In the panic of the COVID-19 pandemic, Plaquenil must not become the new toilet paper
Ever since the COVID-19 outbreak, like any health-care provider, a significant amount of my time was spent attending multiple hospital meetings, reading articles, discussing with colleagues on how to triage the patients, alleviate their anxiety addressing all the questions and contain this pandemic.
I was also following news for updates, and among all that stood out to me was President Trump press briefing on March 19, regarding potential drugs that are being studied by the FDA for the treatment of COVID-19 and considering using them under “compassionate use” provisions.
One of the medicines considered is hydroxychloroquine (brand name: Plaquenil). It is one of the most common drugs used in the field of Rheumatology for chronic conditions like unexplained inflammatory joint pains, rheumatoid arthritis, lupus, undifferentiated connective tissue disease, and as an antimalarial agent in infectious disease world. The good side of Plaquenil is it’s been used for a long time, and rheumatologists have vast experience using the medication, about its safety and efficacy.
Being a rheumatologist myself and having approximately 20% to 25% of my patients treated with Plaquenil, it came to my attention about the evolving shortage of this medication in my area from the patients. My office staff received a phone call the next day after president’s briefing from a patient who is on long-term Plaquenil to call his prescription to a different pharmacy because of the shortage in his regular pharmacy. I called the other pharmacy, and to my surprise heard the same answer that “we are running short of Plaquenil.” I called his second-choice pharmacy, and they were out too, which struck me as like the toilet paper situation. I also heard an anecdotal experience of chloroquine shortage in other countries. An example is a lupus patient of mine who moved to the U..S. from Nigeria, sharing a story of panic buying of this medication in Nigeria and its shortage.
While the FDA is monitoring the production closely and also working with the manufacturers of hydroxychloroquine on any assistance they might need to increase supplies, we from the medical fraternity should take every step to stop unnecessary prescribing of this medication and educating the panic frenzy and demanding patients that there are no proven or approved treatments for COVID-19. It should also be brought to the patient’s attention that it is only recommended as a possible and investigational treatment for patients with COVID-19, but not a prophylactic medication.
Pharmacies should scrutinize requests for the refill of Plaquenil, mainly with new orders, making sure that they are ordered for the appropriate diagnosis to avoid drug shortage and abuse.
The American College of Rheumatology also confirmed in a statement after the president’s briefing hat Sandoz has a good supply, and Novartis has committed to donating up to 130 million doses of hydroxychloroquine to support the global COVID-19 pandemic response. ACR also mentioned about Mylan, saying that it would restart hydroxychloroquine manufacturing at a West Virginia plant.
Title X of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 makes it compulsory for pharmaceutical companies to report any drug shortages, the reasons for the deficit, and the approximate duration of shortage. FDA works with the companies making these drugs addressing the shortages and will make sure that patient needs are met. It will also make sure that the quality, safety, and efficacy of the drug is not compromised during this time of need, which could result in harming the patients. FDA and ASHP (American Society of Health-System Pharmacists) work closely to share information about drug shortages and provide the most current information.
Concerns about the price increase to pharmacies from unknown distributors compared to what the pharmacy usually pays at this time of need should be reported to FDA via the Office of Criminal Investigations at the following link: https://www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm
Concerns related to price changes of the medication can also be reported to the Federal Trade Commission, which enforces consumer protection and federal antitrust laws. More information about drug pricing act and assistance to complain can be found at http://www.ftc.gov
In short, as the virus keeps spreading and can cause a situation of panic demand for medication, we medical professionals, pharmacies, and drug companies should work together along with government regulatory authorities like the FDA to handle any drug shortages before we run out, thus making the problem worse.
This story was originally published March 24, 2020 at 10:49 AM.