Prescription Drug Updates

Transcription

1 Prescription Drug Updates 1

2 Presentation Outline 59 Slides 30 minutes CDC Information DEA Statistics Federal and State Law New Trends Summary & Suggestions Q & A 2

3 Please Brush Your Teeth What Drug Causes This? Source: AP 3

4 Meth Mouth Source: AP 4

5 Disclosure Statement We have no financial relationships to disclose 5

6 Common Illinois Dental Investigations Recordkeeping violations & fines Self abuse MOA s 6

7 Scheduled Investigations Increase in the number of DEA registrants who are required to be investigated to ensure compliance to the CSA and regulations. Increase in the frequency of the regulatory investigations. Verification investigations of customers and suppliers. 7

8 How Do You Lose Your Registration? The Order to Show Cause Process 21 USC 824 a) Grounds 1. Falsification of Application 2. Felony Conviction 3. State License or Registration suspended, revoked or denied, or no longer authorized by State law 4. Inconsistent with Public Interest b) AG discretion, may suspend any registration simultaneously with Order to Show Cause upon a finding of Imminent Danger to Public Health and Safety (ISO)

9 DEA Legal Recourse Administrative Letter of Admonition (LOA) Memorandum of Agreement (MOA) Order to Show Cause (OTSC) Immediate Suspension Order (ISO) Civil Fines Criminal Arrested and Charged With CSA Violations or Other State Violations 9

10 FY200 7 FY200 8 FY200 9 FY201 0 FY201 1 FY201 2 FY201 3 FY201 4 FY201 5 Total Actions OTSCs ISOs * FY2014 as of 10/16/2014

11 Evolving Drug Types Plant Based 1970 s Forward Marijuana Cocaine Heroin * Old Synthetic Meth * approximately 4,400 deaths a year from heroin Pharmaceutical 2000 s Forward Opioids Painkillers* Hydrocodone Oxycodone Methadone Fentanyl Morphine Benzodiazepines* Anti-anxiety drugs Xanax Valium *approximately 20,000 deaths a year New & Emerging Synthetics 2010 s Forward Synthetic Cannabinoids Spice, K-2, Bath Salts, Mepedrone Nbome, etc Targets our most vulnerable our youth accounts for numerous deaths Sourced from China 11

12 12

13 13

14 14

15 Death Rates by Gender CDC/NCHS Data Brief. No /

16 16

17 17

18 Statistical Perspective The population growth for the U.S. is less than 1% per year. Source: U.S. Census Bureau 18

19 19

20 CDC Source: 20

21 CDC Vital Signs July

22 22

23 23

24 24

25 25

26 26

27 27

28 What is This? 28

29 X-Ray of Cocaine Pellet Body Carrier 29

30 Worldwide Hydrocodone Use 67 Countries reported an estimated need requirement for hydrocodone to the International Narcotics Control Board 20 countries reported an estimated need of 1 kilogram or greater. 4 countries reported an estimated need between 500 grams and 999 grams 10 countries reported an estimated need between 100 grams and 499 grams 6 countries reported a need between 25 grams and 99 grams 27 countries reported a need of less than 25 grams SOURCE: UN International Narcotics Control Board website. Estimated World Requirements of Narcotic Drugs in grams for Accessed April 14,

31 Top 10 List Estimated Hydrocodone Requirements 10 Guatemala 09 India 08 Vietnam 07 China 06 Denmark 05 Columbia 04 Syrian Republic 03 Canada 02 United Kingdom 10 kilograms 10 kilograms 20 kilograms 20 kilograms 25.5 kilograms 30 kilograms 50 kilograms kilograms 200 kilograms 01 United States 79,700 kilograms 99.3% SOURCE: UN International Narcotics Control Board website. Estimated World Requirements of Narcotic Drugs in grams for Accessed April 14,

32 INCB: Availability of opioids* for pain management ( average) (Consumption in defined daily doses for statistical purposes (S-DDD) per million inhabitants per day) Date Prepared/ Source: 4/14/14, U.S. Drug Enforcement Administration Office of Diversion Control 32

33 NFLIS National Forensic Laboratory Information System 277 drug crime laboratories across country 90% of the nation s drug analysis cases Represented by 49 states Source: 33

