Robert J. Walters, Senior Assistant Attorney General Wyoming Attorney General's Office June 5, 2014
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Robert J. Walters, Senior Assistant Attorney General
Wyoming Attorney General’s Office
June 5, 2014
Introduction :
Introduction
The prescription drug abuser, or drug seeker, represents a
serious and constant problem for the health care
professional in the United States.
These people, through a variety of methods, are successful
in obtaining an enormous amount of pharmaceutical drugs
from health care professionals. These drugs then
perpetuate personal addictions, or provide a very valuable
product to the prescription drug trafficker.
:
Introduction
the health care professional is a
nurse?
Introduction
THE FACTS
• Reliable statistics on the prevalence of drug diversion
by nurses ARE NOT available
• By its nature, drug diversion is a clandestine activity
• Methods in place in many hospitals, facilities and
institutions leave cases undiscovered or unreported
• Drug diversion by health care providers, including
nurses, is universal among hospitals, facilities and
institutions in the United States
Introduction
Drug diversion may actually be under-reported.
• Fear of negative publicity
• Fear of State and Federal agency involvement
• Uncertainty about reporting requirements and avenues
• Justification that terminating the employee is enough
• Possible inadequate investigative systems in place
: Presentation: “Health Facility Drug Diversion: Essential
Compliance & Auditing Measures,” by Kimberly S. New JD
BSN RN, and Kelly C. Loya CPC-I, CHC, CPhT, CRMA
Introduction
Consequences When
Diverter is dismissed/employment terminated or
allowed to quit:
• May disregard the well being of the diverter
• Opportunity for rehabilitation may be precluded
• Potential violation of laws and regulations
• No reported history will bypass preventive
screening at next employer
: Presentation: “Health Facility Drug Diversion: Essential
Compliance & Auditing Measures,” by Kimberly S. New JD
BSN RN, and Kelly C. Loya CPC-I, CHC, CPhT, CRMA
Introduction Are drug diversion cases complicated?
Introduction
Can drug diversion cases look more like
medication error and/or documentation
substandard practice cases?
Introduction
Introduction
Is it easy to PROCRASTINATE in
drug diversion cases?Introduction Is it ever too early to develop a STRATEGY in drug diversion cases?
DUE PROCESS 101
BASIC RULE:
NOTICE AND
OPPORTUNITY TO BE
HEARDDue Process 101
indicating the charges or GROUNDS FOR DISCIPLINE
upon which proposed disciplinary action will be based
The Wyoming Administrative Procedure Act describes the notice
requirement as follows:
No revocation, suspension, annulment or withdrawal of any license
is lawful unless, prior to the institution of agency proceedings, the
agency gave notice by mail to the licensee of facts or conduct
which warrant the intended action, and the licensee was given an
opportunity to show compliance with all lawful requirements for the
retention of the license.
Wyo. Stat. Ann. § 16-3-113(c).Due Process 101
CONTESTED
CASE
HEARINGDue Process 101 Music to a drug diverter’s ears They think they are covered or that you can’t prove he/she diverted
Due Process 101 Accused nurse has the legal right for opportunity to dispute the charges of diversion
Due Process 101
Usually not
going to catch
nurse with his/
her “hand in the
cookie jar”Due Process 101
Nurses oftentimes
will deny diversion
or any role in any
suspected drug
diversionDue Process 101
“I think you’d be
surprised the
lengths a drug
addict will go to
keep it a secret.”
Nurse Jackie,
“Lost Girls,”
Season 5 (2013).Due Process 101 Going to need strong or solid EVIDENCE of diversion
DUE PROCESS 101 -- EVIDENCE BURDEN OF PROOF
Due Process 101 -- Evidence
Due Process 101 -- Evidence
Due Process 101 -- Evidence
or what are the ELEMENTS that must be proven?
FRAMES NOT ONLY WHAT EVIDENCE MUST BE
PRESENTED AT A HEARING BUT WHAT EVIDENCE ALSO
MUST BE OBTAINED IN INVESTIGATION!Due Process 101 -- Evidence
“Drug Diversion” Defined
Diverting (or taking/removal of) a prescription
drug for other than its intended purpose.
