Kimberly New JD BSN RN DEA Compliance and

Kimberly New JD BSN RN DEA Compliance and Drug Diversion 2014 NPPA Conference

Disclosure Kimberly New: Financial — Received speaking fee for participation in a webinar and live conference from Omnicell/Pandora. Nonfinancial — No relevant nonfinancial relationship exists. 2

Objectives/Discussion Points Scope of the problem Regulatory requirements Signs of impairment and diversion Diversion program essential components Pharmacy controls A word on counterfeiting © K New 2014 3

Is Diversion a Significant Risk? Epidemic proportions (CDC) Universal among institutions Reliable statistics not available Clandestine activity Cases undiscovered or unreported © K New 2014 4

Healthcare Environment a Major Factor The major factors impacting the incidence of drug misuse by healthcare professionals are access and availability of controlled substances. Anyone can divert if controlled substances are available or left unsecured. Bell DM, Mc. Donough JP, Ellison JS, Fitzhugh ED. Controlled drug misuse by Certified Registered Nurse Anesthetists. AANA J 1999; 67(2): 133 -140. © K New 2014 5

Diversion by Healthcare Personnel All facilities and pharmacies vulnerable Incidents not reflective of patient safety commitment Multi-victim crime Significant risk to patient safety Must treat diversion with the same diligence as other patient safety initiatives © K New 2014 6

Impact on Patient Safety Care delivered by impaired provider Withholding medication from patients in need Transmission of bloodborne pathogens or exposure to unsafe substances © K New 2014 7

Impact on Patient Safety Former pharmacy tech orchestrated scheme to steal hundreds of painkillers intended for hospital patients and dispense look-alike pills to mask thefts, prosecutors charge Pharmacist pleads guilty to diluting morphine and hydromorphone with saline solution, gluing lids back on and stealing other prescription painkillers © K New 2014 8

Risk to Community Ga Anesthesia Assistant Arrested For DUI Propofol In Wrong Way Crash Beverly Wilkins © K New 2014 9

Regulatory Requirements Protect patients/consumers Ensure controlled substance security Track controlled substances at all points DEA, State, CMS, TJC © K New 2014 10

Regulatory Requirements Hospitals are required to be in compliance with the Federal requirements set forth in the Medicare Conditions of Participation (Co. P) in order to receive Medicare/Medicaid payment. State Operations Manual Appendix A - Survey Protocol, Regulations and Interpretive Guidelines for Hospitals © K New 2014 11

Regulatory Requirements § 482. 13(c)(2) - The patient has the right to receive care in a safe setting Hospital must: Protect vulnerable patients Identify and evaluate problems and patterns of incidents © K New 2014 12

Regulatory Requirements Pre-employment screening 21 CFR 1301. 90 Employee screening procedures Obtaining certain information by non-practitioners is vital to assess the likelihood of an employee committing a drug security breach • Need to know is a matter of business necessity, essential to overall controlled substances security • Conviction of crimes and unauthorized use of controlled substances are activities that are proper subjects for inquiry © K New 2014 13

Regulatory Requirements § 482. 25(a)(3) - Current and accurate records must be kept of the receipt and disposition of all scheduled drugs • Records of all scheduled drugs must be maintained any discrepancies in count reconciled promptly • Must be capable of quickly identifying loss or diversion of controlled substances and determining the extent of the diversion • Must have policies and procedures in place which minimize scheduled drug diversion © K New 2014 14

Regulatory Requirements Employment disposition for confirmed diversion 21 CFR 1301. 92 Illicit activities by employees Employees who possess, sell, use or divert controlled substances will subject themselves not only to State or Federal prosecution Employer will immediately determine status of continued employment by assessing the seriousness of the violation, the position of responsibility held by the employee, past record of employment, etc. © K New 2014 15

Regulatory Requirements Steps following diversion (RCA) § 482. 25(b)(2)(i-ii) • If tampering or diversion occurs, or if medication security otherwise becomes a problem, the hospital must evaluate its current medication control policies and procedures, and implement the necessary systems and processes to ensure that the problem is corrected, and that patient health and safety are maintained © K New 2014 16

