[Federal Register Volume 64, Number 35 (Tuesday, February 23, 1999)]
[Notices]
[Pages 8855-8860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4329]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 96-32]
Pettigrew Rexall Drugs; Revocation of Registration
On April 8, 1996, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Pettigrew Rexall Drugs (Respondent) of
Adamsville, Tennessee, notifying the pharmacy of an opportunity to show
cause as to why DEA should not revoke its DEA Certificate of
Registration, AP0406911, pursuant to 21 U.S.C. 824(a)(4), and deny any
pending applications for registration pursuant to 21 U.S.C. 823(f), for
reason that its continued registration would be inconsistent with the
public interest.
By letter dated May 1, 1996, Respondent, through counsel, filed a
request for a hearing and the matter was docketed by Administrative Law
Judge Mary Ellen Bittner. In the midst of prehearing proceedings,
Respondent filed a Motion to Dismiss arguing that this action is barred
by the statute of limitations, estoppel, laches and the Double Jeopardy
Clause of the Fifth Amendment. In addition, Respondent filed a Motion
in Limine to Exclude Evidence based upon the hearsay nature of some of
the evidence and that the evidence is barred by the statute of
limitations. Judge Bittner denied both of these motions and a hearing
was held in Memphis, Tennessee on March 4 and 5, 1997. At the hearing,
both parties called witnesses to testify and introduced documentary
evidence. After the hearing, both parties submitted proposed findings
of fact, conclusions of law and argument. On July 9, 1998, Judge
Bittner issued her Opinion and Recommended Ruling, Findings of Fact,
Conclusions of Law and Decision, recommending that Respondent's DEA
Certificate of Registration be revoked. On July 28, 1998, Respondent
filed its Exceptions to the Opinion and Recommended Ruling, Findings of
Fact, Conclusions of Law and Decision of the Administrative Law Judge.
Thereafter, Judge Bittner transmitted the record of these proceedings
to the then-Acting Deputy Administrator on August 13, 1998.
The Deputy Administrator has considered the record in its entirety,
and pursuant to 21 CFR 1316.67, hereby issues his final order based
upon findings of fact and conclusions of law as hereinafter set forth.
The Deputy Administrator adopts the findings of fact and conclusions of
law of the Administrative Law Judge and in part adopts the recommended
decision. The Deputy Administrator's adoption is in no manner
diminished by any recitation of facts, issues and conclusions herein,
or of any failure to mention a matter of fact or law.
The Deputy Administrator finds that Respondent is a pharmacy
located in Adamsville, Tennessee and is owned and operated by Jimmy Max
Pettigrew, R.Ph. Respondent has been in operation since 1963.
During an unrelated investigation in 1993, state investigators
examined Respondent's computerized records and noticed that some
individuals appeared to be filling controlled substance prescriptions
over extended periods of time. The investigators compared the
computerized records with Respondent's prescription records and
discovered that essentially all of the suspect prescriptions were oral
rather than written. The investigators then took patient profiles from
Respondent's computerized records to the doctors listed as the
prescribing physicians and asked them to verify that they had
authorized the oral prescriptions. The doctors compared the patient
profiles from Respondent with their patient records and where there
were discrepancies, the investigators obtained affidavits from the
doctors indicating what prescriptions they had a record or recollection
of authorizing.
As a result of the investigation, a Grand Jury for the United
States District Court for the Western District of Tennessee, Eastern
Division returned a 294-count indictment against Mr. Pettigrew on May
16, 1994, and the case was heard before a jury in March 1995. A number
of the counts were dismissed following a defense motion at trial and
the jury acquitted Mr. Pettigrew of the remaining counts.
Based upon a review of Respondent's patient profiles, the
prescriptions found at Respondent, the doctors' affidavits, testimony
of several of the doctors at the criminal proceeding, and Mr.
Pettigrew's testimony at the hearing in this matter, the Deputy
Administrator makes the following findings regarding the 14 customers
whose prescriptions are at issue in this proceeding.
According to Respondent's records, between January 1, 1987 and
September 11, 1991, it dispensed 2,150 dosage units of Tylenol No. 3 to
Patient 1 that were orally prescribed by John N. Jenkins, M.D. In his
affidavit, Dr. Jenkins stated that his patient file indicated
prescriptions issued to Patient 1 during this time period for a total
of 550 dosage units of Tylenol No. 3, which included refills. Thus,
Respondent dispensed approximately 1,600 dosage units of Tylenol No. 3
to Patient 1 pursuant to purported oral prescriptions that were not
documented in her physician's records.
