Opioids…. An Epidemic! The Hospital’s Role in Safe Prescribing – Focus on the ER

Maureen McCollough MD, FACEP Associate Professor of Emergency Medicine UCLA School of Medicine Department of Emergency Medicine Oliveview UCLA Medical Center

A Story from the CDC* • Bath County, Kentucky

• In 2009, 9 people died from overdose of painkiller meds over an 8 month period • Including a 53 year old mother and

her 35 year old son • Bath County population……..11,000 • 1,000’s of Kentuckians traveled every year to

South Florida’s pain clinics • Monthly prescriptions for hundreds of painkillers • Why Florida?

*CDC National Center for Inj Prevention and Control, Division of Unintentional Inj Prevention 2011

A Story from the CDC • Kentucky and 37 states electronically monitor

narcotic prescriptions written to patients • In CA, called CURES

• In 2009, Florida had no such system • Store-front medical clinics handing out

painkillers for cash

One Such Clinic*… • 2009, two brothers ran multiple pain clinics • Multiple customers ended up dead • Last was 3 customers, car hit by a train,

Roxicodone scattered all over car and tracks • Within 2 years, charged with the largest

painkiller trafficking org in the country • Recruited physicians on Craig’s List

• Asked if they were licensed and had DEA • Willing to write large prescriptions of

oxycodone and Xanax® • Docs were often in financial difficulties

*MSNBC T. Francis 2012

One Such Clinic…. • Mobile MRI was used to find reason for pain meds • Patients submitted urine tests to show not

abusing………not enforced!! • Physical “exams” were limited • Dispensed narcotics from pharmacies they controlled

• One guy’s wife dispensed the meds (strip club dancer) • Multiple clinics opened including the last in 20,000 sq. ft

building in immigrant neighborhood • “Walmart” of addiction • 5 physicians saw 500 per day, $100 per patient,

earning $2 million/year

One Such Clinic… • Out-of-state instructed to park blocks away • Drug dealers sent patients by the van-full • Patients paid $5 per 30mg Oxy….sold for $30

• Pharmacy sold 10,000 tabs/day…. more diverted

• Deluge of cash became a problem • Cash drawers and safes were stuffed • Not worth keeping $1’s so burned by the barrel • Larger bills stuffed into trash bags to taken to bank

• In the end, $40,000,000 and 20 million tablets • 53 Florida deaths linked to pills from these clinics

All over the News: • Prescription Drug Abuse epidemic

• Wall Street Journal • CNN Exclusive with

Bill Clinton • Washington Post

Famous Deaths: • Michael Jackson, 50: propofol, ativan, valium, versed • Heath Ledger, 29: oxycodone, hydrocodone, valium, restoril, ativan, doxylamine • Whitney Houston, 49: cocaine, marijuana, benadry, flexeril, xanax • Anna Nicole Smith, 40: chloral hydrate, valium, klonopin, ativan, serax, benadryl,

topomax • Danny Gans 49: Dilaudid • Philip Seymour Hoffman, 46: heroine, cocaine, benzo’s, amphetamines

How Did We Get Here…

Opioids for Chronic Pain?? • Opioids were not originally prescribed for

chronic pain • 20th Century, U.S. healthcare providers

believed long-term opioid use to treat chronic pain was contra-indicated due to risk of addiction, increased disability, and lack of efficacy over time

How Did We Get Here…

Opioids for Chronic Pain? • All this changed in the 1990’s • Portenoy and Foley Pain 1986

• 38 patients, chronic non-CA pain • Oxycontin, methadon, levorphanol • Maintained it was safe and more

humane than non-treatment • 2 with addiction history had problems

• Tragedy of Needless Pain, Scientific American, 1990, Ronal Melzack

How Did We Get Here…

American Pain Foundation • Organization started in the late 1990’s

as a pain advocate • 90% of its funding from pharmaceutical industry

including Purdue Pharma, maker of Oxycontin, and other manufacturers

• Became both educator on pain management and lobbyist for legislation

• Targeted groups like patients, physicians, and the Veterans Administration

• Lobbied in Congress to pass pain legislation targeting veterans

How Did We Get Here…

California State Medical Board • Mandated all physicians take 12 hours of CME

on “Pain Management”, 2005 • Encouraged increased use of pain medication

How Did We Get Here…

Easier to write prescriptions • 2005, Triplicate prescriptions went away • All prescribed controlled substances are now

required to be written on new California Security prescription • Tamper-resistant security paper

