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| Title: | Methods of Diversion and Effective Controls for Controlled Substances |
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| Body: | Practitioner Diversion
Awareness Conference
Methods of Diversion
Scott Brinks, Acting Unit Chief
LEGAL DISCLAIMER
The following presentation was accompanied by an
oral presentation on November 18-19, 2018, and does
not purport to establish legal standards that are not
contained in statutes, regulations, or other
competent law. Statements contained in this
presentation that are not embodied in the law are
not binding on DEA. Summaries of statutory and
regulatory provisions that are summarized in this
presentation do not purport to state the full extent of
the statutory and regulatory requirements of the
cited statutes and regulations. I have no financial
relationships to disclose.
2
U.S. Drug Enforcement Administration
Diversion Control Division
This presentation is for educational purposes only. This presentation may not be
further copied or used, with the embedded images and videos, without an independent
analysis of the application of the Fair Use doctrine.
Fair Use
Under section 107 of the Copyright Act of 1976, allowance is made for "Fair Use" for
purposes such as criticism, comment, news reporting, teaching, scholarship, education
and research.
Fair Use is a use permitted by the copyright statute that might otherwise be infringing.
Any potentially copyrighted material used in this presentation has been reviewed and
found to be used in a manner consistent with Fair Use. A completed Fair Use checklist
is attached.
Fair Use Act Disclaimer
3
U.S. Drug Enforcement Administration
Diversion Control Division
Course Objectives
.
Laws and Regulations - Review the
responsibilities and regulations that apply to
practitioners.
.
Practitioner Methods of Diversion - Identify
and discuss the schemes used to acquire
controlled substances.
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U.S. Drug Enforcement Administration
Diversion Control Division
Course Objectives
.
Staff Methods of Diversion - Identify and discuss
the schemes used to acquire controlled
substances.
.
Patient Methods of Diversion - Identify and
discuss the schemes used to acquire controlled
substances.
.
Effective Controls - List safeguards that a
practitioner can use to protect his/her medical
practice.
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U.S. Drug Enforcement Administration
Diversion Control Division
Questions to Discuss
At the completion of this block of instruction you will
be able to answer the following questions:
1.
Is a pharmacist obligated to fill a prescription
that is presented by a patient or demanded to be
filled by a practitioner?
2.
All applicants and registrants shall provide
effective controls and procedures to guard
against theft and diversion of controlled
substances?
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U.S. Drug Enforcement Administration
Diversion Control Division
Questions to Discuss
3.
What is the best safeguard to identify if a
patient is doctor shopping?
4.
Who has the potential to divert controlled
substances?
5.
By using EPCS, a practitioner can minimize the
potential of altered/forged prescriptions?
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U.S. Drug Enforcement Administration
Diversion Control Division
Objective #1
Laws and Regulations
Related To Practitioners
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U.S. Drug Enforcement Administration
Diversion Control Division
Practitioner
.
As a practitioner, your role in the proper
prescribing, administering, and dispensing of
controlled substances is critical to patients'
health and to safeguard society against the
diversion of controlled substances.
.
The DEA is committed to working jointly with
the medical community to ensure that
legitimate controlled substances are not being
diverted for illegal use.
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U.S. Drug Enforcement Administration
Diversion Control Division
.
All applicants and registrants shall provide
effective controls and procedures to guard
against theft and diversion of controlled
substances.
21 CFR §1301.71(a).
.
The responsibility for the proper prescribing
and dispensing of controlled substances is upon
the prescribing practitioner.
21 CFR §1306.04(a).
Regulations Applicable to
Practitioners
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U.S. Drug Enforcement Administration
Diversion Control Division
.
Prescription for a controlled substance must
be issued for a legitimate medical purpose
by an individual practitioner acting in the
usual course of professional practice but a
corresponding responsibility rests with the
pharmacist who fills the prescription.
21 CFR 1306.04(a).
Regulations Applicable to
Practitioners
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U.S. Drug Enforcement Administration
Diversion Control Division
.
