Registrant Actions - 2012
[Federal Register Volume 77, Number 116 (Friday, June 15, 2012)]
[Notices]
[Pages 36003-36008]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14653]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Patrick K. Chau, M.D.; Decision and Order
On August 8, 2011, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Patrick K. Chau, M.D. (Registrant), of Vancouver,
Washington. The Show Cause Order proposed the revocation of
Registrant's DEA Certificate of Registration BC1983659, which
authorizes him to dispense controlled substances as a practitioner,
[[Page 36004]]
and the denial of any pending application to renew or modify his
registration, on the ground that his "continued registration is
inconsistent with the public interest." GX 3, at 1 (citing 21 U.S.C.
823(f) & 824(a)(4)).
More specifically, the Show Cause Order alleged that between
February 20 and March 27, 2009, Registrant had issued prescriptions for
alprazolam, a schedule IV controlled substance, to two undercover
officers, without a legitimate medical purpose and outside the usual
course of professional practice, in violation of 21 CFR 1306.04(a) and
Wash. Rev. Code Sec. 18.130.180(4). Id. at 1-2. The Show Cause Order
further alleged that on October 15, 2009, the State of Washington's
Medical Quality Assurance Commission issued an order prohibiting
Registrant from prescribing controlled substances and that Registrant
is therefore without authority to prescribe controlled substances in
the State in which he is registered with DEA. Id. at 2. Finally, the
Show Cause Order notified Registrant of his right to request a hearing
on the allegations or to submit a written statement regarding the
matters of fact and law raised in the Order in lieu of a hearing, the
procedures for doing either, and the consequences for failing to do
either. Id. (citing 21 CFR 1301.43(a), (c), (d), & (e)).
As evidenced by the signed return receipt card, the Government
accomplished service on or about August 11, 2011. GX 4. Since the date
of service of the Show Cause Order, more than thirty days have now
passed and neither Registrant, nor anyone purporting to represent him,
has either filed a request for a hearing or submitted a written
statement in lieu thereof. Accordingly, I find that Registrant has
waived both his right to a hearing and his right to submit a written
statement in lieu of a hearing. 21 CFR 1301.43(e). I therefore issue
this Decision and Order based on relevant evidence contained in the
Investigative Record submitted by the Government. I make the following
findings.
Findings
Registrant is the holder of DEA Certificate of Registration
BC1983659, which authorizes him to dispense controlled substances in
schedules II through V as a practitioner at the registered location of
6816 NE Highway 99, Suite 108, Vancouver, Washington. GX 1. While this
registration was due to expire on August 31, 2010, on August 30, 2010,
Registrant submitted a renewal application. GX 2. Accordingly, I find
that Registrant's registration has remained in effect pending the
issuance of the Final Order in this matter. 5 U.S.C. 558(c).
Registrant, who is a board-certified psychiatrist, is also the
holder of a license to practice as a physician and surgeon issued by
the State of Washington. GX 6, at 2. On October 1, 2009, Registrant
entered into a Stipulated Findings of Fact, Conclusions of Law and
Agreed Order with the State's Medical Quality Assurance Commission
(hereinafter, MQAC or Commission); the MQAC accepted the Order on
October 15, 2009. Id. at 24.
The MQAC's Order contained extensive findings regarding
Registrant's prescribing of controlled substances to numerous patients.
See id. at 3-17. For example, the MQAC found that Registrant had
"violated the standard of care in the following ways" in treating
Patient B, noting that:
Patient B was on addicting doses of benzodiazepines and opioids
when he started seeing [Registrant]. At that point, [Registrant]
should have had Patient B detoxified rather than continue to support
his treatment, and over time, increased the prescribed amounts of
addictive medications.
[Registrant] increased Patient B's already addictive and
dangerous doses of opioids and benzodiazepines. In addition, there
is no evidence of much, if any, resulting improvement to the
patient's condition.
