becker’s 15th annual spine, orthopedic and pain management
TRANSCRIPT
Narcotic Diversion PreventionJOHN KARWOSKI, RPh, MBA
Becker’s 15th Annual Spine, Orthopedic
and Pain Management-Driven ASC Conference
June 24, 2017
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DISCLOSURE
Faculty must disclose to participants the existence of any significant
financial interest or any other relationship with the manufacturer of any
commercial product(s) discussed in an educational presentation.
The speaker listed below disclosed a potential conflict of interest.
John Karwoski, RPH, MBA has received financial support from
PharMEDium Services, LLC to serve as a consultant/speaker.
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OPIOID ABUSE EPIDEMIC FACTS:
In 2012, Americans, constituting only 4.6% of the world’s
population, have been consuming 80% of the global opioid
supply, and 99% of the global hydrocodone supply1.
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OPIOID ABUSE EPIDEMIC FACTS:
In 2012, there were enough opioids prescribed in the US so that every
American could have a full bottle of pills. This is equivalent to medicating
every adult with 5mg of hydrocodone every 6 hours for 45 days2.
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OPIOID ABUSE EPIDEMIC FACTS:
Prescription drug abuse leads into opioid abuse. 14% of people who
abuse or who are dependent on pain medication go on to use heroin3.
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OPIOID ABUSE EPIDEMIC FACTS:
Approximately 1 in 15 patients will become chronic opioid users
after surgery4.
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OPIOID ABUSE EPIDEMIC FACTS:
Approximately one-third of all patients following elective cervical
spine repair surgery were still using opioids 1 year after surgery5.
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ADDICTION
A PRIMARY CHRONIC DISEASE
REFLECTED BY AN INDIVIDUAL
PATHOLOGICALLY PURSUING
REWARD/ RELIEF BY SUBSTANCE
USE
ADDICTION IS CHARACTERIZED BY
THE INABILITY TO ABSTAIN FROM THE SOUGHT SUBSTANCE
DRUG DIVERSION
DEFINED AS:
The transfer of any legally prescribed controlled substance from the individual for whom it was prescribed to another person for any illicit use
DIVERSION includes:
• MISSING NARCOTICS
• STAFF MEMBER USING NARCOTICS
• STEALING NARCOTICS
• OVER-PRESCRIBING NARCOTICS
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THE OPIOID ABUSE EPIDEMIC HAS PROMPTED THESE ACTIONS:
• DEA has re-written regulation, formed task forces, and is offering training to health care
professionals
• States have begun take-back programs and issued emergency prescribing restrictions
• Prior to filling a narcotic prescription, the Pharmacist must look into a data base to
determine if a patient is a drug seeker or prescriber has any patterns of over prescribing
• Multimodal pain management options are being studied to hopefully reduce opioid use
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OTHER EFFORTS TO PREVENT DIVERSION
• DEA Diversion conferences across the US:
https://www.deadiversion.usdoj.gov/mtgs/pharm_awareness/
• DOH surveyors asking for diversion prevention staff education
• Drug diversion coalitions (state level)
• Emergency opioid prescribing restrictions6
• In 2015: 536 bills introduced in 47 states
• In 2016: 434 bills introduced in 46 states
• 9 states limit opioid prescriptions to 7 days (NJ: 5 days)
• 49 states now have a version of a prescription drug monitoring programP20193
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FRIENDS AND FAMILY
• It’s the responsibility of the prescribing physician to counsel patients on proper use, storage and disposal of
the prescribed drug
• The DEA has pin-pointed that in addition to the potential
for patient RX abuse…7
Family members
Friends
ChildrenAnyone who enters your home can potentially be
involved in or impacted by a diversion event
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NARCOTIC TAKE BACK EFFORTS
DEA Take-Back Location Search
• Searchable database of all controlled
substance public disposal locations
• https://www.deadiversion.usdoj.gov/dr
ug_disposal/takeback/
State Take-Back Programs
• Some states have take back initiatives
• Growing trend: the practitioner’s obligation to supply patients with take
back information
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COACH PATIENTS ABOUT MEDICATION STORAGE
and PROPER DISPOSAL
• Where will the drugs be stored?
• Who will have access to the drugs?
• What will the patient do with the medication when they’re finished with the prescription?
• Don’t keep a few “just in case” in the house!