Regulatory Requirements Steps following diversion (RCA) TJC MM. 08. 01 The hospital evaluates the effectiveness of its medication management system: • Analyze data • Keep up with best practices • Identify and implement improvement measures • Re-evaluate system © K New 2014 17

Regulatory Requirements Internal and external reporting 42 CFR 482. 25(b)(7) - Abuses and losses of controlled substances must be reported, in accordance with applicable Federal and State laws, to the individual responsible for the pharmaceutical service, and to the chief executive officer, as appropriate Billing revision and patient notification © K New 2014 18

Reporting Requirements 21 CFR 1301. 91 Employee responsibility to report drug diversion Employees are obligated to report such information to a responsible security official of the employer © K New 2014 19

Reporting Requirements • • • DEA (Form 106) for THEFT State Licensure Board and/or Professional Assistance plus Pharmacy Board Department of Health (patient harm issues and/or possible bloodborne pathogen exposure) Law Enforcement - crimes, issues of abuse/neglect/reckless endangerment, fraud Institutional Infection Control Department © K New 2014 20

Theft and Loss Diversion is a felony and is theft If individual is terminated for diversion and/or reported to professional board, 106 for theft is warranted Small random unexplained discrepancies are generally considered to be loss, but beware of patterns © K New 2014 21

Reach Out To ensure appropriate reporting, reach out to local state and federal regulatory personnel prior to an event: Contact information (all hours) Expectations for involvement (type of activity and at what point) © K New 2014 22

Diversion Program Components Policies to prevent, detect and properly report diversion Internal and external collaboration Method of auditing (beware of investigator bias) Prompt attention to suspicious data received Education for all staff Diversion risk rounds © K New 2014 23

Diversion Risk Rounds © K New 2014 24

Diversion Program Structure Diversion oversight committee Diversion Specialist Diversion response team Diversion intervention team © K New 2014 25

Who and Why Nurses Pharmacists and Pharmacy Techs Supervisors Physicians and NPP Respiratory Therapists Those without legitimate access Patients and families © K New 2014 26

Who and Why High achiever Significant stress in personal life Night shift Critical care or other unit where staff have increased autonomy Agency or traveler Legitimate prescription for drug being diverted Smoker Generally, direct care personnel divert for personal use and are extremely secretive about it © K New 2014 27

Who and Why Pharmacy Staff: May be student Many times PIC, Director or position of authority Personal use but more prone to “entrepreneurial endeavors” © K New 2014 28

Drugs of Choice Injectables: Hydromorphone Morphine Fentanyl Propofol Pills and liquids: Hydrocodone Oxycodone © K New 2014 29

Drugs of Choice Benzodiazepines (lorazepam, alprazolam, clonazepam) Drugs to ease withdrawal and enhance impact of opioid (ondansetron, promethazine, diphenhydramine) Barbiturates (phenobarbital) Non-scheduled (cyclobenzaprine, gabapentin) © K New 2014 30

Signs of Diversion/Impairment Tardiness, unscheduled absences, excessive number of sick days Frequent disappearances from the work site, taking frequent or long trips to the bathroom or to the medication room Volunteering for overtime Being at work when not scheduled Arriving early and staying late Pattern of removal of controlled substances near or at end of shift © K New 2014 31

Signs of Diversion/Impairment Vacillating work performance Mistakes and poor documentation Interpersonal relations suffer Heavy or no "wastage" of drugs Pattern of holding waste until oncoming shift or picking the same witnesses © K New 2014 32

Signs of Diversion/Impairment Pay attention to social media reports! “I have a crazy fascination with needles. I just like the way they feel!" © K New 2014 33

Methods of Diversion An effective surveillance program requires knowledge of common methods of diversion Removal of medication when not needed Removal for discharged patient Removal of duplicate dose Removal of/diversion from fentanyl patches © K New 2014 34

Methods of Diversion Removal of medication without order Giving less than ordered more frequently Failure to waste Frequent wasting of entire doses Substitution in administration and wasting © K New 2014 35

Methods of Diversion Removal of larger doses than necessary Withdrawal from PCA and drip lines Removal under sign-on of colleague Removal of unspent syringes from sharps boxes Pilfering patient medications brought from home © K New 2014 36

Methods of Diversion Circumventing scanning technology Physical break-in Drug cabinets in non-24 hr. units © K New 2014 37

