RE: Comment on Notice of Intended Regulatory Action (NOIRA) 18VAC110-20

Remedi SeniorCare appreciates the Board of Pharmacy's action on the petition for rulemaking to amend 18VAC110-20-540, 18VAC110-20-550 and  18VAC110-20-555. This amendment to regulation will continue to expand the availability of technological advances in the Long Term Care industry allowing pharmacies to better serve the residents of Long Term Care Facilities within the Commonwealth.

Further, we request the board take the following into consideration when revising the regulations to serve this unique population:

• Currently 18VAC110-20-555 permits the use of Automated Dispensing Devices in Long Term Care Facilities (LTCF), but doe not provide any distinction of the device based on the intended use of Routine or Non-Routine Dispensing.

• 18VAC110-20-540 and 18VAC110-20-550 do not specifically permit the utilization of electronic emergency or STAT drug boxes (collectively referred to as Emergency Boxes by the DEA) in Long Term Care Facilities.

• The DEA’s policy statement 70 FR 24128 on April 9, 1980, which addresses the use of emergency kits in LTCFs, is still effective and permits DEA registered pharmacies providing services to LTCFs to place controlled substances kits in non-federal registered Long Term Care Facilities pursuant to the specified conditions.

• In response to an inquiry from Arnold Clayman, American Society of Consultant Pharmacists, the DEA issued a letter on November 30, 2016 addressing “whether electronic emergency kits at LTCFs require a separate registration.” The DEA response noted the difference between 21 CFR § 1301.27 relating to an “Automated Dispensing System” utilized for routine dispensing in LTCFs. Further the DEA stated “All emergency kits – weather or not they are electronic – remain subject to the 1980 policy statement (and thus need not be separately registered), provided they satisfy the criteria of the 1980 policy statement at all times.”

• 18VAC110-20-555 outlines the requirements for pharmacies providing services to LTCFs differing from the STAT and Emergency Box Regulations as follows:

  • 18VAC110-20-555 (1) requires the drugs placed in an automated drug dispensing system to be under the control of the pharmacy; however, the controlled substance permit requires a nurse at the facility to be the Responsibility Party with a pharmacist at the pharmacy being the Supervising Practitioner.

  • 18VAC110-20-555 (2) requires that nursing homes without an in-house pharmacy be required to obtain a controlled substance permit which is not required under 18VAC110-20-540 and 18VAC110-20-550.

  • 18VAC110-20-555 (3)(a) requires all orders to be reviewed by the pharmacist and the pharmacist to electronically authorize the access of the drug which is not required under 18VAC110-20-540 and 18VAC110-20-550.

  • 18VAC110-20-555 (3)(d) requires an audit of medical records for a sample of doses recorded as administered which is not required under 18VAC110-20-540 and 18VAC110-20-550.

  • 18VAC110-20-555 (9) requires monthly audits to review a sample of facility administration records from each device for possible charting diversion which is not required under 18VAC110-20-540 and 18VAC110-20-550.

Specifically amending and designating the regulations based upon the intended utilization of the device provides the following benefits:

• The Virginia Regulations will align with DEA policy statements and guidance related to the differences of Automated Dispensing Systems and Emergency Boxes.

• The alignment will provide better guidance and understanding to state and federal investigators understanding the intended utilization of the devices and the quantities being removed from such devices.

• Residents of Long Term Care Facilities will be afforded increased access to medications as well as the ability to receive them in a timelier manner.

• Providing electronically tracked access to devices allows the pharmacy to provide greater safeguards from potential diversion or theft.

In closing, Remedi SeniorCare appreciates the Board of Pharmacy for their review of these important differences regarding the proposed revision to regulation. We look forward to improved care for the residents of Long Term Care Facilities within the Commonwealth.

Best Regards,

Dale StClair, PharmD. RPh

General Manager

Remedi SeniorCare