Control Substance Drug Diversion: What Keeps us …...What Keeps us Up at Night and Closing the Gaps...
Transcript of Control Substance Drug Diversion: What Keeps us …...What Keeps us Up at Night and Closing the Gaps...
4/22/2015
1
Control Substance Drug Diversion: What Keeps us Up at Night and
Closing the Gaps to Get a Full Night Sleep
Christopher Fortier, PharmD, FASHPChief Pharmacy Officer
Massachusetts General Hospital
STATISTICS
100,000 annually
1 in10
76 million to 210 million
5 million to 45 million
TITLE 54 PT ARIAL, TWO LINE MAXIMUM
24 pt Arial Italic Subtitle, Presenter Name/ DateHOSPITALMASS GENERAL
MASS GENERAL HOPITAL 1,000 bed academic medical center and clinics across
Boston-metro area 1.8 million control substances dispensed annually
2.3 ADM control substance transactions annually
30,000 employees 2,400 physicians 380 pharmacy employees 3,800 nurses 450 anesthesia providers
Automation 190 automated dispensing machines 85 anesthesia workstations
THEBASICS
4/22/2015
2
QUESTION If the DEA issues a warrant at your
institution today could you provide them with 2 years worth of usable control substance records?
1304.04 Maintenance of records and inventories.Every inventory and other records required to be kept under this part must be kept by the registrant and be available, for at least 2 years from the date of such inventory or records, for inspection and copying by authorized employees of the Administration.
QUESTION Are you matching your CSOS orders to
your invoices electronically?
1311.60 Recordkeeping.
(a) A supplier and purchaser must maintain records of CSOS electronic orders and any linked records for two years. Records may be maintained electronically. Records regarding controlled substances that are maintained electronically must be readily retrievable from all other records.
(b) Electronic records must be easily readable or easily rendered into a format that a person can read. They must be made available to the Administration upon
request.
THE BASICS
2‐years readily retrievable data
DEA binder Hospital licensed sites Biennial inventory Power of Attorney forms DEA/DPH licenses Suspicious monitoring Inventory integrity BAA DEA 106 filings
Files CSOS order/invoice matching
DEA 222 forms Reverse distributor Weekly narcotic inventories
Narcotic vault Limited access and hours
Process to remove employees from system
Nationally certified techs
THE BASICS
Biennial inventory Open or close of business
Ideally all on same day
Physical inventory
Pharmacist/tech sign off
Kits, expired drug, quarantined items
Control substance online database files DPH and DEA filing
Investigation documents
Associated safety reports
Task force
A-TEAMTHE
DRUG DIVERSION TASK FORCE
Executive Sponsor: SVP Administration
Nursing Quality & Safety Director &
Staff
Associate Chief Nurse & Staff
Police & Security Director & Staff
Chief Pharmacy Officer & Staff
Chief Compliance Officer & Staff
Sr. Director Control Substance Compliance
&Surveillance
Executive Sponsor: SVP Patient Care
4/22/2015
3
education
STAFF EDUCATION Pharmacy, nursing, anesthesia
Annual mandatory training
Signs and symptoms
Nurse training
Phase I – Wasting, disposal, returning
Phase II – Pandora training
Phase III – Best practices/discrepancy
Phase IV – Override list changes
STAFF EDUCATIONWasting complete doses Removal under someone else
Withdrawing without an order Giving less than what was ordered
Dropping/breaking containers Canceled transactions
Removal for discharged patient Duplicative doses
Withdrawing for patient who do need pain meds
Asks a colleague to witness a waste that has already been wasted
Volunteers for overtime often Frequent trips to bathroom
Willing to float or stay late often Long trips off unit
Comes into work when not assigned or scheduled
Discrepancies between patient reports of pain relief and charted meds
Readily volunteers to medicate other patients Consistently signing out maximum amount of narcotics
Volunteers to waste medication that was not administered by him/her
Fotolia_50770216_1040.jpg
surveillance
SURVEILLANCE
QUESTION What does the DEA statutes say around what an institution should be doing around monitoring surveillance reports?
SURVEILLANCE PROGRAMData Source Application
Software program integration platform
Monitor for changes in purchasing and charging
Control substance safe Screen standard deviations of usual dispensing, the watch list report, and the discrepancy detail report for anomalous user or atypical transactions through the ADC data management system
Electronic health record Confirm HER administration records through unreconciled dispenses and anesthesia narcotic reconciliation reporting
Charging and Billing Monitor for atypical charge quantifies (e.g.. 20 oxycodone)
Police incident reports Check practitioner and staff backgrounds during and investigation
Time clock time stamps Verify user location and time of unusual activity
Admission, discharge, and transfer software
Identify late transactions relative to patient location during encounter
Video surveillance Upon suspicion review video footage
4/22/2015
4
ORGANIZATIONAL DASHBOARD NURSE DISCREPANCY CHECK
Two nurses complete discrepancy check
at change of shift
Discrepancy identified
Nurses check Omnicell
Transaction by item report
and complete review
Discrepancy not resolved....
