Steven Steinberg MD

OPIOIDS

Southern California Permanente Medical Group (Kaiser Permanente)

i.e Narcotics…

Chair of the Regional Controlled Substances Group

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Regional Chief Family Medicine

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Back in the old days.. No pain meds for anyone—die from cancer in pain…

Learning Objectives

Use culturally sensitive opioid medication treatment agreements with patients to reinforce appropriate medication usage for patients on chronic opioid therapy.

But then, the pendulum swung the other way-too far.. If you asked-- this is what people thought….

Use validated tools to determine which patients are at risk for misuse of opioid medications for management of chronic pain.

“Any pain—give whatever dose of opioids it takes to stop the pain” “No such thing as a maximum dose.”

Use of the opioid MED calculator in real time practice.

“Very Low Risk Addiction”

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Global Opioid Consumption, Morphine mg/capita 2010

This was wrong These drugs cause addiction. These drugs are not safe. ps there is no evidence that using opioids for the long term treatment of pain is even helpful

Country

mg/capita1

Austria

122.5

USA

73.7

UK

56.4

Denmark

56.0

Canada

51.5

Australia

45.1

Switzerland

42.4

Iceland

35.1

Americans, constituting only 4.6% of the world's population, have been consuming 80% of the global opioid supply, and 99% of the global hydrocodone supply.2 1. Source: Pain and Policy Studies Group. University of Wisconsin School of Medicine and Public Health. http://ppsg-production.heroku.com/ 2. Manchikanti L, Singh A. Therapeutic opioids: a ten-year perspective on the complexities and complications of the escalating use, abuse, and nonmedical use of opioids. 2008 Mar;11(2 Suppl):S63-88. 5 OTN 44062 PIH refresh PPT

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Rates of Opioid Overdose Deaths, Sales, and Treatment Admissions, United States, 1999–2010 Opioid Sales KG/10,000

Opioid Deaths/100,000

Opioid Treatment Admissions/10,000

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1999-2010

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Opioids

6

Heroin

Cocaine

More deaths from prescription Opioids than heroin, cocaine, and benzo’s combinedM

Benzodiazepines

18,000 16,000

Number of Deaths

Rate

5 4 3 2 1

14,000 12,000 10,000 8,000 6,000 4,000 2,000 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

0 1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

Year

Year

Americans consume 80% of the world supply of prescription opioids and 99% of the world’s hydrocodone! CDC. MMWR 2011. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm60e1101a1.htm?s_cid=mm60e1101a1_w. Updated with 2009 mortality and 2010 treatment admission data. Source: Pain and Policy Studies Group. University of Wisconsin School of Medicine and Public Health. http://ppsg-production.heroku.com/ Manchikanti L, Singh A. Therapeutic opioids: a te-year perspective on the complexities and complications of the escalating use, abuse, and nonmedical use of opioids. 2008 Mar;11(2 Suppl):S63-88. OTN 44062 PIH refresh PPT

1/13/12 MMWR

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2. 7 3.

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Goal From a practical standpoint—

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1) Massive increase in the supply of opioids in the community-with a corresponding increase in overdoses and deaths 2) Greater number of addicted patients—who may want more and more pills 3) Pills getting diverted for sale—and at high value (increased risk of improper behavior by physicians, nurses, pharmacists and pharmacy staff) 4) Risks to our teenagers—these pills are “gateway drugs” to eventual Heroin use.

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Reduce overuse, abuse, and overdosing of opioids (and other controlled prescription drugs) while ensuring patients with pain are treated safely and effectively.

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KNOW YOUR DRUGS!

Morphine Equivalents Codeine (T#3) 5-10:1 to MS Tramadol 5:1

KEY is Morphine Equivalents—that’s how you can figure out really what the patient is taking

Hydrocodone (Norco/Vicodin) 1:1 Oxycodone (Percocet/Oxycotin) 1:1.5-2 Oxymorphone (Opana) 1:3 Hydromorphone (Dilaudid) 1:4-5 Methadone—Variable Fentanyl Patches—Variable 1:4 (Fentanyl 25=MS 100 a day) (for Methadone—lots of variability—ask Pain Management…Don’t do the math yourself..)