• Drop off locations: most municipalities have aMed Drop Box at police stations or fire departments.
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HOW DOES DIVERSION AFFECT
EVERYONE IN THE ASC?
PATIENT SAFETY—COMPROMISED
• Employees under the influence of controlled substances are unfit to care for patients
• If an employee has substituted a drug with saline after
diverting, the patient doesn’t receive the intended
dose of the medication
• Partial dose?
• No medication administered at all?
• Risk of infection?
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DIVERSION POSES A MASSIVE INFECTION RISK
• Employee injects him/herself witha syringe intended for a patient
• Re-fills syringe with saline and then uses the same syringe on a patient
• Refills vial with saline with the same syringe used for self-injection
• 2009 case led to 5,970 effected patients, 88% tested, 18 positive cases of Hep C8
• Diversion is seen across all kinds of staff
• Surgical technicians
• Nurses
• Physicians
• Managers/ Administrators
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Kristen Parker Frederick P. McLeish
Graphic from the Centers for Disease Control and Prevention (CDC) web site https://www.cdc.gov/injectionsafety/drugdiversion/index.html(accessed 2017 May 22)
US Outbreaks Associated with Drug Diversion by Healthcare Professionals, 1983-2013
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THE BEST BARRIER TO DIVERSION BEGINS WITH YOUR MANAGEMENT TEAM!
• A comprehensive and proactive monitoring system: Who, when, what and how to monitor.
• Use of the knowledge and experience of your consultant pharmacist to assist in sourcing or providing education for your staff.
• Engaging in risk analysis programs designed to identify areas of weakness and developing plans of corrective action.
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STRATEGIES for Identifying
and Preventing Diversion
in your ASC.
RECOGNIZE WHICH MEDICATIONS ARE CONTROLLED SUBSTANCES
• SCHEDULE I: No current acceptable medical use in the United States
• SCHEDULE II: Substances in this schedule have a high potential for abuse which may lead to severe physical and psychological dependence
• SCHEDULE III: Substances in this schedule have a lower potential for abuse than schedules I/II and may lead to moderate to lower physical and psychological dependence
• SCHEDULE IV: Substances in this schedule have a low potential for abuse
• SCHEDULE V: Substances in this schedule have the lowest potential for abuse and consist mainly of preparations containing limited quantities of narcotics
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Facility
places order
Wholesaler
fulfills order
Independent
shipper
sends order
Facility
receives
order
Order is
unpacked
Order is signed into
perpetual
inventory
Medication is issued to
Anesthesia
or Nursing
Unit
Medication is
administered
Can you identify the highest areas of risk?
THE INVENTORY CONTINUUM
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PURCHASING AUDITS
• Wholesaler purchasing report
• Compare what was ordered to what was sent to what was received to what was signed into stock
• This audit should be performed by a different individual than who purchases
the narcotics
• How are your DEA 222 forms stored?
• Who has access to CSOS?
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DRUG SECURITY
MEASURES• Storage and access of narcotics
• Video surveillance
• Tamper-evident prefilled syringes
• Multi-person audits
• Proper wastage signatures
• Record keeping
• Legibility
• Perpetual inventory bound booklets
• Automation
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CANARY VIDEO SURVEILLANCE SYSTEM
• Connects to Wi-Fi and sends
information to your phone
• If it senses anything “out of the
ordinary” you’re notified
immediately with a video of the
event
• Can also watch live
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“If you’re not moving forward,
you’re falling back”
Prefilled syringes
• Consistency
• Labeling
• Tamper-evident safety caps
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FacilityName:
DateofReview:
#ChartsReviewed:
ConsultantPharmacist:_________________________
MedicalRecord
NumberSedationMedicationAdministered
MatchesChart?
