Not if, but When: Drug Diversion in Hospitals. Christopher Fortier, PharmD, FASHP Chief Pharmacy Officer Massachusetts General Hospital Boston, MA

Transcription

1 Not if, but When: Drug Diversion in Hospitals Christopher Fortier, PharmD, FASHP Chief Pharmacy Officer Massachusetts General Hospital Boston, MA

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4 Healthcare workers 100,000 annually 1 in 10 Affects people of all demographics equally

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6 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. Accessed August 27, 2016

7 Agenda The MGH Experience Challenges Top critical components Organizational resources Questions

8 Title 54 pt Arial, Two Line Maximum 24 pt Arial Italic Subtitle, Presenter Name/ Date THE MGH EXPERIENCE

9 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

10 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 readily-retrievable ADM records

11 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

12 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

13 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

14 CHALLENGES Drug diversion not necessarily focus for hospitals Competing priorities Lack resources Looking for a needle in a haystack Comprehensive and proactive Little direction from DEA No national best practices or only recently published guidelines American Society of Health-Systems Pharmacists Guidelines Are we looking for the right things? Multidisciplinary

15 CORE STRATEGIES

16 1 6 TASK FORCE

17 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

18 education

19 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

20 Fotolia_ _1040.jpg surveillance SURVEILLANCE

21 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

22 Anomalous Usage Report

23 OR Post-Case Reconciliation Post-Case Reconciliation - Monthly Compliance Trending (Sorted by Incident) "Y" = PCR was Compliant Months user_name y n % y n % y n % y n % y n % y n % y n % Gelineau, Amanda Maria % % % % % % Spencer, Rebecca % % % % % Greenberg, Deborah % % % % % % Levine, Amy % % % % % Lighthall, Samantha 2 0.0% % % % % % Holley, Catherine % % % % Gao, Lei % % % % % % % Walsh, Tomas % % % % % % Sayal, Puneet % % % % Bartels, David DB# % % % % % Norato, Christine % % % % % % % Yelle,Marc % % % % % % Kim, Peggy % % % % Cox, Jessica # % % % % % Vanneman, Matthew % % % % % % % Safavi, Kyan DB# % % % % % % Dougherty, Kelly % % % % % % %

24 investigation INVESTIGATION

25 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?

26 reporting REPORTING

27 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

28 700px/far-back-can-irsaudit_30c97076e46eeec2.jpg AUDITING

29 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

30 Number of Submissions Report Trending 40 FENTANYL 50 MCG/ ML 13 FENTANYL 50 MCG/ ML FENTANYL LORAZEPAM 6 30 METHADONE 6 OXYCODONE 6 25 MIDAZOLAM 5 ATIVAN (LORAZEPAM) (blank) MORPHINE SULFATE DILAUDID (HYDROMORPHONE HCL) FENTANYL (PATCH) FENTANYL 50 MCG/ ML; VERSED (MIDAZOLAM) PREGABALIN VERSED (MIDAZOLAM) Individually Reported Medications

31 technology TECHNOLOGY

32 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

33 lt_3d_wallpaper- HD.jpghttp://fullhdwp.com/images/wallpapers/Ba Pharmacy totes nk_vault_3d_wallpaper-hd.jpg HARMACY ONTROLS

34 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

35 UMAN RESOURCES

36 Human Resources Drug testing upon hire, random? Corrective action Investigational leave, FMLA Bringing employees back after treatment

37 ESOURCES

38 Resources Dedicated resources Technology/automation Control substance surveillance software Automated dispensing cabinets Anesthesia workstations Biometrics Cameras Waste receptacles Indirect costs Nursing time Meetings Investigations

39 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

40 QUESTIONS