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High Opioid Dose and Overdose Risk 11.18

Once you know the total MEDs

Doses > 100mg MED/day are a RED FLAG!

Less than 60 MEDs a day—considered lower dose 60-100 MEDs a day—Medium Dose Greater than 100-120 MEDs a day—High Dose (and a 2% Overdose rate a year and 0.2% Death Rate)

3.11 1.00

1.19

Note—patients chronically taking many pills a day of short acting opioids—generally more than 6-7/day—high risk also * Overdose defined as death, hospitalization, unconsciousness, or respiratory failure. Dunn et al. Opioid prescriptions for chronic pain and overdose. Ann Int Med 2010;152:85-92.

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HYDROCODONE (WILL Be schedule 2 Oct 6th)

HYDROCODONE (with acetaminophen) Short term pain—can use up to 8-10 tablets a day—commonly used after surgery.

(with acetaminophen)

“NORCO” Most commonly prescribed drug in the USA 1:1 equal to Morphine

Chronic Pain—Watch for high numbers of pills a day—patients will take 10, 12, 16 tablets a day. Risk of liver damage.

Not a harmless drug… Principle Gateway drug for teens and eventual drug abuse Any script for Branded Hydrocodone products—always think diversion/illegal resale Other Hydrocodone Drugs: VICODIN (“classic”—hydrocodone-tylenol 500 mg combo—off the market—replaced with “new Vicodin” 300 mg tylenol (Vicoprofen-Hydrocodone and Ibuprofen)

Very large prescriptions—hundreds and hundreds of pills at a time—a marker for either inappropriate long term use and risk, or a sign of diversion

LORCET, LORTAB Watch for yellow “Watsons” (a generic with specific color—higher risk diversion) 15

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Zohydro—recently FDA approved—high risk drug

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TYLENOL WITH CODEINE

TRAMADOL “ULTRAM” Not that commonly used

Tylenol#3—Tylenol with 30 mg codeine—low potency—equal to 5 mg Morphine

Medium Potency Tramadol 50 mg equals 10 mg of Morphine Same warning on large scripts as with other opioids.

Tylenol#4—Tylenol with 60 mg codeine—equal to 10 mg Morphine

Risk of drug interactions with other drugs

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MORPHINE

OXYCODONE

“Back in Fashion” used commonly for pain.

50%-100% more potent mg to mg compared to Morphine

Two different preparations

Multiple different preparations (1) Short acting oxycodone “plain”

(1) Short acting Morphine

(2) Short acting oxycodone with acetaminophen “PERCOCET”

(3) Long acting Morphine “MS Contin”

(3) Long acting Oxycodone “OXYCONTIN”

Overall lower risk of diversion 19

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OXYCONTIN OXYCODONE-Acetaminophen “Percocet”

Very High Risk Drug Many cases of addiction and overdose.

Short acting oxycodone and short acting oxycodone with acetaminophen “PERCOCET”

High diversion—street value about $1 per mg per pill

Same issues as Hydrocodone—watch for large scripts dispensed at a single time, watch for chronic high usage per day (liver risk)

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Watch for “BRAND” scripts—very high risk diversion/resale

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Watch for any script (single script 80 mg, #100—street value is Eight Thousand Dollars) Kids—start with Hydrocodone, “graduate” to Oxycontin, then when they cant afford Oxycontin anymore—go to Heroin 22 OTN 44062 PIH refresh PPT

HYDROMORPHONE

OXYMORPHONE (“OPANA”)

“DILAUDID”

Very High Risk Drug

Very High Risk Drug

300% as potent as Morphine

400-500% as potent as Morphine

This drug is easily abused. High risk due to “irregular pharmokinetics when the drug is abused, leading to accidental overdose and possible death.

This drug is easily abused. High risk due to POTENCY

High street value. Watch all scripts.

