How to Develop a Diversion Program Kimberly New JD BSN RN National Association of Drug Diversion Investigators

Transcription

1 1 How to Develop a Diversion Program Kimberly New JD BSN RN National Association of Drug Diversion Investigators AHIA 32 nd Annual Conference August 25-28, 2013 Chicago, Illinois

2 Discussion Points 2 Scope of the problem Impact of diversion by healthcare professionals Diversion prevention, detection and response program Regulatory requirements for institutions Methods of drug diversion Diversion case walk-through Prevention and early detection techniques

3 Diversion by Healthcare Providers 3 Abuse and diversion of controlled substances in the US has reached epidemic proportions according to the CDC. No one is immune, and there are many occupational factors contributing to the abuse of controlled substances by healthcare professionals.

4 Diversion by Healthcare Providers 4 The major factors impacting the incidence of drug misuse by healthcare professionals are access and availability of controlled substances. Drug diversion by health care providers is universal among institutions in the United States By its nature, diversion is a clandestine activity, and methods in place in many institutions leave cases undiscovered or unreported Every institution must have a robust program to prevent, detect and respond to diversion Bell DM, McDonough JP, Ellison JS, Fitzhugh ED. Controlled drug misuse by Certified Registered Nurse Anesthetists. AANA J 1999;67(2):

5 5 Where Can Diversion Occur in a Facility? Anywhere controlled substances are found by anyone intent on diverting!

6 Impact on Institution 6 Liability-civil, regulatory Negative publicity License and participation in Medicare/ Medicaid in jeopardy Hospitals are required to be in compliance with the Federal requirements set forth in the Medicare Conditions of Participation (CoP) in order to receive Medicare/Medicaid payment. State Operations Manual Appendix A - Survey Protocol, Regulations and Interpretive Guidelines for Hospitals

7 Patients at Risk 7 Healthcare providers who divert usually work impaired As diversion progresses, there isn t enough to share and the diverter will deny controlled substances to patients in need There is a potential to expose patients to unsafe substances or bloodborne pathogens All diversion cases involve falsification of records (fraud) Felony-theft

8 Tampering 8 Exeter Hospital 8 states Nearly 4,000 tested from Exeter alone 45 cases of hepatitis C to date Multiple class action lawsuits including suits against institutions that allegedly failed to properly report Behavioral signs went unreported David Kwiatkowski

9 9 PUBLIC HEALTH VULNERABILITY REVIEW DRUG DIVERSION, INFECTION RISK, AND DAVID KWIATKOWSKI S EMPLOYMENT AS A HEALTHCARE WORKER IN MARYLAND %20Vulnerability%20Review.pdf

10 10 PUBLIC HEALTH VULNERABILITY REVIEW Recommendations regarding: Licensing controls related to allied health professionals Legislation re: disclosure of negative employment references Hospitals and other healthcare facilities should develop processes to prevent and respond to drug diversion The federal government should expand the Data Bank to capture additional information about allied health professionals who may pose risks to patient safety

11 NH HB 597 Suggested Statutory Language 11 Each facility must adopt a prevention, detection and resolution policy including: Education of health care workers; Procedures for monitoring storage, distribution and procurement of inventory of controlled substances; Procedures for voluntary self-referral by addicted employees; Procedures for co-worker reporting; Procedures for appropriate drug testing; Procedures for employee assistance; Provision for confidentiality; A process for the investigation, reporting and resolution of drug misuse or diversion; and Consequences for violation of the diversion policy.

12 Impact on Community 12 Ga Anesthesia Assistant Arrested For DUI Propofol In Wrong Way Crash Beverly Wilkins

13 Program Operations and Oversight 13 Diversion Specialist aka go to person Daily operations including surveillance Maintains database Serves as institutional resource Leads Diversion Team

14 Program Operations and Oversight 14 Diversion Team Meets on short notice and at odd hours Subset typically involved in interview of suspected diverter Must have authority to test and suspend Diversion Committee multidisciplinary SOP and policies Data tracking Overall direction

15 Essential Components of Diversion Prevention, Detection and Response Program 15 Policies to prevent, detect and properly report diversion Collaborative relationship between nursing, pharmacy and other key departments Method of surveillance/auditing including concurrent review of medical records Prompt attention to suspicious data received Collaborative relationship with law enforcement and regulatory agencies Education, education and education

16 Policies 16 Pre-employment screening 21 CFR Employee screening procedures. (Non-practitioners) 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

17 Pre-Employment Screening 17 Criminal background check Primary source verification of licensure Drug screen Social media review? Question: Have you ever been disciplined, terminated, allowed to resign or denied employment because of mishandling of a controlled substance or a drug diversion issue?

18 Policies 18 Reasonable suspicion drug testing What constitutes reasonable suspicion, what method of drug test, who will test and where, refusal to be tested, observed or not Employment disposition for confirmed diversion 21 CFR 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.

