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

Prescription and Over-the-Counter Drug Use

Evergreen Annual ConferenceMarch 24, 2011

Jay JaffeeMinnesota 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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9th Grade

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

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

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

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 20082. American Journal of Psychiatry, March 2008

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)

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

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

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

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 disordersNational Institute on Drug Abuse (NIDA)

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)

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


Psychotherapeutic Drugs -Central Nervous System Depressants-

Barbiturates, benzodiazepenes, fluntrazepanInclude 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.


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


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.


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


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

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).

Consequences

Possible side-effects of excessive DXM* use:

Loss of balance Increased pulse

Cerebral hemorrhages Stroke Permanent coma Hypothermia Loss of consciousness Brain damage Loss of muscle control Seizures Severe high blood pressure Mania

*Dextromethorphan

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

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

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.

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

Poly-drug Use

• Prescription or OTC drugs and alcohol, marijuana and other drugs

• Stimulants with depressants – “Speedball”

• Even Viagra with alcohol or illicit drugs

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

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

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

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

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.

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 20102. Kaiser Family Foundation, 2010


• 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


• 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


• 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

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

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

Extensive Marketing

AdvertisingPrint

• 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

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

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

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

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

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 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.


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 20072. IMS National Prescription Audit, IMS Health, 2010


• 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, 20092. Treatment Episode Data Set (TEDS); Substance Abuse and Mental Health Services Administration, 2010


• More than 19 million prescriptions for ADHD drugs were filled in 2002-up 72 percent from 1995.1

• Use of antidepressant drugs in the United States doubled between 1996 and 2005, – 6% or 13 million people in 1996– 10% or 27 million people in 20052

1. Prevention Alert Volume 6, Number 4, Center for Substance Abuse Prevention, 3/7/032. Archives of General Psychiatry, August 2009


From 2000-2004 prescription use of ADHD drugs among adults ages 20-44 doubled.

During the same period prescription use of ADHD drugs rose:

• 113 percent among women 20-44, • 104 percent among women 45-64,• 56 percent among youth, and• Sales increased from $759 million to $3.1 billion.

Medco Health Solutions, September 2005


• More than 164 million prescriptions were written in 2008 for antidepressants, totaling $9.6 billion in U.S. sales, according to IMS Health

• Promotional spending for antidepressants increased slightly between 1999 ($0.98 billion) and 2005 ($1.02 billion), – But, there was a marked increase in the percentage of

spending on direct-to consumer advertising, from 3.3 percent ($32 million) to 12 percent ($122.00 million)

Archives of General Psychiatry, August 2009

And the Results are…

• 81 percent of American children who visited a doctor for help combating sleep problems were given some form of prescription medication, despite the fact that no sleeping pills are currently approved for use in children

• 7 percent of the patients were recommended diet and nutritional counseling,

• 22 percent were offered behavioral therapy• 17 percent of patients were offered mental health and

stress management treatmentMilap C. Nahata, Pharm.D., Gregg Jacobs, M.D., Sleep, Aug. 1, 2007


ED visits caused by misuse of pharmaceuticals are rapidly increasing while visits caused by illicit drugs remain steady.

Estimated ED visits from all drug use was: • 1.6 million in 2004

– 1 million were from illicit drugs• 2.3 million in 2009

– 1 million were from illicit drugs

Substance Abuse and Mental Health Services Administration (SAMHSA) 2011


• Unintentional poisoning deaths (95% are drug overdoses) increased from 12,186 in 1999 to 26,389 in 2006.

• During that time, prescription drugs overtook cocaine and heroin combined as the leading cause of lethal overdoses

• Opioid painkillers were involved in more than half the deaths, – but deaths from drugs such as sleeping pills, antidepressants,

and tranquilizers increased 84 percent during the same period.

Centers for Disease Control and Prevention, 2008 and 2010


• The leading cause of accidental poisonings among American children can be found in the family medicine cabinet.

• More than 71,000 children 18 and younger are seen in emergency rooms annually for unintentional overdoses of prescription and over-the-counter drugs.

• More than two-thirds of emergency department visits are due to poisoning from prescription and over-the-counter medications -- more than double the rate of childhood poisonings caused by household cleaning products, plants and the like.

American Journal of Preventive Medicine , September 2009


• A vast array of pharmaceuticals -- including antibiotics, anti-convulsants, mood stabilizers and sex hormones -- have been found in the drinking water supplies of at least 41 million Americans

• The presence of prescription drugs -- and over-the-counter medicines such as acetaminophen and ibuprofen could have long-term consequences for human health.

• Bottled water and home filtration systems don't necessarily avoid exposure. They do not typically treat or test for pharmaceuticals, according to the industry's main trade group.

Analysis of scientific reports and public water system databases by Associated Press, March 2008

Prevention Strategies

• Primary prevention – A drug is a drug is a drug!• Use a comprehensive approach

– Educate everyone• Youth, families, older adults, providers, pharmacists, merchants• Use consistent and persistent messages

– Make substances less accessible• Secure prescription and OTC medications at home and in stores• Encourage and make easy disposal of unused medications• Address Internet availability

– Examine norms– Implement and enforce policies

• Enforce laws about use and possession including operating vehicles under the influence

Prevention Strategies

Address issues like mental health, obesity, stress and performance in healthy, appropriate ways:– Treatment and therapy– Healthy choices

Resources

• Minnesota Prevention Resource Centerhttp://www.emprc.org/ or 800/782-1878 or 763-427-5310

• National Institute on Drug Abuse www.nida.nih.gov

• Prevention Online www.health.gov• Minnesota Department of Health

www.health.state.mn.us/alcohol

Resources

• Do the Right Dose http://asyouage.samhsa.gov/dotherightdose/

• Minnesota Pharmacists Association www.mpha.org

• Medline Plus (drugs, supplements, and herbal information) www.nlm.nih.gov/medlineplus/druginformation.html

Contact Information

Jay Jaffee

[email protected]

651-201-5496

Or go to our website:

www.health.state.mn.us/alcohol

Documents

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