[Federal Register Volume 59, Number 137 (Tuesday, July 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17417]
[[Page Unknown]]
[Federal Register: July 19, 1994]
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DEPARTMENT OF JUSTICE
[Docket No. 92-70]
Jay Wheeler Cranston, M.D.; Revocation of Registration
On July 10, 1992, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Jay Wheeler Cranston, M.D. (Respondent), of
Kent, Ohio, proposing to revoke Respondent's DEA Certificate of
Registration, AC0808076, and to deny any pending applications for
registration as a practitioner under 21 U.S.C. 823(f). The Order to
Show Cause alleged that Respondent's continued registration is
inconsistent with the public interest, as that term is used in 21
U.S.C. 823(f) and 824(a)(4).
Respondent timely filed a request for a hearing on the issues
raised in the Order to Show Cause and the matter was docketed before
Administrative Law Judge Mary Ellen Bittner. Following prehearing
procedures, a hearing was held, beginning on February 24, 1993, in
Cleveland, Ohio.
On December 21, 1993, 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 and that any pending applications for renewal be denied.
Respondent filed exceptions pursuant to 21 CFR 1316.66. Shortly
thereafter, Judge Bittner transmitted the entire record to the then-
Acting Administrator, including Respondent's exceptions. The Government
moved to reopen the proceedings and file a response to Respondent's
exceptions because the Government was given inadequate time to respond.
This request was granted and the Government filed a response to
Respondent's exceptions. Respondent filed a reply to the Government's
response which was received by DEA on February 28, 1994. The Government
then filed a motion to strike this pleading based upon the grounds that
it was not authorized under 21 CFR 1316.66. The Deputy Administrator
agrees with the Government's contention and has not considered this
pleading.
The Deputy Administrator has carefully considered the record and
adopts the opinion and recommended decision of the administrative law
judge. Pursuant to 21 CFR 1316.67, the Deputy Administrator hereby
issues his final order in this matter.
The Deputy Administrator finds that Respondent was employed as a
physician in 1972 at the Kent State University (KSU) Health Center,
located in Kent, Ohio. For most of the time period in issue, Respondent
was the physician-in-charge of the KSU Health Center.
An investigation was initiated in 1989, when the KSU Police
Department obtained information that a student was boasting that he was
able to obtain drugs from Respondent by deception at the KSU Health
Center. The KSU Police Department interviewed the KSU Health Center
pharmacist who alerted the campus police to other illegal activity,
relating to controlled substances, taking place at KSU. The KSU Police
then contacted the State of Ohio Pharmacy Board (Pharmacy Board) and
DEA. This joint investigation led to the discovery of a diverse number
of controlled substance violations committed within the University, and
for the most part, involving Respondent.
Various Schedule II, III and IV narcotic and non-narcotic
controlled substances were stored at the KSU athletic department's two
training rooms for some period of time prior to the 1989 investigation.
Respondent wrote ``prescriptions'' for these controlled substances in
the name of the head trainer or the athletic department. Based upon
these ``prescriptions'' the controlled substances were then transferred
from the KSU Health Center to the athletic training rooms. Although the
KSU Health Center had a DEA registration, the training room facilities,
which were located quite a distance from the health center, did not
have DEA registrations. When Respondent was interviewed about this
arrangement he indicated that he thought the training rooms were an
extension of the health facility, but he later admitted that the
practice ``was not entirely proper.'' The athletic trainer, testifying
on behalf of Respondent, noted that he had on many occasions questioned
Respondent about the practice, but Respondent ignored the inquiries.
Respondent also issued standing orders to the athletic trainers to
administer controlled substances to injured athletes even though a
physician could not be contacted until after the drug was given to the
athlete. When Respondent was interviewed about this practice by a KSU
policeman, he initially explained that trainers were instructed to
administer controlled substances to athletes only in the presence of a
physician. When Respondent was told that the police had received other
information from the head athletic trainer, Respondent admitted that
trainers were authorized to provide medication to athletes in
situations where a physician could not be contacted.
The head athletic trainer did keep an informal record of the
receipt and dispensing of controlled substances from the training
rooms. No such records were kept at the KSU Health Facility itself nor
did Respondent attempt to reconcile the records kept by the head
athletic trainer. Although athletes were required to submit to random
urine tests during this period, the tests did not screen for certain
controlled substances that were stored at the athletic training rooms.