Theft of medication, including “waste,” from patients or
health care facilities for personal use.
Wyo. Stat. Ann. § 33-21-146(a)(v): “Has engaged in any unauthorized
possession or unauthorized use of a controlled substance as defined in the
Wyoming Controlled Substances Act[.]”Due Process 101 -- Evidence
“Misappropriation” Defined
Negligently or deliberately taking, misusing,
exploiting, using or selling property belonging
to another, whether temporarily or permanently,
and without regard to consent.Due Process 101 -- Evidence
Emergency/Summary Suspension vs.
Hearing on the Merits
Elements of the underlying Elements of the underlying
ground(s) (e.g., drug diversion, ground(s) (e.g., drug diversion,
misappropriation, theft) misappropriation, theft)
Substantial likelihood of Clear and convincing evidence
prevailing at hearing on standard
merits Sanction imposed by Board is
Nurse presents a clear and not arbitrary or capricious
immediate danger to public (i.e., reasonable under
health and safety if permitted circumstances considering
to practice. mitigating and aggravating factors)Case Digest Tale of Two Cases
Case Digest Administrative complaint alleged: ØAccording to Pyxis reports, nurse (LPN) removed twenty-six (26) Fentanyl patches over the course of three (3) months that were unaccounted for or not signed out on a resident Medication Administration Report (“MAR”). ØFentanyl patches were pulled day after day or on days that they were not due to be changed. ØThree (3) instances where nurse refilled the Pyxis machine with Fentanyl patches and only refilled nine (9), which left one patch unaccounted for each time refills occurred. ØGreater administration of Percocet and Vicodin when nurse was working, indicating a pattern in which five (5) residents were receiving multiple doses of PRN narcotics and in which corresponding documentation of administration was not reflected on the MAR or the pain tracking sheet.
Case Digest Initial recommendation by Disciplinary Committee: ØReprimand for unsafe practice – i.e., medication errors, lack of appropriate documentation (even though suspicious for drug diversion) ØRemedial training in medication errors and documentation Nurse was sent a proposed settlement agreement (consent decree) for reprimand and training, which she “happily” executed. Board DID NOT approve proposed settlement agreement (consent decree) for reprimand and training, and suggested some level of supervision (worksite monitor for an appropriate period with reporting).
Case Digest Nurse retained counsel who communicated dispute of alternative recommendation and requested a hearing. In preparation for hearing, became more evident that drug diversion ACTUALLY could be proven.
Case Digest FACILITY’S INTERNAL AUDIT (data of three-month period from Pyxis reports and corresponding medical records) reflected: ØNUMEROUS incidents of single nurse REMOVAL of significant quantities Vicodin, Norco, Percocet, and Fentanyl, related to several patients, and ØVAST MAJORITY (approximately 85%) in which ADMINISTRATION NOT DOCUMENTED, and ØNO JUSTIFICATION for removal and lack of appropriate care (assessment/reassessment) and failure to document.
Case Digest
ALTOGETHER, OVER 3-MONTH AUDIT PERIOD, NURSE
REMOVED 236 UNITS OF NARCOTICS IN WHICH THE
MAR REFLECTED ONLY 30 WERE ADMINISTERED!!!
OVER 200 UNITS REMAINED UNACCOUNTED FOR.
BREAKDOWN: Vicodin – 118 tablets removed/12 administered;
Norco – 74 tablets removed/8 administered; Percocet – 21 tablets
removed/1 administered; Fentanyl – 32 patches removed/9 administered.
RE Patient “L.D.,”, nurse removed:
•80 Vicodin tablets, via 40 separate occurrences, of which
only 10 were documented as administered per the MAR.
