular diagnostics for people being evaluated for COVID-19.¹⁷ They subsequently broadened the clinical and epidemiological criteria of surveillance as the outbreak evolved and intensified PPE recommendations to all HCWs (face masks for all and N95 respirators for those performing aerosol-generating procedures), which appears to have resulted in no cases of HCW infection or nosocomial transmission.

Data characterizing the extent of occupational infections in HCWs during acute and chronic epidemics is often lacking and subject to wide variability in reporting, which limits its impact. For example, HCWs in high TB incidence countries have at least twice the risk of developing TB, compared with the general population. Although there are still major gaps in national data collection regarding the incidence of occupational TB, recent attempts by WHO to systematically record this data have resulted in increasing prioritization of this group as an at-risk population who may benefit from TB preventive therapy. We strongly advocate that health systems systematically record and share longitudinal data on numbers of HCWs infected with COVID-19. This transparency will facilitate urgent action to replenish and sustain resources such as PPE and enable institutions to share and adapt successful infection prevention strategies. Examples such as the prevention of central line- associated bloodstream infections demonstrate the potential impact of national collaborative efforts to strengthen infection prevention, although further effort is needed to optimize knowledge sharing in the context of outbreaks.

The cost of not investing in public health pandemic preparedness including measures to protect HCWs is now widely apparent. HCWs have a right to safety in their workplaces as they fulfil their duty of care to patients.¹⁸ Rapid scale-up of diagnostic testing capacity, and bundles of infection prevention interventions including universal masking and drive-through testing, can safeguard HCWs and the patients they serve in the current COVID-19 pandemic. Re-establishing immediate access to quality-assured PPE is imperative to reduce the individual and workforce consequences of HCWs developing COVID-19 or other infectious diseases like TB that are continuously a threat to the workforce. Meanwhile, innovative approaches such as repurposing resources to develop PPE and use of GUV air disinfection may help to mitigate PPE shortages, and use of preventive therapies may also decrease COVID-19 risk in HCWs. Reliable surveillance data on HCW infection rates can help identify and track gaps in infection prevention, as well as identify strategies that impact this outcome. Ultimately greater top-down political commitment is urgently needed to ensure that frontline HCWs have the necessary resources to address the current pandemic and to sustain these interventions to protect HCWs in the future.

Noopur Raje, MD, has been sitting at home for 5 weeks waiting for her COVID-19 test to turn negative so she can get back to work. She’s a cancer specialist – head of the Massachusetts General Hospital’s Center for Multiple Myeloma – but Raje says as soon as she’s allowed back to the hospital, she’ll head straight to the front line of COVID-19 caregivers.

“It’s people like us who have to get back in the trenches and do the work now,” she told Medscape Medical News.

“I still will be at risk,” she said. But, having nursed her physician husband through COVID-19 at home until he was admitted to an intensive care unit, she is determined to help in the COVID-19 wards.

“I will be the first one to volunteer to take care of these patients,” she said. “I can’t wait, as I want to give these folks hope. They are so scared.”

Around the world, it’s assumed that she and others like her who’ve recovered from COVID-19 will be immune to the infection.

Some have suggested that with antibodies to the virus coursing through their veins, these survivors might be given immunity passports. They could be the ones to jump-start people’s lives again ― the first to be let out from lockdown, and in healthcare, the ones to head the ongoing battle against this pandemic.

So, there has been a race to develop COVID-19 antibody tests to identify these people.
 

Circumventing the Usual Clearance Process

To speed up the process, the US Food and Drug Administration (FDA) made a much-criticized move to allow a free-for-all for developers to begin marketing antibody tests that had not gone through the agency’s usual evaluation process. The result was a flood of more than 90 unapproved tests “that have, frankly, dubious quality,” said Scott Becker, CEO of the Association of Public Health Laboratories (APHL), which represents local and state public laboratories.

The APHL spoke out in dismay – its chief program officer, Eric Blank, decried the “Wild West” of tests unleashed on the public.

“These tests create more uncertainty than before,” said Kelly Wroblewski, APHL’s director of infectious diseases, in a news conference on April 14. “Having many inaccurate tests is worse than having no tests at all.”

The APHL and the FDA, working with the Centers for Disease Control and Prevention and the National Institutes of Health (NIH), have moved quickly into damage control, conducting evaluations of the tests in an effort to distinguish the potentially useful from the useless.

So far, they have succeeded in issuing emergency use authorizations (EUAs) to only four tests, those marketed by Cellex, Ortho Clinical Diagnostics, Chembio Diagnostic Systems, and the Mount Sinai Laboratory.

For all the other antibody tests on the market that do not have an EUA, “They’re trusting that the test developer has done a good job in validation,” Becker said. But there are worrying anecdotes. “Our members have reported that they’ve seen fraudulent marketing.... We’ve seen the FDA clamp down on some companies... [and] a number of cities and health departments have issued warnings because of what they’ve seen,” he added.

In particular, Wroblewski said, some companies are marketing tests for use in physicians’ offices or pharmacies. “Today, there are no serology tests approved for point-of-care settings,” she warned. “We don’t know how to interpret the test results, if the presence of antibodies indicates immunity, how long it will last, or what titer might be sufficient.”
 

Uncertainty Emphasized

The FDA emphasized the uncertainty about antibody tests in a statement released on April 18.

Although the tests can identify people who have been exposed and who developed an immune response to the virus, the agency noted, “we don’t yet know that just because someone has developed antibodies, that they are fully protected from reinfection, or how long any immunity lasts.”

The FDA says that the role of these antibody tests, at present, lies in providing information to “help us track the spread of the virus nationwide and assess the impact of our public health efforts now, while also informing our COVID-19 response as we continue to move forward.”

The World Health Organization (WHO) also emphasized the current uncertainty over antibody tests at a press briefing on April 17. “Nobody is sure about the length of protection that antibodies may give and whether they fully protect against ... the disease,” said Mike Ryan, MD, executive director of the WHO’s emergencies program. There is also a concern that such tests may give false assurance or be misused. “There is still a lot of work that needs to be done to validate these antibody tests,” he added.

“The WHO are right to highlight that any antibody test, if we get one, won’t be able to definitely say whether someone is immune to the infection, because we just don’t know enough yet about how immunity works with COVID-19,” commented Prof. Chris Dye, Oxford Martin School, University of Oxford, in reaction on the UK Science Media Center.

Expanding on this point on the same site, Andrew Easton PhD, professor of virology at the University of Warwick, noted that “a serology test does not discriminate between neutralising and non-neutralising antibodies; a discriminatory test is much more complex and slow.”

Only the neutralizing antibodies have the ability to inactivate the invading virus, he noted.

“When people are infected, the proportions of neutralising and non-neutralising antibodies can differ. It is not always understood what makes an antibody neutralising and another non-neutralising, or why an infection leads to production of more of one of these types of antibodies,” he explained. “The initial immune response immediately following infection sets the memory of the immune system, so if the person had generated mostly non-neutralising antibodies, the next time that person encounters the same virus, they may not be able to prevent an infection.”

So at present, the information from antibody testing is largely unhelpful to individuals, but it could be valuable to epidemiologists and policy makers.

“States are looking at ways they can integrate reliable serologic tests for surveillance,” explained APHL’s Blank.

Knowing how widespread the infection has been within a community could guide research and possibly public health decisions, Wroblewski said at the APHL press conference. But she’s hesitant here, too. “I know there has been a lot of talk about using this testing to ease restrictions, but I do think we need to be cautious on how quickly we move in that direction.” If people don’t have antibodies, it means they haven’t been exposed and that they’re still vulnerable, she noted. “If nothing else, that still informs policy decisions, even if they’re not the policy decisions we want.”
 

Trials Recruiting, Medical Centers Develop Own Tests

Despite the uncertainties over antibody testing, many efforts are still being guided by this strategy.

The NIH is recruiting volunteers to its antibody testing study and suggests that immunity is “likely” for those who test positive.

In addition, several large medical centers have developed their own antibody tests, including Stanford, the Yale New Haven Hospital, and the Mayo Clinic.

The Stanford test detects two types of antibodies: IgM, which is made early in an immune response and usually wanes quickly, and IgG, which rises more slowly after infection but usually persists longer.

“There’s limited data out of China and Europe showing that this appears to be the response pattern followed with this virus,” commented Thomas Montine, MD, PhD, professor and chair of pathology at Stanford University. “But no one has had this long enough to know how long after infection the antibodies persist,” he added.

“There is enormous demand for serologic testing,” said William Morice, MD, PhD, president of Mayo Clinic Laboratories. “At this time, serology testing needs to be prioritized for efforts to identify individuals in areas where potential immunity is key ― supporting healthcare workers, screening for potential plasma donors, and helping advance the most promising vaccine candidates.”

During a recent webinar with the Association for Value-Based Cancer Care, the largest physician-owned oncology-hematology practice in the country, the president, Lucio Gordan, MD, said his organization was looking into antibody testing for staff. “They wanted to see how many have been exposed,” he said, although “what it means is uncertain.”

When Medscape Medical News checked back with him a few weeks later, Gordan, president of Florida Cancer Specialists and Research Institute, reported that no progress had been made.

