[Federal Register Volume 61, Number 218 (Friday, November 8, 1996)]
[Notices]
[Pages 57896-57901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-28766]
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DEPARTMENT OF JUSTICE
[Docket No. 95-1]
Margaret E. Sarver, M.D., Suspension of Registration;
Reinstatement With Restrictions
On September 7, 1994, the Deputy Assistant Administrator (then-
Director) of the Office of Diversion Control, Drug Enforcement
Administration (DEA), issued an Order to Show Cause to Margaret E.
Sarver, M.D. (Respondent) of Beaver Falls, Pennsylvania, notifying her
of an opportunity to show cause as to why DEA should not revoke her DEA
Certificate of Registration, AS1667623, and deny any pending
applications for registration under 21 U.S.C. 823(f) and 824(a)(4), as
being inconsistent with the public interest.
By letter dated October 12, 1994, the Respondent, through counsel,
timely filed a request for a hearing, and following prehearing
procedures, a hearing was held in Pittsburgh, Pennsylvania on August 15
and 16, 1995, before Administrative Law Judge Paul A. Tenney. At the
hearing, both parties called witnesses to testify and introduced
documentary evidence. After the hearing, both sides submitted proposed
findings of fact, conclusions of law and argument. On January 29, 1996,
Judge Tenney issued his Findings of Fact, Conclusions of Law and
Recommended Ruling, recommending
[[Page 57897]]
that the Respondent's DEA registration should be revoked in Schedules
II and III. On February 16 and 28, 1996, the Government and Respondent
respectively, filed exceptions to the Recommended Ruling of the
Administrative Law Judge, and on February 29, 1996, Judge Tenney
transmitted the record of these proceedings to the Deputy
Administrator. Subsequently, on March 1, 1996, Judge Tenney transmitted
to the Deputy Administrator a facsimile from the Respondent for
inclusion in the record.
The Acting 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 Judge Tenney, except as noted below. However, for
reasons explained below, the Acting Deputy Administrator rejects Judge
Tenney's recommendation as to the appropriate disposition of this case.
The Acting Deputy Administrator finds that the Respondent is an
internist with a general practice in Beaver Falls, Pennsylvania. She
was Board Certified in Internal Medicine in 1965, and has maintained an
active practice for approximately 31 years. Although, Respondent treats
patients with a variety of medical problems, she has a special interest
in weight loss.
Sometime prior to November 18, 1991, the Commonwealth of
Pennsylvania, Department of Public Welfare, Bureau of Quality Assurance
(DPW) identified Respondent as a frequent prescriber of the controlled
substances, Seconal, Tuinal, Noludar, Nembutal, and the combination of
glutethimide and acetaminophen with codeine. On November 18, 1991, DPW
conducted an on-site review at Respondent's office to gather
information about her medical practice and to copy 22 patient records.
The DPW reviewers found Respondent's office to be ``unclean and
unsanitory [sic]'' and discovered that her ``method of record keeping
and billing was fragmented and disorganized.'' During the course of the
review, Respondent stated that she prescribes sleeping medication upon
request and admitted that some patients continue on such medication for
months or years. Respondent also admitted that she was aware of the
effect of the combination of glutethimide and codeine products, but
stated that she prescribes this combination to patients with both
legitimate sleeping and pain problems. The combination of glutethimide
and codeine products is known as a ``set'' on the streets, and the
effect of the two drugs taken together is similar to that of heroin.
When asked by the DPW reviewers about her prescribing of this
combination, Respondent replied, ``when you get drifters asking for
Dilaudid and Demeral [sic], I don't think Tylenol #3 is all that bad.''
Following the on-site review, three physicians conducted a peer
review of the 22 medical records copied during the on-site review. This
peer review concluded inter alia that all of the drug regimens
prescribed for these patients by Respondent ``failed to comply with
[Medical Assistance] Standards of Practice due to insufficient
appropriateness and/or necessity of the drugs prescribed.'' As a result
of the investigation, the DPW concluded, in part, that Respondent's
treatment for one patient was contrary to medical assistance
regulations in that she ``prescribed drugs of high abuse potential . .
