Kimberly S. New RN BSN JD Compliance Specialist University of Tennessee Medical Center

1 Institutional Drug Diversion Kimberly S. New RN BSN JD Compliance Specialist University of Tennessee Medical Center AHIA 31 st Annual Conference August 26-29, 2012 Philadelphia PA www.ahia.org

Discussion Points Scope p of the problem Reporting requirements Profile and predisposing factors Patient safety and harm issues Methods of drug diversion Signs of diversion and impairment Diversion investigation tools Prevention and early detection techniques

Prevalence in Nursing Substance abuse is a primary reason for discipline of nurses across the country Drug g diversion is the top substance abuse-related infraction

Reporting Requirements Must report to DEA immediately The registrant shall notify the Field Division Office of the Administration in his area of any theft or significant loss of any controlled substances upon discovery of such theft or loss. Pharmacy Board Must report to Law Enforcement-issues of abuse/neglect/reckless endangerment, fraud Must report to State Licensure Board Any nurse who knows of any health care provider s incompetent, unethical or illegal practice MUST report that information through proper channels. FDA/OCI (tampering cases) Consider reporting to OIG

Why Don t We Hear More? Drug diversion by health care providers is universal among institutions in the United Statest Fear of negative publicity Fear of State and Federal agency involvement Justification that terminating the employee is enough

Who and Why? Profile High achiever Significant stress in personal life Night shift Critical care or other unit where nursing staff have increased autonomy Agency Legitimate prescription for drug being diverted Smoker

Who and Why? Occupational factors Suppression of feelings and emotions Vicarious trauma Legitimate use and chronic pain Legitimate use and chronic pain Ease of access to prescriptions and medication Knowledge and sense of control

Impact on Patients Impairment and addiction put patients at risk (reckless endangerment) Strong S o g likelihood of denying patients appropriate a pain relief (abuse of a vulnerable individual) Potential to expose patients to bloodborne pathogens Falsification of records (fraud) Theft

Daily Report All Issue/Waste transactions for each department/user Discrepancies Staff that are statistically significant in withdrawals for the day Instances in which a drug was removed without a recognized order (medication override) Drugs issued in large quantities Drugs issued in close time proximity it Drugs issued to discharged patients

Daily Report Data for each unit sent to Nurse Manager Housewide data reviewed daily by Compliance Discrepancies to be resolved within shift Unresolved discrepancies reviewed by Pharmacy Cabinet malfunctions handled by Pharmacy

Methods of Diversion Removal of medication when not needed Often initial method of diversion Very difficult to detect Falsification of records Removal for discharged patient Removal of duplicate dose May not be caring for patient May be preceptor Removal of fentanyl patches

Methods of Diversion Removal too frequently Ordered q 4 hrs, removed q 2 hrs Removal of medication without order Medication override Falsification of verbal order Removal and use from inconspicuous vessel

Methods of Diversion Failure to waste Unwasted medication kept for self (proper waste procedure is to waste upon removing whenever possible) Substitution in administration and wasting Substitution of look-alike pills Saline substituted for injectable medication Potential for tampering charges Frequent null transactions, discrepancies, wastes and returns

Methods of Diversion Removal of larger doses than necessary Withdrawal from PCA and drip lines Removal under sign-on of colleague Stolen password Left alone when colleague is signed in Removal of unspent syringes from sharps boxes Pilfering patient medications brought from home

Handling Excuses I m just not good at documenting/i was too busy to chart Is it just controlled substances or the suspected drug of choice that isn t documented? Is pain documented? Are there contradictory assessments? If dose happened at or near end of shift, is the patient showing signs of pain relief? Is it feasible to drug screen patient?

Handling Excuses I m Im not good at wasting Is failure to waste limited to a particular suspected drug of choice? Look at historical data to see if this a consistent issue over time

Handling Excuses I was too busy to waste until the end of the shift How many times was the nurse at the cabinet and were colleagues at the cabinet at or near those times? Is the witness repeatedly the same person? Is the witness a less experienced nurse? Is this a violation of policy warranting a drug test?

Handling Excuses I dropped a pill/vial and forgot to waste/the patient spit it out Look for duplicate non-controlled drug withdrawals (is it only suspected drug of choice this happens with?) Check timing of administration (if the drug is documented d as given and the duplicate dose is removed 30 min later, this excuse doesn t wash) If the claim is the patient spit the pill out, check to see if this is happening to anyone else Ask the patient what happened

Handling Excuses The medication regurgitated from the g-tube Did anyone witness what happened? Is this excuse used regularly? Were duplicate doses of other simultaneously l administered meds removed?

Handling Excuses The patient refused the injection (multiple instances of wasting full syringes) Does this happen when this nurse isn t working? Is the charting consistent with this? Can the patient verify this happened? Why aren t these syringes returned?

Recognition of Diversion/Impairment Tardiness, unscheduled absences and an excessive number of sick days used; Frequent disappearances from the work site, having long unexplained absences, making improbable excuses and taking frequent or long trips to the bathroom or to the stockroom where drugs are kept; Volunteers for overtime and is at work when not scheduled to be there; Arrive at work early and stay late; Pattern of removal of controlled substances near or at end of shift;

Recognition of Diversion/Impairment Work performance which alternates between periods of high and low productivity and may suffer from mistakes made due to inattention, poor judgment and bad decisions; Interpersonal relations with colleagues, staff and patients suffer. Rarely admits errors or accepts blame for errors or oversights (denial); Heavy or no "wastage" of drugs; Pattern of holding waste until oncoming shift;

Recognition of Diversion/Impairment Insistence on personal administration of injected narcotics to patients; Wearing long sleeves when inappropriate; Personality change - mood swings, anxiety, depression, lack of impulse control, suicidal thoughts or gestures; Patient complaints about health care provider s attitude/behavior; Increasing personal and professional isolation.