“We unfortunately have not been able to test yet, due to concerns with reliability of kits. We are waiting for a better solution so we can reassess our strategy,” he said.

This article first appeared on Medscape.com.

Noopur Raje, MD, has been sitting at home for 5 weeks waiting for her COVID-19 test to turn negative so she can get back to work. She’s a cancer specialist – head of the Massachusetts General Hospital’s Center for Multiple Myeloma – but Raje says as soon as she’s allowed back to the hospital, she’ll head straight to the front line of COVID-19 caregivers.

“It’s people like us who have to get back in the trenches and do the work now,” she told Medscape Medical News.

“I still will be at risk,” she said. But, having nursed her physician husband through COVID-19 at home until he was admitted to an intensive care unit, she is determined to help in the COVID-19 wards.

“I will be the first one to volunteer to take care of these patients,” she said. “I can’t wait, as I want to give these folks hope. They are so scared.”

Around the world, it’s assumed that she and others like her who’ve recovered from COVID-19 will be immune to the infection.

Some have suggested that with antibodies to the virus coursing through their veins, these survivors might be given immunity passports. They could be the ones to jump-start people’s lives again ― the first to be let out from lockdown, and in healthcare, the ones to head the ongoing battle against this pandemic.

So, there has been a race to develop COVID-19 antibody tests to identify these people.
 

Circumventing the Usual Clearance Process

To speed up the process, the US Food and Drug Administration (FDA) made a much-criticized move to allow a free-for-all for developers to begin marketing antibody tests that had not gone through the agency’s usual evaluation process. The result was a flood of more than 90 unapproved tests “that have, frankly, dubious quality,” said Scott Becker, CEO of the Association of Public Health Laboratories (APHL), which represents local and state public laboratories.

The APHL spoke out in dismay – its chief program officer, Eric Blank, decried the “Wild West” of tests unleashed on the public.

“These tests create more uncertainty than before,” said Kelly Wroblewski, APHL’s director of infectious diseases, in a news conference on April 14. “Having many inaccurate tests is worse than having no tests at all.”

The APHL and the FDA, working with the Centers for Disease Control and Prevention and the National Institutes of Health (NIH), have moved quickly into damage control, conducting evaluations of the tests in an effort to distinguish the potentially useful from the useless.

So far, they have succeeded in issuing emergency use authorizations (EUAs) to only four tests, those marketed by Cellex, Ortho Clinical Diagnostics, Chembio Diagnostic Systems, and the Mount Sinai Laboratory.

For all the other antibody tests on the market that do not have an EUA, “They’re trusting that the test developer has done a good job in validation,” Becker said. But there are worrying anecdotes. “Our members have reported that they’ve seen fraudulent marketing.... We’ve seen the FDA clamp down on some companies... [and] a number of cities and health departments have issued warnings because of what they’ve seen,” he added.

In particular, Wroblewski said, some companies are marketing tests for use in physicians’ offices or pharmacies. “Today, there are no serology tests approved for point-of-care settings,” she warned. “We don’t know how to interpret the test results, if the presence of antibodies indicates immunity, how long it will last, or what titer might be sufficient.”
 

Uncertainty Emphasized

The FDA emphasized the uncertainty about antibody tests in a statement released on April 18.

Although the tests can identify people who have been exposed and who developed an immune response to the virus, the agency noted, “we don’t yet know that just because someone has developed antibodies, that they are fully protected from reinfection, or how long any immunity lasts.”

The FDA says that the role of these antibody tests, at present, lies in providing information to “help us track the spread of the virus nationwide and assess the impact of our public health efforts now, while also informing our COVID-19 response as we continue to move forward.”

The World Health Organization (WHO) also emphasized the current uncertainty over antibody tests at a press briefing on April 17. “Nobody is sure about the length of protection that antibodies may give and whether they fully protect against ... the disease,” said Mike Ryan, MD, executive director of the WHO’s emergencies program. There is also a concern that such tests may give false assurance or be misused. “There is still a lot of work that needs to be done to validate these antibody tests,” he added.

“The WHO are right to highlight that any antibody test, if we get one, won’t be able to definitely say whether someone is immune to the infection, because we just don’t know enough yet about how immunity works with COVID-19,” commented Prof. Chris Dye, Oxford Martin School, University of Oxford, in reaction on the UK Science Media Center.

Expanding on this point on the same site, Andrew Easton PhD, professor of virology at the University of Warwick, noted that “a serology test does not discriminate between neutralising and non-neutralising antibodies; a discriminatory test is much more complex and slow.”

Only the neutralizing antibodies have the ability to inactivate the invading virus, he noted.

“When people are infected, the proportions of neutralising and non-neutralising antibodies can differ. It is not always understood what makes an antibody neutralising and another non-neutralising, or why an infection leads to production of more of one of these types of antibodies,” he explained. “The initial immune response immediately following infection sets the memory of the immune system, so if the person had generated mostly non-neutralising antibodies, the next time that person encounters the same virus, they may not be able to prevent an infection.”

So at present, the information from antibody testing is largely unhelpful to individuals, but it could be valuable to epidemiologists and policy makers.

“States are looking at ways they can integrate reliable serologic tests for surveillance,” explained APHL’s Blank.

Knowing how widespread the infection has been within a community could guide research and possibly public health decisions, Wroblewski said at the APHL press conference. But she’s hesitant here, too. “I know there has been a lot of talk about using this testing to ease restrictions, but I do think we need to be cautious on how quickly we move in that direction.” If people don’t have antibodies, it means they haven’t been exposed and that they’re still vulnerable, she noted. “If nothing else, that still informs policy decisions, even if they’re not the policy decisions we want.”
 

Trials Recruiting, Medical Centers Develop Own Tests

Despite the uncertainties over antibody testing, many efforts are still being guided by this strategy.

The NIH is recruiting volunteers to its antibody testing study and suggests that immunity is “likely” for those who test positive.

In addition, several large medical centers have developed their own antibody tests, including Stanford, the Yale New Haven Hospital, and the Mayo Clinic.

The Stanford test detects two types of antibodies: IgM, which is made early in an immune response and usually wanes quickly, and IgG, which rises more slowly after infection but usually persists longer.

“There’s limited data out of China and Europe showing that this appears to be the response pattern followed with this virus,” commented Thomas Montine, MD, PhD, professor and chair of pathology at Stanford University. “But no one has had this long enough to know how long after infection the antibodies persist,” he added.

“There is enormous demand for serologic testing,” said William Morice, MD, PhD, president of Mayo Clinic Laboratories. “At this time, serology testing needs to be prioritized for efforts to identify individuals in areas where potential immunity is key ― supporting healthcare workers, screening for potential plasma donors, and helping advance the most promising vaccine candidates.”

During a recent webinar with the Association for Value-Based Cancer Care, the largest physician-owned oncology-hematology practice in the country, the president, Lucio Gordan, MD, said his organization was looking into antibody testing for staff. “They wanted to see how many have been exposed,” he said, although “what it means is uncertain.”

When Medscape Medical News checked back with him a few weeks later, Gordan, president of Florida Cancer Specialists and Research Institute, reported that no progress had been made.

“We unfortunately have not been able to test yet, due to concerns with reliability of kits. We are waiting for a better solution so we can reassess our strategy,” he said.

This article first appeared on Medscape.com.

Noopur Raje, MD, has been sitting at home for 5 weeks waiting for her COVID-19 test to turn negative so she can get back to work. She’s a cancer specialist – head of the Massachusetts General Hospital’s Center for Multiple Myeloma – but Raje says as soon as she’s allowed back to the hospital, she’ll head straight to the front line of COVID-19 caregivers.

“It’s people like us who have to get back in the trenches and do the work now,” she told Medscape Medical News.

“I still will be at risk,” she said. But, having nursed her physician husband through COVID-19 at home until he was admitted to an intensive care unit, she is determined to help in the COVID-19 wards.

“I will be the first one to volunteer to take care of these patients,” she said. “I can’t wait, as I want to give these folks hope. They are so scared.”

Around the world, it’s assumed that she and others like her who’ve recovered from COVID-19 will be immune to the infection.

Some have suggested that with antibodies to the virus coursing through their veins, these survivors might be given immunity passports. They could be the ones to jump-start people’s lives again ― the first to be let out from lockdown, and in healthcare, the ones to head the ongoing battle against this pandemic.

So, there has been a race to develop COVID-19 antibody tests to identify these people.
 

Circumventing the Usual Clearance Process

To speed up the process, the US Food and Drug Administration (FDA) made a much-criticized move to allow a free-for-all for developers to begin marketing antibody tests that had not gone through the agency’s usual evaluation process. The result was a flood of more than 90 unapproved tests “that have, frankly, dubious quality,” said Scott Becker, CEO of the Association of Public Health Laboratories (APHL), which represents local and state public laboratories.

The APHL spoke out in dismay – its chief program officer, Eric Blank, decried the “Wild West” of tests unleashed on the public.

“These tests create more uncertainty than before,” said Kelly Wroblewski, APHL’s director of infectious diseases, in a news conference on April 14. “Having many inaccurate tests is worse than having no tests at all.”

The APHL and the FDA, working with the Centers for Disease Control and Prevention and the National Institutes of Health (NIH), have moved quickly into damage control, conducting evaluations of the tests in an effort to distinguish the potentially useful from the useless.

