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Prescription and Over-the-Counter Drug Use

Prescription and Over-the-Counter Drug Use. Evergreen Annual Conference March 24, 2011 Jay Jaffee Minnesota Department of Health. We will address…. The extent of the problem. How we got here. -With an emphasis on the 1990s to today What we have to do. - Everyone has a role in this.

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Prescription and Over-the-Counter Drug Use

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  1. Prescription and Over-the-Counter Drug Use Evergreen Annual Conference March 24, 2011 Jay Jaffee Minnesota Department of Health

  2. We will address… The extent of the problem. How we got here. -With an emphasis on the 1990s to today What we have to do. -Everyone has a role in this.

  3. National Youth Prevalence • About 20 percent of teens report abusing a prescription medication at least once in their lives. • About 15 percent of teens report abuse of a prescription pain reliever in the past year. • About 8 percent of teens have abused OTC cough medications in the past year. 2009 Partnership for a Drug-Free America Parents and Teens Attitude Tracking Study Report

  4. National College Students College students reporting past-year non-medical use: • OxyContin – 3.6% • Vicodin – 6.7% • Amphetamines – 5.7% • Ritalin – 3.2% • Sedatives – 3.7% • Tranquilizers – 5.0% 2009 Monitoring the Future Survey, University of Michigan

  5. Prevalence of Use • More than 1.6 million American teens and young adults misused ADHD drugs during a 12-month period • 75,000 became addicted National Institute on Drug Abuse, February, 2006

  6. ADHD Drugs According to National Institute on Drug Abuse research:1 • More than 5 percent of students reported using ADHD medication without a prescription during the past six months. • 9 percent reported doing this since they began college. • Nearly 90 percent of these students felt it was effective in helping them study. • About 2 percent of respondents said they frequently used nonmedical ADHD medication to get high. • Most students using nonmedical ADHD medication tend to be white, belong to a fraternity or sorority, have lower GPAs and engage in substance use and other risky behaviors. A National Institutes of Health study of youth prescribed ADHD drugs found no relationship between having ever received stimulant treatment and the risk of future alcohol or other substance abuse.2 1. Journal of Attention Disorders, December 2008 2. American Journal of Psychiatry, March 2008

  7. Prevalence of Use • Of the 9.2 million current users of illicit drugs other than marijuana in 20091: - 7.0 million were non-medical users of psychotherapeutic drugs, of those; - 5.3 million were non-medical users of pain relievers • Over 50 million people have used psychotherapeutic drugs non-medically in their lifetimes, of those2; - Nearly 35 million have used prescription pain relievers non-medically 1. National Survey on Drug Use and Health, 2009 (based on people aged 12 and older) 2. National Survey on Drug Use and Health, 2008 (based on people aged 12 and older)

  8. Prevalence of Use The number of people using prescription pain relievers non-medically for the first time increased from: -600,000 in 1990 -2.2 million in 2009 National Survey on Drug Use and Health, 2009

  9. Risk Factors for Painkiller Addiction People suffering from chronic pain who have been prescribed opioid painkillers - • 65 years old or younger, • Using psychiatric medications, • Or with histories of drug abuse, • Or depression were more likely to be addicted to the painkillers. Risk factors for drug dependence among out-patients on opioid therapy in a large US health-care system, Addiction, September 2010

  10. Prevalence of Use • One third of drug abuse in the U.S. is prescription drug abuse. • “More than 17 percent of adults over 60, wittingly or not, abuse prescription drugs.” Prevention Alert Volume 6, Number 4, Center for Substance Abuse Prevention, 3/7/03

  11. Psychotherapeutic Drugs “drugs that have an effect on the function of the brain and are often used to treat psychiatric disorders.” They include: • Opioids – prescribed for pain relief • Central Nervous System Depressants – prescribed for anxiety or sleep problems • Central Nervous System Stimulants – prescribed for ADHD, obesity and sleep disorders National Institute on Drug Abuse (NIDA)

  12. Psychotherapeutic Drugs-Opioids- Codeine, fentanyl, morphine, opium, oxycodone, meperidine, hydromorphone, hydrocodone Include such brand name drugs as: Darvon, OxyContin, Tylox, Percoset, Percodan, Demerol, Vicodin, Dilaudid Street names: China white (fentanyl), M (morphine), gum (opium), percs (Percodan/Percoset), hillbilly heroin (OxyContin), juice (Dilauadid), demmies (Demerol), etc. National Institute on Drug Abuse (NIDA)

