[Federal Register Volume 60, Number 155 (Friday, August 11, 1995)]
[Notices]
[Pages 41079-41082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19885]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0193]
The Dr. Oscar E. Carter, Jr., Memorial Rehabilitation Center,
Inc.; Proposal to Revoke Approval of a Narcotic Addiction Treatment
Program; Opportunity for a Hearing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to revoke
approval of an ``Application for Approval of Use of Methadone in a
Treatment Program'' (Form FDA-2632) (renamed ``Application for Approval
for Use of Narcotic Drugs in a Treatment Program'') held by The Dr.
Oscar E. Carter, Jr., Memorial Rehabilitation Center, Inc. (Carter).
The grounds for the proposed revocation are that the three most recent
FDA inspections of the program revealed recurring violations of the
Federal narcotic addiction treatment regulations, and the sponsor has
failed to demonstrate adequately the ability or willingness to correct
and prevent the violations. This document is intended to provide the
sponsor an opportunity for a hearing to show why approval should not be
revoked.
DATES: Submit a written request for a hearing by September 11, 1995;
data and information in support of the hearing request by October 10,
1995.
ADDRESSES: A written request for a hearing, supporting data, and other
comments should be identified with Docket No. 95N-0193 and submitted to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Gerald R. Hajarian, Center for Drug
Evaluation and Research (HFD-342), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1029.
SUPPLEMENTARY INFORMATION:
I. Background
On September 12, 1974, FDA granted Carter approval to operate a
narcotic addiction treatment program. Such programs are governed by the
rules, standards, and procedures set forth in Sec. 291.505 (21 CFR
291.505). Since the program received approval, FDA has conducted
inspections to determine the program's compliance with Sec. 291.505.
This notice will document the specific violations revealed in the three
most recent inspections, and the events leading to this proposed
revocation.
FDA's inspection from September 12 through October 17, 1991,
revealed violations of the narcotic addiction treatment regulation in
the areas of urinalyses, attendance schedules, medical orders,
admission evaluations, counseling, treatment plans, and drug
dispensing.
The specific violations were as follows:
1. Failure to maintain drug dispensing records showing batch or
code marks of the methadone dispensed, and failure to retain drug
dispensing records for 3 years from the date of dispensing
(Sec. 291.505(d)(13)(ii));
2. Failure to maintain methadone daily dispensing records in 5 of
20 patient records reviewed (Sec. 291.505(d)(13)(ii));
3. Failure to conduct initial drug screening urinalyses for
opiates,
[[Page 41080]]
cocaine, methadone, amphetamines, and barbiturates in 17 of 20 patient
records reviewed (Sec. 291.505(d)(2)(i));
4. Failure of the program to document who conducted the urinalyses
in all 20 patients for which ``Urinalysis Record'' forms showed results
of testing for methadone, opiates/opioids, and other drugs
(Sec. 291.505(d)(2)(i) and (d)(13)(iii));
5. Failure to obtain FDA's approval of a change to an in-house
laboratory for the detection of opiates and cocaine in human urine, and
the failure to test patients for methadone, barbiturates, and
amphetamines (Sec. 291.505(d)(2)(i));
6. Failure to conduct monthly urinalyses on six patients with 6-day
take-home privileges (Sec. 291.505(d)(2)(i));
7. Failure to perform initial serological tests for syphilis and
tuberculin skin tests in 19 of 20 patient records reviewed
(Sec. 291.505(d)(3)(i));
8. Failure to maintain current annual treatment plan evaluations by
the program physician in 11 of 20 patient records reviewed
(Sec. 291.505(d)(3)(v)(C));
9. Failure to record vital signs (temperature, pulse, blood
pressure, and respiratory rate) as part of the admission physical
examination in 14 of 20 patient records reviewed
(Sec. 291.505(d)(3)(i));
10. Failure to ensure that the initial dose of methadone did not
exceed 30 milligrams (mg) in 3 of the 20 patients whose records were
reviewed (Sec. 291.505(d)(6)(i)(A));
11. Failure to review, reevaluate, and alter as necessary treatment
plans at least once each 90 days during the first year of treatment in
4 of the 20 patient records reviewed (Sec. 291.505(d)(3)(v)(A));
12. Failure of the program physician to sign one patient's
medication order change and to record the correct date for another
patient's medication order change (Sec. 291.505(d)(6)(i)(B)); and
13. Failure to comply with the take-home medication requirements
for 2 of the 20 patients whose records were reviewed
(Sec. 291.505(d)(6)(iv));
At the conclusion of the inspection, the FDA investigator presented
a list of observations (Form FDA 483), and discussed the findings with
the sponsor and his staff. Program management attributed the violations
to a lack of good recordkeeping practices and the lack of knowledge of
the regulation.