So far, they have succeeded in issuing emergency use authorizations (EUAs) to only four tests, those marketed by Cellex, Ortho Clinical Diagnostics, Chembio Diagnostic Systems, and the Mount Sinai Laboratory.

For all the other antibody tests on the market that do not have an EUA, “They’re trusting that the test developer has done a good job in validation,” Becker said. But there are worrying anecdotes. “Our members have reported that they’ve seen fraudulent marketing.... We’ve seen the FDA clamp down on some companies... [and] a number of cities and health departments have issued warnings because of what they’ve seen,” he added.

In particular, Wroblewski said, some companies are marketing tests for use in physicians’ offices or pharmacies. “Today, there are no serology tests approved for point-of-care settings,” she warned. “We don’t know how to interpret the test results, if the presence of antibodies indicates immunity, how long it will last, or what titer might be sufficient.”
 

Uncertainty Emphasized

The FDA emphasized the uncertainty about antibody tests in a statement released on April 18.

Although the tests can identify people who have been exposed and who developed an immune response to the virus, the agency noted, “we don’t yet know that just because someone has developed antibodies, that they are fully protected from reinfection, or how long any immunity lasts.”

The FDA says that the role of these antibody tests, at present, lies in providing information to “help us track the spread of the virus nationwide and assess the impact of our public health efforts now, while also informing our COVID-19 response as we continue to move forward.”

The World Health Organization (WHO) also emphasized the current uncertainty over antibody tests at a press briefing on April 17. “Nobody is sure about the length of protection that antibodies may give and whether they fully protect against ... the disease,” said Mike Ryan, MD, executive director of the WHO’s emergencies program. There is also a concern that such tests may give false assurance or be misused. “There is still a lot of work that needs to be done to validate these antibody tests,” he added.

“The WHO are right to highlight that any antibody test, if we get one, won’t be able to definitely say whether someone is immune to the infection, because we just don’t know enough yet about how immunity works with COVID-19,” commented Prof. Chris Dye, Oxford Martin School, University of Oxford, in reaction on the UK Science Media Center.

Expanding on this point on the same site, Andrew Easton PhD, professor of virology at the University of Warwick, noted that “a serology test does not discriminate between neutralising and non-neutralising antibodies; a discriminatory test is much more complex and slow.”

Only the neutralizing antibodies have the ability to inactivate the invading virus, he noted.

“When people are infected, the proportions of neutralising and non-neutralising antibodies can differ. It is not always understood what makes an antibody neutralising and another non-neutralising, or why an infection leads to production of more of one of these types of antibodies,” he explained. “The initial immune response immediately following infection sets the memory of the immune system, so if the person had generated mostly non-neutralising antibodies, the next time that person encounters the same virus, they may not be able to prevent an infection.”

So at present, the information from antibody testing is largely unhelpful to individuals, but it could be valuable to epidemiologists and policy makers.

“States are looking at ways they can integrate reliable serologic tests for surveillance,” explained APHL’s Blank.

Knowing how widespread the infection has been within a community could guide research and possibly public health decisions, Wroblewski said at the APHL press conference. But she’s hesitant here, too. “I know there has been a lot of talk about using this testing to ease restrictions, but I do think we need to be cautious on how quickly we move in that direction.” If people don’t have antibodies, it means they haven’t been exposed and that they’re still vulnerable, she noted. “If nothing else, that still informs policy decisions, even if they’re not the policy decisions we want.”
 

Trials Recruiting, Medical Centers Develop Own Tests

Despite the uncertainties over antibody testing, many efforts are still being guided by this strategy.

The NIH is recruiting volunteers to its antibody testing study and suggests that immunity is “likely” for those who test positive.

In addition, several large medical centers have developed their own antibody tests, including Stanford, the Yale New Haven Hospital, and the Mayo Clinic.

The Stanford test detects two types of antibodies: IgM, which is made early in an immune response and usually wanes quickly, and IgG, which rises more slowly after infection but usually persists longer.

“There’s limited data out of China and Europe showing that this appears to be the response pattern followed with this virus,” commented Thomas Montine, MD, PhD, professor and chair of pathology at Stanford University. “But no one has had this long enough to know how long after infection the antibodies persist,” he added.

“There is enormous demand for serologic testing,” said William Morice, MD, PhD, president of Mayo Clinic Laboratories. “At this time, serology testing needs to be prioritized for efforts to identify individuals in areas where potential immunity is key ― supporting healthcare workers, screening for potential plasma donors, and helping advance the most promising vaccine candidates.”

During a recent webinar with the Association for Value-Based Cancer Care, the largest physician-owned oncology-hematology practice in the country, the president, Lucio Gordan, MD, said his organization was looking into antibody testing for staff. “They wanted to see how many have been exposed,” he said, although “what it means is uncertain.”

When Medscape Medical News checked back with him a few weeks later, Gordan, president of Florida Cancer Specialists and Research Institute, reported that no progress had been made.

“We unfortunately have not been able to test yet, due to concerns with reliability of kits. We are waiting for a better solution so we can reassess our strategy,” he said.

This article first appeared on Medscape.com.

As evidence piles up documenting a sudden loss of smell and/or taste as a presenting symptom of COVID-19, the call to screen for these phenomena is growing.

A number of new publications show that a high proportion of people infected with COVID-19 report loss of smell and/or taste, with their authors adding to the clamor to recognize these symptoms as potentially indicative of the infection.

In particular, there is a belief that these signs may be present in many with asymptomatic COVID-19, and therefore asking about them could be a way to prioritize people for initial testing for the SARS-CoV-2 virus in the absence of other symptoms.

Anyone testing positive could then quarantine, and their contacts could be traced.

Despite this, the World Health Organization (WHO) has not listed loss of smell or taste as potential symptoms of SARS-CoV-2 infection.

But the US Centers for Disease Control and Prevention (CDC) has now added “new loss of taste or smell” as a symptom on its COVID-19 information page.

American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS) executive vice president and CEO James C. Denneny III, MD, believes the symptoms may be an early warning signal.

And there’s no downside to checking for these, Denneny told Medscape Medical News.

“Given the fact that this doesn’t require any surgical procedure, biopsy, or specific treatment, I think the upside of getting it early is great,” he said. “The downside of using it as a symptom, and if someone doesn’t turn out to have it, is virtually zero.”

Claire Hopkins, MD, president of the British Rhinological Society, and colleagues, writing in Lancet Infectious Diseases, agree.

“Physicians evaluating patients with acute-onset loss of smell or taste, particularly in the context of a patent nasal airway, should have a high index of suspicion for concomitant SARS-CoV-2 infection.”

They also observe that this appears to occur, in contrast to other respiratory infections, “in the absence of nasal congestion or rhinorrhea.”
 

Newest Publications Find Smell and Taste Loss Is Common

Author of one of the newly published studies, Carol H. Yan, MD, an otolaryngologist and head and neck surgeon at the University of California, San Diego, also thinks that sudden smell and taste loss seem to be fairly specific markers of COVID-19.

In her survey of patients who presented to UC San Diego Health for SARS-CoV-2 testing, Yan and colleagues reported that 68% (40 of 59) of COVID-19–positive patients reported olfactory impairment and 71% (42 of 59) reported taste impairment.

Among the 203 people in the “control” group who were polymerase chain reaction–negative (PCR–) for SARS-CoV-2, just 16% had smell loss and 17% had taste loss, according to their results published in the International Forum of Allergy & Rhinology.

“Based on our study, if you have smell and taste loss, you are more than 10 times more likely to have COVID-19 infection than other causes of infection. The most common first sign of a COVID-19 infection remains fever, but fatigue and loss of smell and taste follow as other very common initial symptoms,” said Yan.

“We know COVID-19 is an extremely contagious virus. This study supports the need to be aware of smell and taste loss as early signs of COVID-19.”

Yan told Medscape Medical News that another not-yet-published analysis indicates that sudden loss of smell or taste “may be more representative of a mild form of disease.”

Getting these people tested and isolated could therefore help prevent spread of COVID-19, she urged.

Based on Yan’s report and other case reports, the UC San Diego Health system is now asking all callers to its COVID-19 hotlines, and all visitors and staff, if they’ve had a sudden loss of taste or smell in the last few weeks, she explained.

And Ahmad R. Sedaghat, MD, PhD, at the University of Cincinnati, Ohio, takes a similar view.

In a new systematic review of the topic published April 14 in Laryngoscope Investigative Otolaryngology, Sedaghat and colleagues write: “Anosmia (total loss of smell) without nasal obstruction, in particular, appears to be a highly specific indicator of COVID-19.”

Sedaghat said a sudden loss of sense of smell wouldn’t necessarily lead people to think they have COVID-19, particularly if they remain asymptomatic, so “these individuals could continue business as usual and spread the disease as a carrier.”

“If someone experiences anosmia without nasal obstruction, aside from quarantining, it would not be unreasonable to reach out to one’s primary care physician about getting tested,” he said in a statement from his institution.
 

Symptom Checkers Add Weight

Several organizations around the world have begun collecting symptom reports from patients and clinicians, which has shone more light on the sudden loss of taste and smell as potential flags for COVID-19.

