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Thursday, January 1, 2015
Oklahoma Board of Pharmacy Revokes Pharmacists License for aking or filing a report or record that he knew or should have known to be false; billing or charging for quantities greater than delivered or for a brand when a generic or a compounded product is dispensed; and submitting fraudulent billing or reports to a third-party payer of prescription drugs
Guy Sheneman, DPh #9806 – Case No. 1295: Admitted
to guilt on 45 counts, including making or filing a report
or record that he knew or should have known to be false;
billing or charging for quantities greater than delivered
or for a brand when a generic or a compounded product
is dispensed; and submitting fraudulent billing or reports
to a third-party payer of prescription drugs (for example,
intentional billing for Aggrenox® name brand when aspirin
81 mg was dispensed; billing for Flovent® HFA when
Ventolin® HFA was dispensed; billing for Abilify® when
n-acetylcysteine was dispensed; billing for Lunesta® when
zolpidem was dispensed). During the partial period audited
by the Board, there was an aggregate overbilling of about
$351,496.85. Respondent agrees that he will never again
own a pharmacy, an interest in a pharmacy, or an interest
in an entity that owns a pharmacy. Respondent agrees to
never work in a pharmacy again in any position, whether
paid or unpaid. Revoked.
quoted from here
to guilt on 45 counts, including making or filing a report
or record that he knew or should have known to be false;
billing or charging for quantities greater than delivered
or for a brand when a generic or a compounded product
is dispensed; and submitting fraudulent billing or reports
to a third-party payer of prescription drugs (for example,
intentional billing for Aggrenox® name brand when aspirin
81 mg was dispensed; billing for Flovent® HFA when
Ventolin® HFA was dispensed; billing for Abilify® when
n-acetylcysteine was dispensed; billing for Lunesta® when
zolpidem was dispensed). During the partial period audited
by the Board, there was an aggregate overbilling of about
$351,496.85. Respondent agrees that he will never again
own a pharmacy, an interest in a pharmacy, or an interest
in an entity that owns a pharmacy. Respondent agrees to
never work in a pharmacy again in any position, whether
paid or unpaid. Revoked.
quoted from here
Oklahoma Board of Pharmacy Reminds of Specific Regulations Regarding Clinical Drug Studies
15.03. Clinical Drug Studies
The federal government has very specific regulations
that deal with drug studies involving human patients. These
regulations include requirements and documentation for
informed consent by the study participants. In most cases,
each clinical trial in the US must be approved and monitored
by an Institutional Review Board (IRB) to ensure that the
risks are minimal and are worth any potential benefits. An
IRB is an independent committee that consists of physicians,
statisticians, and members of the community who ensure that
clinical trials are ethical and that the rights of participants
are protected. Federal regulation requires all institutions in
the US that conduct or support biomedical research involving
people to have an IRB initially approve and periodically
review the research. A clinical study is led by a principal
investigator, who is often a doctor. Members of the research
team regularly monitor the participants’ health to determine
the study’s safety and effectiveness. Charging patients for
medications in a clinical trial is governed by 21 CFR 312.8(a)
and (b). In most cases, a study sponsor must obtain prior
written authorization from Food and Drug Administration
to charge for drugs used in an investigational drug study,
and under 21 CFR 312.8(d)(1), a sponsor may recover only
the direct costs of making its investigational drug available.
Pharmacies and pharmacists must exercise caution in
their involvement in a business model that purports to be a
“study” or “survey” involving human patients, and ensure
that if they are involved in such a study, they have followed
all applicable federal regulations. In the absence of a real
“study,” a pharmacist or pharmacy that pays a prescriber to
write prescriptions as a study director or medical advisor
may be in violation of Board regulations and rules as well as
both state and federal anti-kickback statutes. Additionally,
prescribers who are requested to be participants in a drug
“study” should request and review a copy of the official IRB
study protocols and applicable federal study approvals before
accepting a role in the study. In the absence of following the
federal regulations that apply to human drug studies, prescribers
may also be charged with state and federal law violations
quoted from here
The federal government has very specific regulations
that deal with drug studies involving human patients. These
regulations include requirements and documentation for
informed consent by the study participants. In most cases,
each clinical trial in the US must be approved and monitored
by an Institutional Review Board (IRB) to ensure that the
risks are minimal and are worth any potential benefits. An
IRB is an independent committee that consists of physicians,
statisticians, and members of the community who ensure that
clinical trials are ethical and that the rights of participants
are protected. Federal regulation requires all institutions in
the US that conduct or support biomedical research involving
people to have an IRB initially approve and periodically
review the research. A clinical study is led by a principal
investigator, who is often a doctor. Members of the research
team regularly monitor the participants’ health to determine
the study’s safety and effectiveness. Charging patients for
medications in a clinical trial is governed by 21 CFR 312.8(a)
and (b). In most cases, a study sponsor must obtain prior
written authorization from Food and Drug Administration
to charge for drugs used in an investigational drug study,
and under 21 CFR 312.8(d)(1), a sponsor may recover only
the direct costs of making its investigational drug available.