FDA issued a warning letter on December 6, 1991, listing the
violations. The program sponsor submitted a response on December 14,
1991, listing a number of corrective measures that had been, or would
be, implemented, and pledging that the violations would not recur.
FDA and the Drug Enforcement Administration (DEA) conducted a joint
inspection of the program from July 9 through July 28, 1992. This
inspection revealed recurring violations in the areas of urinalyses,
attendance schedules, medical orders, admission evaluations,
counseling, treatment plans, and drug dispensing.
The specific violations identified in this inspection were as
follows:
1. Failure to conduct monthly urinalyses on 5 patients with 6-day
take-home privileges (Sec. 291.505(d)(2)(i));
2. Failure of the program physician to document his review of
initial drug screening reports in 5 of 10 patient records reviewed
(Sec. 291.505(d)(1)(i)(C), (d)(2), and (d)(4)(ii)(C));
3. Failure to provide counseling to patients whose urinalyses
showed an absence of methadone and/or continued use of drugs of abuse
in 5 of 10 patient records reviewed (Sec. 291.505(d)(3)(v) and
(d)(13)(iii));
4. Failure of the supervisory counselor to countersign treatment
plans in 5 of 10 patient records reviewed (Sec. 291.505(d)(3)(iv)(C));
5. Failure of the program physician to record the rationale for
authorizing take-home medication, and failure to record medication
orders in 4 of 10 patient records reviewed (Sec. 291.505(d)(4)(ii)(D)
and (d)(6)(iv)(A));
6. Failure to perform initial serological tests for syphilis in 3
of 10 patient records reviewed (Sec. 291.505(d)(3)(i));
7. Failure of program physician to ensure that initial serological
tests for syphilis were reviewed in 3 of 10 patient records reviewed
(Sec. 291.505(d)(4)(ii)(C));
8. Failure to perform an initial tuberculin skin test and vital
signs in 1 of 10 patient records reviewed (Sec. 291.505(d)(3)(i)); and
9. Failure to maintain accurate drug dispensing records. For
example, records failed to record dosages for five patients, which were
given to the patients on the 31st of the month (in months with 31
days). Also, records failed to contain batch or code marks of the
methadone dispensed traceable to specific patients
(Sec. 291.505(d)(13)(ii)).
On the basis of recurring violations, FDA issued a ``Proposal To
Revoke Narcotic Treatment Program Approval; Notice of Informal
Conference'' on October 1, 1992, in accordance with Sec. 291.505(h)(2).
The October 1, 1992, notice summarized the violations observed during
the last three inspections and offered the sponsor an opportunity to
appear at an informal conference and explain why the program approval
should not be revoked. The notice also invited the sponsor to submit a
``comprehensive action plan'' for correcting the deficiencies in the
program.
The informal conference was held on January 6, 1993, at FDA's New
Orleans District Office. The sponsor did not submit a comprehensive
written corrective action plan at the conference. The sponsor
indicated, however, that steps had been taken to make necessary
corrections and that he had requested that the State and the Center for
Substance Abuse Treatment (CSAT) provide technical assistance to the
program. FDA's District Office gave the sponsor until February 20,
1993, to submit a written corrective action plan.
In a February 23, 1993, letter to the district office, the sponsor
presented a corrective action plan and timeframes for implementation.
The action plan included: (1) Installing a computerized dispensing
system, (2) hiring additional personnel, and (3) obtaining a commitment
for technical assistance. The sponsor asked FDA for one final
opportunity to implement the recommendations of the technical
assistance group.
FDA held its decision regarding revocation of approval in abeyance
pending completion of the technical assistance from CSAT by June 30,
1993, and pending a reinspection of the program. FDA agreed to give the
program one final opportunity to achieve regulatory compliance.