  13. Consequences-Opioids- • Tolerance – need progressively higher doses to achieve the same effects • Physical dependence and addiction • Severe respiratory depression that can lead to death • Withdrawal can include: cold flashes, diarrhea, insomnia, muscle and bone pain and restlessness National Institute on Drug Abuse (NIDA)

  14. Psychotherapeutic Drugs -Central Nervous System Depressants- Barbiturates, benzodiazepenes, fluntrazepan Include such brand name drugs as: Mebaral, Nembutal, Seconal, Tuinal, Halcion, Valium, Librium, and Rohypnol Street names: barbs (barbiturates), reds (Seconal), phennies (Phenobarbital), tooies, rainbows, Christmas trees (Tuinal), downers (any depressant), tranks (tranquilizers), roofies & rope (Rohypnol), etc. National Institute on Drug Abuse (NIDA)

  15. Consequences-Central Nervous System Depressants- • Lowered inhibitions, confusion, dizziness, impaired judgment, memory and coordination and drowsiness • Tolerance • Physical dependence and addiction • Severe respiratory depression that can lead to death • Withdrawal can include seizures National Institute on Drug Abuse (NIDA)

  16. Psychotherapeutic Drugs -Central Nervous System Stimulants- Amphetamines, cocaine, methamphetamine, methylphenidate Include such brand name drugs as: Dexedrine, Biphetamine, Desoxyn, Ritalin, and Adderall Street names: bennies (benzedrine), crosses & speed (any stimulant), black beauties (Biphetamine), blow, candy, rock & snow (cocaine); crank, crystal & ice (methamphetamine); skippy & vitamin R (Ritalin), etc. National Institute on Drug Abuse (NIDA)

  17. Consequences-Central Nervous System Stimulants- • Hostility, paranoia, panic, high body temperatures, digestive problems, irregular heartbeat, loss of coordination, possible hallucinations, psychotic episodes, cardiovascular failure, lethal seizures, • Tolerance • Addiction National Institute on Drug Abuse (NIDA)

  18. Over-the-Counter (OTC) Drugs Including: • Cough and cold medications containing dextromethorphan, alcohol and pseudoephedrine • Allergy and sleep aids containing alcohol diphenhydramine and chlorpheniramine maleate. • Motion sickness medication containing dimenhydrinate. • Weight loss, body-building and alertness products containing caffeine, ephedra, ephedrine and other stimulants

  19. OTC Slang • Over-the-counter cough medicine with dextromethorphan called Dex, syrup, triple-C, robo, vitamin D or tussin. • Use may be called robo-ing, robo-tripping and users may be called robo-cops (reference to Robitussin DM). • Taking cold and cough pills and tablets called “skittling” (reference to the Skittles).

  20. Consequences Possible side-effects of excessive DXM* use: Loss of balance Increased pulse Cerebral hemorrhages Stroke Permanentcoma Hypothermia Loss of consciousness Brain damage Loss of muscle control Seizures Severe high blood pressure Mania *Dextromethorphan

  21. Consequences Many cough and cold medications also contain acetaminophen. Large doses can cause liver damage. From 1998 to 2003, acetaminophen was the leading cause of acute liver failure in the United States, with 48% of acetaminophen-related cases associated with accidental overdose.* In January 2011 the FDA asked drug manufacturers to limit the strength of acetaminophen in prescription drug products (usually with opioids) to 325 mg. per dosage unit. No recommendation for OTC products. Acetaminophen is not recommended for people who have more than three alcoholic drinks per day. * Drs. Larson, Davern, et al, Hepatology, December, 2005

  22. Consequences Recommended adult daily dose of acetaminophen is 4000 milligrams or 4 grams. • A 6 ounce bottle of NyQuil contains 6 grams of acetaminophen. • NyQuil also contains 180 milligrams of dextromethorphan. • The recommended adult daily dose is 120 milligrams

  23. Consequences Some allergy, cold and skin rash medications contain chlorpheniramine maleate - can cause brain damage or death in large doses. Motion sickness medications like Dramamine contain dimenhydrinate - can cause hallucinations in large doses.