In an April 14 Morbidity and Mortality Weekly report from the CDC on COVID-19 infections in healthcare workers, of the 5000 who reported symptoms, 750 (16%) wrote “loss of smell or taste” as an “other” symptom.

Meanwhile, the COVID Symptom Tracker smartphone app, a joint effort by Massachusetts General Hospital, Boston, Stanford (Calif.) University, and King’s College, London, which as of press time, was monitoring some 2.5 million people, has had similar findings.

In a preprint publication on 400,000 people reporting one or more symptoms between March 24 and 29 on the tracker, 18% had lost their sense of smell or taste — more than the 10% who reported fever, but far less than the 53% who reported fatigue.

Only 1702 of the 400,000 had received a COVID-19 test.

Of those, 579 had tested positive and 1123 were negative.

The organizers estimated that of those who were positive, 59% reported losing smell or taste, compared with just 18% who tested negative.

“When combined with other symptoms, people with loss of smell and taste appear to be three times more likely to have contracted COVID-19 according to our data,” said Tim Spector, MD, a genetic epidemiologist at King’s College and the app’s lead researcher, on the symptom tracker’s website.

These people “should therefore self-isolate for 7 days to reduce the spread of the disease,” he urged.
 

Anosmia Is the Initial Symptom in Many Patients With COVID-19

The AAO-HNS also began collecting data from physicians and patients on March 25 through its Web-based 16-question symptom tracking tool.

It has received more than 500 reports of sudden taste or smell loss, said Denneny.

In a report on the first 237 responses, published in Otolaryngology-Head and Neck Surgery, anosmia (profound loss of smell) was found in 73% of subjects before a COVID-19 diagnosis and was the initial symptom in 27% of those subjects.

That latter determination “was the single most important finding,” said Denneny, noting it shows that smell and taste loss are “a sentinel symptom.”

Anosmia led to testing in only 40% of the cases.

Half of the reports came from otolaryngologists, but a large number came from other medical specialties, especially from family medicine.

Just 2% of reports came from patients in that first group, which was based on responses through April 3.

Denneny said that more reports are now coming in from patients, which he attributes to widespread media coverage about the loss of taste and smell.

It’s still not entirely clear why SARS-CoV-2 might inhibit taste or smell. More common viruses like influenza and other coronaviruses can also cause smell and taste loss.

So far, it seems like the sensory recovery is faster for SARS-CoV-2 than the other viruses, which suggests a potentially different mechanism of action, said Yan. Patients she surveyed at UC San Diego recovered the senses within a few weeks to a month, compared to months or a year with the more common viruses.

Yan’s study was partially supported by the National Institutes of Health. Sedaghat has reported no relevant financial relationships. The COVID Symptom Tracker is supported by Zoe Global Limited and has received grants from the Wellcome Trust, Medical Research Council/British Heart Foundation, and Biological Informative Markers for Stratification of Hypertension.

This article first appeared on Medscape.com.

As evidence piles up documenting a sudden loss of smell and/or taste as a presenting symptom of COVID-19, the call to screen for these phenomena is growing.

A number of new publications show that a high proportion of people infected with COVID-19 report loss of smell and/or taste, with their authors adding to the clamor to recognize these symptoms as potentially indicative of the infection.

In particular, there is a belief that these signs may be present in many with asymptomatic COVID-19, and therefore asking about them could be a way to prioritize people for initial testing for the SARS-CoV-2 virus in the absence of other symptoms.

Anyone testing positive could then quarantine, and their contacts could be traced.

Despite this, the World Health Organization (WHO) has not listed loss of smell or taste as potential symptoms of SARS-CoV-2 infection.

But the US Centers for Disease Control and Prevention (CDC) has now added “new loss of taste or smell” as a symptom on its COVID-19 information page.

American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS) executive vice president and CEO James C. Denneny III, MD, believes the symptoms may be an early warning signal.

And there’s no downside to checking for these, Denneny told Medscape Medical News.

“Given the fact that this doesn’t require any surgical procedure, biopsy, or specific treatment, I think the upside of getting it early is great,” he said. “The downside of using it as a symptom, and if someone doesn’t turn out to have it, is virtually zero.”

Claire Hopkins, MD, president of the British Rhinological Society, and colleagues, writing in Lancet Infectious Diseases, agree.

“Physicians evaluating patients with acute-onset loss of smell or taste, particularly in the context of a patent nasal airway, should have a high index of suspicion for concomitant SARS-CoV-2 infection.”

They also observe that this appears to occur, in contrast to other respiratory infections, “in the absence of nasal congestion or rhinorrhea.”
 

Newest Publications Find Smell and Taste Loss Is Common

Author of one of the newly published studies, Carol H. Yan, MD, an otolaryngologist and head and neck surgeon at the University of California, San Diego, also thinks that sudden smell and taste loss seem to be fairly specific markers of COVID-19.

In her survey of patients who presented to UC San Diego Health for SARS-CoV-2 testing, Yan and colleagues reported that 68% (40 of 59) of COVID-19–positive patients reported olfactory impairment and 71% (42 of 59) reported taste impairment.

Among the 203 people in the “control” group who were polymerase chain reaction–negative (PCR–) for SARS-CoV-2, just 16% had smell loss and 17% had taste loss, according to their results published in the International Forum of Allergy & Rhinology.

“Based on our study, if you have smell and taste loss, you are more than 10 times more likely to have COVID-19 infection than other causes of infection. The most common first sign of a COVID-19 infection remains fever, but fatigue and loss of smell and taste follow as other very common initial symptoms,” said Yan.

“We know COVID-19 is an extremely contagious virus. This study supports the need to be aware of smell and taste loss as early signs of COVID-19.”

Yan told Medscape Medical News that another not-yet-published analysis indicates that sudden loss of smell or taste “may be more representative of a mild form of disease.”

Getting these people tested and isolated could therefore help prevent spread of COVID-19, she urged.

Based on Yan’s report and other case reports, the UC San Diego Health system is now asking all callers to its COVID-19 hotlines, and all visitors and staff, if they’ve had a sudden loss of taste or smell in the last few weeks, she explained.

And Ahmad R. Sedaghat, MD, PhD, at the University of Cincinnati, Ohio, takes a similar view.

In a new systematic review of the topic published April 14 in Laryngoscope Investigative Otolaryngology, Sedaghat and colleagues write: “Anosmia (total loss of smell) without nasal obstruction, in particular, appears to be a highly specific indicator of COVID-19.”

Sedaghat said a sudden loss of sense of smell wouldn’t necessarily lead people to think they have COVID-19, particularly if they remain asymptomatic, so “these individuals could continue business as usual and spread the disease as a carrier.”

“If someone experiences anosmia without nasal obstruction, aside from quarantining, it would not be unreasonable to reach out to one’s primary care physician about getting tested,” he said in a statement from his institution.
 

Symptom Checkers Add Weight

Several organizations around the world have begun collecting symptom reports from patients and clinicians, which has shone more light on the sudden loss of taste and smell as potential flags for COVID-19.

In an April 14 Morbidity and Mortality Weekly report from the CDC on COVID-19 infections in healthcare workers, of the 5000 who reported symptoms, 750 (16%) wrote “loss of smell or taste” as an “other” symptom.

Meanwhile, the COVID Symptom Tracker smartphone app, a joint effort by Massachusetts General Hospital, Boston, Stanford (Calif.) University, and King’s College, London, which as of press time, was monitoring some 2.5 million people, has had similar findings.

In a preprint publication on 400,000 people reporting one or more symptoms between March 24 and 29 on the tracker, 18% had lost their sense of smell or taste — more than the 10% who reported fever, but far less than the 53% who reported fatigue.

Only 1702 of the 400,000 had received a COVID-19 test.

Of those, 579 had tested positive and 1123 were negative.

The organizers estimated that of those who were positive, 59% reported losing smell or taste, compared with just 18% who tested negative.

“When combined with other symptoms, people with loss of smell and taste appear to be three times more likely to have contracted COVID-19 according to our data,” said Tim Spector, MD, a genetic epidemiologist at King’s College and the app’s lead researcher, on the symptom tracker’s website.

These people “should therefore self-isolate for 7 days to reduce the spread of the disease,” he urged.
 

Anosmia Is the Initial Symptom in Many Patients With COVID-19

The AAO-HNS also began collecting data from physicians and patients on March 25 through its Web-based 16-question symptom tracking tool.

It has received more than 500 reports of sudden taste or smell loss, said Denneny.

In a report on the first 237 responses, published in Otolaryngology-Head and Neck Surgery, anosmia (profound loss of smell) was found in 73% of subjects before a COVID-19 diagnosis and was the initial symptom in 27% of those subjects.

That latter determination “was the single most important finding,” said Denneny, noting it shows that smell and taste loss are “a sentinel symptom.”

Anosmia led to testing in only 40% of the cases.

Half of the reports came from otolaryngologists, but a large number came from other medical specialties, especially from family medicine.

Just 2% of reports came from patients in that first group, which was based on responses through April 3.

Denneny said that more reports are now coming in from patients, which he attributes to widespread media coverage about the loss of taste and smell.

It’s still not entirely clear why SARS-CoV-2 might inhibit taste or smell. More common viruses like influenza and other coronaviruses can also cause smell and taste loss.

