Wednesday, April 08, 2020

Physicians, Desist!

"When people become very ill ... your impulse is to try anything that might help, and that's driven the response in some places."
"But as people have been wrapping their heads around the data underpinning these drugs, it's really pretty thin on the ground."
Lynora Saxinger, infectious disease specialist, University of Alberta

"Our message is that we have to exercise a little bit of control  here and rational thinking."
"We're asking for calm in this, and to let the studies unfold."
Allan Malek, chief pharmacy officer, Ontario Pharmacists Association

"[Demand grew significantly for hydroxychloroquine] in odd doses and quantities, with an off-label and unsubstantiated indication of 'COVID-19 prophylaxis or treatment."
"[The result is a] very serious shortage."
Ontario associations of pharmacists, doctors and registered nurses
Pharmacist Jim Giontsis, who runs a pharmacy in Toronto’s Moss Park neighbourhood, warns against using drugs like hydroxychloroquinine to treat COVID-19. (Evan Mitsui/CBC)
During one of his many COVID update press conferences, U.S.President Donald Trump apprehended the administration's chief infectious-disease expert, Dr.Anthony Fauci as he prepared to respond to a reporter's question about the controversy underlining the malaria drug hydroxychloroquine's effectiveness against the novel coronavirus ravaging populations across the globe, and now particularly in the United States.

While President Trump continues his personal promotion of the use of the drug to control and stop COVID-19, used with the antibiotic azithromycin, characterizing it as a "game changer", Dr.Fauci has given his professional opinion that caution is required until such time as more evidence that hydroxychloroquine proves to be safe and effective against the disease. Clearly, they are at odds over the drug, one a politician and layman, the other a neducak authority on disease transmission and vaccines.
Donald J. Trump @realDonaldTrump
HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine. The FDA has moved mountains - Thank You! Hopefully they will BOTH (H works better with A, International Journal of Antimicrobial Agents).....
388K
Long a standard treatment for lupus and rheumatoid arthritis, hydroxychloroquine's sudden popularity as a life-saver from the dread predations of the novel coronavirus have given it an unproven status in the minds of the general population where pharmacies have been sold out of the drug as anxious people begin to stockpile it and those dependent on its use for their legitimate health concerns find themselves unable to get their prescriptions refilled.

Now, it has been revealed that some Canadian doctors seem to have been busy writing personal scripts for their own possible use of the drug as a shield against COVID-19, accounting in part for the surge pharmacists are seeing in prescriptions for the medicine, leaving health-care regulators nationwide concerned about the situation.

Several provincial professional organizations have taken to issuing statements recently discouraging the practise on the basis that no solid evidence has yet been seen that hydroxychloroquine and azithromycin are effective against the coronavirus. "As evidence-based clinicians, we must be diligent in our efforts to not let blind hope drive our decisions", noted a joint statement from associations representing Ontario pharmacists, doctors and registered nurses.

"Inappropriate" was how the Quebec Order of Pharmacists spoke of its members filling prescriptions mean for COVID-19 prevention or treatment. Another regulator, the Alberta College of Pharmacists, referred to having received reports of physicians prescribing hydrxychloroquine for "'office use' to themselves, to family members and when there is no accepted indication" (treatment of COVID-19 infection for example).

Prescriptions "for office use" have been seen by pharmacists in Ontario as well, leaving the confused impression that either these physicians meant to dispense their supply to patients, or for themselves and family, according to the chief pharmacy officer, Allan Malek, with the Ontario Pharmacists Association. The result has been predictable; a concerning shortage of the drug for patients with a proven need for them.

"They are experiencing difficulty", explained Leanne Mielczarek, executive director of Lupus Canada. "In some cases, patients have to go to multiple pharmacies to fill their prescriptions." Patients have spoken to the Canadian Rheumatology Association of being unable to fill prescriptions, since COVID-19-related prescriptions "increased dramatically", according to Ahmad Zbib, the group's CEO.

Research undertaken by Allan Malek with the Ontario Pharmacists Association, revealed that three of the four approved producers of the medicine in Canada have no supply at all, with the fourth having "very limited" stocks even while Health Canada is trying to find manufacturers in other countries to add to Canada's reserves.

Interest was first triggered by a small French study  Lindsey Wasson/Reuters

A small study out of France that found the drug reduced the viral load in some patients, along with a larger trial of 80 patients lacking a control group triggered interest in the potential of the malaria drug for use with the novel coronavirus. As well, a small Chinese study while finding some benefit, balanced out against another that found no difference between patients receiving the drugs and those who did not.

At the present time, given the pandemic status of the coronavirus as it ravages populations around the world, a number of fast-tracked randomized controlled trials are being conducted where the drug is tested on larger groups of patients. According to many experts, the medicines should not be routinely used for COVID-19 until studies bring forward their findings in weeks and months to come.

U.S. regulators and professional associations are facing the very same situation, not surprisingly. They began hearing narratives relating to a spike in prescriptions late last month as well, where demand grew for hydroxychloroquine. Regulators in British Columbia predicted that prescribers will encounter greater pressure yet from "patients, fellow health care workers and even friends and family" to help access the drugs.

An employee checks the production of chloroquine phosphate at a pharmaceutical plant in east China's Jiangsu province in February. The drug, which treats malaria, has shown some efficacy against COVID-19-associated pneumonia in early research, but more study is required, experts say. (Barcroft Media/Getty Images)

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