Just because a prescription is presented by a
patient or demanded to be filled for a
patient by a doctor's office or a doctor, a
pharmacist is NOT obligated to fill the
prescription!
Regulations Applicable to
Practitioners
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U.S. Drug Enforcement Administration
Diversion Control Division
Laws Applicable to Doctors
1.
According to the CSA, a doctor may administer
prescribe or dispense a controlled substance if
the following exists:
a.
Legitimate medical purpose
b. Done "within the usual course of
professional practice"
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U.S. Drug Enforcement Administration
Diversion Control Division
Establishing Doctor/Patient
Relationships
.
Patient has a medical complaint.
.
Doctor takes medical history.
.
Physical examination is performed.
.
Logical connection between the above three
and the drug being prescribed.
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U.S. Drug Enforcement Administration
Diversion Control Division
Good Practices
.
Complete medical history
.
Medical examinations
.
Appropriate tests
.
Diagnosis
.
Treatment plan
.
Appropriate follow-up
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U.S. Drug Enforcement Administration
Diversion Control Division
Objective #2
Methods Of Diversion
By Practitioners
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U.S. Drug Enforcement Administration
Diversion Control Division
.
Money - Financial Gain
.
Fear
.
Stop Blackmail
.
Sexual Favors
.
Keep Business Going/Co-dependency
.
Addiction - Supply Family Members
.
Personal Use - Self Abuse
Motivations for Diversion
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U.S. Drug Enforcement Administration
Diversion Control Division
Case Study Background
.
Doctors office was located in a town of
approximately 3000 people in rural Ohio.
.
Doctors office was in an old gas station.
.
The undercover was DEA Agent from Parma (over
120 miles away).
.
Patients would line up down the street to get into
see the doctor.
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U.S. Drug Enforcement Administration
Diversion Control Division
Problems With Undercover Visit
What did the doctor do wrong?
.
No medical exam.
.
Doctor corrected his injury.
.
No exam room.
.
Parma - 120 miles away
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U.S. Drug Enforcement Administration
Diversion Control Division
20
.
Patient hinted that he used the oxycodone in the
past illegally.
.
Patient directed what controlled substances he
wanted.
.
Patient offered more cash for more drugs. The
doctor said next time after he was offered the extra
cash.
.
Patients were walking in and out during the exam.
Problems With Undercover Visit
U.S. Drug Enforcement Administration
Diversion Control Division
This is the patient chart from
the undercover office visit
that was played earlier.
.Progress notes written on "rapid
memo."
.A lot of the information on this
memo was never told to the
patient.
.This was the complete summary
that the doctor would write for
the patient visit.
.This was almost identical for all
patients.
Documentation
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U.S. Drug Enforcement Administration
Diversion Control Division
Signs Of Practitioner Diversion
Doing one or more of these does not make
prescribing illegal. It is the totality of the
circumstances. This list is not all inclusive.
1.
Does the practitioner follow state laws when
prescribing controlled substances?
2.
Does the practitioner conduct cursory medical
exams or any medical exam at all?
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Diversion Control Division
3.
Does the doctor do diagnostic testing or refer the
patient out for diagnostic testing (x-ray, MRI,
etc)?
4.
Is the practitioner referring patients to other
specialists (surgery, physical therapy, etc)?
5.
Are the initial office visits or follow-up visits
brief?
Signs Of Practitioner Diversion
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Diversion Control Division
6.
Does the practitioner prescribe multiple drugs
within the same drug category?
7.
Does the practitioner prescribe excessive quantities
of controlled substances relative to the medical
condition the prescription is purported to treat?
8.
Do patients travel a great distance to see the
practitioner?
Signs Of Practitioner Diversion
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Diversion Control Division
9.
Does the practitioner ignore signs of abuse?
.
Patient appears to be under the influence.
.
Patient asks for the controlled substances he
wants.
.
Patient is doctor shopping in PMP.
.
Practitioner is warned by family members that
the patient is abusing or selling his controlled
substances.
.
Ignoring toxicology reports.