You will see patients addicted to this drug

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METHADONE

FENTANYL PATCHES

Highest risk of accidental overdose Used for addiction, but also used for

Single patches provide a large dose of opioids.

pain. (for pain any physician can prescribe)

Even the lowest dose patch results in high daily doses of opioids (many pts are on high dose patches allowing very high net opioid daily dosing)

Typical dose range for pain up to 40 mg a day but some patients on a hundred or much higher daily dose.

The Patch can be abused. Watch for “q48hr” dosing—can be a marker of abuse/diversion 25

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KNOW YOUR “LAWS”!

Requirements on Prescribing http://www.mbc.ca.gov/pain_guidelines.html

Requirements on Prescribing

Per the Medical Board of California

Needs a History including what the pain medication is treating, what the medications that are being prescribed, a relevant Physical Exam and the Treatment Plan noting the goals—pain relief & improvement in function from the medication

You need to see patients once every 6 months MINIMUM Email isnt good enough! 27

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OK to start with Tylenol or NSAIA’s (careful with elevated GFR)(document no ulcer hx..)(don’t use indocin…) …but if that doesn’t work

Next Part of the Talk—

PRINCIPLES OF TREATMENT

?TIME FOR OPIOIDS

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General comments

OK to start with Lower dose short acting OPIOIDs for short term use

1) aim for a maximum (using the hydrocodoneAPAP 325 products—generic for Norco) of 6 tabs a day for chronic pain—can use up to 10 tabs a day for acute pain—i.e. post op pain, etc

Hydrocodone/APAP (Norco)

2) If pts are still having pain—you can chg to Oxycodone-APAP medications (recall the MEDs conversion ratios…)

(Tramadol has a number of drug interactions)

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KEY POINTS Beware of the “90 day cliff”

1) Beware of the 90 DAY CLIFF! 2) Opioids should only be used for serious pain—don’t use opioids for everything 3) There are other treatment modalities—pain modulating drugs, physical therapy, steroid injections, cognitive behavioral therapy—its not all Opioids 4) Beware the patient based risk factors 33

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Evidence-Based Principles 90% of pain complaints do not meet these criteria

High-dose opioids may contribute to pain sensitization via opioid induced hyperalgesia (OIH), decreasing patient pain threshold, and potentially masking resolution of a pre-existing pain condition

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7. Lee, et al., Pain Physician 2011; 14:146 8. Cochrane Collaboration (2010), Blue Cross Blue Shield and Kaiser Permanente Tec Assessment

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RISK FACTORS

Prevalence of Misuse, Abuse, and Addiction—65% can get into trouble…

RISK FACTORS  Younger age

Misuse 40%

 Past cocaine or alcohol abuse

Abuse: 20%

 Drug or DUI conviction  Higher dose

Addiction: 2% to 5%

Total Pain Population

 Significant episode of Depression (Ives et al., 2006). 37

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Webster LR, Webster OTN 44062 PIH refresh PPT

HISTORY OF DEPRESSION IS A MAJOR RISK FACTOR triples the risk

Differences Between Males and Females



Women are more likely to have chronic pain



More likely to get opioids in the higher doses



Thus more likely to Overdose



Biggest age risk 45-54



Think about the women you have in your practice.

RM. Pain Med. 2005;6(6):432-442.

Source: Substance Abuse and Mental Health Services Administration. Results from the 2010 National Survey on Drug Use and Health: Mental Health Findings. www.samhsa.gov/data

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So..when you get to the 90 day cliff..it’s time to think..am I going to have this patient become a long term opioid patient?

Two Scenarios…

1) At 90 days (or before) make a decision—do I think this is a good choice to have this patient in long term opioids?

1) You have your own patient that you “have gone over the cliff with” and its been more than 90 days

2) Strongly consider stopping the opioids— change to an alternative treatment

2) You inherit a patient already on long term chronic opioids

3) Again, Beware the patient based risk factors 41

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You inherit a patient already on opioids (>90 days) Your own patient



1) As already noted they should be an appropriate candidate for Chronic Opioid Therapy

Again, think—is this an appropriate patient for chronic opioid therapy?



Evaluate the risk factors—UDS and CURES also

2) You must run a CURES report and Urine Drug Screens



Look at the diagnosis you would be treating the patient for.



