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Worries Of Abuse Force Ky. Pharmacists To Limit Supply Of Coronavirus Trial Drug

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Reports of doctors stockpiling medicine that may treat the COVID-19 disease led the Kentucky Board of Pharmacy on Wednesday to adopt new measures restricting when pharmacists can dispense the drugs.

The drugs are not yet proven to treat the virus, according to the U.S. Food and Drug Administration. Despite that, President Donald Trump has promoted several of them as treatments and there’s been a nationwide run on the medications. The drugs included in the board’s order include chloroquine, hydroxychloroquine, mefloquine and azithromycin. The board will also be able to set limitations on any other medication used to treat the coronavirus disease, as the need arises.

Under the new guidelines, pharmacists can only provide the drugs to people with prescriptions or medical orders that include a written diagnosis from a prescriber. Prescription refills must also include a written diagnosis, as well as a reason for why the prescription is being continued.

Prescriptions for the drugs must be limited to a 10-day supply, unless the patient’s treatment plan predates the board’s ruling, according to the order passed by the board.

The strict standards come amid concerns that doctors are hoarding the drugs, writing prescriptions for themselves and families, according to news reports. Though there isn’t any indication this is happening in Kentucky, the board wanted to prevent any abuse and ensure supplies remain for people who rely on the drugs to treat other conditions including lupus, rheumatoid arthritis, malaria and HIV.

Craig Martin, a board member, said the restrictions will help reduce risks of supply shortages and hoarding.

“Their clinical efficacy against COVID-19 are fairly undocumented at this point,” he said. “This is necessary for multiple reasons.”

President Trump has promoted chloroquine and hydroxychloroquine as a game changing treatment for the coronavirus, which has infected more than 54,000 Americans and killed about 19,000 globally. 

But the drugs have yet to be proven or approved by federal regulators for treating the coronavirus. The U.S. Food and Drug Administration said in a statement last week that there are no therapeutics or drugs to treat, cure or prevent COVID-19.

“The FDA continues to work with interested sponsors to help expedite any additional clinical trials for COVID-19 medical countermeasures that may be appropriate. The FDA is able to, and has been, turning around requests very quickly to assist in initiating clinical trials,” according to the statement.

Yet still, demand for the drugs seems to be surging.

In Ohio, supplies for the drugs were being decimated as prescriptions soared, according to a reportfrom The Cincinnati Enquirer. The state’s pharmacy board took action and now requires patients to have tested positive for COVID-19 before being able to receive the drugs for coronavirus treatment.

Elsewhere, state pharmacy regulators are taking notice that the drugs are suddenly in high demand and they’re clamping down on distribution, according to The New York Times.

In Kentucky, the pharmacy board has received no formal complaints of any doctor abusing their prescribing power in effort to hoard drugs that could cure the pandemic disease. The Kentucky Board of Medical Licensure has “heard rumors” of physicians self-prescribing or over-prescribing the drugs, but has yet to open any investigation, according to Leanne K. Diakov, the board's general counsel.

Don Kupper, the president of the Kentucky Pharmacists Association, said the board’s decision to limit the distribution of the drugs amid the COVID-19 pandemic is a good thing. The action will help stamp out abuse and ensure supplies are maintained for people that rely on the medications.

“To hoard the drug is ridiculous,” he said.

Kupper said the drugs aren’t commonly prescribed and pharmacists will certainly scrutinize any prescription they come across for large quantities of the listed drugs especially if they’re written for multiple members of a family.

“Pharmacists will notice,” he said.

Bill Eley, the director of legislative affairs for American Pharmacy Cooperative Inc., said the limitations are needed during the pandemic to keep drug prices from surging.

Eley lobbies the Kentucky legislature on behalf of independent pharmacies and said these types of restrictions are common during emergencies, when people are likely to stockpile drugs.

“Main Street pharmacies are on the front lines for these big issues,” he said. “We are concerned about serving the people we see.”

Last week, the state pharmacy board issued a memo to pharmacists urging the use of professional judgment to “determine if a valid patient-prescriber relationship exists and consider whether there is enough of the drug in stock” before dispensing prescription. 

During Wednesday’s meeting the state’s six-member pharmacy board also approved a measure that will allow qualified pharmacists from outside of Kentucky to obtain a temporary license to practice in Kentucky “should the need arise” during the COVID-19 pandemic.

The spreading pandemic is shuttering business and disrupting nearly every facet of daily life. It’s also sparking rolling changes to long-practiced procedures and requiring regulating agencies, like the pharmacy board, to adapt to meet demands while also maintaining safe environments for patients and pharmacists

“One of the hallmarks of the situation we are in is that tomorrow’s information may be different than today’s information,” said Martin, the board president. “It’s impossible for us to predict everything.”

Jacob Ryan is the managing editor of the Kentucky Center for Investigative reporting. He's an award-winning investigative reporter who joined LPM in 2014. Email Jacob at jryan@lpm.org.

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