By Greg Barnes
The N.C. Board of Pharmacy approved emergency rules Tuesday designed largely to restrict health care providers from writing prescriptions for themselves and family members for hydroxychloroquine and other drugs that some have said show some promise in the fight against COVID-19.
In a statement, the pharmacy board said a number of health care providers have been writing prescriptions for large quantities of hydroxychloroquine, chloroquine, azithromycin, Kaletra and perhaps other drugs.
Some small studies have indicated they may have potential in helping people recover from the coronavirus, but have not been studied to determine if that’s really the case. Nor have they been federally approved for that purpose.
But rumors have spread online and in the media, in part because President Donald Trump talked up the drugs on Twitter and during press conferences. The publicity has provoked a nationwide rush.
Jay Campbell, executive director of the pharmacy board, said there is concern that a run on the drugs in North Carolina will result in a shortage for people who are taking them for proven relief of lupus, rheumatoid arthritis and other autoimmune diseases.
Some lupus patients in North Carolina are already having trouble getting hydroxychloroquine, a potentially life-saving drug that is starting to disappear from pharmacy shelves, said Jenny Price, CEO and president of the North Carolina chapter of the Lupus Foundation of America.
Price said some members of her organization have called their local pharmacies only to be told that they are out of hydroxychloroquine, a primary drug lupus patients take to relieve joint pain, inflammation of the heart and lungs, fatigue, fever and other ailments. The drug, commonly sold under the brand name Plaquenil, can prevent lupus from damaging the kidneys and other organs.
Price said most of the 53,000 lupus patients in North Carolina take hydroxychloroquine daily. Some insurance companies limit refills of the drug to 30 days, she said.
The new rules were requested by Mandy Cohen, secretary of the N.C. Department of Health and Human Services. The rules apply to the drugs hydroxychloroquine, chloroquine, lopinavir-ritonavir, ribavirin, oseltamivir, darunavir, and azithromycin.
Under the rules, which will also be adopted by the N.C. Medical Board, a pharmacist can fill a prescription for no more than a 14-day supply of the restricted drugs to people suffering from COVID-19.
The rules do not apply to people with other diseases, such as lupus. They were adopted to protect those people from shortages and to stop health care providers from writing prescriptions to people who have not been diagnosed with coronavirus.
- What drugs does the emergency rule apply to? The rule creates a list of “restricted drugs”: hydroxychloroquine, chloroquine, lopinavir-ritonavir, ribavirin, oseltamivir, darunavir, and azithromycin.
- What restrictions does the rule apply to dispensing any of the Restricted Drugs? A pharmacist shall fill or refill a prescription for a Restricted Drug only if that prescription bears a written diagnosis from the prescriber. The diagnosis must be included in any electronic prescription as well. A prescription for a Restricted Drug may be phoned in by a prescriber or a prescriber’s agent, but all of the information required by this rule must be recorded by the pharmacy, as well as the identity of the prescriber or prescriber’s agent transmitting the prescription.
- What if the diagnosis is COVID-19? In that case, a pharmacist may dispense no more than a 14-day supply. And that prescription may not be refilled. Only a new prescription meeting the requirements of the rule may be filled. No emergency refill may be provided for a Restricted Drug prescribed for a COVID-19 diagnosis.
- May a Restricted Drug be dispensed for prevention of, or in anticipation of, a COVID-19 infection? No. No prescription for a Restricted Drug may be dispensed to prevent or in anticipation of a COVID-19 infection.
- What if a patient was already taking a Restricted Drug for something other than COVID-19 prior to this rule? The rule does not apply to prescriptions for a Restricted Drug for a patient previously established on that particular Restricted Drug on or before March 10, 2020.
- Does the emergency rule affect dispensing to in-patients at health care facilities? No. Orders to administer a Restricted Drug to an inpatient of a health care facility are not affected by this rule.
- Are prescribers governed by similar restrictions? Secretary Cohen has requested the North Carolina Medical Board to pass a substantively identical rule governing prescribers. Questions concerning the Medical Board’s progress on Secretary Cohen’s request should be directed to the Medical Board.
The New York Times reported that six other state pharmacy boards — in Texas, Idaho, Kentucky, Oklahoma, Ohio and Nevada — have moved to restrict who can be prescribed chloroquine and hydroxychloroquine and how much can be prescribed.
Barbi Manchester, a lupus patient from Mount Airy, knows what it’s like to go without hydroxychloroquine. About eight or nine years ago, Manchester said, she was taken off hydroxychloroquine for a drug trial. Within a week, she said, she started experiencing a fever, fatigue, joint pain, sores, rashes, ulcers and vasculitis, an inflammation of the blood vessels. She said she had to be hospitalized.
Manchester said she is now visiting relatives in South Carolina. Running low on the lupus medicine she has taken for 13 years, Manchester said she called a pharmacy and was told hydroxychloroquine was out of stock. She said the pharmacist checked with other pharmacists in a 60-mile radius and was told the same thing. She then called a pharmacy in Surf City, near Myrtle Beach, and was told there was no hydroxychloroquine within 90 miles.
