oct 21 2015 webinar combined presentation slides...

Control Substance Drug Diversion: What Keeps Us Up at Night and Closing the Gaps to Get a Full Night SleepCHS Pharmacy Education Series

ProCE, Inc.www.ProCE.com 1

2015 Pharmacy Education Series

October 21, 2015Control Substance Drug Diversion:g

What Keeps Us Up at Night and Closing the Gaps to Get a Full Night Sleep

Featured Speakers:

James Arnold Christopher R. Fortier, PharmD, FASHPChief of Regulatory Policy Chief Pharmacy OfficerOffice of Diversion Control Massachusetts General HospitalDrug Enforcement Administration

1

Submission of an online evaluation is the only way to obtain CE credit

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Go to www.ProCE.com/CHSRx Webinar attendees will also receive an email with a direct link to the

web page Print your CE statement of completion online

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Deadline: November 20, 2015( l bl h )

2

CPE Monitor (applicable to pharmacists)– CE information automatically uploaded to NABP/CPE Monitor within 1 to 2

weeks of the completion of the self‐assessment and evaluation

Event Code

Code will be provided at the end of today’s activity



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October 21, 2015Control Substance Drug Diversion:

What Keeps Us Up at Night and Closing the Gaps to Get a Full Night Sleep

Featured Speakers:

James Arnold Christopher R. Fortier, PharmD, FASHPChief of Regulatory Policy Chief Pharmacy OfficerChief of Regulatory Policy Office of Diversion Control Massachusetts General Hospital

5

It is the policy of ProCE, Inc. to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation. Mr. Arnold has no relevant commercial and/or financial relationships to disclose. Dr. Fortier has no relevant commercial and/or financial relationships to disclose.

Please note: The opinions expressed in this activity should not be construed as those of the CME/CE provider. The information and views are those of the faculty through clinical practice and knowledge of the professional literature. Portions of this activity may include unlabeled indications. Use of drugs and devices outside of labeling should be considered experimental and participants are advised to consult prescribing information and professional literature.

Chief of Regulatory Policy, Office of Diversion Control Massachusetts General HospitalDrug Enforcement Administration

CE Activity Information & Accreditation

ProCE, Inc. (Pharmacist CE)

– 2.0 contact hours

F di

6

Funding:This activity is self‐funded through CHSPSC.



Diversion Prevention in Hospitals for Diversion Prevention in Hospitals for Hospital PharmacistsHospital Pharmacists

October 21, 2015October 21, 2015

James “Jim” ArnoldChief/PolicyDEA Headquarters 202-353-1414 7

The mission of the Office of Diversion Control is to prevent, detect, and investigateth di i f h ti l t ll dthe diversion of pharmaceutical controlled substances (CS) and listed chemicals from legitimate channels of distribution

while …ensuring an adequate and uninterrupted supply of controlled substances to meet legitimate medical, commercial, andscientific needs

8



Foreign Mfr Importer Manufacturer

Distri-butor

?

PractitionerPharmacyHospitalClinic

9

The movement of legitimate controlled substances into other than legitimate channelssubstances into other than legitimate channels for other than legitimate medical, scientific, and/or research needs.

10



Anytime Anyplace Under AnyAnytime, Anyplace, Under AnyCircumstances, with Anyone

11

“Traveler Nurse Who Worked in NHF Maine Suspended”

“Suspended nurse charged with drug possession Nurse accused of trying to divert controlled drugs”

“Portsmouth nurse suspended for alleged fentanyl diversion”

“Ml: Doctor nearly dies of overdose with drugs stolen from hospital”

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“Three Men Indicted On Charges Of Stealing Drugs From Walter Reed And Fort Belvoir Hospitals”

“New York Methodist Hospital Agrees To ImplementCompliance Program, To Settle Civil Claims Under The Controlled Substances Act. Hospital's Residents Issued Improper Prescriptions For Adderall, A HighlyAddictive Stimulant”

“Dignity Health Agrees To Pay $1.55 Million In Civil Penalties To Resolve Controlled Substances Act Claims”

13

“Mass. General Will Pay $2.3M To Settle DrugViolations”

“Doctors, medical staff on drugs put patients at risk”

“Former Employee of Exeter Hospital Sentenced to 39 Years in Connection with Widespread Hepatitis CO tbreak”Outbreak”

14



“The Human Factor”

15

Physicians

Interns

Residents

Pharmacists

Pharmacy Technicians

Physician Assistants

Nurses

Orderlies

Other Employees (e.g. Janitors, Administrative Staff, Contractors, Electricians, General Maintenance Personnel, Volunteers)

Visitors 16



Hydrocodone2 248 000 333 D U i

Oxycodone

Comparison of Comparison of ARCOS ARCOS Reported Reported HospitalHospital PurchasesPurchases