Education All staff (incl. Environmental Services, Central Supply, Maintenance, Dietary) At hire and annually Anonymous or other reporting mechanism © K New 2014 38

Pharmacy Diversion Schemes Destocking Substitution of “benign” drug for CS Dilution of liquids Falsification of records Overfill Pilfering drugs pending reverse distributor pick-up Minor discrepancies © K New 2014 39

Pharmacy Diversion Headlines Norditropon, Humatrope, Somatotropin, Botox and other branded varieties of human growth hormone stolen from two military hospitals Stole Vicodin, Valium, suboxone (a heroin substitute), antibiotics and antiviral medications Stole Percocet by removing it from the stock at one home on a claim that it was needed at the other © K New 2014 40

Pharmacy Environment Beware Bags, hoodies, jackets, personal items Sharps containers and IV prep receptacles Propped doors and work-arounds © K New 2014 41

Ordering Different individual orders, receives and processes reconciliation Records reconciled after receipt Daily activity reconciled frequently and regularly Independent auditing Monitor stock trends for Pharmacy and remote locations © K New 2014 42

Receiving Direct to Pharmacy Package that appears damaged or tampered with Policy regarding handling of damaged or tampered shipments Open with non-ordering witness or in clear view of camera with recording capabilities © K New 2014 43

Transporting Generic secure container or “secure tube” (name badge? ) Regularly reconcile what leaves Pharmacy with what is stocked remotely Monitor discrepancies after stocking © K New 2014 44

Returns Ideally to Pharmacy (not floor stock) © K New 2014 45

$Analyzing for Tampering Refractometry often doesn’t include fentanyl Visualization is essential at all points$

Analyzing for Tampering Refractometry often doesn’t include fentanyl Visualization is essential at all points Make explicit what warrants analysis and how to accomplish it Process per policy Keep records of random and focused checks © K New 2014 46

Records Minimum 2 yrs. (usually longer) Purchasing records, administration and dispensing records, Controlled Substance Ordering Forms (DEA Form 222), and all physical inventories Schedules I and II kept separate Schedule III, IV, and V separate or readily retrievable © K New 2014 47

Policies and Procedures Blind count Regular internal and external auditing Medication handling expectations Wasting and returning Transporting Stocking Discrepancies © K New 2014 48

Policies and Procedures Granting and terminating ADC access Granting and terminating physical access Reasonable suspicion drug testing Disposal of expired and other medications Record keeping Substance analysis © K New 2014 49

Physical Security Cameras at all entry points No visitors without assigned escort and only on limited basis Badge swipe access Biometrics Low profile entry points Units open less than 24 hrs. © K New 2014 50

Camera Surveillance Liberal use Data viable for at least 30 days Data readily accessible

Rx Counterfeiting Huge problem in the United States Appearance of pills and packaging almost identical Requires testing from the manufacturer Can be integrated into the retail drug supply Terrorism (Financing) © 2014 52

Counterfeit Drug Production facilities frequently uncontrolled environments Composition of counterfeit drugs is highly variable Sub-potent/Supra-potent Mixed with other active ingredients or unknown substances Similar to genuine drug Heavy metals, poison, common household Items © 2014 53

Counterfeiter’s Manufacturing Facilities © 2014 54

Counterfeiters Labeling Equipment © 2014 55

Counterfeit Drug Packaging Has Become Virtually Indistinguishable from Packaging for FDA-Approved Drugs Authentic Cialis® Carton Counterfeit Cialis® Carton (expanded) Authentic Cialis® Blister Foil (Red Color-shift) Authentic Cialis® Blister Foil (Gold color-shift) © 2014 Counterfeit Cialis® Blister Foil (No color-shift) 56

To the Naked Eye, Difficult to Distinguish Counterfeit Drug Product Counterfeit Cialis® tablet Authentic Cialis® tablets (5, 10, and 20 mg) © 2014 (This counterfeit tablet contains sildenafil – the active pharmaceutical ingredient in Viagra® , instead of tadalafil, which is the active pharmaceutical ingredient in Cialis®) 57

Counterfeit Blister Genuine Blister © 2014 58

Remember Diversion is a constant threat Diversion will occur Efforts aimed at reducing, detecting quickly and responding appropriately © K New 2014 59