4/22/2015 1 Control Substance Drug Diversion: What Keeps us Up at Night and Closing the Gaps to Get a Full Night Sleep Christopher Fortier, PharmD, FASHP Chief 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/ Date HOSPITAL MASS 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 THE BASICS
8
Embed
Control Substance Drug Diversion: What Keeps us Up at ...c.ymcdn.com/sites/ · PDF fileControl Substance Drug Diversion: What Keeps us Up at Night and ... Phase III –Best...
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
4/22/2015
1
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
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
4/22/2015
3
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
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
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.
MRN Patient Name Medication Date Time AmountOverrid
e Date Time Amount Date Time Amount Witness
reporting
REPORTING
4/22/2015
6
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
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
4/22/2015
8
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.