Rx15 pharma wed_1115_1_lynch_2tuttle

Pharmacy Track:Identifying and Remedying

Internal Diversion Issues

Presenters:• William J. Lynch, Jr., RPh, Clinical Staff Pharmacist,

Kennedy University Hospital-Cherry Hill Division, and Task Force Manager, Camden County (NJ) Addiction Awareness Task Force

• Jeanne Tuttle, RPh, National Pharmacist Program Manager, Pharmacy Benefits Management Services, Department of Veteran Affairs (VA)

Moderator: Tom Handy, Chair, Operation UNITE Board of Directors

Disclosures

• William J. Lynch, Jr., RPh – Speaker’s bureau: Zogenix

• Jeanne A. Tuttle, RPh, has disclosed no relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.

• Tom Handy has disclosed no relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.

Disclosures

• All planners/managers hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.

• The following planners/managers have the following to disclose:– Kelly Clark – Employment: Publicis Touchpoint Solutions;

Consultant: Grunenthal US– Robert DuPont – Employment: Bensinger, DuPont &

Associates-Prescription Drug Research Center– Carla Saunders – Speaker’s bureau: Abbott Nutrition

Learning Objectives

1. Identify internal diversion trends.

2. Outline internal diversion prevention strategies.

3. Describe the VA’s controlled substance inspection program.

Identifying and Remedying Internal Diversion Issues

William J. Lynch, Jr. BS-Pharm, RPhClinical Staff Pharmacist-Kennedy University Hospital

Core Teaching Affiliate of Rowan School of Osteopathic MedicineRutgers University, Ernest Mario School of Pharmacy Preceptor

Camden County New Jersey Addiction Awareness Task ForceState of New Jersey Police Training Commission Instructor

Camden County College Police Academy InstructorDelaware Prevention Coalition Partner

National Prescription Drug Abuse SummitApril 8, 2015

Disclosure Statement

William J. Lynch, Jr. BS-Pharm, RPh wishes to disclose he is a consultant with Zogenix, Inc.

He will present this content in a fair and balanced manner

Learning Objectives

• Identify internal diversion trends

• Outline internal diversion prevention strategies

• Describe the VA’s controlled substance inspection program

A Wise Person Once Said…

It is important to learn from your mistakes

It is truly better to learn from someone else’s

A Wise Person Once Said…

Few things are more important to someone than their life or livelihood

Reality CheckIf you have ever been apart of a narcotic investigation, everyone is under suspicion.

After living through that experience, you will never practice the same way again. EVER!

Diversion…

• “Diversion” means the transfer of a controlled substance from a lawful to an unlawful channel of distribution or use.Uniform Controlled Substances Act (1994)1

• “Diversion” means any criminal act involving a prescription drug.National Association of Drug Diversion Investigators (NADDI)2

1 Berge, KH et al. Diversion of Drugs Within Health Care Facilities, a Multiple-Victim Crime: Patterns of

Diversion, Scope, Consequences, Detection, and Prevention. Mayo Clin Proc. July 2012;87(7):674-682.2 What exactly is drug diversion?

http://www.naddi.org/aws/NADDI/pt/sd/news_article/43411/_self/layout_details/false

Accessed February 24, 2015

http://www.naddi.org/aws/NADDI/pt/sd/news_article/43411/_self/layout_details/false

NIMBY *

If you are not finding any diversion…

You are not looking hard enough!

*NIMBY: Not in My Back Yard

Significant examples of high profile large-scale controlled substances (CS) diversion in hospital, community, and mail-order pharmacy settings

• Maryland (2005): 7,900 oxycodone extended-release (ER) tablets were unaccounted for. No arrests were made. The university hospital agreed to a settlement with the US Attorney’s office and paid a $250,000 fine.19

• Indiana (2007): A female pharmacy technician was responsible for diverting more than 623,000 tablets of hydrocodone-acetaminophen tablets from a hospital’s clinic pharmacy. Her son (not an employee) was also implicated. The not-for-profit hospital paid $2 million in fines.20

Martin, ES. et al. Preventing Large-Scale Controlled Substance Diversion From Within the Pharmacy.

