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Presentation for Alabama Hospital Association

Presentation for Alabama Hospital Association. Objectives. To familiarize Hospital Association Personnel with federal criminal violations that they may encounter. To encourage Hospital Association Personnel and their delegates to report these violations to FDA/OCI (ASAP).

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Presentation for Alabama Hospital Association

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  1. Presentation for Alabama Hospital Association

  2. Objectives • To familiarize Hospital Association Personnel with federal criminal violations that they may encounter. • To encourage Hospital Association Personnel and their delegates to report these violations to FDA/OCI (ASAP).

  3. FDA/ Office of Criminal Investigations • OCI was established in 1992. • The Office of Criminal Investigations currently operates out of 29 offices throughout the United States. • There are approximately 180 Special Agents hired from other traditional law enforcement agencies.

  4. Office of Criminal Investigations • OCI is the criminal investigative arm of the FDA. • OCI is a traditional Federal Criminal Investigative Agency. • OCI does not conduct inspections or conduct typical regulatory functions. • FDA Investigators (Consumer Safety Officers) and Inspectors conduct regulatory inspections; OCI Special Agents have full federal law enforcement authority, conduct criminal investigations and present cases to the U.S. Attorney’s Office for federal prosecution.

  5. OCI Field and Resident Offices Minneapolis Detroit Syracuse Seattle Boston Buffalo New York Chicago Philadelphia San Francisco OCI Headquarters Cincinnati Metro Washington Norfolk Denver Kansas City Nashville Los Angeles Raleigh Birmingham Atlanta Phoenix Headquarters Tampa Austin Dallas New Orleans Miami Field Offices Houston San Antonio Resident Offices .. San Juan Domicile Offices

  6. General Areas ofEnforcement • Manufacturing and Distribution of counterfeit and unapproved drugs • Illicit prescription drug diversion (DEA vs. FDA/OCI) • Product substitution crimes • Product Tampering • Schemes involving fraudulent health treatments • New drug application fraud • Fraud associated with clinical investigations • Frauds involving FDA regulated products

  7. U.S. Intelligence Community Private Industry Federal Law Enforcement Agencies OCI Foreign Law Enforcement Agencies U.S. Attorney’s FDA Federal/State Health Authorities State/Local Law Enforcement Agencies

  8. Federal Anti-Tampering Act 18 USC 1365(a)-Whoever, with reckless disregard for the risk that another person will be placed in danger of death or bodily injury and under circumstances manifesting extreme indifference to such risk, tampers with any consumer product that affects interstate or foreign commerce, or the labeling of, or container for, any such product, or attempts to do so, commits product tampering.

  9. Food, drugs, medical devices, cosmetics, biologics (such as blood) are all considered to be consumer products. • It is not necessary that death or bodily injury occur. • 3. It is not necessary to prove that the suspect intended to cause death or bodily injury. • 4. All that is required is, as a result of the tampering, death or any bodily injury couldhave happened. • 5. Bodily injury is any physical or mental injury, however slight, no matter how temporary. Federal Anti-Tampering Act

  10. Definition of Bodily Injury • (18 USC 1365(h)(4)) • A cut, abrasion, bruise, burn, or disfigurement. • Physical pain. • Illness. • Impairment of the function of a bodily member, organ, or mental faculty. • Any other injury to the body, no matter how temporary. Federal Anti-Tampering Act

  11. Additional charges within the statute • 18 USC §1365(b) – intent to cause serious injury the business of any person, taints any consumer product… • 18 USC §1365(c) – knowingly communicates false information that a consumer product has been tainted,…,and if such tainting, had it occurred, would create a risk of death or bodily jury to another person… • 18 USC §1365(d) – knowingly threatens and threat may reasonably be expected to be believed. • 18 USC §1365(e) – conspiracy – 2 or more persons tamper or attempt to tamper with a consumer product. Federal Anti-Tampering Act

  12. Penalties • Level 25 (57-71 months) • Enhancement for multiple victims. • Enhancement for serious bodily injury or death. • Special Skill or Position of Trust • Maximum penalty is life.

  13. Signs of Tampering/Drug Diversion • Tampering often referred to as “substitution.” • Missing drugs – controlled & non-controlled • Incorrect counts (reconciliation), or not! • Apparent false record reporting • Suspicious behavior by staff member • Multiple unjustified or cancelled accesses to automated medicine dispensing (Pyxis) machines • Visual signs of compromised drug packaging/needles/vials etc. • Exaggerated claims by staff regarding wasting or loss of drug product. • Records reflect the over-prescribing or the inadequate prescribing of drugs to patients. • Increase in patient complaints of pain after receiving pain medication.