•10 Fentanyl patches, none of which were documented
as administered per the MAR.Case Digest RE Patient “D.L.,”, nurse : •Removed 21 Fentanyl patches, and ONLY 9 were documented as administered per the MAR. •Removed 8 Percocet tablets and ONLY 4 were documented as administered per the MAR. •Refilled/Inventoried 9 Fentanyl patches (one missing) RE Patient “W.R.,”, nurse : •Removed 19 Vicodin tablets and ONLY 2 were documented as administered per the MAR. •Removed 8 Norco tablets and ONLY 2 were documented as administered per the MAR.
Case Digest RE Patient “T.R.,”, nurse : •Removed 9 Vicodin tablets and none of which were documented as administered per the MAR. •MAR reflected that Vicodin was not a prescribed medication for this patient. •Removed 12 Norco tablets and ONLY 1 was documented as administered per the MAR. •Removed 8 Ambien tablets and none of which were documented as administered per the MAR. •MAR reflected that Ambien was not a prescribed medication for this patient.
Case Digest RE Patient “D.S.,”, nurse : •Removed 54 Norco tablets and ONLY 5 were documented as administered per the MAR. RE Patient “A.K.,”, nurse : •Removed 1 Fentanyl patch, which was not documented as administered per the MAR. •This patient no longer at facility when patch removed. RE Patient “C.T.,”, nurse : •Removed 4 Percocet tablets, none of which were documented as administered per the MAR. •This patient was not assigned to nurse.
Case Digest RE Patient “R.K.,”, nurse : •Refilled/Inventoried 9 Fentanyl patches (one missing) RE Patient “D.C.,”, nurse : •Refilled/Inventoried 9 Fentanyl patches (one missing)
Case Digest As part of disclosure requirements, and about two weeks prior to hearing, communicated with nurse’s attorney regarding evidence to be presented and strength of case. Suggested that nurse consider a voluntary surrender in lieu of hearing. Nurse agreed to voluntary surrender and Board approved a settlement agreement (consent decree) for voluntary surrender.
WHAT was diverted? WHAT do we know (or need to know) about the diverter? WHAT are the potential explanations (or defenses) to accusations? WHAT systems were in place (are there issues regarding reliability)?
HOW was the situation discovered? HOW did the suspected diversion occur? HOW often were substances diverted – i.e., was there a pattern? HOW were patients impacted?
HOW extensive was investigation by hospital, facility or institution? HOW many other nurses or persons were considered or investigated?
WAS suspected employee interviewed to explain discrepancy (and what was explanation)? WAS suspected employee drug tested? WAS suspected employee suspended or terminated?
Most Commonly Diverted
Controlled Substances
vHydrocodone
vOxycodone
vHydromorphone
vMorphine Sulfate
vFentanyl
What was diverted? vAlprazolam
vDiazepamof a “Drug Diverter”
• High achiever or Model Nurse
• “Team Player”
• The last person you would suspect
What do we know
about the diverter?of a “Drug Diverter”
•Medication removed on the controlled
substances sign-out sheets but not transferred
to or charted as administered on patients’
medical records
•Charts more controlled substances than other
nurses
What do we know •Noticeable increase of PRN or “as needed”
about the diverter? controlled substances charted
(Possible red flags) •Charts out larger doses of controlled
substances than ordered when the appropriate
dose is availableof a “Drug Diverter”
•Excessive amounts of time spent near a drug
supply, such as a cart or medicine room
•Waits for other staff to leave controlled
substances unit before accessing medications
•Frequently checks supply of controlled
substances
What do we know •Preoccupied with medications
•“Disappears” at work (e.g., takes break or visits
about the diverter? restroom especially after accessing controlled
(Possible red flags)
substances)of a “Drug Diverter”
•“Forgetfulness” in routine duties, including
decline in documentation
•Record keeping is sloppy -- some records
falsification is possible with drug shortages
•Changes evident in handwriting and charting
What do we know •Frequent overrides in automated dispensing
systems (ADS)
about the diverter? •Frequently accessing the ADS after coworker
(Possible red flags) fails to log off the system
•Heavy “wastage” of drugsof a “Drug Diverter”
•Makes unusual comments about usage/
disposal of controlled substances
•Defensive responses when questioned about
errors or poor patient care
•Asks coworkers for their user lD and password
What do we know •Asks coworker to sign for opioid wastage
without actually witnessing it
about the diverter? •Asks for help accessing controlled substances
(Possible red flags) •Seen accessing ADS while off dutyof a “Drug Diverter”
•Night shift
•Critical care or other unit where nursing staff
have increased autonomy
•Volunteers for overtime, weekend or extra shifts
•Willingly “floats” to other units
What do we know •Works on a job lower than his/her educational
level
about the diverter?