Recognition of Diversion/Impairment Physical characteristics: Drowsiness and fatigue; Watery or bloodshot eyes, constricted or dilated pupils; Runny nose Diaphoresis Shakiness or tremors Slurred speech Noticeable weight loss or gain

Diversion Investigation Tools Drug cabinet Transaction reports (User, Witness, Patient, Item reports) Dispensing Practices Report Medical records Permitted disclosure: Crime on premises. A covered entity may disclose to a law enforcement official protected health information that the covered entity believes in good faith constitutes evidence of criminal conduct that occurred on the premises of the covered entity. 45 CFR 164.512(f)(5)

Diversion Investigation Tools Refused order reports Patient complaints and survey results relating to pain management Interview with MRO, MD and patients Employee time records PSN or incident reports Locator L t reports

When Diversion Suspected Verification of data and analysis with Pharmacy and Nurse Manager Nurse removed from patient contact or intercepted; drug cabinet access discontinued Initial interview of nurse including review of medical record and drug cabinet records Urine drug screen Suspension pending conclusion of investigation

Drug Screen 12 Panel Amphetamines Cannabinoids Opiates Propoxophene Alcohol Barbiturates Cocaine Oxcodone/oxymorphone Meperidene Benzodiazepines Methadone Phencyclidene Add fentanyl, zolpidem and others as required

Drug Screen Avoid tip-off! Urine: accurate, reliable and least expensive quick test t preliminary i result often available short window of detection (approximately 24-72 hrs) susceptible to alteration Hair follicle: long detection window (90+ days), not always recent use very difficult to alter most expensive method, but affordable

Drug Screen Saliva: less invasive and less susceptible to alteration rapid negative result at time of collection (reasonable suspicion) additional specimen necessary for analysis in lab when rapid result appears positive very short window of detection (current use only) Breathalyzer: Specify when alcohol l suspected

Our Efforts at Prevention Daily pain rounds Liberal reasonable suspicion policy Use of locator reports Review of drugs used to ease withdrawal symptoms (promethazine, ondansetron, diphenhydramine) Diversion training for all staff (not just clinical) CEO C O Summit

Our Efforts at Prevention Monitoring g for and addressing failure to properly p waste (injectables, pills, fentanyl patches) Identifying and addressing peripheral issues (acetaminophen, removing doses too early prior to administration, etc) Reducing number of individuals handling sharps containers Improved security for incoming pharmacy shipments Increased I d used of surveillance in high h risk areas such as pharmacy

Recognition of Patient Harm Patient Harm Diversion of scheduled (non prn) doses Documentation of pain at time medication is diverted Substitution and tampering Impairment resulting in patient harm or reckless endangerment

Relevant Mandatory OIG Exclusions Social Security Act 42 USC Amendment 1128(a)(2) 1320a-7(a)(2) Conviction relating to patient abuse or neglect. Minimum Period: 5 years 1128(a)(3) 1320a-7(a)(3) Felony conviction relating to health care fraud. Minimum Period: 5 years 1128(a)(4) ) 1320a-7(a)(4) ) Felony conviction relating to controlled substance. Minimum Period: 5 years 1128(c)(3)(G)(i) 1320a-7(c)(3)(G)(i) Conviction of two mandatory exclusion ecuso offenses. eses. Minimum Period: 10 years 1128(c)(3)(G)(ii) 1320a-7(c)(3)(G)(ii) Conviction on 3 or more occasions of mandatory exclusion offenses. Permanent Exclusion

Relevant Permissive OIG Exclusions Social Security Act 42 USC Amendment 1128(b)(1)(A) 1320a-7(b)(1)(A) Misdemeanor conviction relating to health care fraud. Minimum Period: 3 years 1128(b)(3) 1320a-7(b)(3) Misdemeanor conviction relating to controlled substance. Minimum Period: 3 years 1128(b)(4) 1320a-7(b)(4) License revocation or suspension. Minimum Period: No less than the period imposed by the state licensing authority.

OIG Exclusion Contact Information Information about OIG Exclusion Program: http://www.oig.hhs.gov/fraud/exclusions.asp Search OIG List of Excluded Providers: http://exclusions.oig.hhs.gov/ Detail about Exclusion Criteria: http://www.oig.hhs.gov/fraud/exclusions/authorities.asp Reporting convictions: Email: sanction@oig.hhs.gov Telephone: (410) 281-3060 Fax: (410) 265-6780 Mailing Address: HHS, OIG, OI Exclusions Staff 7175 Security Boulevard, Suite 210 Baltimore, MD 21244

Links Minnesota Controlled Substance Diversion Prevention Coalition Final Report and Road Map to Controlled Substance Diversion Prevention http://www.health.state.mn.us/patientsafety/drugdiversion/index.html Minnesota Hospital Association-Controlled Substance Diversion Toolkit http://www.mnhospitals.org/index/tools-app/tool.438?view=detail org/index/tools app/tool National Association of Drug Diversion Investigators http://www.naddi.org/aws/naddi/pt/sp/home_page

Save the Date: August 25-28, 2013 32 nd Annual Conference Chicago, IL