The seriousness and speed with which the Covid-19 pandemic has overburdened the American medical system has been troubling. Because of the urgent dangers presented by the virus, drug manufacturers and pharmaceutical companies have been incentivized to develop and market preventative and therapeutic medications to address Covid-19 as quickly as possible. Because these medications are urgently needed, the Food and Drug Administration has been unable to fully test and approve all of the new drugs, instead of granting some of the emergency use authorization while the full approval is pursued.
An antiviral drug regimen that was recently developed by Pfizer has shown much promise at preventing serious cases of Covid-19 based on early studies. The FDA has granted emergency use authorization to the treatment, however, not all of the possible side effects and interactions are yet known. A recently published pharmaceutical industry report discusses possible side effects of the new treatment in patients with moderate to severe kidney disease and emphasizes the requirement for pharmacists to make dosage adjustments for such patients who are prescribed the drugs.
According to the industry report, the new drug regimen Paxlovid was developed by Pfizer and granted emergency use authorization by the FDA. The drug regimen is indicated to be used by patients who have tested positive for the virus that causes Covid-19 and is at moderate to high risk of being hospitalized or dying from the virus. Because the drugs appear to react differently in people with abnormal kidney function, the emergency use authorization included a dosage adjustment instruction for patients with moderate kidney disease. Under the emergency use authorization, patients with severe kidney disease should not be prescribed the treatment at all.
A pharmacist dispensing the medication to a patient with moderate kidney disease should remove and dispose of ten of the 30 pills from the carton, and place a sticker on the carton notifying the patient that their dosage has been adjusted based on their kidney function. If a pharmacist fails to remove the pills or notify a patient of the adjusted dose, a patient with kidney disease may be harmed by taking the larger-than-directed dose. A patient with severe kidney disease could be seriously harmed or die by consuming the drugs. Pharmacists are required to stay up-to-date on the possible interactions and side effects of emerging treatments and can be held accountable for malpractice if they fail to follow the FDA prescribing guidelines. If a patient with diagnosed moderate kidney disease is prescribed and dispensed the full course of Paxlovid without the dosage reduction, then a potentially harmful pharmacy error has occurred.
Seeking Recourse for a Pharmacy Error
If you or someone you love has recently been harmed because of a Maryland, Virginia, or D.C. pharmacy error or medication mistake, the attorneys at Lebowitz & Mzhen can help you seek damages for your loss. To date, the experienced pharmacy error and malpractice lawyers on our team have recovered over $65 million in settlements and awards for our clients, and we can help you too. If you have questions about a possible case, contact us at 800-654-1949 to schedule a free and confidential consultation with one of our attorneys today.