So far, it seems like the sensory recovery is faster for SARS-CoV-2 than the other viruses, which suggests a potentially different mechanism of action, said Yan. Patients she surveyed at UC San Diego recovered the senses within a few weeks to a month, compared to months or a year with the more common viruses.

Yan’s study was partially supported by the National Institutes of Health. Sedaghat has reported no relevant financial relationships. The COVID Symptom Tracker is supported by Zoe Global Limited and has received grants from the Wellcome Trust, Medical Research Council/British Heart Foundation, and Biological Informative Markers for Stratification of Hypertension.

This article first appeared on Medscape.com.

As evidence piles up documenting a sudden loss of smell and/or taste as a presenting symptom of COVID-19, the call to screen for these phenomena is growing.

A number of new publications show that a high proportion of people infected with COVID-19 report loss of smell and/or taste, with their authors adding to the clamor to recognize these symptoms as potentially indicative of the infection.

In particular, there is a belief that these signs may be present in many with asymptomatic COVID-19, and therefore asking about them could be a way to prioritize people for initial testing for the SARS-CoV-2 virus in the absence of other symptoms.

Anyone testing positive could then quarantine, and their contacts could be traced.

Despite this, the World Health Organization (WHO) has not listed loss of smell or taste as potential symptoms of SARS-CoV-2 infection.

But the US Centers for Disease Control and Prevention (CDC) has now added “new loss of taste or smell” as a symptom on its COVID-19 information page.

American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS) executive vice president and CEO James C. Denneny III, MD, believes the symptoms may be an early warning signal.

And there’s no downside to checking for these, Denneny told Medscape Medical News.

“Given the fact that this doesn’t require any surgical procedure, biopsy, or specific treatment, I think the upside of getting it early is great,” he said. “The downside of using it as a symptom, and if someone doesn’t turn out to have it, is virtually zero.”

Claire Hopkins, MD, president of the British Rhinological Society, and colleagues, writing in Lancet Infectious Diseases, agree.

“Physicians evaluating patients with acute-onset loss of smell or taste, particularly in the context of a patent nasal airway, should have a high index of suspicion for concomitant SARS-CoV-2 infection.”

They also observe that this appears to occur, in contrast to other respiratory infections, “in the absence of nasal congestion or rhinorrhea.”
 

Newest Publications Find Smell and Taste Loss Is Common

Author of one of the newly published studies, Carol H. Yan, MD, an otolaryngologist and head and neck surgeon at the University of California, San Diego, also thinks that sudden smell and taste loss seem to be fairly specific markers of COVID-19.

In her survey of patients who presented to UC San Diego Health for SARS-CoV-2 testing, Yan and colleagues reported that 68% (40 of 59) of COVID-19–positive patients reported olfactory impairment and 71% (42 of 59) reported taste impairment.

Among the 203 people in the “control” group who were polymerase chain reaction–negative (PCR–) for SARS-CoV-2, just 16% had smell loss and 17% had taste loss, according to their results published in the International Forum of Allergy & Rhinology.

“Based on our study, if you have smell and taste loss, you are more than 10 times more likely to have COVID-19 infection than other causes of infection. The most common first sign of a COVID-19 infection remains fever, but fatigue and loss of smell and taste follow as other very common initial symptoms,” said Yan.

“We know COVID-19 is an extremely contagious virus. This study supports the need to be aware of smell and taste loss as early signs of COVID-19.”

Yan told Medscape Medical News that another not-yet-published analysis indicates that sudden loss of smell or taste “may be more representative of a mild form of disease.”

Getting these people tested and isolated could therefore help prevent spread of COVID-19, she urged.

Based on Yan’s report and other case reports, the UC San Diego Health system is now asking all callers to its COVID-19 hotlines, and all visitors and staff, if they’ve had a sudden loss of taste or smell in the last few weeks, she explained.

And Ahmad R. Sedaghat, MD, PhD, at the University of Cincinnati, Ohio, takes a similar view.

In a new systematic review of the topic published April 14 in Laryngoscope Investigative Otolaryngology, Sedaghat and colleagues write: “Anosmia (total loss of smell) without nasal obstruction, in particular, appears to be a highly specific indicator of COVID-19.”

Sedaghat said a sudden loss of sense of smell wouldn’t necessarily lead people to think they have COVID-19, particularly if they remain asymptomatic, so “these individuals could continue business as usual and spread the disease as a carrier.”

“If someone experiences anosmia without nasal obstruction, aside from quarantining, it would not be unreasonable to reach out to one’s primary care physician about getting tested,” he said in a statement from his institution.
 

Symptom Checkers Add Weight

Several organizations around the world have begun collecting symptom reports from patients and clinicians, which has shone more light on the sudden loss of taste and smell as potential flags for COVID-19.

In an April 14 Morbidity and Mortality Weekly report from the CDC on COVID-19 infections in healthcare workers, of the 5000 who reported symptoms, 750 (16%) wrote “loss of smell or taste” as an “other” symptom.

Meanwhile, the COVID Symptom Tracker smartphone app, a joint effort by Massachusetts General Hospital, Boston, Stanford (Calif.) University, and King’s College, London, which as of press time, was monitoring some 2.5 million people, has had similar findings.

In a preprint publication on 400,000 people reporting one or more symptoms between March 24 and 29 on the tracker, 18% had lost their sense of smell or taste — more than the 10% who reported fever, but far less than the 53% who reported fatigue.

Only 1702 of the 400,000 had received a COVID-19 test.

Of those, 579 had tested positive and 1123 were negative.

The organizers estimated that of those who were positive, 59% reported losing smell or taste, compared with just 18% who tested negative.

“When combined with other symptoms, people with loss of smell and taste appear to be three times more likely to have contracted COVID-19 according to our data,” said Tim Spector, MD, a genetic epidemiologist at King’s College and the app’s lead researcher, on the symptom tracker’s website.

These people “should therefore self-isolate for 7 days to reduce the spread of the disease,” he urged.
 

Anosmia Is the Initial Symptom in Many Patients With COVID-19

The AAO-HNS also began collecting data from physicians and patients on March 25 through its Web-based 16-question symptom tracking tool.

It has received more than 500 reports of sudden taste or smell loss, said Denneny.

In a report on the first 237 responses, published in Otolaryngology-Head and Neck Surgery, anosmia (profound loss of smell) was found in 73% of subjects before a COVID-19 diagnosis and was the initial symptom in 27% of those subjects.

That latter determination “was the single most important finding,” said Denneny, noting it shows that smell and taste loss are “a sentinel symptom.”

Anosmia led to testing in only 40% of the cases.

Half of the reports came from otolaryngologists, but a large number came from other medical specialties, especially from family medicine.

Just 2% of reports came from patients in that first group, which was based on responses through April 3.

Denneny said that more reports are now coming in from patients, which he attributes to widespread media coverage about the loss of taste and smell.

It’s still not entirely clear why SARS-CoV-2 might inhibit taste or smell. More common viruses like influenza and other coronaviruses can also cause smell and taste loss.

So far, it seems like the sensory recovery is faster for SARS-CoV-2 than the other viruses, which suggests a potentially different mechanism of action, said Yan. Patients she surveyed at UC San Diego recovered the senses within a few weeks to a month, compared to months or a year with the more common viruses.

Yan’s study was partially supported by the National Institutes of Health. Sedaghat has reported no relevant financial relationships. The COVID Symptom Tracker is supported by Zoe Global Limited and has received grants from the Wellcome Trust, Medical Research Council/British Heart Foundation, and Biological Informative Markers for Stratification of Hypertension.

This article first appeared on Medscape.com.

The COVID-19 pandemic is already affecting mental health at a population level, with increased anxiety, feelings of isolation, and concerns about access to mental health care.

Two U.K. surveys were conducted to inform research priorities for mental health research and in an effort to head off a mental health crisis. The U.K. charity MQ conducted a “stakeholder” survey of 2,198 individuals who had a lived experience of mental illness, while Ipsos MORI conducted a poll of 1,099 members of the public.

The online surveys were conducted in late March, the same week the U.K.’s nationwide lockdown measures were announced. Respondents were asked about their biggest mental health and well-being concerns and coping strategies as they relate to the COVID-19 pandemic.

Results showed that across the two surveys, respondents’ primary concern was anxiety, which was cited in 750 responses. Reported symptoms included overthinking, crying, nausea, heart palpitations, sleep disturbance, and a sense of guilt about not knowing how to help others.

In addition, respondents were worried about being social isolated, becoming mentally unwell, and having a lack of access to mental health services, as well as the impact of the pandemic on personal relationships.

The findings were used by a panel of experts to inform a position paper published in the Lancet Psychiatry. The paper outlines a proposed government response to curb the long-term “profound” and “pervasive” impact of the pandemic on mental health.
 

‘Unprecedented response’ needed

“Governments must find evidence-based ways to boost the resilience of our societies and ... to treat those with mental ill health remotely to come out of this pandemic in good mental health,” coauthor of the paper Emily A. Holmes, PhD, of the department of psychology at Uppsala (Sweden) University, said in a press release.

“Frontline medical staff and vulnerable groups such as the elderly and those with serious mental health conditions must be prioritized for rapid mental health support,” she added.