Very Strongly consider tapering to less than 100 MEDs a day. (higher doses of opioids—higher risk of

3) Consider changing over to long acting Opioids with small amount of short acting for breakthru pain (and when you do that—max one month supply schedule 2’s) (for combo meds max 200 pills for opioid-apap meds)

Overdose and death) 

Consider tapering the patient off all opioids .

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Again, you need to know your drugs—and the MEDs (Morphine Sulfate Equivalents)

About Prescribing Opioids.. Be Careful with how much you prescribe—the “30% every 6 months” rule Be careful with “cascading scripts” Be careful with multiple medications with overlapping opioids—patients on hydrocodone-APAP and oxycodone-APAP and oxycodone, all at the same time

Keep the MEDs below 100 MEDs a day …

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…don’t be afraid of the math… If you need to chg a pt over to a long acting opioid--

You inherit a patient on 10 Norco 10-325 a day.

Use Morphine,

Its 1:1 with Morphine—so that’s 100 mg a day of MS equivalent.

or second choice Fentanyl Patches or Methadone (ask for help from Pain Management—these drugs can be tricky—especially methadone)

Given some variation in the conversion—always better to go 25% lower so aim for a total MED or around 75 mg a day Change to long acting Morphine—maybe 30 BID and a few short acting tabs for Breakthrough Pain

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Beware of the Long and the Short…

Sometimes—it’s time to get the patient off opioids

Patients who come in on a lot of short acting opioids-- get converted to long acting opioids and a small amount of short acting for breakthru pain

They are on opioids for a diagnosis which opioids aren’t beneficial—migraines, fibromyalgia, etc They are not improving on higher and higher doses “Doc—I still have terrible pain…”.

BUT over time, if not watched, it is not uncommon for patients to increase the short acting higher and higher

Opioid Hyperalgesia can occur

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Mayo Clinic Experience Patients Want: (and you should avoid…)

Pain Rehabilitation Center Treatment Outcomes

BRAND NAME

Greater Control over pain: 84%



Decrease pain severity despite discontinuing pain meds: 70%

Oxycontin Opana

Increase aerobic activity: 93%

(very

Decrease depression Sx’s: 80%

high street value— single tablets can sell for close to 100 dollars each)

http://www.mayoclinic.org/pain-rehabilitation-center-rst/ (10/16./2013) 51

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Always be careful and think…

Signs You want to Pay Attention to:

Anyone can be abusing or diverting your medicationsand even if its not the patient—could be a family member



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Patients who ask for an opioid by name, especially OxyContin, Opana, Actiq and Brand when Generic Available Opioid

•

Patients with multiple prescribers • Overlapping therapeutics – e.g., Norco one week, Percocet the next • Cascading scripts – Rx for 3 month supply and patient returns in < 1 month

•

The so-called “Trinity” – patients on the combination of SOMA, XANAX, and an OPIOID (Heroin effect)

•

Distance traveled to see prescriber– 40-60 miles (drug-seeking?)

•

Opioids for conditions not indicated (i.e. fibromyalgia)

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Post-bariatric patients

It’s the patient you like that can be trouble— 

(these patients can be very good at what they do..)

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

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DRUG TESTING

Always

think about drug screening—do at least a screen for other drugs of abuse

And

if suspicious of diversion—do a confirm test

DRUG OF ABUSE SCREEN—use this to look for other “unexpected” drugs  A screening test for amphetamines, benzodiazepines, opiates (morphine, codeine, heroin), oxycodone, MDA/MDMA (“ecstasy”), cocaine, PCP and THC (marijuana/dronabinol)  Includes specimen validity tests (pH, specific gravity, and urine creatinine)  This test does NOT detect all synthetic opioids like fentanyl, methadone, tramadol, and buprenorphine. ------------------OPIATES SCREEN, URINE, PAIN MANAGEMENT—to verify if pt is taking the medication—and you would be surprised how often the test comes back negative  Identifies opioids by gas chromatography/mass spectrometry (very specific)  Detects buprenorphine, codeine, fentanyl, heroin, hydrocodone, hydromorphone, meperedine, methadone, morphine, oxycodone, oxymorphone, propoxyphene and tramadol at commonly encountered concentrations.  This test is time- and resource-intensive. Please order appropriately, when there is a clear clinical indication. (i.e it costs more money)

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Urine drug screen results

DRUG TESTING

Anticipated: Prescribed medication present, illicit substances absent

Opioid metabolism is complex. The ordering physician must understand metabolites in order to correctly interpret urine toxicology results (see table).