Dr. Jenkins testified in the criminal trial while Respondent's
patient profile indicates that he had authorized 43 dispensings of
Tylenol No. 3 for Patient 1, the patient record only indicates that he
authorized 14 of them. He acknowledge that it was possible that oral
prescriptions were occasionally not recorded in his patient files, but
that it was unlikely that there would be 29 prescriptions for one
patient that he had authorized but not charted. But according to Mr.
Pettigrew, he called Dr. Jenkins on three or four occasions and Dr.
Jenkins gave Mr. Pettigrew permission to dispense Tylenol No. 3 to
Patient 1 without calling for authorization each time, ``as long as
she's taking it within reason.'' Nonetheless, Mr. Pettigrew indicated
that he called Dr. Jenkins' office each and every time for
authorization to dispense to this patient.
Respondent's records indicate that between November 17, 1986 and
September 5, 1991, it dispensed 2,520 dosage units Ativan 1 mg. to
Patient 2 pursuant to oral prescriptions authorizes by John W. Prather,
M.D. In his affidavit, Dr. Pratcher stated, ``It has been my practice
not to telephone prescriptions for Ativan for my patients. Any
prescriptions for Ativan would have to be written by me.'' In addition,
Dr. Prather stated that he had not seen Patient 2 since April 6, 1988.
Patient 2's profile also indicates that on a number of occasions,
Respondent dispensed more than five refills of a prescription and
without one prescription, refilled it
[[Page 8856]]
five times for more than the amount authorized by the original
prescription.
As to Patient 3, Respondent's records indicate that between January
1, 1987 and September 18, 1991, Respondent dispensed 3,830 dosage units
of Tylenol No. 3 pursuant to prescriptions by Dr. Prather. In his
affidavit Dr. Prather stated, ``It has been my practice not to
telephone prescriptions for Tylenol #3 tablets. Prescriptions for
Tylenol #3 are generally written by me.'' Three written prescriptions
by Dr. Prather for Tylenol No. 3 for Patient 3 were found in
Respondent's records accounting for 170 dosage units and leaving a
3,660 dosage unit discrepancy between Respondent's records and Dr.
Prather's affidavit. In addition, there were three prescriptions for
this patient found in Respondent's records which did not indicate any
refills were authorized, but refills were dispensed.
At the criminal trial, Dr. Prather testified that Patient 3 has
been his patient for approximately 8 to 10 years and was also his
neighbor. Dr. Prather testified that if he did telephone in a
prescription for Tylenol No. 3 for Patient 3, ``it would be no
refills.'' However, Dr. Prather also identified a prescription he had
written for Patient 3 for Tylenol No. 3 that his own office records did
not reflect, and conceded that because Patient 3 is a friend and
neighbor, not all of his dealings with her were recorded in his office
records.
Regarding Patient 4, Respondent's records indicate that between
January 1, 1990 and August 29, 1991, Respondent dispensed 1,480 dosage
units of propoxyphene hydrochloride 65 mg. pursuant to oral
prescriptions authorized by James King, M.D. However, Dr. King
indicated in his affidavit that he had not seen Patient 4 since 1989
and that he did not authorize Respondent to fill or refill
prescriptions for propoxyphene hydrochloride during the time period at
issue.
Respondent's records indicate that between January 1, 1984 and
August 22, 1991, Respondent dispensed 1,680 dosage units of Talwin Nx
50 mg. to Patient 5 pursuant to oral prescriptions authorized by Dr.
King. But Dr. King stated in his affidavit that although Patient 5 was
his patient, he has never prescribed any pain medication for her and
specifically did not authorize Respondent to fill or refill any
prescription for Talwin for Patient 5.
As to Patient 6, Respondent's records indicate that between January
1, 1987 and August 28, 1991, Respondent dispensed 4,365 dosage units of
Fiorinal No. 3 pursuant to oral prescriptions authorized by Michael
Brueggeman, M.D. Dr. Brueggeman stated in his affidavit that he has not
seen Patient 6 since November 16, 1984, that he did not authorize
Respondent to dispense her Fiorinal No. 3, and that he had no record of
ever prescribing that medication to her.
