Prepared for the Foundation of the American College of Healthcare Executives Session 101AB Not If, but When: Drug Diversion in Hospitals Presented by: Christopher Fortier, PharmD
Not if, but When: Drug Diversion in Hospitals Christopher Fortier, PharmD, FASHP Chief Pharmacy Officer Massachusetts General Hospital Boston, MA Disclosure of Relevant Financial Relationships The following faculty of this continuing education activity has no relevant financial relationships with commercial interests to disclose: Christopher Fortier 2 1
Faculty Christopher Fortier, PharmD, FASHP 3 Learning Objectives Outline the DEA s new focus on drug diversion in hospitals Describe the various national hospital diversion headlines and data specific to healthcare provider drug abuse and the opioid crisis Discuss MGH s 2-year DEA investigation experience and the results of a corrective action plan Share essential components and key strategies of a comprehensive and proactive drug diversion program 4 2
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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. 7 Healthcare Workers 100,000 annually 1 in 10 Affects people of all demographics equally Protect patients from substandard care and infection risks 8 4
9 It is extremely important that pharmacies be prepared to meet this challenge by focusing closer attention on prescriptions dispensed, ensuring that hiring policies and accountability policies and procedures are sufficient to detect, discover, and respond to recent opioid drug crisis, as well as identify impaired health care workers and assist them in seeking appropriate programs for recover. - Ruth Carter, DEA spokesperson, October 2015 DEA considering rulemaking on suspicious order reporting. http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/10/dea considering rulemaking on suspicious order reporting.html. Accessed August 27, 2016 10 5
11 Agenda The MGH Experience Top 10 critical components Managing a DEA investigation Organizational resources Questions 12 6
Strategic Priorities Write down 5 strategic control substance diversion priorities that you plan to begin to implement when you return to your organization Share with the audience 2-3 of those strategic priorities 13 THE MGH EXPERIENCE 14 7
Mass General Hospital 1,000 bed academic medical center and clinics across Boston-metro area 2 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 15 DEA Violations at MGH Major nurse diversion Failure to report within timeframe No biennial inventory Not utilizing DEA 222 for off-site license transfer Unable to provide 2 years worth of readilyretrievable ADM records 16 8
MGH Corrective Action Employ a full time Drug Diversion Compliance Officer Establish a drug diversion team Conduct mandatory annual training for all staff Purchasing controlled substance surveillance software ADM s having timed password-reset (90 days) and biometrics Requiring the MGH Department of Pharmacy to conduct daily operating room post case reconciliation of controlled substances dispensed, used or wasted. Requiring at least one nursing leader per clinical area to: Conduct weekly reviews of all controlled substance surveillance software anomalous usage reports for ADM s in that clinical area Conduct daily M-F reviews of controlled substances dispensed from the ADM s in that clinical area 17 MGH Corrective Action Requiring clinical nursing supervisors to review certain ADM reports on Saturdays, Sundays and holidays Requiring Associate Chief Nurses to conduct monthly compliance checks on their nursing leader direct reports Requiring trend and pattern reports to be reviewed quarterly by the DDTF During each year of this CAP, MGH will conduct a self evaluation of all its DEA registered facilities to review compliance with all requirements of the ACT MGH will maintain reports of disciplinary actions taken against employees found to have lost a significant quantity of controlled substances or found to have stolen or diverted controlled substances. MGH will complete biennial inventories of all of its DEA-registered facilities using physical counts (including all ADMs) witnessed by 2 individuals 18 9
MGH Corrective Action MGH will take the following corrective actions in addition to the enhanced controls: MGH will hire external auditors to conduct unannounced audits at all MGH facilities with active DEA registrations of 5 Schedule CII-V randomly chosen by the auditors. Each audit report will be reviewed and signed by the pharmacist in charge or the registrant s DEA-designated person MGH will have 30 days to cure/resolve any deficiencies identified in the audit report and efforts to cure will be documented in the report If the auditors find any discrepancies/losses, MGH will send the audit report within 5 days of the end of the 30 day period MGH will maintain audit records and make them available for the DEA upon request for up to a 2 years after the CAP expires 19 MGH SUD Strategic Initiative Multidisciplinary inpatient consult team (ACT) Post-discharge bridge clinic Opioid task force Recovery coaches Enhanced community health center treatment Education throughout MGH and broader community Research and evaluation Culture change 20 10
MGH ACT Admission to hospital ACT consult ACT Evaluation (MD/NP + SW) MGH Bridge Clinic SNF Residential Treatment Outpatient Treatment Discharge Ongoing ACT support throughout admission 21 22 11
Top 10 1. Task force 2. Training 3. Surveillance 4. Investigation 5. Reporting 6. Auditing 7. Technology 8. Pharmacy controls 9. Human resources 10. Multidisciplinary 23 #1 TASK FORCE 24 12
#2 26 Drug Diversion Task Force Executive Sponsor: SVP Administration Executive Sponsor: SVP Patient Care Sr. Director Control Substance Compliance &Surveillance Nursing Quality & Safety Director & Staff Associate Chief Nurse & Staff Police & Security Director & Staff Chief Pharmacy Officer & Staff Chief Compliance Officer & Staff 25 education 13