The position paper authors call for “moment-to-moment” monitoring of anxiety, depression, self-harm, and suicide, as well as using digital technology and rapid deployment of evidence-based programs and treatments.

Patients will need to be accessible via computer, cell phone, and other remote technologies in order to receive treatment during physical isolation. However, they noted that there is no “one-size-fits-all” approach, and novel approaches custom tailored to particular populations, including frontline health care workers, are necessary.

“To make a real difference we will need to harness the tools of our digital age, finding smart new ways to measure the mental health of individuals remotely, finding creative ways to boost resilience, and finding ways to treat people in their homes. This effort must be considered central to our global response to the pandemic,” coauthor Ed Bullmore, PhD, of the department of psychiatry at the University of Cambridge (England), said in a statement.

Dr. Bullmore added that it will take “unprecedented research response if we are to limit the negative consequences of this pandemic on the mental health of our society now and in the future.”
 

Most vulnerable will bear the brunt

During a webinar held to discuss the paper, Matthew Hotopf, PhD, of the Institute of Psychiatry, Psychology, and Neuroscience at King’s College London, cautioned that society’s most vulnerable citizens will bear the brunt of the pandemic’s mental health consequences.

“These individuals often have unstable housing, unstable work, and are disadvantaged in terms of their physical health and their mental health,” with a “very significant gap” in life expectancy versus the rest of the population, he said. The COVID-19 pandemic will widen the gap between “the haves and the have nots.”

“People with established and significant mental disorders are one version of the ‘have nots’ but actually it applies to a lot of people,” said Dr. Hotopf, noting that his experience of lockdown is “very different” from that of someone “living in overcrowded, unstable accommodation, with kids running around and maybe a partner who has problems with anger control.”

The authors of the position paper noted that the COVID-19 pandemic highlights several important research priorities that need to be addressed in the coming weeks and months. These include:

• Understanding the effect of COVID-19 on risk of anxiety, depression, and other outcomes, such as self-harm and suicide
• Understanding how to create physical and social supports to ensure mental health in a climate of physical distancing
• Determining the mental health consequences of social isolation for vulnerable groups, and how can these be mitigated under pandemic conditions
• Understanding the mental health impact of media reporting of COVID-19 in traditional and social media
• Determining the best methods for promoting successful adherence to behavioral advice about COVID-19 while enabling mental well-being and minimizing distress

Another area highlighted by the experts is the potential for neuropsychiatric sequelae in individuals infected with COVID-19. They called for “experimental medicine studies to validate clinical biomarkers and repurpose new treatments for the potentially neurotoxic effects of the virus.”

The authors/investigators disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The COVID-19 pandemic is already affecting mental health at a population level, with increased anxiety, feelings of isolation, and concerns about access to mental health care.

Two U.K. surveys were conducted to inform research priorities for mental health research and in an effort to head off a mental health crisis. The U.K. charity MQ conducted a “stakeholder” survey of 2,198 individuals who had a lived experience of mental illness, while Ipsos MORI conducted a poll of 1,099 members of the public.

The online surveys were conducted in late March, the same week the U.K.’s nationwide lockdown measures were announced. Respondents were asked about their biggest mental health and well-being concerns and coping strategies as they relate to the COVID-19 pandemic.

Results showed that across the two surveys, respondents’ primary concern was anxiety, which was cited in 750 responses. Reported symptoms included overthinking, crying, nausea, heart palpitations, sleep disturbance, and a sense of guilt about not knowing how to help others.

In addition, respondents were worried about being social isolated, becoming mentally unwell, and having a lack of access to mental health services, as well as the impact of the pandemic on personal relationships.

The findings were used by a panel of experts to inform a position paper published in the Lancet Psychiatry. The paper outlines a proposed government response to curb the long-term “profound” and “pervasive” impact of the pandemic on mental health.
 

‘Unprecedented response’ needed

“Governments must find evidence-based ways to boost the resilience of our societies and ... to treat those with mental ill health remotely to come out of this pandemic in good mental health,” coauthor of the paper Emily A. Holmes, PhD, of the department of psychology at Uppsala (Sweden) University, said in a press release.

“Frontline medical staff and vulnerable groups such as the elderly and those with serious mental health conditions must be prioritized for rapid mental health support,” she added.

The position paper authors call for “moment-to-moment” monitoring of anxiety, depression, self-harm, and suicide, as well as using digital technology and rapid deployment of evidence-based programs and treatments.

Patients will need to be accessible via computer, cell phone, and other remote technologies in order to receive treatment during physical isolation. However, they noted that there is no “one-size-fits-all” approach, and novel approaches custom tailored to particular populations, including frontline health care workers, are necessary.

“To make a real difference we will need to harness the tools of our digital age, finding smart new ways to measure the mental health of individuals remotely, finding creative ways to boost resilience, and finding ways to treat people in their homes. This effort must be considered central to our global response to the pandemic,” coauthor Ed Bullmore, PhD, of the department of psychiatry at the University of Cambridge (England), said in a statement.

Dr. Bullmore added that it will take “unprecedented research response if we are to limit the negative consequences of this pandemic on the mental health of our society now and in the future.”
 

Most vulnerable will bear the brunt

During a webinar held to discuss the paper, Matthew Hotopf, PhD, of the Institute of Psychiatry, Psychology, and Neuroscience at King’s College London, cautioned that society’s most vulnerable citizens will bear the brunt of the pandemic’s mental health consequences.

“These individuals often have unstable housing, unstable work, and are disadvantaged in terms of their physical health and their mental health,” with a “very significant gap” in life expectancy versus the rest of the population, he said. The COVID-19 pandemic will widen the gap between “the haves and the have nots.”

“People with established and significant mental disorders are one version of the ‘have nots’ but actually it applies to a lot of people,” said Dr. Hotopf, noting that his experience of lockdown is “very different” from that of someone “living in overcrowded, unstable accommodation, with kids running around and maybe a partner who has problems with anger control.”

The authors of the position paper noted that the COVID-19 pandemic highlights several important research priorities that need to be addressed in the coming weeks and months. These include:

• Understanding the effect of COVID-19 on risk of anxiety, depression, and other outcomes, such as self-harm and suicide
• Understanding how to create physical and social supports to ensure mental health in a climate of physical distancing
• Determining the mental health consequences of social isolation for vulnerable groups, and how can these be mitigated under pandemic conditions
• Understanding the mental health impact of media reporting of COVID-19 in traditional and social media
• Determining the best methods for promoting successful adherence to behavioral advice about COVID-19 while enabling mental well-being and minimizing distress

Another area highlighted by the experts is the potential for neuropsychiatric sequelae in individuals infected with COVID-19. They called for “experimental medicine studies to validate clinical biomarkers and repurpose new treatments for the potentially neurotoxic effects of the virus.”

The authors/investigators disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The COVID-19 pandemic is already affecting mental health at a population level, with increased anxiety, feelings of isolation, and concerns about access to mental health care.

Two U.K. surveys were conducted to inform research priorities for mental health research and in an effort to head off a mental health crisis. The U.K. charity MQ conducted a “stakeholder” survey of 2,198 individuals who had a lived experience of mental illness, while Ipsos MORI conducted a poll of 1,099 members of the public.

The online surveys were conducted in late March, the same week the U.K.’s nationwide lockdown measures were announced. Respondents were asked about their biggest mental health and well-being concerns and coping strategies as they relate to the COVID-19 pandemic.

Results showed that across the two surveys, respondents’ primary concern was anxiety, which was cited in 750 responses. Reported symptoms included overthinking, crying, nausea, heart palpitations, sleep disturbance, and a sense of guilt about not knowing how to help others.

In addition, respondents were worried about being social isolated, becoming mentally unwell, and having a lack of access to mental health services, as well as the impact of the pandemic on personal relationships.

The findings were used by a panel of experts to inform a position paper published in the Lancet Psychiatry. The paper outlines a proposed government response to curb the long-term “profound” and “pervasive” impact of the pandemic on mental health.
 

‘Unprecedented response’ needed

“Governments must find evidence-based ways to boost the resilience of our societies and ... to treat those with mental ill health remotely to come out of this pandemic in good mental health,” coauthor of the paper Emily A. Holmes, PhD, of the department of psychology at Uppsala (Sweden) University, said in a press release.

“Frontline medical staff and vulnerable groups such as the elderly and those with serious mental health conditions must be prioritized for rapid mental health support,” she added.

The position paper authors call for “moment-to-moment” monitoring of anxiety, depression, self-harm, and suicide, as well as using digital technology and rapid deployment of evidence-based programs and treatments.

Patients will need to be accessible via computer, cell phone, and other remote technologies in order to receive treatment during physical isolation. However, they noted that there is no “one-size-fits-all” approach, and novel approaches custom tailored to particular populations, including frontline health care workers, are necessary.

“To make a real difference we will need to harness the tools of our digital age, finding smart new ways to measure the mental health of individuals remotely, finding creative ways to boost resilience, and finding ways to treat people in their homes. This effort must be considered central to our global response to the pandemic,” coauthor Ed Bullmore, PhD, of the department of psychiatry at the University of Cambridge (England), said in a statement.