[Registrant's] prescriptions of large amounts of opioids likely
caused Patient B to become addicted to narcotics. [Registrant]
failed to consider and try Patient B on non-addictive alternatives
to treat his headaches.
Id. at 5-6. The MQAC thus found that "[a]s a result, [Registrant]
harmed, or created an unreasonable risk of harm, to Patient B." Id. at
6.
The MQAC further found that Registrant "has engaged in a pattern
of prescribing high doses and large amounts of addicting medication,
particularly benzodiazepines, to new patients who claimed to need
ongoing treatment at such doses, but who also provided rationales for
transferring their care to [Registrant], such as that they recently
moved from another state or part of this state, or that they changed or
lost their insurance." Id. at 7. The Commission then found that in
numerous instances Registrant "did not obtain any records or otherwise
verify [a patient's] treatment history." See id. at 7-13 (Patients D,
E, F, G, H, I, J, K, L, M, N, O, P, Q, & R). Moreover, with respect to
Patients D through R, the MQAC found that Registration violated the
standard of care by:
Failing to recognize that the patients were on addicting doses
of medication and refer them to an appropriate detoxification
facility.
Repeatedly providing new patients with three-month supplies of
high doses of addictive medications without planning to see the
patients for three months.
Ignoring possible drug-seeking and diversion behaviors, and not
requesting medical records from other providers or otherwise
substantiating the patients' reported treatment and prescription
histories. As a result, [Registrant] placed these patients at an
unreasonable risk of harm.
Id. at 13.
The MQAC catalogued additional violations by Registrant of the
standard of care with respect to several of the patients. With respect
to Patient K, the MQAC found that Registrant "violated the standard of
care * * * by prescribing two benzodiazepines, both at addicting
doses." Id. Next, the MQAC found that Registrant "violated the
standard of care in prescribing OxyContin to Patient M and Norco to
Patient N because he did not document that they suffered from current
pain complaints." Id. at 14.
With respect to Patient S, the MQAC found that he had told
Registrant "that his symptoms improved when he tried two milligrams of
Xanax supplied by 'other people.'" Id. Registrant "prescribed a daily
regimen of eight milligrams of Xanax, wrote for a three-month supply,
and asked the patient to return in three months. The patient returned
one month early * * * at which time [Registrant] increased the
prescription to ten milligrams per day and again wrote for a three-
month supply." Id. The Commission also found that approximately two
months later, "Patient S told [Registrant] that he was leaving the
area for a summer job in Alaska and that he needed a 90-day supply of
Xanax to last him for that period. [Registrant] provided the requested
prescription." Id.
Regarding his prescribing to Patient S, the MQAC found that
Registrant violated the standard of care, explaining that:
He started the patient on an unduly high and addictive dose of
Xanax instead of starting at a safer, lower dose and titrating up if
warranted. He also disregarded signs that the patient was drug-
seeking and possibly diverting. In accepting the patient's claim
that he needed a 90-day supply of Xanax because he was going to work
in Alaska for the summer, [Registrant] accepted at face value a
brief note to that effect that the patient provided. The note was
purportedly written by another of [Registrant's] patients.
Id.
Based on these and other findings, the MQAC concluded that
Registrant had "committed unprofessional conduct" in violation of RCW
18.130.180(4), (8)(a), and (9). Id. at 18. The Commission placed
Registrant's medical license on probation and prohibited him from
[[Page 36005]]
prescribing controlled substances, explaining that it "will not lift
this restriction unless the Center for Personalized Education for
Physicians in Denver, Colorado * * * determined that [Registrant] can
prescribe safely and with reasonable skill and without posing an
unreasonable risk of harm to the public." Id.