January 1, 2010 January 1, 2010 –– June 30, 2015June 30, 2015

2,248,000,333 Dosage Units2,358,423,526 Dosage Units

36% 34%

9%21%

Remaining 21 Drugs1,349,135,380 Dosage Units

Morphine577,400,062 Dosage Units

Drug Enforcement Administration, Office of Diversion Control, Pharmaceutical Investigations Section, Targeting and Analysis UnitSource: ARCOS

Date Prepared: 10/14/2015

17

Hydrocodone5,135 TheftsOxycodone

Comparison of Comparison of Hospital Hospital Reported Reported TheftsThefts NationwideNationwide

January 1, 2010 January 1, 2010 –– September 30, 2015September 30, 2015(All Theft (All Theft Categories IncludedCategories Included))

5,135 Thefts6,407 Thefts

20% 16%

14%

13%8%4%

25%

Morphine4,380 Thefts

Hydromorphone8%4%

Fentanyl2,597 Thefts

Lorazepam1,432 Thefts

Remaining 56 Drugs8,146 Thefts

4,305 Thefts

Drug Enforcement Administration, Office of Diversion Control, Pharmaceutical Investigations Section, Targeting and Analysis UnitSource: ARCOS

Date Prepared: 10/14/2015

18



ADS Machines (Pyxis Machines)Emergency RoomsMedication CartsMedication CartsNursing Station (CS Holding/Staging Areas)Operating RoomPatient, Patient Rooms, Patient Personal MedicationsPatient Controlled Analgesia (PCA)PharmacyWaste Disposal Areas

19

PYXIS Reports

Can be run/sorted by different variables

Typical sort is to run all CII‐CIV and all patients by user

Information obtained can be reformattedcan be reformatted later

20



PYXIS Record

Automated MAR/Surgery Record

21

22



21 CFR § 1301.71(a) § ( )

“All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances.”

U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control

23

21 CFR § 1306.04(a)

A prescription for a controlledA prescription for a controlled substance to be effective must be issued for a legitimatemedical purpose by an individual practitioner acting in the usual course of histhe usual course of his professional practice.

United States v Moore 423 US 122 (1975)

24



21 CFR § 1306.04(a)

The responsibility for theThe responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests withresponsibility rests with the pharmacist who fills the prescription.

25

• A pharmacist, by law, has a corresponding responsibility to ensure that prescriptionsresponsibility to ensure that prescriptions are legitimate

• Just because a prescription is presented by a patient or demanded to be filled for a patient by a doctor’s office a pharmacist ispatient by a doctor’s office, a pharmacist is not obligated to fill the prescription!!!

26



Suggested Preventative MeasuresSuggested Preventative Measures

• Pre‐Employment Screening– Background Checksg

– Drug Screening

• Updated Background Checks Every Five Years

• Random Drug Screening

• Physical Security Controls

• SOP’s for Handling Controlled Substances

• Limited Access to Controlled Substances

• Limited Access to Alarms, Keys, Pass Codes

27

Suggested Preventative MeasuresSuggested Preventative Measures

• Limited Access to Dispensing Areas• At Least Two employees at all timesp y• Cameras in all areas where CS are being dispensed

• Secure access to CS ordering systems (CSOS) • Do not post the password for ordering CS electronically on the wall of the pharmacy

• Limited Power of Attorney status for signing DEA 222 order forms

• Tell Physicians to secure their prescription pads

28



www.deadiversion.usdoj.gov

DEA WebDEA Web‐‐Based ResourcesBased Resources

29

Thank You / Questions Thank You / Questions

30



CONTROL SUBSTANCE DRUG DIVERSION: WHAT KEEPS US UP ATDIVERSION: WHAT KEEPS US UP AT NIGHT AND CLOSING THE GAPS TO

GET A FULL NIGHT SLEEP

Ch i t h F ti Ph D FASHPChristopher Fortier, PharmD, FASHPChief Pharmacy Officer

Massachusetts General HospitalBoston, MA

September 30, 2015

31

32



STATISTICS

100,000 annually

1 in10

76 million to 210 million76 million to 210 million

5 million to 45 million33

OBJECTIVES

• Describe a hospital’s experience around control substance drug diversion and a regulatory agency’ssubstance drug diversion and a regulatory agency s internal investigation

• Discuss the specific drug diversion process improvement initiatives, policy development, and optimization between pharmacy, nursing, anesthesia and hospital security

• Outline the lessons learned and potential system gaps• Outline the lessons learned and potential system gaps when implementing a comprehensive diversion surveillance program and consistent compliance around regulatory reporting requirements

Speaker has no conflicts of interest to disclose 34



Title 54 pt Arial, Two Line Maximum

24 pt Arial Italic Subtitle, Presenter N / D tName/ Date

HOSPITALMASS GENERAL

35

MASS GENERAL HOPITAL

• 1,000 bed academic medical center and clinics across Boston‐metro area

• 1.9 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

36



THEBASICS 37

QUESTION• If the DEA issues a warrant at your

institution today could you provide them with 2 years worth of usable controlwith 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 b k t b th i t t d bbe 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.

