[Federal Register Volume 60, Number 66 (Thursday, April 6, 1995)]
[Notices]
[Pages 17574-17577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-8402]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 93-51]
Frank's Corner Pharmacy; Revocation of Registration
On June 4, 1993, the Deputy Assistant Administrator (then
Director), Office of Diversion Control, Drug Enforcement Administration
(DEA), issued an Order to Show Cause to Frank's Corner Pharmacy
(Respondent), of Detroit, Michigan, proposing to revoke its DEA
Certificate of Registration, BF1175466, and deny any pending
applications for renewal of such registration. The statutory basis for
the Order to Show Cause was that Respondent's continued registration
would be inconsistent with the public interest pursuant to 21 U.S.C.
823(f) and 824(a)(4).
On July 23, 1993, Respondent, through counsel, requested a hearing
on the issues raised in the Order to Show Cause and the matter was
docketed before Administrative Law Judge Paul A. Tenney. Following
prehearing procedures, a hearing was held in Detroit, Michigan on May 3
and 4, 1994. On August 29, 1994, Judge Tenney issued his Findings of
Fact, Conclusions of Law and Recommended Ruling
[[Page 17575]] recommending that Respondent's registration be suspended
for a period not exceeding six months. The Government filed exceptions
to Judge Tenney's opinion on September 19, 1994. Respondent filed its
exceptions to Judge Tenney's opinion and its response to the
Government's exceptions on September 30, 1994, and filed corrections to
those exceptions on October 11, 1994.
On October 14, 1994, the administrative law judge transmitted the
record of these proceedings, including the exceptions, to the Deputy
Administrator. The Deputy Administrator has considered the record in
its entirety and hereby issues his final order pursuant to 21 CFR
1316.67, based upon the findings of fact and conclusions of law as set
forth herein.
The administrative law judge found that, in September 1986, Alvin
Goldstein, R.Ph (Mr. Goldstein), a pharmacist licensed by the State of
Michigan, became a 50% stockholder owner of Respondent, a pharmacy
licensed and operated in the State of Michigan. From September 1987
onward, Respondent's principal stockholder and operator has been Mr.
Goldstein.
On October 5, 1989, the Michigan Board of Pharmacy (the Board)
filed an administrative complaint charging Respondent and Mr. Goldstein
with violations of Michigan regulations pertaining to controlled
substance recordkeeping and shortages of controlled substances based
upon an audit conducted by the Board on June 29, 1988. The Board's
initial order was appealed to the Michigan Circuit Court for the County
of Oakland where it was affirmed in part, and reversed in part, on
January 14, 1994. The circuit court affirmed the Board's order to the
extent it found that Respondent and Mr. Goldstein: (1) Were responsible
for shortages of controlled substances (including Darvocet, Tylenol
with codeine #4, and Valium); (2) were negligent in the practice of
pharmacy; (3) were incompetent under applicable Michigan State law
based upon a 14% shortage of Darvocet; (4) failed to comply with a
state administrative subpoena by not supplying the state investigators
with records required to be kept pursuant to Michigan law; and (5)
failed to produce drug utilization reports as required under Michigan
law.
The circuit court remanded the case back to the Board which issued
its Amended Final Order on Remand on April 22, 1994. The amended order
suspended Respondent's controlled substances license for a period of
three months. Mr. Goldstein was ordered to pay a $5,000 fine and placed
on probation for one year and Respondent pharmacy also was placed on
probation for one year.
On February 28, 1991, DEA conducted an audit of four controlled
substances covering the period June 6, 1990 through February 28, 1991,
following reports of excessive purchases of controlled substances by
Respondent from local drug distributors. The audit revealed a shortage
of 1,870 dosage units of Valium 10 milligram tablets.
Respondent's computer dispensing records for the period covering
February 2, 1990 through February 7, 1991, revealed that 78 entries
lacked corresponding paper prescriptions which should have been
retained by Respondent. Mr. Goldstein subsequently found, and produced
at the hearing, a number of prescriptions which he maintained had been
accidentally placed at his home with other prescriptions for non-
controlled substances. Judge Tenney found that Mr. Goldstein was
responsible for the unaccounted prescriptions.
