Circular Letter  DHCQ 20-3-700: Schedule II-VI Controlled Substances Approved for Acute Use in Hospice Inpatient Facilities

Date:	03/06/2020
Organization:	Bureau of Health Care Safety and Quality
Referenced Sources:	105 CMR 141.00: Licensure of hospice programs

TO:

Hospice Care Facility Administrators

FROM:

Bureau of Health Care Safety and Quality
Bureau of Health Professions Licensure

_______________________________________

This letter is jointly issued by the Bureau of Health Care Safety and Quality (BHCSQ) and the Board of Registration in Pharmacy (BORP), through the Bureau of Health Professions Licensure. This policy outlines a process through which an inpatient hospice facility’s pharmacy provider is permitted to safely and securely store certain non-patient specific medications on-site at the hospice facility for patient administration.

Attached to this letter is a list of controlled substances in Schedules II-VI that hospice inpatient facilities, as defined in 105 CMR 141.000, may allow a pharmacy to store on its premises via an Automated Dispensing Device (ADD) for acute use.  For the purposes of this policy, the controlled substances on the attached list are medications intended to treat patient symptoms that are not life threatening, but require use in a timely manner to provide prompt palliative care. The medication supply should only be enough to treat the patient until the pharmacy can fill and deliver the full prescription.

Requirements for ADD Storage and Security

The pharmacy provider must utilize an Automated Dispensing Device (ADD) to store and secure acute use medications as well as obtain a machine-specific Controlled Substance Registration (CSR) from the Board of Registration in Pharmacy. The pharmacy provider must also determine whether a machine-specific DEA number is required.

In addition to continuous monitoring by video, other requirements for ADD use and security are found in Joint Policy 2019-02: Automated Dispensing Device Use:

https://www.mass.gov/lists/pharmacy-practice-resources

Contents and Usage of the ADD for Patient Palliative Care

An ADD sited at an inpatient hospice facility may contain up to, but not more than, the allowed quantity for each category of controlled substance shown in the attached list.   The list allows a choice of federally controlled analgesic and sedative/anticonvulsant medications as well as Schedule VI ancillary medications (i.e. antiemetics, antipsychotics, etc.) up to the maximum number of units allowed per facility, based on licensed bed capacity.

Hospice inpatient facilities are not required to have all the items or the maximum allowable quantity.

Working within the allowed quantity, each hospice inpatient facility should develop its own “formulary” in conjunction with the pharmacy providing the onsite ADD  and develop policies and procedures, including measures for controlled substance accountability and security, subject to review.

The contents of the ADD, until dispensed for administration pursuant to a prescriber’s prescription or order, remain the property of the pharmacy. Medications dispensed through the ADD must be reconciled by the pharmacy with prescriptions.

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

Resources

The hospice inpatient facility’s practices, policies, and procedures for acute use medications may be reviewed at any time by BHCSQ or BORP staff.

Questions or concerns regarding this Circular Letter should be directed to:

• Board of Registration in Pharmacy:  [e-mail]
• Bureau of Health Care Safety and Quality:  [e-mail]

List of Controlled Substances in Schedule II-VI Approved for Inclusion in Hospice Care Acute Use Medications

	<10 beds	11-20 beds	>21 beds
Analgesics (CII-CV) Max number of units per facility	50	100	150
Sedatives/Anticonvulsants  (CII-CV) Max number of units per facility	30	60	90
Ancillary Medications (CVI) Max number of units per facility	25	50	75