Suppliers Unable to Meet Orders for Potential COVID-19 Drugs

Vizient recently announced it has sent recommendations to the White House Coronavirus Task Force and FDA to improve access for two potential COVID-19 drugs: chloroquine and hydroxychloroquine.

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The recommendations also focus on redirecting the supply of the drugs from retail pharmacy settings to the hospital/acute care environment where severely ill patients are being cared for.

“Over the last week, we have seen 6,842% and 2,196% increase in orders by Vizient members for chloroquine and hydroxychloroquine, respectively, since the World Health Organization declared COVID-19 a pandemic,” Dan Kistner, group senior vice president, pharmacy solutions for Vizient, said in the announcement.

“Unfortunately, supply has been unable to keep up with the significant demand, with fill rates dropping as low as 1.4% and 12.1% for those medications. Given the limited supply of these medications, and the increasing number of COVID-19 patients being hospitalized for severe illness, as well as those who have been using these products for existing diseases, it is essential that immediate steps be taken to adjust the flow of supply to minimize the potential for even greater negative outcomes.” 

Vizient advocated for two vital steps be taken by the task force and the FDA to ensure current supplies of chloroquine and hydroxychloroquine are used for the patients who are most in need and to ensure efficacy data be properly collected.

The first step is the retail dispensing of chloroquine and hydroxychloroquine must be limited to patients who have been receiving treatment for well-established diseases such as lupus and rheumatoid arthritis. 

Vizient suggested four strategies to address dispensing issues. 

The first strategy recommended was for retail pharmacies and their distributors partners to identify and return any excess inventory into the retail channel back to the distributors so health systems can order them. Pharmacy benefit managers and health plans should also require all new retail prescriptions for chloroquine and hydroxychloroquine to have prior authorization to confirm it’s being used for COVID-19 patients.

Additionally, state boards of pharmacy should limit prophylaxis use and impose dispensing requirements for new retail prescriptions, specifically, for patients who have tested positive for COVID-19. The prescription length should also be 14 days with no refills and any new suppliers coming to market or donating a large inventory of products should request that the distributors prioritize health systems, Vizient stated. 

The second vital step Vizient advocated was for was directing all other distribution of chloroquine and hydroxychloroquine to the health system where critically ill patients with COVID-19 are managed. Any information about its use in the critically ill patient population needs to be collected to inform ongoing understanding about the safety and efficacy of these therapies, the announcement stated.

“The extent of evidence regarding the use of chloroquine and hydroxychloroquine is limited. Hospitals and health systems are best positioned to support this need given their responsibility and managing the most critically ill patients and in investigational drug research for critical care therapies,” Kristner noted.

As the coronavirus outbreak continues to spread, experts believed that drugs such as lopinavir-ritonavir were potentially effective in treating COVID-19.

Last week, hospitalized adult patients with confirmed coronavirus experienced no benefits in lopinavir-ritonavir treatment compared to standard care, according to a clinical trial in LOTUS China. 

The clinical trial conducted from January 2020 through February 3, 2020, found that mortality rate at 28 days was similar in the lopinavir-ritonavir group and the standard care group, but lopinavir patients saw one less day for clinical improvement at 15 days, compared with 16 days in the standard-care group.

Serious adverse events were more common in the standard care group (32 patients) compared to the lopinavir-ritonavir group (19 patients). The clinical trial found that lopinavir-ritonavir was not associated with improvement or mortality in seriously ill COVID-19 patients different from that associated with standard care alone.

“In conclusion, we found that lopinavir-ritonavir treatment did not significantly accelerate clinical improvement, reduce mortality, or diminish throat viral RNA detectability in patients with serious COVID-19,” researchers highlighted. “These early data should inform future studies to assess this and other medication in the treatment of infection with SARS-CoV-2.”