The most recent inspection of December 13, 1994, through January
24, 1995, revealed recurring violations in the areas of urinalyses,
attendance schedules, medical orders, admission evaluations,
counseling, treatment plans, and drug dispensing.
The specific violations were as follows:
1. Failure to provide the required services for two patients
regarding pregnancy evaluation, prenatal counseling, and treatment
outcome of the patient and offspring (Sec. 291.505(d)(4)(i)(B));
2. Failure to document in the 13 patient records reviewed that the
program physician has considered, at a minimum, the following in
determining whether a patient's frequency of clinic visits for observed
drug ingesting may be reduced: Absence of recent drug abuse; regularity
of clinic attendance; absence of behavioral problems; absence of recent
criminal activity; stability of the patient; length of time in
treatment; assurance that take-home medication can be safely handled by
the patient; and whether the benefits of take-outs outweigh the risks
of diversion (Sec. 291.505(d)(6)(iv)(B));
3. Failure to document that two patients on 6-day, take-home
[[Page 41081]]
medication had monthly drug screening urinalyses for opiates,
methadone, amphetamines, cocaine, barbiturates, and other drugs of
abuse performed by a certified clinical laboratory
(Sec. 291.505(d)(2)(i));
4. Failure to justify medication in excess of a 6-day, take-home
supply given to three patients; failure to require two patients to
complete 3 consecutive years of maintenance treatment at the program
before being permitted to reduce their attendance for observation to
once weekly; and failure to place one patient, who was receiving a 6-
day supply of take-home medication, on probation for 3 months after his
urinalysis was positive for a drug of abuse (Sec. 291.505(d)(4)(ii)(F),
(d)(6)(v)(A)(3), and (d)(6)(v)(B)(2));
5. Failure of the program to have a licensed physician record,
date, and sign in 2 of 13 records reviewed a change in each patient's
dosage schedule (Sec. 291.505(d)(6)(i)(B));
6. Failure to document drug addiction and conduct physical
examinations on two patients and failure to ensure that a transferring
patient received a physical examination and documentation of addiction
prior to administering the initial dose of methadone
(Sec. 291.505(d)(1)(i)(C), (d)(4)(ii)(A), and (d)(4)(ii)(B));
7. Failure to ensure that the initial dose of methadone dispensed
to two patients did not exceed 30 mg (Sec. 291.505(d)(6)(i)(A));
8. Failure of the program physician to document his review of
initial drug screening urinalysis reports with his signature for two
patients; and failure to document the review of random drug-screening
urinalysis reports for five patients (Sec. 291.505(d)(2) and
(d)(4)(ii)(C));
9. Failure of the program's counselors to document that three
patients received counseling regarding drug-screening urinalyses that
showed continued use of illicit drugs or the absence of methadone in
these patients while undergoing methadone treatment
(Sec. 291.505(d)(13)(iii));
10. Failure to obtain a signed ``Consent to Treatment With an
Approved Narcotic Drug'' Form from two patients prior to admission to
the program (Sec. 291.505(d)(1)(ii));
11. Failure to document that five patients received counseling on
HIV disease upon admission or readmission for treatment
(Sec. 291.505(d)(4)(i)(C));
12. Failure of the admitting physician to document his review of
tuberculin skin test reports with his signature in the patient record
for four patients; failure of the program physician to include the
results of initial serological tests for syphilis in the patient
records for nine patients (Sec. 291.505(d)(3)(ii));
13. Failure of the primary counselor and/or the program physician
to countersign treatment plans for eight patients; failure to properly
date treatment plan for one patient; failure to have an initial
treatment plan on file for readmission of one patient; and failure of
the primary counselor or program physician to prepare and review the
periodic treatment plan for one patient within the proper timeframes
(Sec. 291.505(d)(3)(iv) and (d)(3)(v));
14. Failure of the program to maintain drug dispensing records that
permit traceability of drug lot numbers to specific patients on those
days when a change from one lot number to another occurs
(Sec. 291.505(d)(13)(ii));
15. Failure of the program physician to document that he requested
from the physician or hospital to which the program referred two
pregnant patients a summary of the delivery outcome for the patients
and the offspring (Sec. 291.505(d)(1)(iii)(B)(3) and (d)(4)(i)(B)(2));
16. Failure to require that a patient, who had only been admitted
to the program for 1 month, demonstrate adherence to the program's
rules for at least 2 years before allowing the patient to decrease his
personal attendance to twice weekly (Sec. 291.505(d)(6)(v)(A)(2)); and
(17) Failure of the program to account for, and require the return
of, six extra doses of take-home medication dispensed to a patient for
use during out-of-town travel that was subsequently postponed
(Sec. 291.505(d)(13)(ii) and (d)(14)).