Medication Missing: Prescribed medication absent (due to prn dosing, binges, diversion, substitution) Positive: Illicit/nonprescribed substance present Diluted/Adulterated: not human urine

(interestingly—drug diverters tend not to think about a negative confirm test.)

Not done/QNS

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Opioid Metabolism

Many times—your patient is getting medications from multiple providers The California Prescription Drug Monitoring Program A.K.A. CURES Report (excludes the VA)

Sign up for CURES—just google it

Supporting Evidenced-Based Drug Use

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Example of Patient Activity Report (PAR) When pts have been on chronic narcotics for 6 months—or anyone on a long acting narcotic

Treatment Agreements (“Pain Contracts”) • •

•

•

Opportunity for a documented conversation Outline expectations, responsibilities, & obligations of mutually-agreed upon plan Opportunity to hold patient & physician accountable for a mutually agreed-upon plan Note—you also want to provide “informed consent”

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Short Comments on other drugs: Injectable Opioids for Patients presenting with exacerbations of chronic pain who are already on chronic opioids

DON’T DO IT —per the AAEM recommendations Do not give opioids injections to these patients—its bad medicine (if the patient can’t tolerate PO’s you can give dilaudid via slow IV infusion) 63 OTN 44062 PIH refresh PPT

Zohydro—very dangerous deadly drug Suboxone (buprenorphine and naloxone)(used off label for pain). Should not be prescribed by primary care. Once patients get on these drugs for chronic pain—very difficult to stop. Don’t combine with Benzodiazepines. • Transmucosal Fentanyl (Actiq, Subsys)—only use for Cancer—no exceptions • Methadone—for pain only—don’t prescribe for addiction—and be careful— very careful—stay at 40 mg or below—no rapid changes in dose—ask for help • SOMA—Never prescribe—its not a muscle relaxant—in humans its converted to Miltowns—tranquilizer—its an opioid potentiator used in abuse with combination of opioids and benzos for a heroin like effect • Fentanyl—don’t use more than q72 hours—patients abuse it—google it…(patients will say it “wears off” early and they state they need to use it more often) • NOTE: Unless you have the additional DEA certification for addiction medicine – You should Never prescribe Methadone or Suboxone for drug 64 medicine reasons. OTN 44062withdrawal/addiction PIH refresh PPT • •

The Epidemic of Prescription Opioids in the U.S. 

Poisoning is now the single leading cause of accidental  death in America. Opioids are involved in more than  40% of all drug poisoning deaths (CDC, 2011).

Opioids have proven efficacy and (relative) safety for  treating acute pain and pain during terminal illness.  Opioids do NOT have proven efficacy or safety for  treating chronic pain long‐term.

Summary



High‐dose opioids might contribute to pain sensitization via  opioid‐induced hyperalgesia, decreasing patient pain  threshold and potentially masking resolution of a pre‐existing  painful condition.



Prolonged use of high‐dose opioids might induce tolerance,  abnormal pain sensitivity, and hormonal effects. 



Opioid doses above 100mg morphine equivalents/day lead to  an increased risk of overdose, hospitalization, and death.

