[Federal Register Volume 66, Number 80 (Wednesday, April 25, 2001)]
[Notices]
[Pages 20833-20835]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10256]



[[Page 20833]]

-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA-215N]


Preventing the Accumulation of Surplus Controlled Substances at 
Long Term Care Facilities

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice; solicitation of information.

-----------------------------------------------------------------------

SUMMARY: DEA is soliciting information from the affected industry, 
Medicare/Medicaid agencies, insurance providers, state regulatory 
agencies and other interested parties regarding preventing accumulation 
of controlled substances at long term care facilities (LTCFs). Because 
of current prescription reimbursement practices by Medicaid and 
Medicare, excess controlled substances often accumulate at LTCFs as 
patient medication requirements change. DEA is soliciting comments on 
proposed alternative solutions, as well as seeking other alternatives 
to prevent the accumulation of excess controlled substances at LTCFs.

DATES: Written comments must be submitted on or before June 25, 2001.

ADDRESSES: Comments should be submitted in triplicate to the Deputy 
Assistant Administrator, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537, Attention: Federal Register 
Representative/CCR.

FOR FURTHER INFORMATION CONTACT: Patricia M. Good, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537, Telephone (202) 307-7297.

SUPPLEMENTARY INFORMATION:

What Is the Purpose of This Notice?

    The disposal of excess controlled substances that accumulate at 
LTCFs is a continuing problem. DEA has frequently been asked to assist 
in resolving the matter. The principal concern is to suggest a means to 
prevent the accumulation of controlled substances that are dispensed 
but not administered to the patient. The current delivery system 
requires use of prescriptions written for a specific patient that may 
only be filled by a pharmacist rather than maintenance of stock at the 
LTCF for dispensing on an as-needed basis pursuant to a practitioner's 
order. This is because most LTCFs are not DEA registrants. Therefore, 
they may not order and maintain institutional stocks of controlled 
substances for general dispensing pursuant to practitioner medication 
orders. Instead, the practitioners must issue prescriptions that are 
dispensed to the specific patients by a provider pharmacy and held by 
the LTCF in a custodial manner for administration to the patient. Any 
medications that are not administered are waste that must be disposed 
of. The purpose of this notice is to solicit comments from state 
regulatory agencies, affected industries, Medicare/Medicaid, insurance 
providers, and other interested parties to be used in resolving this 
problem.

What Has DEA Done To Address This Issue?

    DEA addressed this circumstance through the establishment of 
partial dispensing provisions for Schedule II-V prescriptions 
(including unit-dose dispensing, if desired), to limit the number of 
controlled substances dispensed at one time and avoid waste if the 
treatment was changed or discontinued. According to the pharmacy 
industry, however, dispensing fees, reimbursement practices, and 
difficulties in educating practitioners regarding the need to prescribe 
controlled substances in anticipation of a patient's actual need for 
the controlled substance have effectively precluded using that 
approach.

What Do Current DEA Regulations Permit?

    Although most LTCFs are not presently registered with DEA, DEA 
regulations currently allow a LTCF to register with DEA, if licensed by 
its state to handle controlled substances. DEA issues a registration in 
one of the following categories based upon the type of license/permit 
issued by a state and the authorized activities associated with the 
license/permit:
    <bullet> Retail pharmacy-A pharmacy located on-site at the LTCF 
maintains stocks of controlled substances and a pharmacist dispenses 
patient specific controlled substances to residents of the LTCF 
pursuant to prescriptions.
    <bullet> Hospital/clinic--The LTCF maintains institutional stocks 
of controlled substances for dispensing/administering to residents 
pursuant to medication orders.
    <bullet> Mid-Level Practitioner-Controlled substance activities are 
limited to those authorized by the individual state.
    <bullet> Practitioner-A practitioner, such as the Medical Director 
of the LTCF, registers at the site of the LTCF and is responsible for 
the handling of controlled substances utilized at the LTCF.

What Two Additional Options Is DEA Considering To Address the 
Continued Problem of Excess Controlled Substances at LTCFs?

    To further address the issue of excess controlled substances in 
LTCFs, DEA is considering two additional options.
    <bullet> Allow a provider pharmacy to register at the site of the 
LTCF and store controlled substances in an automated dispensing system. 
A pharmacist would remotely control access to the controlled substances 
and dispense at the time of administration pursuant to medication 
orders.
    <bullet> Allow a provider pharmacy to register at the site of the 
LTCF and store controlled substances in an automated dispensing system. 
A pharmacist would receive a prescription prior to the medication being 
dispensed to a patient. Medications would be dispensed by LTCF 
personnel as needed pursuant to an existing prescription.

