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To Steal or Not to Steal: The Art of Managing Controlled Substances Diversion Nancy Elrod, PharmD, BCPS Manager, Medication Safety Hospital Corporation of America Nashville, Tennessee
Disclosure I do not have a vested interest in or affiliation
with any corporate organization offering
financial support or grant monies for this
continuing education activity or any affiliation
with an organization whose philosophy could
potentially bias my presentation.
Pharmacist Objectives Describe the effects of controlled substances (CS)
diversion on patient safety.
List at least three opportunities for diversion
prevention.
Identify various individuals who may contribute to
active diversion prevention.
Define key concepts in resolving a suspected
diversion.
Technician Objectives Describe the effects of controlled substances (CS)
diversion on patient safety.
List at least three opportunities for diversion
prevention.
Identify various individuals who may contribute to
active diversion prevention.
Define key concepts in resolving a suspected
diversion.
Hospital CS Diversion
“One area of prescription drug abuse that is often overlooked, but perhaps the most important, is the diversion of prescription drugs from health facilities such as hospitals and nursing home.”
Commander John Burke Ohio Drug Task Force
CS Diversion Facts Medication diversion is the unlawful channeling of
regulated pharmaceuticals from legal sources to
individuals who abuse these controlled, prescription
drugs.
From 1992 – 2003, abuse of prescription drugs in the
United States doubled from 7.8 million abusers to 15.1
million.
The 2010-2012 National Survey on Drug Use and Health
(NSDUH) reported Florida illicit drug use between 7-14%
depending on area.
1. CASA Columbia. 2005 2. Inciardi et al. Subst Use Misuse. 2006; 41:255-264 3. NSDUH. 2012
CS Diversion Facts: Who? Approximately 15% of physicians are estimated to be
impaired at some point in their career.
Approximately 10-20% of nurses are estimated to have
substance abuse problems
Nursing accounts for ~63% of hospital diverters
In a study completed by Dabney, 40% of pharmacists
reported prescription drug use without a physician's
authorization with 20% doing so five or more times in
their lifetime.
1. Inciardi et al. Subst Use Misuse. 2006; 41:255-264 2. Boisaubin et al. Am J Med Sci. 2001; 322:31-36 3. Dunn. AORN J. 2005;82:573-588 5. Dabney. J Am Pharm Assoc. 2001;44:684-693 6. Gold et al. J Global Drug Policy Prac. 2006
CS Diversion Facts: Who? Due to the increased access of potent drugs,
anesthesiologists tend to be the most common among
physician drug abusers
In 2003, of the 5.6% of Florida physicians, 25% of impaired
physicians referred for substance abuse were anesthesiologists.
In an 11 year study based in Cincinnati, it was found that
out of 423 cases of diversion by healthcare workers:
63.4% were cases of nurses diverting
8.7% were cases of physicians diverting
Consider other facility employees
1. Inciardi et al. Subst Use Misuse. 2006; 41:255-264 2. Gold et al. J Global Drug Policy Prac. 2006
CS Diversion Facts: What? According to a study in 2006, opioids were the drug
most commonly diverted by all disciplines at 67.4%.
Anesthesiologists are five times more likely to abuse
opioids, typically intravenous drugs.
Fentanyl is the top diverted drug
Nurse Anesthetists are most often diverting opiates and
midazolam with an increase in propofol diversion from
1999-2006.
1. Inciardi et al. Subst Use Misuse. 2006; 41:255-264 2. Wright et al. AANA J. 2012; 80:120-128
CS Diversion Facts: What?
Drug Type Response Rate
Opioids 60%
Tranquilizers 45%
Sedatives 11%
Amphetamines 3.5%
Inhalants 1.9%
Trinkoff et al. J Addict Dis. 1999;18(1):9-17.
Anonymous study of drug misuse among nurses
in hospitals
CS Diversion Facts: What?