(Possible red flags)of a “Drug Diverter”
•Patients and staff make complaints about the
co-worker’s attitude or behavior
•Significant stress in personal life
•Frequent hospitalization or accidents
•Personal history of being on pain medications
What do we know •Legitimate prescription for drug being diverted
•Wears long sleeves in appropriately, such as in
about the diverter? very hot weather
(Possible red flags) •Slight hand tremors
•Pupillary size change and/or bloodshot eyesWhat are the potential explanations/defenses) to accusations?
10. Prejudice or bias by management or other
coworkers
9. The Pyxis machine or ADS malfunctioned
8. Someone else had access to the Pyxis
machine and used my access information
7. Mistakenly administered to another patient
and did not (or forgot to) document/chart
What are the potential
6. Administered the medication but did not/
explanations/defenses) forgot to chart
to accusations?5. Chart portions missing or altered by
someone else
4. Someone else did it
3. Occurrence report filed but disappeared
2. I have no motive because I already
receive prescribed medication for pain
What are the potential
explanations/defenses)
to accusations? I JUST DIDN’T DO IT!Methods of Diversion
Removal from secure storage areas without
any documentation
Removal from storage area and falsification of
an order for administration
Removal and substitution in administration or
wasting
How did the suspected • Substitution of look-alike pills
diversion occur? • Saline substituted for injectable medication
• Potential for tamperingMethods of Diversion
Removal of medication without order
•Medication override
•Falsification of “verbal order”
Removal of medication when not needed
•Often initial method of diversion
•Very difficult to detect
How did the suspected •Falsification of records
diversion occur? •Medication errors
•No documentation of administrationMethods of Diversion
Removal for discharged patient
Removal of duplicate dose
• May not be assigned to care for patient
Removal under sign-on of colleague
• Stolen password
How did the suspected • Left alone when colleague is signed in
diversion occur? Removal and use from inconspicuous vesselMethods of Diversion
Removal of/diversion from fentanyl patches
• Removal of gel with syringe and needle
• Keeping new patch for self and putting used
patch on patient
Removal from PCA and drip lines
Removal of unspent syringes from sharps
How did the suspected containers
diversion occur? • Nurse steals sharps containers and removes
syringes to collect remnants of syringesMethods of Diversion
Failure to waste (properly)
• Claims he/she was too busy or others
unavailable to have a wasted dose witnessed
• Unwasted medication kept for self
• Waste thrown into the general trash and later
picked up by the diverter
How did the suspected Frequent wasting of entire doses (should be
returned)
diversion occur?
Falsification of wastage record (to show a drug
was wasted, but may have wasted water)Methods of Diversion
Charting of administration but patient was not
given quantity documented
Pilfering patient medications brought from
home
Nurse places drugs in coat, purse or car
How did the suspected
diversion occur?Patient indications that drugs have
been diverted
• Patient who had been well controlled with pain
medication has marked change and increasingly
states pain is poorly controlled or exhibits signs
of increased pain.
• Response to pain medication varies with
How were patients different caregivers.
impacted? • Request for prescription refills are made with
increasing frequency.Patient indications that drugs have
been diverted
• Appearance of drugs (pills, capsules) has
changed (indicating they may have been
replaced with non-opioid drugs).
• Patient may show signs of neglect (poor
hygiene, pressure sores, weight loss).