. in a manner determined after medical record review to be of inferior
quality and/or medically unnecessary.'' DPW further concluded that
Respondent ``prescribed drug regimens of high abuse potential
(Percocet, Vicodin, Tylenol w/codeine, Seconal, Hycotuss, Glutethimide,
Tuinal, Noludar) for twenty-two (22) recipients whose medical records
failed to sufficiently document the appropriateness and necessity of
the drugs prescribed.'' By letter dated June 15, 1992, the DPW proposed
to terminate the Respondent as a provider, to preclude Respondent from
participation in the Medical Assistance Program for a period of four
years. Respondent requested a hearing regarding the proposed sanctions,
stating that the DPW did not have the complete medical records on each
of the 22 patients whose medical records were reviewed in the course of
the investigation. Respondent stated that the DPW reviewer had not told
her that they needed all her notes on each patient, and that there was
additional patient chart material waiting to be filed in the records.
The DPW action against Respondent was settled without sanctions,
however, there is no evidence in the record as to the basis for this
resolution.
In July 1992, a DEA investigator interviewed a confidential
informant who stated that he had once been a patient of Respondent's
and had been able to obtain controlled substances, including the
combination of glutethimide and Tylenol with codeine, from Respondent
without a medical examination. As a result of this information, as well
as the DPW investigation, DEA investigators visited approximately 27
area pharmacies to collect prescriptions allegedly written by
Respondent. The investigators discovered that some of the pharmacies
would no longer fill Respondent's prescriptions due to suspicions that
the individuals receiving the prescriptions were drug dependent. At no
time did the investigators instruct the pharmacies to stop filling
Respondent's prescriptions. Among the concerns expressed by the
pharmacists were Respondent's frequent prescribing of the combination
of glutethimide and Tylenol with codeine; prescriptions written by
Respondent were often from outside the pharmacy's trade area; and
Respondent's prescriptions were sometimes post-dated.
In September 1992, the DEA investigators interviewed Respondent,
specifically questioning her about her prescribing practices, including
the glutethimide and Tylenol with codeine combinations. The
investigators informed Respondent of the dangers of taking these
medications together, that they produce a heroin-like effect, and that
glutethimide should not be taken with narcotics. Respondent stated that
if DEA believes that those drugs are dangerous, DEA should take them
off the market. Respondent continued to prescribe combinations of
glutethimide and codeine products after being warned by both DPW and
DEA of the danger and abuse potential.
During the course of the investigation, the DEA investigators
interviewed a number of Respondent's patients. In January 1993, they
interviewed three of Respondent's patients as they left her office. One
indicated that he had been seeing Respondent upon the recommendation of
his girlfriend, who informed him that he could get prescriptions for
controlled substances from Repondent. Another indicated that she had
been a patient of Respondent's for 19 years, and only goes to
Respondent now because she is addicted to various controlled substances
and is able to get them from Respondent. Each had 4 prescriptions for
various Schedule II through IV controlled substances including,
glutethimide, Seconal, Tylox, acetaminophen with codeine, Hycodan,
Vicodin, Adipex, diazepam and Didrex. One had a prescription written by
Respondent for glutethimide for her son. Two indicated that other than
being weighed and occasionally having their blood pressure or pulse
checked, no other examination was performed during office visits before
controlled substance prescriptions were issued. Two indicated that they
were not given
[[Page 57898]]
instructions on how to take the various medications in combination with
one another. Respondent's medical charts on these individuals indicated
a variety of medical conditions.
In November 1993, DEA investigators interviewed M.S. and L.O.
patients of Respondent. M.S. informed the investigators that he had
initially gone to Respondent because he had heard on the street that
she would prescribe the drugs people wanted. He admitted that he was
addicted to Vicodin, that he was attending a methadone clinic, and that
he sometimes sold some of Respondent's prescriptions. In a subsequent
affidavit, M.S. denied selling Respondent's prescriptions. M.S.
indicated to the investigators that other than having his weight and
occasionally his blood pressure and/or pulse checked, Respondent did
not perform a physical examination. Records in Respondent's possession
indicated that M.S. suffered from dependencies to various drugs,
including Dilaudid and Percocet, both Schedule II controlled
substances. An investigator testified that L.O. stated that she also
was addicted to drugs prescribed by Respondent, including Vicodin and
Ativan, a Schedule IV controlled substance. She also was enrolled in a
methadone treatment program. However, in a subsequent affidavit, L.O.
stated that she did not tell the investigators that she was addicted to
her medication. Respondent placed into evidence the medical records for
these individuals. The records indicated a variety of medical
conditions.
In February 1994, the investigators interviewed a husband and wife
who initially went to Respondent for weight loss and back problems.