38



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 fromelectronically 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.39

THE BASICS

• 2‐years readily retrievable data

• Files– CSOS order/invoice matchingdata

• DEA binder– Hospital licensed sites

– Biennial inventory

– Power of Attorney forms

– DEA/DPH licenses

– Suspicious monitoring

CSOS order/invoice matching

– DEA 222 forms

– Reverse distributor

– Weekly narcotic inventories

• Narcotic vault– Limited access and hours

• Process to remove – Inventory integrity

– BAA

– DEA 106 filings

employees from system

• Nationally certified techs

40



THE BASICS

• Biennial inventory • Control substance li d t b fil– Open or close of

business

– Ideally all on same day

– Physical inventory

– Pharmacist/tech sign off

– Kits expired drug

online database files

– DPH and DEA filing

– Investigation documents

– Associated safety reports

Kits, expired drug, quarantined items

41

• Task force

A-TEAMTHE

42



DRUG DIVERSION TASK FORCE

Executive Sponsor: SVP Administration

Sr. Director Control Substance Compliance

&Surveillance

Executive Sponsor: SVP Patient Care

Nursing Quality & Safety Director &

Staff

Associate Chief Nurse & Staff

Police & Security Director & Staff

Chief Pharmacy Officer & Staff

Chief Compliance Officer & Staff

43

• education

44



STAFF EDUCATION• Pharmacy, nursing, anesthesia

A l d t t i i– Annual mandatory training

• Signs and symptoms

• Nurse training

– Phase I – Wasting, disposal, returning

Phase II Control substance electronic– Phase II – Control substance electronic surveillance training

– Phase III – Best practices/discrepancy

– Phase IV – Override list changes

45

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 46



Fotolia_50770216_1040.jpg

• surveillance

SURVEILLANCE

47

QUESTION• What does the DEA statutes say around what ansay around what an institution should be doing around monitoring surveillance reports?

48



ORGANIZATIONAL DASHBOARDNursing Measures

Anomalous User and User Activity Checks. (Daily)

Activity and User Checks (S‐S‐H)

Shift Discrepancy Checksp y

Pharmacy / Anesthesia Measures

Post Case Reconciliation Compliance (Daily)

Pharmacy Measures

DEA 106 Filings

Destock‐Null Transactions (Daily)

Destock‐Null Transactions (Weekly)

Discrepancy Checks (Daily)

Dispense >5 Report (Daily)

DPH Filingsg

Global List Transaction Review (Weekly)

Inventory Integrity Checks‐ Endoscopy (Monthly)

Override Report (Daily)

Suspicious Order Monitoring (Monthly)

Terminated Employee ADM Removal (Monthly)

Annual Inventory

Site Visits

49

NURSE DISCREPANCY CHECK

Two nurses complete discrepancy check at

change of shiftDiscrepancy identified

Nurses check ADM Transaction by item

report

and complete review

Discrepancy not resolved....

Immediately call Pharmacy & notify

nurse director and/or clinical nursingclinical nursing supervisor

50



ANOMALOUS USAGE REPORT

51

ADM OVERRIDE REPORTomni_stid xact_dati pat_id MRN pat_name item_id rx_name qty_rem user_name Compliant? Comments Resolution

MGBLA12L 09‐07‐14 06:36 *011025770 Smith, John 8268800morPHINE

4MG/1ML 1ML 3 RN yMGBLA12L 09 07 14 06:36 011025770 Smith, John 8268800 4MG/1ML 1ML TUBEX

3 RN y

MGBLA12L 09‐07‐14 11:00 *011025770 Smith, John 8268800morPHINE

4MG/1ML 1ML TUBEX

2 RN n No Med OrderDrug Returned to Omnicell

MGELL04L 09‐07‐14 16:15 ***146579 Doe, Jane 8459200Oxycodone

5MG/5ML 5ML SOLUT

2 RN y

MGELL07L 09‐07‐14 03:40 ***1378851 Richard, Richard 8268800morPHINE

4MG/1ML 1ML TUBEX

1 RN y

MGELL09 09‐07‐14 10:11 ****391572 Shine, Sun 8171000Lorazepam

2MG/1ML 1ML VIAL

1 RN y

MGELL09 09‐07‐14 15:30 ***1008642 Bright, Star 8262600morPHINE

2MG/1ML 1ML TUBEX

1 RN y

MGELL14B 09‐07‐14 13:40 ****391646 Stein, Frank N. 8268800morPHINE

4MG/1ML 1ML TUBEX

1 RN y

52



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



53

OPERATING ROOM• Highest area/providers of risk

Kit b– Kits, bags

– Drug waste

• Anesthesia workstations/biometrics

• Post‐case reconciliation

• Trend analysis• Trend analysis

54



OR POST-CASE RECONCILIATIONPost‐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%

55

AMBULATORY CLINICS• Non‐profiled or paper

bl• Tabletop ADM

• Records kept on site

– 222 paperwork

– Biennial inventory

Power of attorney– Power of attorney

• Camera surveillance

56



http://premium.wpmudev.org/blog/wp-content/uploads/2012/07/user-

logging-lineup jpg• investigation

logging lineup.jpg

INVESTIGATION 57

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 ill th i f th l '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.