At the criminal trial, Dr. Brueggeman testified that he had no
recollection of Patient 6, but that his records showed that he
prescribed her Tylenol No. 3 in 1984 for arm pain. He further testified
that he had no record or recollection of ever authorizing any
prescriptions for Fiorinal No. 3 for Patient 6 between May 16, 1989 and
August 20, 1991. Dr. Brueggeman also testified that generally, when a
patient calls his office for a prescription, his nurse collects the
necessary information, obtains authorization from him, telephones the
pharmacy to order the drug, and then notes the prescription on the
patient chart. He stated however that it is not his policy to renew
medications if he has not seen a patient within one year. Dr.
Brueggeman acknowledged that on occasion, he may be asked to authorize
a prescription over the telephone, and also that there was a slight
possibility that his nurse could have failed to chart a particular
prescription. But Dr. Brueggeman stated that it would be ``very
unlikely'' that the nurse failed to chart all of the prescriptions
attributed to him on Respondent's patient profile for Patient 6.
However during cross-examination, Dr. Brueggeman was shown a written
prescription for Fiorinal No. 3 that he issued to Patient 6 in 1984
that was not reflected in her patient chart.
Regarding Patient 7, Respondent's records indicate that between
January 1, 1987 and September 18, 1991, Respondent dispensed 575 dosage
units of Tylenol No. 3 pursuant to oral prescriptions authorized by
Thomas West, M.D. In his affidavit, Dr. West indicated that although
Patient 7 had been a patient since at least 1979, he had no record of
prescribing Tylenol No. 3 to Patient 7. Dr. West further stated that
although it was possible that he orally prescribed Tylenol No. 3 for
Patient 7, it was his practice to prescribe about 12 dosage units at a
time and he would rarely authorize refills of such a prescription.
At the criminal trial, Dr. West essentially reiterated the
statements in his affidavit. He further testified that Patient 7 was
also a personal friend of his. Dr. West would not go as far as to say
that he did not prescribe the medication in question because he did not
``have a particular recollection of any one event'' and he did not
record every controlled substance he prescribed, but he was adamant
that he would not prescribe refills for Tylenol No. 3 or any other
narcotic.
As to Patient 8, Respondent's patient profile indicates that
between October 1, 1986 and September 12, 1991, Respondent dispensed
280 dosage units of Vicodin pursuant to prescriptions authorized by
Yolanda Tai, M.D. Respondent's records contain one written prescription
that Dr. Tai issued for 40 dosage units of Vicodin with no refills,
dated March 26 but not indicating the year, and four oral prescriptions
purportedly authorized by Dr. Tai. In her affidavit, Dr. Tai stated
that the only time she authorized Respondent to dispense Vicodin to
Patient 8 was by written prescription on March 26, 1991, and that she
was not in town on the dates that Respondent's records indicate that
she authorized the other prescriptions for Patient 8. Thus there is a
240 dosage unit discrepancy between Respondent's records and Dr. Tai's
affidavit.
Dr. Becker testified at the criminal trial that she participated in
Patient 8's care as an intern, and that she wrote him a prescription
for 40 Vicodin with no refills upon his release from the hospital
following surgery. She testified that she did not authorize any of the
prescriptions listed on Respondent's patient profile for Patient 8 and
that she never authorizes prescriptions over the telephone because she
feels that a patient in pain needs to be seen by the doctor. Dr. Becker
did acknowledge that the notes of Patient 8's surgeon in charge
indicated that as of June 3, 1991, Patient 8 was still taking Vicodin
twice a day for pain.
Respondent's records also indicate that between October 1, 1986 and
September 12, 1991, Respondent dispensed 3,300 dosage units of
chlordiazepoxide 25 mg. to Patient 8 pursuant to oral prescriptions
authorized by Joseph Rowland, M.D. However, in his affidavit Dr.
Rowland stated that he last saw Patient 8 in 1974 and that he did not
authorize any of the prescriptions listed in Respondent's records for
Patient 8. At the criminal trial, Dr. Rowland testified consistent with
his affidavit and also stated that he would not prescribe any kind of
medication to a patient that he had not seen in 15 years. He admitted
that he had no independent recollection of a particular prescription
for Patient 8, however he would likely remember a patient if he was
prescribing the amount of medication shown on Respondent's patient
profile for Patient 8.
