Circular Letter  Circular Letter: DHCQ 18-6-679 - Controlled Substances in Schedule II-V Approved for Inclusion in Long Term Care Facilities Emergency Kits

Date:	06/15/2018
Organization:	Department of Public Health Bureau of Health Care Safety and Quality Drug Control Program Board of Registration in Pharmacy Bureau of Health Professions Licensure
Referenced Sources:	105 CMR 150.00: Standards for long-term care facilities

This letter is jointly issued by the Bureau of Health Care Safety and Quality, and the Drug Control Program and Board of Registration in Pharmacy, through the Bureau of Health Professions Licensure. Attached to this letter is a copy of the revised list of controlled substances in Schedules II-V that Long-Term Care Facilities (LTCFs) are permitted to store on their premises in a locked Emergency Kit. This letter supersedes Circular Letter DHCQ L06-10-467, issued on October 18, 2006.

This policy change is made in response to the need for flexibility by LTCFs to tailor Emergency Kits to increasingly acute resident populations, especially upon admission, without sacrificing the safety and security of medications from misuse and diversion.

Contents of the Emergency Kit

The attached list was developed pursuant to 105CMR 150.008(E)(1), which states in part:  “The contents of the kit shall be approved by the Department.”

The actual contents of the Emergency Kit are determined by each facility within the framework established by the Department of Public Health (DPH) through this guidance. The framework continues to allow facilities flexibility in choice of Schedule II-V medications, as summarized in the attached list. The list allows a choice of federally controlled analgesic and sedative/ anticonvulsant medication within Schedules II-V up to the maximum number of units allowed per facility, based on licensed bed capacity.

Each LTCF should develop its own “formulary” in conjunction with a single pharmacy provider of its own choosing and develop policies and procedures, including measures for controlled substance accountability and security, subject to review.

LTCFs are not required to have all items or the maximum quantity permitted. The previous list allowed no more than 43 analgesic units and 16 sedative/anticonvulsant units in each facility. The attached revised list bases the allowed maximum number of units for each medication group on the licensed bed capacity of facilities, in a 3:1 ratio of analgesics to sedative/anticonvulsants.

Each unit must be tamper evident/resistant, in an individually packaged, single dose form.

Schedule VI Medications

Facilities that wish to store Schedule VI controlled substances for emergency doses must comply with the requirements related to the procurement, storage, dispensing, administration, recording and disposal of these controlled substances. Further, storage of Schedule VI controlled substances must comply with facility policies and procedures, pursuant to 105 CMR 150.008, and with federal and state laws and regulations, and the use of these controlled substances must be monitored by the LTCF’s Quality Assurance and Assessment Committee.

Automated Dispensing Machines

DPH approves the use of automated dispensing devices by LTCFs in place of the traditional locked boxes for Schedule II-V controlled substances in emergency kits, provided all relevant regulations and guidance requirements are met.

Resources

The LTCF’s emergency kit practices, policies and procedures may be reviewed at any time by BHCSQ or DCP staff.

Questions or concerns regarding this Circular Letter should be directed to The Drug Control Program: [e-mail]

The Division of Health Care Facilities Licensure and Certification: [e-mail].

Revised List of Controlled Substances in Schedule II-V Approved for Inclusion in Long-Term Care Facility Emergency Kits

	<50 beds	51-100 beds	101-150 beds	>150 beds
Analgesics (CII-CV) Max number of units per facility	45	60	75	90
Sedatives/Anticonvulsants (CII-CV) Max number of units per facility	15	20	25	30