Hosp Pharm May 2013; 48 (5):406-412

Significant examples of high profile large-scale controlled substances (CS) diversion in hospital, community, and mail-order pharmacy settings

• Texas (2010): Five hospital pharmacy employees fired after arrested for diverting >370,000 CS dosage forms (primarily hydrocodone-apap tabs) from hospital clinic pharmacies. Some technicians allegedly chose to train as technicians, hired on with express intent of large-scale CS diversion with support of outsiders. Two nonemployees also arrested. Public hospital paid $100,000 in fines.21

• Pennsylvania (2012): Mail-order pharmacy chain paid $2.75 million in settlement with US Attorney’s office for allowing employee diversion of undisclosed amount of prescription controlled substances into ‘‘illicit channels’’ and for other violations.22

Martin, ES. et al. Preventing Large-Scale Controlled Substance Diversion From Within the Pharmacy.

Hosp Pharm May 2013; 48 (5):406-412

Scope of the Problem

• Estimated 7%-24% of nurses practicing in US experience chemical impairment– ER nurses at particular risk due to stressful nature of

position/availability of substances1

• Nurses who divert drugs may not fit substance abuser stereotype– May be overachievers, very outgoing, signing up for all

hard shifts to fill, everyone’s friend, helpful with assisting colleagues with medicine administration

– Most reviewers start investigation process in full denial2

1 Emergency Nurses Association. Position Statement: Chemical impairment of emergency nurses.

December 12,2006. www.ena.org/about/position/PDFs/ChemicalImpairment.PDF2 Journal of Emergency Nursing Narcotics Diversion: A Director’s Experience 2007:33:175-8

http://www.ena.org/about/position/PDFs/ChemicalImpairment.PDF

Scope of the Problem

• Specialty of nurse anesthesia has near 10% of practitioners who face a chemical dependency1

• Between 1996-2006:

– 217,957 violations by 52,297 nurses reported to NURSYS database

– 44/60 member boards of the National Council of State Boards of Nursing

– 60,010 (27.53%) related to ETOH/drugs; 16,268 drug diversion by nurse for own use2

– Underestimated (not just with only 16 not reporting)

1 A Nurses Responsibility: Report Possible Narcotic Diversion, http://allnurses.com, May 18, 20112 Burke, J. Nurse Diversion in Health Facilities Part I Pharmacy Times. August 1, 2010

http://allnurses.com/

Warning Signs of Chemical Dependency: Job Performance

• Inconsistent work quality, alternate periods of high and

low efficiency

• Increased difficulty meeting deadlines

• Unrealistic excuses for lowered work quality

• Job shrinkage, doing minimum work necessary for job

• Sloppy/illogical charting

• Excessive number of mistakes/errors of judgment in

patient care

• Long breaks/lunch hours

2 Adapted from Hughes, TL, Smith, LL,. Is you Colleague Chemically Dependent? Am J Nurs 94(9):31-35, 1994, and Catanzarite, A., Managing the Chemically Dependent Nurse, A guide to identification, intervention, and retention, AHA Books, 1992.

Warning Signs of Chemical Dependency: Job Performance

• Frequent/unexplained disappearances during shift

• Lateness for work and/or returning from lunch

• Volunteering to work overtime despite difficulty showing for scheduled shifts

• Excessive use of sick time, especially following days off

• Absences without notice or last minute requests for time off

• Repeated absences due to vaguely defined illnesses

2 Adapted from Hughes, TL, Smith, LL,. Is you Colleague Chemically Dependent? Am J Nurs 94(9):31-35, 1994,

and Catanzarite, A., Managing the Chemically Dependent Nurse, A guide to identification, intervention, and

retention, AHA Books, 1992.

Chemical Dependency Warning Signs: Behavior, Attitude, Mood and Mental Status

• Wide mood swings from isolation to irritability and outbursts

• Difficulty in concentration • Marked nervousness on job • Decrease in problem solving ability • Diminished alertness, confusion, frequent

memory lapses • Difficulty in determining or setting priorities




Chemical Dependency Warning Signs: Behavior, Attitude, Mood and Mental Status

• Isolates from others, eats alone, avoids informal staff get-togethers, requests transfer to night shift

