1 WHAT ARE YOU DOING WHAT HAVE YOU DONE WHAT SHOULD YOU BE DOINGDRUG DIVERSION PREVENTION WHAT ARE YOU DOING WHAT HAVE YOU DONE WHAT SHOULD YOU BE DOING John Karwoski, RPh, MBA Surgery Center Coalition March 10, 2016
2 It’s not a Problem… Until it’s a Problem.
3 DRUG DIVERSION Is 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 Diverting (prescription) drugs away from their intended uses Diversion can be: Missing narcotics Staff member using stock narcotics for recreational use OR removing the narcotics from the premises The DEA considers the over-prescribing of controlled substances to be a form of diversion A large amount of medication missing usually means re-sale on the street
4 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
5 THE OPIOID ABUSE EPIDEMICWhat prompted the DEA to re-write regulation, begin task forces, and offer training to health care professionals? Increase in number of deaths caused by prescription drug diversion/ abuse Over-prescribing of prescription pain killers In 4 years of medical school physicians only receive an avg of 11 hours of training on use of pain medications Physicians are unable to council patients on the correct use and disposal of pain medications Prescription drug abuse feeds into opioid abuse
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7 THE MOST COMMONLY DIVERTED DRUGSHydrocodone (Vicodin) Oxycodone (Percocet) Oxycontin Fentanyl Carisoprodol (Soma) Alprazolam (Xanax)
8 OPIOID AND HEROIN ABUSE IS NOT AN URBAN ISSUEPrescription and opioid abuse has emerged from the urban setting DEA and local law enforcement are seeing abuse climb dramatically in suburban areas Everyone’s story is the same… They got addicted to prescription pain killers, and then… (When prescription medications become unavailable, Heroine becomes the alternative) Now the DEA is focusing on the origin of the issue… prescription medications and the facilities where they’re coming from Over-prescribing Diversion
9 THE FRIENDS AND FAMILY DISCOUNTDEA has pin-pointed that in addition to the potential for patient RX abuse… Family members Friends Children Anyone who enters your home… It’s the responsibility of the prescribing physician to council patients on proper use and disposal of the drug
10 COACH PATIENTS ABOUT MEDICATION STORAGEWhere 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: NJ now requiring this notice to be given to all patients receiving a prescription for controlled substances!
11 LOCAL EFFORTS TO PREVENT DIVERSIONNJ DOH has begun the Drug Diversion Coalition Annual meetings Quarterly phone conferences Developing resources/ toolkits for diversion prevention DEA Diversion conferences across the US 1 day conference held Dec, 2015 in Pitt., PA attended by JDJ Consulting DOH Surveyors now asking for proof of anti-diversion training for surgery center staff. Staff training module soon to be available from JDJ Consulting for all clients
12 HOW DOES DIVERSION EFFECT US?
13 INFECTION RISK Employee injects themselves with a syringe intended for a patient Could re-fill syringe with saline and then use the same syringe on patient Could refill vial with saline, vial is later used for a patient 2009: Surgical technician was diverting narcotics and reusing syringes/ vials on patients 5970 patients effected 88% submitted to testing 18 positive cases of Hep C linked to the surgical tech were identified Kristen Parker stole Fentanyl and used compromised syringes and vials on patients.
14 BREAKING NEWS In our own backyard… February 26, 2016Pharmacist at Shore Medical Center Ongoing diversion from June, to September, 2014 Replaced morphine with saline solution Self injected morphine Patient Risk Shore Medical Center informed over 200 patients who may have been effected Patients may have been exposed to HIV, Hep B, and Hep C Frederick P. McLeish, 53, of Egg Harbor Township, is charged with theft of drugs from Shore Medical Center. (Atlantic County Justice Facility)
15 US Outbreaks Associated with Drug Diversion by Healthcare Professionals, 1983-2013Graphic taken from the Centers for Disease Control and Prevention (CDC), 2015
16 PATIENT SAFETY 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?
17 THE BEST BARRIER TO DIVERSION… begins with YOUR management team!A comprehensive and proactive monitoring system. Who, when, what and how to monitor. The use of the knowledge and experience of your consultant pharmacist! Education for your staff. Engage in risk analysis programs designed to identify areas of weakness and develop plans of corrective action.