At the conclusion of the inspection, the FDA investigator presented
a list of observations (Form FDA 483), and discussed the inspectional
findings with the sponsor and his staff. The program sponsor promised
to respond to the inspectional findings in writing, but has failed to
do so.
II. Conclusion, Findings, and Proposed Action
As discussed above, the three most recent inspections of Carter
conducted by FDA from September 12 through October 17, 1991; July 9
through July 28, 1992; and December 13, 1994, through January 24, 1995,
revealed recurring violations of the Federal narcotic addiction
treatment regulation, which sets forth the standards for use of
narcotic drugs for medical treatment of narcotic addiction. In letters
of December 14, 1991, December 9, 1992, and February 23, 1993, and
during the January 6, 1993, informal conference, the sponsor made
promises to correct the violations. However, as the December 13, 1994,
through January 24, 1995, inspection demonstrated, the sponsor has
failed to abide by all of the narcotic addiction treatment regulations,
has failed to monitor the activities of those employed in the program
adequately, and has generally failed to correct the program's recurring
problems.
Accordingly, as provided by Sec. 291.505(h)(3) and (i), the
Director, Center for Drug Evaluation and Research, proposed revocation
of Carter's program approval to the Associate Commissioner for
Regulatory Affairs. The Associate Commissioner for Regulatory Affairs
has evaluated the available information and finds that the program
sponsor has failed to submit adequate assurances justifying continued
approval of the program.
III. Notice of Opportunity for a Hearing
Notice is hereby given to the sponsor of the Narcotic Treatment
Program listed above, and to all other interested persons, that the
Associate Commissioner for Regulatory Affairs, under authority
delegated to him (21 CFR 5.20) proposes to issue an order under
Sec. 291.505(h)(3) revoking approval of the ``Application for Approval
for Use of Narcotic Drugs in a Treatment Program'' (Form FDA-2632) held
by The Dr. Oscar E. Carter, Jr., Memorial Rehabilitation Center, Inc.,
5500 North Johnson St., New Orleans, LA 70117, on the grounds stated
above. In accordance with part 314 (21 CFR part 314), the sponsor is
hereby given an opportunity for a hearing to show why approval should
not be revoked.
The sponsor who decides to seek a hearing shall file: (1) On or
before September 11, 1995, a written notice of appearance and request
for a hearing, and (2) on or before October 10, 1995, information and
analyses relied on to demonstrate that there is a genuine issue of
material fact to justify a hearing. Any other interested person may
also submit comments on this notice. The procedures and requirements
governing this notice of opportunity for a hearing, a notice of
appearance and request for a hearing, submissions of data, information,
and analyses to justify a hearing, other comments, and the granting or
denial of a hearing are contained in Sec. 314.200.
The failure of the applicant to file a timely written notice of
appearance and request for a hearing, as required by Sec. 314.200,
constitutes an election by that person not to use the opportunity for a
hearing concerning the action proposed, and a waiver of any contentions
concerning the legal status of that
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person's narcotic addiction treatment program.
A request for a hearing may not rest upon mere allegations or
denials, but must present specific facts showing that there is a
genuine and substantial issue of fact that requires a hearing. If it
conclusively appears from the face of the data, information, and
factual analyses in the request for a hearing that there is no genuine
and substantial issue of fact that precludes the revocation of approval
of the application, or when a request for a hearing is not made in the
required format or with the required analyses, the Commissioner of Food
and Drugs will enter summary judgment against the person who requests
the hearing, making findings and conclusions, and denying a hearing.
All submissions pursuant to this notice of opportunity for a
hearing are to be filed in six copies. Except for data and information
prohibited from public disclosure under 42 CFR part 2, the submissions
may be seen in the Dockets Management Branch (address above) between 9
a.m. and 4 p.m., Monday through Friday.
Dated: August 4, 1995.
Gary Dykstra,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. 95-19885 Filed 8-10-95; 8:45 am]
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