Drug Diversion

1. Drug Diversion Chaitali Chheda, PharmD candidate 2008 Dr. Grace Earl, PharmD, Assist. Professor University of the Sciences in Philadelphia Philadelphia College of Pharmacy January 10, 2008 1

2. Goals 1. Define what drug diversion means and what it encompasses 2. Identify regulatory agencies and regulations that cover drug diversion 3. Understand pharmacists’ responsibilities and interventions to prevent drug diversion 2

3. Objectives 1a Define drug diversion 1b List various schedules of controlled substances 1c Identify the popular drugs diverted 1d Describe ways of drug diversion 3

4. Objectives cont. 2a Discuss monitoring programs employed by the states 2b Explain role of Drug Enforcement Agency 2c State role of FDA’s office of criminal investigations 3a Understand pharmacists’ responsibility and intervention 3b Summarize offenses and penalties 4

5. What is Drug Diversion? (1) • Drug diversion is the use of legal drugs for illegal purposes or the use of prescription drugs for recreational purposes • According to a study by the National Center On Addiction and Substance Abuse (CASA) at Columbia University, between 1992 and 2002, prescriptions written for unscheduled and scheduled drugs increased by 56.6% and 154.3% respectively 5

6. What is Drug Diversion?(1) • In 1992 and 2003, 7.8 million and 15.1 million people respectively, admitted using scheduled drugs. This increase of 94 % was seven times faster than the increase in US population Use of Scheduled Drugs (in millions)

7. 15.1 million people reported using Scheduled Drugs in 2003 • Approximately equal to 2 times the population of New York City

8. Question • Opioid drugs like morphine, oxycodone, and hydrocodone have which of these effects? • Enhance alertness, or wakefulness • Relieve pain • Cause euphoria or “high” • Amnesia, or forgetfullness • Click here for the answer …..☼

9. The Answer IS….. • Opioid drugs have these effects: • Relieve pain • Cause euphoria or “high”

10. Most Frequently Abused Drugs (1) • To relieve pain: opioids like OxyContin® and Vicodin® • To relieve anxiety: sedatives like Valium® and Xanax® • To boost attention and energy: medicines that speed up physical and mental processes like Ritalin®, Adderall® and Dexedrine® • To improve athletic performance: steroids like Anadrol® and Equipoise® 10

11. Abuse Potential and Schedules Examples • I - marijuana, heroin, no medical usage • II - morphine, oxycodone (OxyContin®), hydromorphone (Dilaudid®) • III - methylphenidate (Ritalin®), hydrocodone (Vicodin®, Lortab®), anabolic steroids (Anadrol® ) • IV - benzodiazepines such as diazepam (Valium®) and alprazolam (Xanax®) • V - Medications having limited opioids in combination with other substances (codeine containing analgesics, cough and cold preparations) Schedule Most Abusive Less Abusive

12. Question (1) What are the top 3 most abused substances in America? Alcohol Diazepam (Valium®) Marijuana Methylphenidate (Ritalin®) Oxycodone (OxyContin®) Tobacco Click here for answer ☼ 12

13. The Answer IS…. (1) The top 3 most abused substances in America are: Alcohol Marijuana Tobacco 13

14. How Are These Drugs Diverted?

15. Methods of Drug Diversion I • Patients as a source of drug diversion(1) • changing writing on prescriptions • obtaining prescriptions for a single drug from multiple doctors concurrently • forcing or influencing physicians to write prescriptions • using deceptive prescriptions • patients acting like physicians 15

16. Double-Take! • A woman walks into a pharmacy with a prescription from the ER. The pharmacist recognizes the doctor’s name and signature because the pharmacist receives prescriptions from him often. The pharmacist overlooks the fact that the prescription has a “1” marked in the refill area of the prescription, because this medication is rarely issued refills. The patient picks up the prescription, and then later calls the pharmacy to inform them that her refill has not been entered. The pharmacist tells the patient to return to the pharmacy for a new label, and calls the ER doctor to see if the patient should receive refills. The doctor informs the pharmacist to call the police. E. Emma, Community Pharmacist, June 2007

17. Methods of Drug Diversion II Healthcare professionals as a source(1) lacking skills and failing to recognize diversion Physicians as a source(2) using the wrong drug for diagnosis not having the ability to make good decisions addicted to drugs affecting mental health engaged in illegal drug trafficking activities 17

18. The Failure of Practice • Ronald McIver, 63 years old, and a doctor. He is now in jail following a conviction for drug trafficking. • One patient with a severe pain condition was given high doses of OxyContin 40 mg from the start of therapy and was allowed to control her own dosing. • She didn’t bring any medical records explaining her past history (She had been addicted to crack cocaine in the past). Tina Rosenberg, The New York Times Magazine, June 17, 2007.

