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Opioid prescribing - medical

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Philip Slack

on 1 May 2016

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Transcript of Opioid prescribing - medical

Unintentional Prescription Drug Overdose Deaths
Scope of the Problem

The Perfect Storm

Georgia Update

The
Think About It
Initiative ?
Despite numerous initiatives and reforms at the national and state levels the problem continues to worsen:
Data recently released by the National Center for Health Statistics show
drug overdose deaths increased for the 11th consecutive year in 2010.
Centers for Disease Control and Prevention. National Vital Statistics System.2010 Multiple Cause of Death File. Hyattsville, MD: US Department of Health and Human Services, Centers for Disease Control and Prevention; 2012.
Drug overdose deaths surpassed motor vehicle deaths in 2008
Prescription drugs have become the major source of unintentional drug poisoning deaths
Opioids lead the way
Unintentional injuries are the
5th leading cause of death in the US
Benzodiazepines
29%
Antiseizure / antiparkinson
8%
Antidepessants
17%
Unintentional drug overdose death
OPIOIDS
75%
The Problem: Definition and Scope
The Prescriber
Overview of Prescribers
The "pill mill" prescriber
All other prescribers
1. How definable is the source of pain?
3. Explore all treatment options
4. If opioids are prescribed:
lowest effective dose
lowest number of pills
5. Educate the patient
risks/benefits of opioid use
sharing opioid medications is ILLEGAL
proper storage and disposal
6. Monitor the patient for misuse / diversion
PDMP
controlled substances agreement
drug screening / pill counts
2. Screen for risk of addiction
more discriminating less discriminating
6 Point Checklist to More Discriminating Prescribing
In 2011 CDC termed this phenomenon an “epidemic”
www.cdc.gov/homeandrecreationalsafety/rxbrief
The Perfect Storm
"Quick Fix" Culture
In 2007 the US consumed:
80% of the world's opioid supply
99% of world's hydrocodone
The US constitutes
< 5% of the world's population
Monetary Gain
Professional diverters / street dealers
Pill mills
Doctors
Pharmacies
Hospitals
Drug manufacturers
PAIN is both very common
and very complex
Pain is subjective
Pain is a MIND-BODY phenomenon
Pain complaints account for up to 80% of doctor visits
Prescribing opioids to treat pain is
standard medical practice and legal
Defining ethical boundaries
Defining legal boundaries
Prescription drugs are much more widely dispersed in the general population than illegal drugs
Opioids
High potential for misuse/addiction
Deadly side effect profile
Profound depression of drive to breath
Profound depression of ability to cough
Side effects are greatly magnified when combined with other substances, e.g. alcohol, Xanax, Soma
Exposure
to opioid
Controlled use
Addiction
Misuse
Abuse
4 C's
1. Loss of control
2. Compulsive use
3. Continued use despite harm
4. Craving
Genetics
2000
2014
= deaths
= opioid prescriptions
Letter to the editor - GAINESVILLE TIMES
POSTED: May 29, 2013 1:00 a.m

A member of my family is addicted to narcotic painkillers. She has been addicted for over a decade. But this letter is not about her; it is about all the doctors in the Hall County area who have fed her addiction.

One by one, doctors eventually wise up and realize that this woman is an addict just looking for a fix, and she is banned from the practice. However, there are so many doctors in this area, along with doctors who do not seem to keep their Hippocratic oath in the forefront of their minds, that she is able to always get a prescription written.

I am calling on doctors to confront this epidemic head-on and do their best to fully vet a patient before writing them a narcotic painkiller prescription. I would love to see the creation and utilization of a database with abusers in it accessible to all physician offices to help curtail the addiction and abuse, and also reduce the supply “on the street.”

These prescriptions have ruined the life of this woman, and have deteriorated an entire side of my family. This is a plea to physicians to take this epidemic seriously.