They admitted obtaining prescriptions for controlled substances from
Respondent without a medical examination, and sometimes without an
office visit. According to the wife, Respondent would sometimes leave
them prescriptions behind the office's screen door along with
prescriptions for others. They indicated that they were examined on
their first visit, but that since then they were only weighed and
occasionally their blood pressure was checked. They told the
investigators that they received Schedule II through IV controlled
substances from Respondent, including Dilaudid, Percocet, Seconal,
Hycodan, Vicodin, Adipex, and Soma with codeine. Respondent did tell
them that the prescribed drugs were addictive but did not give them any
instructions regarding taking the drugs in combination with each other.
Respondent's records on these individuals indicated various medical
problems/conditions.
In addition to conducting patient interviews, DEA monitored the
visits of two of Respondent's patients, B.S. and K.C., who had agreed
to cooperate with DEA. On February 16 and March 16, 1993, B.S. went to
Respondent's office in an undercover capacity. As was her normal
practice, before each visit, B.S. prepared a list of the controlled
substances that she wanted Respondent to prescribe for her. On each
occasion she obtained prescriptions for 100 dosage units of diazepam,
30 dosage units of Tylox, 60 dosage units of Adipex, 50 dosage units of
acetaminophen with codeine (with one refill on the second visit), 60
glutethimide, and 8 ounces of Tussi-Organidin (with five refills on the
second visit), a Schedule V cough syrup. On the first visit, B.S. had
asked for Hycodan cough syrup, which Respondent did not prescribe,
instead substituting Tussi-Organidin, stating that Hycodan was
difficult to find at local pharmacies. Other than being weighed, no
other physical examination was performed during either visit. On the
first visit, B.S. also gave Respondent a list of desired prescriptions,
including glutethimide, Darvocet and Vicodin, for her son who would not
be present. Respondent did not issue any prescriptions for B.S.'s son
since he had not been in for an office visit for quite awhile. At the
hearing before Judge Tenney, Respondent admitted, however, that she had
issued prescriptions for B.S.'s son without seeing him because he
suffers from emotional problems and does not like to go to the office
himself.
The second cooperating patient, K.C., went to Respondent's office
on January 31 and February 28, 1994. On both occasions, K.C. received
several prescriptions for controlled substances. No medical examination
was conducted nor was there an inquiry into her medical condition.
Respondent merely asked K.C. what prescriptions she needed and how much
of each medication she wanted. Respondent put into evidence documents
that indicate K.C.'s medical history.
In August 1993, DEA executed a search warrant at Respondent's
office authorizing the seizure of 81 patient records. At the hearing
before Judge Tenney, Respondent testified that her medical files on
each patient consisted of a manila folder stored in a file cabinet,
carbon copies of all prescriptions issued to each patient, and a
medical card on each patient. During the execution of the warrant,
Respondent told the DEA personnel where the medical files were located,
and at no time did she indicate that the medical files seized were not
the complete medical record on each patient.
A medical doctor, who is a board certified clinical pharmacologist
from the University of Pittsburgh Medical School, reviewed seven of the
seized patient records, as well as prescription profiles for the seven
individuals, and concluded that there did not appear to be a
relationship between the drugs prescribed and the established medical
problems. He further opined that the drugs were not prescribed in the
course of legitimate medical practice and were prescribed in a manner
contrary to that utilized by a majority of medical practitioners.
Respondent claimed that the reviewer ignored many of the medical
diagnoses found in the patients' records. At the hearing, it was
revealed that there were several inaccurate dates and amounts/refills
noted in the reviewer's report. Respondent further testified that this
review was incomplete, and therefore inaccurate, since the reviewer did
not have all of Respondent's information regarding the seven patients.
The DEA personnel did not seize the card files for each patient when
they executed the search warrant. However, she did not inform the DEA
personnel about the card files. She testified at the hearing that she
knew that the DEA personnel were not getting the complete medical
records of the 81 patients, but ``I just let it go.'' In addition, the
exhibit that is Respondent's response to the reviewer's report stated
that, ``* * * [DEA] did not get my most important records on the
patients--they thought they did, and I let them think so. * * *''
Respondent testified that she does not do a complete physical
examination of each patient on every visit because many of her patients
are long-term patients, that she sees on a regular basis. She also
testified that she tells patients how to use prescribed medication and
all of her prescriptions have instructions on them. However, if a
patient has been receiving prescriptions for a certain medication, she
does not explain its use every time she issues a prescription.
