The need to fight the coronavirus requires nimble responses from government and the private sector. It also requires new efforts to provide personal protective equipment (PPE) for health care workers and first responders. Already we’ve seen local distilleries switching to make hand sanitizer and local manufacturers and clothiers switching to make PPE.
State government has also set aside some regulatory obstacles, especially Certificate of Need laws limiting hospital beds and certain licensing rules limiting the supply of health care professionals. Sometimes a nimble response also requires being able to pivot as things change.
On March 23 the N.C. Board of Pharmacy announced that:
Board staff and public health officials at the North Carolina Department of Health and Human Services are aware of numerous reports from pharmacists across the state concerning new prescriptions for hydroxychloroquine, chloroquine, azithromycin, Kaletra, and potentially other medications – often in large quantities with a high number of refills — to respond to the COVID-19 pandemic. Reports include these prescriptions being issued by prescribers for themselves and family members, and for persons who have not been exposed to or infected by the COVID-19 virus.
Board staff and public health officials are aware that some prescription drug wholesalers are reporting shortages of these drugs. Board staff are aware that at least three other state boards of pharmacies have passed emergency rules limiting the circumstances under which these drugs may be dispensed, and their quantities.
All health care providers are reminded that, while these drugs are being investigated as potential COVID-19 treatments, there is at this date only anecdotal evidence of their potential usefulness. Public health authorities are working to obtain better data on their potential — and most appropriate — use in the pandemic.
On March 24, N.C. Health and Human Services Secretary Mandy Cohen and State Health Director Betsey Tilson sent a letter to the Medical Board and Pharmacy Board requesting an emergency rule on the anti-malaria drugs hydroxychloroquine and chloroquine, as well as azithromycin and other drugs “to alleviate shortages and ensure that these drugs are available to patients who need them.” The board passed the rule that same afternoon.
Shortages of hydroxychloroquine and chloroquine would affect patients here who need them to treat lupus and rheumatoid arthritis. The drugs have been increasingly discussed, including by Pres. Donald Trump, as effective in treating COVID-19.
The emergency rule makes those medicines “Restricted Drugs,” and with respect to treating COVID-19, it limits prescribing them only to patients already diagnosed with COVID-19, and only for 14 days. In effect, it prohibits their use as preventative or precautionary, such as by health care workers on the front lines, their immediate families, patients awaiting test results, etc.
In terms of research, these are early days still. But findings indicate that the anti-malarial “cocktail” of hydroxychloroquine and azithromycin can be effective in treating the disease:
- An early, small trial out of France found significant antiviral effects of hydroxychloroquine treatment reinforced by azithromycin. (Gautret et al., posted March 20)
- A following small trial out of France did not find strong antiviral effects of hydroxychloroquine reinforced by azithromycin for patients hospitalized with severe cases of COVID-19. (Molina et al., posted March 30)
- Another study from China, with a slightly larger sample of mildly ill patients and using a control group, found that the hydroxychloroquine group recovered quicker, with milder cases of cough, fever, and pneumonia and less likelihood of severe forms of the illness than the control group not given the drug (Zhaowei Chen et al., posted March 31)
The last study attracted the attention of The New York Times, which reported on it April 1.
Meanwhile, a new survey of physicians in 30 countries who have treated COVID-19 patients found that they considered hydroxychloroquine the most effective treatment. Survey results of 2,171 physicians polled from around the world found that 37 percent considered hydroxychloroquine the most effective therapy among 15 options. The survey was conducted on March 25–27 by Sermo, a global health care polling firm.
Furthermore, on March 28, the U.S. Food and Drug Administration authorized the use of hydroxychloroquine and chloroquine to treat teens and adults hospitalized with COVID-19. FDA Chief Scientist Denise Hinton wrote, “Based on the totality of scientific evidence available to FDA, it is reasonable to believe that chloroquine phosphate and hydroxychloroquine sulfate may be effective in treating COVID-19” and that, under the uses authorized, their “known and potential benefits” outweigh their “known and potential risks.”
Those known risks include abnormal heart rhythms as well as certain eye, liver, or kidney problems. As with any treatment, it depends on the patient.
There is good news on the supply front as well. On March 29, the U.S. Department of Health and Human Services announced donations of 31 million doses of hydroxychloroquine to the Strategic National Stockpile. In North Carolina, DHHS just received a donation of 600,000 doses of hydroxychloroquine from Amneal Pharmaceuticals out of New Jersey.
The Amneal donation is a sterling example of private ingenuity able to meet a public need with cooperation from government setting aside red tape and regulatory obstacles. The Charlotte Observer reported:
The North Carolina donation began with Bill Baugh, a Davidson resident and Distinguished Partner and COO of the Washington-based law firm Franklin Scott Conway, which works with Amneal. He talked to his friend, former Republican state Sen. Jeff Tarte of Cornelius. Tarte in turn talked to legislative leaders in Raleigh and officials at DHHS.
“We were able to make this come together in probably five days,” Baugh said Wednesday. “And we’ve been doing this all over the country. It’s not a silver bullet. But we felt the need to get it in places where it could do the most good.”
Tarte said the legislative leaders were able to cut through red tape and work with health officials in Democratic Gov. Roy Cooper’s administration.
Importantly, the donation also relieved the supply pressures for the drug, according to Amanda Moore, a pharmacist for the state Division of Public Health:
With reports of lupus patients finding the drug hard to get, Moore said Amneal’s donation should relieve pressure on supplies of the drug for patients who depend on it “The benefit is that we will not be putting demand on the supply chain for (hospitals and other facilities),” she said, “and that will then make it easier for patients needing it for chronic conditions to get it.”
What all this indicates is that what informed the passage of last week’s emergency rule is no longer the best available information. There are more indications that these treatments are effective and less need to worry about a shortage. Several other states that initially passed limits or prohibitions on hydroxychloroquine have seen the same shifting landscape and subsequently changed their prohibitions.
Recommendation: Allow health care workers and first responders on the front lines to receive preventative prescriptions of hydroxychloroquine, chloroquine, azithromycin, etc.
Why: to protect them from the virus along with masks, gloves, and other PPE
All that being the case, DHHS should move to allow preventative or precautionary prescriptions of hydroxychloroquine, chloroquine, azithromycin, etc. for health care workers and first responders on the front lines in this all-out public health war. State health officials should also consider prescribing for their immediate families as well as patients awaiting test results (for as long as results take days to return). Physicians should, of course, give all due consideration of the risks of the drugs in determining whether it is suitable for each affected individual.
But along with masks, gloves, and other PPE, this could be a big boost in North Carolina’s effort against the coronavirus.