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Texas Pharmacy Board reverses rule on hydroxychloroquine, no longer restricting 'off-label' use

Dr. Ivette Lozano was born in Cuba and came here as her parents escaped the Communist regime.

By TATIANA PROPHET

A rule adopted March 20 by the Texas State Board of Pharmacy restricting the prescribing of anti-malaria and lupus drug hydroxychloroquine has been reversed, after a Dallas physician gained national attention for her difficulty in prescribing the drug for her Covid-19 patients.

“I have patients that recovered within 48 hours,” Dr. Ivette Lozano told fellow protesters May 9 at the “Set Texas Free” event in Dallas. She went on to describe how CVS pharmacy was refusing to fill her prescriptions.

The rule, which applied to chloroquine, hydroxychloroquine and azithromycin, prohibited the dispensing of the medication without a written diagnosis “consistent with the evidence for its use.” Further, it limited prescriptions to a 14-day supply and required “no refills,” according to the taxpayer watchdog site Texas Scorecard.

After the video of Dr. Lozano’s speech was shared widely on the internet, FOX News host Laura Ingraham invited her on the show to tell her story. Ingraham reached out to CVS Pharmacy, which replied with a statement explaining that their policy was coming from a concern about the availability of the drug for patients who take it for lupus and rheumatoid arthritis.

Dr. Lozano told Texas Scorecard that she reached out to Texas State Sen. Bob Hall, (R-Edgewood), who then contacted the pharmacy board. The pharmacy board stated that its motive was to preserve the stockpile of the drugs, as well.

But the stockpile was already protected according to multiple accounts. Hospital orders for the drug waned after a VA Hospital study (not randomized, not controlled, and not double-blind), showed unfavorable outcomes in critically ill patients with various pre-existing conditions, yet garnered major headlines from dozens of legacy media outlets. The decline in orders was reported by the Boston Globe’s health news site Stat, reported that the stockpile had stabilized after demand plunged 62 percent in the week of April 17 to April 24.

”The drug, which is approved to treat lupus and rheumatoid arthritis, as well as malaria, had been widely touted a few weeks ago by President Trump, helping to spark a binge of prescription writing and hospital orders that created severe shortages,” intoned Ed Silverman on April 28 for Stat’s drug blog Pharmalot. “The rush occurred even as evidence was lacking that hydroxychloroquine — and a related drug called chloroquine — might be effective in thwarting the novel coronavirus. The picture was further muddied by a growing number of small studies – especially from France and China – that offered tantalizing suggestions of efficacy, but widely criticized for being poorly designed. Consequently, a growing number of physicians and public health experts cautioned that the tablet should not be embraced as a salve until more data is obtained from several trials under way. Toward that end, the FDA last week issued a cautionary note to health care providers because the drug may cause irregular heart rhythms, especially when used in combination with the azithromycin antibiotic.”

Silverman’s sonorous and grave assessment left out the part about the CDC telling Americans that children and pregnant women in all three trimesters can dose with hydroxychloroquine before traveling to countries where the malaria parasite is alive and well.

“CDC has no limits on the use of hydroxychloroquine for the prevention of malaria,” the CDC malaria pamphlet states. When hydroxychloroquine is used at higher doses for many years, a rare eye condition called retinopathy has occurred. People who take hydroxychloroquine for more than five years should get regular eye exams.” There is no mention of heart problems. There is a possibility that the comorbities in Covid patients, as well as the disease itself, could increase the risk of QT prolongation (a delay in the heart muscle’s response to the previous beat). The Mayo Clinic has come up with screening guidelines for such an eventuality.

By last Thursday, Sen. Hall had met with the Texas pharmacy board; and by the next day they reversed the guidelines.

Dr. Lozano is now free to prescribe hydroxychloroquine as she sees fit. As Texas scorecard quoted her: “100 percent of my patients have recovered very nicely. Within 24 to 48 hours, all symptoms are gone with medications that cost about $25-30 in pharmacies.”