Respondent was often not aware of the schedule of drugs she regularly
prescribed. She admitted at the hearing that she occasionally post-
dated controlled substance prescriptions, however, she did not know
that that practice violated Federal regulations. See 21 CFR 1306.05(a).
Respondent testified before Judge Tenney that she had heard that the
combination of glutethimide and Tylenol with codeine was used on the
street from one pharmacist and from the DEA
[[Page 57899]]
investigators in 1992. She stated that ``I had never heard it from
anyone else.''
Respondent also testified that she only prescribes controlled
substances if there is a medical indication for the drug. If she
suspects that a patient is lying about his or her symptoms, or the
patient is abusing or selling the prescribed substances, Respondent
will discontinue treatment. In fact, Respondent had terminated the
treatment of several of the patients that had been interviewed by DEA
or whose medical records were reviewed by the clinical pharmacologist.
In her post-hearing filings, Respondent argues that all or much of
the evidence used against her is hearsay, which uncorroborated cannot
be substantial evidence. Respondent's Motion to Strike Hearsay Evidence
is denied. ``* * * [H]earsay is both admissible and may, standing by
itself, constitute substantial evidence in support of an administrative
decision.'' Klinestiver v. Drug Enforcement Administration, 606 F.2d
1128 (D.C. Cir. 1979) (citing Richardson v. Perales, 402 U.S. 389
(1971)). It is significant in this case, as it was in Klinestiver and
Perales, that Respondent did not subpoena any of the key declarants
relied upon by the Government thereby providing herself the opportunity
for cross-examination.
Pursuant to 21 U.S.C. Secs. 823(f) and 824(a)(4), the Deputy
Administrator may revoke or suspend a DEA Certificate of Registration
and deny pending applications, 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., Docket No. 88-42, 54 FR 16,422
(1989).
In this case, factors two, four, and five are relevant in
determining whether the Respondent's retention of her Certificate of
Registration would be inconsistent with the public interest. As to
factor two, the clinical pharmacologist and the three DPW peer
reviewers all criticized Respondent's prescribing practices. While it
appears that the DPW has settled its investigation of Respondent with
no sanctions, there is nothing in the record to indicate the basis for
this resolution. There does however appear to be some question as to
whether the DPW peer reviewers had Respondent's complete medical
records when rendering their opinions, which will be discussed in
detail below. Therefore, unlike Judge Tenney, the Acting Deputy
Administrator finds the conclusions of the DPW peer reviewers to be of
little relevance in determining Respondent's experience in dispensing
controlled substances. Respondent argues that the clinical
pharmacologist's review was incomplete based upon his failure to
consider the medical diagnoses in the records provided; inaccuracies in
dates and amounts of controlled substances prescribed; and most
importantly, because the reviewer did not have Respondent's complete
medical records when rendering his opinion. The reason that the
reviewer did not have the patients' complete medical records will be
discussed in connection with factor five. However, while not
specifically found by Judge Tenney, the Acting Deputy Administrator
concludes that the fact that the reviewer did not have the complete
medical records does significantly minimize the weight to be given to
his conclusions regarding Respondent's prescribing practices.
Nevertheless, there is other evidence that seriously calls into
question Respondent's dispensing of controlled substances.
At least three area pharmacists expressed concerns about the
combination of drugs prescribed by Respondent, the types of patients
bringing in prescriptions written by Respondent, and the fact that some
of the prescriptions were post-dated. The Acting Deputy Administrator
is extremely troubled by Respondent's frequent prescribing of the
highly abused combination of glutethimide and codeine produces which
produces a heroin-like effect. As Judge Tenney noted, Respondent was
repeatedly advised of the effect of this combination and its potential
for abuse. In November 1991, Respondent indicated to DPW that she was
aware of the effect of this combination of drugs, but stated that,
``when you get drifters asking for Dilaudid and Demeral [sic], I don't
think Tylenol No. 3 is all that bad.'' Respondent indicated at the
hearing in this matter that a local pharmacist had also called to her
attention the dangers of this combination. Then in September 1992, when
DEA investigators questioned Respondent about her prescribing of this
combination of drugs, Respondent stated that if the DEA does not want
people taking these medications, the drugs should not be on the market.
