Transcript DEA Compliance and Drug Diversion 2014 NPPA Conference

Kimberly New JD BSN RN
Disclosure
Kimberly New:
Financial — Received speaking fee for
participation in a webinar and live
conference from Omnicell/Pandora.
Nonfinancial — No relevant nonfinancial
relationship exists.
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Objectives/Discussion Points
Scope of the problem
 Regulatory requirements
 Signs of impairment and diversion
 Diversion program essential
components
 Pharmacy controls
 A word on counterfeiting
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Is Diversion a Significant Risk?
Epidemic proportions (CDC)
 Universal among institutions
 Reliable statistics not available
 Clandestine activity
 Cases undiscovered or unreported
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Healthcare Environment a
Major Factor
The major factors impacting the incidence of drug
misuse by healthcare professionals are access
and availability of controlled substances.
Anyone can divert if controlled substances are
available or left unsecured.
Bell DM, McDonough JP, Ellison JS, Fitzhugh ED. Controlled drug misuse by Certified
Registered Nurse Anesthetists. AANA J 1999;67(2):133-140.
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Diversion by Healthcare
Personnel
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All facilities and pharmacies vulnerable
Incidents not reflective of patient safety
commitment
Multi-victim crime
Significant risk to patient safety
Must treat diversion with the same
diligence as other patient safety initiatives
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Impact on Patient Safety
Care delivered by impaired provider
 Withholding medication from patients in
need
 Transmission of bloodborne pathogens or
exposure to unsafe substances
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Impact on Patient Safety
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Former pharmacy tech orchestrated scheme to
steal hundreds of painkillers intended for hospital
patients and dispense look-alike pills to mask the
thefts, prosecutors charge
Pharmacist pleads guilty to diluting morphine and
hydromorphone with saline solution, gluing lids
back on and stealing other prescription painkillers
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Risk to Community
Ga Anesthesia Assistant Arrested For DUI
Propofol In Wrong Way Crash
Beverly Wilkins
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Regulatory Requirements
Protect patients/consumers
 Ensure controlled substance security
 Track controlled substances at all points
 DEA, State, CMS, TJC

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Regulatory Requirements
Hospitals are required to be in compliance with
the Federal requirements set forth in the Medicare
Conditions of Participation (CoP) in order to
receive Medicare/Medicaid payment.
State Operations Manual Appendix A - Survey Protocol, Regulations and Interpretive
Guidelines for Hospitals
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Regulatory Requirements
§482.13(c)(2) - The patient has the
right to receive care in a safe setting
Hospital must:
 Protect vulnerable patients
 Identify and evaluate problems and
patterns of incidents
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Regulatory Requirements
Pre-employment screening
21 CFR 1301.90 Employee screening procedures
Obtaining certain information by non-practitioners
is vital to assess the likelihood of an employee
committing a drug security breach
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Need to know is a matter of business necessity,
essential to overall controlled substances security
•
Conviction of crimes and unauthorized use of
controlled substances are activities that are
proper subjects for inquiry
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Regulatory Requirements
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§482.25(a)(3) - Current and accurate records
must be kept of the receipt and disposition of all
scheduled drugs
Records of all scheduled drugs must be maintained
and any discrepancies in count reconciled promptly
Must be capable of quickly identifying loss or
diversion of controlled substances and determining
the extent of the diversion
Must have policies and procedures in place which
minimize scheduled drug diversion
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Regulatory Requirements
Employment disposition for confirmed
diversion
21 CFR 1301.92 Illicit activities by employees
 Employees who possess, sell, use or divert
controlled substances will subject themselves
not only to State or Federal prosecution
 Employer will immediately determine status of
continued employment by assessing the
seriousness of the violation, the position of
responsibility held by the employee, past
record of employment, etc.
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Regulatory Requirements
Steps following diversion (RCA)
§482.25(b)(2)(i-ii)
• If tampering or diversion occurs, or if
medication security otherwise becomes a
problem, the hospital must evaluate its current
medication control policies and procedures,
and implement the necessary systems and
processes to ensure that the problem is
corrected, and that patient health and safety
are maintained
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Regulatory Requirements
Steps following diversion (RCA)
TJC MM.08.01.01
The hospital evaluates the effectiveness of
its medication management system:
• Analyze data
• Keep up with best practices
• Identify and implement improvement
measures
• Re-evaluate system
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Regulatory Requirements
Internal and external reporting
 42 CFR 482.25(b)(7) - Abuses and losses
of controlled substances must be reported,
in accordance with applicable Federal and
State laws, to the individual responsible
for the pharmaceutical service, and to the
chief executive officer, as appropriate
Billing revision and patient notification
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Reporting Requirements
21 CFR 1301.91 Employee
responsibility to report drug
diversion