How Would the Use of an Automated Dispensing System Address This 
Circumstance?

    One way to eliminate the accumulation of unneeded medications is to 
alter the process so that drugs are not dispensed until they are to be 
administered. This could be done if the drugs were stored and dispensed 
by a DEA registrant at the LTCF site. Most definitions of ``dispense'' 
under state and federal regulations require or imply that a pharmacist 
orchestrate the dispensing at the request of the licensed (and, in the 
case of controlled substances, DEA-registered) practitioner. The most 
appropriate application of this type of registration would be for the 
provider pharmacy to use an automated dispensing system (ADS), 
programmed by a pharmacist according to specific patient prescription 
orders, that would serve as the LTCF pharmacy. The provider pharmacy 
would purchase the controlled substances from its primary location for 
subsequent transfer to the LTCF system. The controlled substances would 
be stored at the LTCF in the ADS. The pharmacist would ``dispense'' the 
controlled substances from a remote location via the ADS. The 
appropriate staff at the LTCF would then provide the controlled 
substances to the patient. The controlled substances stored in the ADS 
are pharmacy stock, have not been dispensed, and would not become 
waste.
    Generally, residents of LTCFs are visited infrequently by their 
physicians. Consequently, if a nurse determines that

[[Page 20834]]

a patient's medications need to be changed, the nurse contacts the 
physician who authorizes the change. The nurse subsequently calls the 
pharmacist to relay the change in the treatment. DEA is often advised 
that physicians consider contacts from provider pharmacies burdensome 
when they have already communicated the patient's medical needs to 
nursing staff at the LTCF. However, a pharmacist may only fill an order 
issued by a physician and communicated by the physician or the 
physician's agent. Since no legal agency relationship exists between 
the LTCF nurse and the physician, this widely-used system is not in 
compliance with legal requirements. If the pharmacist contacts the 
physician after speaking with the nurse, all requirements will be 
satisfied, and the physician will receive only one communication. 
Although it is common practice for the nurse to communicate a patient's 
needs to the physician, it is suggested the nurse contact the provider 
pharmacy, and the pharmacist then contact the physician. This 
procedural change would assist the pharmacist in fulfilling the 
requirement to communicate with the prescriber prior to filling the 
prescription. If an ADS were located at the LTCF, the nurse could 
telephone the pharmacist, who would communicate with the doctor prior 
to remotely dispensing the new prescription. Schedule III-V controlled 
substances would be treated as oral prescriptions. Orders for Schedule 
II controlled substances would have to be provided to the pharmacist by 
the practitioner in the form of a written, signed prescription or 
facsimile thereof. This requirement will be mitigated by a pending 
electronic prescription process. In order to implement this solution, 
states would need to grant approval for the provider pharmacy to 
function at the location of the LTCF, allow use of an ADS, and certify 
the location to DEA for purposes of controlled substance registration. 
States could define such an operation so as to avoid the many 
peripheral requirements of traditional pharmacies such as sinks, 
reference books, etc. Since the provider pharmacy would likely be 
ordering controlled substances for all of the LTCFs it serviced, 
current regulations (limiting total distribution to 5% of all 
controlled substances dispensed in the course of a year) would be 
amended to provide an exemption to accommodate this activity. 
Utilization of official order forms (DEA Form-222) for transfer of 
Schedule II controlled substances would remain necessary due to federal 
statutory requirements. The future implementation of electronic 
transmission of order forms would make this transfer easier. Transfers 
of stock for Schedules III-V controlled substances to the LTCF would 
have to be documented. Parameters for secure storage of the controlled 
substances in the absence of a registered pharmacist would also need to 
be defined. Most can be addressed through security measures of the ADS. 
When preparing comments, please include the feasibility of applying 
these parameters in the absence of an ADS.

Why Is DEA in Favor of This Option?

    DEA recommends allowing for the use of an automated dispensing 
system located at the LTCF. Sufficient flexibility exists to 
accommodate such a system within the existing law and regulations. The 
key elements of an automated dispensing system would be:
    <bullet> Issuing DEA registrations to the provider pharmacy at the 
LTCF as an extension of the current DEA registration;
    <bullet> Locating pharmacy stock in the automated dispensing units 
at the LTCF; and
    <bullet> Establishing the appropriate protocols with respect to 
access to pharmacy stock by LTCF nursing personnel, secure storage of 
the controlled substances, transfer of the controlled substances from 
the primary pharmacy location to the LTCF site, etc.