Respondent's records indicate that between January 1, 1987 and
August 28, 1991, Respondent dispensed 1,170 dosage units of Valium 5
mg. to Patient
[[Page 8857]]
9 pursuant to oral prescriptions authorized by Robert Mandle, M.D. But
in his affidavit, Dr. Mandle stated that although Patient 9 had been
his patient since 1976, he had never prescribed her Valium 5 mg. and
did not authorize Respondent to dispense any Valium to her. At the
criminal trial, Dr. Mandle testified that he had no records of
prescribing Valium to Patient 9 since 1976. During cross-examination,
Dr. Mandle was shown a patient history for Patient 9 written by his
partner Dr. Jenkins in 1986, which indicated that Patient 9 was a
``regular patient of Dr. Mandle'' and that she ``takes thyroid and
Valium.'' In addition, Dr. Mandle was shown a 1986 psychiatric
consultation written by another physician which stated, ``[Patient 9]
is taking Valium, 5 milligrams, as needed but never frequently. This
[is] prescribed by Dr. Mandle.'' However, Dr. Mandle explained at the
trial that when a doctor takes a patient history, he generally obtains
such information from the patient and does not verify its accuracy.
As to Patient 10, Respondent's records indicate that between
January 1, 1987 and October 2, 1991, Respondent dispensed 7,715 dosage
units of Darvocet-N pursuant to oral prescriptions authorized by Harry
Peeler, M.D. Dr. Peeler stated in his affidavit that he last prescribed
Darvocet for Patient 10 on September 24, 1985, and that he did not
authorize any of the Darvocet precriptions listed in Respondent's
records during the time period at issue.
Regarding Patient 11, Respondent's records indicate that between
January 1, 1986 and September 5, 1991, Respondent dispensed 1,020
dosage units of generic phentermine 30 mg. or Fastin pursuant to oral
prescriptions authorized by Dr. Peeler. However, Dr. Peeler stated in
his affidavit that he neither recalled nor had any record of ever
having seen Patient 11 and that he did not authorize Respondent to fill
any prescriptions for Fastin or phentermine 30 mg. for her.
Respondent's records indicate that between January 1, 1987 and
February 5, 1991, it dispensed 570 dosage units of phentermine 30 mg.
to Patient 12 pursuant to oral prescriptions authorized by Dr. Peeler.
Dr. Peeler stated in his affidavit that he had not seen this patient
since April 2, 1985, that he did not authorize Respondent to fill any
prescriptions for phentermine for her, and that it was his practice to
not authorize refills on weight control medications.
Regarding Patient 13, Respondent's records indicate that between
December 19, 1987 and April 12, 1991, Respondent dispensed 1,095 dosage
units of Tylenol No. 3 pursuant to oral prescriptions authorized by
J.L. Freeman, M.D. In his affidavit, Dr. Freeman stated that he did not
authorize any Tylenol No. 3 for his patient during the relevant time
period and that he moved his practice to another city in Tennessee in
January 1990.
Finally, as to Patient 14, Respondent's records indicate that
between January 1, 1987 and September 18, 1991, it dispensed 930 dosage
units of Fastin pursuant to oral prescriptions authorized by James
Thomas, M.D. However, Dr. Thomas stated in his affidavit that he had no
record of having seen this patient in the previous five years, that it
was his practice not to prescribe more than a one month supply of diet
pills without seeing the patient, and that he did not authorize
Respondent to fill any prescriptions for Fastin for this patient during
the time period at issue.
In addition during the course of reviewing Respondent's records,
the investigators noted that a number of the oral prescriptions did not
contain all of the required information including the date, the
physician's DEA registration number and address, and/or the patient's
address. Also, Respondent's records indicated that on occasion it
refilled prescriptions more than five times, it dispensed refills of
controlled substances in an amount exceeding that of the original
prescription, and it dispensed refills even though the original
prescription did not authorize them. Further on a number of
prescriptions, there were no initials of the pharmacist who received
the oral prescription on the written memorialization as required by the
State of Tennessee.