  24. Consequences Some weight-loss products contain sibutramine, an appetite suppressant that's a chemical cousin of amphetamines. -It can cause heart attacks, strokes and heart palpitations, especially in people with a history of high blood pressure or heart problems. Some contain phenolphthalein, a laxative, which is now being withdrawn from the market because of cancer risks. Some weight-loss and body building products contain hydroxycitric acid, linked to liver problems in at least one medical journal study. -The FDA has recalled at least 14 Hydroxycut products Food and Drug Administration, 2009

  25. Poly-drug Use • Prescription or OTC drugs and alcohol, marijuana and other drugs • Stimulants with depressants – “Speedball” • Even Viagra with alcohol or illicit drugs

  26. Why the Increase in Use? • Many people want a quick fix! • Many experience a high demand for performance: - At school - In athletics - In the business world… • They are perceived as “safe and legal” products • They are readily available and accessible • There is extensive marketing of these products

  27. Safe and Legal Products In a survey of the perceptions of over 1200 college freshmen: • Nonmedical use of prescription painkillers and stimulants is safer than taking cocaine but riskier than smoking marijuana or drinking alcohol • Those who perceived use as relatively harmless were 10 times more likely to use them as those who viewed them as highly hazardous Prevention Science Journal, September 2008

  28. Readily Accessible • More than half of all insured Americans are taking prescription medicines regularly for chronic health problems • Americans buy much more medicine per person than any other country Medco Health Solutions Inc, 2008

  29. Readily Accessible – Families, Friends and Homes • Prescription and OTC drugs are in most of our homes. • Many young people taking them from their own or other people’s homes. • There are reports of visitors to real estate open houses and garage sales taking them. • Many people offer remedies to others

  30. Readily Accessible - Stores • Many OTC medications are prominently displayed, depending on the season. • They are easily purchased or stolen. • Medications containing ephedrine and pseudo-ephedrine are now behind the counter by federal law. • Oregon and Mississippi require a prescription for any drugs containing pseudo-ephedrine. • Some states have considered putting medications containing dextromethorphan behind the counter. • One Maryland supermarket chain banned sales of medications containing dextromethorphan to people under age 18.

  31. Readily Accessible - Prescriptions • Physicians report that half of the requests they receive for advertised drugs are inappropriate choices for the patients. • Yet physicians fill about two-thirds of such requests, including about 6% that might actually be harmful.1 • Spending on prescription drugs in the U.S. increased from $40.3 billion in 1990 to $234.1 billion in 2008.2 • From 1999 to 2009 the number of prescriptions dispensed rose 39% (from 2.8 billion to 3.9 billion) compared to a U.S. population growth of only 9% over the same period.2 1. FDA Weighs Limits for Online Ads, Journal of the American Medical Association, January 2010 2. Kaiser Family Foundation, 2010

  32. Readily Accessible - Prescriptions • More than 40 percent of physicians did not ask about prescription drug abuse when taking a patient’s health history. • One-third did not regularly call or obtain records from the patient’s previous (or other treating) physician before prescribing controlled (substances). • 47.1 percent said that patients commonly tried to pressure them into prescribing a controlled drug. Controlled Prescription Drug Abuse at Epidemic Level, Center on Addiction and Substance Abuse, July, 2005

  33. Readily Accessible - Prescriptions • Nearly thirty percent of pharmacists did not regularly validate the prescribing physician’s information (DEA number) when dispensing controlled drugs. • Three-fifths (61 percent) did not regularly ask if the patient is taking any other controlled drugs when dispensing a controlled medication. • From 1992 to 2002, prescriptions written for controlled drugs increased more than 150 percent Controlled Prescription Drug Abuse at Epidemic Level, Center on Addiction and Substance Abuse, July, 2005

  34. Readily Accessible - Prescriptions • Over the past 10 years, drug and device companies have increased their funding medical education meetings by over 300 percent, according to industry figures. • Companies now provide more than half of the $2.5 billion spent annually on medical education. • Companies can see a return of $3 in sales for every $1 spent on medical education, according to an industry study. U.S. Department of Health and Human Services, July 2009

  35. We All Have a Role in This! Among persons aged 12 or older who used pain relievers non-medically in the past 12 months: • 55.3 percent reported in that they got them from a friend or relative for free. • 9.9 percent bought the drugs from a friend or family member. • 5.0 percent stole them from a friend or relative. • 17.6 percent reported they got the drugs from just one doctor. • Only 4.8 percent got the pain relievers from a drug dealer or other stranger, and • Only 0.4 percent reported buying the drug on the Internet. National Survey on Drug Use and Health, 2009

  36. We All Have a Role in This! According to recent research in Utah: 97 percent of individuals who misused painkillers like Vicodin and OxyContin said that they got the drug from a friend or relative with a prescription. • 85.2 percent said friends or relatives gave them the drug willingly. • 9.8 percent said they took the drug from friends or relatives without their knowledge. • 4.1 percent of those surveyed said they had bought the drug. Morbidity and Mortality Weekly Report, Centers for Disease Control and Prevention, Feb. 19, 2010