On February 20, 2009, a DEA Special Agent (S/A) made an undercover
visit to Registrant. During the visit, which was recorded, Registrant
explained that he is a psychiatrist and asked the S/A if he was looking
for psychiatric services and that his fee was $140, which the S/A paid
in cash. GXs 8 & 9. The S/A told Registrant that he had a friend in
Seattle who was giving him Xanax and that his girlfriend had also given
him some of the drug. GX 9. Registrant asked the S/A to tell him about
his symptoms; the SA replied that he had a friend who gave him a couple
of pills, stated that he was really relaxed and "just more relaxed
after" taking the drug, that "I feel better after I take the pill,"
and "I definitely feel better after than before." Id. Registrant than
asked the S/A whether anyone in his family had anxiety; the S/A denied
that anyone in his family had "an anxiety problem." Id. Registrant
then reviewed some type of agreement with the S/A, and after completing
this, Registrant stated that "my diagnosis for you is some sort of
general anxiety problem." Id.
However, at no point during the visit, did the S/A state that he
felt anxious. Registrant nonetheless gave the S/A a prescription for 90
tablets of Xanax 1mg. GX 10.
The Government also submitted a recording of a second undercover
visit, which was conducted on March 27, 2009 by a different S/A. In his
affidavit, the S/A stated that he had paid $140 cash; that he told
Registrant that he had been referred by the S/A, who had performed the
previous visit; and that Registrant gave him a prescription for 73
tablets of Xanax 1mg. GX 11, at 1-2; see also GX 13 (copy of Rx).
During the visit, the S/A told Registrant that he had not seen a
doctor in a long time, and after confirming that he lived in Seattle,
the S/A denied having a doctor in Seattle, stating that he was
"actually pretty healthy to be honest with you." After discussing the
S/A's purported job, Registrant asked the S/A to "tell me about what
kind of symptoms you would like me to help you with?" The S/A
answered: "Well actually * * * I'm not doing bad, I'm doing very
good." Registrant replied: "OK," and asked the S/A why he wanted to
see him. The S/A explained he wanted to get some Xanax and when asked
to explain why, stated that "the only reason I can think of is it
makes me feel good when I take it. Can't think of anything else to be
honest with you."
Registrant then asked the SA if he had previously taken Xanax; the
S/A replied that he had taken it about two years ago. Registrant asked
the S/A why he had then taken Xanax; the S/A stated: "the same reason
really." After Registrant asked: "You feel relaxed"?; the S/A said:
"It makes me feel good," and that he had bought it on the street
then, but that it was too expensive. After discussing the price the S/A
had paid on the street, Registrant asked: "Can you tell me the benefit
when you taking it? Like when you're on it compared to when you're not
on it? And the difference to justify the benefit, the reason you pay
money to take it?" The S/A answered: "It just makes me feel good. I
mean in general."
Registrant then asked if a doctor had "ever formally
prescribe[d]" the drug; the S/A stated "No, No, I'll be honest with
you." Next, Registrant asked if the Xanax helped him sleep; the S/A
denied having any problem sleeping. Registrant then asked: "And in the
way you feel good that means you're relaxed? Able to do your job
better? Is that right?" The SA responded: "I don't know if I could
say that. I'm trying to be honest with you. I'm not trying to lie to
you." Registrant then told the SA to "try to justify the reason you
come to visit me and to get the medication and so there's a reason. It
just feels good. If you don't take it, if you feel good also, that
might not be really reasonable right?" The S/A replied "right," and
Registrant continued, stating: "So in order for you to pay that much
money and to come all the way to see me you must have some reason you
want to do so." The S/A stated: "right, right, right. It just makes
me feel better in general." Registrant remarked: "General well-being.
So I suppose it takes away some kind of a tense, some kind of anxiety
feeling." The S/A replied: "well if we've * * * if that. If we've
gotta say that, yes we can say that if we've gotta say that, yes."