Drug Schedule Cost
Hydrocodone II $6-$8 per pill
Oxycodone II $6-$8 per pill (oral) $0.50-$1 per mg (snort/inject)
Methadone II $10 per pill
Hydromorphone II $5-$100 per pill
Fentanyl patches II $10-$40 per patch
Alprazolam IV $3 per pill
Diazepam IV $1-$2 per pill
1. NADDI. http://www.naddi.org/aws/NADDI/asset_manager/get_file/3143/drug_diversion_the_scope_of_the_problem.pdf. Accessed 2014. 2. DEA. http://www.deadiversion.usdoj.gov/drug_chem_info/hydromorphone.pdf. 2013.
Diversion for sale (focus is on oral medications)
CS Diversion & Patient Safety
“The reason that this form [hospital and nursing homes] of diversion is important is that oftentimes innocent patients are the ultimate victims of this type of drug diversion.”
Commander John Burke Ohio Drug Task Force
Denial of essential pain medications or therapy
Exposure to life-threatening infections
Transmission of viral and bacterial pathogens
Diversion and tampering are the leading causes of provider-
to-patient transmission of the Hepatitis C Virus
Potential for impaired performance by healthcare
personnel leading to substandard patient care
Injury or death of diverter, patient, or other healthcare
worker
Increased risk of suicide by 40% in male physicians and 130%
in female physicians
Patient Safety: Effects
1. CDC. http://www.cdc.gov/injectionsafety/drugdiversion/ . 2014. 2. Gold et al. J Global Drug Policy Prac. 2006
U.S. Outbreaks Associated with Drug Diversion by Healthcare Providers, 1983-2013
CDC. http://www.cdc.gov/injectionsafety/drugdiversion/2014.
Question Drug diversion within a hospital can lead to
which of the following patient safety
concerns?
A. Transmission of pathogens
B. Denial of therapy
C. Substandard patient care
D. All of the above
CS Diversion Prevention “The Centers for Disease Control and Prevention has classified prescription drug abuse as an epidemic.”
Office of National Drug Control Policy (ONDCP)
“The American Medical Association (AMA) strongly agrees with the Centers for Disease Control and Prevention (CDC) that we need to put a stop to pill mills and illegal prescribing practices. This must include a strong emphasis on increasing access to substance abuse treatment and prevention efforts across the nation…to reduce the crisis of prescription drug abuse, diversion, overdose and death.”
Dr. Robert Wah President, American Medical Association
CS Diversion: How? Removal from storage/dispensing units
Directly from patient
False waste
False administration
Mislabeling of syringe
Removal from vials/ampuls and replacement with normal
saline or sterile water
Removal from sharps containers
Inappropriate prescribing
False prescriptions
And the list goes on…
CS Diversion Prevention
ONDCP Prescription Drug Abuse Prevention Plan
includes:
Education
Monitoring
Proper Medication Disposal
Enforcement
Translating these elements into the hospital setting
requires an understanding of controlled substance
management.
CS Diversion: Real World New York hospital pharmacy director diverted nearly
200,000 oxycodone pills (street value of $5.6 million)
Arrested July 2014 – diverting since 2009, relying on
knowledge of system policies & procedures
False entries in electronic systems
Use of investigational drug services
Filling fraudulent prescriptions
Individual process for ordering, receiving, and distributing
Facing one count of grand larceny and 247 counts of
criminal possession of a controlled substance
Blum. Anesthesiology News. 2014
Diversion Prevention: CS Management
Access
Procurement
Storage
Prescribing
Dispensing
Administration
Returns
Disposal/Destruction
*Discrepancies *Surveillance *Recordkeeping
Diversion Prevention: Access CS stored in double locked system
Stored in a secure area
Limited access to secure area
Key pads, badge access, camera
surveillance
24-hour areas versus non 24-hour areas
Limited access to locked system
1. CMS. 2013 2. Florida Statutes. 2014 3. TJC. 2014
Diversion Prevention: Access
Access process in place for temporary staff and
permanent staff
Verification of CS access
Automated dispensing unit (ADU) access
PIN changes, Bio ID
Inventory and control of keys accessing CS
Pharmacy, pharmacy vault/safe, ADUs, lock
boxes, mobile carts, prescription printers, PCA/drip
lock boxes
Diversion Prevention: Procurement
Diversion can occur throughout the procurement
process
Minimizing opportunities for diversion may include:
Only authorized personnel ordering CS
Maintaining inventories of DEA Form 222s
Involving multiple qualified individuals in ordering
process
Separating the ordering and receiving functions
Ensuring order matches drug and amount received
Ensuring delivery of all CS is made directly to pharmacy 1. Florida Statutes. 2014 2. DEA. 2014