Despite these warnings, Respondent continued to prescribe the
combination of these drugs to her patients. As the Government noted, in
a recent case, the DEA Administrator concluded that:
[r]egarding factor two, Respondent's experience in dispensing
controlled substances is poor based on his prescribing the
combination of Tylenol with codeine and Doriden [the brand name for
glutethimide] to an individual, especially when Respondent was aware
that this combination was subject to abuse. Leonard Merkow, M.D., 60
FR 22,075 (1995) (emphasis added).
Respondent's complete disregard for the warnings about the prescribing
of this combination, as well as her statements to DPW and DEA personnel
about the drugs, reflects poorly on her experience in dispensing
controlled substances. As Judge Tenney noted, ``Respondent's
prescribing practices in this situation evidences a disregard to the
danger to her patients and the community at large by prescribing such a
highly abused combination of drugs.''
The Acting Deputy administrator concurs with the Government's
contention that Respondent's lack of knowledge, and apparent
disinterest, in the schedule of the substances she was actively
prescribing is evidence of her cavalier attitude towards the proper
dispensing of controlled substances. In addition, Respondent's careless
behavior is further evidenced by her prescribing of glutethimide to
patients with sleeping disorders. On most of her prescriptions for
glutethimide, Respondent indicated a dosage of 1 or 2 tablets at
bedtime, yet one of Respondent's patients received prescriptions for a
total of 250 dosage units over a 79 day period. In addition, some of
Respondent's prescriptions contained the instructions to take one
tablet at bedtime ``PRN'', which according to Respondent means ``as
needed for pain''. Glutethimide is not a pain medication, and according
to Respondent was meant to be used as a sleeping aid. As argued by the
Government, ``Respondent's prescribing of and directions for use for
powerful controlled substances demonstrate an
[[Page 57900]]
alarming lack of experience and lack of concern for her patients'
welfare.''
As further evidence of Respondent's casual approach to the handling
of controlled substances is the fact that she seems to allow patients
to determine what controlled substances they will be prescribed and in
what amount. This behavior was clearly evident during the undercover
visits by Respondent's patients. Allowing a patient to dictate the drug
and drug quantity is a highly suspicious practice and clearly conduct
which threatens the public health and safety. See Robert L. Dougherty,
Jr., M.D., 60 Fed. Reg. 55,047 (1995). Also, patients stated, and
Respondent admitted at the hearing, that she sometimes issues
controlled substance prescriptions without even seeing the patient. The
Government argued that Respondent would issue controlled substance
prescriptions without conducting a physical examination. Respondent
testified that she does conduct a physical examination on the initial
visit, and when one is medically indicated. The Acting Deputy
Administrator concurs with Judge Tenney that, ``when seeing a patient
on a frequent basis, a complete physical examination may not be
necessary every time.''
Additionally, Respondent has maintained several patients on
controlled substances for prolonged periods of time, in contradiction
of information contained in the Physician's Desk Reference (PDR). For
example, as Judge Tenney noted, five patients were prescribed Hycodan
cough syrup for extended periods of time. However, the PDR warns that
``physical dependence, the condition in which continued administration
of the drug is required to prevent the appearance of a withdrawal
syndrome, assumes clinically significant proportions only after several
weeks of continued . . . use, although some mild degree of physical
dependence may develop after a few days of narcotic therapy.''
Respondent admitted to prescribing Hycodan for a few patients for
periods of approximately two years.
According to the PDR, Adipex is indicated for the ``management of
exogenous obesity as a short-term adjunct (a few weeks) in a regimen of
weight reduction based on caloric restriction,'' and ``tolerance to the
anorectic effect develops within a few weeks.'' Respondent prescribed
Adipex to several of her patients for over a year or two. Regarding
Seconal, the PDR states that it is indicated for the ``short term
treatment of insomnia, since it seems to lose its effectiveness for
sleep induction and sleep maintenance after 2 weeks,'' and ``should not
be administered in the presence of acute or chronic pain. . . .'' The
recommended dose for sleeping disorders is 100 mg. at bedtime. The
record indicates that Respondent issued Seconal prescriptions to
several individuals over extended periods of time; she wrote a number
of Seconal prescriptions to an individual, who according to Respondent,
was suffering from acute back pain; and between May 26, 1992 and
September 28, 1992, Respondent prescribed a total of 325 dosage units
of Seconal (100 mg.) to an individual, well over the recommended
dosage.
The Acting Deputy Administrator is aware that the PDR is a
reference tool and that a physician is not bound by its information.