Registrant responded that "anxiety is not like a panic that comes
and goes and for some kind of anxiety that is pervasive always there,
and that if the anxiety is being resolved and the people feel liberated
from those feelings, that's how you feel better or general sense of
well-being." The S/A replied: "I mean if we have to say that, general
well-being then you know, let's say that. I thank God I'm doing very
good in everything, really, you know." Registrant then stated:
So what I would do since there's not a very severe degree of
symptom and may not be as drastic as other people I've had and
there's also a considerable benefit like that you tell me that makes
you come all the way. So what I would call a middle of the road
approach, ok? Of course I believe you are not selling drugs either
and not trying to take the medicine from me to go to the streets
sell eighty bucks a pill. So I have to trust the best of you. You go
to a lawyer, the lawyer have to trust you instead of think that
you're bad. Otherwise, won't be a client relationship.
Continuing, Registrant said that in "this good willing or good faith,
I would give you a try, ok, a preliminary trial of medication," but
that it wouldn't be "what you get from the street but according to our
standard of trial I will start you on a very preliminary dose."
Registrant then explained his dosing regimen and that he would not give
the S/A more than a one-month prescription for a patient that had not
been receiving the medication on an ongoing basis from another doctor.
Registrant further said that he was "fighting the State of
Washington over the controversial [sic] of prescribing Xanax and
Klonopin because some people doesn't want to, some people says it's
excess, but for me its justified for the patient's presentation. Except
in your case, we are ambiguous, ambiguity. So I want the patient to use
only one pharmacy." Registrant then told the S/A that he would have to
use a local WalMart pharmacy and required him to sign an agreement for
their "mutual protection," which required that he use only one
pharmacy, that he was not on methadone or heroin, that he would not
divert or sell the controlled substance to others, and that he would
not have more than one doctor prescribe the same class of controlled
substances.
Subsequently, in between small talk, Registrant asked the S/A
whether he had "any other physical illness" and whether family
members "have any anxiety problem"; the S/A answered: "No, they're
doing great." Registrant then calculated the number of tablets he was
prescribing per his dosing regimen and wrote out the prescription,
which he then gave to the S/A.
Discussion
Section 304(a) of the Controlled Substances Act (CSA) provides that
"[a] registration pursuant to section 823 of this title to * * *
dispense a controlled substance * * * may be suspended or revoked by
the Attorney General upon a finding that the registrant * * * has
committed such acts as would render his registration under section 823
of this title inconsistent with the public interest as determined under
such
[[Page 36006]]
section." 21 U.S.C. 824(a)(4). In making the public interest
determination in the case of a practitioner, Congress directed 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 * * * 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.
21 U.S.C. 823(f).
"[T]hese factors are considered in the disjunctive." Robert A.
Leslie, 68 FR 15227, 15230 (2003). I may rely on any one or a
combination of factors and may give each factor the weight I deem
appropriate in determining whether to revoke an existing registration
or to deny an application. Id. Moreover, while I "must consider each
of these factors, [I] 'need not make explicit findings as to each
one.'" MacKay v. DEA, 664 F.3d 808, 816 (10th Cir. 2011) (quoting
Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009)); see also Hoxie v.
DEA, 419 F.3d 477, 482 (6th Cir. 2005) (citing Morall v. DEA, 412 F.3d
165, 173-74 (DC Cir. 2005)).
With respect to a practitioner's registration, the Government bears
the burden of proving by substantial evidence that the continuation of
a registration would be inconsistent with the public interest. Cf. 21
CFR 1301.44(d).\1\ In this matter, I have considered all of the factors
and conclude that the evidence with respect to factors one, two, and
four supports a finding that Registrant's continued registration would
be inconsistent with the public interest.
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\1\ As found above, Registrant neither requested a hearing nor
submitted a written statement explaining his position on the matters
of fact and law asserted. By contrast, in a contested case, where
the Government satisfies its prima facie burden, as for example, by
showing that a registrant has committed acts which are inconsistent
with the public interest, the burden then shifts to the registrant
to demonstrate why he can be entrusted with a registration. Medicine
Shoppe-Jonesborough, 73 FR 363, 380 (2008).
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Factor One--The Recommendation of the State Licensing Board
As found above, on October 15, 2009, the MQAC adopted the Agreed
Order which Registrant has previously entered into, pursuant to which
Registrant is prohibited from prescribing controlled substances under
Washington law. See Rev. Code Wash. Sec. 18.130.160(3) (authorizing a
"[r]estriction or limitation of [license's holder's] practice"); id.