34 Most Commonly Abused Pharmaceutical Drugs 34

35 Top Five Narcotic Analgesics Submitted to Crime Laboratories Across Country Oxycodone (Percocet/Oxycontin) 39% Hydrocodone (Vicodin/Lortab) 30% Buprenorphine (Suboxone) 8.3% Morphine 6.6% Methadone 5.4% Source: National Forensic Laboratory Information System

36 Top Three Benzodiazepines Submitted to Crime Laboratories Alprazolam (Xanax) 51% Clonazepam (Klonopin) 15% Diazepam (Valium) 8% Carisopodol (Soma) 6% Source: National Forensic Laboratory Information System

37 The Holy Trinity Prescription Drug Combination that Gives Heroin - Like - High Hydrocodone Vicodon/Lortab/Norco Alprazolam - Xanax Soma - Carisprodol No legitimate medical purpose 37

38 What is This? 38

39 Key Studies 39

40 Journal of Urology Key Findings Two thirds of the patients prescribed narcotic painkillers after surgery had leftover pills More than 90% of patients in 213 person study had received no instruction from doctor or pharmacist with what to do with unused pills. Lead researcher, Dr. Cory Bates is now cutting what he would normally give in half. Source : Journal of Urology, 2/11 40

41 CDC Death Information While there were 16,167 deaths involving prescription opioids in 2013, an increase of 1% from 2012, the number of deaths involving heroin increased dramatically. There were 8,260 heroin-related deaths in 2013, up 39% from Total drug overdose deaths in 2013 hit 43,992, up 6% from Deaths involving opioids, heroin continue to rise, report shows - Forbes - CJ Ariotta

42 CDC Information Deaths from drug overdose are tragic, and we need to scale up both prevention and treatment of addiction, said CDC Director Tom Frieden, M.D., M.P.H. Most people who use heroin in the U.S. today used prescription opioids first. Reducing inappropriate prescribing will prevent overdose from prescription opioids and heroin drug overdose mortality data announced Health Canal 42

43 2013 SAMSHA Study Illegal use of prescription pain drugs increases risk of using heroin 19 times Nearly 80% of heroin users previously used prescription pain drugs Source: Abuse of painkillers raises risk of heroin use, U.S. News and World Reports,

44 Circle of Addiction & the Next Generation Oxycodone Combinations Percocet $7 $10/tab Hydrocodone Lorcet $5 $7/tab OxyContin $80/tab Roxicodone Oxycodone IR 15mg, 30mg $30-$40/tab Heroin $10/bag

45 2014 Survey of Primary Care Physicians John Hopkins Bloomberg School of Public Health 580 primary doctors surveyed in % say they believe that opioids are overused in clinical practice. Surprisingly, despite concerns about overprescribing, nearly all physicians surveyed (88 percent) expressed confidence in their own ability to prescribe opioids appropriately. Prior studies have shown that most doctors believe their colleagues prescribing decisions are swayed by pharmaceutical marketing and promotion, yet they themselves are immune to such effects. Source: 45

46 Florida Pill Mill 46

47 1/2/2014 Snowstorm 47

48 1/8/

49 Lower hallway 6:49 a.m. Office Hallway 6:59 a.m. 49

50 Key Federal Laws Title 21 Code of Federal Regulations (CFR) Section Purpose of issue of prescription. (a) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances. Section Manner of issuance of prescriptions. (a) All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address and registration number of the practitioner. (f) A prescription may be prepared by the secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations. A corresponding liability rests upon the pharmacist, including a pharmacist employed by a central fill pharmacy, who fills a prescription not prepared in the form prescribed by DEA regulations. Source:

51 New Trends? Abuse of Suboxone strips Strips are soaked in water and then snorted Photo source: 51

52 Narcan Use by Law Increase in opioid overdoses and heroin use has law enforcement officers being trained to use and carry Narcan Enforcement 52

53 DEA Reference Documents 53

54 Dispensing Controlled Substances for the Treatment of Pain page Federal Register /Vol. 71, No. 172/Wednesday, September 6, 2006/Notices Source: 54

55 DEA Practitioner Manual Source: 55

56 DEA s Role DEA s statutory responsibility under the Controlled Substance Act (CSA) is twofold: 1) prevent diversion and abuse of drugs 2) ensure an adequate and uninterrupted supply is available to meet the country s legitimate medical, scientific, and research needs. In carrying out this mission, DEA works in close cooperation with state and local authorities and other federal agencies. 56