A number of the doctors who testified at the criminal trial, as
well as the state investigator, noted that physicians are not required
to keep a record of their prescribing of controlled substances. An
expert physician who testified on behalf of Respondent at the hearing
in this matter stated that the general practice in Western Tennessee
regarding noting prescriptions in patient records has not been very
good until recently. The expert testified that ``[t]he problem is that
if you're at the hospital and someone calls and needs medication, you
may call the druggist and say, hey, refill the medication. And that
never gets--that rarely gets into the chart. Or you can be in your car
calling it in. Or you can tell your staff to call it in, and they may
not put it down.'' The state investigator testified at the hearing that
a doctor may be out of the office when authorizing an agent or employee
to telephone a prescription for a patient to a pharmacy, and those
prescriptions may not necessarily be recorded in the patient's chart.
But the investigator noted that it is not common for doctors to not
record prescribed medications since ``it's a good medical practice,''
to keep accurate patient records.
Respondent's expert also testified that he reviewed Respondent's
patient profiles and the patient records of 16 patients at issue in the
criminal proceeding and that in his opinion, the patients had
legitimate medical needs for the controlled substances dispensed by
Respondent, and there was nothing in these records that would cause him
to become concerned about either the dosage or the frequency of these
patients' prescriptions for controlled substances. Respondent also
introduced into evidence the extensive medical records for some of
these patients.
A relief pharmacist from Respondent testified that she never
dispensed medications at Respondent without proper authorization, nor
did Mr. Pettigrew ever instruct her to do so. She further testified
that she had no knowledge of Mr. Pettigrew ever dispensing controlled
substances without a physician's authorization. This pharmacist
suggested that the reason that the physicians denied authorizing
certain prescriptions could be that a nurse in the doctor's office
actually took the call. The pharmacist estimated that 80% of the calls
authorizing oral prescriptions were made by personnel other than the
authorizing physician. In addition, the pharmacist suggested that the
doctor who actually authorized a particular prescription may not have
been accurately listed on Respondent's patient profiles because the
computer system in use at that time would automatically bring up the
name of the last physician who prescribed for that patient. If the
doctor's name was not manually changed, which was cumbersome when the
pharmacy was busy, the previous doctor's name would remain as the
prescribing physician.
In 1996, an individual who is an attorney and a pharmacist was
hired by Respondent to conduct an inspection of the pharmacy. The
individual testified at the hearing in this matter that Respondent
appeared to be in compliance with all relevant state and Federal
requirements. Specifically, the individual testified that Respondent's
prescription drug stock appeared to be up to date and the quantities of
drugs on hand were normal. He looked at random samples of patient
profiles and prescriptions and found that all of the
[[Page 8858]]
prescriptions contained the required information. Additionally, he
randomly selected various prescriptions and verified with the
prescribing physicians that the prescriptions were authorized as
indicated.
The individual further testified that he saw no correlation between
unauthorized refills that occurred five to ten years ago, and the
public interest as of the date of the hearing. According to the
individual, Respondent is located in a very small town which is a
medically underserved area, and because there are only two pharmacies
in the area, it is his opinion that it is in the public's interest for
Respondent to remain in business.
The part owner of the other pharmacy in town, who is also a
physician, testified at the hearing. In his opinion, even if it is true
that Respondent dispensed controlled substances without a physician's
authorization, it would not be in the public interest to close
Respondent because two pharmacies are necessary to serve this medically
underserved area. According to this physician, as well as Mr.
Pettigrew, it would be very difficult for Mr. Pettigrew to sell
Respondent because a large number of its customers participate in the
state medical assistance program which does not pay very much to
pharmacies for prescriptions.
This individual also testified that on approximately 10 or 12
occasions, Respondent failed to obtain his authorization before
refilling some of his patients' prescriptions. But, he also testified
that he still believed it would be in the public interest for
Respondent to retain its DEA registration since he would have
authorized these prescriptions had he been consulted. However, he did
express concern about the possible side effects his patients might
suffer and about the risk that they might become addicted to the
controlled substances that Respondent dispensed to them without
authorization.
At the hearing in this matter, Mr. Pettigrew indicated that he
knows the physicians at issue personally. He denied dispensing any
controlled substances without a physician's authorization, but
testified that he has nonetheless instituted new procedures at
Respondent. He testified that now when a doctor's office telephones in
a prescription, the pharmacist immediately writes down all of the
required information on a prescription pad. If a patient brings in an
expired prescription, the pharmacist telephones the doctor and requests
authorization, which is then logged into Respondent's records as a new
prescription. In addition, oral prescriptions are now initialed twice,
once by the pharmacist who receives the authorization and again by the
dispensing pharmacist. Further, Respondent has a new computer system
which provides more details about a prescription than the system used
in 1987-1991.