Sec. 18.130.180(9) (providing that "[f]ailure to comply with an order
issued by the disciplining authority or a stipulation for informal
disposition entered into with the disciplining authority" is
unprofessional conduct).
The CSA defines "the term 'practitioner' [to] mean [] a * * *
physician * * * or other person licensed, registered or otherwise
permitted, by * * * the jurisdiction in which he practices * * * to
distribute, dispense, [or] administer * * * a controlled substance in
the course of professional practice." 21 U.S.C. 802(21). Consistent
with this definition, Congress, in setting the requirements for
obtaining a practitioner's registration, provided that "[t]he Attorney
General shall register practitioners * * * if the applicant is
authorized to dispense * * * controlled substances under the laws of
the State in which he practices." 21 U.S.C. 823(f).
Accordingly, because one cannot obtain a practitioner's
registration unless one holds authority under state law to dispense
controlled substances, and because where a registered practitioner's
state authority has been revoked or suspended, the practitioner no
longer meets the statutory definition of a practitioner, DEA has
repeatedly held that the possession of authority to dispense controlled
substances under the laws of the State in which a practitioner engages
in professional practice is a fundamental condition for both obtaining
and maintaining a practitioner's registration.\2\ See, e.g., Calvin
Ramsey, 76 FR 20034, 20036 (2011); Dominick A. Ricci, 58 FR 51104,
51105 (1993); Bobby Watts, 53 FR 11919, 11920 (1988). Because the CSA
expressly conditions the holding of a practitioner's registration on
the practitioner's being "authorized to dispense controlled substances
under the laws of the State in which he practices," id., and also
limits the definition of the term "practitioner" to a physician who
is licensed, registered or otherwise permitted to dispense a controlled
substance in the course of professional practice, id. Sec. 802(21),
and Registrant, by virtue of the Agreed Order, is no longer authorized
under his license to dispense a controlled substance, this factor
provides reason alone to revoke his registration.
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\2\ To effectuate this requirement, in 21 U.S.C. 843(a)(3),
Congress also granted the Attorney General authority to revoke a
registration "upon a finding" that a registrant "has had his
State license or registration suspended, revoked, or denied by
competent State authority and is no longer authorized by State law
to engage in the * * * dispensing of controlled substances."
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Factors Two and Four--Registrant's Experience in Dispensing Controlled
Substances and Record of Compliance With Applicable Laws Related to
Controlled Substances
The MQAC Findings
As found above, the MQAC found that Registrant had repeatedly
violated the standard of care and committed unprofessional conduct in
prescribing controlled substances to numerous patients. More
specifically, the MQAC found that Registrant had committed
"[i]ncompetence, negligence, or malpractice which results in injury to
a patient or which creates an unreasonable risk that a patient may be
harmed." GX 6, at 18 (citing Rev. Code Wash. Sec. 18.130.180(4)). The
MQAC also found that Registrant committed unprofessional conduct by
"[f]ail[ing] to cooperate with the disciplinary authority," as well
as by "[f]ail[ing] to comply with an order issued by the disciplinary
authority," id. (citing Rev. Code Wash. Sec. 18.130.180(8) & (9)).
However, the MQAC did not find that Registrant had prescribed
controlled substances "other than for legitimate or therapeutic
purpose" or that he diverted controlled substances, in violation of
Rev. Code Wash. Sec. 18.130.180(6)).\3\ Id.
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\3\ Under a longstanding DEA regulation, a prescription for a
controlled substance is not "effective" unless it is "issued for
a legitimate medical purpose by an individual practitioner acting in
the usual course of his professional practice." 21 CFR 1306.04(a).
This regulation further provides that "[a]n order purporting to be
a prescription issued not in the usual course of professional
treatment * * * is not a prescription within the meaning and intent
of [21 U.S.C. 829] and * * * the person issuing it, shall be subject
to the penalties provided for violations of the provisions of law
relating to controlled substances." Id.
