Reports from physicians who stocked medications to treat COVID-19 disease prompted the Kentucky Board of Pharmacy to take new measures on Wednesday that restrict when pharmacists can deliver the medication.
According to the US Food and Drug Administration, it has not yet been proven that the drugs treat the virus. Even so, President Donald Trump advertised several of them as treatments, and the drugs were used nationwide. Medicines included in the board's order include chloroquine, hydroxychloroquine, mefloquine, and azithromycin. The board will also be able to restrict other medications used to treat coronavirus disease if necessary.
According to the new guidelines, pharmacists can only provide the medication to people with prescriptions or medical instructions who have a written diagnosis from a prescriber. Refilling prescriptions must also include a written diagnosis and a reason for continuing the prescription.
Prescriptions for the medication must be limited to 10-day care unless the patient's treatment plan is prior to the decision of the board in accordance with the order issued by the board.
The stringent standards are based on concerns that doctors hoard medicines and write prescriptions for themselves and their families, as described in news reports . While there is no evidence that this is happening in Kentucky, the board wanted to prevent any abuse and ensure that care for people who depend on the medication continues to treat other conditions such as lupus, rheumatoid arthritis, malaria and HIV .
Craig Martin, a board member, said the restrictions would help reduce the risk of supply shortages and hoarding.
"Your clinical efficacy against COVID-19 is fairly undocumented at this point," he said. "This is necessary for several reasons."
President Trump has promoted chloroquine and hydroxychloroquine as pioneering treatments for the coronavirus, which has infected more than 54,000 Americans and killed approximately 19,000 people worldwide.
However, the drugs still have to be proven or approved by the federal authorities for the treatment of the coronavirus. The US Food and Drug Administration said in a statement last week that there were no therapeutics or medicines to treat, cure, or prevent COVID-19.
“The FDA continues to work with interested sponsors to accelerate additional clinical trials for potentially appropriate COVID-19 medical countermeasures. The FDA is able and has been able to turn around requests to initiate clinical trials very quickly, ”says the statement from .
Nevertheless, the demand for drugs seems to be increasing.
In Ohio, supplies for medicines were decimated as prescriptions increased, according to a report by The Cincinnati Enquirer. The state pharmacy agency has taken action and is now demanding that patients test positive for COVID-19 before they can receive the coronavirus medication.
Elsewhere, state pharmacy regulators note that medication is suddenly in high demand and is restricting distribution, according to the New York Times .
In Kentucky, the pharmacy agency has received no formal complaints that a doctor is using his prescribing powers to hoard medication that could cure the pandemic. A spokesman for the Kentucky Board of Medical Licensure said the agency has heard "rumors" about doctors prescribing or prescribing the medication themselves, but has not yet initiated an investigation.
Don Kupper, president of the Kentucky Pharmacists Association, said the board's decision to limit drug distribution amid the COVID-19 pandemic was a good thing. The action will help eradicate abuse and ensure that care for people in need of medication is maintained.
"Hoarding the drug is ridiculous," he said.
Kupper said the medicines are not generally prescribed and pharmacists will certainly review every prescription they come across for large quantities of the listed medications, especially if they are written for multiple family members.
"Pharmacists will notice," he said.
Bill Eley, director of legislative affairs at American Pharmacy Cooperative Inc., said the pandemic restrictions are necessary to prevent drug prices from rising.
Eley campaigned for Kentucky lawmakers on behalf of independent pharmacies, saying that these types of restrictions are common in emergencies where people are likely to store drugs.
"Main Street pharmacies are at the forefront of these big problems," he said. "We are concerned about serving the people we see."
Last week, the state pharmacy agency issued a memo to pharmacists requesting the professional assessment to “determine whether the patient and prescriber relationship was valid and to determine if there was sufficient medication in stock are ”before the prescription is dispensed.
During Wednesday's session, the state's six-member pharmacy agency also approved a measure that would allow qualified pharmacists outside of Kentucky to obtain a temporary license to practice in Kentucky, "if this occurs during the COVID-19 pandemic should be necessary "
The expanding pandemic closes the business and disrupts almost all facets of everyday life. It also triggers ongoing changes to long-established procedures and requires regulators such as the pharmacy office to adapt to requirements while ensuring a safe environment for patients and pharmacists
"One of the hallmarks of our situation is that tomorrow's information may be different than today's information," said Martin, the chairman of the board. "It is impossible for us to predict everything."