58



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 interviewPolice & 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

59

• reporting

REPORTING60



QUESTION• What is the minimum drug quantity loss that

requires an institution to file a DEA 106?• 1301.76 Other security controls for practitioners.y p

(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;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.

61

REPORTING• Utilize organizational safety report system to file loss

Rule of Thumb: < or >5– Rule of Thumb: < or >5

• Regulatory filings– DPH within 7 days (<5) – Massachusetts regulation– DEA 106 with 24 hours (>5)– Addendums within 45 days

• Will document what disciplinary action took place

• Other agenciesOther agencies– BOP, DPH, CMS, FDA, Board of Nursing, Board of Medical Practice

62



http://cx.aos.ask.com/question/aq/700px-700px/far-back-can-irs-audit 30c97076e46eeec2 jpgaudit_30c97076e46eeec2.jpg

AUDITING 63

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• Pharmacy employees

– Null transactions, destock, overrides

• Suspicious monitoring

• Inventory integrity

64



REPORT TRENDING

10

11

13

FENTANYL

FENTANYL 50 MCG/ ML

FENTANYL 50 MCG/ ML

40

2

3

3

4

5

6

6

6

10

DILAUDID (HYDROMORPHONE HCL)

MORPHINE SULFATE

(blank)

ATIVAN (LORAZEPAM)

MIDAZOLAM

OXYCODONE

METHADONE

LORAZEPAM

ren

d C

ate

go

ry

12

32

14

18

15

20

25

30

35

Number of Submissions

20

2

2

2

2

2

0 5 10 15 20 25

Individually Reported Medications

VERSED (MIDAZOLAM)

PREGABALIN

FENTANYL 50 MCG/ ML; VERSED (MIDAZOLAM)

FENTANYL (PATCH)

( )

Tr

5 54

10 10

1

0

5

10

2014‐01 2014‐02 2014‐03 2014‐04 2014‐05 2014‐06 2014‐07 2014‐08 2014‐09 2014‐10

N

Month of Submittal

65

• technology

TECHNOLOGY 66



AUTOMATION/TECHNOLOGY

• Understanding how technology works/limitationsworks/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 data67

http://fullhdwp.com/images/wallpapers/Bank_Vault_3D_Wallpaper-

HD jpghttp://fullhdwp com/images/• Pharmacy totesHD.jpghttp://fullhdwp.com/images/wallpapers/Bank_Vault_3D_Wallpa

per-HD.jpg

PHARMACYCONTROL 68



ORDERING, RECEIVING, STORAGE, RETURNING

• Ordering– Different than person

• Storage– Patients own meds

receiving– Limited to certain

employees/POA

• Receiving– Totes immediately to vault

and processed– CSOS matching

– Cameras– Biometrics– Override list– Profile vs. non‐profiled– Downtime procedures

• Returning– Return bins– Limiting vault and staff

access

• Distribution– Limited daily pulls– Locked delivery cabinets

– Return bins– Drug waste– Reverse distributors

69

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 p y p ( g ,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.

70



OTHER AREAS OF CONSIDERATION

• Human resources

– Drug testing?– Drug testing?

• Non‐clinical hospital employees

• Waste containers

– Syringe with drug waste, liquid

• Compounding

• Research

• Policies

• Non‐pharmacy DEA licenses

71

LESSONSLEARNED 72



DEA SETTLEMENTS• California‐ 2014

– Settlement: $1.55 million to resolve claims it mishandled control substances

– Violations:– 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 inventoriesFailed 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.

73

LESSONS LEARNED• Are you looking hard enough?

l idi i li ll b i i i i l• Multidisciplinary collaboration is critical

• Variety of surveillance and audit tools

• Resources dedicated to sustaining program

• Program visibility is major deterrent

74



Questions?

Chris Fortier

[email protected]

75

U d t C tU d t C t PhPhUpdate on Current Update on Current Pharmacy Pharmacy Initiatives and StrategiesInitiatives and Strategies

77

Robert Fink, Pharm.D., M.B.A., FASHP, FACHE, BCNSP, BCPS

Chief Pharmacy Executive

Community Health Systems



78

oct 21 2015 webinar combined presentation slides...

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