As the Supreme Court has explained, "the prescription
requirement * * * ensures patients use controlled substances under
the supervision of a doctor so as to prevent addiction and
recreational abuse. As a corollary, [it] also bars doctors from
peddling to patients who crave the drugs for those prohibited
uses." Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (citing United
States v. Moore, 423 U.S. 122, 135 (1975)).
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As I have previously acknowledged,\4\ numerous federal courts of
appeal have held "the offense of unlawful
[[Page 36007]]
distribution requires proof that the practitioner's conduct went
'beyond the bounds of any legitimate medical practice, including that
which would constitute civil negligence.'" Laurence T. McKinney, 73 FR
43260, 43266 (quoting United States v. McIver, 470 F.3d 550, 559 (4th
Cir. 2006)). See also United States v. Feingold, 454 F.3d 1001, 1010
(9th Cir. 2006) (The Supreme Court in United States v. Moore, 423 U.S.
122 (1975), "based its decision not merely on the fact that the doctor
had committed malpractice, or even intentional malpractice, but rather
on the fact that his actions completely betrayed any semblance of
legitimate medical treatment.").
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\4\ I also assume, without deciding, that the facts as found by
the MQAC in the Agreed Order do not establish a violation of 21 CFR
1306.04(a). But see George Mathew, M.D., 75 FR 66138, 66146 (2010)
(rejecting MQAC's finding that physician had not diverted controlled
substances when "[s]everal Federal courts of appeals have held that
conduct similar to what the MQAC found [the physician] to have
engaged in by prescribing over the Internet violates the
prescription requirement of Federal law and constitutes an unlawful
distribution under 21 U.S.C. 841(a)"), pet. for rev. denied, Mathew
v. DEA, No. 10-73480, slip op. at 5 (9th Cir. Mar. 16, 2012).
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However, as the Agency has explained in multiple cases, "the
Agency's authority to deny an application [and] to revoke an existing
registration * * * is not limited to those instances in which a
practitioner intentionally diverts a controlled substance." Bienvenido
Tan, 76 FR 17673, 17689 (2011) (citing Paul J. Caragine, Jr., 63 FR
51592, 51601 (1998)); see also Dewey C. MacKay, 75 FR 49956, 49974
(2010), pet. for rev. denied 664 F.3d 808 (10th Cir. 2011). As Caragine
explained: "[j]ust because misconduct is unintentional, innocent, or
devoid of improper motive, [it] does not preclude revocation or denial.
Careless or negligent handling of controlled substances creates the
opportunity for diversion and [can] justify" the revocation of an
existing registration or the denial of an application for a
registration. 63 FR at 51601.
"Accordingly, under the public interest standard, DEA has
authority to consider those prescribing practices of a physician,
which, while not rising to the level of intentional or knowing
misconduct, nonetheless create a substantial risk of diversion."
MacKay, 75 FR at 49974. Likewise, "[a] practitioner who ignores the
warning signs that [his] patients are either personally abusing or
diverting controlled substances commits 'acts inconsistent with the
public interest,' 21 U.S.C. 824(a)(4), even if [he] is merely gullible
or na[iuml]ve." Jayam Krishna-Iyer, 74 FR 459, 460 n.3 (2009).
Here, even if the MQAC's findings do not establish that Registrant
engaged in intentional or knowing misconduct, they nonetheless
establish numerous instances in which he recklessly prescribed
controlled substances and that his prescribing practices created a
substantial risk of diversion and abuse. More specifically, the MQAC
found that Patient B was already on addictive doses of benzodiazepines
and opioids when he/she started seeing Registrant and that he should
have referred B to detoxification. Yet Registrant increased B's doses,
failed to try non-addictive alternatives, and as a result, B likely
became addicted. GX 6, at 5-6.