Immediately call Pharmacy & notify
nurse director and/or clinical
nursing supervisor
ANOMALOUS USAGE REPORT ADM OVERRIDE REPORTomni_stid xact_dati pat_id MRN pat_name item_id rx_name qty_rem user_name Compliant? Comments Resolution
MGBLA12L09-07-14
06:36*011025770 Smith, John 8268800
morPHINE 4MG/1ML
1ML TUBEX3 RN y
MGBLA12L09-07-14
11:00*011025770 Smith, John 8268800
morPHINE 4MG/1ML
1ML TUBEX2 RN n
No Med Order
Drug Returned to
Omnicell
MGELL04L09-07-14
16:15***146579 Doe, Jane 8459200
Oxycodone 5MG/5ML
5ML SOLUT2 RN y
MGELL07L09-07-14
03:40***1378851 Richard, Richard 8268800
morPHINE 4MG/1ML
1ML TUBEX1 RN y
MGELL0909-07-14
10:11****391572 Shine, Sun 8171000
Lorazepam 2MG/1ML 1ML VIAL
1 RN y
MGELL0909-07-14
15:30***1008642 Bright, Star 8262600
morPHINE 2MG/1ML
1ML TUBEX1 RN y
MGELL14B09-07-14
13:40****391646 Stein, Frank N. 8268800
morPHINE 4MG/1ML
1ML TUBEX1 RN y
GREATER THAN 5G143041390583 NAME
March 17, 2015 12:22 AM METHADONE ORAL SOLN 5MG/5ML QTY: 13.00
March 17, 2015 9:13 AM METHADONE ORAL SOLN 5MG/5ML QTY: 13.00
March 17, 2015 3:38 PM METHADONE ORAL SOLN 5MG/5ML QTY: 13.00
March 17, 2015 11:16 PM METHADONE ORAL SOLN 5MG/5ML QTY: 13.00
L083041861194 NAME
March 17, 2015 6:12 PM hydroMORPHone 2MG/ML 1ML SYRINGE QTY: 6.00
March 17, 2015 7:05 PM hydroMORPHone 2MG/ML 1ML SYRINGE QTY: 6.00
March 17, 2015 7:49 PM hydroMORPHone 2MG/ML 1ML SYRINGE QTY: 6.00
March 17, 2015 9:41 PM hydroMORPHone 2MG/ML 1ML SYRINGE QTY: 6.00
March 17, 2015 10:45 PM hydroMORPHone 2MG/ML 1ML SYRINGE QTY: 6.00
March 17, 2015 11:39 PM hydroMORPHone 2MG/ML 1ML SYRINGE QTY: 6.00
L093041616118 NAME
March 17, 2015 9:17 PM OXYCODONE 5MG TABLET QTY: 8.00
L103031615396 NAME
March 17, 2015 6:03 AM OXYCODONE IMMED RELEASE 20 MG TAB QTY: 6.00
March 17, 2015 9:27 AM OXYCODONE IMMED RELEASE 20 MG TAB QTY: 6.00
March 17, 2015 11:53 AM OXYCODONE IMMED RELEASE 20 MG TAB QTY: 6.00
3041430347 NAME
March 17, 2015 12:38 AM OXYCODONE 5MG TABLET QTY: 6.00
March 17, 2015 4:33 AM OXYCODONE 5MG TABLET QTY: 6.00
March 17, 2015 8:31 AM OXYCODONE 5MG TABLET QTY: 6.00
OPERATING ROOM Highest area/providers of risk
Kits, bags
Drug waste
Anesthesia workstations/biometrics
Post‐case reconciliation
Trend analysis
Anesthesia workrooms
4/22/2015
5
OR POST-CASE RECONCILIATION
Post‐Case Reconciliation ‐ Monthly Compliance Trending (Sorted by Incident)
"Y" = PCR was Compliant 2014‐09 2014‐10 2014‐11 2014‐12 2015‐01 2015‐02 6 Months
user_name y n % y n % y n % y n % y n % y n % y n %
Gelineau, Amanda Maria 50 100.0% 136 5 96.5% 9 100.0% ‐ ‐ ‐ 82 100.0% 107 100.0% 384 5 98.7%
Spencer, Rebecca 47 100.0% 53 5 91.4% 62 100.0% 29 100.0% ‐ ‐ ‐ ‐ ‐ ‐ 191 5 97.4%
Greenberg, Deborah ‐ ‐ ‐ 2 4 33.3% 7 100.0% 6 100.0% 6 100.0% 7 1 87.5% 28 5 84.8%
Levine, Amy 2 100.0% 2 4 33.3% 4 100.0% ‐ ‐ ‐ 4 100.0% ‐ ‐ ‐ 12 4 75.0%
Lighthall, Samantha 2 0.0% 2 100.0% 2 100.0% 6 100.0% ‐ ‐ ‐ 2 2 50.0% 12 4 75.0%
Holley, Catherine 2 4 33.3% ‐ ‐ ‐ ‐ ‐ ‐ 2 100.0% 2 100.0% ‐ ‐ ‐ 6 4 60.0%
Gao, Lei 50 100.0% 96 3 97.0% 126 100.0% 86 100.0% 24 100.0% 86 100.0% 468 3 99.4%