Citizen of Gainesville
Your Views: Doctors should do their part to head off painkiller addictions
OPIOIDS
An opioid is a psychoactive chemical that works by binding to opioid receptors – μ κ δ
Receptors are found both in the CENTRAL and PERIPHERAL nervous systems including the gastrointestinal tract
Same family of receptors mediate BOTH the BENEFICIAL EFFECTS and the SIDE EFFECTS of opioids
Primary therapeutic effect is ANALGESIA
IMMEDIATE side effects - sedation, respiratory depression, constipation, nausea , pruritis, and
euphoria/sense of well being
LONG-TERM side effects – physical dependence; tolerance; hypotestosteronism; hyperalgesia
What Is An Opioid?
Opioids (II-III)
III – hydrocodone; buprenorphine
Benzodiazepines (IV) – ex. Xanax
Soma (IV) - carisoprodol meprobamate
The Cocktail
Pain = Mind-Body Phenomenon
http://www.raidundant.com/wordpress/wp-content/uploads/2012/10/dreamstime_s_23141374.jpg
http://cdp.sagepub.com/content/18/4/237/F1.large.jpg
http://www.regulationsbiologie.de/image/project5_2.png
http://3.bp.blogspot.com/-s5xhpQ0oH0Q/T01N48kryCI/AAAAAAAAF1c/0ZXFGOd0DQA/s1600/pin+prick.png
http://www.painpolicy.wisc.edu/sites/www.painpolicy.wisc.edu/files/prc2012.pdf
Pain & Policy Studies Group
University of Wisconsin School of Medicine and Public Health
Opioid Equivalencies
http://www.agencymeddirectors.wa.gov/Files/OpioidGdline.pdf
Georgia Update
Three principle state level reforms
1. State medical board rules and regulations (2.1.2012)
2. Legislation targeting "pill mills" (effective 7.1.2013)
3. Prescription drug monitoring program (PDMP)
Pain Rules (2.1.12)
Summary of Board Pain Rules
2 rules effective 2.1.2012
360-3-.02 Unprofessional conduct defined
360-3-.06 Definitions and minimum standards of practice
Pre-signing prescriptions
H & P must be performed in person
Records must be maintained for minimum of 10 years
360-3-.02 Unprofessional conduct defined
360-3-.06 Minimum standards of practice
Additional training if > 50% of patients on opioids
Schedule II /III > 90 days / year
Written treatment agreement
One prescriber / one pharmacy
Monitoring required
Office visit ≤ 3 months
MONITORING must include a urine, saliva, sweat, or serum test
Board supports random testing
Exception for documented hardship
Documented attempt to obtain old records
Referral for addiction treatment if documented abuse
HB 178
Georgia Pain Management Clinic Act (HB 178)
Purpose: To license and regulate pain management clinics for the public good
'Pain management clinic' means a medical practice advertising 'treatment of pain' or utilizing 'pain' in the name of the clinic or a medical practice or clinic with greater than 50 percent of its annual patient population being treated for chronic pain for nonterminal conditions by the use of Schedule II or III controlled substances.
Exemptions: owned or operated by hospital, health system ,ambulatory surgical center, skilled nursing facility, hospice, or home health agency
All pain management clinics shall be licensed by the board and shall biennially renew their license with the board
All pain management clinics shall be owned by physicians licensed in this state
Major provisions
Failing to use medications and other modalities based on generally accepted or approved indications, … to avoid adverse physical reactions, habituation, or addiction in the treatment of patients
cynicism compassion
body mind
Evaluating Pain
A question of balance
The Prescription Opioid Overdose Epidemic
Protecting the public from the
consequences of over-prescribing
Providing patients access to opioids for legitimate pain relieving purposes
P. Tennent Slack, MD
Pain Medicine and Anesthesiology
Northeast Georgia Physicians Group

Pain
Treatment of Pain
Gold Standard Drug = Opioid
High Demand for Opioids
in the US
The Perfect Storm
Monitary Gain
Professional diverters / street dealers
Pill mills

Physicians
Pharmacies
Hospitals
Drug manufacturers
Substance abuse treatment facilities
In 2010 the US consumed:
83% of the world's oxycodone supply
>99% of world's hydrocodone
The US constitutes
~5% of the world's population
potentially habit-forming / addictive
Circa 2000
Annual volume of opioid prescriptions reaches "tipping point" ~ 2000
Initially weak regulatory environment
Aggressive marketing by opioid manufacturers
Purdue Pharma fined $600 M in 2007
Notoriety of oxycodone and sustained-release oxycodone as drugs of abuse
Rise of internet sales
Push for more aggressive
treatment of pain
Substance Abuse
uniquely deadly side effect profile
perfectly legal and standard to prescribe
Exposure to opioid
Controlled use
Addiction
Misuse
Abuse
Genetics
LOSS of CONTROL
> Compulsive use
> Continued use despite harm
> Craving
Common
Complex
physiologic + psychological + social
subjective
difficult to assess
What Can We Do About It?
Professional
Public
Non-medical arena
Prescribers
Pharmacists
Preventing diversion
Use drug as prescribed
Proper storage and disposal
Opioid
Abuse
Court system
Prescribers
Addiction treatment programs
Pharmacy
Law enforcement
Coroner's office
State medical board
High schools and colleges
Drug dealers / pill mills
The public at large
Employers / work place
Drug manufacturers
Family and friends of individuals who abuse
The Impact of Opioid Abuse
THINK ABOUT IT


s


The Power of Addiction
"The first opiate I ever took was codeine....It made me feel right for the first time in my life....I never felt right from as far back as I can remember, and I was always trying different ways to change how I felt. I used lots of drugs, but none of them really did it for me. Codeine was a revelation, and I've been opiate addicted ever since...Opiates have caused me lots of trouble, but what they do for my head is worth it..."