• Unwillingness to cooperate with co-workers or inability to compromise

• Avoids contact with supervisor

• Over reaction to real or imagined criticism

• On unit when not on duty




Chemical Dependency Warning Signs: Medication Centered Problems

• Consistently volunteering to be medication nurse

• Offering to hold narcotic keys during report

• Volunteering to work with patients who receive regular or large amounts of pain medication

• Frequently found around medication room or cart

• Insists on administering drugs via IM when other nurses give it PO to same patient

• Patient charting reflects excessive use of PRN pain medication compared to shifts when other nurses are assigned to same patient





• Patients complaining of little or no relief from pain

medications when nurse is assigned to patient

• Use of two smaller tablets of medication to give

prescribed dose (three 5 mg oxycodone tablets instead

of one 15 mg tablet)

• Use of larger than necessary dose, wasting the rest

(4 mg morphine when patient is to receive only 2 mg)

• Overzealous/always willing to sign for receipt of

controlled pain meds





• Missing drugs or unaccounted doses

• Frequently reporting spills, wastage or breakage of medications

• Charting errors include medication errors

• Defensive when questioned about medication errors

• User names/passwords used by individuals when their shift is over/off the clock/not working

• User names/passwords used by other individuals when that nurse’s shift is over/off the clock/not working




Common Behaviors that Raise Suspicions of Diversion

• Frequent tardiness

• Prolonged/frequent bathroom breaks

• Arrival at work when not scheduled

• Early arrival/late departure from work

• Regular requests for overtime/offers to work overtime

• Frequent withdrawal of larger doses than needed

• Wasting of entire doses

• Pattern of removal or wasting near the end of a shift

• Poor judgment

• Inconsistent medical record entries

• Erratic work performance/implausible excuses for poor performance

• Change in personality, appearance, or demeanor

• Drugs or syringes in pockets

• Syringes inappropriately left out

• Patients complaining-unrelieved pain

• Missing medications or discrepancies

• Signs of medication tampering, holes in packaging or glue around caps

• Missing prescription pads

• Evidence of tampering with sharps containers

New, Kimberly. Preventing, Detecting, and Investigating Drug Diversion in Health Care Facilities. Missouri

State Board of Nursing . November, December 2014, January 2015. p. 12. Reprinted with Permission Journal

of Nursing Regulation Volume 5, Issue 1, April 2014 Publisher: National Council of State Boards of Nursing

Common Methods of Diversion• Removal of medication when patient does not need it• Removal of medication for a discharged patient• Removal of a duplicate dose• Removal of fentanyl patches• Removal of medication without an order• Removal under a colleague’s sign-on• Substitution of a non-controlled substance for a controlled

substance• Theft of patient medications brought from home• Failure to waste when indicated• Frequent wasting of entire doses




Diversion Causing Patient Harm

“Drug diversion harms patients, staff members, the community, institutions, and the diverters

themselves.”





• Patients can be harmed by:

– Receiving care from an impaired provider

– Being denied pain medication

– Receiving an unsafe substance instead of a controlled substance

– Receiving injections from tainted needles, syringes, or vials





In 2012, nurse pleaded guilty to theft of hydromorphone in hospital. Nurse removed hydromorphone from medication bags replaced it with saline. Twenty-five patients infected with Ochrobactrum anthropi, a blood-borne pathogen. Six required treatment in intensive care setting; three underwent surgical intervention because of symptoms from unidentified source; one died. Nurse sentenced to 2 years in prison (Hanners, 2013).





In 2013, radiology technician who worked extensively as a traveler pleaded guilty in federal court to charges of drug theft and tampering after he was found to have stolen fentanyl at several institutions. He took syringes containing fentanyl, injected himself, replaced fentanyl with saline, and returned tainted syringes for patient use. More than 45 patients contracted hepatitis C as a result of his diversion. Technician was sentenced to 39 years in prison. (Marchocki, 2013).