How Would Registration of LTCFs Address the Waste and Disposal 
Issues?

    Another possible solution to the accumulation of waste controlled 
substances at LTCFs is to register LTCFs with DEA as institutional 
practitioners. Registration would address the waste issue, as well as 
ancillary issues that have been raised regarding the problems 
associated with prescriptions as opposed to medical orders. As DEA 
registrants, the LTCFs could order and maintain institutional stocks of 
controlled substances that could be administered to patients pursuant 
to medical orders issued by the practitioners. Unlike the present 
system that relies on prescriptions and patient-specific stock (which 
becomes excess if not administered), any unadministered medications 
would remain institutional stock and be available for administration to 
other patients.
    The use of institutional registrations would allow medications to 
be dispensed pursuant to medication orders rather than prescriptions. 
With prescriptions, the medications are dispensed when they are 
delivered by the pharmacy to the LTCF for the patient. The LTCF must 
maintain the drugs as patient-specific stock and any portion that is 
not used cannot be re-dispensed. With medication orders, the drugs are 
not dispensed until they are administered to the patient. Any unused 
drugs remain institutional stock and are available for dispensing to 
other patients. The institutional practitioner would be able to dispose 
of any remaining waste as a registrant. It is conceivable that the use 
of the automated dispensing system, as described previously, would 
suffice in this instance as well.

Why Does DEA Believe the Institutional Practitioner Alternative Is 
Less Likely To Succeed?

    DEA believes this option is less likely to succeed and raises a 
number of problematic issues. If a LTCF is registered as an 
institutional practitioner, it may need staff pharmacists to dispense 
medications. In reality, this option tries to compare a LTCF to a 
hospital--and most hospitals have pharmacists dispense medications. 
Hospitals operate as one entity with the doctors and pharmacists all 
working, either as staff members or through contract, for the liable 
party. In a LTCF, the doctors and pharmacists have no responsibility to 
the facility or each other, and necessary communication and legal 
responsibilities are more difficult to define.

Will Medication Delivery Systems Currently Utilized by LTCFs Still 
Be Allowed?

    Yes. DEA is not suggesting that unit dose delivery systems or other 
medication delivery systems currently utilized by most LTCFs be 
replaced. DEA recognizes that the cost of an automated dispensing 
system as well as other requirements associated with its use at a LTCF 
may not be warranted by every provider pharmacy. Therefore, the 
utilization of an automated dispensing system for storage and 
dispensing of controlled substances to residents of LTCFs would be an 
option available to the provider pharmacy. Any changes to the 
regulations DEA proposes based upon this solicitation for comment would 
be in addition to, not a replacement of, the existing regulations, and 
would be subject to notice and comment.

What Information Is DEA Soliciting?

    DEA has identified possible approaches to prevent the accumulation 
of controlled substances at LTCFs. However, any solution to this 
problem must fit within state as well as federal regulations. The 
alternatives suggested in this notice are not meant to exclude

[[Page 20835]]

any other possible solutions to this problem. Therefore, DEA is 
soliciting comments from the affected industries, Medicare/Medicaid 
agencies, insurance providers, state regulatory agencies, and other 
interested parties regarding the feasibility of these options, 
alternative options, and suggestions to resolve the problem of excess 
controlled substances at LTCFs. DEA is requesting comments in support 
of allowing controlled substances to be stored at the LTCF and 
dispensed at the time of administration utilizing an automated 
dispensing system as well as comments in opposition to this proposed 
allowance. DEA is specifically seeking information on the following:
    1. Do state regulations currently allow for nonpatient-specific 
medications to be stored and dispensed at a LTCF other than in 
emergency kits?
    2. Do state regulations currently allow, or are states considering 
allowing, the use of automated dispensing systems at LTCFs? If states 
allow the use of automated dispensing systems at LTCFs, who is 
responsible and accountable for the controlled substances stored in 
those systems?
    3. In states that currently allow the use of an automated 
dispensing system at the LTCF, please comment on any problems 
associated with utilization of an automated dispensing system for 
controlled substances and provide any data regarding the amount of 
excess generated and/or diversion of controlled substances.
    4. What are the roles of dispensing pharmacists and consultant 
pharmacists in LTCFs?
    Please submit written comments no later than June 25, 2001 to 
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration, Washington, D.C. 20537, Attention: Federal 
Register Representative/CCR.

    Dated: April 12, 2001.
Laura M. Nagel,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 01-10256 Filed 4-24-01; 8:45 am]
BILLING CODE 4410-09-U