Thirty-four year old woman quoted in From Chocolate to Morphine (1993) by Andrew Weil and Winifred Rosen
~ 100 million adults = chronic pain
More than 12 million people reported using prescription painkillers nonmedically in 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.
Dr. Robert Kerns is the Department of Veterans Affairs national program director for pain management. A professor of psychiatry, neurology and psychology at Yale University, Kerns also serves on the Institute of Medicine's Committee on Advancing Pain Research, Care, and Education.

Kerns spoke recently with staff writer John Ramsey about the painkiller epidemic. Here's the full conversation:

Q: The number of hydrocodone prescriptions at the Fayetteville VA went from about 1,100 in 2001 to more than 47,000 last year. That's a 4,100 percent increase when hydrocodone prescriptions have gone up nationally by about 56 percent. Do those number raise any red flags?
The University of Wisconsin School of Medicine and Public Health’s Pain and Policy
Studies Group (PPSG) awarded Georgia a grade of “A” for its pain management
policies in 2012, marking the largest improvement in the nation from 2006 to 2012.
fayobserver.com Published: 09:12 PM, Wed Jul 17, 2013
Bitter Pills series: The Department of Veterans Affairs's position on prescription drugs and their use
JCAHO Pain Management Standards Are Unveiled
JAMA July 26, 2000 - Vol. 284 No. 4
JCAHO
Ga. Code Ann., § 16-13-43
§ 16-13-43. Distribution without order form; fictitious registration; fraudulently obtaining controlled substance; false reports

(a) It is unlawful for any person:
(1) Who is a registrant to distribute a controlled substance classified in Schedule I or II, except pursuant to an order form as required by Code Section 16-13-40;
(2) To use, in the course of the manufacture or distribution of a controlled substance, a registration number which is fictitious, revoked, suspended, or issued to another person;
(3) To acquire or obtain possession of a controlled substance by misrepresentation, fraud, forgery, deception, subterfuge, or theft;
(4) To furnish false or fraudulent material information in, or omit any material information from, any application, report, or other document or record required to be kept or filed under this article;
(5) To make, distribute, or possess any punch, die, plate, stone, or other thing designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing, upon any drug or container or labeling thereof so as to render the drug a counterfeit substance; or
(6) To withhold information from a practitioner that such person has obtained a controlled substance of a similar therapeutic use in a concurrent time period from another practitioner.
(b) Any person who violates this Code section is guilty of a felony and, upon conviction thereof, may be imprisoned for not more than eight years or fined not more than $50,000.00, or both.

Reduced hedonic tone
"right to effective pain management"
PERCIEVED PAIN STIMULUS
BRAIN
SPINAL CORD
PERIPHERAL NERVE
Rise of pill mills
availability
uniquely deadly side effect profile of opioids
Institute of Medicine Report from the Committee on Advancing Pain Research, Care, and Education: Relieving Pain in America,
A Blueprint for Transforming Prevention, Care, Education and Research. The National Academies Press, 2011.
http://www.incb.org/documents/Narcotic-Drugs/Technical-Publications/2011/Part_FOUR_Comments_NAR-Report-2011_English.pdf
Georgia Update
http://www.cdc.gov/homeandrecreationalsafety/Poisoning/laws/pain_clinic.html#states
as of 2010
3 Major State Level Reforms
1. Medical board rules and regulations
2. Prescription drug monitoring program
3. Legislation targeting pill mills
Other state level activity
PDMP - SB 134
share data across state lines
Medical cannibis - HB 885
already approved in research setting for glaucoma and chemotherapy/radiation-induced nausea/vomiting
expanded to treatment of refractory seizure disorder
National Update
Extended-release hydrocodone (Zohydro™) approved by FDA - Oct 2013
GA state board rule 360-3-.06 as of Jan 2014
Lecture Outline
1. Overview of the Problem
2. The Perfect Storm
3. Pertinent Updates
4.
THINK ABOUT IT
5. Questions Going Forward
Annual volume of opioid prescriptions steadily on the rise throughout the 1990's
Perception that pain undertreated; opioid addiction rates low
ease of ingestion
FDA votes Jan 2013 to reschedule hydrocodone-containing compounds from schedule III to schedule II
FDA label change to ER/LA opioids Sept 2013 - “pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.”
Medical Association of Ga. Foundation
Ask the patient!
Push for more aggressive
treatment of pain ~ 2000
JCAHO Pain Management Standards Are Unveiled
JAMA July 26, 2000 - Vol. 284 No. 4
JCAHO
"patient's right to effective pain management"
Initially weak regulatory environment
Aggressive marketing by opioid manufacturers
Purdue Pharma fined $600 M in 2007
Notoriety of oxycodone and sustained-release oxycodone as drugs of abuse
Rise of internet sales
Rise of pill mills
Annual volume of opioid prescriptions steadily on the rise throughout the 1990's
Perception that pain undertreated
Prescription opioid addiction rates low
http://www.cdc.gov/HomeandRecreationalSafety/poisoning/laws/index.html
"safe" if prescribed by doctor
http://www.theskeeterhawkexperiment.org/2013/04/09/prescription-drug-drop-box/
3rd Party Payer
Wide variations in coverage of drug and pain treatment modalities among plans
Routinely covered
oxycodone; hydrocodone
Variable coverage
co-analgesics - e.g. pregabalin; duloxetine; gabapentin; cyclobenzaprine
physical therapy

