Federal Register / Vol. 66, No. 80 / Wednesday, April 25, 2001 / Notices 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:

• 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.

• Hospital/clinic—The LTCF

maintains institutional stocks of

controlled substances for dispensing/

administering to residents pursuant to

medication orders.

• Mid-Level Practitioner-Controlled

substance activities are limited to those

authorized by the individual state.

• 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.

• 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.

• 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

20834 Federal Register / Vol. 66, No. 80 / Wednesday, April 25, 2001 / Notices

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:

• Issuing DEA registrations to the

provider pharmacy at the LTCF as an

extension of the current DEA

registration;

• Locating pharmacy stock in the

automated dispensing units at the LTCF;

and

• 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 patientspecific 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 redispensed. 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

Federal Register / Vol. 66, No. 80 / Wednesday, April 25, 2001 / Notices 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

DEPARTMENT OF JUSTICE

Immigration and Naturalization Service

Agency Information Collection

Activities: Comment Request

ACTION: Notice of information collection

under review; screening requirements of

carriers.

The Department of Justice,

Immigration and Naturalization Service

has submitted the following information

collection request for review and

clearance in accordance with the

Paperwork Reduction Act of 1995. The

proposed information collection is

published to obtain comments from the

public and affected agencies. Comments

are encouraged and will be accepted for

sixty days until June 25, 2001.

Written comments and suggestions

from the public and affected agencies

concerning the proposed collection of

information should address one or more

of the following four points:

(1) Evaluate whether the proposed

collection of information is necessary

for the proper performance of the

functions of the agency, including

whether the information will have

practical utility;

(2) Evaluate the accuracy of the

agencies estimate of the burden of the

proposed collection of information,

including the validity of the

methodology and assumptions used;

(3) Enhance the quality, utility, and

clarity of the information to be

collected; and

(4) Minimize the burden of the

collection of information on those who

are to respond, including through the

use of appropriate automated,

electronic, mechanical, or other

technological collection techniques or

other forms of information technology,

e.g., permitting electronic submission of

responses.

Overview of this information

collection:

(1) Type of Information Collection:

Extension of a currently approved

collection.

(2) Title of the Form/Collection:

Screening Requirements of Carriers.

(3) Agency form number, if any, and

the applicable component of the

Department of Justice sponsoring the

collection: No Agency Form Number

(File No. OMB–16). Inspections

Division, Immigration and

Naturalization Service.

(4) Affected public who will be asked

or required to respond, as well as a brief

abstract: Primary: Business or other forprofit. This information is used by the

Immigration and Naturalization Service

to determine whether sufficient steps

are taken by a carrier demonstrating

improvement in the screening of its

passengers in order for the carrier to be

eligible for automatic fines mitigation.

(5) An estimate of the total number of

respondents and the amount of time

estimated for an average respondent to

respond: 65 responses at 100 hours per

response.

(6) An estimate of the total public

burden (in hours) associated with the

collection: 6,500 annual burden hours.

If you have additional comments,

suggestions, or need a copy of the

proposed information collection

instrument with instructions, or

additional information, please contact

Richard A. Sloan 202–514–3291,

Director, Policy Directives and

Instructions Branch, Immigration and

Naturalization Service, U.S. Department

of Justice, Room 4034, 425 I Street, NW.,

Washington, DC 20536. Additionally,

comments and/or suggestions regarding

the item(s) contained in this notice,

especially regarding the estimated

public burden and associated response

time may also be directed to Mr.

Richard A. Sloan.

If additional information is required

contact: Mr. Robert B. Briggs, Clearance

Officer, United States Department of

Justice, Information Management and

Security Staff, Justice Management

Division, National Place Building, 1331

Pennsylvania Avenue, NW., Suite 1220,

Washington, DC 20530.

Dated: April 19, 2001.

Richard A. Sloan,

Department Clearance Officer, Immigration

and Naturalization Service, Department of

Justice.

[FR Doc. 01–10167 Filed 4–24–01; 8:45 am]

BILLING CODE 4410–10–M

DEPARTMENT OF LABOR

Employment and Training

Administration

Proposed Collection; Comment

Request

ACTION: Notice.

SUMMARY: The Department of Labor, as

part of its continuing effort to reduce

paperwork and respondent burden

conducts a preclearance consultation

program to provide the general public

and Federal agencies with an

opportunity to comment on proposed

and/or continuing collections of

information in accordance with the

Paperwork Reduction Act of 1995

(PRA95) (44 U.S.C. 3506(c)(2)(A)). This

program helps to ensure that requested

data can be provided in the desired

format, reporting burden (time and

financial resources) is minimized,

collection instruments are clearly

understood, and the impact of collection

requirements on respondents can be

properly assessed. Currently, the

Employment and Training

Administration (ETA) is soliciting

comments concerning the proposed