  14. Signs of Tampering/Drug Diversion Suspect is acting suspicious and may be doing the following: • Taking a great deal of time off or always on-duty or in the hospital when not on-duty • Extended unexplained absences • Extended restroom breaks • Mood swings • Personal life issues • Coming in early, staying late • Always where they shouldn’t be or not where they should be • Dealing with patients who require pain medications • Nervousness, nausea, change in behavior

  15. If you suspect tampering • Call FDA/OCI immediately • Even if only a mere suspicion – let us do our job and reduce your liability • Don’t wait until someone gets hurt • Collect and segregate evidence – chain of custody – but don’t talk to suspect and don’t conduct a full investigation • Press/Discovery Issues • Why it is better to be a part of the solution instead of being part of the problem

  16. Course of Action by FDA/OCI • Arrange for interview of MedExec/Hospital Staff or delegate (away from suspect) • Obtain documents and evidence • Initiate investigation • Surveillance • Interviews • Cameras (non-private areas) • Subpoenas directed towards suspect

  17. Review • Not every drug theft is a tampering case. Not every tampering case is going to get prosecuted. • Must be an adulteration of the product, its container, or its labeling. • As a result of the tampering, there must be the risk of death or any bodily injury – just the risk! • Take custody of any suspected tampered drug products – minimize handling and maintain chain of custody. Check remaining sources – or ask us to check as soon as possible. • Engage OCI as soon as possible. This is a Federal crime – not a state or local police department matter.

  18. Concealing Unlawful Activity • Telling patients or staff to not tell anyone. • 2. Destroying or altering documents to conceal the activity or minimize liability. • 3. Lying to any regulatory or law enforcement agency. • 4. Withholding information/documents pertinent to the investigation.

  19. Preventative Measures to avoid tampering/drug diversion • Create Rules/policies and procedures that deter such activity. • Incorporate a “check and balance” system. • Always have at least two qualified individuals responsible for accountability of the drugs. • Require documentation - Review documentation. • Random Audits of both paperwork and physical inventory. • Random drug testing-Don’t wait for incident to occur. (Make sure testing facility will provide you with what you expect.) Conduct the “right” tests. • Play “devil’s advocate” – look for risks, then eliminate them. • Pay attention to your employees and their behavior.

  20. Drug Diversion • Theft of commercial quantities of drugs for profit. • * Controlled vs. non-controlled. • * Drugs are resold at a profit to a third • party distributor. • Diverted for personal use • * Discuss need to determine if tampering • was an issue. If simple theft, then • discuss DEA’S involvement

  21. U.S. v Nancy L. Moyer (No. 98-1981/8th Circuit, 1999)FACTS • Moyer, a medical doctor, was charged with product tampering (18 USC 1365(a)) after an investigation determined that she had been inserting a needle-syringe into a morphine delivery device in a hospital, removing morphine and replacing it with saline. Moyer was subsequently found guilty and appealed her conviction on several grounds.

  22. U.S. v Nancy L. Moyer (No. 98-1981/8th Circuit, 1999)Issues • Moyer argued that the government was required to prove that Moyer performed a malicious act when tampering with a consumer product beyond merely tampering with the product. • Moyer argued that her actions did not constitute a reckless disregard of exposing others to the possibility of death or bodily injury and that she did not act with extreme indifference to such risk. • Moyer contended that her tampering with the drug delivery device did not constitute any effect upon interstate commerce. • Moyer argued that she did not act with extreme indifference regarding risks to which her tampering exposed her patients to. • Moyer argued that her resulting sentence was too harsh.

  23. U.S. v Nancy L. Moyer (No. 98-1981/8th Circuit, 1999)Decision • The court ruled that there was no requirement for the government to show that Moyer acted maliciously. The court ruled that the term, "tampering," merely describes the physical act of product adulteration. • As a result of Moyer's morphine thefts, her hospital was required to order additional morphine from out-of-state manufacturers. This was sufficient to support a finding that Moyer's tampering had an effect upon interstate commerce. • Testimony by expert witnesses that Moyer's morphine thefts placed her patients at risk of increased pain, agitation, infection, and air embolism and the defendant, as a physician, was aware at the time of the tampering that her actions could have created health risks for her patients was sufficient to support a jury's finding that Moyer acted with reckless disregard of serious health risks to which her actions exposed her critically ill patients.