Risks To Diverting Health Care Worker

• Loss of professional license• Excluded from health care employment by federal government

under Office of Inspector General’s (OIG) exclusionary authority– exclude individuals from work in health care if guilty of felony or

misdemeanor drug related offense

• Incarceration – (42 U.S.C. § 1320a-7(a)(4), 1996; 21 U.S.C. §841 et. seq., 1980)

• Physical injury/death• Infected with a blood-borne pathogen/die of an overdose

– (Berge, Dillon, Sikkink, Taylor, & Lanier, 2012)

• Many diverted opiates in fixed combination with acetaminophen– diverter’s opiate need escalates, acetaminophen dose can reach lethal

levels




National Institute of Drug Abuse (2014). Gene Variants Reduce Opioid Risks Retrieved from

http://www.drugabuse.gov/news-events/nida-notes/2014/06/gene-variants-reduce-opioid-risks

on October 1, 2014

http://www.drugabuse.gov/news-events/nida-notes/2014/06/gene-variants-reduce-opioid-risks

Detecting Diversion: Diversion Rounds

• Program to prevent diversion must operate with understanding that any person with access to controlled substances may divert. Frequently, detection of diversion is hampered by preconceived notions of the characteristics of a diverting health care worker.

• Erroneously believe diverter will be unkempt, lazy, poor performer

• Often “last person” supervisor would suspect

• Hindered by close relationships between managers & staff

• Because of diverter’s desire to maximize opportunities to divert, circumstances associated with higher risk of diversion include night-shift work, assignment to critical care area or other unit with increased autonomy, and agency or travel work

New, Kimberly. Preventing, Detecting, and Investigating Drug Diversion in Health Care Facilities. Missouri State

Board of Nursing . November, December 2014, January 2015. p11. Reprinted with Permission Journal of Nursing

Regulation Volume 5, Issue 1, April 2014 Publisher: National Council of State Boards of Nursing

It broke….

• Ampules fell off cart transporting them to the floor to put in ADC

• All narcotics when transported are placed in a separate bag for each drug and marked with “Controlled Substance”

• Carefully remove ampules, remove remaining liquid from each ampule

• Tilt bag, insert syringe. Remove remaining fluid.

• Is total fluid present near equivalent that which should be present in this closed system?

• Should be close, barring any leakage

It broke…

• Carpujects fell off cart while transporting to floor

• Carefully remove Carpujects, remove remaining liquid from each Carpuject if possible

• Tilt bag, insert syringe. Remove remaining fluid.

• Is total fluid present near equivalent that which should be present in this closed system?

• Should be close, barring any leakage

• Check rubber stopper end of Carpujects under a microscope

• Has stopper been compromised? Punctured?

Preventing Diversion: Pre-Employment Screening

• First line of defense is comprehensive pre-employment screening

• Clinical applicants who fail to provide a clinical reference should be regarded with suspicion.

• During one investigation of a new employee who was diverting the examiner found that no clinical references had been provided during the hiring process. New nurse had worked in clinical settings at other institutions over the years, but none of his references were clinical personnel. Eventually, examiner learned that nurse had been caught diverting but had been allowed to resign without being reported to appropriate authorities.


Board of Nursing . November, December 2014, January 2015. p11. Reprinted with Permission Journal of

Nursing Regulation Volume 5, Issue 1, April 2014 Publisher: National Council of State Boards of Nursing

Preventing Diversion: Employee Orientation

• Orientation of new employees should include education about risks of diversion and institution’s policies regarding diversion

• New employees should be made aware of resources available to them if they find themselves at risk, such as Employee and Professional Assistance programs.

• Self-reporting protocols should be detailed, if relevant. Any policy of immunity from corrective action, such as allowing individuals who comply with treatment and rehabilitation to keep their jobs, should be fully explained




Preventing Diversion: Drug Security

• Most important feature of a diversion prevention program is drug security

• Many diverting nurses prefer to divert from waste because they believe such diversion does not harm the patient or institution.

• One nurse developed a practice of hanging a new bag of hydromorphone for patient controlled analgesia at start of every shift, regardless of whether or not existing bag contained sufficient hydromorphone. She later admitted that this practice allowed her to divert enough hydromorphone waste to meet her ever-increasing needs without having to resort to a more easily identifiable means of diversion.