Between 1986 and 1989, Respondent wrote a number of
``prescriptions'' for controlled substances, including cocaine,
morphine and Seconal. These ``prescriptions'' were issued to students
who obtained the drugs from the KSU Health Center pharmacy and then
used the controlled substances for both animal and human research. The
KSU psychology department had its own separate DEA registration and the
department supervised the students' controlled substance research. The
``prescriptions'' issued by Respondent did not indicate a DEA number
nor an address; most did not indicate the reason for issuing the
``prescription''; and many of these prescriptions did not have the
student's name but were simply written for ``Taylor Research''. (Dr.
Taylor was a KSU psychology professor.) One of the psychology
professors did discuss with Respondent the possibility of using DEA
official order forms to transfer the Schedule II controlled substances
from the KSU Health Center to the psychology department, but Respondent
dismissed this suggestion.
DEA conducted an audit of the KSU psychology department in 1989
which revealed a 60 milliliter overage of morphine. There were no
records to verify where this morphine was procured. DEA discovered that
the discrepancy was based upon the morphine ``prescriptions'' that
Respondent issued for the research experiments. The investigation of
the psychology department uncovered that the students disposed of
unused controlled substances by pouring any excess down a drain. There
were, however, no records of such disposal and no way to verify if all
excess substances were destroyed in this manner. In addition,
Respondent authorized three prescriptions for Schedule II controlled
substances with the notation ``outdated''. These controlled substance
prescriptions were also issued to the psychology department for the
purpose of conducting research experiments.
While Respondent was in charge of operating the KSU Health Center,
he allowed three physician assistants to diagnose and write
prescriptions for various medications, including controlled substances.
The physician assistants were given initial training and supervision by
a physician. After such training was deemed complete by Respondent, the
physician assistants could issue Schedule III, IV and V controlled
substances to treat students without supervision by a physician.
Respondent expressed misgivings about this system when he was
questioned by the KSU police in 1989. He admitted that prescriptions
signed by physician assistants could not be honored in a pharmacy other
than the KSU Health Center Pharmacy. In fact the health center
pharmacy's records showed that such prescriptions were issued by a
physician rather than a physician assistant. The KSU Health Center
pharmacist questioned Respondent about this arrangement, but Respondent
convinced him that the system should continue.
As early as 1985, Respondent was instructed by the Dean of Student
Affairs to have physicians supervise the physician assistants instead
of allowing the assistants to issue prescriptions independently. After
some initial hesitation, Respondent complied by countersigning such
prescriptions. Such countersigning, however, was accomplished well
after the prescription was issued to the student/patient. In any event,
after this particular dean left the university, Respondent stopped
countersigning the physician assistants' prescriptions and continued
this practice until 1989 when he was confronted by the KSU Police
Department and the DEA.
Respondent treated a student in 1986. Sometime later, this student
was being treated by an off-campus psychiatrist. Respondent
occasionally issued controlled substance prescriptions to this student
at the request of the treating psychiatrist. In January 1989,
Respondent received a handwritten list of drugs on the treating
psychiatrist's letterhead which was unsigned. The list of drugs
included methylphenidate (spelled ``methyilfenidayt'') and Librium,
Schedules II and IV controlled substances, respectively. Based upon
this person's representation that it was a valid prescription by his
psychiatrist, Respondent issued this ex-student a prescription for
these controlled substances. Only after Respondent was confronted with
a report from a dormitory resident director that he heard this person
boasting that he was able to obtain drugs from Respondent by deception,
did Respondent contact the psychiatrist who informed Respondent that
the ``prescription'' was, indeed, not authentic.
Another person, who was a student at KSU from 1967 to 1976, was
treated by Respondent from about 1975 to 1986 or 1987. Respondent
indicated that he treated this person for chronic anxiety. Respondent
prescribed Valium for this person on a consistent basis, despite being
warned by a pharmacist in 1983 that this person ``bugged'' physicians
to obtain controlled substances he desired and despite Respondent's own
admission in 1985 that he was prescribing too much Valium to this
person. He often issued these prescriptions based only on telephone
conversations with this individual, who lived fifty miles from the KSU
campus.
