Betsy Sears, MSM, MT(ASCP) EVP Sales Support...

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Death by Prescription

NEHOUA

Betsy Sears, MSM, MT(ASCP)

EVP Sales Support

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Old news

Confidential – Do not copy or distribute | 2

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More recent


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No one is immune. . .

1 in 20 using Rx painkiller for non-medical use


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Outline

• History of prescription drug abuse

• Definition of “misuse”

• Statistics

• Demographics

• Who is at risk

• Drug culprits

• Quest Diagnostics studies

• Costs

• Protective solutions


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History of Rx drug abuse

• Laudanum – 1800’s; opium and alcohol (women)

• Morphine – 1827; Germany; painkiller of choice Civil War

• Cocaine – post Civil War; coca cola

• Heroin – 1898; Bayer Company Germany – remedy for morphine addiction

• Called “patent” medicines – secret ingredients

• Food and Drug Act – 1906; label ingredients

• Harrison Narcotic Tax Act – 1914; Rx needed


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Prescription drug misuse

• What is it?

Use of a medication without a

prescription in a way other than as

prescribed for the experience or

feelings elicited

Sell or give away medications

Combine prescribed and illicit drugs

Forgetfulness to take meds as directed

• Each pattern – potential for risk

• Is equivalent to the term "nonmedical use," used

by many of the national surveys or data collection

systems

www.drugabuse.gov


http://www.drugabuse.gov/

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Sobering statistics

• 116 million Americans suffer from chronic pain – more than the number of people

affected by diabetes, heart disease, and cancer combined

• 475,000 ER visits in 2009

• Drug fatalities increased 3% in 2010

• Prescription painkillers kill more people than heroin and cocaine

• Sales of oxycodone, hydrocodone and methadone up 300%: ’98–’08

• In 2010, 12 million using Rx painkillers non-medically; 2 million people reported using

for the first time within the last year

• Narcotic pain relievers now cause or contribute to nearly 3 out of 4 prescription drug

overdoses and about 20,000 deaths (2012)

Substance Abuse and Mental Health Services Administration.

Results from the 2010 National Survey on Drug Use and Health

Centers for Disease Control and Prevention, National Center for Injury Prevention and Control. Web-based Injury Statistics Query and Reporting System

(WISQARS). (2012) [cited 2012 Feb 1].


http://www.cdc.gov/injury/wisqars




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In 2008, there were 14,800 prescription painkiller deaths

CDC. Vital Signs: Overdoses of Prescription Opioid Pain Relievers

—United States, 1999-2008. MMWR 2011; 60: 1-6


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Death rates – >100/day


http://www.cdc.gov/HomeandRecreationalSafety/pdf/PolicyImpact-PrescriptionPainkillerOD.pdf

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Where and how much – 300 million Rx/year!


Automation of Reports and Consolidated Orders System (ARCOS) of the Drug Enforcement

Administration (DEA), 2010

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Source of prescription drugs


Free From

Friend/Relative

55%

Other

5.0%

Internet

0.3%> One Doctor

1.9%

Drug Dealer Stranger

3.9%

One Doctor

18.1%

Took from

Friend/Relative

4.4%Bought from

Friend/Relative

12.2%

How nonmedical users of prescription pain relievers obtained the drugs

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Death rate by state - 2010

National Vital Statistics System. Drug overdose death rates by state. 2010


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Who is most at risk?

Good to know!

• Those who obtain multiple controlled substance prescriptions from multiple providers

• Those who take high daily dosages of Rx painkillers

• Those who misuse multiple commonly misused Rx drugs

• Those with history of substance misuse

• Those on Medicaid

Centers for Disease Control and Prevention, National Center for Injury Prevention and Control. Web-based Injury Statistics Query and Reporting System

(WISQARS). (2012) [cited 2012 Feb 1].

Wizbangblue.com (Image)






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Commonly misused medications

• Opioids – derived from opioid poppy (or synthetic version) used for pain relief

Hydrocodone (Vicodin™)

Oxycodone (Oxycontin™, Percocet™)

Fentanyl ( Duragesic™, Fentora™)

Methadone

Codeine

• Benzodiazepines – CNS depressants used as sedatives

Alprazolam (Xanax™)

Diazepam (Valium™)

Lorazepam (Ativan™)

• Amphetamine-like – CNS stimulant used to treat attention deficit hyperactivity

disorder (ADHD)

Dextroamphetamine/Amphetamine (Adderall™, Adderall XR™)

Methylphenidate (Ritalin™, Concerta™)


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Prescription opiate dispensing

0

20

40

60

80

100

120

140

160

2005 2006 2007 2008 2009 2010 2011

To

tal R

x (

millio

ns

)

hydrocodone/acetaminophen oxycodone/acetaminophen

IMS Health, National Prescription Audit™


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Positivity rates for “expanded” opiates (percentages)