Signs Of Practitioner Diversion
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U.S. Drug Enforcement Administration
Diversion Control Division
10.
Does the practitioner start on a low dose or low
level controlled substance and then over time
work up to higher levels, or does the practitioner
just start the patient on a high dose narcotic?
11.
Does the practitioner continue to prescribe
controlled substances to patients even though it
would be ineffective for treatment purposes?
Signs Of Practitioner Diversion
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Diversion Control Division
12.
Does the practitioner only treat patients with
narcotic controlled substances?
13.
Does the practitioner allow the non-medical staff to
determine the narcotic to be prescribed, the
practitioner just signs the prescription?
Signs Of Practitioner Diversion
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Diversion Control Division
14.
Does the practitioner coach patients on what to say
so that the patient can get the narcotics they want?
15.
Does the practitioner violate his own pain
management policies and guidelines?
16.
Does the practitioner ignore warnings from
insurance companies, law enforcement, other
practitioners, family members, etc?
Signs Of Practitioner Diversion
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17.
Does the practitioner receive other
compensation for narcotic prescriptions (sex,
guns, drugs etc)?
18.
Does the doctor still charge the patient for a
visit if they do not get a narcotic prescription?
19.
Patient deaths.
20.
Doctors use inventory for personal use.
Signs Of Practitioner Diversion
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U.S. Drug Enforcement Administration
Diversion Control Division
Objective #3
Methods of Diversion
By Staff/Employees
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Diversion Control Division
Methods of Diversion
(Employee/Staff Involvement)
1.
Steals prescriptions or forges doctor prescriptions.
2.
Steals and adjusts doctor's inventory.
3.
Calls in fake prescriptions.
4.
Falsifies verifications when pharmacist calls the
doctor's office.
5.
Pretends to dispose of drugs.
6.
Replaces medication with placebo.
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Methods of Diversion
(Employee/Staff Involvement)
7.
Takes advantage of older/busy doctors.
8.
Uses the DEA number of a retired
doctor.
9.
Orders inventory without doctor's
knowledge.
10.Sets up break-ins, burglaries or armed
robberies.
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U.S. Drug Enforcement Administration
Diversion Control Division
Hydromorphone Drip Bag- Sugar Cubes
Source: Hospital
Price per cube: $15/cube
Drops per cube: 10
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U.S. Drug Enforcement Administration
Diversion Control Division
Objective #4
Methods Of Diversion
By Patients
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U.S. Drug Enforcement Administration
Diversion Control Division
Methods of Diversion
(Patient Involvement)
1.
Patients who want appointments towards the
end of office hours or arrives after regular
business hours.
2.
Patients who demand immediate attention.
3.
Patients who are not interested in an
examination or undergoing diagnostic tests.
4.
Patients who are unwilling to give permission to
obtain past medical records.
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U.S. Drug Enforcement Administration
Diversion Control Division
Doctor Shopping
PATIENT
i.e. Patient visits several doctors to obtain multiple prescriptions
*To protect your practice from this problem: use PDMP regularly
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U.S. Drug Enforcement Administration
Diversion Control Division
Possible Signs of Drug Seekers
5.
Fictitious Records.
6.
Carry own records.
7.
Wounds inflicted to self, family members, and
pets.
8.
Request specific medication due to allergies.
9.
Vacationing in area, no local address.
10.
Request pain meds for a pet.
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Diversion Control Division
11.Patient recites textbook symptoms.
12.Patient gives very vague medical history.
13.Patient claims they failed to pack
medication, lost it, or that it was stolen.
14.Patient claims that hospital or clinic, with
past medical records, is out of business or
burned down.
Methods of Diversion
(Patient Involvement)
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U.S. Drug Enforcement Administration
Diversion Control Division
15.Patient deceives doctors or seeks alternate
doctors while normal doctor is out of the
office.
16.Patient exaggerates medical condition.
17.Patient solicits Medicaid recipients to use
Medicaid cards as payment method.
18.Patient targets a lax doctor.
Methods of Diversion
(Patient Involvement)
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U.S. Drug Enforcement Administration
Diversion Control Division
19.