  24. U.S. v Nancy L. Moyer (No. 98-1981/8th Circuit, 1999)Decision (cont) • Evidence that Moyer stole morphine from an elderly patient who was dying of lung disease and who was taking morphine to relieve pain through the dying process, was sufficient to support a finding that the defendant acted under circumstances manifesting extreme indifference to the risk of pain and suffering to which her tampering exposed the patients. • The court found that Moyer's prison sentence was typical of similar product tampering cases around the country.

  25. U.S. v. Ashton Paul DAIGLE

  26. U.S. v. Ashton Paul DAIGLE Oct 2008 • Anesthesiologist’s complaint • Hospital Pharmacy staff checked vials in Pyxis machines in 9 Operating Rooms • Removed 67 suspect Fentanyl vials – • FDA OCI sent 64 suspect vials to the Forensic Chemistry Center

  27. DAIGLE’S ACCESS TO PYXIS • Pyxis accessed 108 times in 8 Operating • rooms over 20 days • As much as 25 times in one day • Used “Cancelled/Remove” access code

  28. U.S. v. Ashton Paul DAIGLE Forensic Chemistry Center Analysis • 63 of 64 vials contained glue-like residue on metallic crimp tops. 63 were firmly affixed and not able to spin. The one remaining vial’s top fell off. • Random sample of 20 vials * ALL 20 contained less than 2 mcg/mL of the labeled 50 mcg/mL of Fentanyl * 18 had a minimum of 2 punctures on top & bottom stopper surfaces

  29. Fentanyl Vials - Evidence

  30. Fentanyl Vials - Evidence

  31. Fentanyl Vials - Evidence

  32. U.S. v. Ashton Paul DAIGLE December 16, 2008 Indicted on: 108 counts of Tampering with a Consumer Product 18 USC §1365 67 counts of Creating a Counterfeit Controlled Substance 21 USC §841(a)(2) and (b)(1)(C) 4 counts of Adulteration of a Drug 21 USC §331(b) & §333(a)(2)

  33. U.S. v. Ashton Paul DAIGLE DAIGLE’S Proffer/Polygraph: • Battled drug addiction since he was 11 years old • Did not sell, give, trade or transfer drugs to others – for personal use • Shot up in restroom and refilled vials with saline at first, then tap water from restroom sink • Removed from BCH and used Fentanyl, Morphine, Versed® (Midazolam), Sufenta® (Sufentanil) and Nubain® (Nalbuphine) for personal use • Stole prescription controlled substances from patients while he worked at Windsor Healthcare Center prior to his employment at BCH

  34. U.S. v. Ashton Paul DAIGLE Daigle Plea Agreement:(June 1, 2009) • Pled guilty to * 5 counts of Tampering with a Consumer Product * 1 count of Creating a Counterfeit Controlled Substance • Government recommends: * 1 full year of blood testing for HIV and Hepatitis * Surrender of Nursing license * Never to work in the healthcare field or in any medical capacity * No less than 54 months prison time & 3 years supervised release thereafter

  35. U.S. v. Ashton Paul DAIGLE Lessons Learned or to be Learned! • Do not send out evidence to be tested • Call FDA/OCI first – State & Local Police will end up turning it over to us anyway • Addicts are Addicts…Understand you may not understand! • Listen to your employees – they are an extension of your eyes and ears. • Don’t assume the patients have a tolerance for controlled substances. • If an employee should not have access to a particular drug – don’t grant him access! • Review your reports.

  36. U.S. v. Kristen Diane PARKER “I have a crazy fascination with needles.. I just like the way they feel! ;)” www.myspace.com www.myspace.com

  37. U.S. v. Kristen Diane PARKER SUMMARY • Hospital scrub tech (Parker) was taking fentanyl-filled syringes and replacing them with saline-filled syringes – syringes she had already used. • Parker had Hepatitis C – exposed approximately 5,000 patients from RMC and over 1,200 from ASC • Parker knew she had Hep C

  38. U.S. v. Kristen Diane PARKER BACKGROUND • March 24, 2009 – Parker stuck a nurse with a needle that she kept in her front pocket – counseled, documented & drug tested. • March 30, 2009 – Negative drug test. Returned to work. Specific drug test for Fentanyl not conducted!! • April 13, 2009 - Employee reported seeing Parker place a syringe in her front pocket from an anesthesia cart. • Parker immediately taken from OR and drug tested – this time for Fentanyl. • April 22, 2009 – Positive Fentanyl test. Parker terminated from RMC. • April 23, 2009 - RMC reported to Denver PD potential theft.