HB 965
provides immunity from certain arrests, charges, or prosecutions for those seeking medical assistance for a drug overdose and allow a healthcare practitioner, pharmacist, or person acting in good faith to administer an opioid antagonist to a person at risk or experiencing an opioid related overdose
Downsides of Physician Non-engagement
encourages villification of physicians by the public
Shaping of narrative by non-prescribers
potential erosion of control over decisions that are fundamentally medical in nature
misunderstanding regarding the utility of opioids in the treatment of pain, especially in long-term pain treatment scenarios - including pharmacists and law enforcement
government / non-physician organizations are observing level of physician engagement - e.g. REMS
Opioid treatment environment
"red flags"
treatment of a medical condition with a prescription medication
Practice of Medicine
Outside the practice of medicine
law enforcement
State Medical Board
> 100 MOEs / d
simultaneous rx's
> 1 SA opioid
+ benzodiazepine
+/- carisoprodol
government response
public response
Tramadol now a controlled substance (CS IV) in the state of Georgia
% rise = 72%
1991-2000
% rise = 67%
2000-2011
Low prescriber awareness / low public awarness
Patient request for pain medication
complex mind-body phenomenon
Physician prescribes opioid
opioids are gold standard of treatment for moderate to severe pain
Pharmacist dispenses opioid
The Basic Cycle
PAIN
PERCEPTUAL
PHYSICAL
chronic non-terminal pain
very high demand / consumption opioid consumption in the US
uniquely problematic side effect profile
potential for misuse overuse; diversion; addiction
potential for death respiratory depression
Decision to prescribe
Compassion
Cynicism
Financial gain
Medical assessment
Despite numerous initiatives and reforms at the national and state levels the problem continues to worsen:
Data recently released by the National Center for Health Statistics show
drug overdose deaths increased for the 11th consecutive year in 2010.
Centers for Disease Control and Prevention. National Vital Statistics System.2010 Multiple Cause of Death File. Hyattsville, MD: US Department of Health and Human Services, Centers for Disease Control and Prevention; 2012.
Reached tipping point around the year 2000
In 2011 CDC termed this phenomenon an “epidemic”
www.cdc.gov/homeandrecreationalsafety/rxbrief
widely available
Push for more aggressive
treatment of pain ~ 2000
JCAHO Pain Management Standards Are Unveiled
JAMA July 26, 2000 - Vol. 284 No. 4
JCAHO
"patient's right to effective pain management"
DEADLY SIDE EFFECT PROFILE
More than 12 million people reported using prescription painkillers nonmedically in 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.
prescribed = not dangerous
easy to get into the body
Initially weak regulatory environment
Aggressive marketing by opioid manufacturers
Purdue Pharma fined $600 M in 2007
Notoriety of oxycodone and sustained-release oxycodone as drugs of abuse
Rise of internet sales
Rise of pill mills
Annual volume of opioid prescriptions steadily on the rise throughout the 1990's
Perception that pain undertreated
Prescription opioid addiction rates low
alcohol
Xanax
http://www.theskeeterhawkexperiment.org/2013/04/09/prescription-drug-drop-box/
In 2010, there were 38, 329 drug overdose deaths in the United States

most (22 134; 57.7%) involved pharmaceuticals

opioids - 16, 651 (75.2%)

benzodiazepines - 6497 (29.4%)

JAMA, February 20, 2013—Vol 309, No. 7
Full transcript