Preventing Diversion: Drug SecurityDetailed Policies & Procedures Should Ensure

• Storage areas are in locations that can be monitored to prevent unauthorized access

• Traffic into storage areas is minimized• Controlled substance handling, including removal, wasting, and

returning, is strictly managed• Staff members who administer controlled substances know

requirements that must be met• Amount of time drugs are out of secure storage is minimal• Unused doses are returned, not wasted• Controlled substances are withdrawn for one patient at a time• Controlled substances are administered immediately after they are

removed from cabinet• Controlled substances are not handed off from one provider to

another, or such handoffs are strictly limited




Drug Security: Wasting

• Because wasting a full or partial dose of a controlled substance is an opportunity for diversion, waste should be kept to a minimum

• Stock should consist of the smallest practical dosage given the needs of the patients

• Facilities should require that all wasting be witnessed by a second authorized person, that wasting be documented, and that both persons sign off on waste

• Any pattern of wasting full doses or maximizing opportunities to waste should be investigated promptly




Drug Security: Continuous Infusions

• Because of the large doses and accessibility, continuous infusions of controlled substances warrant strict control measures

• Frequently, these infusions take place where direct supervision is not feasible

• Institutions should use locking cases and port less tubing to reduce the opportunity for diversion

• Policies for controlled substance infusions should require frequent documentation of infusion rate and the amount infused; titration or a bolus dose should be documented when it occurs. Totals should be reconciled at the end of each shift.




Compliance With Selected Recommended Practices for Diversion Detection and Preventiona for Pharmacy

Witness and documentation required for wasting of controlled substances

If an expired-returns company is used, DEA form 222 provided by company is reconciled against central pharmacy vault inventory

Audit of controlled substance purchases against products added to pharmacy inventory performed at least quarterly

Automated vault for storage of controlled substances used

If CSOS not used, log of DEA form 222 kept to ensure all are accounted forb

Individual who submits a controlled-substance purchase order not responsible for receiving the order

Use and waste of multi-dose vials of controlled substances audited

Discrepancies reviewed by individual not routinely involved in controlled-substance handling

Person-to-person transfers of controlled substances audited, including transfers to non-automated storage areas

Cameras directed at controlled-substance storage areas (working, angles, sufficient view)

Cameras directed at storage areas for high-cost non-controlled medications

Purchases periodically reconciled against dispensings for high-cost non-controlled medications

Personal belongings banned from drug storage areas

Packaging of high-cost non-controlled medications defaced to inhibit diversion and resale

McClure, SR, et al. Compliance with Recommendations for Prevention and Detection of

Controlled Substance Diversions in Hospitals. Am J Health Syst Pharm 2011;68(8):689-694.

Compliance With Selected Recommended Practices for Diversion Detection and Preventiona for Nursing

Decentralized ADMs used for controlled-substance distribution

ADM discrepancy resolution explanations investigated for validity

Use of system capable of electronically identifying discrepancies between central pharmacy vault withdrawals and nursing unit-based ADM receipts

Use of "blind" count (ADM user forced to enter inventory count when accessing a pocket)

ADM discrepancies analyzed to identify individuals most frequently involved in discrepancies

ADM stock outages investigated for potential diversion

Biometric fingerprint scan used for ADM access

Locking cases used to secure non-PCA controlled-substance infusion containers while being administered

If diversion detection software used, flagged individuals are investigated for potential diversion

Diversion detection software flags users for controlled-substance ADM transaction counts significantly above peer group mean (standard deviation 3-4 fold above average)

Alert (e-mail, voice mail, pager) sent to pharmacy leaders when a specified ADM per-transaction threshold exceededa For fractional data, numerator denotes number reporting use; denominator denotes number answering survey item. DEA = Drug Enforcement Administration, CSOS = controlled-substances ordering system, OR = operating room, ADM = automated dispensing machine, PCA = patient-controlled analgesia. b Not applicable to 29 institutions that use electronic systems other than CSOS. cData limitations precluded statistical analysis

McClure, SR, et al. Compliance with Recommendations for Prevention and Detection of

Controlled Substance Diversions in Hospitals. Am J Health Syst Pharm 2011;68(8):689-694.

Significant Impact…

“If a large scale CS diversion occurs, employee morale is impacted and the

aftermath can disrupt a pharmacy department’s ability to provide optimal

services.”

Martin, ES. et al. Preventing Large-Scale Controlled Substance Diversion from within the Pharmacy.

Hosp Pharm. May 2013; 48 (5):406-412

Steps to Minimize the Risks for Large-Scale Controlled Substances Diversions

Method ofDiversion

How it is done? How it is discovered & prevented?