The MQAC further identified numerous other practices by Registrant
which created a substantial risk of diversion and abuse. For example,
the MQAC found that he "engaged in a pattern of prescribing high doses
and large amounts of addicting medication, particularly
benzodiazepines, to new patients who claimed to need ongoing treatment
at such doses," and who represented that they had either moved or
changed/lost their insurance, and yet Registrant "did not obtain any
records or otherwise verify [the patient's] treatment history." Id. at
7. Indeed, the MQAC identified fifteen patients who obtained controlled
substances from Registrant in this manner. Id. at 7-13. With respect to
each of these patients, the MQAC found that: (1) Registrant failed to
recognize that they were on addictive doses and refer them for
detoxification; (2) he repeatedly prescribed three-month supplies of
high doses of controlled substances "without planning to see the
patients for three months"; (3) he ignored "drug-seeking and
diversion behaviors"; and (4) he did not request the patient's medical
records from other providers and otherwise failed to "substantiat[e]
the patients' reported treatment and prescription histories." Id.
With respect to still another patient (K), the MQAC found that he
"violated the standard of care * * * by prescribing two
benzodiazepines, both at addicting doses." Id. at 13. In addition, the
MQAC found that Registrant prescribed OxyContin (a schedule II
controlled substance) to Patient M and Norco (hydrocodone, a schedule
III controlled substances) to Patient N but "did not document that
they suffered from current pain complaints." \5\ Id. at 14.
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\5\ No explanation was provided by the MQAC as to why these two
instances do not constitute violations of Rev. Code Wash. Sec.
18.130.180(6).
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Finally, the MQAC found that Patient S had told Registrant that he
had obtained Xanax from non-medical sources and yet started him at "an
unduly high and addictive dose" of eight milligrams a day and wrote
him a prescription for a three-month supply. Id. Yet, Patient S
returned one month early and at this visit, Registrant wrote him
another prescription for a three-month supply and increased his daily
dose to ten milligrams. Id. Moreover, two months later, Patient S
returned and said that he was going to take a summer job in Alaska and
needed a 90-day supply, and presented a note to this effect. Id.
Registrant issued the requested prescription to Patient S. The MQAC
found that Registrant had accepted at face value Patient S's
representation and that Registrant "disregarded signs that [Patient S]
was drug-seeking and possibly diverting." Id. at 14.
As the forgoing demonstrates, even if Respondent did not
intentionally divert controlled substances to any of the patients
identified in the MQAC's Order, the Order identified numerous instances
in which Respondent recklessly prescribed controlled substances to
persons who were likely engaged in either self-abuse or diversion.
Respondent's repeated failure to obtain the medical records for his
patients, as well as to otherwise verify their treatment histories and
other claims, created a substantial risk of diversion and abuse.
MacKay, 75 FR at 49974.
So too, Respondent's practice of "[r]epeatedly providing new
patients with three-month supplies of high doses of addictive
medications without planning to see the patients for three months,"
id. at 13, created a substantial risk that the patients were either
diverting the drugs or abusing them. As the Supreme Court explained in
Gonzales, one of the core purposes of the CSA's "prescription
requirement [is to] ensure[] [that] patients use controlled substances
under the supervision of a doctor so as to prevent addiction and
recreational abuse." 546 U.S. at 274 (other citation omitted). The
MQAC's Order makes clear that Respondent failed to properly monitor
numerous patients to ensure that they were not abusing or diverting the
drugs he prescribed to them.
Accordingly, I hold that the MQAC's findings alone support findings
under factors two and four that Registrant has committed acts which
render his registration "inconsistent with the public interest." 21
U.S.C. 824(a)(4). See also Tan 76 FR at 17689; Krishna-Iyer, 74 FR at
460 n.3; Caragine, 63 FR at 51601. I further hold that this finding
supports the revocation of Registrant's registration.