Walsh, Tomas ‐ ‐ ‐ 58 3 95.1% 7 100.0% 48 100.0% 2 100.0% 103 100.0% 218 3 98.6%
Sayal, Puneet ‐ ‐ ‐ 22 3 88.0% ‐ ‐ ‐ 25 100.0% 36 100.0% ‐ ‐ ‐ 83 3 96.5%
Bartels, David DB#2046 ‐ ‐ ‐ 41 2 95.3% 111 100.0% 111 100.0% 90 100.0% ‐ ‐ ‐ 353 2 99.4%
Norato, Christine 15 100.0% 40 2 95.2% 30 100.0% 75 100.0% 82 100.0% 80 100.0% 322 2 99.4%
Yelle,Marc 40 100.0% 63 2 96.9% ‐ ‐ ‐ 5 100.0% 9 100.0% 74 100.0% 191 2 99.0%
Kim, Peggy 1890 ‐ ‐ ‐ ‐ ‐ ‐ 46 100.0% 12 2 85.7% 61 100.0% ‐ ‐ ‐ 119 2 98.3%
Cox, Jessica #1975 16 100.0% ‐ ‐ ‐ 9 2 81.8% ‐ ‐ ‐ 54 100.0% 36 100.0% 115 2 98.3%
Vanneman, Matthew 60 100.0% 111 1 99.1% 100 100.0% 146 100.0% 6 100.0% 127 100.0% 550 1 99.8%
Safavi, Kyan DB#2044 ‐ ‐ ‐ 97 1 99.0% 141 100.0% 117 100.0% 78 100.0% 115 100.0% 548 1 99.8%
Dougherty, Kelly 16 100.0% 58 1 98.3% 56 100.0% 65 100.0% 62 100.0% 93 100.0% 350 1 99.7%
AMBULATORY CLINICS Non‐profiled or paper
Tabletop ADM
Records kept on site
222 paperwork
Biennial inventory
Power of attorney
Camera surveillance
After‐hours
http://premium.wpmudev.org/blog/wp-content/uploads/2012/07/user-logging-lineup.jpg investigation
INVESTIGATION
QUESTION Do you have a formal multidisciplinary drug
diversion investigations team at your institution?
1301.92 Illicit activities by employees.
It is the position of DEA that employees who possess, sell, use or divert controlled substances will subject themselves not only to State or Federal prosecution for any illicit activity, but shall also immediately become the subject of independent action regarding their continued employment. The employer will assess the seriousness of the employee's violation, the position of responsibility held by the employee, past record of employment, etc., in determining whether to suspend, transfer, terminate or take other action against the employee.
INVESTIGATION DDTF Special Task Force
Pharmacy, nursing, police & security, occupational health, HR, employee assistance
Data collection time period 3‐6 months, 1‐2 years
Police & Security interview
Drug screen
Removed from Omnicell
Documented in eMAR Wasted Waste Comments
MRN Patient Name Medication Date Time AmountOverrid
e Date Time Amount Date Time Amount Witness
reporting
REPORTING
4/22/2015
6
QUESTION What is the minimum drug quantity loss that
requires an institution to file a DEA 106? 1301.76 Other security controls for practitioners.
(b) The registrant shall notify the Field Division Office of the Administration in his area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. The registrant shall also complete, and submit to the Field Division Office in his area, DEA Form 106 regarding the loss or theft. When determining whether a loss is significant, a registrant should consider, among others, the following factors:
(3) Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances;
(4) A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known,
(5) Whether the specific controlled substances are likely candidates for diversion;
(6) Local trends and other indicators of the diversion potential of the missing controlled substance.
