At least 11 states have acted to limit the dispensing of chloroquine and hydroxychloroquine – prescription drugs that have been cited as providing protection against coronavirus (COVID-19) without adequate clinical evidence to support that claim. To protect consumers with or at risk of COVID-19 and to prevent stockpiling of these drugs, which treat malaria, rheumatoid arthritis, and lupus, at least 10 state pharmacy boards have issued rules and recommendations that limit the use of these drugs while assuring those with non-COVID-19-related illnesses can continue to receive their medicines.
These state actions were taken before the US Food and Drug Administration’s (FDA) emergency authorization allowing the limited use of chloroquine and hydroxychloroquine. FDA stipulated that the drugs “may only be used to treat adult and adolescent patients who weigh 50 kg or more and are hospitalized with COVID-19, for whom a clinical trial is not available, or participation is not feasible.” The FDA had earlier authorized drug manufacturers to donate these drugs to the Strategic National Stockpile for distribution to hospital for these targeted populations.
FDA’s authorization is limited and may be accommodated by state regulatory guidance. Other states are expected to – and may have already implemented – similar limits on dispensing or other guidance regulating the use of these drugs in the fast-moving world of protecting consumers and the supply of drugs during the COVID-19 pandemic
To date, seven states prohibit pharmacists from dispensing these drugs unless the prescription bears a written diagnosis consistent with evidence of its use.
- New York explicitly requires prescribing of these drugs for a Food and Drug Administration-approved indication or as part of an approved trial. North Carolina, New York, and Ohio also require a confirmed positive COVID-19 test result prior to dispensing the drugs for that experimental purpose.
- Most states limit supply to 14 days and limit or prohibit refills.
- New York and Ohio explicitly prohibit use of the drugs for experimental or prophylactic purposes.
- Texas and North Carolina include additional drugs in their new rules, all of which have been cited either by social media or by limited studies to hold promise for the treatment of COVID-19.
- Pharmacy boards in Louisiana, Kansas, and Missouri have issued recommendations that encourage pharmacists and prescribers to use due diligence and professional judgement when prescribing these drugs and to limit the quantities prescribed.
At least one state insurance department has issued guidance detailing the prescribing of chloroquine and hydroxychloroquine. Last week, the Massachusetts’ Insurance Commissioner released a bulletin to all health insurers with the stated expectation that carriers directly, or through their pharmacy benefit managers, establish prior authorization systems to prevent the hoarding of these drugs and avoid inappropriate prescribing.
The National Academy for State Health Policy will continue to track and provide updates about state actions.