__________________________ 1 Baron MJ, McDonald PW. Significant pain reduction in chronic pain patients after detoxification from highdose opioids. J Opioid Manag. 2006;2:277–282. 2 Ballantyne JC, Mao J. Opioid therapy for chronic pain. N Engl J Med. 2003 Nov 13;349(20):1943-53. 3 Cochrane Collaboration (2010), Blue Cross Blue Shield and Kaiser Permanente Tec Assessment (2012) 4 Dunn, et al., Opioid Prescriptions for Chronic Pain and Overdose. Annals of Internal Med. 2010;152:85-92)

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Prescribing Opioids for Chronic Non-Cancer Pain

Prescribing Opioids for Chronic Non-Cancer pain 1)

Know what you’re prescribing – Morphine Equivalent Dose (MED) is the standard for measuring total opioid intake (morphine or its equivalent in other opioids, adjusted for relative potency); it is recommended to keep total MED dose to < 120 mg MED/day to avoid the increased risk of overdose and death. Opioid calculator http://agencymeddirectors.wa.gov/mobile.html

2)

recommendations are to limit all short acting opioid acetaminophen combination (norco, percocet, etc.) medications to a maximum of 200 pills per script.

Start with non-pharmaceuticals whenever possible. -The standard of care for chronic pain is treatment in a multidisciplinary practice including physical therapy, cognitive behavioral therapy, and injections to help reduce pain. - Referrals to chronic pain programs can help patients avoid or minimize medications and gain skills to manage their pain, rather than depend on medications. If medications are needed:

3)

Start with non-opioids whenever possible as they have strong pain relieving properties as well

STRONGLY consider limiting fills to a 30 day supply for all opioids; patients should receive all opioid prescriptions from 1 prescriber whenever possible.

4)

2)

Opioids are powerful drugs and should be reserved for serious pain (90% of pain complaints do not meet this criteria). If opioids are needed, start with a low dose and titrate slowly ONLY if needed.

Injectable opioids should not be given to treat exacerbations of chronic non-cancer, nonhospice pain in patients already on chronic opioid medications, in the Emergency Department and Urgent Care.

5)

3)

Communicate the expected duration of treatment to patient—be aware that treatment longer than 90 days puts the patient at much higher risk of drug dependence. “AVOID THE 90 DAY CLIFF”

Per the Medical Board of California, you should see chronic opioid patients in your office every 6 months minimum and properly document the visit regarding the pain medications.

6)

If patient is on any opioid regularly for more than 6 months, complete a Treatment Agreement to document a conversation including what you are treating (goal=pain relief, improvement in function).

7)

Urine toxicology screen at least once a year: at least a Drug of Abuse Screen to detect illicit use; Pain Management screen to confirm adherence. More often for higher risk

8)

Sign up for the CURES database- https://pmp.doj.ca.gov/pmpreg

1)

- Use generics whenever possible (brand drugs have a high street value; generics have significantly less value) 4)

If the condition is chronic, consider a combination of long acting medication with a short acting medication for pain flare ups ONLY if needed (on a PRN basis)

5)

Opioid use along with benzodiazepines, sleep meds, muscle relaxants (especially Soma) are the highest risk combinations for overdose. Soma should NEVER be prescribed (except to taper patients who are currently on Soma)

The Common Drug Seeking Red-Flag Behaviors •

Feigns Illness - complaints of back/neck pain, headaches, cough without other symptoms.

•

Repeated requests for replacement of "lost“ or stolen drugs or prescriptions.

•

Insists on specific medication and/or brand-name and/or large amounts

The Common Drug Seeking Red-Flag Behaviors Patients with multiple prescribers Overlapping therapeutics – e.g., Norco one week, Percocet the next Cascading scripts – Rx for 3 month supply and patient returns in < 1 month

• Oxycontin, Opana have very high street value—single tablets can sell for $100 each

The so-called “Trinity” – patients on the combination of SOMA, XANAX, and an OPIOID (Heroin effect)

•

Abusive or threatening behavior when denied drugs.

•

Does not get appropriate treatment for legitimate medical issues

Opioids for conditions not indicated (i.e. fibromyalgia)

•

Wants prescriptions to be filled at multiple different pharmacies

Post-bariatric patients

•

Cancels follow-up appointments.

•

Won’t fill prescriptions for non-controlled medications

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Frequent Emergency Room / Urgent Care Visits and “Doctor Shopping”

Willing to travel a long distance to see a specific doctor—seeks out specific physicians who will prescribe larger doses of pain medication

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