Feature

Rheumatologists, pharmacists debate 'right to try' hydroxychloroquine for COVID-19

Hannah Fish

More than 80% of surveyed U.S. pharmacists believe that hydroxychloroquine sulfate should be used as a potential treatment for COVID-19, raising access concerns among rheumatologists for patients with systemic lupus erythematosus and rheumatoid arthritis who rely on the drug.

After a small number of data sets demonstrated moderate efficacy of hydroxychloroquine sulfate and chloroquine to treat the virus, President Donald J. Trump touted the drugs as having “tremendous promise” during a news conference on March 19. Shortages of hydroxychloroquine were reported less than 24 hours following the president’s announcement, accompanied by accounts of widespread hoarding and stockpiling of these drugs.

In an effort to alleviate pressures on the hydroxychloroquine supply, on March 28, the FDA issued an emergency use authorization for hydroxychloroquine and chloroquine products donated to the Strategic National Stockpile to be distributed and used for patients with COVID-19 who had been hospitalized. Yet, despite this new pipeline, the FDA has offered sparse detail or guidance on hydroxychloroquine’s use in this population, which could result in continued drug overuse and renewed shortages in the coming months.

In a survey of approximately 460 independent pharmacy owners and managers, the National Community Pharmacists Association noted that 84% of pharmacists responded that patients had a “right to try” and, despite limited efficacy data, should have access to hydroxychloroquine sulfate or chloroquine as potential treatments against COVID-19. Rheumatology groups, on the other hand, have been outspoken in urging judicious use of hydroxychloroquine and chloroquine for investigational COVID-19 purposes.

 
More than 80% of surveyed U.S. pharmacists believe that hydroxychloroquine sulfate should be used as a potential treatment for COVID-19, raising access concerns among rheumatologists for patients with SLE and RA who rely on the drug.
Source: Adobe

To gain perspective on this burgeoning conundrum, Healio Rheumatology spoke with Hannah Fish, PharmD, the National Community Pharmacists Association’s associate director of strategic initiatives, and Gregg J. Silverman, MD, professor of medicine and pathology at the NYU School of Medicine. They addressed the science, the politics and how pharmacists and rheumatologists can make the best of a nearly impossible situation.

Scientific Concerns

“Our general thought, and the general thought of our members, is that we want to see access to these drugs for COVID-19, but with a lot of caveats,” Fish said in an interview. “This is obviously a very serious public health crisis. We have got to try something — we just want to make sure we do it safely.”

To that point, the surveyed pharmacists suggested that two key conditions should apply to patients with COVID-19 who wish to be treated with hydroxychloroquine sulfate: One is that the patient should have tested positive for the infection, and the other is that treatment should be managed by both a physician and a pharmacist.

Gregg J. Silverman, MD
Gregg J. Silverman

A main point of contention is that while there are some data demonstrating the efficacy of hydroxychloroquine and chloroquine to treat the virus, the evidence is scant at the moment. “There is still so little known about this virus and what is truly working against it,” Fish said.

Still, Silverman acknowledged a long history of empiric use of antimalarials to treat rashes and fevers. “In the modern age, we have learned that there may be a molecular mechanism at work,” he said, noting that endosomal transport in the autoimmunity processes may also be associated with viral infection and replication. “You can see how virologists could look at this and see how it might provide a means to interfere with the pathways of infection.”

However, Silverman was cautious in his optimism. “We hope that these agents are helping, but I do not believe they are going to be a cure for this disease,” he said. “The data so far have been very limited and the results mixed at best. Hope is important in a time of national crisis, but we also need to be sure we are engaged with the science of infection.”

An important consideration for Fish is that the safety and adverse event profiles of hydroxychloroquine sulfate and chloroquine are well known, with pharmacists having been dispensing these drugs safely for years. “With some of these other investigational drugs being used to treat this disease, we have no idea about safety and tolerability, what it is going to do to these patients,” she said. “This is a positive for hydroxychloroquine.”

Supply and Demand

For rheumatologists like Silverman, there is one over-arching, primary concern. “We need to make sure our patients, particularly those with SLE and RA, can access their medications,” he said. “Continuity and adherence are essential.”

That said, Silverman recognizes the unique nature of the current circumstances. “You never want to be in a situation where one patient population has a higher priority than another,” he said. “You do not want to be robbing Peter to pay Paul.”

Pharmacists are sympathetic to the shortages, noted Fish. Other findings from the survey showed that 90% of local pharmacists — who are frequently the sole health care providers in rural and underserved communities — are reporting access issues for hydroxychloroquine and chloroquine. Yet, 68.4% of respondents believe that state restrictions on the drugs are too harsh.

“As an organization, we are absolutely concerned with the shortages, and the fact that it is on the FDA’s official shortage list,” Fish said. “We applaud state efforts to restrict hoarding and stockpiling, and those that are putting into place guidance on specific use of these drugs.”

Fish also offered some unique solutions to manage drug supply during the pandemic. “One way of managing supplies is to fill prescriptions to manage COVID-19 only for 7 or 14 days, or for 30 days instead of 90 for chronic disease management.”

