New Jersey Restricts Prescribing Medicines Used to Treat COVID-19

New Jersey’s attorney general’s office and its State Board of Medical Examiners have taken an extraordinary step, issuing a directive to pharmacists and physicians in the state limiting the prescription of certain medications for COVID-19.¹

Demand for chloroquine and hydroxychloroquine, which are generally used to treat malaria and rheumatologic conditions, have increased dramatically, leading to shortages. Reports to the State Board of Medical Examiners allege that physicians are prescribing the medicines for family members, office staff members, or even themselves. There are reports of hoarding in order to take the medications as prophylaxis.

The board felt it necessary to issue the directive stating that pharmacists cannot fill a prescription for chloroquine or hydroxychloroquine unless it is for a valid medical reason. If they prescribe either for patients who have COVID-19, those patients must prove that they have had a positive test before the pharmacist can dispense the medication. And such patients would be limited to a 14-day supply.

President Donald J. Trump commented during a news briefing and in his tweets that the combination of chloroquine and Zithromax could be a "real game-changer" in the treatment of COVID-19 infection, soon after a frenzy of buying activity across the United States began, with allegations of physicians hoarding supplies.

Chris Castagna, RPh, owner of Pennington Apothecary in New Jersey, reported that he has a regular customer base that regularly purchases hydroxychloroquine. But soon after the news broke about COVID-19 cases, he began to get requests for hydroxychloroquine from all around the United States, often in large quantities.

Castagna said that he also knows of a few physicians who have purchased hydroxychloroquine for family members, as well, but he has not seen any hoarding.

The new directives forbid him from dispensing large amounts of hydroxychloroquine, and all prescriptions must have a valid diagnosis code. The directive also mentioned limiting the dispensing of metered-dose inhalers of bronchodilators to 1 per month. Patients who take chloroquine and hydroxychloroquine for rheumatologic conditions will be limited to a 1-month supply.

The board directive stated that "medical professionals have a duty to make conscientious prescribing and dispensing decisions that ensure every patient is able to obtain the medication. This includes only issuing prescriptions necessary for the treatment of patients in reasonable quantities to ensure continuity of care for all who rely upon them."

Paul R. Rodriguez, New Jersey’s acting director of the Division of Consumer Affairs in the Attorney General’s office said, "It is imperative that these rules are not violated, especially during the public health emergency."

The division's order applies immediately and until further notice and mandates that any prescription for chloroquine, hydroxychloroquine, or any other medication used to treat COVID-19 must have a diagnosis code and should be supported in the patient record. Prescriptions without this information are considered invalid. Additionally, all orders written should be for the treatment of conditions within the prescriber's scope of practice. As an example, dentists, podiatrists, and veterinarians should not necessarily prescribe medications designated to treat COVID-19.

The directive states that pharmacists should not fill prescriptions if they think that the prescribers are acting outside the scope of their practices.

Suspected violations of this order should be reported to the State Board of Medical Examiners.

The antimalarials chloroquine and hydroxychloroquine have demonstrated antiviral activity against severe acute respiratory syndrome—coronavirus 2 (SARS–CoV-2) in vitro and in small, poorly controlled or uncontrolled clinical studies.² Studies using chloroquine against influenza and other viruses have been inconclusive.³ A small study from France indicated some benefits. Still, the study was marred by methodological flaws, and a second study done was lacking a control.⁴

Chloroquine and hydroxychloroquine are not benign drugs. A man recently took chloroquine in the form of a fish tank cleaner and died. These drugs can cause QT prolongation, ventricular arrhythmia, and other cardiac toxicities, which may be exacerbated in patients who are sick. Chloroquine, which was used for a century to treat malaria, is designed to be dosed high for a limited number of days in order to minimize adverse effects, which increase the longer the medication is taken. It is rarely used to treat malaria, because of resistance. Hydroxychloroquine has a more favorable safety profile but can cause retinitis and cardiac conduction problems in some patients.

The evidence for benefit in treating COVID-19 with chloroquine and hydroxychloroquine is equivocal. However, there is no doubt that there is a benefit to patients with rheumatologic diseases. There is a considerable body of evidence that abruptly stopping these medicines in patients with rheumatologic diseases poses a significant problem to their health. Should the drugs become scarce, because of hoarding and inappropriate use, it could cause harm to patients who rely upon them.

Therefore, I applaud New Jersey’s State Board of Medical Examiners for restricting access to chloroquine and hydroxychloroquine to bona fide legitimate cases. They have left the door open for physicians to prescribe for COVID-19 infections but limit it to a 14-day supply, which is unlikely to cause any harm. In circumstances where a patient is at risk of dying and there is no other therapy available, I understand why physicians might try hydroxychloroquine. These patients would be hospitalized, and the board directive only applies to outpatients.

In some areas, these medicines are already in short supply in part because of alleged hoarding by physicians and physician's offices taking it for prophylaxis against COVID-19. Long-term use increases the chances of toxicity and limits the supply for proven uses. Manufacturers have promised to increase the supply. Fortunately, there is no evidence that they have increased their price of the medications, and they remain relatively inexpensive.

Castagna said that it would be a particularly bad idea politically for drug makers to raise prices now.

Meanwhile, there are several trials in progress to study the efficacy of chloroquine and hydroxychloroquine in the treatment of COVID-19.

Simon Murray, MD, is chief medical officer at MJH Life Sciences, the parent company of Pharmacy Times.

REFERENCES

• To prevent drug shortages, AG Grewal imposes emergency statewide restrictions on certain prescription medications [news release]. Newark, NJ: March 30, 2020. State of New Jersey Governor Phil Murphy’s website. nj.gov/governor/news/news/562020/20200330c.shtml. Accessed April 2, 2020.
• Yao X, Ye F, Zhang M, et al. In vitro antiviral activity and projection of optimized dosing design of hydroxychloroquine for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Clin Infect Dis. 2020;pii:ciaa237. doi:10.1093/cid/ciaa237
• Paton NI, Lee L, Xu Y, et al. Chloroquine for influenza prevention: a randomised, double-blind, placebo controlled trial. Lancet Infect Dis. 2011;11(9):677-68 doi:10.1016/S1473-3099(11)70065-2
• Gautret P, Lagier JC, Parola P, et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020:105949. doi:10.1016/j.ijantimicag.2020.105949.