• Made it easier to write for more potent opioids like dilaudid

How Did We Get Here…

Pain Evaluation was Mandated! • “Pain” became the 5th vital sign

• In competition with O2 Sats!! • Joint Commission mandated that pain be

assessed and if treated, reassessed, 2001 • Myths developed that Joint Commission

mandated treatment of pain • Attempts or rumors about not being able to

discharge ED patients home if not below a certain pain score

The Perfect Storm • Encouraged by national

organizations to treat pain • Mandated by state med board to learn about pain • Mandated by regulators to assess pain • Regulators made it easier to write for stronger opioids • Opioids for chronic pain was the new national mantra • Numerous opioid formulations were developed –

oral, transdermal, intranasal, IV • Combo meds also developed

• Opioids deliver pain relief in addition to euphoria and other addictive desirable effects

• States were slow to develop regulations

Today…

More Prescriptions • By 2010, 300% increase in the sales of prescription

painkillers (opioids) • #1 written prescription in the U.S. – hydrocodone!

• More than diabetes or cardiac meds • U.S. accounts for 5% of world’s population…

• But accounts for 84% of global oxycodone (Oxycontin) consumption

• And 99% of global hydrocodone (Vicodin, Lortab) consumption*

*Forbes Feb 2014

Today…

More Prescriptions

Today…

More Prescriptions • FDA approves Zohydro ER® October 2013

• 5-10x stronger than hydrocodone (Vicodin) • Touted as safer because it’s not mixed with Tylenol • Thought that “opioid virgins” could die from just 2 tabs….kids

1 tab! • Euphoria/high can last 12 hours! • No “antidote” mixed with the med to prevent crushed or IV • Congressional reps and State AG’s wrote FDA to reconsider • Coalition of physician groups, pharmacies, addiction

specialists against the drug • FDA Advisory Panel had voted 11 to 2 against approving

Zohydro®

Today…

More Deaths Center for Disease Control and Prevention 2010

Prescription Opiate Deaths: 2008: 14,000+ people died 2009: 37,000+ people died

More than in car accidents 100 people die every day!

• 3/4 prescription drug overdoses are caused by prescription painkillers…..aka opioids • In 2010, 43% of drug OD deaths were

due to opioids • In 1999, in 24%*

• Prescription deaths have surpassed heroine and cocaine combined

Today…

More Deaths

*MMWR March 29, 2013 vol 62, No 12

Today…

More Deaths Death Rates per 100,000 people State avg 11.4 High rate Lake

County 55.6 Low Rate Tulare 6.3 Los Angeles 7.3 San Diego 12.4

Today…

More Abuse • National Survey on Drug Use and Health

• 1st time abusers of prescription opioids: 1990: 600,000 vs 2004: 2.4million

• ED visits for prescription abuse increased 45% from 2000 to 2002

• Largest increase – oxcodone, hydrocodone

Today…

More Abuse • In 2010, 12 million people reported using

prescription painkillers non-medically* • 2 million of them reported using for the first

time in 2010…that’s almost 5,500 per day! • Just behind marijuana in regard to

non-medical use • Prescriptions often “diverted”

• 3 out of 4 who misuse prescription painkillers use drugs prescribed to someone else

*those who answered the survey

Today…

CDCP 2013

The Solution

Steps to control

addiction and abuse

Legitimate and evidence-based

use still available for patients

and providers

Solution is NOT….blaming the doctors

www.governing.com June 2014

Chronic Pain Re-education

Re-education on Chronic Pain and Opioids • Data on opioids for chronic pain is

at least controversial and confusing • Systematic reviews on use for chronic pain

show only modest evidence for pain improvement or increase in function* • Chou 2003 • Kalso 2004 • Eisenberg 2005 • Furlan 2006 • Trescot 2006, 2008 • Deshpande 2007 • Martell 2007 *Rosenblum Exp Clin Psychopharm July 2009

Re-education on Chronic Pain and Opioids • Grattan Annals Family Med 2012

• Surveyed 1,300 pts, at Kaiser Permanente in No. CA and Group Health Coop in WA

• non-cancer pain, no history subs abuse • Depression was linked to increase misuse of

opioids for non-pain symptoms (stress or insomnia) and increasing dosages

• 1/3 of the patients without depression admitted to misuse

• Actual numbers probably higher!!