However, Respondent's prolonged maintenance of patients on the above-
referenced medications, along with the other evidence of Respondent's
questionable prescribing practices, raised extremely serious concerns
about Respondent's ability to responsibly dispense potentially
dangerous and highly abused controlled substances.
As to factor four, ``compliance with applicable State, Federal, or
local laws,'' the DPW reviewers concluded that Respondent violated
various Pennsylvania Medical Assistance regulations. DPW found that
Respondent's prescribing of controlled substances in a manner deemed to
be of inferior quality and/or medically unnecessary constituted a
violation of 55 Pa. Code 1101.77(a)(10), and that Respondent prescribed
drug regimens of high abuse potential for 22 medical assistance
recipients whose medical records failed to document sufficiently the
appropriateness and necessity of the drugs prescribed in violation of
55 Pa. Code 1101.51(d)(1). However, unlike Judge Tenney, the Acting
Deputy Administrator is unable to determine whether Respondent was in
fact in violation of these provisions since as discussed above, the DPW
reviewers did not appear to have Respondent's complete medical records
in rendering their opinions.
The Acting Deputy Administrator does conclude that Respondent
violated Federal regulations relating to controlled substances.
Respondent admitted that she would on occasion post-date prescriptions
which is a violation of 21 CFR 1306.05(a). Respondent testified at the
hearing that she was unaware that this was a violation and did it when
her patients could not pay for a full month's supply at once or when
they would not be available to pick up their prescriptions at a later
date.
As to factor five, ``such other conduct which may threaten the
public health and safety,'' the Acting Deputy Administrator finds that
Respondent's unconscionable failure to turn over her complete medical
records during DEA's execution of the search warrant shows a lack of
respect for the law. As Judge Tenney found, Respondent was present when
the warrant was served. She testified at the hearing that she
intentionally did not tell the agents that they were not retrieving the
complete records on each patient, and she knew, or should have known
that the DEA would require the full medical records in order to
complete its investigation. This is especially distressing in light of
DPW's earlier review of her prescribing practices, when Respondent
complained that the DPW peer reviewers could not accurately review her
records for sufficiency, since the reviewers did not have her complete
patient records. Nonetheless, Respondent's failure to turn over her
complete records to DPW and DEA does in fact call into question the DPW
peer reviewers' and the clinical pharmacologist's conclusions that
Respondent did not prescribe controlled substances for legitimate
medical purposes and that her records were inadequate to justify the
prescribing. The Acting Deputy Administrator is not happy that
Respondent will benefit from her failure to cooperate with DPW and DEA,
but the Acting Deputy Administrator is unable to draw any conclusions
as to the legitimacy of Respondent's prescriptions or sufficiency of
her medical records based upon the DPW peer reviewers' and the clinical
pharmacologist's reviews.
But regardless of the inability of the Acting Deputy Administrator
to rely on these reviews, there is ample other evidence in the record
that illustrates Respondent's callous disregard for the proper and
careful handling of controlled substances. The Acting Deputy
Administrator is profoundly troubled by Respondent's unwillingness to
recognize the seriousness of her prescribing practices, most
significantly regarding the combination of glutethimide and Tylenol
with codeine, and allowing patients to dictate what controlled
substances they receive. In a previous case, the Administrator found
that a pharmacist's ``refusal to acknowledge the impropriety of his
dispensing practices . . . even after the initiation of this
investigation, give[s] rise to the inference that [he] is not likely to
act more responsibly in the future.'' Medic-Aid Pharmacy, 55 FR 30,043
(1990).
[[Page 57901]]
In his opinion, Judge Tenney noted as mitigating factors that
Respondent has maintained a medical practice for 31 years, during which
time the state licensing board has not taken any adverse action against
her medical license, and until 1991, neither had DPW or DEA. In
addition, Judge Tenney recognized Respondent's efforts to identify and
discontinue treatment of patients who she suspected of abusing
controlled substances. Judge Tenney recommended that Respondent's DEA
registration be revoked in Schedules II and III, the more serious
classes of controlled substances.
Both parties filed exceptions to Judge Tenney's recommended
decision. In essence, the Government argued that Respondent's DEA
registration should be revoked in all schedules, not just in Schedules
II and III. In support of its exceptions, the Government contended that
Respondent ``indiscriminately prescribed a variety of controlled
substances, including Schedule IV and V controlled substances. . . .''