In addition, the investigation revealed that Respondent dispensed a
combination of glutethimide (brand name ``Doriden'') and Tylenol #4, a
combination known to have a high abuse potential and which typically is
not prescribed for a legitimate medical purpose. Mr. Goldstein
testified that he did not agree with manufacturers' guidelines with
respect to glutethimide because new studies may refute those
guidelines. He also testified that he did not receive any information
from the State of Michigan, the DEA or any other source notifying him
that glutethimide in combination with Tylenol #4 is dangerous or should
not be prescribed in excess of seven dosage units.
Judge Tenney found that Mr. Goldstein knew or should have known of
the dangers of combining the controlled substances and chose to ``shut
his eyes'' while filling prescriptions. He further found that the
prescriptions were not issued in the usual course of professional
treatment.
On several occasions Respondent dispensed two prescriptions of the
same or similar controlled substance to the same individual within days
of dispensing the original prescription. The prescriptions in question
typically were issued by different physicians. In one such example, a
physician issued an individual a prescription for 30 dosage units of
Tylenol #3 on January 24, 1990, which was dispensed by Respondent on
January 25, 1990. On January 29, 1990, a second physician issued a 30
dosage unit prescription for Tylenol #4 to the same individual, which
was dispensed by Respondent on the same date-four days after the
initial prescription was dispensed.
This patter continued approximately every two months through
February 1991, with the individual obtaining two or more prescriptions
for Tylenol #3 and #4, from a combination of four physicians, which
Respondent would subsequently dispense within days of each
prescription. At the hearing on this matter, Mr. Goldstein testified
that he had contacted each of the prescribing physicians who indicated
that, although the individual was a drug addict, Mr. Goldstein should
not be concerned about the prescriptions.
Prescriptins written for two other individuals were filled under
similar circumstances. Respondent received a prescription issued to one
individual for 30 dosage units of Tylenol #3 on June 4, 1990, which was
dispensed the same day. Respondent then dispensed another prescription
for Tylenol #3 written to the same person by a second physician on June
7, 1990. Under the instructions of the first prescription, this
individual should not have finished the prescription for seven days.
Respondent dispensed the second prescription only three days after the
first.
On January 10, 1990, a third individual was issued a prescription
for 30 dosage units of Tylenol #4 with one refill. This prescription
was dispensed by Respondent on January 15, 1990. Two days later,
Respondent dispensed a second prescription for 30 dosage units of
Tylenol #4 to the individual based on the prescription of a different
physician. Throughout 1990, this individual received two prescriptions
for Tylenol # approximately every two months, from two different
physicians. The prescriptions were dispensed by Respondent within days
of each other. One physician informed Mr. Goldstein that this
individual was a codeine addict.
The DEA investigator, who testified at the hearing, placed some
reliance on the number of days set forth in Respondent's computer
records as to the amount of days that should pass prior to refilling
prescriptions. In response, Mr. Goldstein testified that his computer
record of the number of days that should pass prior to refiling a
prescription is an arbitrary number and does not represent the number
of days that should pass before a prescription is refilled. Judge
Tenney, while accepting Mr. Goldstein's explanation of the numbers,
found that the practice of dispensing prescriptions for the same
controlled substances to one patient, from several doctors, over an
excessive [[Page 17576]] period of time to be in violation of 21 CFR
1306.04.
The computer printout of prescriptions from Respondent obtained
through the audit revealed that one individual was dispensed 40 Tylenol
#3 tablets two times on January 17, 1990, based on one prescription. On
April 5, 1990, a ``double entry'' also was noted for a prescription for
Valium to the same person. Mr. Goldstein testified that the individual
required two separate identification numbers for insurance billing
purposes, so that Respondent could bill the insurance carrier for the
cost of the prescription and Medicaid for the co-payment. Mr. Goldstein
offered the same explanation for the ``double dispensing' of Tylenol #3
to another individual on November 26, 1990.
The administrative law judge also found persuasive evidence of
other recordkeeping and dispensing violations, including dispensing a
prescription without a DEA registration number on the prescription;
dispensing three refills of Tylenol #3 to an individual without
authorization from the prescribing physician; and dispensing a
prescription that was not signed by the issuing physician.