How were patients • Patient may exhibit fear or anxiety, especially
impacted? in the presence of a suspect caregiver.Preparation of Drug Diversion Cases
Preparation of Drug Diversion Cases
Preparation of Drug
Diversion Cases
Can a PATTERN of drug
diversion by subject nurse
be demonstrated?
vIs supporting evidence sufficient?
vWhat are possible explanations or
counter-indications?
vIs the nurse’s “side of the story
credible” – can it be rebutted?
vIs there a smoking gun?Preparation of Drug Diversion Cases How strong is your
Preparation of Drug Diversion Cases
Preparation for Drug Diversion Cases
Evidence Needed
(MINIMUM)
• Automated system audit (e.g., Pyxis report of removal of
substances by suspected employee over meaningful period of time)
• Corresponding patient medical records (reflecting orders, charting
of pain assessments, medication administration, etc.)
• Medication Administration Record (MARS) or Daily Medication Log
(DML)
• Chart audits comparing physician’s orders, MARS or DML,
nurse’s notes & Pyxis reports (to determine if there is a discrepancy from
audits to show drug diversion – especially if there is a clear pattern)Preparation for Drug Diversion Cases
OTHER IMPORTANT EVIDENCE
• Copy of hospital’s or facility’s internal investigation
documents
• Patient complaints and survey results relating to pain management
• Drug test (if done and particularly if positive for substance(s)
diverted)
• Personnel disciplinary action (particularly if issues re
substance abuse or past medication errors or failure to document)
• Prescription Drug Monitoring Program (PDMP) report/
prescription profile (particularly if the profile indicates a substance use
disorder)
• Medical records of subject (particularly if being treated for
chronic pain – pain management contract; noncompliant drug tests)
• Employee time recordsPreparation for Drug Diversion Cases
OTHER IMPORTANT EVIDENCE
• Testimony of pharmacist, DON/CNO or other head of
facility/hospital, prescribing physicians, or other witnesses
(persons most knowledgeable – possibly also for rebuttal
purposes)
• Testimony of other nurses (possibly also for rebuttal
purposes)
• Law enforcement investigative reports (if available)
• Disciplinary action by another state BON or other
licensing authority – especially if substance abuse issue or
suspicion of or actual diversion (inference of past behavior
indicating present – goes more to recommendation for
disciplinary sanction)Preparation for Drug Diversion Cases
OTHER IMPORTANT EVIDENCE
• Testimony of nurse (possible credibility issues)
• Psychological and /or treatment records of nurse
(e.g., substance abuse evaluations, discharge summaries
from treatment facilities -- particularly if information reveals
admissions to diversion)
• Employment records of nurse from former
employment (particularly if reveal personnel action related to
actual or suspected diversion of controlled substances, or
indications of substance use disorder)
• Documentation of occurrences since facility
investigation completed
• Testimony/statements from patients (if available
and strong recollection of Rx nonadministration)Preparation for Drug Diversion Cases
What to look for in Chart/Pyxis Audits:
• Frequent removal by override in Pyxis
• Withdrawal then cancels action in Pyxis
• Appropriate documentation of wasting or lack of
documentation
• Waste and frequency of waste
• Waste without witness
• Frequency of medication and amount
• Correlation of removal activity with documentation
• Physician orders match medication administration to
patient
• Documentation of pain assessment and control or failure to
control pain despite continued administration of medication
• Date and time of medication administration comparison to
MAR and nurse’s notes may varyPreparation for Drug Diversion Cases
What to look for in Chart/Pyxis Audits:
• Frequent new physician orders for different or stronger
pain medication
• Administration of pain medications at frequent intervals
above and beyond expected
• If range is ordered for medication, look for upper limits
being administered and documented
• Review patient's pain range and usage on previous and
following shifts
• Drug removal occurs at or shorter intervals as ordered
• Drug removal from other patients that nurse is not
assigned or caring for
• Drugs are removed for patients no longer on unit or in
hospital (e.g., patient moves from ED to inpatient unit or is
discharged)Preparation for Drug Diversion Cases
Evaluating Medication Orders and the Nurse Who
Administered Medication
•Is a controlled substance (CS) signed out for a patient who has no
order for the medication?