19. Methods of Drug Diversion III • Pharmacist as a source(1) • not checking for the accuracy of physicians’ DEA number • receiving phone orders and dispensing or giving out medications based on incomplete information on prescription 19

20. Method of Drug Diversion IV Internet pharmacies: unregulated and illegal, not requiring a prescription, offering online consultation (1) Pharmaceutical companies: not adding antagonists in drugs with high abuse potential, vigorously using promotional activities to influence patients (1) Theft from: physicians, pharmacies, (2) and residential properties(3) Losses: during transportation (2) or from pharmacies(3) 20

21. Case of Pharmacy Theft (4) • There was a theft on Sunday at a local pharmacy in Pennsylvania. The suspect went behind the pharmacy counter and demanded OxyContin® and oxycodone. The suspect warned the employees not to call for help and said he had several accomplices in the store. The suspect took the drugs and left the store, grabbing a soda on way out.

22. Risky Business (5) • There was a robbery on Monday at a grocery store pharmacy located within a supermarket in Connecticut. The suspect reached the pharmacy counter and passed a note on paper which stated “I have a gun pointed at you, I want Xanax® and Klonapin® “ The pharmacist grabbed a couple of bottles and gave them to suspect. Later it was found that suspect was given one bottle of Xanax® 0.5 mg off the shelf and another sealed bottle, also one and a half bottles of clonazepam.

23. Regulation and Control

24. Regulation and Control (1) • All new drugs and their marketing activities have to be approved by The Food and Drug Administration (FDA) • The Controlled Substances Act (CSA) of 1970 created a system for classifying prescription drugs according to their medical use and potential for abuse • Prescriptions written for scheduled drugs must meet certain criteria • Professional boards such as the State Board of Pharmacy provides licenses and can take action against members within their profession • State bureaus of narcotics and local law enforcement are important in controlling diversion • Twenty states have implemented Prescription Drug Monitoring Programs to control diversion and abuse. 24

25. Monitoring Programs Employed by States (2) • State-administered prescription monitoring programs are very effective in controlling diversion of scheduled substances at retail pharmacy. 25

26. Monitoring Programs Employed by States (2) Multiple copy prescription programs (MCPPs): Prescriber writes prescription for schedule II (in certain states III, IV, and V) substance on a state issued, preprinted, serialized double or triple form. Copies of the prescription are kept with the pharmacist, state agency and physician. Electronic data transmission system (EDT): Prescriber writes prescription for schedule II (in certain states III, IV, and V) substance on a prescription form, retains original prescription and sends the information either electronically or using a claim form to the state’s agency. 26

27. Does Pennsylvania have MCPP? • For more information visit: • http://oig.hhs.gov/oei/reports/oei-12-91-00490.pdf

28. Pharmacist Guilty: (4) • Kentucky pharmacist pleads guilty to illegally selling prescription drug samples and agrees to pay $10.5 million • A conspiracy was uncovered by the Office of Criminal Investigation. It was found that a Kentucky pharmacy owner, along with other people, obtained drug samples, repackaged them, and sold them illegally to public • What agency oversees controlled drugs?

29. Drug Enforcement Administration (6) • The Drug Enforcement Administration (DEA) overlooks distribution of controlled prescription drugs to control diversion. • It monitors shipping of legal controlled substances across United States borders, and gives permits for imports/exports. 29

30. More Conspiracies Uncovered (4) • Counterfeit Lipitor®: Three businesses and eleven individuals were indicted for their involvement in a $42 million dollar conspiracy to sell counterfeit, smuggled, and misbranded Lipitor®, and other drugs, and for participating in a conspiracy to sell stolen drugs. The case resulted in nine convictions, $2.8 million in forfeitures, and 12 others are under indictment awaiting trial, $10,000,000 more in alleged proceeds are to be forfeited. In June 2006, one of the defendants was sentenced to nine years and six months in federal prison and ordered to pay $1,806,905 in restitution to Pfizer, Inc.  • California Man Arrested on Counterfeit Drug Charges: California man was arrested on June 2006 for distributing fake drugs purchased over internet from a Chinese supplier

31. Office of Diversion Control (6) • DEA Office of Diversion Control is responsible for: diversion of controlled pharmaceuticals and diversion of controlled chemicals • It’s activities include: coordinating investigations; writing and putting laws into effect; controlling imports and exports of drugs and chemicals; monitoring distribution of certain controlled drugs; providing distribution intelligence to the states. 31

32. Q: What over-the-counter drug is used to make illegal methamphetamine?

33. Diversion of Controlled Chemicals(6) Is it….. a. Acetaminophen (Tylenol) b. Glucosamine c. Potassium chloride (KCl) d. Pseudoephedrine (Sudafed) Click here for answer: ☼ 33

34. The answer is… d. Pseudoephrine can be used to make methamphetamine

35. Diversion of Controlled Chemicals • Until recently there were no laws to control distribution of chemicals needed to synthesize illegal drugs. • The Chemical Diversion and Trafficking Act of 1988 applied the concept of commodity control to chemicals commonly used for manufacturing and synthesizing drugs of abuse.