0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

Codeine

Morphine

Hydrocodone

Hydromorphone

Urine Drug Tests, General Workforce

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Hydrocodone

• Semi-synthetic opioid derived from codeine

• Lortab™, Vicodin™

• Treat moderate to severe pain; cough suppressant

• 1.5 x less potent than oxycodone

• Side effects: nausea, vomiting, dizziness, constipation, anxiety

• High dose: shallow or stopped breathing, slow, stopped heartbeat, loss of

consciousness, seizures, death

• U.S. consumes 99% of all hydrocodone in world

• Estimate of 131.2 million prescriptions written in 2010


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Hydrocodone overdose


en.m.wikipedia.org

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Positivity rates for Hydrocodone by testing reason

0

0.5

1

1.5

2

2.5

3

3.5

4

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

Pre-Employment

Random

Post-Accident

Quest Urine Drug Tests, General Workforce –

8 million/year


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Oxycodone

• Synthesized from poppy-derived thebaine; developed 1916

• Oxycontin™, Roxicodone™, Oxecta™

• Prescribed for relief of moderate to severe pain

• Stronger than morphine - 1.5-2x; fewer side effects

• Side effects: nightmares, memory loss, constipation, dizziness, nausea

• High dose: bradycardia, apnea, hypotension, respiratory arrest, death


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Oxycodone side effects – recreational users


Commons.wikimedia.org

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Positivity rates from Oxycodone by testing reason

0

0.5

1

1.5

2

2.5

2005 2006 2007 2008 2009 2010 2011 2012

Pre-Employment

Random

Post-Accident

Urine Drug Tests, General Workforce



The effect….

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Opiate-based prescription drug overdose


Source: Centers for Disease Control and Prevention

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Benzodiazepine

• CDC analysis of deaths caused by overdose of opioid painkillers

- in 30.1% of deaths, benzodiazepines present

• Possess sedative, hypnotic, anticonvulsant, muscle relaxant, and amnesic

actions; useful in a variety of indications such as alcohol dependence,

seizures, anxiety, panic, agitation and insomnia.

• Most common:

Ativan (lorazepam)

Klonopin (clonazepam)

Xanax (alprazolam)

Valium (diazepam)

• Well tolerated-safe but. . .

risk of dependence


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Amphetamine-like

• Dextroamphetamine/Amphetamine - Adderall® , Adderall® XR

• Methylphenidate (Ritalin, Concerta)

• CNS stimulant - controls symptoms of attention deficit hyperactivity disorder

(ADHD); used to treat narcolepsy

• Side effects: nervousness, restlessness, difficulty falling asleep or staying

asleep, uncontrollable shaking of a part of the body, headache, changes in

sex drive or ability, dry mouth, stomach pain, nausea, vomiting

• High dose: fast or pounding heartbeat, shortness of breath, chest pain,

excessive tiredness, slow or difficult speech, dizziness or faintness,

weakness or numbness of an arm or leg, seizures, sudden death, heart

attack, or stroke in adults or children, especially those with heart defects or

serious heart problems



Top 10 in Southern California – L.A. Times

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Physiology of prescription painkillers

• Bind receptors in the brain to

decrease the perception of pain

• Create a feeling of euphoria, cause

physical dependence . . .addiction

• Cause sedation - slow down breathing

• A person who is misusing prescription

painkillers might take larger doses to

achieve a euphoric effect and reduce

withdrawal symptoms; larger doses

can cause breathing to slow down so

much that breathing stops, resulting in

a fatal overdose


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National Vital Statistics - multiple drug deaths - 2011

• 38,329 drug overdose deaths in USA; 58% - more than single drug

• Of the pharmaceutical-related deaths from overdose

74.3% were unintentional

17.1% were intentional (suicides)

8.4% were of "undetermined intent“

• Most common medications (in combination or alone)

75.2% - opioids

29.4% - benzodiazepines

17.6% - antidepressants

7.8% - drugs used for epilepsy and Parkinson's disease

• Opioids present in many deaths involving other drugs

In 77.2% of benzodiazepine deaths

In 65.5% of anti-epileptic and anti-parkinsonism drug deaths

In 58% of antipsychotic and neuroleptic drug deaths

In 57.6% of antidepressant drug deaths

In 56.5% other analgesics, anti-pyretics, and anti-rheumatics


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Quest Diagnostics Health Trends™

• Series of analyses on status of nation’s health

• Quest database – de-identified data

• 1.5 million patient encounters since 2000

• Laboratory information on majority of conditions and diseases

• Identify and track diseases and trends


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Quest Diagnostics Health Trends™ Prescription Drug Monitoring Report 2012

• 75,997 de-identified urine specimen results performed in 2011 (no rehab)

– Included results of patients of both genders

– ranging in age from 10 years old and above

– from 45 states and the District of Columbia.