Partnerships with community clinics such as Community Clinic Association of Los Angeles County

Opioids for Chronic Pain Guidelines for Primary Care

Opioids for Chronic Pain Guidelines for Primary Care

Opioids for Chronic Pain Guidelines for Primary Care

• Boston University School of Medicine • SCOPE of Pain: Safe and Competent Opioid Prescribing

Education. http://www.scopeofpain.com/ • American Society of Addiction Medicine - ER/LA Opioid REMS:

Achieving Safe Use While Improving Patient Care http://www.softconference.com/asam/slist.asp?C=5383

• American College of Physicians - Safe Opioid Prescribing http://www.pri-med.com/PMO/Featured/Pain%20Management/Default.aspx

• AAFP training resource (1 hour) aafp.org/webcast/chronic-pain • http://www.drugabuse.gov/opioid-pain-management-cmesces • California Medical Board soon will be offering a 3-hour,

web-based CME on chronic pain management

Opioids for Chronic Pain Guidelines for All Providers

Treatment Agreements

Recommended to be used when a patient has been prescribed opioids for >3 months or has a

history of addiction

Joint Commission

• Joint Commission pendulum has swung the other way!

• Much less emphasis on pain issues • Joint Commission still mandates the

assessment of pain, then either the treatment of OR referral for pain management

Safe Pain Medication Prescribing Guidelines for Emergency Departments

Safe Pain Medication Prescribing Guidelines for Emergency Departments

• Highlights : • Our goal is to treat your medical conditions including

pain, effectively, safely and in the right way. • You should only have ONE provider and

ONE pharmacy helping you with your pain. • We will not refill prescriptions that are lost, stolen

or destroyed. • We do not prescribe long-acting

pain medication like methadone.

Safe Pain Medication Prescribing Guidelines for Emergency Departments

San Diego and Imperial Counties Medical Society

March 2013

Kaiser-Permanente of Southern California

Jan 2014

Safe Pain Medication Prescribing Guidelines for Emergency Departments

CURES • Controlled substance Utilization Review and

Evaluation System • State database includes names of patients

receiving narcotics, MDs who prescribe, pharmacies that dispense

• Unfortunately underfunded…..at one point, had 1 employee!!

• 2013 Legislation passed…..fee applied to State Licensure

• Improvements in the system expected by 2016 • All providers will be mandated to have access

Remember the American Pain Foundation? • In early May 2012, the Senate Finance

Committee launched an investigation* • ProPublica article Dec 2011 in The Washington

Post described ties to Pharmaceuticals • Investigation alleged that guides for patients,

journalists, lawmakers had played down risks while exaggerating the benefits

• Same day….APF announced “cease to exist, effective immediately”

*The Washington Post C.Ornstein, T.Weber May 8, 2012

Senate Investigation… • ?? Any influence on the Fed of State Med Boards

and their guidelines to doctors on pain management

• ?? Any influence on the Joint Commission and their 2001 decision to make pain mgt a national priority • 2003, JC partnered with Purdue Pharm to

distribute pain educ materials nationwide • ?? Any influence on written guidelines from the

American Pain Society • ?? Any influence on the APF Military / Veterans Pain

Initiative which resulted in legislation passed

DA Lawsuit • May 21, 2014 LA Times*

• Orange County and Santa Clara County DA’s • Suing 5 largest narcotics manufacturers….

on behalf of California • “Campaign of deception” • Allege drug makers broke CA laws against false

advertising, unfair business practices • Manipulated doctors to believe benefits outweighed

risks • Encouraged patients, including veterans and elderly,

to ask for opioids for arthritis and back pain *LA Times S. Glover, L.Girion

DA Lawsuit • Seeks compensation for damages, force companies

to forfeit revenue • Similar to tobacco industry lawsuits • Not the first lawsuit regarding opioids

• 2007 Purdue agreed to pay $635 million to settle criminal, civil charges by the Feds

• Underplayed Oxycontin’s addiction risk • New Orange County and Santa Clarita DA lawsuit

alleges Purdue continued its deceptive marketing • 2013 LA Times article revealed Purdue kept

database of “reckless” doctors

What You Can Do? • Realize that we are all in this together – hospitals,

EDs and clinics • Make it transparent to patients

• Prescription pain killers can be dangerous and addicting

• We want to make sure you get the right care safely and effectively

• Encourage clinics to re-educate on chronic pain • Encourage clinics, primary care providers to use

Treatment Agreements patients on long-term opiates or with history of addiction

What Can You Do? • Understand EMTALA and Joint Commission

mandates • Encourage EDs to have Safe Pain Medication

Prescribing Guidelines • Ensure all opiate or other controlled substances

prescriptions are recorded in the hospital’s or clinic’s EMR

• Once it’s been improved, support providers’ access to CURES

• Ensure patients leave with information regarding primary care access