Mr. Pettigrew noted at the hearing that there have been no
allegations of any wrongdoing at Respondent since 1991. According to
Mr. Pettigrew the state investigators conduct a random inspection about
once a year. Mr. Pettigrew further testified that he has instituted any
changes suggested by the state investigators and that he is willing to
do whatever is necessary to continue in compliance.
Pursuant to 21 U.S.C. 823(f) and 824(a)(4), the Deputy
Administrator may revoke a DEA Certificate of Registration and deny any
application for such registration, if he determines that the continued
registration would be inconsistent with the public interest. Section
823(f) requires that the following factors be considered:
(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.
(5) Such other conduct which may threaten the public health or
safety. These factors are to be considered in the disjunctive; the
Deputy Administrator may rely on any one or a combination of factors
and may give each factor the weight he deems appropriate in determining
whether a registration should be revoked or an application for
registration be denied. See Henry J. Schwarz, Jr., M.D., 54 FR 16,422
(1989).
Regarding factor one, there is no evidence that the Tennessee Board
of Pharmacy has taken any action against Respondent or Mr. Pettigrew.
However, as Judge Bittner stated, ``inasmuch as state licensure is a
necessary but not sufficient condition for DEA registration, * * * this
factor is not dispositive.''
As to factors two and four, Respondent's experience in handling
controlled substances and its compliance with applicable laws relating
to controlled substances, there is considerable evidence in the record.
The Government alleged that between 1987 and 1991 Respondent dispensed
approximately 35,000 dosage units of controlled substances without a
physician's authorization. Some of the physicians merely stated in
their affidavits that their records did not reflect authorization for
the oral prescriptions at issue. However, many of the physicians stated
unequivocally that not only did their records not reflect authorization
for oral prescriptions, but also that they did not orally prescribe the
medication at issue; that they did not prescribe that specific
medication for that patient; that the patients were not under their
care during the relevant time period, and in fact had not been seen by
the physician in years; or that they were not even their patients. The
Deputy Administrator recognizes that neither Federal or state law
requires physicians to keep records of their controlled substance
prescriptions. Nevertheless the Deputy Administrator agrees with Judge
Bittner that ``[t]he sheer quantity of `prescriptions' Respondent
filled and the number of physicians who stated that they had not
authorized them suggests that practitioners' failure to maintain
accurate records does not account for all of the dispensings at
issue.''
Mr. Pettigrew contended that he contacted the physicians' offices
to receive authorization for every controlled substance prescription.
But, Judge Bittner did not find Mr. Pettigrew's contention credible,
stating that ``Mr. Pettigrew did not favorably impress me as a witness;
he did not appear candid or forthright and his testimony appeared to be
tailored to Respondent's defense in this proceeding.''
The Deputy Administrator finds it hard to believe that all of the
oral prescriptions at issue were authorized but not noted in the
physicians' patient charts when other instances of prescribing were
specifically noted in the charts. In addition, according to Respondent
the physicians' patient charts did not reflect the prescriptions at
issue, yet during the independent inspection of Respondent conducted in
1996, the physicians were able to verify that they authorized oral
prescriptions found in Respondent's records. Consequently, the Deputy
Administrator agrees with Judge Bittner that while some prescriptions
may have been orally authorized by a practitioner or his agent, most
were not. Respondent therefore dispensed controlled substances on
numerous occasions without a physician's authorization in violation of
21 U.S.C. 829 and 21 C.F.R. 1306.21.
Respondent also presented evidence that the patients had medical
needs for
[[Page 8859]]
the controlled substances dispensed to them. While this appears to be
true, the Deputy Administrator concludes that this does not justify
Respondent's dispensing of controlled substances to them without a
physician's authorization. The law specifically states that ``no
controlled substance in Schedule III or IV, . . . may be dispensed
without a written or oral prescription. . . .'' See 21 U.S.C. 829(b).
Controlled substances in Schedules III and IV may not be dispensed
without a physician's authorization regardless of whether a pharmacist
believes that there is a legitimate medical need for the drug.
