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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 A. Brinks, Section Chief
Regulatory Drafting & Policy Support Section
LEGAL DISCLAIMER
The following presentation was accompanied by an oral presentation
on August 19 & 20, 2019, 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.
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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
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U.S. Drug Enforcement Administration
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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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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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Diversion Control Division
Objective #1
Laws and Regulations
Related To Practitioners
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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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.
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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.
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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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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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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Good Practices
.
Complete medical history
.
Medical examinations
.
Appropriate tests
.
Diagnosis
.
Treatment plan
.
Appropriate follow-up
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Objective #2
Methods Of Diversion
By Practitioners
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.
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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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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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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.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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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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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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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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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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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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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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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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Objective #3
Methods of Diversion
By Staff/Employees
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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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Hydromorphone Drip Bag- Sugar Cubes
Source: Hospital
Price per cube: $15/cube
Drops per cube: 10
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Objective #4
Methods Of Diversion
By Patients
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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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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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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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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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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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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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Objective #5
Effective Controls
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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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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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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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Effective Controls
.
Contractual agreements: Doctor/Patient
.
Drug testing at hiring
.
Random drug testing
.
Safeguard prescriptions
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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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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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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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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.
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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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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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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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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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Post Questions
5.
By using EPCS, a practitioner can minimize the potential
of altered/forged prescriptions.
A.
True
B.
False
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Diversion Control Division
Thank-you for your time
and attention !
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