Fraudulenttransfer of drug between facilities or floors

Complete paperwork for fictitious transfer CIII CS to another facility, diverts supply.

Request transfer of class 3 CS from outside facility and divert stock.

Same diversion risk present if CS transferred between patient care areas. Limit number of persons authorized to transfer CS. Secure audit DEA 222 forms. Perform audit of transferred CS, ensure receiving facility/floor actually received drugs. Before paying invoices for drugs transferred between facilities, confirm inventory received into stock. When transferring CS between ADC units, return CS to secure narcotic vault prior to reissue to another ADC.

Martin, ES. et al. Preventing Large-Scale Controlled Substance Diversion from within the Pharmacy.

Hosp Pharm. May 2013; 48 (5):406-412

Preventing Large-Scale Controlled Substance Diversion Summary of Recommendations

• Screen & rescreen pharmacy employees: – UDS, Criminal, Credit

• Divide Duties– Separate CS ordering & receiving

– Cross train staff/rotate separate roles:perspective

• Limit CS Access– Control # handle/order bulk CS

– Lock CIII-V like CII

• Optimize use of CS automation– Record all hand-offs

– Simplify reporting/auditing

– Take advantage of all features

• Improve Surveillance– Improve video camera surveillance

– Install “bird’s eye view” above CS receive/ dispense

areas

– Mandate transactions done there

• Guard the Door– Door controls/e-badge; monitor non Rx personnel

– Restrict off duty access/no bags to work/escort

• Understand your Process– Map out your process

– Examine CS handoffs/diversion risk points

• Audit In vs. Out– How much of this CS is ordered/received?

– How does this compare w/previous months?

– How much is going out & being billed through normal

channels?

• Create Calendar for Success– Delineate daily, monthly, annual CS security tasks

• Get Smart– Learn CS ordering, distribution, dispensing,

administration, destruction, security best practices

• Foster Culture of Control– Ask questions/Make suggestions

– Report Concerns

– Rigorous internal/external monitoring

Martin, ES. et al. Preventing Large-Scale Controlled Substance Diversion

From Within the Pharmacy. Hosp Pharm May 2013; 48 (5):406-412

What Would You Do?

“Helping the impaired nurse is difficult, but not impossible. The

choices for action are varied. The only choice that is clearly

wrong is to do nothing.” 1

1 National Council of State Boards of Nursing (2001). Chemical Dependency Handbook for Nurse

Managers-A Guide for Managing Chemically Dependent Employees. Chicago: NCSBN, p. IV.

Reporting Diversion Rationale

• Regardless of the reason, facilities that do not report diversion are complicit in individual’s subsequent diversion activities at other institutions

• Drug diversion is an emotionally charged issue, and having policies and procedures can help ensure that cases are handled consistently

• Disposition of cases should not depend on employee’s job title, seniority, or preference of employee’s supervisor. Imperative that investigation and reviews be consistent; accusations of bias can easily occur when investigative method is erratic or inconsistent (O’Neal & Siegel, 2007).

• Institutions must have policies and procedures in place to prevent, detect, and respond to diversion, and policies and procedures must be followed consistently and without prejudice.




Checks and Balances Under Controlled Substances Act (CSA)

“The responsibility for the proper prescribing and dispensing of controlled substances is upon

the practitioner, but a corresponding responsibility rests with the pharmacist who fills

the prescription.”

(21 CFR §1306.04(a))

US v. Hayes 595 F. 2d 258 (5th Cir 1979)US v Leal 75 F. 3d 219 (6th Cir 1996)

US v Birbragher 603 F. 3d 478 (8th Cir 2010)East Main Street Pharmacy 75 Fed. Reg. 66149 (Oct 27, 2010)

Pharmacists – The Last Line of Defense

Duty To Report…

“Pharmacists have a responsibility to protect patients, as well as the public, from the abuse,

misuse and diversion of prescription drugs.”

American Association of Colleges of Pharmacy (AACP)Annual Meeting Program Guide

July 26-30, 2014

Acknowledgements: Thank You!