Additionally, Respondent failed to properly reduce to writing oral
prescriptions for Schedule III and IV controlled substances as required
by 21 CFR 1306.05. A number of the prescriptions in evidence failed to
include a date, the physician's DEA registration number, the patient's
address, and/or the physician's address. Also, prescriptions were
refilled more times than authorized, in amounts exceeding what was
originally prescribed, and/or after the original prescription expired
in violation of 21 U.S.C. 829 and 21 CFR 1306.22. Further, Respondent
violated the state requirement that the pharmacist who receives an oral
prescription must initial the documentation of it.
However, the Deputy Administrator notes that the most recent of
these violations occurred in 1991. Evidence in the record suggests that
Respondent has properly dispensed controlled substances and been in
compliance with controlled substance laws since that time. An
independent inspection conducted in 1996 found Respondent to be in
compliance and apparently, yearly state inspections have not revealed
any wrongdoing. Respondent has also installed a new computer system and
instituted changes regarding its handling of oral prescriptions.
As to factor three, Mr. Pettigrew was acquitted of all criminal
charges arising out of this investigation. It is undisputed that
neither Respondent, Mr. Pettigrew or any other officer or agent of
Respondent has been convicted of any controlled substance related
offense.
The Deputy Administrator agrees with Judge Bittner that as to
factor five, the record contains no evidence of other conduct that may
threaten the public health or safety.
Judge Bittner concluded that Respondent's continued registration
would not be in the public interest based upon its dispensing of
``enormous quantities'' of controlled substances without a physician's
authorization; its violations of Federal and state laws relating to
controlled substances; Mr. Pettigrew's failure to indicate any remorse
for his actions; and that the changes to its operation do not address
the particular problem. Judge Bittner concluded that in light of Mr.
Pettigrew's denial of any wrongdoing, ``Respondent has not shown that
the misconduct is not likely to recur and that Mr. Pettigrew is either
unwilling or unable to carry out the responsibilities inherent in a DEA
registration.'' Therefore, Judge Bittner recommended that Respondent's
DEA registration be revoked.
Respondent filed exceptions to Judge Bittner's recommended decision
and attached its earlier motions to dismiss and to exclude certain
evidence. Respondent argued that all of the alleged misconduct occurred
before September 1991, and thus this action and reliance on certain
evidence is barred by 28 U.S.C. 2462 which establishes a five year
statute of limitations for ``. . . an action, suit or proceeding for
the enforcement of any civil fine, penalty, or forfeiture, pecuniary or
otherwise. . . .'' The Deputy Administrator agrees with Judge Bittner
that 28 U.S.C. 2462 is inapplicable in these proceedings. These
proceedings are not punitive in nature, but instead are administrative
and remedial. In looking to protect the public health and safety, it is
clearly relevant to consider a registrant's past history in handling
controlled substances to determine if it can be trusted to responsibly
handle controlled substances in the future. Further, 21 U.S.C. 824(c)
specifically states that proceedings such as these ``shall be
independent of, and not in lieu of, criminal prosecutions or other
proceedings under this subchapter or any other law of the United
States.'' Therefore, these proceedings are clearly distinguished from
civil proceedings.
Respondent also argues that the Government is estopped from
bringing this action because it renewed Respondent's DEA registration
after it had knowledge of the alleged misconduct and Respondent made
changes to its procedures and purchased a new computer system based
upon the suggestions of a state investigator. The Deputy Administrator
agrees with Judge Bittner that estoppel is not available as a defense
against the Government. Respondent further contends that this action is
barred by the doctrine of laches. As Judge Bittner noted, as a general
rule laches does not apply against the Government. DEA has consistently
held that passage of time since the wrongdoing is not dispositive,
however it is a factor to be considered. See Hagura Pharmacy, 62 FR
16,191 (1997); John Porter Richards, D.O., 61 FR 13,878 (1996) and
cases cited therein. In addition, Respondent argues that its due
process rights were violated by the unreasonable delay in bringing this
action. In support of its argument, Respondent cites several cases
dealing with the violation of a party's due process rights based upon
the delay in bringing a civil forfeiture action. This proceeding is
clearly not analogous to a civil forfeiture action and therefore the
Deputy Administrator does not find Respondent's argument persuasive.