Diversion Prevention: Storage Proper security and regular oversight
Maintaining a perpetual inventory of pharmacy
vault/safe and any storage in patient care areas
Refrigerators, anesthesia stations, mobile carts, mobile
kits
Internal and external return bins
Manual process -- ensure inventory reconciliations
at each shift change
Automated process – ensure regular review of
electronic transactions
1. DEA. 2014 2. Florida Statutes. 2014
Diversion Prevention: Storage
Patient owned medications and expired
medications
Crash carts
Investigational Drug Service
Appropriateness of drug storage given
patient care areas
Diversion Prevention: Prescribing Ensuring CS prescribing is limited to only those
with CS prescribing privileges
Identifying prescriber and verification of
prescribing privileges
Establishing processes when inappropriate
prescribing occurs
Ensuring additional licensing for special
programs (i.e. addiction recovery programs)
Diversion Prevention: Prescribing Ensuring proper control of prescription
pads and/or electronic prescription paper
Appropriateness of prescribing
Appropriateness of medication overrides
and timely provider orders
Appropriate provider documentation in
patient chart
Diversion Prevention: Dispensing Involves transfer from pharmacy vault/safe to
patient care areas (i.e. stocking/restocking) and
preparation & dispensing for patient administration
Ensure appropriate individuals are handling
controlled substances
Ensure appropriate labeling of medication especially
in procedural areas
Ensure inventory verification when medications are
stocked, removed or returned
1. TJC. 2014 2. Florida Statutes. 2014
Diversion Prevention: Dispensing Documentation of delivery and returns of any
drug kits
Delivery receipts or forms are available with
drug item, quantity, location, and signatures
Hand-off forms are utilized with drug item,
quantity, location, and signatures
Sound process for use of patient owned
medications
Diversion Prevention: Administration Appropriate administration documentation
Use of electronic administration system with regular
review
Audits of anesthesia records
Ensuring drips and PCA devices are in locked
systems
Use of smart pumps
Documentation of immediate administration
Determine through documentation or patient
interview of a decrease in pain level 1. ISMP. 2014
Diversion Prevention: Administration Use of patient owned medications through sound
process
Use of chain of custody forms when necessary
Necessary wasting is appropriate and witnessed
Auditing of waste practices and documentation
Monitoring of frequency and quantity of controlled
substances administered by the same person
compared to peers and similar patient care areas
Auditing of ancillary areas
Diversion Prevention: Returns Use of secure internal/external return bins
Expired medications
Reconcile immediately upon removal from patient
care areas
Maintained under same control as other
controlled substances
Authorized individuals are reconciling and signing
for reverse distributor destruction
DEA form 222 completed by appropriate
individuals
Diversion Prevention: Disposal/Destruction
Implement a pharmaceutical waste policy
reflective of current federal and state
regulations.
Obtain witness for any wasting of controlled
substances including patches.
When using a reverse distributor, ensure
appropriate personnel are involved in process
and all necessary paperwork is signed and
maintained.
Diversion Prevention: Discrepancies
Review of discrepancies by nursing and
pharmacy staff
Appropriateness of discrepancies
Existence of patterns
Resolve discrepancies in timely manner
Use of witness in resolving discrepancies
Reporting of discrepancies
Diversion Prevention: Surveillance Consider designation of a controlled substance manager
Conduct surveillance regularly (daily, weekly, monthly,
quarterly, yearly)
Conduct regular inventory counts
Conduct random audits of charts – waste, administration,
and drug use velocity
Use electronic reports when possible
Administration records, health records, automated dispensing
units, automated CS safe, order entry systems
Drug integrity testing periodically or when needed
Diversion Prevention: Recordkeeping Ensure all records are maintained for a minimum of
two years
Conduct a physical inventory at least every two
years, but consider completing yearly
Review past CS orders for anomalies in purchasing
quantities
Review CS orders and deliveries
Review transfer records
Occurrence reporting and investigations 1. DEA. Pharmacist Manual. 2010 2. Florida Statute 2014
Question
Which of the following is an opportunity for
diversion?