  39. U.S. v. Kristen Diane PARKER JUNE 30, 2009 INTERVIEW • Denver PD interviewed Parker – she confessed to taking the Fentanyl-filled syringes off the anesthesia cart, placing a needle on it, shooting up, refilling with saline and placing the contaminated syringe back onto the anesthesia cart. She carried a couple previously used syringes in her front scrub pocket so she could capitalize on her “opportunity” when anesthesiologists left the Fentanyl-filled syringes on their carts unattended – even if for only a few seconds.

  40. U.S. v. Kristen Diane PARKER INTERVIEW • Parker prowled OR to OR looking for unattended carts with syringes placed on top by anesthesiologists when they prepared for upcoming surgeries. • If asked what she was doing – she would ask if anyone needed help preparing for surgery – or she would claim she was looking for a band-aid or cleaning up. • Claimed it never crossed her mind about contaminating the syringes she used and placed back on the anesthesia cart.

  41. U.S. v. Kristen Diane PARKER INTERVIEW • June 2009 - Parker started work at ASC. She claimed she was still working at RMC and would prefer them to NOT contact them for references – they did not… • Parker claimed to have switched out syringes at RMC 15-20 times and about five times at ASC. • Parker admitted to sharing needles while shooting up with heroin while she lived in New Jersey a few months before starting work at RMC. She believed that is where she got Hep C.

  42. U.S. v. Kristen Diane PARKERINTERVIEW • Parker denied knowing she had Hep C and then contradicted herself a few times stating she had been informed her first day of work but did not think it was a big deal. • July 1, 2009 - Denver PD and DEA immediately referred to FDA OCI due to tampering – significantly greater penalties than state charges. • July 3, 2009 – we arrested Parker on a criminal complaint.

  43. U.S. v. Kristen Diane PARKER • July 23, 2009 and August 27, 2009– Parker was indicted on: * Tampering with a Consumer Product 18 USC §1365(a) * Obtaining a Controlled Substance by Deceit or Subterfuge 21 USC §843(a)(3) and (d)(1) • Trial set for September 28, 2009 • Parker was denied bond and remains in jail.

  44. U.S. v. Kristen Diane PARKER • RMC “War Room” & swift action • Almost 5,000 were tested • Center for Disease Control (CDC) conducted genetic sequencing analysis on cases CDPHE identified as probable in contracting Hep C from Parker. • Obtained medical releases from 35 highest risk patients (genotype 1b, no previous history)

  45. U.S. v. Kristen Diane PARKER September 24, 2009 • CDC Report: * 16 genetic sequencing analysis completed * 16 samples genetically linked, including Parker * 97% level of confidence that Parker is source to other 15 cases

  46. U.S. v. Kristen Diane PARKER September 25, 2009 • Pled guilty to * 5 counts of Tampering with a Consumer Product * 5 counts of Obtaining a Controlled Substance by Deceit or Subterfuge • Government recommends: * Full cooperation and disclosure * 1 full year of blood testing for HIV * Surrender of any license/certification * Ceasing to ever work in the healthcare field or in any medical capacity * no less than 240 months prison time & 3 years supervised release thereafter • Sentencing set for January 22, 2010

  47. U.S. v. Kristen Diane PARKER Lessons Learned or to be Learned • Immediately notify FDA/OCI and DEA for theft & tampering • Do a good background on employees that will have access to controlled substances • Test for Fentanyl in addition to other drug screens • Identify potential patients • Assume and prepare for us to get copies of patient files with proper subpoenas • Share your information/findings with us – work with us, but not for us or against us • Be ready for the onslaught of the press – good and bad (it’s rarely good….)

  48. Contact Information Special Agent Martha Hughes Office (205) 966-6074

  49. http://www.fda.gov/ • Report a Problem • Drugs, Medical Devices…(MedWatch) • To Report an Emergency • To Report a Non-Emergency • Report Suspected Criminal Activity • For Industry: Reportable Food Registry

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