Manchester said she called a pharmacy near her home in Mount Airy and was able to order a limited supply of the drug.
“Luckily, my dad picked it up and was able to mail it to me. Now I just have to wait for it to get here,” she said Tuesday.
Better data needed
Hydroxychloroquine and chloroquine are anti-malarial drugs. Of the two, hydroxychloroquine is said to be less toxic and cause fewer side effects. Both drugs have been used in other countries to treat COVID-19 patients in limited amounts, but they have not been approved here by the Federal Drug Administration for that purpose.
“Collecting and interpreting that data really depends on the other medications that people are getting,” explained David Kroll, a pharmacology professor at the University of Colorado. “If you’re giving something [else]… on top of giving hydroxychloroquine and the patient responds, how do you know which one helps or was it a combination of the two?
“How do you know which it was that did the job?” he asked.
Kroll said he understands the impulse to try different things in the midst of an emergency, and there’s not the luxury of doing a randomized, controlled clinical trial. But he also said physicians and the public need to not rush to judgment on a particular therapeutic.
“We need to look at safety and effectiveness while we’re doing these trials on the fly,” he said.
“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,” the state Board of Pharmacy wrote in its statement. “Public health authorities are working to obtain better data on their potential — and most appropriate — use in the pandemic.”
Hydroxychloroquine has been in the news since last Thursday, when Trump touted its potential to save lives in the battle against the coronavirus. Trump said his administration planned to make the drugs available “almost immediately,” even though they are not federally approved for that purpose.
The president continues to push for the use of the drugs on COVID-19 patients.
According to the Centers for Disease Control and Prevention’s website, chloroquine and hydroxychloroquine have been recommended for treatment of hospitalized coronavirus patients in several countries and have been used on an uncontrolled basis in the United States. Clinical trials will be underway soon in the U.S., the website says.
A small study in China suggested that COVID-19 patients treated with chloroquine had somewhat milder cases and shorter hospital stays than those who did not, however that data have not been published. A small study in France of only 20 patients concluded that a combination of hydroxychloroquine and azithromycin helped coronavirus patients.
The data supporting use of the drug are thin, concluded the Society of Critical Care Medicine and at the end of last week, issued guidance noting “there is insufficient evidence to issue a recommendation on the use of chloroquine or hydroxychloroquine in critically ill adults with COVID-19.”
Researchers skeptical, while politicians embrace it
Researchers, including Dr. Anthony Fauci, the nation’s leading infectious disease expert, say there haven’t been enough large-scale studies on the drugs’ efficacy and safety for their widespread use against the coronavirus.
Two researchers quoted in The Scientist magazine, Nabil Seidah, a molecular biologist at the Montreal Clinical Research Institute, and Jeremy Rossman, a virologist at the University of Kent, concluded that chloroquine is potentially dangerous at high levels over prolonged periods and “agree that larger clinical trials are a must before chloroquine is considered safe and effective as a treatment for COVID-19.”
Regardless, New York Gov. Andrew Cuomo announced at a news conference Sunday that his administration has received 750,000 doses of chloroquine and 10,000 doses of hydroxychloroquine, which he said he plans to use in clinical coronavirus trials starting Tuesday. New York had recorded nearly 22,000 cases of the virus by Tuesday morning, more than any other state.
On Monday, Trump tweeted about a Florida man with the virus who says hydroxychloroquine saved his life.
“A great early result from a drug that will start tomorrow in New York and other places!” Trump said in his tweet.
On the same day, it was reported that an Arizona couple ingested an aquarium cleaner that included an ingredient with the name chloroquine, thinking it was the same substance Trump had been praising. The toxic ingredient killed the man and left his wife seriously ill.
This among other reports prompted the Food and Drug Administration to issue consumer guidance on Tuesday about fraudulent coronavirus treatments that included the admonishment that “Personal testimonials are no substitute for scientific evidence.”
North Carolina case
In North Carolina, a Harnett County man suffering from the coronavirus was given hydroxychloroquine while being hospitalized. Jeff Hensley returned home Sunday after spending three days in a Harnett County hospital.
His wife, Toni Hensley, declined to speculate on whether the hydroxychloroquine helped her husband, who has had trouble breathing.
“He is a little better today,” she said Monday. “Is that due to the virus running its course or is that due to the medicine? I don’t know.”
“Without it would he still be real sick? I don’t know.”
Price, head of North Carolina’s lupus foundation chapter, said the organization has made a plea to manufacturers and Congress to ensure that enough hydroxychloroquine is available to people with lupus.
The drug company Mylan said in a news release last week that it plans to ramp up production of hydroxychloroquine at its West Virginia plant to provide 50 million tablets for more than 1.5 million people.
Another drug company, Teva, said in a March 19 statement that it plans to donate 6 million tablets through wholesalers to hospitals by March 31 and more than 10 million within a month.