In this plan, local pharmacists can keep track of exactly when patients with SLE or RA are due for their next refill and set aside enough stock for those purposes. “This helps with inventory control and helps us to understand usage of these medications,” Fish said.

Another strategy is for pharmacists to compound hydroxychloroquine sulfate themselves. “Whether it be for patients with lupus or RA, or for COVID-19, our members are stepping up to increase the supply in their area,” Fish said.

Silverman applauded pharmacists’ and the pharmaceutical industry’s efforts to increase production and availability of these drugs under the pressure of the pandemic. “The irony of all of this is that, as rheumatologists, we are used to borrowing treatments from another specialty,” he said. “So, we can understand the need to ensure adequate supplies.”

Playing Politics

If there is an X factor in all of this, it is that the pandemic has become inextricably linked to the political divisiveness that has been a hallmark of American culture for the last decade.

“As an organization, we are politically neutral,” Fish said. “We are in the business of taking care of patients.”

Fish stressed that it is important that pharmacists are able to take care of their patients “without barriers.”

“However, I have to acknowledge that, in some ways, politics has obviously gotten us to where we are now,” she said. “But I do not think that politics is going to get us out of this situation. Science is science. We are doing our best to make sense of the science that is emerging and changing each day and move forward as best we can.”

For Silverman, the politics puts the FDA in an extremely difficult position. “They have a mandate to protect Americans,” he said. “They have a reputation for being biased toward being overly cautious, and they have been known to make an example of a doctor or industry professional who advocates for off-label use of a medication.”

But this is exactly what President Trump has been doing in his news conferences, according to Silverman. “If anyone else was saying the things he has been saying, the FDA might cite them, with threat of punishment, as being not much more than an infomercial spokesperson,” he said. “The way he voices things is not how the FDA likes to communicate. So, for the moment, we are certainly in a bind.” – by Rob Volansky

For more information:

Hannah Fish, PharmD, can be reached at National Community Pharmacists Association, 100 Daingerfield Road, Alexandria, VA 22314; email: Hannah.fish@ncpa.org.

Gregg J. Silverman, MD, can be reached at NYU School of Medicine, 435 East 30th St., New York, NY 10016; email: gregg.silverman@nyumc.org.

Disclosures: Fish reports no relevant financial disclosures. Silverman reports consulting for Lilly, Onyx, Pfizer, Quest and Roche and receiving grant support from the American College of Rheumatology Research Foundation, the Lupus Research Institute and NIH.

Hannah Fish

More than 80% of surveyed U.S. pharmacists believe that hydroxychloroquine sulfate should be used as a potential treatment for COVID-19, raising access concerns among rheumatologists for patients with systemic lupus erythematosus and rheumatoid arthritis who rely on the drug.

After a small number of data sets demonstrated moderate efficacy of hydroxychloroquine sulfate and chloroquine to treat the virus, President Donald J. Trump touted the drugs as having “tremendous promise” during a news conference on March 19. Shortages of hydroxychloroquine were reported less than 24 hours following the president’s announcement, accompanied by accounts of widespread hoarding and stockpiling of these drugs.

In an effort to alleviate pressures on the hydroxychloroquine supply, on March 28, the FDA issued an emergency use authorization for hydroxychloroquine and chloroquine products donated to the Strategic National Stockpile to be distributed and used for patients with COVID-19 who had been hospitalized. Yet, despite this new pipeline, the FDA has offered sparse detail or guidance on hydroxychloroquine’s use in this population, which could result in continued drug overuse and renewed shortages in the coming months.

In a survey of approximately 460 independent pharmacy owners and managers, the National Community Pharmacists Association noted that 84% of pharmacists responded that patients had a “right to try” and, despite limited efficacy data, should have access to hydroxychloroquine sulfate or chloroquine as potential treatments against COVID-19. Rheumatology groups, on the other hand, have been outspoken in urging judicious use of hydroxychloroquine and chloroquine for investigational COVID-19 purposes.

 
More than 80% of surveyed U.S. pharmacists believe that hydroxychloroquine sulfate should be used as a potential treatment for COVID-19, raising access concerns among rheumatologists for patients with SLE and RA who rely on the drug.
Source: Adobe

To gain perspective on this burgeoning conundrum, Healio Rheumatology spoke with Hannah Fish, PharmD, the National Community Pharmacists Association’s associate director of strategic initiatives, and Gregg J. Silverman, MD, professor of medicine and pathology at the NYU School of Medicine. They addressed the science, the politics and how pharmacists and rheumatologists can make the best of a nearly impossible situation.

Scientific Concerns

“Our general thought, and the general thought of our members, is that we want to see access to these drugs for COVID-19, but with a lot of caveats,” Fish said in an interview. “This is obviously a very serious public health crisis. We have got to try something — we just want to make sure we do it safely.”

To that point, the surveyed pharmacists suggested that two key conditions should apply to patients with COVID-19 who wish to be treated with hydroxychloroquine sulfate: One is that the patient should have tested positive for the infection, and the other is that treatment should be managed by both a physician and a pharmacist.