Dr. Bullmore added that it will take “unprecedented research response if we are to limit the negative consequences of this pandemic on the mental health of our society now and in the future.”
 

Most vulnerable will bear the brunt

During a webinar held to discuss the paper, Matthew Hotopf, PhD, of the Institute of Psychiatry, Psychology, and Neuroscience at King’s College London, cautioned that society’s most vulnerable citizens will bear the brunt of the pandemic’s mental health consequences.

“These individuals often have unstable housing, unstable work, and are disadvantaged in terms of their physical health and their mental health,” with a “very significant gap” in life expectancy versus the rest of the population, he said. The COVID-19 pandemic will widen the gap between “the haves and the have nots.”

“People with established and significant mental disorders are one version of the ‘have nots’ but actually it applies to a lot of people,” said Dr. Hotopf, noting that his experience of lockdown is “very different” from that of someone “living in overcrowded, unstable accommodation, with kids running around and maybe a partner who has problems with anger control.”

The authors of the position paper noted that the COVID-19 pandemic highlights several important research priorities that need to be addressed in the coming weeks and months. These include:

• Understanding the effect of COVID-19 on risk of anxiety, depression, and other outcomes, such as self-harm and suicide
• Understanding how to create physical and social supports to ensure mental health in a climate of physical distancing
• Determining the mental health consequences of social isolation for vulnerable groups, and how can these be mitigated under pandemic conditions
• Understanding the mental health impact of media reporting of COVID-19 in traditional and social media
• Determining the best methods for promoting successful adherence to behavioral advice about COVID-19 while enabling mental well-being and minimizing distress

Another area highlighted by the experts is the potential for neuropsychiatric sequelae in individuals infected with COVID-19. They called for “experimental medicine studies to validate clinical biomarkers and repurpose new treatments for the potentially neurotoxic effects of the virus.”

The authors/investigators disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

How do you run a chemotherapy infusion center during a pandemic?

Courtesy Levine Cancer Institute

Quick action, innovative staffing solutions, and nimble leadership are allowing one cancer center to continue providing care for the most vulnerable patients, while keeping patients and staff safe.

When nursing leaders at Atrium Health’s Levine Cancer Institute in Charlotte, N.C., realized that business was not going to continue as usual for American health care during the COVID-19 pandemic, they knew they had to act quickly to keep the institute’s 82-chair infusion center up and running.

North Carolina had already imposed restrictions on mass gatherings and closed educational facilities and some businesses by mid-March. Stay-at-home orders were being issued in surrounding states (North Carolina came under a statewide order on March 30). Physical distancing and a healthy, resilient team were prerequisites to an effective COVID-19 solution for the infusion clinic, said Angela Hosking, MBA, MSN, RN, director of nursing for Levine Cancer Institute. In an interview, she said that, at meetings on Monday, March 23, “we divided the team exactly in half.”

Infusion center staff members were broken into an “A” and a “B” rotation, with each team either on site or remotely for a 14-day stretch, and then switching at the 2-week mark. The 14-day rotation, she said, was chosen so that each cohort would have a full 2 weeks away after having been in clinic to ensure they were symptom free before returning. The cohorting scheme also serves to minimize between-staff exposure and risk of transmission.

These changes were implemented immediately, said Ms. Hosking, and included all but the most senior leadership – Ms. Hosking alternates days on site with another senior colleague to help with continuity.

Infusion center patients were triaged to determine “who absolutely needed to be seen,” and clinic staff started making phone calls and reshuffling the schedule so the clinic could continue at half-strength staffing.

The clinic was rearranged to ensure each infusion chair had appropriate space but the nursing work flow was still safe with reduced staff, said Jessica Stewart, MSN, RN, Levine Cancer Institute’s hematology–sickle cell nurse manager.

Patients were receptive, said Ms. Stewart. The team that was working remotely made sure all patients were called the day before their appointments, so they could understand what to expect when they arrived. Any needed updates to the medical history and patient teaching can also be done over the phone the day before the visit, she said, noting that patients are also queried about any concerning symptoms such as fever or cough.

In the spirit of providing information and managing expectations, patients are also informed that they will not be able to bring a visitor along and are advised to expect additional screening when they arrive. In addition to a repeat of symptom screening, patients are checked for fever with a temporal thermometer.

Any patient who arrives reporting symptoms or who has a fever is then subject to additional screening. Physician phone consultation is available, if needed, and patients may be routed to a drive-through screening and testing setup, or to the ED if there are concerns the patient may be seriously ill.

Several weeks into the new operations, Ms. Stewart said, “we’ve fine-tuned the processes we currently have in place. There’s new practices with virtual visits to make reaching our patients easier. Our senior leadership is communicating in a weekly video sent to all [Levine Cancer Institute] teammates for updates; it’s very transparent and the team is appreciative of being kept in the loop.”

Thus far, said Ms. Hosking, “it’s gone well – we’ve successfully operationalized this plan. … I think it shows that people that care about each other and their mission can collaborate with each other” to make change happen in a hurry.

Though it’s too soon to know exactly what the future holds once the pandemic has passed, some aspects of the new way of doing things may carry forward, said Ms. Stewart. “Communication has been massively streamlined,” and staff has found the previsit phone calls an efficient and effective way to gather and impart information.

A staff nurse at the infusion center, Whitney Hollifield, RN, added that patients have seen – and appreciate – the added precautions taken by all. “I feel that we have done well with protecting our patients from unneeded exposure and patients have expressed this to me,” said Ms. Hollifield. “They have said: ‘Thank you for doing this because I am scared to come in right now so I appreciate that your office is thinking of protecting us.’ ”

Ms. Hollifield added that “patients have been very responsive to our strategy for their care because we are truly concerned for them and I think that this shows. I believe that we are doing everything we can to keep them safe during a tumultuous time, and they feel genuine care for them during a frightening time is reassuring.”

On the practical side of things, Ms. Stewart noted, patients and families have provided infusion center staff with a seemingly endless supply of food: “We have never been more well fed!”

Rhonda Davis, RN, is a nurse at the Levine Cancer Institute. Speaking of the changes that have been made in recent weeks, she said, “Some of the changes that I think have been meaningful these last 3 weeks are making sure that the patients are the No. 1 priority. We are doing this by allowing patients options such as phone and virtual visits. This helps patients have some control over their health during this scary time for all.”

Ms. Davis acknowledged her own feelings about the uncertain times ahead. “As an individual with good health, I am scared, so to imagine the fear that these patients are facing must be overwhelming to them. Along that line, one of the most meaningful things that has happened for me is calling patients and having them concerned about my health and telling me to be safe.”

Despite her trepidation, she said, it’s meaningful for her to hear from patients who are in the clinic that they appreciate her presence. She found it heartening “that they are also considering our safety as well as their own.”

The two-cohort scheme has been well received by nursing staff, both administrators and clinic staff agreed. “I think that allowing staff to work 2 weeks on and 2 weeks at home helps keep patients and teammates safe,” Ms. Davis said.

Another infusion nurse, Ursel Wallace, RN, said that she appreciated the speed and efficiency with which the pandemic adaptations were made, including the nuts and bolts of reshuffling a complicated infusion schedule. “I know there were many different moving parts and it took a village” to move with such alacrity without dropping balls, she said.

The infusion nursing team’s spirit was summed up by Patricia Ashworth, RN: “Together, we will prevail!”

koakes@mdedge.com

How do you run a chemotherapy infusion center during a pandemic?

Courtesy Levine Cancer Institute

Quick action, innovative staffing solutions, and nimble leadership are allowing one cancer center to continue providing care for the most vulnerable patients, while keeping patients and staff safe.

When nursing leaders at Atrium Health’s Levine Cancer Institute in Charlotte, N.C., realized that business was not going to continue as usual for American health care during the COVID-19 pandemic, they knew they had to act quickly to keep the institute’s 82-chair infusion center up and running.

North Carolina had already imposed restrictions on mass gatherings and closed educational facilities and some businesses by mid-March. Stay-at-home orders were being issued in surrounding states (North Carolina came under a statewide order on March 30). Physical distancing and a healthy, resilient team were prerequisites to an effective COVID-19 solution for the infusion clinic, said Angela Hosking, MBA, MSN, RN, director of nursing for Levine Cancer Institute. In an interview, she said that, at meetings on Monday, March 23, “we divided the team exactly in half.”

Infusion center staff members were broken into an “A” and a “B” rotation, with each team either on site or remotely for a 14-day stretch, and then switching at the 2-week mark. The 14-day rotation, she said, was chosen so that each cohort would have a full 2 weeks away after having been in clinic to ensure they were symptom free before returning. The cohorting scheme also serves to minimize between-staff exposure and risk of transmission.

These changes were implemented immediately, said Ms. Hosking, and included all but the most senior leadership – Ms. Hosking alternates days on site with another senior colleague to help with continuity.

Infusion center patients were triaged to determine “who absolutely needed to be seen,” and clinic staff started making phone calls and reshuffling the schedule so the clinic could continue at half-strength staffing.

The clinic was rearranged to ensure each infusion chair had appropriate space but the nursing work flow was still safe with reduced staff, said Jessica Stewart, MSN, RN, Levine Cancer Institute’s hematology–sickle cell nurse manager.

