9/5/2011. Outline. 1. Past and Current Trends re: RX Abuse 2. Diversion Methods 3. Regulatory Reporting Requirements 4. Q/A

Transcription

1 Prescription Drug Abuse Crises Outline 1. Past and Current Trends re: RX Abuse 2. Diversion Methods 3. Regulatory Reporting Requirements 4. Q/A 1

2 1970s 1980s 2

3 The 1990s OXYCODONE Oxycodone/APAP OxyContin Today and Beyond Carisoprodol Hydrocodone Alprazolam OxyContin 80mg Oxycodone 30 mg 3

4 Prescription Drug Abuse More Americans abuse prescription drugs than the number of: Cocaine, Hallucinogen, Heroin, and Inhalant abusers COMBINED!!! Current Users % ANY ILLICIT DRUG: 21.8 million (8.7% of population) 9.8% MARIJUANA: 16.7 million 12% PSYCHOTHERAPEUTIC DRUGS: 7 million COCAINE: 1.6 million METHAMPHETAMINE: 502, ,000 Source: 2009 NSDUH, released September 2010 HEROIN: 213,000 4

5 Scope and Extent of Problem million 1.3 million 2 million 5.3 million Sedatives Stimulants Anti-Anxiety Narcotic Pain Relievers Source: 2004, 2007, 2008, 2009 National Survey on Drug Use and Health Past Year Initiates for Specific Drugs Persons Aged 12 or Older 2009 Numbers in the Thousands 2,500 2,000 Avg. 6,027 persons per day initiating with pain relievers 1,500 1, Source: 2009 NSDUH survey 5

6 Number of Forensic Cases ,000 35,000 30,000 Percent Increase Methadone- 281% Oxycodone- 330% Hydrocodone- 314% Number of Cases 25,000 20,000 15,000 10,000 Methadone Oxycodone Hydrocodone 5, Years Source: NFLIS State & Local Laboratories Emergency Room Data Increase of 98.4%: ER visits attributable to pharmaceuticals (627,291 to 1,244,679) No Significant Change: ER visits attributable to cocaine, heroin, marijuana, or methamphetamine Rx Drugs most frequently implicated: Opiates/OpioidsOpioids pain relievers Oxycodone products 242.2% increase Hydrocodone products 124.5% increase Fentanyl products 117.5% increase Insomnia or Anti-Anxiety Anxiety medications Zolpidem 154.9% increase Alprazolam 148.3% increase Clonazepam 114.8% increase Carisoprodol 100.6% increase For patients aged 20 and younger misuse/abuse of pharmaceuticals increased 45.4% For patients aged 20 and older the increase was 111% SOURCE: The DAWN Report, Highlights of the 2009 Drug Abuse Warning Network (DAWN) Findings on Drug-Related Emergency Department Visits, December 28,

7 % Increase in Poisoning Deaths in the U.S % Increase All poisoning deaths Methadone Other opioid Other synthetic narcotics Cocaine -100 Source: CDC Hennepin Drug Overdose Deaths 7

8 Teens and Their Attitudes Source: Partnership for Drug Free America 2 in 5 teens believe that Rx meds are much safer than illegal drugs 31% teens believe there s nothing wrong with using Rx meds without a prescription once in a while Nearly 3 in 10 teens believe Rx pain relievers are not addictive Teens and Their Attitudes Every day 2,100 teens use Rx drugs to get high for the first time 60% of teens who have abused Rx painkillers did so before the age of 15 1 in 7 teens admit to abusing Rx drugs to get high in the past year 56% believe that Rx drugs are easier to get than illegal drugs 62% believe that teens get Rx drugs from their own family s medicine cabinet for FREE Source: 2009 NSDUH & Partnership for Drug Free America 8

9 Parents and Their Attitudes (Fairfax school presentation) Parents are still not discussing the risks of abusing prescription and over-the-counter medicines Increase in parent / teen discussions about the risks of illegal drugs, but not prescription drugs Parents have a misperception of Rx drugs too. Only 24% of teens report that their parents talked with them about the dangers of prescription drugs or use of medications outside of a doctor s supervision Just 18% of teens say their parents discuss the risks of abusing over-the-counter (OTC) cough medicine SOURCE: 2008 Partnership Attitude and Tracking Study (PATS) Released FEB 2009 Chasing the Dragon 9

10 Top Five Prescription Drugs Sold in the U.S. ( ) 2009) Source: Verispan/ IMS (By Number of Prescriptions Sold) Hydrocodone Lipitor Amoxicillin Lisinopril Hydrochlorothiazide ,680, ,639, ,652, ,200, ,266, ,200,000 Simvastatin Atenolol Levothyroxine Azithromycin 1. Pain reliever 2. Cholesterol 3. Antibiotic 4. Blood pressure 5. Diuretic 6. Cholesterol 7. Heart disease Oxymorphone Opana Other Narcotics Hydromorphone Meperidine Morphine Codeine Propoxyphene 10

11 Fentanyl Fentora Actiq Fentanyl Patches Fentanyl Citrate dispensed in a berry flavored lollipop-type unit Fentanyl is 100 times more potent than morphine Intended to be used for chronic cancer pain & only for people who are tolerant to prescription opioid (narcotic) pain medicines Abused for its intense euphoric effects Alprazolam Benzodiazepines Clonazepam Diazepam Lorazepam Midazolam Triazolam Temazepam Flunitrazepam 11

12 9/5/2011 Methods of Diversion Practitioners / Pharmacists Illegal distribution Self abuse Trading drugs for sex Employee pilferage Hospitals Practitioners offices Nursing homes Retail pharmacies Manufacturing / distribution facilities Pharmacy / Other Theft Armed robbery Burglary (Night BreakBreak-ins) In Transit Loss (Hijacking) Smurfing Patients / Drug Seekers Drug rings Doctor Doctor--shopping Forged / fraudulent / altered prescriptions The medicine cabinet / obituaries The Internet Pain Clinics Pain Clinic "Customers" 12

13 Reporting Requirements Theft or Loss: Must notify DEA within one business day, 21 CFR (c) Complete and submit DEA Form 106 after notification What is a significant loss? Theft or Significant Loss (1) The actual quantity of controlled substances lost in relation to the type of business; (2) The specific controlled substances lost; (3) Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances; (4) A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known, (5) Whether the specific controlled substances are likely candidates for diversion; (6) Local trends and other indicators of the diversion potential of the missing controlled substance. 13

14 How can you help? Practice due diligence Use Prescription Monitoring Programs Regular contact with law enforcement and regulatory boards Questions? 14