•Does order authorize the amount of CS removed?
•Does patient chart reflect assessment for administration of CS?
•Do withdrawal times on sign out sheets or Pyxis report match the
administration time on the MAR?
•Was the patient/resident present when the medications were
administered?
•Did the nurse medicate another nurse’s patient?
•Are another nurse’s initials forged on a MAR?Preparation for Drug Diversion Cases
Evidence of TYPES of Diversion
•Signing out controlled substance but not administering to patient
•Nurse ordering PRN controlled substances takes entire container
when delivered
•Switching tablets
•Emptying capsules (substituting other substances)
•Diluting oral liquid controlled substance with water
•Diluting injectables with water or saline
•Theft from emergency kits
•Theft of discontinued controlled substances awaiting destruction by
pharmacist or nurses
•Dropped medicationPreparation for Drug Diversion Cases
Investigate the Pyxis or Automatic Dispensing System
POTENTIAL ISSUES
•Lack of reliability of automated system
•Lack of reliability of how automated system is used
•Lack of security or controls
•Lack of regular or routine checks and balances
•Lack of training for nurses using
•Lack of familiarity or investigation of “issues”
related to malfunctions, etc.
•Lack of “triggers” to prompt review for possible
discrepancies or irregularitiesPreparation for Drug Diversion Cases
Investigate the Pyxis or Automatic Dispensing System
•What are the recommended settings for the system used?
• Understand the programming and options available
•What functions are “on”?
•What is available that is “off”?
•Why is it “off”? (how can this be detected?)
• Understand the end user’s view
•Who authorizes access?
•What are the settings on access and exit?
•What are the different access levels?
• How do these differ in different care areas?
•Who can override (and how/why)?
•Who can waste? (what system is in place?)*Preparation for Drug Diversion Cases
Possible Areas of Systemic Weaknesses
• User passwords not changed (bioprinting system available?)
• Users not terminated from system (access limited promptly?)
• Discharged patient list remaining available for hours or days after
discharge (are alerts available?)
• Built in system controls “turned off” (too cumbersome)
• Overrides that permit removals without justification (documented in
MAR?)
• Lack of internal controls over controlled substances stored in
emergency kits for trauma or urgent needs
• Pain response documentation not regularly reviewed for patterns
• Inadequate segregation of duties
• Staff with no or little training/competency on system (poor practices)Preparation for Drug Diversion Cases
Preparation for Drug Diversion Cases
Additional Litigation Considerations
vWill formal discovery be required to obtain needed
evidence?
• Objections to prosecution evidence
vWhat constraints may be faced in presenting at the hearing?
• Time constraints
• Limitations or availability of witnesses
vWhat creative methods can be used to present evidence?
• Use of demonstrative exhibits
• Power Point in closing
vCan a theme (theory of the case) be developed?Preparation for Drug Diversion Cases
Preparation for Drug Diversion Cases
Demonstrative ExhibitsPreparation for Drug Diversion Cases
CHARACTERISTICS
ü Theory must be credible / believable
" Consistent with facts
" Explain away bad facts
ü Theory must be interesting / entertaining
" Non-abrasive or demeaning
" Balanced with seriousness or sensitivity
ü Theory must be consistent with common sense / human experience
ü Theory must reveal the true nature / character of the major players
ü Theory must lend itself to outcomePreparation for Drug Diversion Cases
Preparation for Drug Diversion Cases
Preparation for Drug Diversion Cases
ØInvestigating staff/Board member ØAttorney ØHospital/Facility Personnel (DONs/CNOs, Drs., other nurses and Pharmacists) ØOther agencies (law enforcement, Board of Pharmacy) ØOther Boards of Nursing
Robert J. Walters Senior Assistant Attorney General Wyoming Attorney General’s Office 2424 Pioneer Avenue, 2nd Floor Cheyenne, Wyoming 82002 307-777-8662 bob.walters@wyo.gov
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