• Objective - to assess the scope and demographic drivers of prescription drug

misuse in America and impact of laboratory testing on monitoring for

prescription drug adherence

• Patients tested for presence of up to 26 commonly prescribed medications,

including analgesics, and illicit drugs, such as cocaine and marijuana

• Laboratory results characterized as “Consistent” or “Inconsistent”

Quest Diagnostics 2012


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Misuse of Drugs

• “Consistent:”

only prescribed drugs were detected

• “Inconsistent:”

a) did not take prescribed drugs

b) took prescribed drugs plus other

unauthorized drugs/substances

c) took only unprescribed or unknown

drugs/substances


Quest Diagnostics 2012

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Gender breakdown


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Age range differences


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Summary of Quest Diagnostics 2012 study

• Majority of patients misused their prescription drugs – across all demographics

• “Inconsistent” does not necessarily mean misuse

• 6 out of 10 patients showed inconsistencies:

- Clinicians may not have asked pertinent questions about all medications

- If asked, patients may not have been forthright

• Further points on “inconsistent” results

- Less affluent may limit or forego

- Patients may not know what doctor has prescribed

- Can’t be assumed that follow-up testing will be the same


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Marijuana

• Cannabis sativa – affects areas of brain: pleasure, memory, thinking,

coordinated movement; THC – psychoactive chemical

• Health risks – neurological functioning, cardiovascular and mental health

risks in adults, carcinogens in smoke (not linked to lung CA)

• Some studies show marijuana use precedes use of other potentially

dangerous drugs; 2.5x more likely to misuse prescription drugs

• 29 million Americans (11.5%) using in 2010

• Eighteen states allow medical marijuana

• Colorado and Washington – 2012 legal

Fiellin L, Tetrault J, Becker W, Fiellin D, Hoff R. Previous use of alcohol, cigarettes, and marijuana

and subsequent abuse of prescription opioids in young adults. Journal of Adolescent Health,

August 2012


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Quest Diagnostics Health Trends™ Prescription Drug Monitoring Report 2013

• Report on marijuana and prescription drugs

• Quest Diagnostics medical and health informatics experts analyzed 227,402

de-identified urine specimen results performed in 2011 and 2012

– Included results of patients of both genders

– ranging in age from 10 years old and above

– from 45 states and the District of Columbia.

• Objective- to focus on the role of marijuana in the use, and misuse, of

prescription and other illicit drugs

• Patients tested for presence of up to 26 commonly prescribed and misused

drugs (pain medications, CNS meds, amphetamines) as well as illicit drugs

• Laboratory results characterized as “Consistent” or “Inconsistent”


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Key findings

• Prescription drug misuse continues to be highly prevalent – 60%

• Marijuana was the most misused drug - 26%

• Recreational marijuana users more likely than non-users to misuse other

drugs; 45% THC + used other non-prescribed drugs vs. 36% non-users

• Those using prescription cannabinoids: not more likely to misuse other drugs

than non-marijuana users

• Dr. Harvey Kaufman, Quest – “decline in misuse. . . not the case”

QuestDiagnostics.com/dms/Documents/health-

trends/2013_health_trends_prescription_drug_misuse.


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Other misused drugs


In Quest Diagnostics study, marijuana was the most frequently detected non-

prescribed drug. Non-prescribed marijuana was detected in more than one in four

patients (26%) with inconsistent test results.

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Recreational marijuana users – 1.3x more likely to use more


Among recreational marijuana users, the most frequently detected additional non-

prescribed drugs were sedative medications, such as alprazolam and oxazepam, and

narcotic pain killers, such as hydromorphone;

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Costs associated with prescription drug misuse

• Fighting wrong war? $15 billion on illicit drugs

• Coalition Against Insurance Fraud 2007 study: the annual cost to health

insurers due to the nonmedical use of prescription painkillers - $72.5 billion

• Doctor shoppers cost insurers $10,000 to $15,000 apiece

• 2011 Study: Loss in total productivity - $42 billion

Criminal justice costs - $8.2 billion

• Department of Justice - estimated annual costs related to health, crime and

productivity associated with illicit drug use, including prescription drug

misuse, total more than $193 billion


Centers for Disease Control and Prevention 2012

James O'Toole @CNNMoney February 24, 2012

https://twitter.com/intent/user?screen_name=cnnmoney

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How do we reduce the abuse?

