Alerts

FDA and State Boards of Pharmacy React to Coronavirus – March 23 Update

Alerts / March 23, 2020

Hand sanitizer, critical infrastructure, drug shortages and Emergency Use Authorizations (EUAs) are the FDA updates on COVID-19 over the weekend. State Boards of Pharmacy also continue to stay busy issuing guidance and policy. The potential treatment of COVID-19 with chloroquine or hydroxychloroquine received attention at both the federal and state levels.

FDA Actions

As we previously mentioned, Attorney General Barr sent a memo to all U.S. attorneys directing them to “prioritize the detection, investigation, and prosecution of all criminal conduct related to the current pandemic.” Now, the FDA has alerted consumers that the FDA has not authorized any test that is available to purchase for testing yourself for COVID-19 at home. This alert is in response to the FDA becoming aware of unauthorized fraudulent test kits that are being marketed to test for COVID-19 in the home. FDA has set up an email hotline to report fraudulent test kits for COVID-19. This shows that FDA is committed to aggressively pursuing firms that do not seek approval or an EUA for their COVID-19 products.

FDA issued the first EUA for a point of care diagnostic. The manufacturer plans to introduce the product by Mar. 30. Typically, specimens are collected and sent to a laboratory for testing. With point-of-care testing, specimens can be tested inpatient care settings, like hospitals, urgent care centers and emergency rooms, instead of samples being sent to a laboratory. The FDA previously issued an EUA to the same manufacturer for a COVID-19 diagnostic test for use in high- and moderate-complexity clinical laboratory improvement amendment -certified laboratories as well as in certain patient care settings.

In another attempt to encourage social distancing, FDA issued a new policy that allows manufacturers of certain FDA-cleared noninvasive, vital sign-measuring devices to expand their use so that healthcare providers can use them to monitor patients remotely. FDA Principal Deputy Commissioner Amy Abernethy remarked, “Allowing these devices to be used remotely can help health care providers access information about a patient’s vital signs while the patient is at home, reducing the need for hospital visits and minimizing the risk of exposure to coronavirus.” The policy itself is limited to the duration of the COVID-19 public health emergency. Under the policy, FDA will allow several modifications to FDA-cleared devices subject to the policy, such as the inclusion of monitoring statements related to patients with COVID-19 or co-existing conditions (such as hypertension or heart failure); a change to the indications or claims regarding use in the home setting for certain devices previously cleared only for use in hospitals or other healthcare facilities; and hardware or software changes to allow for increased remote monitoring capability.

FDA sent a letter to healthcare providers referring specifically to potential shortages relating to surgeons’ gloves and patient examination gloves. In the letter, FDA offers conservation strategies for medical gloves.

Updating its previous guidance on the compounding of hand sanitizers by pharmacies and outsourcing facilities, FDA clarified in updated guidance that compounders may compound hand sanitizer for healthcare personnel use subject to the temporary guidance and labeled accordingly. FDA also issued new temporary guidance for the temporary preparation of certain alcohol-based hand sanitizer products by firms that register as over-the-counter (OTC) drug manufacturers to prepare alcohol-based hand sanitizers. The acting administrator of the Alcohol and Tobacco Tax and Trade Bureau also issued guidance on hand sanitizers; it is waiving provisions of internal revenue law with regard to distilled spirits, and therefore is providing certain exemptions and authorizations to distilled spirits permittees that wish to produce ethanol-based hand sanitizers to address the demand for such products during this emergency. The two FDA guidance’s differ in the type of ingredients that may be used, which will surely cause confusion in the industry. We expect additional updated guidance in the future.

FDA posted the Memorandum on Identification of Essential Critical Infrastructure Workers During COVID-19 Response developed by the Department of Homeland Security’s Cybersecurity & Infrastructure Agency, which lists critical infrastructure workers and is to be used by local governments in identifying critical infrastructure as more state and local governments issue restrictions on movement. The list includes FDA-regulated industries as essential workers in the food, healthcare and public health sectors.

Reports indicate that U.S. hospitals doubled the amount of hydroxychloroquine they bought in the past two weeks compared with what they bought each month in the last year. Hydroxychloroquine is the drug that President Trump suggested could be a promising treatment for COVID-19 based on reports from doctors outside the U.S. Hydroxychloroquine does not yet appear on the FDA drug shortage list, but it does appear on the American Society of Health-System Pharmacists (ASHP) drug shortage list as of Mar. 19. Often the ASHP drug shortage list is more robust than the FDA drug shortage list. If, and more likely when, hydroxychloroquine is placed on the FDA drug shortage list, more opportunities will become available for hospitals and pharmacies to purchase the drug. Once a drug is placed on the FDA drug shortage list, FDA-registered outsourcing facilities may compound the drug from bulk drug substance to increase patient access.

