Dear Mr. St. Clair:

Please accept this letter on behalf of PharmScript, LLC as comments on the proposed rulemaking to exempt automated dispensing devices stocked solely with emergency or stat-use medications from certain requirements of 18VAC110-20-555. PharmScript supports the rulemaking because it will eliminate a hurdle to speedy patient care and ultimately lower risk of patient harm.

PharmScript is one of several long-term care pharmacy services companies who provide remote pharmacy services such as distributing and dispensing emergency and stat-use pre-packaged drugs via automated dispensing devices (ADDs) to nursing homes in Virginia. 

18VAC110-20-555 presents an issue that is unique to our operation in Virginia, and that is the required extra-step pharmacist authorization (PV1 order verification) of stat-drugs being dispensed from an ADD.  Requiring the pharmacist to review and electronically authorize each stat-drug prior to administration is a time-consuming and unnecessary task during a critical period in patient care when the patient needs medication.

PharmScript operates in twenty-three states and the District of Columbia, and Virginia is the only jurisdiction that requires this authorization prior to administration. Other states, including neighbors DC, Maryland, Tennessee, and North Carolina, allow for the pharmacist verification of stat drugs (also referred to as “starter drugs” or “emergency drugs”) after administration, usually within 24 hours.

Stat-drugs, synonymous and used as a term interchangeable with emergency drugs, are drugs that should be administered immediately to avoid or reduce patient harm. Stat-drug boxes contain pre-packaged drugs that are ready for administration. The risk of improper administration by the caregiver accessing the ADD is extremely low to nonexistent as there are many safeguards, including electronic controlled access, already built into the ADD system.

In short, the net effect of this requirement is delayed patient care. Delayed care increases the risk of harm to the patient. The increased risk of harm due to delayed care significantly outweighs any potential risk associated with eliminating the PV1 authorization prior to removing stat drugs from an ADD.

Accordingly, PharmScript strongly supports the proposed rulemaking as it would provide patients faster access to the medication they need while reducing potential risk of harm. Please feel free to contact me if you or any Board member wishes to discuss the operational effect of this regulation further.

Sincerely,

John Camperlengo

Chief Legal Officer, PharmScript LLC