A. Ordering controlled substances
B. Administering controlled substances
C. Wasting controlled substances
D. All of the above
Diversion Prevention: Who Can Contribute?
EVERYONE
Diversion Prevention: Who Can Contribute?
Key players may include:
Controlled Substance Manager
Director of Pharmacy
Quality and Risk
Security
Senior leadership (i.e. C-Suite)
Ethics and Compliance
Human Resources
CS Diversion Prevention Education
Policies & procedures, consequences, surveillance
communication, diversion awareness
Staff, patients, providers, leadership
Monitoring (CS management process)
Important for:
Patient and employee safety
Federal regulations require employees to report
suspected controlled substance diversion to the
employer and the employer has a responsibility to
investigate
CS Diversion Prevention Proper Medication Disposal
Implementation of pharmaceutical waste policy
Enforcement
Enforcement of policies & procedures
Recognize, investigate, and report controlled substance
diversion in a responsible manner
Mandatory reporting requirements include:
Report to DEA of any theft, even a theft of a single tablet
Civil Monetary Penalties up to $10,000 per incident for failure to
report
Facility is responsible for every controlled substance from the
“cradle” to the “grave”
Also must account for all wastage of controlled substances
Question Who should be involved in active prevention
of controlled substances diversion?
A. Director of Pharmacy
B. Human Resources
C. Quality and Risk
D. All of the above
CS Suspected Diversion Does innocent until proven guilty apply?
When a diversion is suspected, what do I
look for?
What should I document?
Who should I report to?
When is the suspected diversion resolved?
CS Suspected Diversion Drug testing – not always a strong indicator
Conduct a review of the following:
Dispensing and administration records
Waste logs
Patient medical records
Surveillance footage, if applicable
Badge access use, if applicable
Work schedule
Recent behavior changes
CS Suspected Diversion: Signs
Increase in ordering or use for patient care area
High controlled substance removals from inventory
Large waste amounts or wasting of entire dose
High frequency of same waste witness partners
Increased absenteeism, tardiness, frequent or
unexplained disappearance from the unit
Impaired behavior such as shakiness, diaphoresis,
slurred speech, or constricted/dilated pupils
1. Dunn. AORN J. 2005;82(5):777-799 2. Blair. Nurs Manag. 2005; 36(2):20-21,52 3. Clark et al. Medsurg Nurs. 2006;15(4):223-230
CS Suspected Diversion: Signs
Deteriorating personal appearance
Reduced productivity and diminished alertness
Frequent reports of ineffective pain management by
patients
Frequent drug count discrepancies
Frequent volunteering to count or administer
controlled substances
Eagerness to relieve colleagues for lunch who have
patients who are likely to receive pain medications
1. Dunn. AORN J. 2005;82(5):777-799 2. Blair. Nurs Manag. 2005; 36(2):20-21,52 3. Clark et al. Medsurg Nurs. 2006;15(4):223-230
CS Suspected Diversion: Resolution Depends on investigation findings
Recovery of medication
Evidence of actual diversion
No conclusive evidence of diversion
Lack of documentation
Don’t stop at the drug test
Go beyond initial investigation
Conduct continued monitoring
Document, document, document
47
Question What is NOT a key concept of resolving a
suspected diversion?
A. Understanding signs of drug diversion behavior
B. Believing the suspected diverter could never divert
controlled substances
C. Responsibly investigating, documenting and
reporting a suspected diversion
D. Utilizing reporting tools to conduct an investigation
Handling Substance Abuse
Ensure facility has a substance abuse
policy
Random drug testing
Behavior monitoring
Educate staff and provides on available
substance abuse programs
Summary Medication drug diversion is an epidemic and occurs
frequently within the hospital setting.
It affects patient safety.
Diversion can occur at various points within CS
management.
Establish a CS diversion prevention program.
Detecting diversion involves EVERYONE.
Documentation is key in diversion prevention and in
investigating suspected diversion.
Active prevention involving key players can result in
better patient care.
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Blum K. Anesthesiology News. 2014.
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