• Rachel M. Lynch– Doctor of Pharmacy Candidate 2016– Rutgers University, Ernest Mario School of Pharmacy

• Brian V. Blazovic– Doctor of Medicine Candidate 2018– Jefferson Medical College, Thomas Jefferson University

• David Z. Yang– Pharmacy Intern-Doctor of Pharmacy Candidate 2016– Rutgers University, Ernest Mario School of Pharmacy

• Kurt D. Meakim– Pharmacy Intern-Doctor of Pharmacy Candidate 2015– Rutgers University, Ernest Mario School of Pharmacy

Identifying and Remedying Internal Diversion Issues

Jeanne A. Tuttle, R.Ph.National Pharmacist Program Manager

Department of Veterans AffairsPharmacy Benefits Management Services

Disclosure Statement

Jeanne A. Tuttle, R.Ph., has disclosed no relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.

Learning Objectives

• Identify internal diversion trends.

• Outline internal diversion prevention strategies.

• Describe the VA’s controlled substance inspection program.

Acronyms

• PBM = Pharmacy Benefits Management Services. http://www.pbm.va.gov/

• BCMA = Bar Code Medication Administration, barcode system designed to prevent errors and improve the quality and safety of medication administration

• OIG-CAP = VA Office of Inspector General Combined Assessment Program. http://www.va.gov/oig/– Ensure that high quality health care is provided to our

Nation's veterans

– Provides collaborative assessments of VA medical facilities on a cyclical basis

• ADR = Adverse Drug Reaction

http://www.pbm.va.gov/

http://www.va.gov/oig/

• 8.92 M Total enrollees in VA Health Care System (FY13)

• 6.48 M Total unique patients treated (FY13)

• 150 VA Hospitals

• 819 Community-Based Outpatient Clinics (CBOC)

*http://www.va.gov/vetdata/docs/pocketcards/fy2015q1.pdf

Importance• When someone diverts drugs, public trust is damaged

and funds designated to care for Veterans are miss-used.

• When the drugs are sold on the street, it has caused catastrophic impact on the people who were caught diverting and to those who end up taking the drugs.

• Pharmacists, physicians, and nurses have lost their licenses to practice as a medical professional causing devastating impact to their families, and in some cases, costing them their freedom.

• Maintaining accountability of CS Inventory and use is critical to preventing diversion

Background

• Inspection program in place over 40 years

• Initially focused on physical inventory of all CII and CIII narcotics

• Slowly expanded based on thefts and diversions

• Most requirements today are linked to previous losses– Adjust Inspection program limit vulnerability

• Types of diversion keep changing

Impetus for Major Change

• Around 2002, VA Supervisory pharmacist stole 235,000 dosage units of Schedule II and III controlled substances

• Entered fake prescriptions which were filled and diverted

• Transferred to her uncle and others for street distribution

http://www.va.gov/oig/pubs/sars/VAOIG-SAR-2003-2.pdf

Impetus for Major Change

• VA financial loss was $194,000, street value much higher

• Pharmacist sentenced to 8 years confinement, 3 years probation and ordered to surrender $500,000 as part of plea agreement

• Uncle sentenced to 5 years, 10 months imprisonment and 3 years probation

Changes Made

• In response to this diversion, Office of Medical Inspector partnered with PBM to conduct unannounced inspections at 5 randomly selected VA facilities to review controlled substance programs and assess vulnerability to similar schemes

• Changed inspection program to focus more on use and “hard copy” data such as prescriptions, provider orders, BCMA, etc.

• Developed optional monitoring tools

• Inspection program requirements increased significantly

VA Inspection Program Structure

• Programs falls under the Medical Center Director• Composed of:

– Controlled Substance Coordinator (CSC)• Overall program management, training, reporting, competency

assessment• Duties included in position description• May have alternate or “co” CSC

– Controlled Substance Inspectors (CSI)• Collateral duty• Perform the inspections

• No involvement in ordering, prescribing, dispensing, administration

• Link to Policy: http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2183

http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2183

Program Requirements

• CSIs must complete web based course and local training prior to serving– Annual training focused on problematic areas, new

requirements, survey findings

• Inspect every area where controlled drugs are stored monthly

• Inspections random and unannounced– May not inspect same area 2 months in a row

• Monthly report of findings, includes patient self reporting shortages/complaints

