[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