REPORTING Utilize organizational safety report system to file loss
Rule of Thumb: < or >5
Regulatory filings DPH within 7 days (<5) DEA 106 with 24 hours (>5) Addendums within 45 days Will document what disciplinary action took place
Other agencies BOP, DPH, CMS, FDA, Board of Nursing, Board of Medical Practice
http://cx.aos.ask.com/question/aq/700px-700px/far-back-can-irs-audit_30c97076e46eeec2.jpg
AUDITING
AUDIT Trending reports
Event type, medication, location, user
Post‐case reconciliation
Employee volume comparisons
Accountability audits
6 selected drug by independent auditor annually
On‐site record audits of all DEA licenses
Biennial inventory, powers of attorney, 222 forms, DEA 106’s, invoices
Pharmacy employees
Null transactions, destock, overrides
Suspicious monitoring
Inventory integrity
REPORT TRENDING
20
2
2
2
2
2
3
3
4
5
6
6
6
10
11
13
0 5 10 15 20 25
Individually Reported Medications
VERSED (MIDAZOLAM)
PREGABALIN
FENTANYL 50 MCG/ ML; VERSED(MIDAZOLAM)
FENTANYL (PATCH)
DILAUDID (HYDROMORPHONE HCL)
MORPHINE SULFATE
(blank)
ATIVAN (LORAZEPAM)
MIDAZOLAM
OXYCODONE
METHADONE
LORAZEPAM
FENTANYL
FENTANYL 50 MCG/ ML
FENTANYL 50 MCG/ ML
Tre
nd
C
ateg
ory
5 5
12
4
10 10
32
14
18
1
0
5
10
15
20
25
30
35
40
2014‐01 2014‐02 2014‐03 2014‐04 2014‐05 2014‐06 2014‐07 2014‐08 2014‐09 2014‐10
Number of Submissions
Month of Submittal
technology
TECHNOLOGY
4/22/2015
7
AUTOMATION/TECHNOLOGY Understanding how technology works/limitations
ADM, anesthesia workstation, surveillance systems, pharmacy CS inventory system
e.g. When patients are discharged from system
System configurations
Upgrades/system enhancements
Access to quick and usable data
2 years worth of readily retrievable data
http://fullhdwp.com/images/wallpapers/Bank_Vault_3D_Wallpaper-HD.jpghttp://fullhdwp.com/images/wallpapers/Bank_Vault_3D_Wallpaper-HD.jpg
Pharmacy totes
PHARMACYCONTROL
ORDERING, RECEIVING, STORAGE, RETURNING
Ordering Different than person receiving
Limited to certain employees/POA
Receiving Totes immediately to vault and
processed
CSOS matching
Limiting vault and staff access
Distribution Limited daily pulls
Locked delivery cabinets
Storage Patients own meds
Cameras
Biometrics
Override list
Profile vs. non‐profiled
Downtime procedures
Returning Return bins
Drug waste
Reverse distributors
COLLECTING UNUSED CONTROLS
DEA rule went into effect October 9, 2014 1317.75 Collection receptacles.
(b). Controlled and non‐controlled substances may be collected together and be comingled, although comingling is not required.
(c) Collectors shall only allow ultimate users and other authorized non‐registrant persons in lawful possession of a controlled substance in Schedule II, III, IV, or V to deposit such substances in a collection receptacle at a registered location. Once a substance has been deposited into a collection receptacle, the substance shall not be counted, sorted, inventoried, or otherwise individually handled.
(d) Collection receptacles shall be securely placed and maintained:
(2) At a registered location, be located in the immediate proximity of a designated area where controlled substances are stored and at which an employee is present (e.g., can be seen from the pharmacy counter)..
(g) The installation and removal of the inner liner of the collection receptacle shall be performed by or under the supervision of at least two employees of the authorized collector.
OTHER AREAS OF CONSIDERATION
Human resources
fingerprinting, reference checks, drug testing
Non‐clinical hospital employees
Waste containers
Syringe with drug waste, liquid
Compounding
Research
Policies
Non‐pharmacy DEA licensesLESSONSLEARNED
4/22/2015
8
DEA SETTLEMENTS California‐ 2014
Settlement: $1.55 million to resolve claims it mishandled control substances
Violations: Theft of between 20, 000 – 30,000 hydrocodone tablets from its outpatient pharmacy in 2010 and 2011.
Numerous recordkeeping errors, such as missing signatures on delivery slips and inventory adjustments, as well as missing invoices.
Oklahoma ‐ 2011 Settlement: $1,000,000,
Violations: Inconsistencies in narcotic inventories resulting from pharmacy transfers to Surgical center.
Disclosed discrepancies to Board of Pharmacy and DEA.
Distributed methadone to medical facility not registered
Failed to maintain proper methadone records and inventories.
Indiana ‐ 2007 Settlement: $2 million
Violations: Investigation began based on allegations a pharmacy tech was stealing hydrocodone.
DEA discovered that the hospital was unable to account for 623,843 hydrocodone tablets.
Failed to keep accurate records and make accurate reports designed to safeguard the public against diversion.
LESSONS LEARNED Are you looking hard enough
Multidisciplinary collaboration is critical
Variety of surveillance and audit tools
Resources dedicated to sustaining program
Program visibility is major deterrent