(Y/N)
WastageCo-
Signed(Y/N/NA)
Single-UseVial
Maintained(Y/N)`Comments
NOTES:
MedicalRecordAuditBasicPrinciplesPart1
JDJ
Consultant
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JDJ Consulting Risk Analysis
• Core Principles
• Storage and Security
• Procurement
• Ordering / Prescribing
• Preparation / Dispensing
• Administration
• Disposal
• Inventory & Record Keeping
• Surveillance
• Investigation & Response
• Education
• Quality Improvement
Controlled Substance Detection and Prevention Program:
“Elements of Best Practice”
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PROPER DISPOSAL OF CONTROLLED SUBSTANCES
• Expired narcotics must be kept secure until they are disposed of or destroyed
• If your state allows for on-site
destruction, you may use either a
chemical digestion agent or an incinerator
• Reverse Distributors can be used in all
50 states
• OR Wastage, i.e. partial syringes and vials
• DO NOT use kitty litter or coffee grounds
• DO NOT flush or shoot down the sink
• DO NOT shoot into the red sharps container
• You have a responsibility to ensurethe controlled substance is notretrievable
• Potential solutions: chemicaldigestion agent
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EXPIRED
MEDICATIONS
NARCOTIC
WASTAGE
NARCOTICSNON-
NARCOTICS
HAZARDOUS
WASTE
TRASHCHEMICAL
DIGESTION
REVERSE
DISTRIBUTOR
OR
CHEMICAL
DIGESTION
HAZ. WASTE
RECEPTACLE
REMEMBER:
NEVER SHOOT
LIQUIDS INTO YOUR
SHARPS CONTAINER!
PROPER DISPOSAL OF CONTROLLED SUBSTANCES
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BETTER EMPLOYEES
=BETTER ASCs
• Putting up barriers to diversion shows you’re on defense—doing what you can to prevent diversion
from happening
• Hiring employees you feel confident
in and maintaining good lines of
communication helps to ensure that there is no predisposition or cultural
tolerance for diversion
• Staff buy-in to anti-diversion efforts
is key!
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IN THE CASE OF SUSPECTED DIVERSION
Contact your consultant pharmacistContact
Notify the DEA after your initial (and timely) investigation
•Complete DEA Form 106 AND notify your local field office in writing
•(21 CFR 131.74 (c))
Notify
File a police reportFile
If your state has a CDS department, notify themNotify
Your consultant pharmacist will be able to help you determine if additional steps are necessaryAssist
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THE DUTY TO REPORT
• All ambulatory surgery centers have a legal AND ethical duty to report drug diversion
• Failure to report may result in:
• Civil and regulatory liability
• Negative publicity
• Jeopardize the surgery center’s license and Medicare participation
• Failure to report puts additional patients at risk
• Releasing a diverter from employment without reporting is illegal!
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QUESTIONS?
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John Karwoski, RPh, MBAJDJ Consulting, LLC
609-313-7572
www.JDJConsulting.net
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1. AMERICAN SOCIETY OF INTERVENTIONAL PAIN PHYSICIANS . (n.d.). The American Society of Interventional Pain Physicians (ASIPP) Fact Sheet .
2. Centers for Disease Control and Prevention. (2014). Opioid Painkiller Prescribing, Where You Live Makes a Difference. Atlanta, GA: Centers for Disease Control and Prevention. Available at http://www.cdc.gov/vitalsigns/opioid-prescribing/.
3. Pacira. (October, 2016). Opioid Abuse Facts. Opioid-reducing Multimodal Pain Strategy Consultant Meeting.
4. Carroll I, et al, A pilot study of the determinants of longitudinal opioid use after surgery. Anesth Analg. 2102; 115(3): 694-702. NIH, National Institute on Drug Abuse. Prescription and over-the-counter medications. Drug Facts. Revised Nov 2015. http://www.drugabuse.gov/publications/drugfacts/prescription-over-the-countermedications. Accessed 08/24/16.
5. Reynolds, R., Legakis, J., & Tweedie, J. (2013). Postoperative Pain Management after Spinal Fusion Surgery: An Analysis of the Efficacy of Continuous Infusion of Local Anesthetics. Global Spine Journal,2013(3), 1st ser., 7-14. Retrieved May 5, 2017, from
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3854576/.
6. Wilson, R. (2017, March 08). Amid federal uncertainty, states confront opioid crisis. Retrieved June 02, 2017, from http://thehill.com/homenews/state-watch/323021-amid-federal-uncertainty-states-confront-opioid-crisis
7. Prevoznik, T., & Drug Enforcement Administration. (n.d.). Drug Trends. Pharmacy Diversion Awareness Conference. doi:https://www.deadiversion.usdoj.gov/mtgs/pharm_awareness/conf_2015/december_2015/index.html
8. CBS4. (2011, January 18). Kristen Parker Appeals For Lighter Sentence. Retrieved May 05, 2017, from http://denver.cbslocal.com/2011/01/18/kristen-parker-appeals-for-lighter-sentence/