Respondent contends that Judge Bittner erred by failing to properly
consider that the patients at issue had demonstrated medical needs for
the medications dispensed by Respondent ``thereby making it likely that
the drugs were, in fact prescribed by the physicians * * * and,
therefore, did not and could not pose a threat to the public health and
safety.'' In addition, Respondent argues that Judge Bittner erred by
determining that most of the prescriptions were not authorized by a
physician or his agent. The Deputy Administrator does not agree with
Respondent's argument that since the individuals had medical needs for
the drugs it is more likely that they were authorized by a physician.
As discussed previously, the Deputy Administrator agrees with Judge
Bittner's conclusion that most of the prescriptions at issue were not
authorized by a physician or his agent. Of particular significance is
that a number of the physicians had no record of even treating these
patients for years prior to the relevant time period let along
prescribing them controlled substances. Also, the one physician who did
testify stated that there were 10 to 12 prescriptions found at
Respondent that were attributed to him that he had not authorized.
Respondent further contends in its exceptions that in rendering her
recommended decision in this matter, Judge Bittner erred in failing to
consider that Respondent has been in compliance with Federal and state
requirements since the alleged misconduct occurred; that it has taken
corrective action regarding its operation; and that the loss of its DEA
Certificate of Registration will result in Respondent's closure which
would have a severe adverse impact on the community by eliminating one
of two pharmacies serving a poor, medically underserved population. As
discussed herein, the Deputy Administrator has considered
[[Page 8860]]
these facts in rendering his decision in this matter.
The Deputy Administrator concludes that the Government has made a
prima facie case for revocation of Respondent's DEA registration. The
Deputy Administrator is quite concerned about the nature and extent of
the violations that occurred between 1987 and 1991. But of even greater
concern is Respondent's failure to acknowledge or accept responsibility
for any wrongdoing. That Respondent continues to argue that there is no
danger to the public health and safety because the controlled
substances were medically necessary indicates that Mr. Pettigrew still
does not appreciate Respondent's role in the dispensing of controlled
substances. Also of concern to the Deputy Administrator is Mr.
Pettigrew's claims of ignorance of the requirements at the time of the
events in question.
Therefore, the Deputy Administrator finds that revocation of
Respondent's DEA registration is justified as inconsistent with the
public interest. However, the Deputy Administrator also recognizes that
Respondent is one of two pharmacies in a relatively poor, medically
underserved community and it would most likely close if its DEA
registration is revoked; that it has changed its procedures regarding
oral prescriptions and its computer system; and that there is no
evidence of any wrongdoing since the events at issue in this
proceeding. As a result, the Deputy Administrator concludes that the
public interest would be served by requiring Mr. Pettigrew to undergo
training in order to fully appreciate the pharmacy's responsibilities
as a DEA registrant and by subjecting Respondent to random unannounced
inspections, while still being permitted to handle controlled
substances.
Therefore the Deputy Administrator will stay the revocation of
Respondent's DEA registration for six months during which time
Respondent must present evidence to the Deputy Administrator of Mr.
Pettigrew's completion of a training course regarding the proper
handling of controlled substances and must submit to random unannounced
inspections by DEA personnel without requiring an administrative
inspection warrant. If alleged violations are discovered during these
inspections, the Deputy Administrator will extend the stay pending
proceedings to determine whether violations in fact occurred. If
Respondent does not comply with these terms, or if it is determined
that subsequent violations have occurred, an order will be issued
lifting the stay and Respondent's DEA Certificate of Registration will
be revoked. If Respondent does comply, the Deputy Administrator will
issue a subsequent order indicating that the conditions have been met
and that the DEA Certificate of Registration is reinstated and renewed
without limitations.
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 AP0406911, issued to Pettigrew Rexall
Drugs, be, and it hereby is, revoked, and any pending applications for
renewal of such registration, be, and they hereby are, denied. It is
further ordered that this order will be stayed for a period of six
months from its effective date. If during the six month period,
Respondent fails to comply with the above described conditions, the
stay will be removed and Respondent's DEA Certificate of Registration
will be revoked and any pending applications for renewal will be
denied. This order is effective March 25, 1999.
Dated: February 16, 1999.
Donnie R. Marshall,
Deputy Administrator.
[FR Doc. 99-4329 Filed 2-22-99; 8:45 am]
BILLING CODE 4410-09-M