Pharmacies and pharmacists must exercise caution in
their involvement in a business model that purports to be a
“study” or “survey” involving human patients, and ensure
that if they are involved in such a study, they have followed
all applicable federal regulations. In the absence of a real
“study,” a pharmacist or pharmacy that pays a prescriber to
write prescriptions as a study director or medical advisor
may be in violation of Board regulations and rules as well as
both state and federal anti-kickback statutes. Additionally,
prescribers who are requested to be participants in a drug
“study” should request and review a copy of the official IRB
study protocols and applicable federal study approvals before
accepting a role in the study. In the absence of following the
federal regulations that apply to human drug studies, prescribers
may also be charged with state and federal law violations
quoted from here
Beware of your Requirements as an Oklahoma Licensed PIC--Phantom PICS Will Not be Tolerated
15.02. Phantom PICs
The Board has received several questions from Oklahomalicensed
pharmacists who have been approached by outof-state
pharmacies asking them to be employed as their
pharmacist-in-charge (PIC) for their Oklahoma license, and
suggesting to the pharmacists that they do not have to actually
work at the pharmacy. A term for this might be an “absent”
or “phantom” PIC. This situation is no doubt occurring more
frequently due to the new requirement that nonresident pharmacies
that do sterile compounding must have an Oklahomalicensed
PIC. In one case, the Oklahoma-licensed pharmacist
was not even living in the United States at the time of the
employment offer; the pharmacy just wanted a pharmacist
with an Oklahoma license to sign its application or renewal
in a fraudulent attempt to meet the legal requirement. The
required PIC duties for an Oklahoma-licensed pharmacist
include accepting the full responsibility of all aspects of the
pharmacy’s operation, responsibility for controlled and noncontrolled
drugs in the pharmacy, as well as
(A) supervision of all employees as they relate to the
practice of pharmacy;
(B) establishment of policies and procedures for safekeeping
of pharmaceuticals that satisfy Board requirements,
including security provisions when the
pharmacy is closed;
(C) maintaining a proper record-keeping system for the
purchase, sale, delivery, possession, storage, and
safekeeping of drugs;
(D) proper display of all licenses;
(E) annual controlled drug inventory; and
(F) maintenance of prescription files.
Notably, OAC 535:15-3-2(b)(4) states: “A pharmacy
manager shall work sufficient hours in the pharmacy to exercise
control and meet the responsibilities of the pharmacy
manager.”
OAC 535:15-3-2(c)(1) states: “Where the actual identity
of the filler of a prescription is not determinable, the manager
of the pharmacy and the pharmacy where the prescription was
filled will be the subject of any charges filed by the Board
of Pharmacy.” And OAC 535:15-3-2(c)(4) states that the
pharmacy manager must “[e]stablish and maintain effective
controls against the diversion of prescription drugs into other
than legitimate medical, scientific, or industrial channels as
provided by federal, state or local laws or rules.”
It would not be possible for a PIC to exercise and fulfill
these responsibilities without being physically present in the
pharmacy a substantial amount of time. Keep in mind the
legal aspects of the responsibilities that are assumed if you
are approached by a pharmacy for a position as “phantom”
or “absent” PIC
quoted from here
The Board has received several questions from Oklahomalicensed
pharmacists who have been approached by outof-state
pharmacies asking them to be employed as their
pharmacist-in-charge (PIC) for their Oklahoma license, and
suggesting to the pharmacists that they do not have to actually
work at the pharmacy. A term for this might be an “absent”
or “phantom” PIC. This situation is no doubt occurring more
frequently due to the new requirement that nonresident pharmacies
that do sterile compounding must have an Oklahomalicensed
PIC. In one case, the Oklahoma-licensed pharmacist
was not even living in the United States at the time of the
employment offer; the pharmacy just wanted a pharmacist
with an Oklahoma license to sign its application or renewal
in a fraudulent attempt to meet the legal requirement. The
required PIC duties for an Oklahoma-licensed pharmacist
include accepting the full responsibility of all aspects of the
pharmacy’s operation, responsibility for controlled and noncontrolled
drugs in the pharmacy, as well as
(A) supervision of all employees as they relate to the
practice of pharmacy;
(B) establishment of policies and procedures for safekeeping
of pharmaceuticals that satisfy Board requirements,
including security provisions when the
pharmacy is closed;
(C) maintaining a proper record-keeping system for the
purchase, sale, delivery, possession, storage, and
safekeeping of drugs;
(D) proper display of all licenses;
(E) annual controlled drug inventory; and
(F) maintenance of prescription files.
Notably, OAC 535:15-3-2(b)(4) states: “A pharmacy
manager shall work sufficient hours in the pharmacy to exercise
control and meet the responsibilities of the pharmacy
manager.”
OAC 535:15-3-2(c)(1) states: “Where the actual identity
of the filler of a prescription is not determinable, the manager
of the pharmacy and the pharmacy where the prescription was
filled will be the subject of any charges filed by the Board
of Pharmacy.” And OAC 535:15-3-2(c)(4) states that the
pharmacy manager must “[e]stablish and maintain effective
controls against the diversion of prescription drugs into other
than legitimate medical, scientific, or industrial channels as
provided by federal, state or local laws or rules.”
It would not be possible for a PIC to exercise and fulfill
these responsibilities without being physically present in the
pharmacy a substantial amount of time. Keep in mind the
legal aspects of the responsibilities that are assumed if you
are approached by a pharmacy for a position as “phantom”
or “absent” PIC
quoted from here
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