Employees are obligated to report such
information to a responsible security official
of the employer
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Reporting Requirements
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DEA (Form 106) for THEFT
State Licensure Board and/or Professional
Assistance plus Pharmacy Board
Department of Health (patient harm issues
and/or possible bloodborne pathogen exposure)
Law Enforcement - crimes, issues of
abuse/neglect/reckless endangerment, fraud
Institutional Infection Control Department
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Theft and Loss
Diversion is a felony and is theft
 If individual is terminated for diversion
and/or reported to professional board,
106 for theft is warranted
 Small random unexplained
discrepancies are generally considered
to be loss, but beware of patterns
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Reach Out
To ensure appropriate reporting, reach out
to local state and federal regulatory
personnel prior to an event:
 Contact information (all hours)
 Expectations for involvement (type of
activity and at what point)
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Diversion Program Components
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Policies to prevent, detect and properly report
diversion
Internal and external collaboration
Method of auditing (beware of investigator bias)
Prompt attention to suspicious data received
Education for all staff
Diversion risk rounds
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Diversion Risk Rounds
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Diversion Program Structure
 Diversion
oversight committee
 Diversion Specialist
 Diversion response team
 Diversion intervention team
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Who and Why
Nurses
 Pharmacists and Pharmacy Techs
 Supervisors
 Physicians and NPP
 Respiratory Therapists
 Those without legitimate access
 Patients and families
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Who and Why
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High achiever
Significant stress in personal life
Night shift
Critical care or other unit where staff have
increased autonomy
Agency or traveler
Legitimate prescription for drug being diverted
Smoker
Generally, direct care personnel divert for
personal use and are extremely secretive about it
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Who and Why
Pharmacy Staff:
May be student
Many times PIC, Director or position of
authority
Personal use but more prone to
“entrepreneurial endeavors”
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Drugs of Choice
Injectables:
Hydromorphone
Morphine
Fentanyl
Propofol
Pills and liquids:
Hydrocodone
Oxycodone
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Drugs of Choice
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Benzodiazepines (lorazepam,
alprazolam, clonazepam)
Drugs to ease withdrawal and enhance
impact of opioid (ondansetron,
promethazine, diphenhydramine)
Barbiturates (phenobarbital)
Non-scheduled (cyclobenzaprine,
gabapentin)
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Signs of Diversion/Impairment
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Tardiness, unscheduled absences,
excessive number of sick days
Frequent disappearances from the work
site, taking frequent or long trips to the
bathroom or to the medication room
Volunteering for overtime
Being at work when not scheduled
Arriving early and staying late
Pattern of removal of controlled substances
near or at end of shift
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Signs of Diversion/Impairment
Vacillating work performance
 Mistakes and poor documentation
 Interpersonal relations suffer
 Heavy or no "wastage" of drugs
 Pattern of holding waste until oncoming
shift or picking the same witnesses
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Signs of Diversion/Impairment