In 1990, Respondent was interviewed by a DEA investigator about the
Valium prescriptions he issued to this ex-student and if Respondent
suspected this individual was addicted. Respondent replied that he had
no reason to suspect such a problem because the individual had
reassured Respondent that he was not addicted and that Respondent
believed there was a difference between abuse and addiction.
In December of 1987, Respondent asked another KSU Health Center
physician to issue Respondent a prescription (which was undated) for
forty dosage units of Percodan, a Schedule II controlled substance, in
anticipation of surgery. Respondent altered this prescription by
changing it to fifty dosage units of Demerol, another Schedule II
controlled substance. During a subsequent Pharmacy Board hearing, the
physician who signed the prescription believed, but was not absolutely
certain, that he signed the prescription before it was altered. In any
event, Respondent admitted that he was the one who altered the
prescription.
Respondent wrote two prescriptions, for Percodan and Demerol, both
Schedule II controlled substances, in his own name in 1988. The purpose
of these prescriptions was to supply his own medical bag. In December
of 1990, Respondent issued as prescription for Ritalin, a Schedule II
controlled substance and authorized two refills. Schedule II
prescriptions are not allowed to be refilled. Respondent testified at
the hearing that he had no explanation for issuing the prescription
with two refills other than it was simply a mistake.
Although no criminal or administrative action by any state or
Federal agency was initiated against Respondent prior to these
proceedings, DEA and the Pharmacy Board did take action against other
participants involved in the controlled substance violations occurring
throughout the university. In October 1989, the Pharmacy Board filed an
accusation against the KSU Health Center pharmacy and its pharmacist
alleging violations, including: filling and maintaining prescriptions
known to have been written by physician assistants; filling and
maintaining an altered prescription for a Schedule II controlled
substance; providing controlled substances to the athletic department
pursuant to prescriptions; and providing controlled substances to the
psychology department pursuant to prescriptions. Following a hearing in
May of 1990, the Pharmacy Board found that these violations occurred
and that the university pharmacy and pharmacist were responsible for
such violations. The pharmacist was fined $500.00 and placed on
probation for five years. The pharmacy also was placed on probation for
the same period of time.
In August of 1990, DEA entered into a memorandum of understanding
with the KSU Psychology Department, in which the department agreed to
use DEA official order forms to obtain Schedule I and II controlled
substances; maintain proper records for receipt and disposition of
controlled substances; and generally comply with the Controlled
Substances Act and its attendant regulations.
Also, in August of 1990, DEA entered into a memorandum of
understanding with the KSU Health Service, in which the service agreed
to terminate the practice of distributing controlled substances to the
athletic facilities; to fill only those prescriptions signed by
physicians who were properly registered with DEA to issue them; to not
dispense controlled substances for research activities via
prescriptions or documents purporting to be prescriptions; to not
distribute controlled substances for physicians' medical bags; and to
maintain valid prescription and other records required by the
Controlled Substances Act and its attendant regulations.
In evaluating whether Respondent's continued registration by the
Drug Enforcement Administration would be inconsistent with the public
interest, as that term is used in 21 U.S.C. 824(a)4), the Deputy
Administrator considers the factors enumerated in 21 U.S.C. 823(f).
They are as follows:
(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 and
safety.
In determining whether a registrant's continued registration is
inconsistent with the public interest, the Deputy Administrator is not
required to make findings with respect to each of the factors listed
above. Instead, the Deputy Administrator has the discretion to give
each factor the weight he deems appropriate, depending upon the facts
and circumstances of each case. See David E. Trawick, D.D.S., Docket
No. 88-69, 53 FR 5326 (1988).
The Deputy Administrator concurs with the opinion and recommended
decision of the administrative law judge and finds that factors two,
four and five apply. Respondent, by writing unauthorized prescriptions
in order to distribute controlled substances to an unregistered
location, violated 21 CFR 1306.04(b). Respondent allowed athletic
trainers to dispense Schedule III and IV controlled substances to
athletes without any supervision by a physician in violation of 21
U.S.C. 829(b). The prescriptions written by Respondent for the
psychology department for purposes of conducting research on animals
and humans violated 21 CFR 1306.04 (a) and (b). Such ``prescriptions''
were not for individual patients, were not in the course of
Respondent's practice and were not for the purpose of dispensing to an
ultimate user as defined under 21 CFR 1306.02(f). Respondent authorized
physician assistants to issue and sign controlled substance
prescriptions to patients without direct supervision of a physician in
violation of 21 CFR 1306.03 and 1306.05(a).
