COVID: West Virginia Board of Pharmacy Issues Emergency Rule Limiting Prescriptions for Chloroquine and Hydroxychloroquine

West Virginia Board of Pharmacy Issues Emergency Rule Limiting Prescriptions for Chloroquine and Hydroxychloroquine 

Written by Luke Schmitt, Flaherty Sensabaugh Bonasso PLLC

On March 21, 2020, the West Virginia Board of Pharmacy proposed an emergency rule pursuant to its general rulemaking authority seeking to ensure that chloroquine and hydroxychloroquine – two drugs thought to be potentially helpful in the treatment of COVID-19 – are only dispensed to individuals currently in need of these drugs. The emergency rule, Section 15-1-26.1, provides:

26.1 No prescription for chloroquine or hydroxychloroquine may be dispensed except if all the following apply:

26.1.a. The prescription bears a written diagnosis from the prescriber consistent with the evidence for its use;

26.1.b. The prescription is limited to no more than thirty (30) tablets, unless the patient was previously established on the    medication prior to the effective date of this rule; and

26.1.c. No refills may be permitted unless a new prescription is furnished. This requirement does not apply to the patient previously established on the medication prior to the effective date of this rule.

This rule has been approved by the West Virginia Secretary of State and is now in effect.

Both nationally and in West Virginia, some prescribers have begun writing prescriptions for these drugs for family, friends, and coworkers in anticipation of the further spread of COVID-19. This rule limits the ability for persons to obtain prescriptions for these medications by requiring that all new prescriptions for these medications contain a written diagnosis from the prescribing health care provider that is consistent with the medication’s use, limiting the supply to 30 days, and prohibiting refills on prescriptions for these medications.

Today, March 23, 2020, the West Virginia Board of Medicine indicated in its notification "Emergency Rule Regarding Chloroquine and Hydroxychloriquine" that licensees should conform their prescribing practices to align with this emergency rule.

West Virginia E-Prescribing Regulations

On January 4, 2008, the West Virginia Board of Pharmacy filed a Notice of Emergency Rule amending CSR 15-1, Licensure and Practice of Pharmacy, implementing the requirements of SB 1001 (See SB 69 and HB 2289) passed during the 2007 Legislative Session permitting electronic prescribing (e-prescribing) of legend drugs in West Virginia, including through the use of electronic data intermediaries.

The Board also filed on January 4, 2008, the Notice of a Comment Period on a Proposed Rule amending CSR 15-1, Licensure and Practice of Pharmacy. Comments on the Proposed Rule must be submitted before February 8, 2008.

The summary and statement of circumstances included in the notice reads:

SB 1001, passed during the First Special Session, 2007, and duly enacted into law, permits electronic prescribing (e-prescribing) of legend drugs in this State, including through the use of electronic data intermediaries as defined therein. SB 1001 contains the following directive to the West Virginia Board of Pharmacy as set forth in West Virginia Code Section 30-5-12C(d): "The board shall promulgate emergency rules pursuant to the provisions of article three, chapter twenty-nine-a of this code to implement and enforce the provisions of this section." E-prescribing is already being done by prescribers around the state, with the amount and frequency of electronic prescriptions being received by pharmacies increasing each day as the technology becomes more accepted and available in the industry. While the current rules allowed for electronic transmission of prescriptions, SB 1001 states that e-prescribing may not be done in this State until emergency rules are promulgated, and further sets additional parameters defining this growing area. As such, the e-prescribing currently being done in this State is being done without appropriate legislative rules in place to protect the integrity, privacy, security and confidentiality of the prescription orders. In addition, prescription drug diversion is an ongoing problem in this State and nation; e-prescribing done correctly is one method to combat the problem often perpetrated through passing fraudulent written prescriptions. Finally, e-prescribing aids in the accuracy of prescriptions by more timely presenting them electronically from the prescriber's office to the pharmacy in a clearly legible format, thus reducing fill-errors and facilitating patient compliance with the prescribed treatment.

Given these factors, the Legislature, through its deliberative process, has determined that an emergency exists requiring the need for emergency rules to govern the use of e-prescribing and electronic data intermediaries in this State for patients to access prescription medications in a safe and efficient manner. Therefore, in accordance with that directive, the purpose of this emergency rule is to revise existing rules governing issuance of prescription orders to set specific standards to govern e-prescribing in West Virginia, thereby protecting the public health, safety, and welfare with regard to restricted drugs which may only be obtained by patients with a proper prescription.