The Government further argued that ``[w]hile revoking Respondent's
authority with respect to Schedule II and III controlled substances may
prevent the diversion of some dangerous drugs, it will not protect the
public from the diversion of Schedule IV and V controlled substances,
many of which are highly abused.'' The Acting Deputy Administrator
agrees with the Government, that any sanction taken against
Respondent's registration should not be limited to Schedule II and III
controlled substances, since the practices of Respondent that threaten
the public health and safety are not confined to drugs in those
schedules.
A significant amount of Respondent's exceptions dealt with the
Administrative Law Judge's reliance on the reviews of Respondent's
records conducted by DPW and the clinical pharmacologist. As discussed
previously, the Acting Deputy Administrator has reluctantly declined to
rely on those reviews since they were not based, through no fault of
their own, upon Respondent's complete medical records. In addition,
Respondent takes exception to Judge Tenney's finding that Respondent
knew about the abuse of the combination of glutethimide and Tylenol
with codeine prior to November 1991, yet continued to prescribe that
combination of drugs to her patients. The Acting Deputy Administrator
does not believe that the Administrative Law Judge made such a finding.
Instead, Judge Tenney found, and the Acting Deputy Administrator
concurs, that the evidence clearly shows that Respondent continued to
prescribe this extremely dangerous combination after November 1991,
when she acknowledged being aware of its heroin-like effect.
Also as stated in her exceptions, ``[i]t is the Respondent's
position that the Administrative Law Judge disregarded the information
admitted through her exhibits at hearing.'' The Acting Deputy
Administrator has carefully considered all evidence submitted in this
proceeding in rendering his decision. Further, Respondent continues to
object to the consideration of hearsay evidence. The Acting Deputy
Administrator has already addressed and rejected this exception.
The Acting Deputy Administrator concludes that some sanction is
necessary against Respondent's DEA Certificate of Registration in order
to protect the public interest. This conclusion is based upon
Respondent's continued prescribing of the heroin-like combination of
glutethimide and codeine products after acknowledging its dangerous
nature, her allowing patients to dictate the type and amount of
controlled substances to be prescribed, her overprescribing of highly
addictive controlled substances in contradiction of the PDR, her
refusal to comply with the mandate of a criminal search warrant, and
her refusal to acknowledge the impropriety of her prescribing
practices. However, the record does not clearly establish that these
substances were prescribed for no legitimate medical purposes.
Accordingly, the Acting Deputy Administrator does not believe that
Respondent's behavior warrants the severe sanction of revocation.
The Acting Deputy Administrator concludes that in order to protect
the public interest, Respondent needs to be better educated in the
proper handling and effects of controlled substances. Therefore, the
Acting Deputy Administrator will suspend Respondent's DEA registration
for at least 120 days and until she presents evidence to the Resident
Agent in Charge of the DEA Pittsburgh Resident Office, or his designee,
of the successful completion of at least 24 hours of training in the
pharmacology and/or proper handling of controlled substances. Once
Respondent has satisfied this requirement, her DEA Certificate of
Registration will be reinstated subject to the following restriction:
Respondent shall maintain a separate log of all prescriptions that she
issues. At a minimum, the log shall indicate the date that each
prescription was written, the name of the patient for whom it was
written, the name and dosage of the controlled substance(s) prescribed,
and the medical indication for the substance prescribed. The Respondent
shall maintain this log for a period of three years from the
reinstatement of her DEA Certificate of Registration. Upon request by
the Resident Agent in Charge of the DEA Pittsburgh Resident Office, or
his designee, the Respondent shall submit or otherwise make available
her prescription log for inspection.
Accordingly, the Acting Deputy Administrator of the Drug
Enforcement Administration, pursuant to the authority vested in him by
21 U.S.C. Secs. 823 and 824 and 28 CFR 0.100(b) and 0.104, hereby
orders that DEA Certificate of Registration, AS1667623, issued to
Margaret E. Sarver, M.D., be suspended for at least 120 days and until
she presents evidence of the successful completion of 24 hours of
training in the pharmacology and/or proper handling of controlled
substances. It is further ordered that upon receipt of such evidence,
Dr. Sarver's DEA Certificate of Registration will be reinstated subject
to the restriction outlined above. This order is effective December 9,
1996.
Dated: November 4, 1996.
James S. Milford, Jr.,
Acting Deputy Administrator.
[FR Doc. 96-28766 Filed 11-7-96; 8:45 am]
BILLING CODE 4410-09-M