  37. Extensive Marketing Advertising Print • First appeared in magazines in doctors’ offices • Then in magazines and newspapers for the public Broadcast – even “info-mercials” • U.S is one of two industrialized countries allowing broadcast ads for prescription drugs • Pharmaceutical companies have increased their spending on direct-to-consumer advertising 330 percent since 1996* • They spend almost $30 billion annually to promote their products • FDA has been issuing fewer warnings to pharmaceutical firms about their ads. • In 2006, only 21 warning letters were issued, compared to 142 in 1997. FDA announced it will study whether style of ads distracts consumers from warnings about the drugs' risks (August, 2007) *The New England Journal of Medicine, August 2007

  38. FDA Draft Guidelines on Advertising and Promotion Television ads for drugs and medical devices should: • Avoid distracting images and music that can reduce viewers' comprehension of potential side effects • Use similar type styles and voice-overs when conveying benefits and risks • Not use contrasting colors to highlight information, nor alter the location and timing of risk details and other factors that can influence how well viewers understand a product • Not use busy scenes, frequent scene changes and moving camera angles “(that) can misleadingly minimize the risks of the product being promoted by detracting from the audience's comprehension” • Not speed up an announcer's description of risks Draft Guidance for Industry Presenting Risk Information in Prescription Drug and Medical Device Promotion , FDA, May 2009

  39. Extensive Marketing • Internet • Many prescription and over-the-counter ads on a variety of websites • In-Store • End caps, positioning on shelves, displays • Marketing to youth including social media sites like Facebook, e-mail and text messaging • Word-of-mouth

  40. One Example:The Marketing of OxyContin • Purdue Pharma introduced OxyContin in1996 • Targeted the highest prescribers for opioids across the country • Bonus system for sales reps ranging from $15,000 to nearly $240,000 ($40 million total in 2001) • Distributed 34,000 “starter” coupons • Branded promotional items for physicians (fishing hats, stuffed toys and music CDs) The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy, American Journal of Public Health, February, 2009

  41. The Marketing of OxyContin • From 1996 to 2000, increased internal sales force from 318 to 671 • Sales grew from $48 million in1996 to almost $1.1 billion in 2001 • In 2001, the company spent $200 million to market and promote OxyContin. • By 2004 OxyContin had become a leading drug of abuse in the United States The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy, American Journal of Public Health, February, 2009

  42. The Marketing of OxyContin • Aggressively promoted OxyContin in the “non-malignant” pain market which is much larger than the cancer market. • Minimized the worries about the risk of addiction. • From 1995 to 2001, the number of patients treated for opioid abuse in Maine increased 460 percent. The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy, American Journal of Public Health, February, 2009

  43. The Marketing of OxyContin • On May 10, 2007, Purdue Frederick Company Inc, an affiliate of Purdue Pharma, along with 3 company executives, pled guilty to criminal charges of misbranding OxyContin by claiming that it was less addictive and less subject to abuse and diversion than other opioids, and • They were ordered to pay $634 million in fines. • The 3 executives have been barred from doing business with Medicare or any taxpayer-funded healthcare program for 12 years. The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy, American Journal of Public Health, February, 2009

  44. And the Results Are… The amount of five major painkillers sold at retail establishments rose 90 percent between 1997 and 2005.1 • More than 200,000 pounds of codeine, morphine, oxycodone, hydrocodone and meperidine were purchased at retail stores in 2005 • enough to give more than 300 milligrams of painkillers to every person in the country Hydrocodone with acetaminophen was the most commonly prescribed drug in 2008 - 124 million retail prescriptions.2 1. Associated Press analysis of Drug Enforcement Administration data, August 2007 2. IMS National Prescription Audit, IMS Health, 2010

  45. And the Results Are… • US residents have more than tripled their spending on prescription pain killers for outpatient use from $4.2 billion in 1996 to $13.2 billion in 20061. • The average amount spent per pain killer purchase more than doubled during the same period, from $26 to $571. • The percent of treatment admissions involving prescription pain relievers more than quadrupled from 2.2% in 1998 to 9.8% in 2008.2 1. Agency for Healthcare Research and Quality, Published in JAMA, March 25, 2009 2. Treatment Episode Data Set (TEDS); Substance Abuse and Mental Health Services Administration, 2010

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