• Quarterly trend reports

Physical Inventory &

RX pads

Invoice Review

Rx Verification

Drugs held for

Destruction

Required Inventories Completed

Pharmacy Inspection

Requirements

Unit/Clinic Inspection Requirements

• Physical Inventory

• Inventory transfer between units

• Verify meeting local policy requirements on cycle counts

• Verify order and documentation of administration for 5 randomly selected dispensing activities

• Reconcile 1 day’s dispensing from the pharmacy to EVERY automated device

“Wasting” of Partial Doses

• VA OIG October 2014 Monthly Highlight Report:Former VA Contractor Arrested for Burglary and Possession of Controlled Substance Paraphernalia A former VA contractor was arrested for burglary and possession of controlled substance paraphernalia. An OIG and VA Police Service investigation revealed that the defendant stole sharps containers that held used syringes and mostly empty narcotic vials from the Palo Alto, CA, VAMC. The defendant used his position as an exterminator to gain access to a biohazard-holding cage that contained sharps containers ready for disposal. A search of the defendant’s work vehicle revealed approximately 20 gallons of used syringes and empty narcotic vials. During an interview, the defendant admitted that he used syringes from the stolen sharps containers to inject himself with morphine and dilaudid.

National Support

• Virtual learning calls for CSCs

– Self-identified learning needs

– Regulatory and VHA policy changes

– Sharing of strong practices

• National CSC SharePoint Community

• OIG – CAP

– External review process

– Medication Management component

Additional Safeguards

• Ordering, receiving and destruction– Separation of duties within pharmacy– Involvement of staff outside of pharmacy

• All losses greater than 5 doses reported for further investigation to:– VA Police– VA Office of Inspector General– DEA– VA Central Office

• Utilization of ADDs reports and other vendor software (e.g. Pandora)

Lessons Learned

• Include detailed instructions on inspection worksheets

• Give inspectors flexibility in choosing the day they inspect

• Teach inspectors to be “inquisitive”

– If they do not understand an answer regarding a discrepancy they should report and discuss with CSC

– If they see drugs in boxes or shelves that they are not included in the count – ask and report

Lessons Learned

• Create a facility wide culture that supports CS Management and mitigates diversion

– Newsletter article highlighting importance of program

– “Did you know” screen banners during patient safety and/or quality week

– Educate front line staff on their responsibilities to participate and support the program and support their participation

Model for Change

Minimize Diversion

Risks

Independent Oversight

Data and Metrics

Quality Improvement

Approach


• “Inspection Program”– Staff not involved in medication use process

– External survey

• Integrate into existing processes– Environment of care rounds – look for BCMA wrist

bands laying around

– Ward inspections

• Educate all staff on what to look for– Communicate clear expectations for reporting and

accountability


Data and Metrics

• Examine the underlying data

• Always start with the validated source data

• Define what you want to look at and how often– Changes in purchase activity

– Reports from automated dispensing devices• Access

• Overrides

• Cancelled transactions

• Customizable report

• Track and trend

Data and Metrics

Quality Improvement Approach

• Integrate data and metrics into the overall PI/QA plan for the organization

• Use an inter-professional approach– Similar to med-error or ADR analysis

– Findings to a committee for review and action

• Focus on risk points versus just actual diversion– Look at “near misses” and reported diversions outside

your organization

• Create a non-punitive culture of “see something, say something”

Quality Improvement

Approach

Final Thoughts….Should the impetus for change come after something bad happens or from news media headlines? OR, do we need a national, non-punitive, open system similar to med-error and ADR reporting that makes data available to everyone to identity ways to improve and mitigate the risk of diversion in our organizations?

How many of you use information found in the ISMP or Joint Commission newsletter or FDA Bulletins to drive organizational change?

Wouldn’t it be nice to have something similar for this topic?

Pharmacy Track:Identifying and Remedying

Internal Diversion Issues

Presenters:• William J. Lynch, Jr., RPh, Clinical Staff Pharmacist,

Kennedy University Hospital-Cherry Hill Division, and Task Force Manager, Camden County (NJ) Addiction Awareness Task Force

• Jeanne Tuttle, RPh, National Pharmacist Program Manager, Pharmacy Benefits Management Services, Department of Veteran Affairs (VA)

Moderator: Tom Handy, Chair, Operation UNITE Board of Directors

Rx15 pharma wed_1115_1_lynch_2tuttle

Healthcare

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