ACR issues guidelines to ensure hydroxychloroquine supply, patient access amid COVID-19 demand
In the wake of increasing reports of hydroxychloroquine shortages in the United States, sparked by its still-untested potential as a COVID-19 treatment, the American College of Rheumatology has issued new guidelines on its scarce allocation.
Among the recommendations include ensuring an adequate supply of hydroxychloroquine for patients with systemic lupus erythematosus and rheumatoid arthritis who need them, as well as for those with COVID-19, where indicated. Further, in light of shortages, rheumatologists and rheumatology health professionals may reasonably pursue hydroxychloroquine dose reductions, and extend dosing intervals, based on the patient’s needs.
“The ACR wants there to be an adequate supply and distribution of hydroxychloroquine to everyone who needs it,” ACR President-elect David Karp, MD, PhD, told Healio Rheumatology. “We know that this drug, for many of our patients, is the safest and most effective drug that has been controlling their symptoms. We are also very aware of the public health concerns that surround the potential for hydroxychloroquine or chloroquine to be a useful drug in the treatment of COVID-19.”
“We are looking very carefully at the data as they come out, and hope that as there are more expertly done clinical trials available, we will understand the exact role for this drug,” he added. “We are aware there are no treatments currently for COVID-19 or the pneumonia that it can cause, so we think that everything should be tested rigorously, including hydroxychloroquine and chloroquine.”
In addition to the list of recommendations, the ACR also warned against unrestricted access to hydroxychloroquine for COVID-19 prophylaxis in the absence of clinical trial data supporting its use. The group declared its opposition to pharmacy-level restrictions on new starts of hydroxychloroquine for patients with SLE, as well as “predatory price increases or cost-sharing requirements,” particularly during the COVID-19 pandemic.
The ACR recommendations include:
- Ensure an adequate supply of hydroxychloroquine for all patients who need it, including supporting increased production and distribution for rheumatology patients, as well as patients with COVID-19 where indicated, and protections in all aspects of the supply chain;
- Adequate supplies of hydroxychloroquine should be allocated for patients with SLE, especially those who are pregnant and who would experience flare during even a brief pause in treatment;
- In the cases of COVID-19, adequate allocation of hydroxychloroquine should be prioritized, but not limited, to support clinical trials designed to test the efficacy of the drug as preexposure prophylaxis, post-exposure prophylaxis, and therapy both in mild-to-moderate as well as severe cases;
- Hydroxychloroquine trials for COVID-19 should be performed by experienced investigators equipped to generate and interpret reliable results while safeguarding patient safety and informed consent;
- Decisions about allocation of hydroxychloroquine should be made locally, with input from experts, based on local conditions and reviewed over time as circumstances change, and should not be made ad hoc by individual pharmacies acting in isolation;
- Allocation decisions, whenever possible, should include recommendations from rheumatologists and rheumatology health professionals;
- When faced with shortages, rheumatologists and rheumatology health professionals, in shared decision making with a patient, may reasonably pursue hydroxychloroquine dose reductions, and extend dosing intervals, based on the patient’s needs;
- A limit on hydroxychloroquine refills to 30 days for patients prescribed prior to the COVID-19 pandemic is reasonable if local circumstances make it necessary;
- Restricting new starts of hydroxychloroquine in the outpatient setting, pending approval by a rheumatologist or rheumatology health professional, may be reasonable in settings where rheumatologists and rheumatology health professionals are available to fulfill this role;
- In cases where hydroxychloroquine is prescribed for cutaneous SLE, dermatologists or dermatology health professionals should be allowed to approve new hydroxychloroquine prescriptions;
- Insurers should exempt rheumatology patients from prior authorization, step therapy protocols and other use management practices during hydroxychloroquine shortages, so that they may more easily access appropriate alternatives as determined by their rheumatologist; and
- Importation restrictions on hydroxychloroquine should be relaxed during the COVID-19 pandemic to create alternative avenues for the drug’s distribution in the United States.
According to Karp, ACR members, and their patients, have been reporting hydroxychloroquine shortages in pharmacies across the country.
“We have all heard from our patients about shortages,” he said. “We haven’t done a systematic survey of the membership, but each of us locally and in our national discussions have heard from patients who say that they have gone to their pharmacy and the pharmacy just says they are out.” – by Jason Laday
Disclosures: Karp reports no relevant financial disclosures.