Pay attention to social media reports!
“I have a crazy fascination
with needles. I just like the
way they feel!"
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Methods of Diversion
An effective surveillance program
requires knowledge of common
methods of diversion
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Removal of medication when not
needed
Removal for discharged patient
Removal of duplicate dose
Removal of/diversion from fentanyl
patches
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Methods of Diversion
Removal of medication without order
 Giving less than ordered more
frequently
 Failure to waste
 Frequent wasting of entire doses
 Substitution in administration and
wasting
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Methods of Diversion
 Removal of larger doses than
necessary
 Withdrawal from PCA and drip
lines
 Removal under sign-on of
colleague
 Removal of unspent syringes
from sharps boxes
 Pilfering patient medications
brought from home
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Methods of Diversion
Circumventing scanning technology
 Physical break-in
 Drug cabinets in non-24 hr. units
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Education
All staff (incl. Environmental Services,
Central Supply, Maintenance, Dietary)
 At hire and annually
 Anonymous or other reporting
mechanism
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Pharmacy Diversion Schemes
Destocking
 Substitution of “benign” drug for CS
 Dilution of liquids
 Falsification of records
 Overfill
 Pilfering drugs pending reverse
distributor pick-up
 Minor discrepancies
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Pharmacy Diversion Headlines
Norditropon, Humatrope, Somatotropin,
Botox and other branded varieties of
human growth hormone stolen from two
military hospitals
 Stole Vicodin, Valium, suboxone (a
heroin substitute), antibiotics and
antiviral medications
 Stole Percocet by removing it from the
stock at one home on a claim that it was
needed at the other
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Pharmacy Environment
Beware
 Bags, hoodies, jackets, personal items
 Sharps containers and IV prep
receptacles
 Propped doors and work-arounds
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Ordering
Different individual orders, receives and
processes reconciliation
 Records reconciled after receipt
 Daily activity reconciled frequently and
regularly
 Independent auditing
 Monitor stock trends for Pharmacy and
remote locations
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Receiving
Direct to Pharmacy
 Package that appears damaged or
tampered with
 Policy regarding handling of damaged or
tampered shipments
 Open with non-ordering witness or in
clear view of camera with recording
capabilities
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Transporting
Generic secure container or “secure
tube” (name badge?)
 Regularly reconcile what leaves
Pharmacy with what is stocked remotely
 Monitor discrepancies after stocking
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Returns
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Ideally to Pharmacy (not floor stock)
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Analyzing for Tampering
Refractometry often doesn’t include
fentanyl
 Visualization is essential at all points
 Make explicit what warrants analysis
and how to accomplish it
 Process per policy
 Keep records of random and focused
checks
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Records
Minimum 2 yrs. (usually longer)
 Purchasing records, administration and
dispensing records, Controlled
Substance Ordering Forms (DEA Form
222), and all physical inventories
 Schedules I and II kept separate
 Schedule III, IV, and V separate or
readily retrievable
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Policies and Procedures
Blind count
 Regular internal and external auditing
 Medication handling expectations
 Wasting and returning
 Transporting
 Stocking
 Discrepancies
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Policies and Procedures
Granting and terminating ADC access
 Granting and terminating physical
access
 Reasonable suspicion drug testing
 Disposal of expired and other
medications
 Record keeping
 Substance analysis
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Physical Security
Cameras at all entry points
 No visitors without assigned escort and
only on limited basis
 Badge swipe access
 Biometrics
 Low profile entry points
 Units open less than 24 hrs.
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Camera Surveillance
Liberal use
 Data viable for at least 30 days
 Data readily accessible
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Rx Counterfeiting
Huge problem in the United States
 Appearance of pills and packaging
almost identical
 Requires testing from the manufacturer
 Can be integrated into the retail drug
supply
 Terrorism (Financing)
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Counterfeit Drug Production
Production facilities frequently uncontrolled
environments
 Composition of counterfeit drugs is highly
variable
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 Sub-potent/Supra-potent
 Mixed with other active ingredients or unknown
substances
 Similar to genuine drug
 Heavy metals, poison, common household
Items
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Counterfeiter’s Manufacturing
Facilities
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Counterfeiters Labeling
Equipment
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Counterfeit Drug Packaging Has Become Virtually
Indistinguishable from Packaging for FDAApproved Drugs
Authentic Cialis® Carton
Authentic Cialis®
Blister Foil (Red Color-shift)
Counterfeit Cialis® Carton (expanded)
Authentic Cialis®
Blister Foil (Gold color-shift)
© 2014
Counterfeit Cialis®
Blister Foil (No color-shift)
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To the Naked Eye, Difficult to
Distinguish Counterfeit Drug
Product
Counterfeit Cialis® tablet
Authentic Cialis® tablets (5, 10, and 20 mg)
© 2014
(This counterfeit tablet contains sildenafil –
the active pharmaceutical ingredient in
Viagra® , instead of tadalafil, which is the
active pharmaceutical ingredient in Cialis®)
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Counterfeit Blister
Genuine Blister
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Remember
Diversion is a constant threat
 Diversion will occur
 Efforts aimed at reducing, detecting
quickly and responding appropriately

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Thank You!
Kimberly New
[email protected]
865.456.1813
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