Patients were receptive, said Ms. Stewart. The team that was working remotely made sure all patients were called the day before their appointments, so they could understand what to expect when they arrived. Any needed updates to the medical history and patient teaching can also be done over the phone the day before the visit, she said, noting that patients are also queried about any concerning symptoms such as fever or cough.

In the spirit of providing information and managing expectations, patients are also informed that they will not be able to bring a visitor along and are advised to expect additional screening when they arrive. In addition to a repeat of symptom screening, patients are checked for fever with a temporal thermometer.

Any patient who arrives reporting symptoms or who has a fever is then subject to additional screening. Physician phone consultation is available, if needed, and patients may be routed to a drive-through screening and testing setup, or to the ED if there are concerns the patient may be seriously ill.

Several weeks into the new operations, Ms. Stewart said, “we’ve fine-tuned the processes we currently have in place. There’s new practices with virtual visits to make reaching our patients easier. Our senior leadership is communicating in a weekly video sent to all [Levine Cancer Institute] teammates for updates; it’s very transparent and the team is appreciative of being kept in the loop.”

Thus far, said Ms. Hosking, “it’s gone well – we’ve successfully operationalized this plan. … I think it shows that people that care about each other and their mission can collaborate with each other” to make change happen in a hurry.

Though it’s too soon to know exactly what the future holds once the pandemic has passed, some aspects of the new way of doing things may carry forward, said Ms. Stewart. “Communication has been massively streamlined,” and staff has found the previsit phone calls an efficient and effective way to gather and impart information.

A staff nurse at the infusion center, Whitney Hollifield, RN, added that patients have seen – and appreciate – the added precautions taken by all. “I feel that we have done well with protecting our patients from unneeded exposure and patients have expressed this to me,” said Ms. Hollifield. “They have said: ‘Thank you for doing this because I am scared to come in right now so I appreciate that your office is thinking of protecting us.’ ”

Ms. Hollifield added that “patients have been very responsive to our strategy for their care because we are truly concerned for them and I think that this shows. I believe that we are doing everything we can to keep them safe during a tumultuous time, and they feel genuine care for them during a frightening time is reassuring.”

On the practical side of things, Ms. Stewart noted, patients and families have provided infusion center staff with a seemingly endless supply of food: “We have never been more well fed!”

Rhonda Davis, RN, is a nurse at the Levine Cancer Institute. Speaking of the changes that have been made in recent weeks, she said, “Some of the changes that I think have been meaningful these last 3 weeks are making sure that the patients are the No. 1 priority. We are doing this by allowing patients options such as phone and virtual visits. This helps patients have some control over their health during this scary time for all.”

Ms. Davis acknowledged her own feelings about the uncertain times ahead. “As an individual with good health, I am scared, so to imagine the fear that these patients are facing must be overwhelming to them. Along that line, one of the most meaningful things that has happened for me is calling patients and having them concerned about my health and telling me to be safe.”

Despite her trepidation, she said, it’s meaningful for her to hear from patients who are in the clinic that they appreciate her presence. She found it heartening “that they are also considering our safety as well as their own.”

The two-cohort scheme has been well received by nursing staff, both administrators and clinic staff agreed. “I think that allowing staff to work 2 weeks on and 2 weeks at home helps keep patients and teammates safe,” Ms. Davis said.

Another infusion nurse, Ursel Wallace, RN, said that she appreciated the speed and efficiency with which the pandemic adaptations were made, including the nuts and bolts of reshuffling a complicated infusion schedule. “I know there were many different moving parts and it took a village” to move with such alacrity without dropping balls, she said.

The infusion nursing team’s spirit was summed up by Patricia Ashworth, RN: “Together, we will prevail!”

koakes@mdedge.com

How do you run a chemotherapy infusion center during a pandemic?

Courtesy Levine Cancer Institute

Quick action, innovative staffing solutions, and nimble leadership are allowing one cancer center to continue providing care for the most vulnerable patients, while keeping patients and staff safe.

When nursing leaders at Atrium Health’s Levine Cancer Institute in Charlotte, N.C., realized that business was not going to continue as usual for American health care during the COVID-19 pandemic, they knew they had to act quickly to keep the institute’s 82-chair infusion center up and running.

North Carolina had already imposed restrictions on mass gatherings and closed educational facilities and some businesses by mid-March. Stay-at-home orders were being issued in surrounding states (North Carolina came under a statewide order on March 30). Physical distancing and a healthy, resilient team were prerequisites to an effective COVID-19 solution for the infusion clinic, said Angela Hosking, MBA, MSN, RN, director of nursing for Levine Cancer Institute. In an interview, she said that, at meetings on Monday, March 23, “we divided the team exactly in half.”

Infusion center staff members were broken into an “A” and a “B” rotation, with each team either on site or remotely for a 14-day stretch, and then switching at the 2-week mark. The 14-day rotation, she said, was chosen so that each cohort would have a full 2 weeks away after having been in clinic to ensure they were symptom free before returning. The cohorting scheme also serves to minimize between-staff exposure and risk of transmission.

These changes were implemented immediately, said Ms. Hosking, and included all but the most senior leadership – Ms. Hosking alternates days on site with another senior colleague to help with continuity.

Infusion center patients were triaged to determine “who absolutely needed to be seen,” and clinic staff started making phone calls and reshuffling the schedule so the clinic could continue at half-strength staffing.

The clinic was rearranged to ensure each infusion chair had appropriate space but the nursing work flow was still safe with reduced staff, said Jessica Stewart, MSN, RN, Levine Cancer Institute’s hematology–sickle cell nurse manager.

Patients were receptive, said Ms. Stewart. The team that was working remotely made sure all patients were called the day before their appointments, so they could understand what to expect when they arrived. Any needed updates to the medical history and patient teaching can also be done over the phone the day before the visit, she said, noting that patients are also queried about any concerning symptoms such as fever or cough.

In the spirit of providing information and managing expectations, patients are also informed that they will not be able to bring a visitor along and are advised to expect additional screening when they arrive. In addition to a repeat of symptom screening, patients are checked for fever with a temporal thermometer.

Any patient who arrives reporting symptoms or who has a fever is then subject to additional screening. Physician phone consultation is available, if needed, and patients may be routed to a drive-through screening and testing setup, or to the ED if there are concerns the patient may be seriously ill.

Several weeks into the new operations, Ms. Stewart said, “we’ve fine-tuned the processes we currently have in place. There’s new practices with virtual visits to make reaching our patients easier. Our senior leadership is communicating in a weekly video sent to all [Levine Cancer Institute] teammates for updates; it’s very transparent and the team is appreciative of being kept in the loop.”

Thus far, said Ms. Hosking, “it’s gone well – we’ve successfully operationalized this plan. … I think it shows that people that care about each other and their mission can collaborate with each other” to make change happen in a hurry.

Though it’s too soon to know exactly what the future holds once the pandemic has passed, some aspects of the new way of doing things may carry forward, said Ms. Stewart. “Communication has been massively streamlined,” and staff has found the previsit phone calls an efficient and effective way to gather and impart information.

A staff nurse at the infusion center, Whitney Hollifield, RN, added that patients have seen – and appreciate – the added precautions taken by all. “I feel that we have done well with protecting our patients from unneeded exposure and patients have expressed this to me,” said Ms. Hollifield. “They have said: ‘Thank you for doing this because I am scared to come in right now so I appreciate that your office is thinking of protecting us.’ ”

Ms. Hollifield added that “patients have been very responsive to our strategy for their care because we are truly concerned for them and I think that this shows. I believe that we are doing everything we can to keep them safe during a tumultuous time, and they feel genuine care for them during a frightening time is reassuring.”

On the practical side of things, Ms. Stewart noted, patients and families have provided infusion center staff with a seemingly endless supply of food: “We have never been more well fed!”

Rhonda Davis, RN, is a nurse at the Levine Cancer Institute. Speaking of the changes that have been made in recent weeks, she said, “Some of the changes that I think have been meaningful these last 3 weeks are making sure that the patients are the No. 1 priority. We are doing this by allowing patients options such as phone and virtual visits. This helps patients have some control over their health during this scary time for all.”

Ms. Davis acknowledged her own feelings about the uncertain times ahead. “As an individual with good health, I am scared, so to imagine the fear that these patients are facing must be overwhelming to them. Along that line, one of the most meaningful things that has happened for me is calling patients and having them concerned about my health and telling me to be safe.”

Despite her trepidation, she said, it’s meaningful for her to hear from patients who are in the clinic that they appreciate her presence. She found it heartening “that they are also considering our safety as well as their own.”

The two-cohort scheme has been well received by nursing staff, both administrators and clinic staff agreed. “I think that allowing staff to work 2 weeks on and 2 weeks at home helps keep patients and teammates safe,” Ms. Davis said.

Another infusion nurse, Ursel Wallace, RN, said that she appreciated the speed and efficiency with which the pandemic adaptations were made, including the nuts and bolts of reshuffling a complicated infusion schedule. “I know there were many different moving parts and it took a village” to move with such alacrity without dropping balls, she said.

The infusion nursing team’s spirit was summed up by Patricia Ashworth, RN: “Together, we will prevail!”

koakes@mdedge.com