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4/22/2015

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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

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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

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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

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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






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



3041430347 NAME

March 17, 2015 12:38 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

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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

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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

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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

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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

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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

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