The DEA Undercover Visits
As found above, in February and March 2009, two S/As made
undercover visits to Registrant and at each visit, obtained Xanax
prescriptions. At the first visit, the S/A told Registrant that he had
gotten Xanax from both a friend and his girlfriend, and when Registrant
asked him to describe his symptoms, the
[[Page 36008]]
S/A reiterated that a friend had given him a couple of pills and that
he was just more relaxed after taking the drug, and that he felt better
after taking the drug. Significantly, at no point during the meeting
did the S/A relate that he had anxiety, and denied that anyone in his
family had anxiety.
Registrant then stated that he was diagnosing the S/A with some
sort of general anxiety problem. However, given that the S/A stated
that he was getting the pills from non-medical sources, and that when
asked to relate his symptoms, simply stated that the pills just made
him relax and that he felt better after taking the drug, I conclude
that substantial evidence supports a finding that Registrant lacked a
legitimate medical purpose and violated 21 CFR 1306.04(a) when he
prescribed Xanax to the first S/A.\6\
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\6\ While I have considered the audio recordings submitted in
this matter, in future cases such evidence must be accompanied by a
transcript.
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Likewise, when asked to relate what symptoms he wanted Registrant
to help him with, the second S/A stated that he wasn't doing badly but
was doing "very good" and that he actually wanted to get some Xanax.
When asked to explain why, the S/A explained that the drug made him
feel good when he took it. Subsequently, the second S/A made clear that
he had gotten Xanax off the street and that the drug had never been
prescribed to him. Upon further questioning by Registrant, the second
S/A again said that the drug made him feel good and denied that he had
any problem sleeping. Moreover, when asked whether taking Xanax helped
him relax and do his job better, the S/A said that he did not know that
he "could say that" and later added that the drug just made him
"feel better in general." Finally, after Registrant explained that
the S/A's statement suggested that taking the drug took "away some
kind of a tense, some kind of anxiety feeling," the S/A replied that
"if we have to say that, yes we can say that," but that he was
"doing very good in everything." Subsequently, Registrant stated that
the S/A's presentation of his reason for taking Xanax was ambiguous.
However, I conclude that there was nothing ambiguous in the S/A's
presentation because he never once acknowledged being anxious, and
repeatedly denied having symptoms or problems that would provide a
medical justification for prescribing the drug. Indeed, whenever
Registrant questioned him, the S/A response was that he took Xanax
because it just made him feel better. Accordingly, I conclude that
substantial evidence supports a finding that Registrant lacked a
legitimate medical purpose and violated 21 CFR 1306.04(a) when he
prescribed Xanax to the second S/A.
Registrant's prescribing of Xanax to the two S/As thus provides
additional support for my conclusion that he has committed acts which
render his registration "inconsistent with the public interest." 21
U.S.C. 824(a)(4). However, as explained above, the findings of the MQAC
are, by themselves, more than adequate to reach this conclusion and to
support the revocation of his registration.\7\
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\7\ It is acknowledged that there is no evidence that Registrant
has been convicted of an offense falling within factor three.
However, this is not dispositive of the public interest inquiry. See
MacKay, 664 F.3d at 817-18 (quoting Dewey C. MacKay, 75 FR 49956,
49973 (2010)). I also deem it unnecessary to make any findings under
factor five.
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Sanction
Having found that Registrant lacks state authority to dispense
controlled substances, and that he has committed numerous acts which
render his registration inconsistent with the public interest, I
conclude that the Government has made out a prima facie case for
revocation. Because Registrant failed to request a hearing or to submit
a written statement in lieu of a hearing, and has thus offered no
evidence to rebut the Government's prima facie case, I will order that
his registration be revoked and that any pending application be denied.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and
824(a)(4), as well as 28 CFR 0.100(b), I order that DEA Certificate of
Registration BC1983659, issued to Patrick K. Chau, M.D., be, and it
hereby is, revoked. I further order that any pending application of
Patrick K. Chau, M.D., to renew or modify his registration, be, and it
hereby is, denied. This Order is effective July 16, 2012.
Dated: June 5, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-14653 Filed 6-14-12; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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