• Prescription Drug Monitoring Programs

(PDMPs) - databases used to track the

prescribing and dispensing of controlled

prescription drugs to patients

• Patient review and restriction programs

• Health care provider accountability

• State laws to prevent Rx drug misuse and

diversion-doc shopping & pill mills

• Better access to substance misuse

treatment

• Synthetic Drug Abuse Prevention Act of

2012 – outlaw 2C-E

• FDA – tighter regulations for Hydrocodone;

restrict to 90 day supply; Schedule II

• ER docs – “ask the right questions; save

more lives, they don’t want to die”


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Insurance drug screens

Drug 5

• Amphetamine/Methamphetamine

• Cocaine

• Opiates (codeine, morphine)

• Phencyclidine (PCP)

• Marijuana (THC)

Drug 8

• Amphetamine/Methamphetamine

• Cocaine

• Opiates (codeine, morphine)

• Phencyclidine (PCP)

• Marijuana (THC)

• Methadone

• Benzodiazepine

• Barbiturates


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Detection

• Screening by Immunoassay

• Confirmation by Gas Chromatography/Mass Spectrometry (GC/MS)


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Protective solutions

• Expanded opiate panel

• Prescription drug history


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Expanded opiate panel

• Current opiate panel – codeine, morphine, heroin

• Not sensitive enough!

• Opiate screen; 300 ng/mL cutoff; good cross-reactivity with hydrocodone

Will report - morphine/codeine/hydrocodone/hydromorphone/oxycodone,

if confirmed

• Oxycodone screen; 100 ng/mL; will report - oxycodone/oxymorphone,

if confirmed.

• More poppy seed positives


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Prescription drug history

• Broad access to prescription drug records

Results of five-year history

Detailed drug and insurance eligibility information

Treating physicians

Drug indications

Pharmacy information

• Critical real-time insight in assessing an applicant’s risk

• Data underwriters can utilize


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Possible?


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Raise awareness


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References

• LA Times Legal drugs, deadly outcomes By Scott Glover, Lisa Girion. Video and photos by Liz O. Baylen November 11, 2012

• Valarie Honeycutt Spears. Ky. sees rise in overdose deaths from pills obtained in Fla. Lexington Herald-Leader 2009 Apr 12.

Available from URL: http://www.kentucky.com/2009/04/12/758845/ky-sees-rise-in-overdose-deaths.html.

• Cathy McKitrick. Youth’s overdose sends strong message. Salt Lake City Tribune 2011 May 17. Available from URL:

http://www.sltrib.com/sltrib/news/51689248-78/prescription-drugs-drug-watson.html.csp.

• CDC. Vital Signs: Overdoses of Prescription Opioid Pain Relievers—United States, 1999-2008. MMWR 2011; 60: 1-6

• Substance Abuse and Mental Health Services Administration. Drug Abuse Warning Network: selected tables of national

estimates of drug-related emergency department visits. Rockville, MD: Center for Behavioral Health Statistics and Quality,

SAMHSA; 2010.

• Substance Abuse and Mental Health Services Administration. Results from the 2010 National Survey on Drug Use and Health:

volume 1: summary of national findings. Rockville, MD: Substance Abuse and Mental Health Services Administration, Office of

Applied Studies; 2011. Available from URL: http://oas.samhsa.gov/NSDUH/2k10NSDUH/2k10Results.htm#2.16.

• CDC. Warner M, Chen LH, Makuc DM. Increase in fatal poisonings involving opioid analgesics in the United States, 1999-

2006. NCHS Data Brief;22 Sept 2009. Available from URL: http://www.cdc.gov/nchs/data/databriefs/db22.pdf .

• Substance Abuse and Mental Health Services Administration. Substance abuse treatment admissions by primary substance

of abuse, according to sex, age group, race, and ethnicity 2009 (Treatment Episode Data Set). Available from URL:

http://wwwdasis.samhsa.gov/webt/quicklink/US09.htm.

• Volkow ND, McLellan TA, Cotto JH, Karithanom M, Weiss SRB. Characteristics of opioid prescriptions in 2009. JAMA

2011;305(13):1299–1301.

• Hall AJ, Logan JE, Toblin RL, Kaplan JA, Kraner JC, Bixler D, et al. Patterns of abuse among unintentional pharmaceutical

overdose fatalities. JAMA 2008;300(22):2613-20.


http://www.kentucky.com/2009/04/12/758845/ky-sees-rise-in-overdose-deaths.html











http://www.sltrib.com/sltrib/news/51689248-78/prescription-drugs-drug-watson.html.csp









http://oas.samhsa.gov/NSDUH/2k10NSDUH/2k10Results.htm2.16

http://www.cdc.gov/nchs/data/databriefs/db22.pdf

http://www.cdc.gov/nchs/data/databriefs/db22.pdf

http://wwwdasis.samhsa.gov/webt/quicklink/US09.htm

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Thanks for your time

Betsy Sears

[email protected]

913.577.1306


mailto:[email protected]

Betsy Sears, MSM, MT(ASCP) EVP Sales Support...

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