By issuing a prescription to a student based upon an unsigned
document on which one of the controlled substances was misspelled,
Respondent again dispensed controlled substances in violation of 21
U.S.C. 829 (a) and (b). Respondent also issued Valium prescriptions to
an ex-student over a long period of time well after Respondent was
aware that this person was abusing this controlled substance. Although
Respondent's initial treatment with Valium of this person may have been
justified, the continued prescribing of Valium was not proper under 21
CFR 1306.04(a). Respondent authorized unregistered athletic training
room facilities to store and dispense controlled substances in
violation of 21 CFR 1301.12. Respondent also violated applicable
Federal law when he wrote several Schedule II controlled substance
prescriptions in 1988 for the purpose of supplying his medical bag. 21
CFR 1306.04(b).
By allowing physician assistants to prescribe controlled
substances, Respondent's actions violated applicable state law, Ohio
Administrative Code 4731-4-03(C) and 4731-4-01(A). Allowing the
psychology department to use controlled substances which were outdated
also violated applicable state law, Ohio Administrative Code, 4729-9-
01)B) and Ohio Revised Code 3715.52 (A) and (C).
The Deputy Administrator finds that Respondent committed these long
standing systemic violations despite warnings and, in one case, despite
an order to desist from the unlawful behavior. Respondent often
rationalized and tried to justify these violations to investigators as
well as during the hearing. Respondent, for example, made an
unsupported assertion that other universities employed similar systems
with regard to storing and dispensing controlled substances from their
athletic training rooms.
The administrative law judge in her opinion and recommended ruling,
findings of fact, conclusions of law and decision recommended that
Respondent's DEA registration be revoked. In his exceptions to the
administrative law judge's ruling, Respondent argues that such action
is not appropriate due to the fact that the state medical board took no
action against Respondent nor were any criminal changes filed against
Respondent based upon these acts. Revocation of a registration based
upon the public interest is intended to allow DEA to take action when
other law enforcement or regulatory agencies have not taken action. The
Deputy Administrator notes that action has been taken against other
registrants involved in these activities even though Respondent was a
key player, if not the initiator, in all of these illegal practices.
Respondent also argues that his actions did not result in
diversion. Respondent's conduct, however, resulted in controlled
substances being stored, dispensed and utilized outside of the closed
system created by DEA registration. Under these circumstances, the
potential for diversion of controlled substances is increased. It is
not a valid defense to violate controlled substance laws and then, in
hindsight, claim that such violations are of no matter because no
illicit use of controlled substances actually resulted. If no actual
abuse of the controlled substances occurred, it was in spite of, and
not because of, Respondent's illegal actions. Moreover, Respondent's
actions of prescribing controlled substances based upon an obviously
forged document and the continual prescribing of Valium to an ex-
student when Respondent knew this person was abusing Valium, can
certainly be characterized as diversion.
Respondent additionally argues that DEA has not alleged, much less
proven, any violations since 1989 (with the exception of the December
1990 Schedule II prescription which authorized two refills) and
therefore revocation is not justified. This argument fails to account
for the fact that Respondent continually ignored warnings and even
directives that his conduct was unlawful. It was not until various
agencies initiated investigations that the university made any
substantial changes to comply with applicable controlled substance
laws. Moreover, Respondent's continual rationalizations and
disingenuous statements both at the hearing and to investigators, gives
DEA no assurance that he will not resume his cavalier behavior
regarding controlled substances.
Under these circumstances, the Deputy Administrator cannot be
assured that the public interest will be protected if Respondent is
allowed to retain his registration at this time. The Deputy
Administrator concurs with the administrative law judge's
recommendation and also orders that a new application for registration
shall be considered no earlier than one year after the effective date
of this final order and only after a convincing showing by Respondent
of his rehabilitation.
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 (59 FR 23637), hereby orders
that DEA Certificate of Registration, AC0808076, previously issued to
Jay Wheeler Cranston, M.D., be, and it hereby is, revoked, and any
pending applications for the renewal of such registration, be, and they
hereby are, denied. Furthermore, no new application will be considered
until at least one year from the effective date of this final order.
This order is effective August 18, 1994.
Dated: July 13, 1994.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 94-17417 Filed 7-18-94; 8:45 am]
BILLING CODE 4410-09-M