Judge Tenney noted several possible mitigating factors. First,
Respondent is located in a low social economic area where many patients
are Medicaid recipients. Second, Mr. Goldstein's contentions that he
was not informed that glutethimide had been reclassified from a
Schedule III to a Schedule II controlled substance, nor was he put on
notice as to any potential danger concerning glutethimide. Third, Mr.
Goldstein testified, as evidence toward his care in dispensing
controlled substances, that he would confiscate prescriptions that he
felt were not legitimate.
In determining whether Respondent's continued registration by DEA
would be inconsistent with public interest, as that term is used under
21 U.S.C. 823 and 824, the Deputy Administrator considers the following
factors set forth in 21 U.S.C. 823(f):
(1) The recommendation of the appropriate State licensing board or
professional disciplinary authority;
(2) The applicant's experience in dispensing or conducting research
with respect to controlled substances;
(3) The applicant's conviction record under Federal or State laws
relating to the manufacture, distribution, or dispensing, of controlled
substances;
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances; and
(5) Such other conduct which may threaten public health and safety.
The Deputy Administrator is not required to make findings with
respect to each of the above enumerated factors, but, instead, has the
discretion to give each factor the weight he deems appropriate,
depending on the facts and circumstances of each case. See, Henry J.
Schwartz, Jr., M.D., 54 16422 (1989).
The administrative law judge found that the Government had met its
burden of proof with respect to factors (1), (2), (4), and (5) as set
forth under 21 U.S.C. 823(f). Factor (1) was met based upon the
Michigan Board of Pharmacy proceedings taken against Respondent and Mr.
Goldstein. The ultimate findings established significant shortages for
several controlled substances pursuant to an audit completed in 1989,
and also encompassed other recordkeeping violations.
Judge Tenney found that the DEA had met its burden of proof with
respect to Factor (2) based upon indications from Respondent's records
that Respondent had dispensed unauthorized prescriptions as reflected
in the fact that Respondent could not account for 19 paper copies of
prescriptions. Additionally, Respondent, on numerous occasions,
dispensed a prescription refill before the prior prescription could
have been completely consumed by the patient, as determined by the
prescribing physician's directions or based on the estimates Respondent
had placed in its dispensing records, and that on many occasions the
original and the refills were issued by different physicians. Judge
Tenney noted that a pharmacy may be found in violation of the public
interest where the pharmacy dispensed controlled substances before the
prior expiration period had expired and based upon evidence that the
pharmacy had accepted many prescriptions from various physicians for
the same substance and patient. See Ralph J. Bertolino's Pharmacy, 55
FR 4729 (1990). Additionally, where Respondent knowingly dispensed
these refills to individuals who were characterized by their physicians
as ``addicts'', Respondent's actions pose a threat to public health and
safety.
The administrative law judge found factor (4) was met by evidence
that Respondent dispensed a prescription without a physician's
signature and dispensed another prescription without a DEA registration
number in violation of 21 CFR 1306.04(a). Further, the shortages in
Respondent's controlled substance inventory, as revealed by the DEA
audit, constitute a violation of 21 U.S.C. 842(a)(5).
Finally, concerning factor (5), and with regard to Mr. Goldstein's
testimony that the glutethimide and Tylenol prescriptions were
``legal'' and therefore he was not concerned about dispensing
combinations of these drugs, Judge Tenney found that a pharmacy has a
responsibility, with respect to controlled substances, to do more than
merely fill prescriptions as written by a physician. A pharmacy is
obligated to refuse to fill a prescription if it knows, or has reason
to know that the prescription was not written for a legitimate medical
purpose. Medic-Aid Pharmacy, 55 FR 30043 (1989). Indications that a
prescription is not for legitimate medical use include filling
prescriptions for customers who received controlled substances in
quantities far exceeding those recommended by the Physician's Desk
Reference, too frequently and for excessive periods of time. Id.
Verification of the prescription with the prescribing doctor is not
necessarily enough. See United States v. Hayes, 595 F. 2d 258, 260 (5th
Cir. 1989). Judge Tenney found that Mr. Goldstein purposely ignored
suspicious prescribing practices by dispensing prescriptions clearly
not issued for a legitimate medical purpose by presuming that the
prescriptions were legal because the physicians' signatures did not
appear to be forged.
