ACR Issues Guidelines To Ensure Access To Hydroxychloroquine

Editor’s Note: This article was first published on April 6, 2020. Further developments in what we know about the coronavirus are continuously emerging.

Many people who need hydroxychloroquine (HCQ) are concerned about access to the drug during the COVID-19 outbreak. This drug is FDA-approved for malaria, lupus, and rheumatoid arthritis (RA). For many people with these conditions, HCQ is irreplaceable.

Recent studies have generated hype about HCQ as a treatment for COVID-19. This has caused demand to overwhelm the current supply.

The American College of Rheumatology (ACR) and other health organizations have issued guidelines to ensure access to HCQ for its intended use. The FDA and drug companies are also addressing the shortage.

Because of these efforts, experts are confident that the drug shortage will be temporary. But it is still a good idea to talk to your doctor about how to minimize the impact of the shortage.

Why are there concerns about access to HCQ?

Doctors prescribe HCQ for people with lupus and RA unless there is a reason otherwise. It reduces flares and prevents long-term organ damage. And HCQ is the only medication known to increase survival for people with lupus. For many people, there is no alternative drug.1

However, people are facing shortages as pharmacies are unable to fill their prescriptions. This is because of excitement about HCQ as a treatment for COVID-19. A few studies showed that HCQ is lethal to the virus in tissue culture.2–4 Another report showed positive results when using HCQ alone or with the antibiotic azithromycin to treat people with COVID-19.5 However, there were serious flaws in the study’s approach.6

Government officials then publicized hydroxychloroquine as a therapeutic option for COVID-19 on March 19. And the FDA approved the testing of HCQ in clinical trials for COVID-19. But doctors have started using it for prevention or treatment when side effects risks are low. And many hospitals increased orders for HCQ, anticipating using it as treatment.

After that, the FDA has approved an emergency authorization for HCQ for treatment of COVID-19.7 And another small study showed that HCQ accelerated recovery for people with mild illness from COVID-19. We still need a larger, controlled clinical trial to know if HCQ is effective and safe, and what dosage to use.8

Now, despite no clinical trial data, doctors generally believe HCQ is the most effective therapy for COVID-19.9 Because of this, shortages have been reported across the country. This is particularly concerning for people who rely on HCQ for lupus and RA.

What are the ACR guidelines?

To address this, the ACR released guidelines on March 26 for distributing HCQ. Here are their recommendations:1

  • Production should be increased for people with lupus or RA.
  • Supplies should be prioritized for people with lupus.
  • Supplies should also be prioritized for clinical trials for the prevention and treatment of COVID-19.
  • Controlled clinical trials should be accelerated and carried out by experienced investigators.
  • Decisions about distribution should include input from rheumatologists.
  • Rheumatologists may reduce dosage depending on individual needs.
  • Insurers should allow easy access to alternatives to HCQ.
  • Alternative ways to distribute HCQ should be created.

The ACR notes that we should avoid:1

  • Unrestricted access for COVID-19 without clinical trial data support
  • Pharmacy level restrictions on new prescriptions for people with lupus
  • Price increases or cost-sharing requirements

These guidelines reinforce a joint statement to the White House by the ACR, Lupus Foundation of America, American Academy of Dermatology, and Arthritis Foundation.10

How are the FDA and drug companies addressing this?

The FDA is taking proactive steps to ensure access to necessary medications. The agency supports policies to limit over-prescribing and over-dispensing HCQ.11

As of March 31, the FDA is assessing supplies and evaluating demand for people with lupus and RA. All manufacturers of HCQ are ramping up production. The FDA is ensuring that this happens quickly and safely.12

The Department of Health and Human Services (HHS) accepted a donation of 30 million doses of HCQ from Sandoz. They accepted 1 million doses of chloroquine from Bayer for treating people with COVID-19 or for clinical trials. These donations will help ease supply pressures.13

What can I do to ensure access to HCQ?

Experts believe that the shortage is temporary. However, here are some ways to ensure access to HCQ:14

  • Contact the pharmacy before asking your doctor to refill prescriptions to ensure it is available.
  • If the pharmacy does not have it, call other local pharmacies.
  • Ask for a 90-day prescription instead of the normal 30-day prescription.
  • Tell your pharmacist why you are taking the medication.
  • If you were inappropriately denied a refill, contact the state board of pharmacy.
  • If it is not in stock in the area, ask your doctor or pharmacist for guidance.
  • Report shortages to the FDA at drugshortages@fda.hhs.gov.

Even now, you may want to talk to your doctor about your specific situation. Here are some questions to ask:

  • How does the shortage affect my current healthcare situation?
  • Is it possible to ration my supply by decreasing my dosage or increasing the time between doses?
  • Can I get a prescription for longer than 30 days?
  • Would I ever be unable to access HCQ? What would I do in this situation?
  • Are there alternative drugs I can take?

Editorial Note: On April 24, 2020, the FDA announced that there have been reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine. Because of these reports, the FDA cautions against the use of hydroxychloroquine or chloroquine for COVID-19 outside of a hospital or a clinical trial.15 Close monitoring by a medical team is strongly recommended. Hydroxychloroquine and chloroquine can cause abnormal heart rhythms and other complications. If you are receiving hydroxychloroquine or chloroquine for COVID-19 and have an irregular heartbeat, dizziness, or fainting, call 911 right away.

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