19 Policies 19 Internal and external reporting 42 CFR (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

20 Reporting Is Essential 20 Must report to DEA (Form 106) State Licensure Board and/or Professional Assistance Department of Health (patient harm issues) Law Enforcement - crimes, issues of abuse/neglect/ reckless endangerment, fraud Pharmacy Board FDA/OCI (tampering cases) OIG (exclusionary database) Institutional Infection Control Dept

21 Policies 21 Steps following diversion (RCA) TJC MM 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

22 Policies 22 Medication handling Shipments, storage, transporting, wasting, returns, removal from packaging, discrepancies, time from dispense to admin 42 CFR (a)(3) - Current and accurate records must be kept of the receipt and disposition of all scheduled drugs 42 CFR (b)(2)(i-ii) - All drugs and biologicals must be kept in a secure area, and locked when appropriate

23 TJC 23 Joint Commission Medication Management (MM) Standards: Procurement Storage and Security Dispensing and Administration

24 Policies 24 Surveillance/auditing What will be done, by whom and how often Statistical thresholds Requirements when threshold met Take emotion out of detection, particularly if objective/neutral data review is not feasible

25 Internal and External Collaboration 25 Internal Comprehensive program requires multidepartmental involvement Division of labor according to area of expertise Ensure communication between all involved and all relevant departments External Know reporting channels, expectations and resources in advance

26 Surveillance Method 26 Dictated by institutional resources and corporate culture Electronic surveillance is beneficial but not required Set attainable goal and be consistent Always include concurrent review of the medical record and when concerns arise, discussion with leadership of the relevant department

27 Prompt Attention to Surveillance or Audit Data 27 Patient safety concerns dictate quick response Diversion team meets Verification of data and analysis of situation Nurse immediately removed from patient contact or intercepted; drug cabinet access discontinued Initial interview of nurse including review of records Drug screen Suspension pending conclusion of investigation

28 Getting Help 28 Have EAP or other work related assistance information available Most states have an alternative program to assist in the rehabilitation of impaired healthcare professionals Law enforcement may use generic wording if an arrest is made and a treatment in lieu of conviction program may be offered Be alert to signs the diverter might harm him/herself

29 Education 29 Most essential component of any diversion program! All-inclusive At hire and at least annually Emphasize recognition and reporting Use actual cases Be sure to discuss assistance options available (prior to committing a felony) Goal Develop a culture in which employees recognize the risks and feel individual responsibility for reporting

30 Recognition of Diversion 30 Hospitals may have automated drug cabinets that produce sophisticated data about controlled substance transactions, but many diversion schemes can t be detected this way. Personal observation is vital! It may be the only clue.

31 Recognition of Diversion 31 Not limited to patient care areas Maintenance worker finds sharps containers stored in ceiling tiles Housekeeper sees nurse taking a sharps container into the staff bathroom Patient tells dietary aide the medication the nurse is giving isn t easing her pain Laundry staff find syringes hidden in linen cart Even visitors can identify diversion

32 Education 32 Address Common Misconceptions Profile High achiever Significant stress in personal life Night shift Critical care or other unit where nursing staff have increased autonomy Agency or traveler Legitimate prescription for drug being diverted Smoker Detail signs of diversion/impairment and opioid abuse

33 Surveillance Technology 33 Many hospitals have surveillance technology Not as common in long term care facilities Provides flags and reveals issues to focus on Many selective reports can be run when doing an investigation

34 Drug Cabinet Transactions 34 Single Access Bin Wasting Return Bin

35 Methods of Diversion 35 An effective surveillance program requires knowledge of common methods of diversion is required Removal of medication when not needed Removal for discharged patient Removal of duplicate dose Removal of/diversion from fentanyl patches

36 Methods of Diversion 36 Removal of medication without order Giving less than ordered more frequently Failure to waste Frequent wasting of entire doses Dividing doses Substitution in administration and wasting

37 Methods of Diversion 37 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

38 Suspicious Activity 38 A single suspicious transaction may be easily explained Watch for a pattern of activity Consider using a watch list An intensified review may be warranted before you are sure (i.e., review of all transactions) Gather data from every source

39 Prevention/Detection Opportunities 39 Wasting all CS from procedural areas in OR Pharmacy Random refractometry on 10% or more of all procedural waste; focused refractometry when indicated Review of: Verbal orders for controlled substances which are not accepted electronically by the physician Patient complaints and survey responses relating to unrelieved pain are reviewed by Compliance PSN/Incident/Occurrence reports relating to medication handling reviewed by Compliance Drugs used to ease withdrawal symptoms (promethazine, ondansetron, diphenhydramine)

40 Prevention/Detection Opportunities 40 Strict controlled substance handling policies with appropriate corrective action measures Daily pain rounds Liberal reasonable suspicion policy Surveillance by neutral investigator Reducing number of individuals handling sharps containers Treatment of high abuse risk non-controlled substances as controlled substances (cyclobenzoprine, tramadol, propofol) Use of surveillance cameras in high risk areas and as needed in non-patient care areas

42 Save the Date September 21-24, rd Annual Conference Austin, Texas 42