Judge Tenney recommended that Respondent's registration be
suspended for a period not to exceed six months. He based this
recommendation on the fact that the Michigan Board of Pharmacy
previously had suspended Respondent's license for three months and had
placed Mr. Goldstein on probation for a year and ordered payment of a
fine of $5,000, and, therefore, had exacted ``full and fair
retribution'' for Respondent's actions. Charles A. Buscema, M.D., 59 FR
42857 (1994).
The Deputy Administrator has carefully reviewed the entire record
and adopts all of the administrative law judge's findings of fact, with
the exception of the following: (1) Mr. Goldstein's testimony
concerning the arbitrary nature of his computer records pertaining to
the number of days that should pass before a prescription is refilled;
(2) Mr. Goldstein's testimony regarding instances of creating double
computer entries for each dispensed prescription as his method of
accounting for insurance billing purposes. The Deputy Administrator
also concurs with Judge Tenney's conclusion that the Government has met
its burden with respect to public [[Page 17577]] interest factors (1),
(2), (4), and (5) under 21 U.S.C. 823(f).
The Deputy Administrator, concurring with the Government's
exceptions, does not agree with Judge Tenney's finding that
Respondent's location in a low socio-economic area constitutes a
mitigating factor for Respondent's numerous violations of the laws and
regulations relating to controlled substances. The Deputy Administrator
similarly rejects as a mitigating factor, Respondent's plea of good
faith ignorance in that he was not actually informed of the
reclassification of glutethimide from a Schedule III to a Schedule II
controlled substance.
The Deputy Administrator disagrees with, and declines to follow,
Judge Tenney's proposed suspension of Respondent's registration. Judge
Tenney's reliance on Buscema is not applicable to the facts in the
instant case. In Buscema, Judge Tenney found that Respondent's actions
in failing to account for the disposition of Schedule II controlled
substances and his subsequent guilty plea to a felony charge of
falsifying records concerning controlled substances, occurred over a
limited period of time and was motivated by his desire to protect his
wife, an employee of his office and a subsequently rehabilitated drug
addict suspected of diverting the missing drugs for her own use. In
finding that the State of New York had exacted ``full and fair''
retribution and recommending that Dr. Buscema's registration not be
revoked, Judge Tenney found, and the Deputy Administrator concurred,
that Dr. Buscema had served his probationary sentence, had been
discharged from probation two and one-half years early and had accepted
responsibility for his conduct and failures regarding his wife's
chemical dependency.
The Deputy Administrator finds that the leniency exercised in
Buscema should not similarly be extended to Respondent in this
proceeding. Respondent's numerous recordkeeping violations have
resulted in the diversion of large quantities of controlled substances
to a number of individuals, including drug addicts. Further, these
violations were ongoing while previous violations by the State of
Michigan were being appealed, and, therefore, the State of Michigan
cannot be found to have exacted its ``retribution'' against Respondent
for violations which it never had the opportunity to address.
Additionally, as noted in Judge Tenney's thorough Findings of Fact,
even aside from the numerous recordkeeping violations, Respondent also
diverted large amounts of Tylenol with codeine and glutethimide for no
legitimate medical purpose. Finally, contrary to Dr. Buscema's
acceptance of responsibility for his actions, Mr. Goldstein, owner of
Respondent pharmacy, continues to deny any misconduct, including those
State violations upheld on appeal.
The Deputy Administrator finds merit in all of the Government's
exceptions, and further finds that Respondent's ongoing violations of
Federal and State controlled substance rules and regulations strongly
indicate that his continued registration with DEA would not be
consistent with the public interest.
Accordingly, the Deputy Administrator of the Drug Enforcement
Administration, pursuant to the authority vested in him by 21 U.S.C.
823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that DEA
Certificate of Registration, BF1175466, issued to Frank's Corner
Pharmacy, be and it hereby is, revoked, and that any pending
applications for registration be denied.
This order is effective May 8, 1995.
Dated: March 30, 1995.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 95-8402 Filed 4-5-95; 8:45 am]
BILLING CODE 4410-09-M