Patient takes half and sells rest of their
medication.
20.
Patient offers to buy other patient's pills.
21.
Patient looks for employment or volunteers at
locations where drugs or prescriptions are
exposed.
22.
Patient alters prescriptions.
Methods of Diversion
(Patient Involvement)
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U.S. Drug Enforcement Administration
Diversion Control Division
Objective #5
Effective Controls
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U.S. Drug Enforcement Administration
Diversion Control Division
Effective Controls
.
Cost effective controls:
1.
Follow policies and procedures - don't be lax
2.
Don't share passwords
3.
Verify destructions
4.
Question and report suspicious activities
5.
Limit access to drug inventory
6.
Train and update staff
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U.S. Drug Enforcement Administration
Diversion Control Division
Effective Controls
7.
Be vigilant of staff members
8.
Use PDMP regularly
9.
Conduct backgrounds of employees (FELONY)
10.
Audits - discover discrepancies, losses or thefts in
the inventory (2 persons)
11.
Keep complete and accurate records
12.
Security - store CS in a securely locked,
substantially constructed cabinet
21 CFR § 1301.75
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Diversion Control Division
13.
Prescriber personally verifies the
prescription orders with pharmacist.
14.
Electronic prescriptions (EPCS) - reduces
the # of forged/altered/fraudulent scripts.
15.
Never sign prescription blanks in advance.
16.
Request DEA to terminate your DEA # so
that no one can use it illegally.
Effective Controls
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U.S. Drug Enforcement Administration
Diversion Control Division
Effective Controls
.
Contractual agreements:
Doctor/Patient
.
Drug testing at hiring
.
Random drug testing
.
Safeguard prescriptions
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U.S. Drug Enforcement Administration
Diversion Control Division
Safeguarding Prescriptions
.
Keep prescription pads locked in a cabinet when
not in use.
.
Do not leave prescription pads around the office
or in your jacket pockets during off hours.
.
Maintain a record of your prescriptions.
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U.S. Drug Enforcement Administration
Diversion Control Division
Safeguarding Prescriptions
.
Inspect and number your prescription pads.
.
Be vigilant of those working near your office.
.
Write actual amount prescribed (in words).
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U.S. Drug Enforcement Administration
Diversion Control Division
.
DEA local office and Tactical Diversion
Squad
.
Local Police, County, State
.
State Board of Pharmacy, Medicine,
Nursing, Dental
.
Health Department
.
HHS OIG if Medicare, Medicaid fraud
Contacts for Reporting Drug Diversion
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U.S. Drug Enforcement Administration
Diversion Control Division
Course Review
.
Reviewed the responsibilities and
regulations that apply to practitioners.
.
Identified and discussed the methods
used to divert controlled substances.
.
Listed the safeguards used to protect a
practitioner's medical practice.
49
U.S. Drug Enforcement Administration
Diversion Control Division
Post Questions
1.
A pharmacist is obligated to fill a
prescription that is presented by a patient
or is demanded to be filled by a
practitioner.
A.
True
B.
False
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U.S. Drug Enforcement Administration
Diversion Control Division
Post Questions
2.
All applicants and registrants shall provide
effective controls and procedures to guard
against theft and diversion of controlled
substances.
A.
True
B.
False
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U.S. Drug Enforcement Administration
Diversion Control Division
Post Questions
3.
What is the best safeguard to identify a
patient who is doctor shopping?
A.
Secure prescriptions
B.
Routinely use the PDMP
C.
Conduct routine examinations
D.
Never sign blank prescriptions
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U.S. Drug Enforcement Administration
Diversion Control Division
Post Questions
4.
Diversion of controlled substances can be
conducted by:
A.
Staff members
B.
Practitioners
C.
Patients
D.
All of the above
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Diversion Control Division
Post Questions
5.
By using EPCS, a practitioner can
minimize the potential of altered/forged
prescriptions.
A.
True
B.
False
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U.S. Drug Enforcement Administration
Diversion Control Division
Thank-you for your time
and attention !
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