57 Common Illinois Dental Investigations Recordkeeping violations & fines Self abuse MOA s 57

58 Safeguards & Suggestions for Prescribers Treat your prescription pad like your checkbook Minimize the number of prescription pads in use and secure others Never sign prescription blanks in advance Use tamper-resistant prescription pads Practice due diligence Use IL PMP more than less Be careful with opiate/benzodiazepines combinations drug seeker combo & increases possibilities of death. 58

59 Questions Demetra Ashley Diversion Program Manager Dennis Wichern Special Agent in Charge 59

60 What Common Occurrences Do You See in Practitioner Investigations? Pre-signed prescriptions Patients receiving CS s without being seen by Doctor Lack of oversight on Physician Assistants and Nurse Practioniers relating to CS prescriptions and weight loss drugs Healthcare practitioners paid by # of patients seen & tied to CS prescriptions Sex for drugs Medicaid fraud combined with CS issues 60

61 What Are the Common Elements of a Typical Healthcare Investigation? Generally small private practices Usually involves solo practitioner but can go up to a handful of practitioners Almost always involves opioids & benzos Commonly involves pre-signed prescriptions Patients receiving CS prescriptions without being seen by Doctor 61

62 What Are the Common Elements of a Typical Healthcare Investigation? Often tied to Medicaid billing irregularities and upcoding Prescriptions sometimes tied to back injections Commonly involves PA s or NP s & CS s Generally found more in rural settings Almost always involves older male FP doctors, 45 yoa + Sex for drugs on some occasions 62

63 Hospital Investigations What do we see? Controlled substance thefts and diversion Usual cause is poor oversight of drugs in pharmacies Nurses self abusing liquid painkillers from patients Do not see significant practitioner issue in hospitals?? due to management oversight & peer pressure?? 63

64 Pharmacy Investigations What do we see? Controlled substance thefts and diversion by pharmacy techs. 64

65 Ambulance Service Investigations What do we see? EMT personnel self abusing liquid painkillers from kits. Poor accounting of CS s 65

66 PAIN MEDICINE Physicians Charged with Opioid Analgesic- Prescribing Offenses Volume 9, Number 6, 2008 Study undertaken by Center for Bioethnics in partnership with the National Association of Attorneys General and the Federation of State medical Boards Case review period, Source: 66

67 Specialty of Physicians Involved in Criminal and Administrative Cases Speciality % General Practice 39.3 Physical medicine 2.7 Pain medicine 3.5 Psychiatry 8.1 Internal medicine 23.7 Anesthesiology 7.5 Emergency medicine 5.3 General Surgery 5.1 Obstetrician/Gynecologist 3.2 Pediatrics

68 Physicians Involved in Criminal and Administrative Cases Gender % Male 89.4 Female 10.6 Age Range % 35 & under

69 Case Outcomes Plead Guilty or No Contest 79.5 Plead Not Guilty 20.5 % Plead Not Guilty % Found guilty or susequently plead

70 Los Angeles Time, March 3, 2014 Doctors are top source of prescription drugs for chronic abusers Doctors are fueling the nation's prescription drug epidemic and represent the primary source of narcotic painkillers for chronic abusers, according to a new government study. Dr. Tom Frieden, director of the Centers for Disease Control and Prevention, which conducted the study, said the research showed the need for greater focus on doctors who are "problem prescribers." The study, published Monday by the Journal of the American Medical Assn., echoes a 2012 Times investigation that found drugs prescribed by doctors caused or contributed to nearly half of the prescription overdose deaths in Southern California in recent years. Frieden said problem doctors are those "who may just not realize that the risks are so high and benefits so limited," as well as "a very small number of prescribers who are using their medical licenses to sell drugs." By Lisa Girion and Scott Glover 70

71 Medical Training & Pain Drugs Medical students receive about 11 hours of training on pain education.* 2011 GAO Study, most prescribers receive little training on the importance of appropriate prescribing and dispensing of prescription pain relievers, on how to recognize substance abuse in their patients, or on treating pain. ** *The Journal of Pain, 12(12) Mezei, L. & Murison, B.B 2011 ** GAO 2011 Prescription Pain Reliever Abuse, 71