PAGE BREAK
Gregg J. Silverman, MD
Gregg J. Silverman

A main point of contention is that while there are some data demonstrating the efficacy of hydroxychloroquine and chloroquine to treat the virus, the evidence is scant at the moment. “There is still so little known about this virus and what is truly working against it,” Fish said.

Still, Silverman acknowledged a long history of empiric use of antimalarials to treat rashes and fevers. “In the modern age, we have learned that there may be a molecular mechanism at work,” he said, noting that endosomal transport in the autoimmunity processes may also be associated with viral infection and replication. “You can see how virologists could look at this and see how it might provide a means to interfere with the pathways of infection.”

However, Silverman was cautious in his optimism. “We hope that these agents are helping, but I do not believe they are going to be a cure for this disease,” he said. “The data so far have been very limited and the results mixed at best. Hope is important in a time of national crisis, but we also need to be sure we are engaged with the science of infection.”

An important consideration for Fish is that the safety and adverse event profiles of hydroxychloroquine sulfate and chloroquine are well known, with pharmacists having been dispensing these drugs safely for years. “With some of these other investigational drugs being used to treat this disease, we have no idea about safety and tolerability, what it is going to do to these patients,” she said. “This is a positive for hydroxychloroquine.”

Supply and Demand

For rheumatologists like Silverman, there is one over-arching, primary concern. “We need to make sure our patients, particularly those with SLE and RA, can access their medications,” he said. “Continuity and adherence are essential.”

That said, Silverman recognizes the unique nature of the current circumstances. “You never want to be in a situation where one patient population has a higher priority than another,” he said. “You do not want to be robbing Peter to pay Paul.”

Pharmacists are sympathetic to the shortages, noted Fish. Other findings from the survey showed that 90% of local pharmacists — who are frequently the sole health care providers in rural and underserved communities — are reporting access issues for hydroxychloroquine and chloroquine. Yet, 68.4% of respondents believe that state restrictions on the drugs are too harsh.

PAGE BREAK

“As an organization, we are absolutely concerned with the shortages, and the fact that it is on the FDA’s official shortage list,” Fish said. “We applaud state efforts to restrict hoarding and stockpiling, and those that are putting into place guidance on specific use of these drugs.”

Fish also offered some unique solutions to manage drug supply during the pandemic. “One way of managing supplies is to fill prescriptions to manage COVID-19 only for 7 or 14 days, or for 30 days instead of 90 for chronic disease management.”

In this plan, local pharmacists can keep track of exactly when patients with SLE or RA are due for their next refill and set aside enough stock for those purposes. “This helps with inventory control and helps us to understand usage of these medications,” Fish said.

Another strategy is for pharmacists to compound hydroxychloroquine sulfate themselves. “Whether it be for patients with lupus or RA, or for COVID-19, our members are stepping up to increase the supply in their area,” Fish said.

Silverman applauded pharmacists’ and the pharmaceutical industry’s efforts to increase production and availability of these drugs under the pressure of the pandemic. “The irony of all of this is that, as rheumatologists, we are used to borrowing treatments from another specialty,” he said. “So, we can understand the need to ensure adequate supplies.”

Playing Politics

If there is an X factor in all of this, it is that the pandemic has become inextricably linked to the political divisiveness that has been a hallmark of American culture for the last decade.

“As an organization, we are politically neutral,” Fish said. “We are in the business of taking care of patients.”

Fish stressed that it is important that pharmacists are able to take care of their patients “without barriers.”

“However, I have to acknowledge that, in some ways, politics has obviously gotten us to where we are now,” she said. “But I do not think that politics is going to get us out of this situation. Science is science. We are doing our best to make sense of the science that is emerging and changing each day and move forward as best we can.”

For Silverman, the politics puts the FDA in an extremely difficult position. “They have a mandate to protect Americans,” he said. “They have a reputation for being biased toward being overly cautious, and they have been known to make an example of a doctor or industry professional who advocates for off-label use of a medication.”

PAGE BREAK

But this is exactly what President Trump has been doing in his news conferences, according to Silverman. “If anyone else was saying the things he has been saying, the FDA might cite them, with threat of punishment, as being not much more than an infomercial spokesperson,” he said. “The way he voices things is not how the FDA likes to communicate. So, for the moment, we are certainly in a bind.” – by Rob Volansky

For more information:

Hannah Fish, PharmD, can be reached at National Community Pharmacists Association, 100 Daingerfield Road, Alexandria, VA 22314; email: Hannah.fish@ncpa.org.

Gregg J. Silverman, MD, can be reached at NYU School of Medicine, 435 East 30th St., New York, NY 10016; email: gregg.silverman@nyumc.org.

Disclosures: Fish reports no relevant financial disclosures. Silverman reports consulting for Lilly, Onyx, Pfizer, Quest and Roche and receiving grant support from the American College of Rheumatology Research Foundation, the Lupus Research Institute and NIH.

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