FDA issued guidance on a temporary policy for certain risk evaluation and mitigation strategies (REMS) requirements for the duration of the public health emergency. A REMS may include a medication guide or a patient package insert. Some REMS include elements to assure safe use (ETASU), in which the patient must go to a laboratory or imaging center for testing prior to receiving the drug. For drugs that are subject to REMS with ETASU requiring laboratory testing (e.g., liver enzyme testing) or imaging studies (e.g., magnetic resonance imaging), FDA does not intend to take enforcement action against sponsors or others for accommodations made during the COVID-19 public health emergency. Healthcare providers prescribing or dispensing such drugs may forgo laboratory and imaging studies after weighing the benefits and risks. Manufacturers should document and summarize in their next REMS assessment report steps that were taken to accommodate patient access to these REMS drugs during COVID-19.

Following concern over the number of ventilators available in the U.S., FDA issued guidance to help expand the availability of ventilators as well as other respiratory devices and their accessories during this pandemic. FDA does not intend to object to limited modifications to the indications, claims or functionality, or to the hardware, software or materials, of FDA-cleared devices used to support patients with respiratory failure or respiratory insufficiency, without prior submission of a premarket notification. Manufacturers may make modifications to certain components such as motors or batteries. FDA will also allow the shelf-life and duration of certain breathing circuits to be extended. Labeling should reflect the changes that are not FDA-cleared. Lastly, FDA provided information on submitting EUAs to the agency for ventilatory support devices.

State Boards of Pharmacy

As of Monday morning, six states have issued broad statewide lockdowns: Ohio, New York, California, Illinois, Connecticut and New Jersey.

The State of Ohio Board of Pharmacy has been one of the leaders in issuing guidance and rules for COVID-19. Most recently, following reports that chloroquine and hydroxychloroquine may be viable treatments for COVID-19, Ohio issued an emergency rule for dispensing chloroquine and hydroxychloroquine. This rule follows an uptick in the number of prescriptions being written for chloroquine and hydroxychloroquine. Under the Ohio rule, no prescription for chloroquine or hydroxychloroquine may be dispensed by a pharmacist unless the prescription contains a diagnosis code. If the diagnosis code is for COVID-19, then the prescription is limited to a 14-day supply and no refills. Prescribing chloroquine or hydroxychloroquine for presumptive positive or prophylactic use is prohibited.

The New York State Board of Pharmacy has not issued any specific guidance or policy relating to pharmacy practice during the COVID-19 public health emergency. The New York Department of Health has issued Medicaid pharmacy guidance. Under this guidance, pharmacies that choose to provide delivery to quarantined individuals may confirm receipt of the medications by the member through a phone call, text or email, in lieu of getting a signature. Early refills are also allowed at the provider’s discretion. Pharmacists may override an early fill denial at the point of sale during the declared disaster emergency in the state of New York.

California continues to waive various provisions of pharmacy law including staffing ratio, remote processing, signature requirements, emergency room dispensing and personal protective equipment provisions. The ratio of pharmacists to pharmacy technicians may increase to allow for one additional pharmacy technician for each supervising pharmacist under the waiver. Remote processing has been expanded to almost everything except dispensing and final product verification. Remote processing may also include order entry, other data entry, prospective drug utilization review, clinical data interpretation, insurance processing, therapeutic interventions, drug information services and release authorization of medication for administration.

Illinois has not issued any specific guidance for pharmacies or pharmacists during the COVID-19 pandemic.

Pursuant to an executive order, Connecticut pharmacists may refill non-controlled substance prescriptions for up to 30 days in the event they are unable to contact the prescribing practitioner. The executive order also permits the commissioner of the Department of Consumer Protection, rather than the commission of Pharmacy, to grant a waiver or modification of any regulation pertaining to the operation of a pharmacy during COVID-19.

New Jersey has issued guidance for pharmacies and an update. The guidance outlines reuse of compounding personal protective equipment, relaxed requirements for capturing signatures at the point of sale, early refills up to a 90-day supply and waiver requests. Pharmacies may apply to take part in the pharmacy remote processing pilot. Remote processing allows some pharmacists and pharmacy technicians to work remotely rather than be present in the pharmacy, and applications are being reviewed in an expedited manner.

Takeaways

Rapid response in the life sciences and pharmacy sector continues to occur at both the federal and state levels to address the threat of the new coronavirus. We expect to see continued activity in this space and will keep you updated as we become aware of developments.

Authorship credit: Lee Rosebush, Lindsay Holmes and Marc Wagner

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