Staff Education Pharmacy, nursing, anesthesia Annual mandatory training Signs and symptoms Nurse training Phase I Wasting, disposal, returning Phase II Control substance electronic surveillance training Phase III Best practices/discrepancy Phase IV Override list changes 27 Staff Education Wasting complete doses Withdrawing without an order Dropping/breaking containers Removal for discharged patient Withdrawing for patient who do need pain meds Volunteers for overtime often Removal under someone else Giving less than what was ordered Canceled transactions Duplicative doses Asks a colleague to witness a waste that has already been wasted Frequent trips to bathroom Willing to float or stay late often Long trips off unit Comes into work when not assigned or scheduled Readily volunteers to medicate other patients Volunteers to waste medication that was not administered by him/her Discrepancies between patient reports of pain relief and charted meds Consistently signing out maximum amount of narcotics 28 14
#3 SURVEILLANCE 29 Organizational Dashboard Nursing Measures Anomalous User and User Activity Checks. (Daily) Activity and User Checks (S S H) Shift Discrepancy Checks 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 Filings 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 30 15
Anomalous Usage Report 31 Nurse Discrepancy Checks Two nurses complete discrepancy check at change of shift Discrepancy identified Nurses check ADM Transaction by item report and complete review Discrepancy not resolved... Immediately call Pharmacy & notify nurse director and/or clinical nursing supervisor 32 16
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% 33 http://premium.wpmudev.org/blog/w p-content/uploads/2012/07/userlogging-lineup.jpg investigation #4 INVESTIGATION 34 17
Investigation Diversion Response Team Pharmacy, nursing, police & security, occupational health, HR, employee assistance Data collection time period 3 6 months, 1 2 year, depends on scenario Police & Security interview Drug screen Reporting to local police? 35 reporting #5 REPORTING 36 18
Reporting Utilize organizational safety report system to file loss 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 agencies BOP, DPH, CMS, FDA, Board of Nursing, Board of Medical Practice 37 http://cx.aos.ask.com/question/aq/7 00px-700px/far-back-can-irsaudit_30c97076e46eeec2.jpg #6 AUDITING 38 19
Audit Biennial inventory Trending reports 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 39 Report Trending 40 FENTANYL 50 MCG/ ML 13 FENTANYL 50 MCG/ ML 11 35 FENTANYL 10 32 LORAZEPAM 6 30 METHADONE 6 Number of Submissions 25 20 15 10 12 10 10 14 18 OXYCODONE MIDAZOLAM ATIVAN (LORAZEPAM) (blank) MORPHINE SULFATE DILAUDID (HYDROMORPHONE HCL) FENTANYL (PATCH) FENTANYL 50 MCG/ ML; VERSED (MIDAZOLAM) 6 5 4 3 3 2 2 2 5 0 5 5 4 1 2014 01 2014 02 2014 03 2014 04 2014 05 2014 06 2014 07 2014 08 2014 09 2014 10 PREGABALIN 2 VERSED (MIDAZOLAM) 2 Individually Reported Medications 20 0 5 10 15 20 25 40 20
technology #7 TECHNOLOGY 41 Automation/Technology Control substance surveillance system Automated dispensing cabinets, anesthesia workstations Biometrics Access to quick and usable data 2 years worth of readily retrievable usable data Security cameras Understanding how technology works/limitations When patients are discharged from system System configurations, upgrades 42 21
http://fullhdwp.com/images/wallpap ers/bank_vault_3d_wallpaper- Pharmacy totes HD.jpghttp://fullhdwp.com/images/ wallpapers/bank_vault_3d_wallpa per-hd.jpg #8 PHARMACY CONTROLS 43 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 44 22
Collecting Unused Medications 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. 45 #9 HUMAN RESOURCES 46 23
Human Resources Drug testing upon hire, random? Corrective action Investigational leave, FMLA Bringing employees back after treatment 47 #10 MULTI- DISCIPLINARY 48 24
Multi-Disciplinary Collaboration Executive leadership Pharmacy Anesthesia Policy compliance Leadership accountability Employee corrective action Nursing Daily surveillance Discrepancies Weekly cycle counts Policy and process accountability Employee corrective action 49 OTHER AREAS OF CONSIDERATION Non pharmacy DEA licenses Non clinical hospital employees Removing employee access Policy updates Research Waste containers Patients own meds 50 25
WORKING WITHTHE DEA 51 Working with the DEA Legal counsel Cause or no cause Be organized Readily retrievable data Lack understanding of hospital operations and processes Accountability audits Outside auditor or consultants Implement improvements while investigation ongoing Understand hot buttons 52 26
Working with the DEA Which violations are you agreeing to or contesting Double counting violations How audits were conducted Precedent based on previous cases Corrective action plan 53 RESOURCES 54 27
Resources Dedicated resources Technology/automation Control substance surveillance software Automated dispensing cabinets Anesthesia workstations Biometrics Cameras Waste receptacles Indirect costs Nursing time Meetings Investigations 55 MGH INITIAL COSTS 56 28
Strategic Priorities Write down 5 strategic control substance diversion priorities that you plan to begin to implement when you return to your organization Share with the audience 2-3 of those strategic priorities 57 Resources ASHP Guidelines on Preventing Diversion of Control Substances ASHP Controlled Substances Diversion Prevention Program Elements of Implementation Use for gap analysis 58 29
Lessons Learned Are you looking hard enough? Proactive vs. reactive Comprehensive Multidisciplinary collaboration is critical Variety of surveillance and audit tools Resources dedicated to sustaining program Program visibility is major deterrent 59 60 30
Questions? Chris Fortier cfortier@partners.org Faculty Biography & Contact Info Christopher Fortier, PharmD, FASHP (cfortier@partner.org) Chief Pharmacy Officer, Massachusetts General Hospital, Boston, MA Graduated from the University of Connecticut with a Doctor of Pharmacy degree in 2003 Completed a PGY-1 Practice and PGY-2 Health-System Pharmacy Administration Residency at the Medical Univ. of South Carolina in Charleston, SC Adjunct Associate Professor: Univ. of Connecticut, Northeastern University, and Massachusetts College of Pharmacy 62 31