36. Diversion of Controlled Pharmaceuticals(6) • Goal is to control abuse and illegal use of controlled substances and at the same time make sure that they are easily available for medical use. • Under federal law, manufacturers, distributors, dispensers, administers, or prescribers of controlled substances, and all pharmacies must register with DEA. Registrants must act in accordance with requirements related to drug security and maintenance of standards and records. 36

37. FDA’s Office of Criminal Investigations (OCI) (4) • FDA believes that a closed drug supply chain is very important to prevent illegal drugs from reaching consumers • OCI focuses its action on investigations of illegal drug diverters and others who threaten the security of drug supply chain 37

38. Examples of Significant Counterfeit Drug Cases (4) A package containing several thousand fake Viagra® and Cialis® tablets was mailed from China, seized, and a case was started by OCI and U. S. Immigration and Customs Enforcement (ICE). In May 2006, the pharmacist was guilty of conspiracy and was awaiting sentencing. The OCI investigation of illegal medical products diversion, which defrauded Medicaid and Medicare programs of more than $45,000,000, led to arrest of two owners of a Florida pharmaceutical wholesale distributor on more than 247 criminal counts, on March 2006. 38

39. More Examples (4) An Investigation was conducted by the OCI and ICE which helped the Chinese authorities in determining the source of counterfeit drugs. This joint effort resulted in the arrest of 11 individuals. They will be prosecuted by the Chinese government for their involvement in making and distributing fake Lipitor, Viagra, and Cialis. • For more examples got to: http://www.fda.gov/ola/2006/appendixa0711.html 39

40. What Are Your Responsibilities?

41. Truth or Consequence • A pharmacist receives a prescription from an ER physician with a small quantity intending to last the patient until they can visit their regular doctor. The pharmacist notices that the “15” written on the prescription, has been changed to a “45” with different ink. The pharmacist contacts the physician to clarify the prescription, makes a copy of the prescription, instructs the customer to wait, and contacts the police. E. Emma, Community Pharmacist, June 2007

42. Approximately what percent of pharmacies will call a physician if they suspect a fake prescription? a. 30% b. 55% c. 78% d. 93% Click here: ☼

43. Actions taken or would be taken by pharmacist if suspected a patient of drug diversion (1) • Call prescribing physician: 92.8% • Refuse to fill prescription: 76.6% • Confront patient with suspicions: 32.3% • Tell patient to leave pharmacy: 16.3% • Take no action: 1.7%

44. Pharmacist responsibility (7) • Share responsibility for controlling prescription drug abuse and diversion • Ethics: support laws to protect society from abuse • Professional: prescribe and dispense controlled substances using standard practices, make sure that medications are available for legal use to patients and simultaneously prevent abuse of medications • Personal: have knowledge of ways of drug diversion and actions that can be taken to prevent diversion • Legal: be familiar with the state and federal laws regarding dispensing of controlled substances • Link to PA State Board of Pharmacy: http://www.dos.state.pa.us/bpoa/cwp/view.asp?a=1104&q=432995 44

45. Actions taken or would be taken by pharmacists if suspected a professional colleague of drug diversion (1) • Document it: 62.9% • Confront colleague: 50.1% • Report colleague to professional association: 49.5% • Contact police: 11.7% • Take no action: 0.7%

46. What Can You Do to Help Impaired Co-Worker?(7) • Talk to them about their deteriorating performance at work • Let them know that they may loose job • Encourage joining drug treatment assistance programs • A number of state licensing boards, employee assistance programs, state diversion programs, and peer assistance organizations direct individuals to appropriate counseling and treatment services. These services try to keep the confidentiality of individuals needing assistance. 46

47. Strategies for Assessing Questionable Prescriptions(1) • Examine for mistakes or irregularities • Verify with prescribing physician, provider number • Observe patient nervousness, unusual behavior, paying by cash • Appropriateness of dosage, number of refills and refill date • Handwriting too legible, different ink used • Acceptable standard abbreviations • Prescription for antagonist drugs such as depressants and stimulants at the same time • A number of people coming within a short time with similar prescriptions from the same physician 47

48. Who’s On “Candid Camera” • Two customers arrive at a pharmacy on the same day with almost identical prescriptions for OxyContin 20mg, #90, one tablet TID, from the same doctor. Both pay cash and the prescriptions are filled by two different pharmacists on different shifts. The pharmacy manager notices the similarity at night during an audit. • He called the doctor the next day who verified that neither patient was hers and was unaware that she was missing pages from her prescription pad. The manager pulled the pick up time from each prescription from the pharmacy computer, and matched those times to the camera over the pick up counter, and gave copies of the video to the police. E. Emma, Community Pharmacist, June 2007

49. Offenses and Penalties

50. Offenses and Penalties • The Office of Diversion Control’s Title 21 “Unites States Code (USC) Controlled Substances Act, Part D - Offenses and Penalties” lists the various unlawful acts and the penalties • Penalties could be imprisonment, fines, or both • For specific examples go to: http://www.deadiversion.usdoj.gov/21cfr/21usc/21idusct.htm