18 Recognize which medications are controlled substancesSCHEDULE 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
19 THE INVENTORY CONTINUUMSTART Facility places order Wholesaler fulfills order Independent shipper sends order Facility receives order Medication is administered Medication is issued to anes. or nursing unit Order is signed into perpetual inventory Order is unpacked Can you identify the highest areas of risk?
20 It’s not a Problem… Until it’s a Problem.
21 TRACKING USAGE OF NARCOTICSAnesthesia count sheets Daily count sheets Chart reviews Properly filing DEA 222 forms Retain for 2 years In NJ, retain for 5 years Security systems or cameras Refractometer Correct disposal of controlled substances Biennial Narcotic Count Performed every 2 years Performed sooner than every 2 years IF there’s a change in the pharmacist in charge
22 JDJ Consulting: Controlled Substance Diversion, Detection and Prevention Program Elements of Best Practice Core Principles Storage and Security Procurement Ordering / Prescribing Preparation / Dispensing Administration Disposal Inventory & Record Keeping Surveillance Investigation & Response Education Quality Improvement
23 SAMPLE DEA 222
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28 PROPER DISPOSAL OF CONTROLLED SUBSTANCESExpired 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 ensure the controlled substance is not retrievable Potential solutions: Smart Sinks or chemical digestion agent
29 PREFERRED METHODS OF NARCOTICS DISPOSALRxDestroyer Cactus Smart Sink
30 Refractometer
31 Canary Video Surveillance SystemConnects 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 “Smart” Video Surveillance System
32 BETTER EMPLOYEES = BETTER SURGERY CENTERSBy putting up barriers to diversion you’re not presenting an opportunity for diversion to happen Hiring employees you feel confident in and maintaining good lines of communication helps ensure that there is no room for diversion Staff buy-in to anti-diversion efforts is key!
33 EMPLOYEE DRUG SCREEN 2014 Survey from JDJ Consulting:ONLY 15 of the 49 respondents performed drug testing upon hire of a new employee! 14 of the 49 respondents reported random drug testing What is YOUR center’s drug testing policy? How do you determine when to randomly drug test?
34 Staff In-Servicing: JDJ Consulting’s Four Step ProgramOverview and history of the national illicit drug use epidemic Steps that federal and state authorities are taking to prevent, combat, and eliminate prescription narcotics getting into the wrong hands The steps that every employee in the ASC should take to help prevent diversion Every employee has a legal and ethical responsibility to report their concerns
35 This individual has completed the drug diversion prevention training program and has: Has been educated on the national epidemic of illegal drug use, federal regulations addressing this issue, and the impact on the local community and ASC Has been provided training on the importance of diversion prevention Learned ways to identify potential diversion within the ASC and has an understanding of their legal and ethical duty to report such activity Pledged to do all in their ability to act against drug diversion ____________________________________________________________ Employee Signature Employee Name and Date
36 WHEN DIVERSION HAPPENSHow to handle the worst case scenario
37 REQUIRMENTS IF YOU HAVE ANY THRFT OR LOSSContact your consultant pharmacist Notify the DEA after your initial (and timely) investigation Complete DEA Form 61 AND notify your local field office in writing (21 CFR (c)) File a police report If your state has a CDS department, notify them Notify NJ DOH
38 THE DUTY TO REPORT The surgery center has 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!
39 And then...you have a REALLY BIG PROBLEM!It’s not a Problem… Until it’s a Problem. And then...you have a REALLY BIG PROBLEM!
40 THANK YOU JOHN KARWOSKI, RPh, MBA BRITTNEY LODATO, MPH President and Founder Administrative Director